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commentor namecommentor url commentor descriptionlink to commentsComments on Machine Readable Formularies (if any)med formulary data for/againstComments about Machine Readable Provider Directories (if any)typeprovider data for/againstnotes
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Biotechnology Industry Organization (BIO)
https://www.bio.org/
The Biotechnology Industry Organization (BIO) is the largest trade organization to serve and represent the biotechnology industry in the United States and around the world.http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0172HHS should finalize requirements that will improve patients’ access to information on a plan’s formulary before, during, and after enrollment:

HHS proposes to require EHB plans to publish an up-to-date, accurate, and complete list of all covered drugs on its formulary drug list, including any tiering structure that it has adopted and any restrictions on the manner in which a drug can be obtained.

As described in the Proposed Rule, this list must be easily accessible to plan enrollees, prospective enrollees, the State, the Exchange, HHS, and the Office of Personnel Management (OPM), and the general public. BIO strongly supports this crucial transparency provision and urges HHS to further require that cost-sharing requirements be made available in addition to the other aspects of a plan’s prescription drug formulary described in the Proposed Rule.

Making cost-sharing information readily available is critical in helping patients anticipate their annual out-of-pocket costs. Moreover, all of this information—including on cost-sharing—is necessary for individuals to make informed decisions about which plan best meets their anticipated healthcare needs.

HHS also is considering requiring issuers to make this information publicly available on their websites in a machine-readable file and format to allow third parties to create resources that aggregate information on different plans to help enrollees better understand plans’ formulary drug lists.

We support the opportunity for third parties to create consumer friendly resources on available plan options as another tool to improve the information available to patients at the time they are making decisions about healthcare insurance.


forHHS should finalize the proposals to improve the information contained in and availability of provider directories maintained by plans subject to EHB: HHS proposes to strengthen the provider directory requirements by insisting that QHPs publish an up-to-date, accurate, and complete provider directory, including information on which providers are accepting new patients, the provider’s location, contact information, specialty, medical group, and any institutional affiliations, in a manner that is easily accessible to plan enrollees, prospective enrollees, the State, the Exchange, HHS, and OPM.

HHS proposes to require QHPs to update this directory at least once per month and that the general public must be able to easily access the directory online through the plan’s website without creating any form of a user account. HHS also is considering requiring issuers to make this information publicly available on their websites in a machine-readable file and format specified by HHS so that third parties can aggregate this information to further inform consumers.

BIO strongly urges HHS to finalize this proposal to make detailed information on providers publicly available, as we believe consumers should have the best information at hand when choosing an insurance plan to meet their healthcare needs. In addition to the proposed requirements, BIO asks HHS to consider requiring plans to update the directory within a certain time period (e.g., 72 hours) in cases where an in-network provider becomes out-of-network for any reason.
biotechfor
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Pharmaceutical Research and Manufacturers of America (PhRMA)
http://www.phrma.org/
Pharmaceutical Research and Manufacturers of America (PhRMA, pronounced /ˈfɑrmə/), founded in 1958, is a trade group representing the pharmaceutical research and biopharmaceutical companies in the United States.

PhRMA's stated mission is advocacy for public policies that encourage the discovery of new medicines for patients by pharmaceutical and biopharmaceutical research companies. PhRMA's current CEO is John J. Castellani and its chairman is Robert J. Hugin.

http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0052Formulary Transparency. HHS should require health plans subject to the EHB rule to publish and maintain on their website fully up-to-date formularies for each of their plans, reflecting the cost sharing and utilization management rules applicable to each drug, and should require plans to make this information available in a machine-readable format so that HHS and third parties can integrate this information into consumer assistance tools.forz nonebiotech
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Clear Choices Campaignz noneClear Choices is a consumer-industry coalition dedicated to making health markets more transparent, accountable and consumer-friendly. Clear Choices is committed to ensuring patients have as much access to information as possible, so they can make informed plan selections and have adequate access to the healthcare system.

We believe doing so will not only empower consumers, it will improve quality, improve health outcomes and lower health costs. Realizing this potential will require the broader availability and use of information and data to generate meaningful and accurate comparative information on health plan and provider choices.
http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0270Creating Opportunities to Innovate: HHS is considering making the formulary drug list available in machine readable format so that third parties might create consumer facing resources to allow prospective enrollees to make more informed decisions about their health coverage.

We support this approach as comparisons currently must be done on a one-off basis, which is highly inefficient and largely ineffective. We note that a similar requirement applies to Medicare Part D and that the Medicare.gov web site allows prospective enrollees to compare plans based on formulary lists.

Furthermore, we strongly encourage the Department to consider developing tools, similar to the tools used in Medicare, such as Medicare Plan Finder. We believe giving patients the ability to compare plans is critical to ensuring they select plans that best meet their needs.

for HHS is also considering making the provider directory available in machine readable format so that third parties might create consumer facing resources to allow prospective enrollees to make more informed decisions about their health coverage.

We believe both provisions create innovation opportunities. After decades of languishing at the back of the pack in terms of IT adoption, the health sector is investing heavily in a new infrastructure of secure health records and communication systems.

Clinical routines are changing to accommodate both the input and uses of data. Advances in big-data analytics are dramatically expanding our capacity to process data in ways that generate actionable, real-time insights with respect to both the efficacy of cures and efficiency of care delivery.

Producing comparison tools via machine readable formulary and provider directories creates new opportunities to drive market efficiencies via more competitive exchanges. We strongly encourage HHS to require submission of the data in this format.
consumerfor
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Clear Choices Campaign (2nd submission)
z noneClear Choices is a consumer-industry coalition dedicated to making health markets more transparent, accountable and consumer-friendly. Clear Choices is committed to ensuring patients have as much access to information as possible, so they can make informed plan selections and have adequate access to the healthcare system. http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0301Creating Opportunities to Innovate: HHS is considering making the formulary drug list available in machine readable format so that third parties might create consumer facing resources to allow prospective enrollees to make more informed decisions about their health coverage. We support this approach as comparisons currently must be done on a one-off basis, which is highly inefficient and largely ineffective.

We note that a similar requirement applies to Medicare Part D and that the Medicare.gov web site allows prospective enrollees to compare plans based on formulary lists. Furthermore, we strongly encourage the Department to consider developing tools, similar to the tools used in Medicare, such as Medicare Plan Finder. We believe giving patients the ability to compare plans is critical to ensuring they select plans that best meet their needs.
forHHS is also considering making the provider directory available in machine readable format so that third parties might create consumer facing resources to allow prospective enrollees to make more informed decisions about their health coverage. We believe both provisions create innovation opportunities. After decades of languishing at the back of the pack in terms of IT adoption, the health sector is investing heavily in a new infrastructure of secure health records and communication systems.

Clinical routines are changing to accommodate both the input and uses of data. Advances in big-data analytics are dramatically expanding our capacity to process data in ways that generate actionable, real-time insights with respect to both the efficacy of cures and efficiency of care delivery. Producing comparison tools via machine readable formulary and provider directories creates new opportunities to drive market efficiencies via more competitive exchanges. We strongly encourage HHS to require submission of the data in this format.
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American Autoimmune Related Diseases Assn
http://www.aarda.org/
AARDA is the only national nonprofit health agency dedicated to bringing a national focus to autoimmunity, the major cause of serious chronic diseases. Approximately 50 million Americans, 20 percent of the population or one in five people, suffer from autoimmune diseases.

Women are more likely than men to be affected; some estimates say that 75 percent of those affected--some 30 million people--are women. Still, with these statistics, autoimmunity is rarely discussed as a women's health issue.
http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0263Formulary and Provider Network Transparency: AARDA strongly supports CMS’ proposal to require plans to publish up-to-date, readily accessible, and understandable formulary information that not only includes the listing of drugs on each EHB plan formulary and the applicable tier structure, but also clearly specifies any utilization management restrictions that may apply to each drug. As noted, we also strongly support a requirement for plans to specify all applicable cost-sharing information as part of the formulary transparency requirements.

This information must be publicly available and readily accessible prior to enrollment, and must remain up-to-date, publicly available, and readily accessible throughout the plan year. CMS should require that the formulary information be updated at least quarterly, if not more frequently.

Further, because some medicines are covered through plans’ medical benefits (instead of the pharmacy benefit), CMS should require transparency with respect to the drugs provided through each EHB plan’s medical benefit, including the same protections that apply for the pharmacy benefit coverage.

In addition, AARDA strongly supports the proposed requirements for provider network transparency, including requirements for issuers to publish an up-to-date, accurate, and complete provider directory in a format that is easily accessible and digestible by the general public.

We also support the requirement for this provider network information to identify which providers are accepting new patients. Because provider information changes frequently, CMS should require plans to update their provider network listings and related information at least monthly, if not more frequently.

CMS also, as the proposed rule suggests, should require that plans’ formulary and provider network information be provided in a “machine-readable” format, so that third parties can use and compile the data to develop health plan “shopping” tools for consumers.

We encourage CMS to provide tools of this kind, as well, such as a by providing a plan finder and benefit calculator for each marketplace website. Similar tools are provided already to assist Medicare Part D consumers; CMS could use those existing tools as models.
forRefer to “Comments on Machine Readable Formularies”.consumerfor
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HIV Health Care Access Working Groupz noneHHCAWG is a coalition of more than 100 national and community-based HIV service organizations representing HIV medical providers, public health professionals, advocates, and people living with HIV who are all committed to ensuring access to critical HIV-related health care and support services.http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0144Formulary Transparency: Consumers must be able to review a plan’s full formulary, any prior authorization or other utilization management restrictions, and associated out-of-pocket costs in order to make an informed decision to enroll in the plan that will best be able to meet care and treatment needs.

Currently, most issuers present QHP formulary coinsurance information as a percentage of the rate negotiated with pharmacies. Without the total cost of prescription medications, cost-sharing and coinsurance information by percentage is not helpful to consumers who want to assess the overall affordability of QHPs.

This is particularly true for people living with HIV and other chronic conditions who depend on access to affordable drugs to stay healthy.

We strongly urge that HHS require issuers to provide complete and accurate formulary information as applicable to each plan offered in a standard format3, including the actual out-of-pocket costs that will be imposed on enrollees.

This information must be accessible to those comparing plans as well as enrollees of the plan. Formularies should be updated monthly.

We also support federal oversight to ensure that plans do not change their formulary composition or increase prescription cost-sharing mid-year (except for adding medications to the formulary), and urge HHS to consider state laws and regulations proposing similar protections (e.g., Nevada4).

45 CFR § 147.106 allows issuers to make uniform modifications to a product only at the time of coverage renewal, and we believe increased federal monitoring and oversight are necessary to ensure that plans adhere to this requirement. Finally, we support requiring issuers to submit formulary information in a standard machine-readable file.

forRequire 30-day transition coverage for new enrollees we urge you to require rather than recommend that QHPs cover out-of-network providers for at least 30-days to allow for a transition period for new enrollees whose providers are not included in a QHP’s provider network.

This is a reasonable requirement and for people with HIV and others with chronic condition is medically necessary to ensure that they have sufficient time to identify a provider with the appropriate expertise within their new QHP network.

This is warranted given the difficulties accessing up-to-date provider directory information and the challenges that QHPs report maintaining accurate directory information.

In addition to the recommendations above, we strongly support the requirement for provider directory data to be available in machine-readable files as another step toward improving transparency of provider networks.
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National Health Council
http://www.nationalhealthcouncil.org/
The National Health Council (NHC) is a nonprofit association of health organizations.http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0133Prescription Drug Benefits: The NHC expresses support for the proposed standardized exceptions process for non-exigent circumstances. We also support the proposed requirement that medications accessed through the exceptions process be considered EHB and therefore count toward a plan’s benefit structure, including the maximum out-of-pocket limit. This is crucial to ensure affordability of care.

Further, we appreciate the requirement that formularies must be easily accessible—without requiring the creation of an account or other patient hurdles—and machine readable. However, we argue that plans should be required to list all of their covered medications on a single formulary. Currently, some plans have multiple formulary documents for circumstances including the standard formulary, formulary updates, specialty medications covered, and medical benefit coverage, etc.

We encourage the agency to consider methods to make formularies available in a standardized template that could be used, in the future, for a “plan finder” type tool on healthcare.gov. Additionally, we strongly support the requirement that tier placement and utilization management details be included in the formulary.

However, the NHC believes that the changes proposed to the prescription drug benefits within EHB are insufficient to provide access to comprehensive drug coverage that is similar in nature and scope to employer-sponsored coverage—a requirement defined by statute. The rule proposes that the drug counting methodology based on the USP Medicare Model Guidelines is replaced entirely by an issuer’s use of a P&T committee.

A P&T committee alone will not ensure adequate protections for formulary breadth and depth; HHS must develop, and implement in regulation, some level of minimum standard formulary coverage requirements to establish a baseline for health plans.

These two elements, taken together with comprehensive reviews for non-discrimination, could help resolve some of the issues surrounding the continued development of exchange plans seeking to avoid risk by attracting enrollees with less-than-ideal health profiles.

Network Adequacy Standards: We understand the HHS perspective to limit formal rulemaking on network adequacy requirements until the National Association of Insurance Commissioners workgroup completes development of their model act related to network adequacy.

As this model act is finalized, the NHC urges HHS to consider how well the NAIC requirements measure against the eleven elements of network adequacy standards identified by Families USA as key standards for successful network requirements across states: 1) Accurate Information about Providers; 2) Timely Access to Care; 3) Adequate Numbers of Providers; 4) Adequate Types of Providers; 5) Inclusion of Essential Community Providers; 6) Adequate Geographic Distribution of Providers; 7) Access to Out-of-State Providers; 8) Accessible Hours; 9) Language-Accessible and Culturally-Competent Care; 10) Rights to Go Out-of-Network; and 11) Continuity of Care.

The proposed rule, however, also introduces a new suggestion for plans to have at least a 30-day transition period for new enrollees in an ongoing course of treatment. The NHC argues that this proposal should be both strengthened and finalized. First, health plans are under no obligation to retain the same set of providers in their network throughout the plan year. Therefore, at any time a provider is removed from the plan’s network, an individual undergoing an ongoing course of treatment should be permitted at least a 30-day transition period to allow the individual time to conclude their therapy and/or find a new network provider.

This transition period should be extended, as needed, for patients who cannot find a network provider who is accepting new patients and can continue the individual’s course of treatment without delay. People who enroll in health plans by aligning their providers with a plan’s network should not be harmed by a plan or provider’s decision to end their contracting arrangement. Adequate, flexible transition requirements for health plans will minimize the disruption that patients might experience in such situations.

The NHC also strongly supports the proposed requirements that health plans must make available accurate, timely, machine readable provider directories to the public. We also encourage the agency to consider methods to make provider directories available in a standardized template that could be used, in the future, for a “plan finder” type tool on healthcare.gov.







consumerfor
but with lots of pharma money...
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Enroll America
http://www.enrollamerica.org/
Enroll America is a nonprofit, nonpartisan 501(c)(3) organization focused on one goal: maximizing the number of Americans who are enrolled in and retain health coverage.http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0149Prescription drug benefits. Given that marketplace issuers’ formulary drug lists have, to date, been difficult for consumers to find, access, and understand, we are pleased that CMS is taking steps to ensure marketplace enrollees have up-to-date, accurate, and complete information about their prescription drug benefits. These are issues of particular import to consumers with specific prescription needs, but all consumers will benefit from increased transparency, accuracy, and timeliness of formulary drug lists.

The steps proposed in this NPRM to make the application and enrollment process more efficient and straightforward can better position in-person assisters working with consumers to select a plan and generally improve consumer satisfaction with the enrollment process and the subsequent coverage they receive.

We appreciate the proposed rules at §156.122(d)(1)(i) that would require formulary drug lists to be easily accessible from the plan’s public website, not requiring consumers to enter policy numbers or access accounts. However, we hope that CMS clarifies this provision by specifying that marketplaces and QHP issuers must work together so formulary drug lists are easily accessible via marketplace websites.

Specifically, we would like to see a link to this information from the plan comparison page—both before and after a consumer has completed the full application—so that consumers and assisters do not have to search within an issuer site to find a specific plan’s formulary drug list.

The proposed rules at §156.122(d)(1)(ii) note that consumers should be able to easily discern which formulary drug list apply to a given plan. We support the intent of this proposal but seek clarification about how such an approach would be implemented.

Namely, we are concerned about a scenario where a consumer is redirected to a page on an issuer’s website that lists a number of plans that the consumer has to pick from to see a specific formulary drug list. Many plans have similar names and consumers may get confused and look at a different plan than they intended to look at. As such, this provision must protect consumers from having to navigate such a situation.

We strongly support the idea of requiring drug formularies to be publicly available in a machine-readable file and format. This increases the potential for both CMS and/or third parties to develop valuable tools to assist consumers compare and pick plans. The plan selection process is an important, time-consuming step in the enrollment process and we are pleased that CMS is working to make the creation of plan selection tools—that would serve to make this process quicker and easier—more of a reality.

However, we would like more detail, clarity, and specificity about what would be included and required in a machine-readable file. We urge CMS to require plans to provide and regularly update this machine-readable file to CMS—as opposed to merely posting the file on the issuer site—so that CMS can warehouse this information and provide it to the public on a regular, ongoing basis. Having this aggregated information will make it far easier for consumer tools to be created.

We also appreciate that CMS is seeking comment on whether to require issuers to include cost-sharing information in formulary tiering information. We strongly support including this information; merely including formulary tiers without the associated cost-sharing may not be meaningful enough to fully inform consumers.

It is essential that this information is provided in plain, easy-to-understand language, as many consumers have limited understanding of drug formularies15 and will not inherently what different tiers mean.

We further ask CMS to require issuers to create a mechanism for consumers to report inaccurate formulary drugs lists so that issuers may update their information. In order for these reports to be actionable, CMS should require issuers verify reports and make changes within a specified timeline designated by CMS.









forRecommendation: Amend §156.230(b)(2) to require marketplaces to have redirects from a plan selection page to a plan’s specific network. Clarify at §156.230(b)(2)(ii) that “easily discernable” means sending the consumer to a designated page listing at specific plan’s network.

Provide detail about what a machine-readable file and format means, and require issues to regularly update the information provided to CMS in this format. Create a mechanism for consumers to report inaccurate networks and require issuers to respond to these changes in a timely manner designated by CMS. Clarify the use of the term “issuer” in §156.230.

Require issuers to regularly audit and update a share of their directories, contact providers who have not submitted claims within a given period, and not hold consumers accountable for seeing providers incorrectly listed as being in network.

consumerfor
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Arthritis Foundation
http://www.arthritis.org/
The Arthritis Foundation is a nonprofit organization that is dedicated to addressing the needs of people living with arthritis in the United States. There are more than 50 million adults and 300,000 children living with arthritis, the nation’s leading cause of disability. The Foundation works to provide information and resources, access to care, advancements in science and community connections.http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0233Transparency. People with substantial prescription drug needs, especially those living with chronic conditions such as rheumatoid arthritis, need the ability to access information and make comparisons of health insurance plans. We applaud CMS’s proposal to require more detailed information in health plan drug lists.

We agree that the drug lists should contain information about tiering and utilization management, and that this information should be available to both enrollees and prospective enrollees. We urge CMS to also require drug lists to include information on out-of pocket costs, including co-insurance and deductibles for each medication. This information should be presented as both a percentage and a dollar value to make it clear to patients what their financial responsibility would be across plans.

Plans should also disclose formulary changes on a monthly basis and within 72 hours during open enrollment. Requiring the information to be available in a machine-readable format will also help enrollees and other stakeholders access the information more easily, and there should also be alternative methods for formulary listings to those people without internet access.
forWe applaud CMS’s commitment to improving the transparency of provider networks available within health plans, and requiring directories to be updated at least once a month. Provider directories are an important tool for patients to compare and assess health plans.

We recommend that directories be required to include information on whether physicians are accepting new patients, as this is crucial information for determining the adequacy of a provider network. Requiring these directories to be machine-readable will also help enrollees to more readily access the information.

Directories should be available to both members and non-members so prospective enrollees have the most up-to-date and detailed information possible to choose the plan that will work best for them.
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Children's Dental Health Project
https://www.cdhp.org/
The Children’s Dental Health Project (CDHP) is a national nonprofit organization that creates and advances innovative policy solutions and programs to achieve oral health for all children so that they can reach their full potentials. CDHP partners broadly with professionals, policy makers, and advocates to forge and promote research-driven solutions that support prevention and ensure equity in oral health for all children. http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0272z noneIn general, we applaud CMS for enhancing the provider directory requirements for issuers, especially with regard to identifying providers that are accepting new patients; this is particularly important for ensuring access to pediatric dental providers. In addition, we support a requirement to publish provider directory data in a machine-readable format so as to ensure transparency and wide access to provider information for all marketplaces.

Furthermore, CDHP recognizes CMS’ encouragement of state based marketplaces to adopt the same network adequacy standards as are applicable to federally facilitated marketplaces. However, we strongly encourage CMS to establish a minimum standard that applies to all marketplaces, including those that are state based.

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Immune Deficiency Foundation (IDF)
http://primaryimmune.org/
The Immune Deficiency Foundation (IDF), founded in 1980, is the national non-profit patient organization dedicated to improving the diagnosis, treatment and quality of life of persons with primary immunodeficiency diseases through advocacy, education and research.

Primary immunodeficiency diseases, or PI, affect children and adults who are born with an immune system that’s either absent or severely compromised, which leads to a greater risk of infections. In most cases, there is a pattern of chronic infections before PI is suspected, like ear, sinus and other infections as well as more severe illnesses like pneumonia.
http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0147z noneProvider directories. We support CMS’ proposals to strengthen the provider directory requirements by requiring that a QHP issuer must publish an up-to-date, accurate, and complete provider directory, including information on which providers are accepting new patients, the provider's location, contact information, specialty, medical group, and any institutional affiliations, in a manner that is easily accessible to plan enrollees, prospective enrollees, the State, the Exchange, Health and Human Services (HHS) and Office of Personnel Management (OPM).

We support a monthly requirement as an initial step to ensuring provider directories are up-to-date in 2016. For 2017, CMS should require health plans to make their provider directory accessible in “real-time”. We also encourage CMS to require issuers to make this information publicly available on their Web sites in a machine-readable file and format so as to provide the opportunity for third parties to create resources that aggregate information on different plans in a consumer-friendly format.


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Immune Deficiency Foundation (IDF)
http://primaryimmune.org/
The Immune Deficiency Foundation (IDF), founded in 1980, is the national non-profit patient organization dedicated to improving the diagnosis, treatment and quality of life of persons with primary immunodeficiency diseases through advocacy, education and research. Primary immunodeficiency diseases, or PI, affect children and adults who are born with an immune system that’s either absent or severely compromised, which leads to a greater risk of infections. In most cases, there is a pattern of chronic infections before PI is suspected, like ear, sinus and other infections as well as more severe illnesses like pneumonia. http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0215z noneProvider directories. We support CMS’ proposals to strengthen the provider directory requirements by requiring that a QHP issuer must publish an up-to-date, accurate, and complete provider directory, including information on which providers are accepting new patients, the provider's location, contact information, specialty, medical group, and any institutional affiliations, in a manner that is easily accessible to plan enrollees, prospective enrollees, the State, the Exchange, Health and Human Services (HHS) and Office of Personnel Management (OPM).

We support a monthly requirement as an initial step to ensuring provider directories are up-to-date in 2016. For 2017, CMS should require health plans to make their provider directory accessible in “real-time”. We also encourage CMS to require issuers to make this information publicly available on their Web sites in a machine-readable file and format so as to provide the opportunity for third parties to create resources that aggregate information on different plans in a consumer-friendly format.
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Consumers Union
http://consumersunion.org/
Consumers Union is a non-profit organization based in the United States whose mission is to advocate on policy issues related to telecommunications, mass media, vehicle safety, health care, product safety, financial services, investing, food safety, housing, and energy and utility deregulation.http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0278z noneWe support the provision that defines that the directory is “easily accessible” by being on the issuer’s public website with a clearly identifiable link.

We especially agree with the requirement that when there are multiple provider networks, the website and links to the directory must be clear in indicating which network is associated with a particular plan. In our research of issuer directories, this clarity has been lacking.

In addition, the preamble suggests that provider directories should be updated at least once per month. We applaud HHS for establishing a standard for regular updating. We believe, however, that issuers should update provider directories more frequently than the suggested once per month.

Issuers keep extremely current about which providers are in their networks in relation to their claims payments, and we see no reason why, in this electronic era, that information cannot be shared with consumers in an equally timely way by updating their web sites in an ongoing manner, every week or more frequently.

The preamble also suggests that HHS is considering requiring that publicly accessible provider directories be in a machine-readable file and format. We strongly support the preamble language and would urge HHS to incorporate this into an actual regulatory requirement.

An integrated provider directory available on an Exchange’s website, for example, will best allow consumers to shop for and compare plans.

The requirement that all directories be in a machine-readable file will ensure that consumers have access to integrated provider directories at the earliest date possible.


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Families USA
http://familiesusa.org/
Families USA is an American liberal non-profit consumer health-care advocacy organization. It was co-founded by attorney Ronald Pollack, its current executive director, and Philippe Villers, the organization's current President. Families USA is an influential health-care lobbyist in Washington, D.C. and has taken positions on every major piece of health care legislation, including the Medicare Part D plan.http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0268z noneImplementing these standards will more directly address provider directory inaccuracies than simply waiting for updates from providers that may never come.

These recommended standards will also serve to catch and eliminate inaccurate provider directory information that has lingered in directories for years because providers failed to submit changes or because plans failed to update directories based on reported changes.

Finally, Families USA supports the concept of requiring issuers to make their provider network information publicly available in machine-readable files and formats as specified by HHS. We believe this would be beneficial for creating different ways for consumers to access provider information, and hopefully could also catalyze increased accuracy of provider directories as more entities review directory information and make it publicly accessible.

We also support the submission of this type of information directly to HHS and hope that HHS can eventually create integrated provider directories for the FFM. Integrated, searchable directories could potentially be more accurate than existing directories if they allowed integrated updates. For example, if a provider retired, the provider could inform the marketplace or marketplace directory manager that he or she was no longer practicing, and the provider could be removed from all plans’ directories simultaneously, instead of having to communicate with multiple issuers’ and wait for each of those issuers to remove the information from their directories.

In terms of how to update information, we are interested in whether HHS could discuss with issuers whether their claims payment systems or databases present an opportunity to obtain more accurate and timely information about which providers are in network that could also be used for provider directories.

Since these systems provide real-time information to determine whether a provider should be paid an in-network or out-of-network rate, it would be helpful to know whether the same systems could be used to provide more timely information to update provider directories.


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Epilepsy Foundation
http://www.epilepsy.com/
The Epilepsy Foundation, also Epilepsy Foundation of America (EFA), is a non-profit national foundation, headquartered in Landover, Maryland, dedicated to the welfare of people with epilepsy and seizure disorders. The foundation was established in 1968 and now has a network of 59 affiliates.

The foundation's programs aim to "ensure that people with seizures are able to participate in all life experiences; and to prevent, control and cure epilepsy through research, education, advocacy and services."
http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0280*Data on Drug Formularies and Provider Lists: We support the requirement that issuers submit drug formularies and provider lists in machine-readable file. Currently, there is no standard formulary design and only some have search capabilities.

All consumers would benefit from an interactive web tool such as a plan finder or benefit calculator that matches an individual’s prescriptions and provider needs with appropriate plans (such as the one utilized by the Medicare Part D program). Submitting information in a standard machine-readable format can assist in developing such tools.


*Data Collection: We support HHS’ proposal to require issuers to make available information about provider networks and drug formularies in machine readable files and encourage HHS to consider what other data could be made available for research purposes and to develop additional tools for consumers, and make more information available in machine-readable formats.
for z noneconsumer
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Easter Seals
http://www.easterseals.com/
Easter Seals (founded in 1919 as the National Society for Crippled Children) is a American nonprofit charitable organization that assists more than one million children and adults with autism and other disabilities and special needs annually through a network of more than 550 service sites in the United States, Canada, Australia and Puerto Rico.

Sites provide services, therapies and treatments tailored to meet the specific needs of the particular community they serve. The organization assists children and adults with physical and mental disabilities and special needs resulting from any cause, whether diagnosed at birth or incurred through disease, accidental injury or the aging process.
http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0164*We strongly support stricter requirements for the provision of accurate, up-to-date and machine readable formulary lists where they can be seen by the public.

We urge stronger enforcement of the current requirement that links to formularies appear on the Summary of Benefits & Coverage. We agree that full disclosure of cost-sharing requirements is critical, since information about drug tier placement is relatively meaningless to enrollees without it.

Finally, we greatly appreciate greater flexibility with regard to enrollees’ preferences for getting their prescriptions directly from pharmacies in their communities.


*We also are very supportive of the proposal to require plans to submit drug formularies and provider lists in machine-readable file. Currently, there is no standard formulary design and some have search capabilities while others do not.

We would very much like to see an interactive web tool such as a plan finder or benefit calculator that matches an individual’s prescriptions and provider needs with appropriate plans (such as the one utilized by the Medicare Part D program).

Submitting information in a standard machine-readable format can assist in developing such tools. We also support the inclusion of other data in a machine-readable format to facilitate research (see further comments on data collection above).


*Access to Data: We support HHS’s proposal to require issuers to make available information about provider networks and drug formularies in a machine-readable files. The ACA and establishment of exchanges created a new opportunity to gather data and conduct research on health and health insurance.

We support the proposal to include provider network and drug formulary information in machine-readable files and encourage HHS to release additional data, including benefit information and quality data, in machine readable formats to facilitate transparency and research on health care.

All data should be released in formats accessible through screen-readers and other technologies used by people with disabilities.
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Consortium for Citizens with Disabilities
http://www.c-c-d.org/
The Consortium for Citizens with Disabilities is a coalition of approximately 100 national disability organizations working together to advocate for national public policy that ensures the self determination, independence, empowerment, integration and inclusion of children and adults with disabilities in all aspects of society.
http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0296*We strongly support stricter requirements for the provision of accurate, up-to-date and machine readable formulary lists where they can be seen by the public. We urge stronger enforcement of the current requirement that links to formularies appear on the Summary of Benefits & Coverage.

We agree that full disclosure of cost-sharing requirements is critical, since information about drug tier placement is relatively meaningless to enrollees without it.

Finally, we greatly appreciate greater flexibility with regard to enrollees’ preferences for getting their prescriptions directly from pharmacies in their communities.



*We also are very supportive of the proposal to require plans to submit drug formularies and provider lists in machine-readable file. Currently, there is no standard formulary design and some have search capabilities while others do not.

We would very much like to see an interactive web tool such as a plan finder or benefit calculator that matches an individual’s prescriptions and provider needs with appropriate plans (such as the one utilized by the Medicare Part D program).

Submitting information in a standard machine-readable format can assist in developing such tools. We also support the inclusion of other data in a machine-readable format to facilitate research (see further comments on data collection above).



*Transparency and Access to Data: We support HHS’s proposal to require issuers to make available information about provider networks and drug formularies in a machine-readable files. The ACA and establishment of exchanges created a new opportunity to gather data and conduct research on health and health insurance.

We support the proposal to include provider network and drug formulary information in machine-readable files and encourage HHS to release additional data, including benefit information and quality data, in machine readable formats to facilitate transparency and research on health care. All data should be released in formats accessible through screen-readers and other technologies used by people with disabilities.


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Cancer Leadership Council
http://www.cancerleadership.org/
CLC is a patient-centered forum of national advocacy organizations addressing public policy issues in cancer.http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0166Formulary Drug List Transparency: Consumers will be served well by the requirement that health plans publish an “up-to-date, accurate and complete list of all covered drugs on its formulary drug list, including any tiering structure that it has adopted and any restrictions on the manner in which a drug can be obtained.”

HHS asks for advice regarding the inclusion of cost-sharing information, including the pharmacy deductible, copayment amounts, or cost-sharing percentage, on the formulary drug list. We recommend that such information be included.

HHS has indicated that it is considering a requirement that issuers make information about formulary drug lists available on their websites in a machine-readable file and format identified by HHS. The department indicates that imposing this data requirement would permit third parties to aggregate information on a range of health plans. Consumer access to aggregate information of this sort would help to transform the insurance marketplaces into patient- and consumer-friendly plan selection and purchasing options.
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National Partnership for Women & Families
http://www.nationalpartnership.org/
The National Partnership for Women & Families is a nonprofit, nonpartisan organization based in Washington, D.C. Founded in 1971, the National Partnership works on public policies, education and outreach that focus on women and families.http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0206Formulary information is available in a machine-readable file and format, as this allows for the marketplaces or other entities to create tools to help consumers compare health plans and understand their drug coverage.forz noneconsumer
21
Health Care For All New York
http://hcfany.org/
Health Care For All New York (HCFANY) is a statewide coalition of consumer-focused organizations and entities. Founded in late 2007 with a Robert Wood Johnson Foundation “Consumer Voices for Coverage” grant, HCFANY came together under the leadership of 8 organizations: The American Cancer Society, Center for Working Families, Community Service Society, Children’s Defense Fund of NY, Citizen Action of New York/Public Policy Education Fund, Metro New York Health Care For All, New Yorkers for Accessible Health Coverage, and the New York Immigration Coalition.http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0174HCFANY supports proposals to increase formulary and provider transparency. In order for patients to select the plans that best meet their individual health care needs, they must have access to easy-to-understand, detailed information about plan benefits, formularies, provider networks, and the costs of medications and services.

HCFANY recommends that formularies should be made available in PDF format as well as through a prescription search tool. HCFANY urges CMS to consider an interactive web tool, such as a plan finder or benefit calculator, that matches an individual’s prescriptions and provider needs with appropriate plans (such as the one utilized by the Medicare Part D program). Requiring plans to submit information in a standard, machine-readable format can assist in developing such tools.
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22
AARP
http://www.aarp.org/
AARP, Inc., formerly the American Association of Retired Persons, is a United States-based non-governmental organization and interest group, founded in 1958 by Ethel Percy Andrus, PhD, a retired educator from California, and based in Washington, D.C. It is a membership organization for people age 50 and over.http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0117HHS has proposed increased transparency requirements for issuers’ drug formularies that would become effective for the 2016 benefit year. These include a requirement that plans make public an up-to-date, accurate, and complete list of all covered drugs, including the tier structure and any utilization management restrictions (e.g., prior authorization). The formulary list would have to be easily accessible to enrollees, prospective enrollees, the state, the Exchange, HHS, OPM and the general public. To meet this requirement, the information would have to be available on the issuer’s public Web site through a clearly identifiable link or tab without requiring an individual to create or access an account or enter a policy number. It would also need to be clear which formulary list applies to which of the issuer’s plans. AARP strongly supports these proposed and much needed transparency requirements.

The unsatisfactory shopping and enrollment experience for many consumers in 2014 highlighted major gaps in the accessibility and accuracy of information regarding prescription drug coverage. It was often exceptionally challenging to find what was and was not covered by a particular plan, potential out-of-pocket costs (with or without cost sharing subsidies), and whether utilization management techniques, such as prior authorization, step therapy and quantity limitations, applied. Substantial improvement is evident among the 2015 plan options available through healthcare.gov but more needs to be done to ensure that consumers in FFEs and state-based Exchanges are well informed before making plan selections. AARP strongly believes that consumers need information about a given plan’s drug coverage that is complete and up-to-date, easy to understand, and easy to navigate. To further that objective, a plan’s formulary drug list URL link should be the same as the formulary drug list URL link for obtaining information on prescription drug coverage in the SBC.

The information that is available today on the current Medicare Part D Plan Finder should serve as the model of what level of transparency is expected from plans subject to the EHBs. Specifically, without having to establish an account, the drug benefit information should include at the plan-specific level (down to the metal level and specific product name) whether a given prescription drug is covered, any limitations on access, such as prior authorization, and the enrollee cost-sharing for that drug (including whether the amount is reduced as a result of being eligible for cost-sharing reductions). As noted below, we also urge that plans be required to flag drugs that must be obtained from specialty pharmacies (with an explanation of what that means). We appreciate that making the latter accessible via Exchange and plan Web sites may require time but this capability should be required no later than 2017.

All other information should be required no later than 2016. AARP has observed with much concern the trend towards notably higher cost-sharing for drugs purchased from non-preferred pharmacies. Therefore, we strongly support a requirement that plans must disclose on their public Web sites whether an enrollee will be subject to higher cost-sharing if their drug is purchased from a non-preferred pharmacy. This information should also be linked to on the Exchange Web site and included in the SBC. HHS notes in the Notice preamble that it is considering whether to require that formulary lists be available in a machine-readable file or submitted through an HHS designed standardized template. The intent appears to be to permit the public access to this information in a way that will more readily permit evaluation and analysis. AARP strongly supports providing full public disclosure of plan-specific drug coverage, including cost-sharing requirements and utilization restrictions. The information should be provided at least annually in a format that can be easily downloaded and analyzed, without charge to the user. There is no reason why these data should not be accessible on a timely basis to the public.
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National Women's Law Center
http://www.nwlc.org/
The National Women's Law Center (NWLC) is a United States non-profit organization founded in 1972 and based in Washington, D.C. Through litigation and policy initiatives, the Center strives to improve the lives of women and their families in the areas of health, employment, family economic security, and education. NWLC was founded by Marcia Greenberger and Nancy Duff Campbell.http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0163The formulary information should be provided in a machine-readable file and format, as this would allow for the exchanges or other entities to create tools to help consumers compare health plans and understand their drug coverage.forz noneconsumer
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National Alliance on Mental Illness
http://www.nami.org/
The National Alliance On Mental Illness (NAMI) is a nation-wide grassroots advocacy group, representing families and people affected by mental illness in the United States. NAMI provides support, psychoeducation and research for people and their families impacted by mental illness through various public education and awareness activities.

The National NAMI organization is based out of Arlington, Virginia. NAMI is organized further into State and Local affiliates, all operating mainly with the work of thousands of volunteers. Members of NAMI are typically consumers of mental health services, family members, and professionals working together toward common goal.
http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0269Transparency NAMI is also supportive of the proposals to increase formulary and provider transparency. In order for patients to select the plans that best meet their individual health care needs, they must have access to easy-to-understand, detailed information about plan benefits, formularies, provider networks, and the costs of medications and services.

While we have seen some transparency improvements with the 2015 plans, many plans still do not have a direct link to a plan’s formulary on the “Summary of Benefits and Coverage” as required by the ACA. In order to find the formulary multiple searches must be conducted for some plans.

The proposed rule reiterates the ACA requirement, and proposes that each plan publish up-to-date, complete formularies with tiering and any restrictions on accessing the drug.

CMS is also seeking comment on whether formulary tiering information should include cost sharing information, including pharmacy deductible and cost-sharing

NAMI supports all of these common sense proposals that help patients make the best decisions to meet their needs. Additionally, since plans are employing the use of coinsurance more frequently, plans should detail what the actual patient cost sharing will be in dollar terms.

By not detailing this information, patients are left in the dark when it comes to how much they will have to pay for a drug or service.

NAMI also supports the proposal to require plans to submit drug formularies and provider lists in machine-readable file. Currently, there is no standard formulary design and some have search capabilities while others do not.

We would very much like to see an interactive web tool such as a plan finder or benefit calculator that matches an individual’s prescriptions and provider needs with appropriate plans (such as the one utilized by the Medicare Part D program). Submitting information in a standard machine-readable format can assist in developing such tools.
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25
American Lung Association
http://www.lung.org/
The American Lung Association is a voluntary health organization whose mission is to save lives by improving lung health and preventing lung disease.http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0047Transparency: Transparency has always been a top priority for and a large concern of the American Lung Association in the implementation of the ACA, especially regarding information on what QHPs are covering and limits on that coverage. In order for patients to select the plans that best meet their individual health care needs, they must have access to easy-to-understand, detailed information about plan benefits, formularies, provider networks and the costs of medications and services.

While transparency has improved somewhat with the 2015 plans, many plans still do not have a direct link to a plan’s formulary on the “Summary of Benefits and Coverage” page on www.healthcare.gov as required by the ACA. In order to find the formulary multiple searches must be conducted for some plans. The proposed rule reiterates the ACA requirement for formulary links, and proposes that each plan publish up-to-date, complete formularies with tiering and any restrictions on accessing the drug. CMS is also seeking comment on whether formulary tiering information should include cost sharing information, including pharmacy deductible and cost-sharing. The Lung Association supports these common sense proposals that help patients make the best decisions to meet their needs. Additionally, since plans are employing the use of co-insurance more frequently, plans should detail what the actual patient cost sharing will be in terms of dollars. By not detailing this information, patients are unaware of how much they will have to pay out-of-pocket for a drug or service.

The Lung Association is also very supportive of the proposal to require plans to submit drug formularies and provider lists in a machine-readable file. Currently, there is no standard formulary design and some have search capabilities while others do not. An interactive web tool such as a plan finder or benefit calculator that matches an individual’s prescriptions and provider needs with appropriate plans (such as the one utilized by the Medicare Part D program) would be very helpful to patients and potential enrollees. Submitting information in a standard machine-readable format can assist in developing such tools.

While these proposed or implemented improvements in formulary and cost transparency are encouraging, there are many more to make. Even for drug coverage, transparency in formularies is not enough. Many plans cover certain over-the-counter (OTC) drugs, including nicotine-replacement therapies (NRT). But many plans do not list OTC drugs on formularies, or maintain a separate OTC-only drug list. Additionally, some plans cover these OTC NRTs via a smoking cessation program vendor, and the drugs are available to enrollees of the program, but are not listed on the formulary. Therefore, formularies do not portray complete information on which drugs are available to patients. Giving patients and groups like the Lung Association easy access to plan formularies is an important step, but will not necessarily reveal the full picture of drug coverage in that plan.

Additionally, while coverage of drugs is an important element of health insurance coverage, it is far from the only element. Finding information about other treatments that QHPs cover is still very difficult. Plans often consider detailed information about their coverage benefits to be proprietary information, and only make it available to members after they have enrolled. But patients need to know this information as they are deciding which plan is right for them to enroll in. Organizations like the Lung Association also need access to this information to help patients make these decisions and to better monitor the quality of coverage being offered in the plans.

Recognizing the standardized summary plan document is intentionally short so as not to overwhelm the potential enrollee with information, other documents that are more detailed and longer need to also be made available to those interested in viewing them and helping patients better navigate their healthcare. These needed documents include:
• Plan policy documents
• Over-the-counter drug lists
• Member handbooks
• Provider handbooks

In summary, the American Lung Association makes the following recommendations:
• Finalize the proposal’s provisions to increase transparency around QHP’s formularies, including a requirement to publish out-of-pocket cost information for drugs
• Require plans to submit drug formularies in machine-readable format
• Implement measures to increase transparency of coverage information beyond drug coverage
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American Cancer Society Cancer Action Network
http://www.acscan.org/
The American Cancer Society Cancer Action Network (ACS CAN) is a nonprofit, nonpartisan sister advocacy organization to the American. It was founded in December 2001 to directly advocate the goals of the American Cancer Society, which is subject to restrictions on advocacy activities because of its tax classification.

ACS CAN works to make cancer a national priority. Specifically, it advocates for better access to care, cancer prevention and early detection programs, cancer research funding, regulation, better quality of life for cancer patients, and attempts to raise awareness of and reduce cancer disparities. Members include cancer survivors, caregivers, patients, volunteers, and students, including Colleges Against Cancer.

http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0209Transparency: Transparency has always been a top priority for and a large concern of the American Lung Association in the implementation of the ACA, especially regarding information on what QHPs are covering and limits on that coverage. In order for patients to select the plans that best meet their individual health care needs, they must have access to easy-to-understand, detailed information about plan benefits, formularies, provider networks and the costs of medications and services.

While transparency has improved somewhat with the 2015 plans, many plans still do not have a direct link to a plan’s formulary on the “Summary of Benefits and Coverage” page on www.healthcare.gov as required by the ACA. In order to find the formulary multiple searches must be conducted for some plans. The proposed rule reiterates the ACA requirement for formulary links, and proposes that each plan publish up-to-date, complete formularies with tiering and any restrictions on accessing the drug. CMS is also seeking comment on whether formulary tiering information should include cost sharing information, including pharmacy deductible and cost-sharing. The Lung Association supports these common sense proposals that help patients make the best decisions to meet their needs. Additionally, since plans are employing the use of co-insurance more frequently, plans should detail what the actual patient cost sharing will be in terms of dollars. By not detailing this information, patients are unaware of how much they will have to pay out-of-pocket for a drug or service.

The Lung Association is also very supportive of the proposal to require plans to submit drug formularies and provider lists in a machine-readable file. Currently, there is no standard formulary design and some have search capabilities while others do not. An interactive web tool such as a plan finder or benefit calculator that matches an individual’s prescriptions and provider needs with appropriate plans (such as the one utilized by the Medicare Part D program) would be very helpful to patients and potential enrollees. Submitting information in a standard machine-readable format can assist in developing such tools.

While these proposed or implemented improvements in formulary and cost transparency are encouraging, there are many more to make. Even for drug coverage, transparency in formularies is not enough. Many plans cover certain over-the-counter (OTC) drugs, including nicotine-replacement therapies (NRT). But many plans do not list OTC drugs on formularies, or maintain a separate OTC-only drug list. Additionally, some plans cover these OTC NRTs via a smoking cessation program vendor, and the drugs are available to enrollees of the program, but are not listed on the formulary. Therefore, formularies do not portray complete information on which drugs are available to patients. Giving patients and groups like the Lung Association easy access to plan formularies is an important step, but will not necessarily reveal the full picture of drug coverage in that plan.

Additionally, while coverage of drugs is an important element of health insurance coverage, it is far from the only element. Finding information about other treatments that QHPs cover is still very difficult. Plans often consider detailed information about their coverage benefits to be proprietary information, and only make it available to members after they have enrolled. But patients need to know this information as they are deciding which plan is right for them to enroll in. Organizations like the Lung Association also need access to this information to help patients make these decisions and to better monitor the quality of coverage being offered in the plans.

Recognizing the standardized summary plan document is intentionally short so as not to overwhelm the potential enrollee with information, other documents that are more detailed and longer need to also be made available to those interested in viewing them and helping patients better navigate their healthcare. These needed documents include:
• Plan policy documents
• Over-the-counter drug lists
• Member handbooks
• Provider handbooks

In summary, the American Lung Association makes the following recommendations:
• Finalize the proposal’s provisions to increase transparency around QHP’s formularies, including a requirement to publish out-of-pocket cost information for drugs
• Require plans to submit drug formularies in machine-readable format
• Implement measures to increase transparency of coverage information beyond drug coverage

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I AM (Still) ESSENTIAL
http://www.theaidsinstitute.org/
I AM (Still) ESSENTIAL Coaltion (The AIDS Institute)

The AIDS Institute promotes action for social change through public policy research, advocacy and community education.

The AIDS Institute (TAI) began as a grass roots community advocacy effort in the mid 1980s. In 1992, this advocacy network became incorporated as Florida AIDS Action, a nonprofit organization. Over the years, TAI expanded its vision to become a leading national public policy research, advocacy, and education agency with offices in Tampa, and Washington, DC.

Affiliated with the Division of Infectious Diseases and International Medicine at the University of South Florida College of Medicine, The AIDS Institute remains focused on HIV/AIDS while incorporating work on related healthcare issues such as Hepatitis, as well as other infectious and chronic diseases.

http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0049Transparency: We are also very supportive of the proposals to increase formulary and provider transparency. In order for patients to select the plans that best meet their individual health care needs, they must have access to easy-to-understand, detailed information about plan benefits, formularies, provider networks, and the costs of medications and services.

While we have seen some transparency improvements with the 2015 plans, many plans still do not have a direct link to a plan’s formulary on the “Summary of Benefits and Coverage” as required by the ACA. In order to find the formulary multiple searches must be conducted for some plans. The proposed rule reiterates the ACA requirement, and proposes that each plan publish up-to-date, complete formularies with tiering and any restrictions on accessing the drug.

CMS is also seeking comment on whether formulary tiering information should include cost sharing information, including pharmacy deductible and cost-sharing. We are highly supportive of all these common sense proposals that help patients make the best decisions to meet their needs. Additionally, since plans are employing the use of co-insurance more frequently, plans should detail what the actual patient cost sharing will be in dollar terms.

By not detailing this information, patients are left in the dark when it comes to how much they will have to pay for a drug or service.We also are very supportive of the proposal to require plans to submit drug formularies and provider lists in machine-readable file. Currently, there is no standard formulary design and some have search capabilities while others do not.

We would very much like to see an interactive web tool such as a plan finder or benefit calculator that matches an individual’s prescriptions and provider needs with appropriate plans (such as the one utilized by the Medicare Part D program). Submitting information in a standard machine-readable format can assist in developing such tools.
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New Yorkers for Accessible Health Coverage
http://www.cidny.org/nyfahc.php
New Yorkers for Accessible Health Coverage (NYFAHC) is a statewide coalition of 53 voluntary health organizations and allied groups who serve and represent people with chronic illnesses and disabilities, including cancer, HIV/AIDS, cognitive impairments, multiple sclerosis and epilepsy. NYFAHC is a project of Center for the Independence of the Disabled, NY. http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0254Transparency: We are also very supportive of the proposals to increase formulary and provider transparency. In order for patients to select the plans that best meet their individual health care needs, they must have access to easy-to-understand, detailed information about plan benefits, formularies, provider networks, and the costs of medications and services.

While we have seen some transparency improvements with the 2015 plans, many plans still do not have a clearly identifiable direct link to a plan’s formulary on their website. The proposed rule proposes that each plan publish up-to-date, complete formularies with tiering and any restrictions on accessing the drug.

CMS is also seeking comment on whether formulary tiering information should include cost sharing information, including pharmacy deductible and cost-sharing. We are highly supportive of all these common sense proposals that help patients make the best decisions to meet their needs.

We believe that formularies should be made available in pdf format as well as through a prescription search tool. We would very much like to see an interactive web tool such as a plan finder or benefit calculator that matches an individual’s prescriptions and provider needs with appropriate plans (such as the one utilized by the Medicare Part D program). Submitting information in a standard machine-readable format can assist in developing such tools.
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Disability Rights Education and Defense Fund
http://dredf.org/
The Disability Rights Education and Defense Fund (DREDF), founded in 1979, is a leading national civil rights law and policy center directed by individuals with disabilities and parents who have children with disabilities.http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0283We strongly support stricter requirements for the provision of accurate, up-to-date and machine readable formulary lists where they can be seen by the public. We urge stronger enforcement of the current requirement that links to formularies appear on the Summary of Benefits & Coverage.

We agree that full disclosure of cost-sharing requirements is critical, since information about drug tier placement is relatively meaningless to enrollees without it. Finally, we appreciate greater flexibility with regard to enrollees’ preferences for getting their prescriptions directly from pharmacies in their communities.

We also support the proposals to increase formulary and provider transparency. In order for patients to select the plans that best meet their individual health care needs, they must have access to easy-to-understand, detailed information about plan benefits, formularies, provider networks, and the costs of medications and services.

While we have seen some transparency improvements with the 2015 plans, many plans still do not have a direct link to a plan’s formulary on the “Summary of Benefits and Coverage” as required by the ACA. In order to find the formulary multiple searches must be conducted for some plans. The proposed rule reiterates the ACA requirement, and proposes that each plan publish up-to-date, complete formularies with tiering and any restrictions on accessing the drug.

HHS is also seeking comment on whether formulary tiering information should include cost sharing information, including pharmacy deductible and cost-sharing. We support all of these common sense proposals that help people make the best decisions to meet their needs. Additionally, since plans are employing the use of co-insurance more frequently, plans should detail what the actual cost sharing will be in dollar terms. By not detailing this information, people are left in the dark when it comes to how much they will have to pay for a drug or service.

We also support the proposal to require plans to submit drug formularies and provider lists in machine-readable files. Currently, there is no standard formulary design and some have search capabilities while others do not. We recommend an interactive web tool such as a plan finder or benefit calculator that matches an individual’s prescriptions and provider needs with appropriate plans (such as the one utilized by the Medicare Part D program).

Submitting information in a standard machine-readable format can assist in developing such tools. We also support the inclusion of other data in a machine-readable format to facilitate research (see further comments on data collection above).

We support providing people with the choice of how they receive their prescriptions and prohibit the practice of a mail-order only option. As the proposed rule describes, there are legitimate instances in which an individual may need to access a retail pharmacy and can benefit from interaction with a pharmacist. We see no reason why this option should be delayed until 2017 and think it should be implemented in 2016.

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Disability Rights Education and Defense Fund
http://dredf.org/
The Disability Rights Education and Defense Fund (DREDF), located in Berkeley, California and Washington, DC, USA is a national cross-disability civil rights law and policy center directed by individuals with disabilities and parents who have children with disabilities. Founded in 1979, DREDF advances the civil and human rights of people with disabilities through legal advocacy, training, education, and public policy and legislative development.The Berkeley office is located in the Ed Roberts Campus.http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0283We strongly support stricter requirements for the provision of accurate, up-to-date and machine-readable formulary lists where they can be seen by the public. We urge stronger enforcement of the current requirement that links to formularies appear on the Summary of Benefits & Coverage. We agree that full disclosure of cost-sharing requirements is critical, since information about drug tier placement is relatively meaningless to enrollees without it. Finally, we appreciate greater flexibility with regard to enrollees’ preferences for getting their prescriptions directly from pharmacies in their communities. We also support the proposals to increase formulary and provider transparency.

In order for patients to select the plans that best meet their individual health care needs, they must have access to easy-to-understand, detailed information about plan benefits, formularies, provider networks, and the costs of medications and services. While we have seen some transparency improvements with the 2015 plans, many plans still do not have a direct link to a plan’s formulary on the “Summary of Benefits and Coverage” as required by the ACA. In order to find the formulary multiple searches must be conducted for some plans. The proposed rule reiterates the ACA requirement, and proposes that each plan publish up-to-date, complete formularies with tiering and any restrictions on accessing the drug. HHS is also seeking comment on whether formulary tiering information should include cost sharing information, including pharmacy deductible and cost-sharing.

We support all of these common sense proposals that help people make the best decisions to meet their needs. Additionally, since plans are employing the use of co-insurance more frequently, plans should detail what the actual cost sharing will be in dollar terms. By not detailing this information, people are left in the dark when it comes to how much they will have to pay for a drug or service. We also support the proposal to require plans to submit drug formularies and provider lists in machine-readable files. Currently, there is no standard formulary design and some have search capabilities while others do not. We recommend an interactive web tool such as a plan finder or benefit calculator that matches an individual’s prescriptions and provider needs with appropriate plans (such as the one utilized by the Medicare Part D program).

Submitting information in a standard machine-readable format can assist in developing such tools. We also support the inclusion of other data in a machine-readable format to facilitate research (see further comments on data collection above). We support providing people with the choice of how they receive their prescriptions and prohibit the practice of a mail-order only option. As the proposed rule describes, there are legitimate instances in which an individual may need to access a retail pharmacy and can benefit from interaction with a pharmacist. We see no reason why this option should be delayed until 2017 and think it should be implemented in 2016.

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31
National Campaign to Prevent Teen and Unplanned Pregnancy
http://thenationalcampaign.org/
The National Campaign is a private, nonprofit organization funded largely by private donations. Major support for our activities comes from the William and Flora Hewlett Foundation. We also recognize the generous current and past support of other foundations, organizations, and individuals as well as the public support afforded The National Campaign.http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0216We support additional changes discussed in the preamble related to the formulary including that:

• the formulary drug list be easily accessible by the general public so that consumers can access and compare formularies prior to enrolling in coverage;
• the plan associated with each formulary be clearly identified on the plan’s web site;
• the information be up-to-date including the interpretation that up-to-date means the “URL must accurately list all of the health plan’s covered drugs “at that time” rather than allowing for a grace period that could result in a consumer receiving misinformation;
• the formulary information made available be provided in a machine-readable file and format, as this would allow for the exchanges or other entities to create tools to help consumers compare health plans and understand their drug coverage; and
• consumers who cannot access plan information through an issuer’s website will also be guaranteed access to the same information.
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New Hampshire Voices for Health
http://www.nhvoicesforhealth.org/
New Hampshire Voices for Health is a trusted leader, bringing together health care advocates, consumers, and policy makers working to increase access to affordable, quality health care so NH residents can lead healthy and productive lives. http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0262Prescription Drug Benefits As formulary drug lists have been difficult for consumers to find, access, and understand, we are pleased that the Department is taking steps to ensure consumers have up-to-date, accurate, and complete information about their prescription drug benefits.

These are issues of particular import to consumers with specific prescription needs, but all consumers will benefit from increased transparency, accuracy, and timeliness of formulary drug lists. Such steps to make the application and enrollment process more efficient and straightforward can better position in person assisters working with consumers to select a plan and generally improve consumer satisfaction with the enrollment process and the subsequent coverage they receive.

We appreciate the proposed rules at §156.122(d)(1)(i) that would require formulary drug lists to be easily accessible from the plan’s public website that do not require consumers to enter policy numbers or access accounts. However, we hope that the Department clarifies this provision by specifying that marketplaces and QHP issuers must work together so formulary drug lists are easily accessible via marketplace websites.

Specifically, we would like to see a link to this information from the plan comparison page—both before and after a consumer has completed the full application—so that consumers and assisters do not have to search within an issuer site to find a specific plan’s formulary drug list.

The proposed rules at §156.122(d)(1)(ii) note that consumers should be able to easily discern which formulary drug list apply to a given plan. We support the intent of this proposal but seek clarification about how such an approach would be implemented. Namely, we are concerned about a scenario where a consumer is redirected to a page on an issuer’s website that lists a number of plans that the consumer has to pick from to see a specific formulary drug list.

However, many plans have similar names and consumers may get confused and look at a different plan than they intended to look at. As such, this provision must protect consumers from having to navigate such a situation.

We strongly support the idea of requiring drug formularies to be publicly available in a machine readable file and format. This increases the potential for both the Department and/or third parties to develop valuable tools to assist consumers compare and pick plans. The plan selection process is an important, time consuming step in the enrollment process and we are pleased that the Department is working to make the creation of plan selection tools—that would serve to make this process quicker and easier— more of a reality. However, we would like more detail, clarity, and specificity about what would be included and required in a machine readable file.

We urge the Department to require plans to provide and regularly update this machine-readable file to CMS—as opposed to merely posting the file on the issuer site—so that CMS can warehouse this information and provide it to the public on a regular, ongoing basis. Having this aggregated information will make it far easier for consumer tools to be created.

We also appreciate that the Department is seeking comment on whether to require issuers to include cost-sharing information in formulary tiering information. We strongly support including this information; merely including formulary tiers without the associated cost-sharing may not be meaningful enough to fully inform consumers. It is essential that this information is provided in plain, easy-to-understand language, as many consumers have limited understanding of drug formularies11 and will not inherently what different tiers mean.

We further ask the Department to require formularies to include information on the contraceptive waiver process and to require issuers to create a mechanism for consumers to report inaccurate formulary drugs lists so that issuers may update their information. In order for these reports to be actionable, the Department should require issuers verify reports and make changes within a specified timeline designated by the Department.




forImplementing these standards will more directly address provider directory inaccuracies than simply waiting for updates from providers that may never come. These recommended standards will also serve to catch and eliminate inaccurate provider directory information that has lingered in directories for years because providers failed to submit changes or because plans failed to update directories based on reported changes.

Finally, VOICES supports the concept of requiring issuers to make their provider network information publicly available in machine-readable files and formats as specified by the Department. We believe this would be beneficial for creating different ways that consumers could access provider information, and hopefully could also catalyze increased accuracy of provider directories as more entities review directory information and make it publicly accessible.

We also support the submission of this type of information directly to the Department and hope that it can eventually create integrated provider directories for the FFM. Integrated, searchable directories could potentially be more accurate than existing directories if they allow integrated updates.
consumersfor
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National Health Law Program
http://www.healthlaw.org/
Founded in 1969, the National Health Law Program protects and advances the health rights of low income and underserved individuals. The oldest non-profit of its kind, NHeLP advocates, educates and litigates at the federal and state level. http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0276z noneHHS should require issuers to provide their directories in a format or template that facilitates comparison. Consumers will benefit from being able to easily compare QHP’s provider networks. To this end, we support the preamble language suggesting that the final regulation should require QHPs to provide their directories in a machine-readable format for easy aggregation.

25 We would also support the alternative proposed in the preamble: a requirement that QHPs submit their directories to HHS using a template.26 we believe this would be beneficial for creating different ways that consumers could access provider information, and hopefully could also catalyze increased accuracy of provider directories as more entities review directory information and make it publicly accessible.

We also support the submission of this type of information directly to HHS and hope that HHS can eventually create integrated provider directories for the FFM. Integrated, searchable directories could potentially be more accurate than existing directories if they allowed integrated updates.

For example, if a provider retired, the provider could inform the Exchange or Exchange directory manager that he or she was no longer practicing, and the provider could be removed from all plans’ directories simultaneously, instead of having to communicate with multiple issuers’ and wait for each of those issuers to remove the provider’s information from their directories.
consumersfor
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Oregon Insurance Division
http://www.oregon.gov/dcbs/insurance/pages/index.aspx
The Oregon Insurance Division empowers and protects consumers through fair and efficient regulation while encouraging a financially stable, innovative, and competitive insurance marketplacehttp://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0211z noneWe propose changing the current text to read as (b)(1) and adding (b)(2) in order to strengthen the provider directory requirement. Specifically, we propose that a QHP issuer must publish an up-to-date, accurate, and complete provider directory, including information on which providers are accepting new patients, the provider’s location, contact information, specialty, medical group, and any institutional affiliations, in a manner that is easily accessible to plan enrollees, prospective enrollees, the State, the Exchange, HHS and OPM. As part of this requirement, we propose that a QHP issuer must update the directory information at least once a month, and that a provider directory will be considered easily accessible when the general public is able to view all of the current providers for a plan on the plan’s public Web site through a clearly identifiable link or tab without having to create or access an account or enter a policy number.

The general public should be able to easily discern which providers participate in which plan(s) and provider network(s) if the health plan issuer maintains multiple provider networks and the plan(s) and provider network(s) associated with each provider should be clearly identified on the Web site. We seek comment on this proposal, including with respect to how often updating should occur. We also are considering requiring issuers to make this information publicly available on their Web sites in a machine-readable file and format specified by HHS. The purpose of establishing machine-readable files with this data would be to provide the opportunity for third parties to create resources that aggregate information on different plans. We believe this would increase transparency by allowing software developers to access this information and create innovative and informative tools to help enrollees better understand the availability of providers in a specific plan.

As an alternative, we could also require that this information be submitted to HHS though an HHS designed standardized template, but we recognize that there may be challenges with keeping this type of template information updated. Thus, we specifically solicit comments on these options, including the technical requirements for developing a machine-readable file and format for a provider directory, as well as other technical considerations, such as processes and considerations that should be taken into account for the updating of this information under either of the options being considered. We are proposing these requirements to enhance transparency of QHP provider directories and to help consumers make more informed decisions about their health care coverage. We solicit comments on these proposed requirements, as well as with respect to how frequently provider data should be updated, and whether other technical considerations, such as processes and considerations that should be taken into account for the updating of this information under either of the options being considered.

We are proposing these requirements to enhance transparency of QHP provider directories and to help consumers make more informed decisions about their health care coverage. We solicit comments on these proposed requirements, as well as with respect to how frequently provider data should be updated, and whether additional types of information should be required to be included in the provider directory. We also seek comment on the feasibility and merits of incorporating information on physical accessibility for individuals with disabilities, including accessibility information regarding facilities and equipment, or other information that would be important to enrollees and potential enrollees, as a part of network adequacy standards in the future.

exchangeneither
this is comments from another exchange which is also taking comments on this issue
35
Kaiser Foundation Health Plan
https://healthy.kaiserpermanente.org/
Kaiser Permanente is an integrated managed care consortium, based in Oakland, California, United States, founded in 1945 by industrialist Henry J. Kaiser and physician Sidney Garfield. Kaiser Permanente is made up of three distinct groups of entities: the Kaiser Foundation Health Plan and its regional operating subsidiaries; Kaiser Foundation Hospitals; and the autonomous regional Permanente Medical Groups. As of 2014, Kaiser Permanente operates in eight states and the District of Columbia, and is the largest managed care organization in the United States.http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0143Publication of Formulary Lists. The NPRM would require issuers to publish current, accurate,
and complete lists of all covered drugs, including any tier structure and any restrictions on how
to obtain specific drugs. Formulary drug lists must be easily accessible to enrollees and the
public, and be made available in a machine readable format. We agree that transparency will
help consumers choose a plan that best meets their needs, including information on covered
drugs, and we support making information publically available.

The fundamental objective of any drug benefit is to ensure that patients have access to the prescription drugs necessary to treat their medical conditions. We are concerned about providing machine readable files of formularies; in addition to issues of data integrity, accuracy, interpretation, and confidentiality,
such lists alone may not accurately represent what plans’ benefits actually cover. Different health plans provide access to these drugs in different ways. Some health plans include many (or all) drugs on their formularies and seek to encourage the use of favored drugs through differential cost sharing, or tiered benefits.

Other plans use more traditional closed formularies and provide access to medically necessary non-formulary drugs through medical exception processes. In some cases, plans will cover (at the appropriate brand or generic on-formulary level of cost-sharing) non-formulary drugs that the physician determines are necessary to treat a particular patient, based on his/her medical judgment that all of the available formulary drugs may not be suitable for that patient. For these reasons, a machine readable formulary list may be misleading and confusing to patients enrolled in such a plan.
forProvider Directories. We support the majority of HHS’ proposals relating to provider
directories. We believe that consumers should be able to rely on the information published in
provider directories. We therefore agree that QHPs should maintain updated, accurate and
complete provider information including the types of information listed in HHS’ proposal.
We agree that monthly updates to provider directory information would be appropriate, but we
suggest that this language be adjusted to allow plans to make updates within a month (31 days)
after receiving an update from the provider.


We have concerns about consumer confusion that could be caused by the requirement to indicate
whether specialists are “accepting new patients.” For specialists for whom a referral is needed,
indicating the specialist is “accepting new patients” could be misleading to consumers, who may
understand that to mean that they can request an appointment directly with the specialist.
Additionally, in an integrated system, specialists may always be able to accommodate new
patients, but to promote care coordination an initial appointment may be facilitated by primary
care or another department or specialist. To prevent confusion for members, we recommend that
an additional data point or column be included to allow the QHP to indicate whether there are
plan requirements prior to visiting a specialist. For example, a QHP could include a notation that
“A referral may be required to schedule an appointment with this specialist.”


We also have concerns about HHS’ proposal to require that QHPs make a machine-readable
provider directory file publicly available. We support HHS’ goal of increasing transparency but
we are concerned that, even today, third parties may often manipulate or aggregate publicly
available provider information, resulting in inaccuracies in the published information. We
recommend that, rather than making such a file publicly available and able to be manipulated by
third parties, HHS should require that files be provided in a machine-readable format for the sole
purpose of allowing the state or federally-facilitated Marketplace to produce an easy-to-use tool
that will allow enrollees (or potential enrollees) to determine if their providers are available to
them in a plan. However, should HHS proceed to require such public posting of a machine-readable
file, we recommend that HHS work with QHP issuers to develop appropriate uses and
safeguards to preserve the integrity and accuracy of the provider information and to ensure that it
stays up to date. We also recommend that third parties be required to provide links back to the
QHP’s original directory information.
inscoagainstone of few opposed
36
Blue Cross Blue Shield Association
http://www.bcbs.com/
The Blue Cross Blue Shield Association (BCBSA) is a federation of 37 separate United States health insurance organizations and companies, providing health insurance to over 100 million Americans.http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0184Regarding the requirement to submit information to HHS in a standard template, issuers already submit information on their formularies as part of the QHP certification process and therefore issuers should not be required to resubmit this information in a different format for other purposes. We are concerned with third parties manipulating formulary data if provided in machine readable format and how HHS would hold third parties accountable for the accuracy of their end products, which could cause considerable consumer harm if they produce inaccurate results (e.g., enrollment in wrong plans). againstRecommendation #5: BCBSA recommends that HHS not require issuers to provide network information in machine-readable files and formats for third parties to access. This requirement is extremely problematic, and we strongly recommend that HHS not pursue this approach.
Rationale:
Making provider directory information machine-readable is problematic for reasons of consumer confusion, technical feasibility, and cost.
Consumer Confusion. For QHP enrollees, provider directory information is often meaningful only in the context of broader issues such as network and benefit design (e.g., consumers need to know a provider’s tier status and understand what that means) and cost of services (e.g., how much will it cost to use a specific provider for a certain service?). The QHP issuer has the most comprehensive understanding of provider information and is best situated to ensure transparency and resolve any consumer confusion. Letting a third party come between the QHP issuer and its enrollees disrupts this relationship, and greatly increases the risk that transparency will diminish rather than improve, because the third party will only be able to publish information regarding provider lists in isolation.

Any disintermediation between QHP and member will adversely impact an issuer’s ability to educate and engage a member on programs related to physician quality, board certification, PCMHs, ACOs, etc. Indeed, it will be extremely complex to develop files and formats that are able to illustrate the interaction between provider directories and benefit design (e.g., tiered networks). A provider may be in a QHP’s network, but depending on the QHP design, that provider may be assigned to a specific tier within a product and therefore the listing of the provider name in absence of the broader benefit design contextual information would be confusing or misleading to members. This will only get more complicated in the future as dynamic benefit designs and networks will be developed to meet the needs of different members.
Finally, we would note that giving third parties the ability to aggregate information on different plans raises thorny issues of liability. For example, if a third party takes a machine-readable file and there is an error between what was in the file and what ultimately was posted on the third party website, who would be responsible? And who would the member call for customer service needs, the third party or the QHP? If a provider is listed by the third party as being in-network, even though the information provided on the file by the QHP listed the provider as out-of-network, it’s the consumer that ultimately would get hit with the bill. Adequate protections would need to be in place so that consumers and health plans are not penalized for errors resulting from a third party’s mishandling of the information.
Technical Feasibility. Considering the current state of the technology and HHS’ and most QHPs’ health IT capabilities and resources, producing machine readable files for 2016 is not feasible. As standardized machine-readable files and formats for all the required data elements do not yet exist, it is doubtful HHS will have the time to develop and test such standards in time for QHP issuers to implement them. As HHS contemplates the use of machine-readable files, it must consider the planning, resources and challenges involved in creating a national, multi-carrier, uniform tool. This should be a multi-year process to properly test and develop the use of machine-readable files, not one that is completed in less than twelve months to be ready for 2016 implementation.

Cost. Once standardized machine-readable files and formats are developed and tested, QHP issuers would have to commit significant resources to implementing the new standards and integrating the new files and formats into their current IT systems.
inscoagainst
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United Concordia
https://www.unitedconcordia.com/dental-insurance/
United Concordia is a dental insurance company headquartered in Harrisburg, Pennsylvania, United States. It is one of the largest dental insurers in the United States. The company currently insures more than 8 million members worldwide.

The corporation also operates regional offices covering the rest of the United States in Pennsylvania, Maryland, Virginia, North Carolina, Alabama, Florida, Georgia, Michigan, New York, California, Washington, Oregon, Arizona, New Mexico, Colorado, and Texas.
http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0126z noneNetwork Adequacy Standards (Provider Directories): HHS is proposing that a QHP issuer must publish an up-to-date, accurate, and complete provider directory in a manner that is easily accessible to plan enrollees, prospective enrollees, the state, the Exchange, HHS and OPM.

HHS is also considering a requirement that issuers make this information publicly available on their websites in a machine-readable file and format specified by HHS. The purpose of establishing machine readable files with this data would be to provide the opportunity for third parties to create resources that aggregate information on different plans.

As an alternative, HHS proposes it could also require that this information be submitted to HHS though an HHS-designed standardized template, but recognizes that there may be challenges with keeping this type of template information updated.

United Concordia is encouraged that CMS is waiting for the NAIC workgroup to complete its work regarding network adequacy standards prior to making changes to the network adequacy policy.

We strongly support provider directories being as accurate as possible and consumers having access tools that include adequate information so that informed decisions can be made when purchasing a plan and seeking care. Issuers devote considerable time and resources to updating information about providers, giving members timely notice as soon as they learn a provider is leaving a network.

With regard to the requirement for issuers to have an “up-to-date, accurate, and complete provider directory,” we respectfully point out that provider directories are only as current, accurate and complete as the information network providers share with the issuer.

Issuers must periodically validate their network data, but providers are more adequately equipped to ensure accuracy by promptly informing issuers of changes to their practice locations, affiliations, and network status. Issuers alone should not be penalized if a provider has failed to update information necessary to meet the proposed standard.

This is a shared responsibility of issuers, providers and consumers. Requirements should be flexible enough to acknowledge these responsibilities and set appropriate standards for compliance.

Further, the requirement that issuers provide network information in a machine-readable format for third parties to access is extremely problematic and we strongly recommend that HHS not pursue this approach.

Once machine-readable formats and files are developed and tested, issuers will have to commit significant resources to implement these new standards and integrate new files and formats into their current IT systems.

Additionally, the accuracy of third party manipulations of the data files cannot be controlled or guaranteed, nor can the timeliness of their data refresh processes be controlled. How the third party would be held accountable for inconsistencies between the issuer’s data files and what is posted on the third party’s website? For example, a provider is listed as in-network by the third party, but listed by the issuer as out-of-network could have substantial impact on the consumer’s decisions and who is accountable for this error? Adequate protections need to be in place so that consumers and issuers are not penalized for errors resulting from a third party’s mishandling of the information.

Ultimately, this risk of misidentification of network data or misrepresentation of network information by third parties would cause consumer confusion. Issuers are best suited to control their network information, and the risks of inaccuracy by third party aggregators cannot be overstated.


inscoagainst
one of few that is entirely against
38
National Association of Dental Plans
http://www.nadp.org/
NADP is the representative and recognized resource of the dental benefits industry. NADP is the largest non-profit, national trade association focused exclusively on the entire dental benefits industry, i.e. dental HMOs, dental PPOs, discount dental plans and dental indemnity products. - See more at: http://www.nadp.org/About.aspx#sthash.GgETLL44.dpufhttp://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0289z noneRecommendation
‐ The Notice sites ACA 1311 as including dental plans as part of the network standards; however, this section of the law does not include dental plans. In addition, while CMS’s “Letter to Issuers 2014” may have applied network adequacy standards to SADPs, the letter only provided detailed guidelines for QHP networks, regarding various medical providers and hospital systems (not SADPs). SADPs were subjected to a requirement without any guidance as to what that standard meant. Therefore CMS is applying standards to Exchange certified SADPs but have not outlined those guidelines.

‐ NADP would recommend CMS to evaluate 2014 Exchange‐certified SADPs to gauge whether NA standards should even be applied. In 2012, 89% of all active dentists in private practice participated in dental networks. NADP recommends the deletion of dental plans from NA standards, and more specifically, this section as NA is only applied to Exchange‐certified SADPs. The Notice should be made clear that NA standards do not apply to SADPs nor non‐ Exchange certified dental policies in the private market. State insurance regulators should maintain their oversight and continue to monitor and regulate dental networks when appropriate.

*According to HHS, there are currently 4,900 Dental Health Professional Shortage Areas (HPSAs)ii . While 89% of dentists participate in a network, this leaves areas in which very few dentists are available. The Notice states the general availability of out‐of‐network providers will not be counted for purposes of meeting NA requirements. SADPs need the ability to utilize out‐of‐network providers in some counties to meet state NA standards.

‐ The notice regulates continuity of care to lessen the probability of missing care when an enrollee changes carriers and their current provider is not part of the new carrier’s network. Carriers of both QHPs and SADPs already have transitional care as part of their current provider contracts. In addition, transitional care usually is related to chronic or acute medical conditions, which does not typically occur in pediatric dental except for medically necessary orthodontia, which is a condition specifically addressed in those enrollee and provider contracts.

-The Notice includes new requirements related to provider directories. QHP and SADP issuers make concerted efforts to keep their directories updated with the latest provider information. However, dental offices generally have a small staff, and in many cases the dentist does not contact carriers when they change their status. Once a carrier is aware of a provider change, that modification should be implemented within 30 days in a carrier’s online directory. Carriers should not be penalized when a provider is delinquent in forwarding updated information to the issuer. In addition, clarification is needed when referencing a ‘complete’ directory and whether this would differ between QHPs and SADPs.

-The Notice addresses the concept of machine‐readable files to allow the aggregation and easier comparison of providers within various networks for consumers. While this is an admirable goal, NADP opposes the proposal as carrier IT resources are still concentrating on Exchange displays and data transactions. SADPs in particular do not have any additional resources to devote to automation projects at this time.




inscoagainst
39
Cigna
http://www.cigna.com/
Cigna (pronounced sig-nuh), headquartered in Bloomfield, Connecticut, US, is a global health services organization. Its insurance subsidiaries are major providers of medical, dental, disability, life and accident insurance and related products and services, the majority of which are offered through employers and other groups (e.g. governmental and non-governmental organizations, unions and associations).

Cigna also offers Medicare and Medicaid products and health, life and accident insurance coverages primarily to individuals in the U.S. and selected international markets. In addition to its ongoing operations described above, Cigna also has certain run-off operations, including a Run-off Reinsurance segment. In the Phoenix, Arizona metro area Cigna runs a full-service staff-model HMO (health maintenance organization) with satellite clinics throughout the region, known as the Cigna Medical Group, ‘Cigna Global Health Benefits' also operates under the Cigna corporation.
http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0134*A new provision would be added requiring issuers publish their formulary drug list in a manner that is accessible to existing and prospective enrollees, the state, the Exchange, HHS, OPM, and the general public. HHS would expect the issuer's formulary URL be up to date, i.e., it must accurately list all of the health plan's covered drugs at that time. Also, the formulary drug list URL under this section should be the same formulary URL for obtaining information on prescription drug coverage that is provided in the Summary of Benefits and Coverage.

HHS is also considering requiring issuers to make this information publicly available on their websites in a machine-readable file and format specified by HHS, which would allow third parties to aggregate formulary information for different plans. As an alternative, HHS is also considering whether the formulary could be submitted to HHS through a standardized template.

*We agree it is important for consumers to have information available to them to ensure they choose a plan that best meets their needs -including information on covered drugs; however, we have concerns with the risks inherent in aspects of HHS' proposed approach (e.g., requiring machine-readable formats for formularies when no standard for such machine-readable formularies currently exists) and urge additional stakeholder input around key issues, such as data integrity, accuracy, potential for consumer confusion and confidentiality.
concerned*Network Adequacy Standards HHS proposes adding new requirements regarding enrollee access to provider directories. A QHP issuer would update the information at least once a month. HHS is also considering requiring issuers to make this information publicly available on their websites in a machine-readable file and format specified by HHS, which would allow third parties the opportunity to aggregate network information for different plans.

As an alternative, it could also require that this information be submitted to HHS through a standard template. HHS seeks comment on these proposals, as well as the feasibility and merits of incorporating information on physical accessibility for individuals with disabilities.

*Issuers strive on a daily basis to make sure their provider directories are up-to-date; however, part of that effort depends on collaboration with providers to inform us when there are changes to be made. We realize the importance to consumers that our provider directory be accurate and make efforts to ensure that the information provided online represents the most up-to-date information we have.

We are unclear as to what is meant by a "machine-readable file" and have concerns regarding third-party use of such information. While we understand the importance such a consumer tool could provide, because of the constant updates being made to our provider directory, we are hesitant that such a tool would be able to provide the most up-to-date and accurate information for every insurer and are concerned the representation would be of a snapshot in time rather than a real time representation.

Finally, any information on physical accessibility for individuals with disabilities should not be limited to providers participating in a QHP. We strongly support all providers being required to provide this information.
inscoconcerned
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Association of Web-Based Health Insurance Brokers (AWHIB)
http://www.marketwired.com/press-release/health-insurance-web-brokers-announce-formation-of-trade-association-1970966.htm
The Association will advocate for key technical changes to enable the private sector to better facilitate the efficient enrollment of Americans in state and federal health insurance exchange marketplaces. AWHIB will seek to educate policy makers, government technical staff and the general public about the important role web brokers play in helping millions of Americans evaluate and select health insurance policies that best meet their needs and economic situations. AWHIB seeks to collaborate with consumers, insurers, regulators, lawmakers and other industry groups to continually develop technologies and inform policy that provide Americans with the greatest access to health insurance products and services.http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0068The rule proposes to add a requirement that health plans publish up-to-date, accurate, and complete lists of all covered drugs on its formulary drug list. Similarly, in §156.230(b), the rule proposes that a QHP issuer must publish an up-to-date, accurate and complete provider directory.

With respect to both provisions, the proposed rule solicits comments on whether to require health plans and QHP issuers to make formulary drug lists and provider directories available in a machine-readable format.

The Association enthusiastically shares CMS’s goals of increasing transparency within the health insurance market, and providing consumers with timely and accurate information about what prescriptions and providers are covered by their health plan relative to other available health plans.

We look forward to playing an important role in this process. While we are prepared to contribute to that effort, we are cautious that plan year 2016 is a realistic goal. As both carriers and web-brokers are still adapting to exchange technology and policy requirements, the proposed timeline of this requirement may lead to temporary solutions that do not sufficiently address transparency needs.

Given the importance of the goals underlying this proposed rule, CMS should provide sufficient time for web brokers and our carrier partners to develop and deploy ideal machine-readable universal data templates. Overall, we look forward to the final version of this proposed rule, and are ready and willing to assist with its development and implementation.

We thank CMS for providing the opportunity to provide comments on the proposed Notice of Benefit and Payment Parameters, and we look forward to continuing to partner with CMS to make the Marketplaces a success.


concernedRefer to “Comments on Machine Readable Formularies”.inscoconcerned
Support the idea, but they want to wait..
41
HealthPartners
https://www.healthpartners.com/
HealthPartners is an integrated, nonprofit health care provider and health insurance company located in Bloomington, Minnesota offering care, coverage, research and education to its members, patients and the community.http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0176We fully support the proposed P&T committee process as the method health plans would use to establish their prescription drug formularies. This proposal is consistent with our existing process to ensure access and appropriate use of medications without needing to add drugs merely to meet a numerical requirement.

This is how we determine formulary for our commercial business and for our Medicare business. Leveraging a P&T committee can help promote and preserve access to high-quality and cost-effective drug coverage. However, P&T membership requirements – particularly the inclusion of specific specialties – make the proposal more cumbersome and should be reconsidered.

P&T committee standards should be consistent with current guidelines and standards that exist under the National Committee for Quality Assurance (NCQA) and Medicare Part D.

Guidelines around P&T committees should support a flexible approach that would allow for adjustments to make formulary changes in a timely manner to address up-to-date evidence on drug safety and efficacy.

CMS is also proposing to require access to covered drugs via retail pharmacies unless (1) the drug is subject to restricted distribution by the U.S. Food and Drug Administration; or (2) the drug requires special handling, provider coordination, or patient education that cannot be provided by a retail pharmacy.

The NBPP does clarify that enrollees can be charged higher cost sharing for drugs accessed through a retail pharmacy. We recommend that access through retail pharmacies not become a requirement, but rather that we accommodate this on an as-needed basis.

We would not want this proposal to prevent plans from using designated pharmacies for specialty drugs when it is appropriate. We also support the ability of issuers to charge

The NBPP proposes changes to the requirements around the availability of plan formulary drug lists. Issuers would be required to publish an up-to-date, accurate, and complete list of all covered drugs, including any tiering structures and restrictions on the manner in which the drug can be obtained. We support the goal of making formulary drug lists publically available.

We agree that it is important for consumers to have information available to ensure they choose a plan that best meets their needs – including information on covered drugs. At the same time, we strongly counsel against mixing formulary lists with indications of benefit levels (tiering and drug restrictions) in the same concept.

They are very different. This proposal would increase complexity by proliferating the number of formulary lists that an issuer might have to post and would correspondingly increase member confusion.

If CMS does decide to require separate formulary drug lists for each tiering structure, we advocate strongly for a delay until 2017 to allow time to develop the administrative infrastructure to meet such requirements.

We also have concerns with the risks inherent in aspects of CMS’ proposal to require machine readable formats for formularies when no standard for such machine-readable formularies currently exists. We strongly urge additional stakeholder input around key issues, such as data integrity, accuracy, and potential for consumer confusion, plan liability and confidentiality.

We recommend that CMS develop the systems necessary to create a “drug compare” tool similar to that in Medicare Part D so that consumers can easily gather the information they need without relying on potentially unaudited and misleading aggregations of information across issuers by third parties who may or may not have specific agendas in presenting the information.
concernedWe are supportive of transparent provider networks to ensure choice among consumers, but recommend postponing the inclusion of a machine-readable provider file or alternative to a later date. Currently no standards exist around data integrity, accuracy, or a process to keep files up to date, as well as protections around release of competitive information.

These issues could increase the risk to consumers, shoppers, and enrollees if they rely on inaccurate information to make health plan choices. Additionally, allowing for a machine-readable provider file or alternative may exacerbate inaccuracies because of lack of notification by some providers.

While some health plans currently allow consumers to save a PDF file of provider search results for their own use, there currently isn’t a complete online directory in a format that is machine-readable and exportable. We urge CMS to assist in developing an end-to-end approach for third party analysis and aggregation which includes a provider-side responsibility.

Additional discussions between QHP issuers and CMS would be needed to discuss third-party use of provider directory data as the focus should be on consumer access to these directories.

We suggest issuers continue to make their provider directory available in a format that is most usable for consumers. Similarly to our current practices, we recommend confidentiality, use controls, and cost should also be addressed in this proposal.
inscoconcerneddelay..
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Americas Health Insurance Plans
http://www.ahip.org/
America’s Health Insurance Plans (AHIP) is a national political advocacy and trade association with about 1,300 member companies that sell health insurance coverage to more than 200 million Americans.http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0218We support the goal of making formulary drug lists publically available. We agree that it is important for consumers to have information available to them to ensure they choose a plan that best meets their needs – including information on covered drugs. However, we have concerns with the risks inherent in aspects of HHS’ proposed approach (e.g., requiring machine-readable formats for formularies when no standard for such machine-readable formularies currently exists) and urge additional stakeholder input around key issues, such as data integrity, accuracy, potential for consumer confusion, and confidentiality. We note that the Medicare Part D program does provide users with the ability to search for Medicare plans that cover specific drugs. However an important distinction is that many Medicare Part D beneficiaries are only purchasing stand-alone prescription drug coverage, not comprehensive medical coverage from a private plan. For such beneficiaries, the logical starting point in their choice of plan is whether or not it covers the drugs they take. While consumers in Exchanges may be interested in whether medications they take are covered, they are also likely to consider other factors to be equally or more important (such as coverage of other benefit categories and whether their plan includes certain providers or hospitals). We also note that health plans already submit detailed information to HHS on their formularies as a requirement for QHP certification. However HHS has not yet developed the systems necessary to create a “drug compare” tool similar to that in Part D. concernedWe recommend that the language requiring a QHP issuer to update provider directory information "at least once a month" be modified to read that a QHP issuer must update the directory information "within at least 30 days of notification of a change by a network provider". Health plans consistently make an effort to ensure provider directories are as up-to-date as possible and health plans currently meet standards provided under various health plan accreditation programs, such as providing the frequency of validation or last validation date for physicians listed in their online directories. A requirement that QHPs update the directory information within at least 30 days of notification of a change by a network provider would allow plans to make rolling updates or a single bulk update within a 30 day window.


We recommend that physician directory reporting requirements apply only to network providers as plans only have provider information on those providers with which they contract. Health plans want consumers to have the best information to make informed decisions regarding providers. Considering there may be an extended timeline to add new providers to the directories due to the complexity of credentialing requirements, allowing for fully credentialed network providers to be included in the provider directories would be consistent with current health plan accreditation standards and provide information to inform consumer choice.


We support the requirement to make the provider directory available but need timely and accurate information to be submitted by providers, including information on the acceptance of new patients or changes in network status. Health plan efforts to ensure that provider directories are up-to-date and accurate can be challenging because providers often do not notify the issuer of changes in their provider status as a participating provider or changes regarding their acceptance of new members. Providers often accept and stop accepting particular health plans’ members off and on throughout the year and fail to notify the plan in a timely manner. As a result, issuers are unable to guarantee the accuracy of the provider's status presented in the directory. Therefore, we encourage HHS to support policies that embrace a shared responsibility between health plans and providers, which enlist the assistance of providers to maintain up-to-date health plan physician directories. In addition, we ask HHS to work with the Joint Commission on enhancing hospital requirements (via guidance or standards) to request that when granting privileging to a physician, the physician disclose if he or she has a contract with the same insurance carriers with which the hospital contracts. In such instances that the privileged physician does not accept an insurance which the hospital accepts or the hospital utilizes providers, such as anesthesiologists, pathologists etc., who do not have contracts with a health plan, the hospital would then be responsible for notifying the patient prior to scheduling of services of the out-of-network status of such a provider and the possible implications including the incurrence of out-of-network charges.

We support transparent provider networks to ensure choice among consumers, but recommend postponing the inclusion of a machine-readable provider file or an alternative until standards exist to ensure uniformity. Currently, there are no accepted standards regarding data integrity, accuracy, and process to maintain provider directory information, as well as protections around the release of competitive information. Such standards are critically important to decrease the risk of consumers, shoppers, and enrollees relying on inaccurate information to make health plan choices. Additionally, allowing for a machine-readable provider file or an alternative may exacerbate inaccuracies because of the failure of notification by some providers in updating or revising their data on file with the health plan. While some health plans currently allow consumers to save a PDF file of their search results for their use, there currently isn’t a complete online directory in a format that is exportable. We urge HHS to assist in developing an end-to-end approach for third party analysis and aggregation which includes a provider-side shared responsibility.
Additional discussions between QHP issuers and HHS are needed to discuss third-party use of provider directory data as the focus should be on consumer access to these directories. We suggest issuers continue to make their provider directory available in a format that is most usable for consumers. Similar to our current practices, confidentiality, use controls, and cost should also be addressed related to this proposal.


We recommend that changes to the directory be specifically applied to online directories only. Typically a health plan’s online directory uses a search engine to pull from internal systems; therefore an online directory is not a stand-alone product like a paper directory. Additionally, changes to provider information can be made in a more timely and accurate manner using an online directory.

We recommend HHS allow health plans the ability to tailor their provider directories based on benefit and product design. Provider directory information is intended to ensure that consumers are being presented with the most accurate and relevant information on providers that is based on benefit and product design. Additionally, certain provider groups which consumers do not have the ability to directly access or select should be excluded from the provider directory to avoid consumer confusion. These include providers who may be (1) providing services outside of a health plan network i.e. non-participating physicians such as Anesthesiologist or Pathologists, and (2) covering for another physician for a temporary period. Also, some specialist providers such as surgeons may be unable to accept new patients due to time limitations and panel size. In such instances HHS should promote policies that encourage providers to share their in-network status with patients to ensure consumers can make informed choices.
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Association for Community Affiliated Plans
http://www.communityplans.net/
The Association for Community Affiliated Plans (ACAP) is a national trade association representing 57 Medicaid-focused health plans in 24 states. Headquartered in Washington, D.C., ACAP advocates on behalf of its community-affiliated member health plans operating throughout the United States.

ACAP's advocacy work focuses on representing publicly sponsored programs and health care providers who serve vulnerable populations. ACAP also promotes universal access to quality and cost-efficient care.
http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0124z none• Network Adequacy. ACAP supports CCIIO’s proposed provider directory requirements under sections 156.230(b)(1)-(2), including the requirement that directories be updated at least monthly.

We oppose the requirement that issuers complete a provider directory template and believe that CCIIO should a) engage members of the issuer community, consumer advocates, providers and other relevant parties in a workgroup to develop a definition of and discuss the feasibility and details of a machine-readable format, b) provide the public an opportunity to comment on that definition, and b) provide a three-year transition period before any such requirement goes into effect.


*Network Adequacy: Under section 156.230(b)(1)-(2), CCIIO is proposing additional requirements of provider directories including requiring directories be easily accessible, updated at least monthly, and available in hardcopy as requested. Also, at a minimum provider directories must contain information regarding: providers accepting new patients, providers’ location, contact information, specialty, medical group and providers’ institutional affiliation(s).

ACAP and its member plans are committed to finding ways to enhance the transparency of provider networks and thus are supportive of the provider directory requirements CCIIO has proposed under this section.

CCIIO has also requested comments on potentially requiring that provider directories be machine-readable or that issuers complete a provider directory template to aide third parties in creating consumer-friendly provider directory tools.

ACAP is in favor of consumer-friendly tools that will help consumers pick the best plan for themselves and their families but these tools are only helpful when accurate and up-to-date, otherwise they serve as another point of potential consumer confusion.

ACAP shares CCIIO’s concerns regarding maintenance of a provider directory template and therefore we are opposed to requiring issuers to submit such a template. Before ACAP is able to formally comment on the machine-readable format proposed requirement, we request additional guidance from CCIIO on what this requirement might entail.

ACAP suggests that CCIIO define “machine-readable” in a draft rule and provide the public an opportunity to comment on that definition. Furthermore, we recommend that CCIIO engage members of the issuer community, consumer advocates, providers and other relevant parties in a workgroup to develop a definition of and to discuss the feasibility and details of a machine-readable format.

Should CCIIO decide to move forward with the machine-readable provider directory requirement, we request a three-year transition period before the requirement would go into effect.


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Alliance of Community Health Plans (ACHP)
http://www.achp.org/
The Alliance of Community Health Plans (ACHP) is a national leadership organization bringing together innovative health plans and provider groups that are among America’s best at delivering affordable, high-quality coverage and care. ACHP’s member health plans provide coverage and care for more than 18 million Americans.
http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0057z noneProvider Directory Requirements: ACHP supports the proposed changes to the provider directory requirements for QHPs in §156.230. Up-to-date, accurate and complete provider directories are a critical source of information for individuals and families to select a plan that will meet their needs.

Both marketplaces and carriers are learning and improving their capabilities to provide online, consumer-friendly, up-to-date directories at the time of plan selection. Carriers rely on the ongoing cooperation of their contracted or network providers to assist them in maintaining up-to-date, accurate information.

In addition to including provider location, contact information, specialty, medical group, and any institutional affiliations, we support the requirement to designate whether the provider is accepting new patients. This is a significant challenge, however, that depends in part on providers sharing the responsibility to update information.

To promote greater understanding of a plan's structure and process for accessing care, directories may also inform consumers about how to access specialty care through referrals, or access afterhours advice and urgent care contact and location information.

Efforts by marketplaces to aggregate provider directory information to create online tools for consumers should be sourced with the most up-to-date information held by health plans. We recommend that provider directory files be provided in a machine-readable format for the sole purpose of the State Based Marketplace or Federally-Facilitated Marketplace producing an easy-to-use tool for enrollees or potential enrollees.

(Additional specificity will be needed on requirements for machine-readable formats.) To promote accuracy and provide more complete information, we recommend that a Marketplace tool that aggregates provider directory information should also include links directly to the plan’s own public facing provider directory.

As proposed in the rule, the plan's directory should be updated monthly to reflect changes in contracted, network, or employed providers.

We would also like to comment on the feasibility of incorporating information on physical accessibility for individuals with disabilities. If HHS moves forward with requiring this information, gathering this data would most likely take more time than is available for the 2016 submission dates. We recommend that if this information is required, it should be made effective for the 2017 plan year submission.
inscoformy favorite insco so far...
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Delta Dental Plans Association
https://www.deltadental.com/Public/index.jsp
Delta Dental is the largest dental plan system in the United States. The Delta Dental Plans Association is composed of 39 independent Delta Dental member companies operating in all 50 states, the District of Columbia and Puerto Rico. These member companies provide coverage to 59.5 million people, enrolled in over 97,900 groups. While many of the Delta Dental member companies and the Delta Dental Plans Association (DDPA) are non-profit organizations, a few of the member companies have for-profit segments.http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0138z noneThe Notice of Proposed Rule Making (NPRM) proposes Qualified Health Plans (QHPs) continue to use the reasonable access standard adopted in the 2015 Letter to Issuers in the Federally Facilitated Marketplaces (2015 Letter to Issuers) as the Department of Health and Human Services (HHS) awaits the outcome of the National Association of Insurance Commissioners’ (NAIC) Network Adequacy Model Review Subgroup revisions to the Managed Care Plan Network Adequacy Model Act (#74)(Model Act).

Also, the NPRM proposes that issuers must publish and update provider directories at least monthly. In addition, provider directories must indicate which providers are accepting new patients. The NPRM invites comments on requiring QHPs to make provider information publicly available on their websites in a machine-readable file and format specified by HHS or requiring that this information be submitted to HHS through a HHS-designed standardized template.

DDPA supports keeping provider information available on issuer websites as opposed to submitting it to HHS. The submission of files to HHS and the inevitable reconciliation process between SADP and HHS file formats would add administrative burdens and cost without an added benefit to subscribers. Further, the availability of this information on issuers’ websites, which are updated nightly by at least some SADPs, is the best way to ensure consumers can easily access current information and can utilize search functions geared to local needs.
inscofor
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UnitedHealth Group
http://www.unitedhealthgroup.com/
UnitedHealth Group Inc. is a diversified managed health care company headquartered in Minnetonka, Minnesota, U.S. It is No. 14 on Fortune magazine's top 500 companies in the United States. UnitedHealth Group offers a spectrum of products and services through two operating businesses: UnitedHealthcare and Optum. Through its family of subsidiaries and divisions, UnitedHealth Group serves approximately 70 million individuals nationwide. In 2011, the company posted a net earnings of $5.142 billion.http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0274Formulary Drug List: The Agency should not impose a machine-readable file and format itself but instead engage with the industry on a detailed technical level to develop an open standard. The setting of a data standard involves significant complex technology and process considerations which vary from company to company and which should be addressed by multiple stakeholders in the system with the requisite experience and knowledge.

Instead of imposing the standard itself, HHS should engage with the industry through the National Council for Prescription Drug Programs (NCPDP). NCPDP is a not-for-profit, ANSI-accredited, standards development organization with over 1500 members representing most sectors of the pharmacy services industry. NCPDP has successfully created industry open standards such as the Telecommunication Standard and Batch Standard, the SCRIPT Standard for Electronic Prescribing, the Manufacturers Rebate Standard and other standards to improve communication within the pharmacy industry.

We believe that NCPDP, or some other similar industry group, is best situated to create an industry open standard machine-readable file and format that would be of the most use to consumers, pharmacy benefit managers, HHS itself, and other healthcare participants. We also believe that the effective date for any requirement should be at least one year after the development of the open standard so that companies have sufficient time for the significant technology systems development that will likely be necessary.
concernedz noneinsco
appreciate that they just say "this should be done.. just not by HHS"
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Anthem
https://www.anthem.com/
Anthem Inc., previously known as WellPoint, Inc., is the largest for-profitmanaged health care company in the Blue Cross and Blue Shield Association.http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0123HHS also proposes to require issuers to make their formulary lists available in a machine-readable format. Anthem agrees that consumers need tools to make decisions, but any formulary tool should be created and maintained by the exchange, which already has these data. Anthem believes that issuers are already providing ample formulary information, and creating additional files would create significant burden. Moreover, Anthem is concerned about potential uses of its formulary data by third parties with whom Anthem does not have a business or contractual relationship. If issuers were required to post machine-readable files for general consumption by third parties, issuers would have no ability to ensure that their benefit information was correctly represented by those third parties. Inaccurate information not only would increase the burden on issuers; it also would create consumer confusion and potential dissatisfaction.againstz noneinsco
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Anonymous (Dean Health Plan)
http://www.deancare.com/insurance/
Established in 1983, Dean Health Plan is the insurance services subsidiary of Dean Health System and SSM Health Care. It maintains a position of leadership in insurance services through a physician-led integrated health system that improves the health status of its members and delivers a superior level of service and care.http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0032Publication of List of Drugs on Formulary Drug List (156.122(d)

a. DHP opposes defining up-to-date to mean that the formulary drug list URL must accurately list all of the health plan’s covered drugs at that time. Instead, we suggest that up-to-date be defined as monthly. This is because of the fluid nature of drug additions and withdrawals from the market--daily changes are not uncommon.

b. DHP opposes having the formulary tiering information include cost-sharing information, as there are many multiples of cost-sharing for a single formulary. For instance, a plan may offer tens, if not hundreds, of plan variations that are based on the same formulary. This requirement would vastly increase the complexity of formulary publication and maintenance, as a separate posting for each variation of a plan would be necessary.

c. DHP requests that, prior to adopting a requirement that issuers make information available in a machine-readable format, HHS define “machine-readable” and allow interested parties make comments on the definition.



concernedz noneinsco
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DocSpot
https://www.docspot.com/
DocSpot connects people with appropriate doctors, therapists, dentists, optometrists, and other health care providers.http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0298z noneAs a representative of DocSpot (a company that helps people make health care decisions), I would like to underscore the usefulness and importance of requiring insurance companies to publish their provider directory in a machine-readable format that identifies physicians with NPI numbers.

Knowing which doctors accept a patient's insurance plan is one of the top questions that people ask; after all, who wants to be stuck with a bill from an out-of-network physician?

Currently, people find comfort when selecting doctors from their insurance carrier's website, since they believe that their carrier has accurate network information.

However, provider directories have not been a priority for traditional insurance companies (when is the last time you heard someone gush about their insurance company's doctor directory?).

As a result, patients end up missing out on a whole host of features that have been and may be developed by organizations that focus on doctor directories.


Additionally, by requiring insurance companies to publish their doctor directories, external organizations can develop better tools to help consumers select insurance plans that are appropriate to their situations. For example, someone needing very specialized care might gladly pay higher premiums for a stronger network.

Currently, however, there is not a great way for consumers to assess how broad each insurance plan's network is.

Insurance companies should compete on the strength of their networks, the quality of their services, and the price of their premiums, not on how few other organizations have access to their network information.

Requiring insurance companies to release this information in a machine-readable format will support innovation by enabling consumers to better evaluate insurance plans and more easily select physicians.
opendatafor
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U.S. Open Data Institute
https://usopendata.org/
The U.S. Open Data Institute is a grant-funded, non-profit organization that partners with government and private-sector organizations to facilitate the publication of open data. It is our mission to improve governance and society through open data.http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0040z noneI’m writing recording the Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2016 (CMS9944P, RIN 0938-AS19). Specifically, I’m writing to provide comment in favor of the addition of 156.230(b)(2), which would require that QHP issuers publish their provider directory.

The U.S. Open Data Institute is a grant-funded, non-profit organization that partners with government and private-sector organizations to facilitate the publication of open data. It is our mission to improve governance and society through open data.

We have discussed this proposed rule change with information technology professionals working in the public and private sectors, in order to determine the technological difficulty of fulfilling this requirement. We spoke with high-level employees (CTO-level) and engineers who would be responsible for fulfilling this mandate.

Based on this research, and our own experience, it is our conclusion that the proposed requirement that QHP issuers make [provider directory] information publicly available on their Web sites in a machine-readable file and format specified by HHS is a wholly obtainable goal that will not prove burdensome to providers, and that will simplify enormously consumers task of selecting an insurance plan that fits their needs.

Insurers already store this data electronically, so it would be easier for them to provide this as data than in a traditional format (e.g., on paper, as a PDF, etc.) Providing this data electronically, updated periodically, will allow the data to be used at its full potential, creating significant value within government and within the private sector.

Provider directories could be published as simple Extensible Markup Language (XML) or JavaScript Objection Notation (JSON) files, available on QHP issuers websites. Because there are no existing standards for provider directories, we support the proposal that HHS specify a format for QHP issuers to use, since that will eliminate any need for them to define their own standard while also defining a universal standard. These records could be harvested by services like HealthCare.gov, allowing consumers to select plans that allow them to maintain their relationships with their existing healthcare providers.

Publishing these records as static files would require computing resources too minuscule to meter. QHP issuers would not need to invest in new servers, software, employees, or infrastructure this is all well within their existing capabilities. Maintaining these files should be automatic, since they’re generated using QHP issuers existing internal databases of providers.

The U.S. Open Data Institute enthusiastically supports the proposed addition of 156.230(b)(2). Requiring QHP issuers to publish provider directories as open data will serve consumers well, create transparency that is essential to a well-functioning market, and help HHS to better understand and monitor the market. Thank you for proposing an important change in the ACA.
opendatafor
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Health 2.0 LLC
http://www.health2con.com/
Health 2.0 is a conference and health technology innovation company. It fosters new development in consumer health care technologies, and is a rallying point for the community trying to improve health care for all. http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0304z noneSubject--Immediately updated provider directories machine readable via APIs should be mandated for health insurers.


We are Matthew Holt and Indu Subaiya, the Co-Chairman of Health 2.0 LLC, a conference and consulting company that works with many companies and individuals at the hub of the patient/consumer use of new technology in health care. In addition our CTO, Daniel Kogan has significant experience building provider search web sites including working with companies such as Healthgrades, Vitals and BetterDoctor.


Finding accurate information about providers is one of the hardest things for consumers to do while interacting with the health care system. While regulation cannot fix all of these issues, these proposed regulations in section 156.230 can greatly help,

But they should be strengthened by requiring (under subsection 2) that health insurers immediately add new information about providers in their networks to a publicly available machine readable database accessible via a freely available API.


Currently companies trying to aid consumers in provider search and selection tell us that the information pertaining to which providers are in a particular network is the least accurate of all data they can receive. For consumers the biggest question for plan selection is trying to find out which provider is in their plan, and at the least this requires searching multiple websites.

Worse, particular insurer's plans can even have the same name but can have different networks (in one instance in our personal experience Aetna in New York state had two different plans with effectively the same name but different networks).

This is essentially impenetrable for consumers and that is assuming that the information on the websites is accurate or timely--which it is often not.


Provider search companies (like Vitals, Better Doctor, Healthgrades, Angies List) often turn to third party vendors who sell information about insurance company provider networks but these services are both expensive and incomplete.


If each insurer provided information on its networks as soon as they change their data in their own database and had open API access to that data set, provider search companies could immediately both receive this information and they could also build comparison tools across insurers' different products.

Very quickly a market would emerge in providing this information in a central place (and quickly thereafter it could be included directly into the health insurance exchanges). This would help consumers who would be able to immediately understand which doctors were in the networks--often the most important part of their insurance selection decision.


In addition, providers themselves could query this data set, and if there was inaccurate information, they could request for it to be changed publicly, or "challenge" it--just as frequently retailers or vendors criticized on Yelp do. (For example, they could say, "no we don't accept Aetna Gold" if the data was wrong)


Additionally, others will be able to include this directory information in yet more data sets that will help with the overall transparency of the system. Something those across the political spectrum agree is beneficial.


You will likely hear from insurance companies saying that this data provision is too hard or would take them too long to update. But the fact is that once the information about a provider being part of a network is collected, it gets entered in some data base within the insurer.

As long as that database has a publicly available API, there's no reason why there need be any additional expense or barrier to making that information public.

Given the billions of dollars of taxpayers' money we are currently giving insurers as part of the ACA, there is no reason why they shouldn't make this minor change to their systems--which will vastly improve the experience of health care consumers and providers.
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Wilbanks, Johnz nonez nonehttp://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0084z none- Provider Directories should be updated monthly, with previous versions of data files kept available for at least one year.

- Each insurance provider should provide a single csv file, which includes data for all of their plans.
- The provider directory data files should be served by HTTPS.

- Specifically the links to the data files in question should contain no redirects or other methods to prevent deep linking. The URL to this HTTP/S web directory in question should be provided to HHS for inclusion in the HHS PUF files. URLs should include the https:// portion of the URL for clarity.

- PDF and web-browsable versions of the provider directories should be required to link the URL where the machine readable provider directories data files are kept.

- All files should be in the *.csv format.

- The field names and field ordering in *.csv files should be specified by HHS.




personfor
53
Gleason, Amyz nonez nonehttp://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0028z noneThank you for proposing that insurance companies provide plans to release machine readable data about their provider networks. It is very important that providers, and therefore patients, be able to know when a provider is in our out of network. This becomes an issue when selecting an insurance plan as well as when selecting a doctor or place to have a procedure. It is often an answer that feels impossible to get a 100% accurate answer. Instead, the usual answer is, "We think" or "You should" and that isn't enough when decisions are being made that can literally mean financial ruin for people if they pick the wrong one.

Please do not create a duplication of the NPPES database. Instead require the listings to use the most recent NPPES database listing so that the data is consistent. Providers often forget to update those, and when they start getting used more regularly, it makes connecting systems and information in healthcare better - something that has traditionally been very, very challenging. In order to improve these things, we have to start reusing things that we already have. We also encourage a PDF file that can easily be read by patients, even from their smartphone, in case they need an answer quickly and on the go.

personfor
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Pfizer Inc
http://www.pfizer.com/
Pfizer, Inc. /ˈfaɪzər/ is an American multinational pharmaceutical corporation headquartered in New York City, and with its research headquarters in Groton, Connecticut, United States. It is one of the world's largest pharmaceutical companies by revenues. http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0181*Transparency requirements: Pfizer supports all improved transparency proposals and urges HHS to finalize them for implementation in 2016.

In particular, we support the use of machine-readable formats for formulary documents that include clear coverage, tiering, utilization management, and cost-sharing data, as well as information on coverage of medical benefit drugs.



*Transparency requirements: HHS proposes a number of transparency requirements with a target implementation date of 2016. Plans would be required to make public an up-to-date, accurate, and complete list of all covered drugs, including tiering and utilization management.

The proposed rule would require that formulary documents are easily accessible to enrollees, prospective enrollees, the state, the Exchange, HHS, OPM and the general public, as well as posted on the plan’s public website.

HHS is also considering whether to require that the formulary be available in a machine readable format, or whether HHS should consider implementing a standardized template.

HHS also notes that all plans subject to EHB are also subject to guaranteed renewability requirements and can only make product modifications at the time of coverage renewal. However, HHS is unclear about whether it considers mid-year formulary changes to be prohibited modifications.










for z nonepharma
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Anonymous (Curtis G. Oltmans)
https://www.linkedin.com/pub/curt-oltmans/a/108/57

http://www.novonordisk-us.com/documents/article_page/document/l_coltmans.asp

Curtis G. Oltmans is Corporate Vice President & General Counsel for Novo Nordisk Inc., North America. He is responsible for strategy and initiatives in the areas of law, quality, intellectual property, US corporate giving & social impact, government affairs & public affairs for the company’s substantial business in North America.

He is a member of the company’s North American executive team and serves on various internal and global steering groups and committees. He joined Novo Nordisk Inc. in 2005.
http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0018Formulary Transparency: Novo Nordisk strongly supports the requirement for plans to publish an up-to-date, accurate and complete list of all covered drugs on the formulary-including the plan's tiering structure and any restrictions on how drugs can be obtained.

It is critical for patients to understand their cost sharing for medications, including when they must meet a deductible and any other applicable cost sharing requirements. As such, Novo Nordisk would support including this information on the formulary.

We believe this information is critical to ensuring patients (particularly those with chronic conditions, like diabetes) can select a plan that best meets their needs. Furthermore, we encourage HHS to require that this information be available in a machine-readable file and format, to allow third parties to create resources to assist potential enrollees when selecting a plan.
forz nonepharma
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Lilly USA LLC
http://www.lilly.com/Pages/Home.aspx
Lilly is a global health care leader that unites caring with discovery to make life better for people
around the world. For more than a century, we have stayed true to a core set of values—excellence,
integrity, and respect for people—that guide us in all we do: discovering medicines that meet real
needs, improving the understanding and management of disease, and giving back to communities
through philanthropy and volunteerism.
http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0220Formulary Transparency: The proposed regulation includes several enhancements to health plan transparency. Lilly supports the proposed requirements that health plans publish an up-to-date, accurate and complete list of all covered drugs, including any tiering structure it has adopted, and any restrictions on the manner the drug can be obtained.

Lilly seeks clarification regarding what is meant by a “tiering” structure. Lilly also supports the proposed standard requiring the information to be made easily accessible, and providing examples of ways plans can meet this requirement.

In the preamble, HHS solicits comments on whether the formulary tiering information should include cost-sharing information, such as the enrollee’s applicable pharmacy deductible, copayment or cost sharing percentage.

14 Lilly supports requiring the provision of this additional information as it provides enrollees with important information about the total costs they will incur in obtaining prescription medications. This will thereby improve beneficiaries’ ability to select a plan best-suited to their individual health needs.

HHS also states that it is considering requiring that health plans make the formulary information publicly available on plan websites in a machine-readable format. Lilly supports this proposal as it will facilitate the ability of third-parties to develop formulary tools that can help enrollees in their plan selection. However, Lilly continues to believe that a plan finder tool similar to the one used in the Part D program is the optimal approach for enrollees as it can help minimize the complexity associated with plan selection and help enrollees find a plan best aligned to their current treatment regimen and medical needs.

Lilly believes that HHS should continue to work towards the creation of a Medicare Part D-like Plan Finder tool for Exchange plans so that enrollees can receive all of the advantages of a competitive and diverse insurance marketplace. In the meantime, Lilly supports HHS’ proposed formulary transparency requirements as a positive step towards this broader goal and urges the Department to finalize them in regulation.
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Sunovion Pharmaceuticals Inc.
http://www.sunovion.com/
Sunovion Pharmaceuticals, Inc. ( former NASDAQ: SEPR ), known until October 12, 2010 as Sepracor, Inc. prior to its acquisition by Dainippon Sumitomo Pharma of Japan,[2] is a pharmaceutical company founded in 1984 by Timothy J. Barberich, Steve Matson, and Bob Bratzler. It was originally located in Princeton, New Jersey and then re-located to Marlborough, Massachusetts.[3]http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0200Formulary Transparency. Sunovion applauds CMS’ proposal to require plans to publish, in a manner that is easily accessible to patients, clear, up-to-date, and accurate formulary information that fully discloses all covered drugs and includes any tiering structure and/or other restrictions that apply to each drug.18 Too often, patients are unable to make an informed choice when selecting an insurance plan because they are not provided with sufficient information to determine how their medications will be covered under the available plans. Patients must have this information prior to December 22, 2014 CMS–9944–P Page 6 of 9
enrollment in order to make informed decisions. Ensuring that such information is provided will facilitate appropriate access, which, in turn, will help manage patients’ long-term health conditions and treatment costs. Accordingly, we support CMS’ proposal to require that plans provide this important formulary information to current and prospective enrollees in an easily accessible manner and user-friendly format.
Additionally, Sunovion supports CMS’ proposal to require that each formulary be provided in a machine-readable format. Currently, many formularies require patients to type each of their drugs into a search engine, rather than fully listing all of the drugs covered; this type of formulary format hinders the ability of patients and their providers to readily determine which drugs are covered for a particular condition. We also support the proposed requirement that formularies must be up-to-date with current coverage, as newly covered drugs may not otherwise be listed on the formulary, discouraging providers from prescribing them for their patients.

To further promote transparency, we urge CMS to develop an interactive web tool, to be posted on each Marketplace website, that will include a plan finder, benefit calculator, and cost calculator based on a prospective enrollee’s individual health conditions and current medications. While the proposed rule suggests that third parties might develop such tools based upon machine-readable formularies, we believe that CMS is in the best position to develop a tool that best supports prospective enrollees. CMS does not need to create new tools, as models already exist in the Part D program.
We also note that, although the proposed rule, if finalized, will significantly improve the transparency of prescription drug benefit formularies, it does not address the current lack of transparency for patients with respect to drugs covered under a plan’s medical benefit. We encourage CMS to require plans to disclose their coverage of drugs under a medical benefit, either in the same formulary as the prescription drug benefit or in a separate formulary with the same transparency and access requirements reflected in the proposed rule.
Finally, and quite critically, Sunovion strongly urges CMS to require the inclusion of cost-sharing information in formulary information that must be posted publicly as part of these important transparency standards. For purposes of patient compliance (as well as overall health care system cost containment), medications must be covered and affordable for the patients who need them. The absence of cost-sharing information is a glaring omission from formulary transparency under the current standards. Such cost-sharing information should be provided with full transparency for each drug and in a manner that is easily accessible and understandable. This includes enrollees as well as potential enrollees in a plan. We appreciate that CMS has requested comments on this issue, and we strongly urge the agency to require that plans provide full, accurate, and up-to-date cost-sharing information on plan formularies for all listed drugs. This information should include deductibles, co-pay and/or co-insurance obligations, and any other relevant cost-sharing responsibilities. December 22,

These improvements to formulary transparency should take effect by January 1, 2016.
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CVs Health
http://www.cvshealth.com/
CVS Health (formerly CVS Caremark Corporation and originally founded as Melville Corporation) is an American retailer andhealth care company. CVS Health operates over 7,700 CVS Pharmacy and Longs Drugs stores; a pharmacy benefit manager, mail order and specialty pharmacies, a retail-based health clinic subsidiary, Minute Clinic; and an online pharmacy, CVS.com.

CVS Health is chartered in Delaware, and is headquartered in Woonsocket, Rhode Island, where its four business units are also headquartered. As of 2014, it ranked 35th in the Fortune Global 500 list of the world's largest companies, and 12th in the United States-only Fortune 500. It was the largest company in either list with operations solely in the United States
http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0099Publication of Formulary: CMS proposes to require issuers to publish an up-to-date, accurate, and complete formulary and any restrictions in an easily accessible manner, such as on the plan’s public Web site. This formulary would be required to be accessible without creating or accessing an account or entering a policy number, and in a manner that allows an individual to easily discern which formulary applies to which plan if the issuer has multiple formularies.

CMS states that “up-to-date” means that the formulary drug list URL link must accurately list the plan’s covered drugs at that time. CMS solicits comments on whether the formulary should be required to list cost sharing information, whether the URL link for this purpose should be the same as for obtaining drug coverage information in the Summary of Benefits and Coverage, and whether the information on the Web site should be in machine-readable file and format.

CVS Health supports the requirement for issuers to publish a current, accurate and complete formulary on their public Web sites, and agree with CMS that this will increase transparency and allow enrollees and potential enrollees to make more informed decisions.

We recommend that CMS not require plans to include cost sharing, day supply and other plan design information on the formulary. This specific information may differ for each plan variation, resulting in exponentially more formulary variations that must be maintained, with the attendant complexity, potential for confusion and mistakes, particularly with the proposed requirement that Web sites be kept accurate and up-to-date at all times.

Because such benefit information is in reality part of the plan design, rather than the formulary, it should, more appropriately, be available in the summary of benefits and coverage documents.

We also recommend that CMS allow issuers some latitude in the requirement that the formulary be accurate and up-to-date at all times to account for situations where the formulary change is outside the control of an issuer, such as the removal of a drug from the market.

In addition, we ask CMS to clarify that this requirement applies only to negative formulary changes. Issuers should always have the leeway to add new drugs on the formulary, even if there may be a time lag before the online formulary reflects those new drugs on the formulary.

This will allow issuers to make positive formulary changes effective more quickly for enrollees, rather than delaying them until such time as the online formulary tool can be updated to reflect them.
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one of few who actully commented on content options
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Johnson & Johnson
http://www.jnj.com/
Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886. Its common stock is a component of the Dow Jones Industrial Average and the company is listed among the Fortune.http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0114Transparency CMS proposes that plan formularies and provider network lists must be updated and available, and seeks comment on whether formularies and provider network documents should be required to be available in machine-readable form.

We commend CMS on proposing this important step toward plan transparency, and we recommend that CMS finalize the proposal and that CMS require machine-readable files so that third party enrollment assisters will have the information needed to help patients choose the right plans.


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GlaxoSmithKline (GSK)
http://us.gsk.com/
GlaxoSmithKline (GSK) is a global healthcare company that is committed to helping people to do more, feel better and live longer.http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0065Transparency to prescription drug formularies. GSK strongly supports CMS’ proposal to add a new requirement to the EHB prescription drug benefit requiring issuers to publish an up-to-date, accurate, and complete list of all covered drugs on its formulary drug list, as well as, any tiering structure, formulary restrictions and cost-sharing specific to a QHP. GSK recommends that these provisions apply both to drugs covered by the pharmacy benefit as well as to drugs covered by the medical benefit when delivered in an outpatient setting.

We believe that heightened transparency to this information will assist consumers shopping for a health plan to make a better and more informed choice on their healthcare coverage. Additionally, GSK agrees with CMS on its proposal that would require plans to make their drug formulary: (1) accessible on its’ public website through a clearly identifiable link without necessitating the patient to create an account or entering a policy number; (2) listed in a machine-readable file and format, which would provide an opportunity for third party vendors to create resources that can aggregate information on different plans, thus assisting enrollees in making more informed choices, and (3) consistent with the prescription drug coverage found in the Summary of Benefits and Coverage.

In addition, we believe that it would be helpful for consumers to have access to two versions of the drug list, one version organized alphabetically and the other organized by category or call of medicine. Lastly, GSK recommends that CMS should clarify that the formulary be inclusive of all drugs including specialty drugs. This level of transparency will benefit beneficiaries and providers alike.
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Pharmaceutical Care Management Association
http://www.pcmanet.org/
The Pharmaceutical Care Management Association (PCMA) is the American national trade association representing pharmacy benefit managers. According to the association's mission statement, PCMA advocates on behalf of its member companies, which claim to improve affordability of prescription drugs and quality of care through the use of tools such as electronic prescribing (e-prescribing), promoting the increased use of generic drugs and mail-service pharmacies, and other innovative cost-saving tools.http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0175
c. Should the formulary transparency rule also mean that plans must make the information publicly available in a machine-readable file and format specified by HHS?

We would be pleased to provide input on acceptable technical specifications for a
“machine-readable file and format.” However, in light of the short comment
period provided for these rules, we suggest that HHS provide an industry work
group or other stakeholder vehicle to obtain this type of technical input.


concernedz nonepharma
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American Hospital Association
http://www.aha.org/
The American Hospital Association (AHA) is a professional association that seeks to promote quality health care provision byhospitals and health care networks through public policy and providing information about health care and health administration to health care providers and the public.

Founded in 1898 with offices in Chicago, Illinois and Washington, D.C., the AHA hosts a Resource Center with over 47,000 books on health care (some services fee based) and maintains a Health Planning and Administration (HEALTH) database that provides current information on health care unrelated to clinical treatment. Membership includes close to 5,000 organizations and 37,000 individuals.
http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0101z noneNetwork Adequacy Standards . The AHA believes it is important to ensure that enrollees have access to a selection of high quality providers in or near their communities, while not inhibiting care coordination and the growth of integrated care systems.

The AHA supports the enhancements to network adequacy standards that were contained in the Issuer Letter for 2015 QHPs offered under the federally facilitated exchange, such as notice, disclosure and special enrollment procedures, when significant changes are made to provider networks during or after open enrollment. We are pleased to see in this proposal that those enhancements will continue to be applied to 2016 QHP applicants.

The AHA also supports the additional enhancements included with respect to provider directories and the “encouragement” that plans provide a transitional period for new enrollees during which they can continue to receive services from a previous provider not in the new plan’s network if they are in the midst of an active treatment plan, though we recommend that the 30-day limit be changed to 60 days to allow sufficient time to transition care.

We are concerned that 30 days is not a sufficient time for a new enrollee to identify a new in-network physician, obtain an appointment, see that physician and enable a smooth transition from the previous physician to a new physician so that their course of treatment is not disrupted. This is especially the case for treatment by sub-specialists.

With respect to provider directories, we believe the proposed requirements will improve and standardize somewhat the information that will be available to consumers and enrollees. In the preamble, HHS asks for comment on how often provider directories should have to be updated on issuer websites.

The AHA recommends as much standardization of the content of provider directories as possible, the movement toward machine readable formats to enable the development of cross-plan search and comparison functions, and online updating no less often than the first day of each month. Updates should reflect additions, deletions, changes in a provider’s status (such as whether a physician is accepting new patients), and changes in provider affiliations (such as where a physician has hospital admitting privileges). Such network changes should be incorporated in online directories within 30 days of notice from the provider.

Plans should not rely solely on provider notice of changes, however. They also should do outreach to providers periodically, especially when providers stop submitting claims to the plan

Finally, we understand the desire to wait for the revised model state act on network adequacy that the National Association of Insurance Commissioners is developing, but regret that it will then push changes in the federal standards out an additional year to 2017. Given the further delay in significant changes, we urge HHS to continue monitoring for unaddressed problems related to network adequacy.
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American Medical Association
http://www.ama-assn.org/ama
The American Medical Association (AMA), founded in 1847 and incorporated in 1897, is the largest association of physicians—both MDs and DOs—and medical students in the United States.http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0129(2014 December 18 Comments on Benefits of Proposed Rule Letter)

Formulary Transparency: The AMA strongly supports the proposed rule’s provisions to increase formulary transparency. Under the proposal, health plans would be required to publish on their public website up-to-date, accurate and complete lists of all covered drugs on their formulary drug list where they could be accessed without a consumer creating or accessing an account or entering a policy number.

If an issuer offers more than one plan, the list would need to clearly identify which formulary goes with which plan. The information would need to include any tiering structure that the plan has adopted and any restrictions on obtaining the drug.

In addition, CMS notes in the preamble that the information on formularies should be linked to the URL link for obtaining prescription drug information in the Summary of Benefits and Coverage; however, CMS does not include this expectation in the actual regulatory text and we recommend that CMS do so.

We believe that all of these additions will improve the transparency of prescription drug benefits in EHB plans and help patients make the best decisions to meet their needs, and urge that they be implemented in 2016.

We also think that these provisions would be strengthened by including cost sharing information, such as the enrollee’s applicable pharmacy deductible, copayment, or cost-sharing percentage, for each formulary tier.

Since plans are using co-insurance more frequently, plans should provide what the actual enrollee cost sharing will be in dollar terms. We believe this information is critical to allow informed consumer decision-making about out-of-pocket expenses that may be incurred, and urge CMS to require this information in the final rule.

CMS is also considering making insurers release machine-readable information so that third parties could use it to develop search and shopping tools. There is currently no standard formulary design and some formularies have search capabilities while others do not.

We support this proposal as a way to make it easier for patient and consumer groups to analyze plan data and develop tools, such as a plan finder or benefit calculator that matches an individual’s prescriptions with appropriate plans, similar to the one utilized by the Medicare Part D program.

One area that CMS does not address is restrictions on the ability of plans to change formularies during an enrollee’s period of coverage. While plans should be able to make changes during the plan year to add newly approved or newly approved uses for drugs, as well as remove drugs for safety reasons, plans should not be allowed to take drugs off their formulary for non-safety reasons or move them to higher cost-sharing tiers year during an enrollee’s period of coverage due to the potential for adverse and medical and financial implications to the patient.

for CMS is also considering requiring insurers to submit provider directory information in machine-readable form or using an HHS-designated standardized template so that software developers can create tools for consumers to better access this information. We support such a proposal and believe it would help increase transparency on plan information.



CMS acknowledges the work on network adequacy currently underway by the National Association of Insurance Commissioners (NAIC), which released a draft model act last month, and notes that it will await the NAIC’s final model act before proposing significant changes in its requirements.


The AMA has been working very closely with the NAIC and has submitted extensive comments on the draft model bill. Interested stakeholders representing hospitals, physicians, and other health care providers serving children and adults, as well as health care consumers, signed onto a letter drafted by the AMA and the Children’s Hospital Association that was sent to the NAIC in November (see attached copy). We believe that this letter can help inform future policy development by CMS. The letter sets forth the following key principles:
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American Heart Association/American Stroke Association
http://www.heart.org/HEARTORG/

http://www.strokeassociation.org/STROKEORG/
The American Heart Association (AHA) is a non-profit organization in the United States that fosters appropriate cardiac care in an effort to reduce disability and deaths caused by cardiovascular disease and stroke.

Originally formed in New York City in 1915 as the Association for the Prevention and Relief of Heart Disease, it is currently headquartered in Dallas, Texas. The American Heart Association is a national voluntary health agency.


Created in 1997, the American Stroke Association is dedicated to prevention, diagnosis and treatment to save lives from stroke — America’s No. 5 killer and a leading cause of serious disability.
We fund scientific research, help people better understand and avoid stroke, encourage government support, guide healthcare professionals and provide information to enhance the quality of life for stroke survivors.
http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0077There is an additional protection for consumers that we urge HHS to consider: prohibiting plans from deleting drugs from their formulary mid-year or moving them to a higher cost-sharing tier (with some exceptions for some limited circumstances, such as when a drug is found by the FDA to be unsafe or it is switched to over-the-counter status).

Many patients needing certain medications carefully choose a plan to ensure they will have coverage for them but are then trapped in a plan that no longer meets their needs if their insurance company removes the drug from the formulary.

We are also very supportive of the proposals to increase formulary transparency. In order for patients to select the plans that best meet their individual health care needs, they must have access to easy-to-understand, detailed information about formularies, and the costs of medications. While we have seen some transparency improvements with the 2015 plans, many plans still do not have a direct link to a plan’s formulary on the SBC as required by the ACA.

In order to find the formulary, multiple searches must be conducted for some plans. The proposed rule reiterates the ACA requirement and proposes that each plan publish up-to-date, complete formularies with information about tiers and any restrictions on accessing the drug. HHS is also seeking comment on whether formulary tier information should include cost-sharing information, such as the pharmacy deductible, if any, and cost-sharing.

We are supportive of all of these common-sense proposals that help patients understand and utilize their coverage. However, since plans are employing the use of co-insurance more frequently, plans should detail what the actual patient cost-sharing would be in dollar terms. Co-insurance percentages are often meaningless to patients since they have no way of knowing how the percentage translates to how much they will have to pay for a drug or service.

We also are very supportive of the proposal to require plans to submit drug formularies in machine-readable file. Currently, there is no standard formulary design and some have search capabilities while others do not.

We would very much like to see an interactive web tool such as a plan finder or benefit calculator that matches an individual’s prescription needs with appropriate plans, such as exists for the Medicare Part D program. Submitting information in a standard machine-readable format can assist in developing such tools.
forThe preamble to section 156.230(b) states, “we propose that a QHP issuer must update the directory information at least once a month.” We support this standard and recommend that the final regulation be modified to require that directory information be updated as frequently as required under guidance from HHS.

Given that most plans do update their directories frequently based on the information they receive from providers, but very severe provider directory inaccuracies persist, we encourage HHS to put in place additional measures to address this problem.

Inaccurate directories mask issues of inadequate networks and make it impossible for consumers to identify plans that meet their needs when shopping and find providers when it is time for them to obtain care. While standards that require plans to conduct timely directory updates are important for directory accuracy, they simply are not sufficient.

The types of requirements that HHS could also institute to help achieve greater directory accuracy include:
• A requirement that all plans prominently list in their directories an email address or phone number for members of the public to directly notify the plan when provider directory information is inaccurate and a requirement that plans be accountable for investigating these reports and modifying directories accordingly in response.
• A requirement that plans internally audit their directories and modify directories accordingly based on audit findings.
• A requirement that plans contact providers listed as in-network who have not submitted claims within the past six months to determine whether the provider still intends to be in network and modify their directories accordingly.
• A requirement that plans honor provider directory information. If a consumer relies on materially inaccurate information from a directory indicating that a provider is in-network and receives care from that provider, the plan should be required to hold the consumer harmless and charge the consumer only in network cost-sharing for the care.


Finally, we support the concept of requiring issuers to make their provider network information publicly available in machine-readable files and formats as specified by HHS. We believe this would be beneficial for creating different ways that consumers could access provider information, and hopefully could also catalyze increased accuracy of provider directories as more entities review directory information and make it publicly accessible.

We also support the submission of this type of information directly to HHS and hope that HHS can eventually create integrated provider directories for the FFM. Integrated, searchable directories could potentially be more accurate than existing directories if they allowed integrated updates. For example, if a provider retired, the provider could inform the marketplace that he or she was no longer practicing, and the provider could be removed this provider from all plans’ directories simultaneously, instead of having to communicate with multiple issuers’ and wait for each of those issuers to remove the provider’s information from their directories.
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American College of Physicians
https://www.acponline.org/
The American College of Physicians (ACP) is a national organization of internal medicine physicians (internists) specialists who apply scientific knowledge and clinical expertise to the diagnosis, treatment, and compassionate care of adults across the spectrum from health to complex illness. With 141,000 members, ACP is the largest medical-specialty organization and second-largest physician group in the United States.http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0131z noneACP supports the proposed rule’s requirement that provider directories be up-to-date, accurate, complete, and, at a minimum, include the provider information specified in the rule. Online provider directories should be updated at least monthly.

The College reiterates its support for the development of an online search tool to allow federally-facilitated marketplace users to search for QHPs by clinician and hospital name and filter out health plans that do not include the consumer’s chosen clinician or hospital in network. Requiring QHP issuers to provide network data in machine-readable format may facilitate the development of such tools by third-party entities; however, this should not substitute the agency’s work to develop tools to improve the consumer shopping experience.


ACP requests adoption of the continuity of care provisions that would allow an out-of-network physician to continue treatment of a patient regardless of network status during the first 30 days following enrollment in a new QHP. ACP supports language that would require issuers to count out-of-network cost-sharing toward the annual out-of-pocket limit.

While the language in 156.130 would make this optional, the College requests that at a minimum, out-of-network cost-sharing for care received when appropriate physicians (i.e. subspecialists) or services are not offered in the plan’s existing network be applied to the annual limitation on cost sharing.
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American College of Nurse-Midwives
http://www.midwife.org/
The American College of Nurse-Midwives (ACNM) is the professional association that represents certified nurse-midwives (CNMs) and certified midwives (CMs) in the United States.

With roots dating to 1929, ACNM sets the standard for excellence in midwifery education and practice in the United States and strengthens the capacity of midwives in developing countries.
http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0017z noneProvider Directories:
Discussion
CMS has proposed to require plans to:

• Publish an up-to-date, accurate, and complete provider directory, including information on which providers are accepting new patients, the provider’s location, contact information, specialty, medical group, and any institutional affiliations, in a manner that is easily accessible to plan enrollees, prospective enrollees, the State, the Exchange, HHS and OPM.
• Update the directory information at least once a month, and that a provider directory will be considered easily accessible when the general public is able to view all of the current providers for a plan on the plan’s public Web site through a clearly identifiable link or tab without having to create or access an account or enter a policy number.
• Ensure the general public is able to easily discern which providers participate in which plan(s) and provider network(s).
• Make this information publicly available on their web sites in a machine-readable file and format specified by HHS.

ACNM is strongly in favor of these proposed requirements. As noted above, our survey found that ten percent of plans that contract with CNMs do not list them in their provider directories, making it impossible for current or potential plan enrollees to find them as providers. Furthermore, many plans list CNMs under the obstetrician/gynecologist category, which may make it difficult for women who are searching for a “midwife” to find them within the directory. Additionally, of the plans in our survey that contract with birth centers (often staffed by CNMs), eight percent stated they do not list them in their provider directory.

In the course of our survey, conversations with plans uncovered the fact that several contract with physician groups that employ midwives and as a consequence, will cover the services of the midwives in those contracted groups, but will not separately list the midwives within their provider directory.

These incomplete directories or categorization of midwives in the OB/GYN section are problematic. They obscure an important provider resource within the plans, which ultimately damages the plans themselves, as current and potential enrollees are unable to get a full picture of the value of the plan without clear information.



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Alliance of Specialty Medicine
http://www.specialtydocs.org/index.php
The Alliance of Specialty Medicine (the Alliance) is a coalition of national medical societies representing specialty physicians in the United States.

This non-partisan group is dedicated to the development of sound federal health care policy that fosters patient access to the highest quality specialty care.
http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0086z noneProvider directories. Regarding provider directories, we support CMS’ proposals to strengthen the provider directory requirements by requiring that a QHP issuer must publish an up-to-date, accurate, and complete provider directory, including information on which providers are accepting new patients, the provider's location, contact information, specialty, medical group, and any institutional affiliations, in a manner that is easily accessible to plan enrollees, prospective enrollees, the State, the Exchange, Health and Human Services (HHS) and Office of Personnel Management (OPM).

In addition to the specialty designation, we urge CMS to include subspecialty designations. The directory should also include a field that provides advance notice (of at least 90 days) to consumers if a provider is expected to be terminated or will drop from the plan, including the date at which the termination or provider will no longer be part of the plan network.

As part of this requirement, CMS is proposing that a QHP issuer must update the directory information at least once a month, and that a provider directory will be considered easily accessible when the general public is able to view all of the current providers for a plan on the plan's public Web site through a clearly identifiable link or tab without having to create or access an account or enter a policy number.

According to CMS, the general public should be able to easily discern which providers participate in which plan(s) and provider network(s) if the health plan issuer maintains multiple provider networks and the plan(s) and provider network(s) associated with each provider should be clearly identified on the Web site.

We support a monthly requirement as an initial step to ensuring provider directories are up-to date in 2016; however, effective for 2017, CMS should require health plans should have improved their information and technology infrastructures and capabilities such that their in network provider directory can be maintained and accessible to the public in “real-time.” In its final rule for 2016, CMS should encourage health plans to begin working to modify and upgrade their systems for a “real-time” provider directory in 2017. Furthermore, CMS should require plans to

We encourage CMS to require issuers to make this information publicly available on their Web sites in a machine-readable file and format so as to provide the opportunity for third parties to create resources that aggregate information on different plans in a consumer-friendly format.
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Graham, Emily (The Alliance of Specialty Medicine members )
http://www.specialtydocs.org/index.php
The Alliance of Specialty Medicine (the Alliance) is a coalition of national medical societies representing specialty physicians in the United States. This non-partisan group is dedicated to the development of sound federal health care policy that fosters patient access to the highest quality specialty care.http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0110z noneProvider directories. Regarding provider directories, we support CMS’ proposals to strengthen the provider directory requirements by requiring that a QHP issuer must publish an up-to-date, accurate, and complete provider directory, including information on which providers are accepting new patients, the provider's location, contact information, specialty, medical group, and any institutional affiliations, in a manner that is easily accessible to plan enrollees, prospective enrollees, the State, the Exchange, Health and Human Services (HHS) and Office of Personnel Management (OPM).

In addition to the specialty designation, we urge CMS to include subspecialty designations. The directory should also include a field that provides advance notice (of at least 90 days) to consumers if a provider is expected to be terminated or will drop from the plan, including the date at which the termination or provider will no longer be part of the plan network.

As part of this requirement, CMS is proposing that a QHP issuer must update the directory information at least once a month, and that a provider directory will be considered easily accessible when the general public is able to view all of the current providers for a plan on the plan's public Web site through a clearly identifiable link or tab without having to create or access an account or enter a policy number.

According to CMS, the general public should be able to easily discern which providers participate in which plan(s) and provider network(s) if the health plan issuer maintains multiple provider networks and the plan(s) and provider network(s) associated with each provider should be clearly identified on the Web site.

We support a monthly requirement as an initial step to ensuring provider directories are up-to-date in 2016; however, effective for 2017, CMS should require health plans should have improved their information and technology infrastructures and capabilities such that their in-network provider directory can be maintained and accessible to the public in “real-time.”

In its final rule for 2016, CMS should encourage health plans to begin working to modify and upgrade their systems for a “real-time” provider directory in 2017. Furthermore, CMS should require plans to

We encourage CMS to require issuers to make this information publicly available on their Web sites in a machine-readable file and format so as to provide the opportunity for third parties to create resources that aggregate information on different plans in a consumer-friendly format.
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Alliance of Specialty Medicine
http://www.specialtydocs.org/index.php
The Alliance of Specialty Medicine (the Alliance) is a coalition of national medical societies representing specialty physicians in the United States. This non-partisan group is dedicated to the development of sound federal health care policy that fosters patient access to the highest quality specialty care.http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0235z noneProvider directories. Regarding provider directories, we support CMS’ proposals to strengthen the provider directory requirements by requiring that a QHP issuer must publish an up-to-date, accurate, and complete provider directory, including information on which providers are accepting new patients, the provider's location, contact information, specialty, medical group, and any institutional affiliations, in a manner that is easily accessible to plan enrollees, prospective enrollees, the State, the Exchange, Health and Human Services (HHS) and Office of Personnel Management (OPM). In addition to the specialty designation, we urge CMS to include subspecialty designations.

The directory should also include a field that provides advance notice (of at least 90 days) to consumers if a provider is expected to be terminated or will drop from the plan, including the date at which the termination or provider will no longer be part of the plan network. As part of this requirement, CMS is proposing that a QHP issuer must update the directory information at least once a month, and that a provider directory will be considered easily accessible when the general public is able to view all of the current providers for a plan on the plan's public Web site through a clearly identifiable link or tab without having to create or access an account or enter a policy number. According to CMS, the general public should be able to easily discern which providers participate in which plan(s) and provider network(s) if the health plan issuer maintains multiple provider networks and the plan(s) and provider network(s) associated with each provider should be clearly identified on the Web site.

We support a monthly requirement as an initial step to ensuring provider directories are up-to-date in 2016; however, effective for 2017, CMS should require health plans should have improved their information and technology infrastructures and capabilities such that their in-network provider directory can be maintained and accessible to the public in “real-time.” In its final rule for 2016, CMS should encourage health plans to begin working to modify and upgrade their systems for a “real-time” provider directory in 2017. Furthermore, CMS should require plans to We encourage CMS to require issuers to make this information publicly available on their Web sites in a machine-readable file and format so as to provide the opportunity for third parties to create resources that aggregate information on different plans in a consumer-friendly format.
providersfor
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Coalition of State Rheumatology Organizations
http://www.csro.info/
The Coalition of State Rheumatology Organization (CSRO) is comprised of over 30 state and regional professional rheumatology societies whose mission is to advocate for excellence in the field of rheumatology, ensuring access to the highest quality care for the management of rheumatologic and musculoskeletal disease.http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0260z noneProvider directories. Regarding provider directories, we support CMS’ proposals to strengthen the provider directory requirements by requiring that a QHP issuer must publish an up-to-date, accurate, and complete provider directory, including information on which providers are accepting new patients, the provider's location, contact information, specialty, medical group, and any institutional affiliations, in a manner that is easily accessible to plan enrollees, prospective enrollees, the State, the Exchange, Health and Human Services (HHS) and Office of Personnel Management (OPM). In addition to the specialty designation, we urge CMS to include subspecialty designations.

We also urge CMS to require issuers to provide advance notice (of at least 90 days) to consumers if a provider is expected to be terminated or will drop from the plan, including the date at which the termination or provider will no longer be part of the plan network, as part of the directory.

Also, we support a “real-time” provider directory, and urge CMS to direct issuers to make this possible not later than 2017. We can support a monthly requirement as an initial step to ensuring provider directories are up-to- date in 2016.

Finally, we encourage CMS to require issuers to make this information publicly available on their Web sites in a machine-readable file and format so as to provide the opportunity for third parties to create resources that aggregate information on different plans in a consumer-friendly format.
providersfor
71
Coalition of State Rheumatology Organizations
http://www.csro.info/
The Coalition of State Rheumatology Organization (CSRO) is comprised of over 30 state and regional professional rheumatology societies whose mission is to advocate for excellence in the field of rheumatology, ensuring access to the highest quality care for the management of rheumatologic and musculoskeletal disease. http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0081z noneProvider directories. Regarding provider directories, we support CMS’ proposals to strengthen the provider directory requirements by requiring that a QHP issuer must publish an up-to-date, accurate, and complete provider directory, including information on which providers are accepting new patients, the provider's location, contact information, specialty, medical group, and any institutional affiliations, in a manner that is easily accessible to plan enrollees, prospective enrollees, the State, the Exchange, Health and Human Services (HHS) and Office of Personnel Management (OPM). In addition to the specialty designation, we urge CMS to include subspecialty designations.

We also urge CMS to require issuers to provide advance notice (of at least 90 days) to consumers if a provider is expected to be terminated or will drop from the plan, including the date at which the termination or provider will no longer be part of the plan network, as part of the directory.

Also, we support a “real-time” provider directory, and urge CMS to direct issuers to make this possible not later than 2017. We can support a monthly requirement as an initial step to ensuring provider directories are up-to-date in 2016.

Finally, we encourage CMS to require issuers to make this information publicly available on their Web sites in a machine-readable file and format so as to provide the opportunity for third parties to create resources that aggregate information on different plans in a consumer-friendly format.
providersfor
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Oncology Nursing Society (ONS)
https://www.ons.org/
The Oncology Nursing Society (ONS) is a nonprofit membership organization of more than 37,000 registered nurses and other healthcare providers in patient care, education, research, and administration in oncology nursing.http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0083z noneProvider directories. We support CMS’ proposals to strengthen the provider directory requirements by requiring that a QHP issuer must publish an up-to-date, accurate, and complete provider directory, including information on which providers are accepting new patients, the provider's location, contact information, specialty, medical group, and any institutional affiliations, in a manner that is easily accessible to plan enrollees, prospective enrollees, the State, the Exchange, Health and Human Services (HHS) and Office of Personnel Management (OPM). We also urge CMS to require plans to include advanced practice nurses (APRN) in their directories.

We support a monthly requirement as an initial step to ensuring provider directories are up-to-date in 2016. For 2017, CMS should require health plans to make their provider directory accessible in “real-time”.

We also encourage CMS to require issuers to make this information publicly available on their Web sites in a machine-readable file and format so as to provide the opportunity for third parties to create resources that aggregate information on different plans in a consumer-friendly format.
providersfor
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Oncology Nursing Society
https://www.ons.org/
The Oncology Nursing Society (ONS) is a nonprofit membership organization of more than 37,000 registered nurses and other healthcare providers in patient care, education, research, and administration in oncology nursing.http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0247z noneProvider directories. We support CMS’ proposals to strengthen the provider directory requirements by requiring that a QHP issuer must publish an up-to-date, accurate, and complete provider directory, including information on which providers are accepting new patients, the provider's location, contact information, specialty, medical group, and any institutional affiliations, in a manner that is easily accessible to plan enrollees, prospective enrollees, the State, the Exchange, Health and Human Services (HHS) and Office of Personnel Management (OPM). We also urge CMS to require plans to include advanced practice nurses (APRN) in their directories.

We support a monthly requirement as an initial step to ensuring provider directories are up-to-date in 2016. For 2017, CMS should require health plans to make their provider directory accessible in “real-time”.

We also encourage CMS to require issuers to make this information publicly available on their Web sites in a machine-readable file and format so as to provide the opportunity for third parties to create resources that aggregate information on different plans in a consumer-friendly format.
providersfor
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American College of Mohs Surgery
http://www.mohscollege.org/
Founded in 1967 by Dr. Frederic E. Mohs, the American College of Mohs Surgery (ACMS) is a membership organization of more than 1,200 fellowship trained skin cancer and reconstructive surgeons specializing in the Mohs micrographic surgical technique used to treat skin cancer.

The ACMS serves as the voice of the specialty, promoting and advancing the highest standards of patient care through fellowship training, research, education and public advocacy
http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0082z noneProvider directories. We support CMS’ proposals to strengthen the provider directory requirements. In addition to the inclusion of the provider’s specialty designation, we urge CMS to also include subspecialty designations, such as Mohs micrographic surgeon, which is a recognized subspecialty of dermatology.

In addition, we urge CMS to require that provider directories include a field that provides advance notice (of at least 90 days) to consumers if a provider is expected to be terminated or will drop from the plan, including the date at which the termination or provider will no longer be part of the plan network.

We also support CMS proposal that a QHP issuer must update the directory information at least once a month during 2016. Moving into 2017, however, CMS should require health plans maintain a “real-time” provider directory. In its final rule, CMS should make this clear to plans so they have time to modify and upgrade their information technology systems to accommodate this requirement.

Finally, we encourage CMS to require issuers to make this information publicly available on their Web sites in a machine-readable file and format so as to provide the opportunity for third parties to create resources that aggregate information on different plans in a consumer-friendly format.
providersfor
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American Nurses Association (ANA)
http://www.nursingworld.org/
The American Nurses Association (ANA) is the only full-service professional organization representing the interests of the nation's 3.1 million registered nurses through its constituent and state nurses associations and its organizational affiliates. The ANA advances the nursing profession by fostering high standards of nursing practice, promoting the rights of nurses in the workplace, projecting a positive and realistic view of nursing, and by lobbying the Congress and regulatory agencies on health care issues affecting nurses and the public.http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0070z noneWhen considering future revisions to network adequacy rules, ANA strongly urges CMS to consider the important role APRNs play in meeting the demand for primary care.

The reported failure of Medicaid and/or Medicare managed care organizations to assure coverage of the services of clinicians specifically mentioned in those respective programs’ benefit packages suggests that CMS must do more to address that issue. Medicare operations are delineated in Title 18 of the Social Security Act. All four APRN roles are separately identified as part of the Medicare benefit package as follows:

Certified nurse-midwives—1861(gg)(2)
Nurse practitioners—1861(aa)(5)(A)
Certified Registered Nurse Anesthetists—1861(bb)(2)
Clinical Nurse Specialists—1861(aa)(5)(B).

In order to fully provide Medicare benefits, a Medicare Advantage Plan offering to enroll Medicare beneficiaries through a State-based Health Insurance Exchange or a Federallyfacilitated Marketplace must include sufficient numbers of the specified APRNs credentialed in its proposed network of providers.

Similarly, the Medicaid benefit package separately identifies certified nurse-midwife services and nurse practitioner services as distinct parts of an enrollee’s benefits (in sections 1905(a)(17) and 1905(a)(21), respectively). Section 1906 authorizes State Medicaid plans to designate additional clinicians in order to incorporate their services into their Medicaid benefit packages. Many States have so designated CRNA services and CNM services. Again, in order to fully provide Medicaid benefits, a Medicaid Managed Care Plan offering to enroll Medicaid enrollees through a State-based Health Insurance Exchange or a Federally-facilitated Marketplace must include sufficient numbers of the specified APRNs credentialed in its proposed network of providers. Medicaid section 1932(a)(5)(B)(iv) suggests that if any services mandated for the benefit package are not made available by a managed care entity, that entity is obliged to inform the beneficiaries and also to inform them how they can get access to such services. Section 1932(b)(7) further suggests that a managed care entity cannot exclude providers by specialty except if the entity can demonstrate that they already have sufficient numbers of such specialists in their networks.

Finally, with regard to the current proposals, ANA supports the proposal to revise §156.230(b) concerning the provider directory requirements. Providing up-to-date, accurate and complete provider directories would improve transparency for patients seeking contact information as well as information such as which providers are accepting new patients and where the providers are located. We also support the proposal to make this information publically available in a machinereadable format, as that would also enhance transparency by allowing patients and consumer groups to better analyze data and develop tools to compare plans.





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American College of Mohs Surgery
http://www.mohscollege.org/
The American College of Mohs Surgery (ACMS) is a membership organization of fellowship trained skin cancer and reconstructive surgeons specializing in the Mohs micrographic surgical technique used to treat skin cancer.

The ACMS serves as the voice of the specialty, promoting and advancing the highest standards of patient care through fellowship training, research, education and public advocacy.

http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0229z noneProvider directories. We support CMS’ proposals to strengthen the provider directory requirements. In addition to the inclusion of the provider’s specialty designation, we urge CMS to also include subspecialty designations, such as Mohs micrographic surgeon, which is a recognized subspecialty of dermatology.

In addition, we urge CMS to require that provider directories include a field that provides advance notice (of at least 90 days) to consumers if a provider is expected to be terminated or will drop from the plan, including the date at which the termination or provider will no longer be part of the plan network.

We also support CMS proposal that a QHP issuer must update the directory information at least once a month during 2016. Moving into 2017, however, CMS should require health plans maintain a “real-time” provider directory. In its final rule, CMS should make this clear to plans so they have time to modify and upgrade their information technology systems to accommodate this requirement.

Finally, we encourage CMS to require issuers to make this information publicly available on their Web sites in a machine-readable file and format so as to provide the opportunity for third parties to create resources that aggregate information on different plans in a consumer-friendly format.
providersfor
77
American Medical Association
http://www.ama-assn.org/ama
The American Medical Association (AMA), founded in 1847 and incorporated in 1897,[3] is the largest association of physicians—both MDs and DOs—and medical students in the United Stateshttp://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0129CMS is also considering making insurers release machine-readable information so that third parties could use it to develop search and shopping tools. There is currently no standard formulary design and some formularies have search capabilities while others do not. We support this proposal as a way to make it easier for patient and consumer groups to analyze plan data and develop tools, such as a plan finder or benefit calculator that matches an individual’s prescriptions with appropriate plans, similar to the one utilized by the Medicare Part D program. We support this proposal as a way to make it
easier for patient and consumer groups to analyze plan data and develop tools, such as a plan finder or
benefit calculator that matches an individual’s prescriptions with appropriate plans, similar to the one
utilized by the Medicare Part D program.

One area that CMS does not address is restrictions on the ability of plans to change formularies during an enrollee’s period of coverage. While plans should be able to make changes during the plan year to add newly approved or newly approved uses for drugs, as well as remove drugs for safety reasons, plans should not be allowed to take drugs off their formulary for non-safety reasons or move them to higher cost-sharing tiers year during an enrollee’s period of coverage due to the potential for adverse and medical and financial implications to the patient.
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National Community Pharmacists Association
http://www.ncpanet.org/
The National Community Pharmacists Association, founded in 1898 as the National Association of Retail Druggists (NARD), represents the pharmacist owners, managers, and employees of more than 23,000 independent community pharmacies across the United States. The nation's independent pharmacies, independent pharmacy franchises, and independent chains dispense nearly half of the nation's retail prescription medicines.http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0282Formulary Drug Lists: NCPA generally supports the proposed rule that health plans publish up-to-date, accurate and complete list of all covered drugs on its formulary list and in a manner that is easily accessible. Inclusion of formulary tiering information and cost sharing information would improve transparency for enrollees and potentially reduce out-of-pocket spending.

NCPA is concerned, however, with the proposed requirement that issuers make formulary lists “publicly available on their websites in a machine-readable file and format specified by HHS” to provide the opportunity for third parties to create resources that aggregate information on different plans. Is the intention to establish a web portal similar to Plan Finder in the Part D program? Without clear marketing standards, we are concerned about the potential of information being shared with third parties that may engage in misleading marketing, or efforts to steer patients to plan options that do not best meet their needs.


concernedz noneproviders
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American Congress of Obstetricians and Gynecologists et al
http://www.acog.org/
The American Congress of Obstetricians and Gynecologists (ACOG), a 501(c)(6) organization, is the nation's leading group of physicians providing health care for women. As a private, voluntary, nonprofit membership organization of approximately 55,000 members, ACOG strongly advocates for quality health care for women, maintains the highest standards of clinical practice and continuing education of its members, promotes patient education, and increases awareness among its members and the public of the changing issues facing women's health care. The American College of Obstetricians and Gynecologists (The College), a 501(c)(3) organization, is its companion organization.http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0250§156.122(d): Publication of Formulary Drug List: We strongly support the proposed requirements for publication by health plans of the formulary drug list. The proposals will simplify the process for consumers to find the formulary that corresponds with their health plan and could prevent consumers from making decisions based on the incorrect drug list.

We support the proposal in the preamble that formulary tiering information include cost sharing information. Although all FDA-approved methods of contraception must be covered without cost-sharing (and thus not tiered) providing the public with clear information as to whether there is cost-sharing is critical. In addition, other drugs that may be used for women’s reproductive health may be subject to cost-sharing and consumers will need this information as well. We urge the Department to consider ways plans can provide accurate cost information on the formulary for drugs covered with coinsurance amount.

We support additional changes discussed in the preamble related to the formulary including that:
• The formulary drug list be easily accessible by the general public so that consumers can access and compare formularies prior to enrolling in coverage;
• The plan associated with each formulary be clearly identified on the plan’s web site;
• The information be up-to-date including the interpretation that up to date means the “URL must accurately list all of the health plan’s covered drugs “at that time” rather than allowing for a grace period that could result in a consumer receiving misinformation;
• The formulary information made available be provided in a machine-readable file and format, as this would allow for the exchanges or other entities to create tools to help consumers compare health plans and understand their drug coverage; and
• Consumers who cannot access plan information through an issuer’s website will also be guaranteed access to the same information.
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American Health Data Institute, Inc. (AHDI)
https://www.ahdi.com/
The American Health Data Institute (AHDI) is a data warehouse and targeted utilization management partner that combines all the necessary elements for controlling healthcare costs from both the demand and supply side of the healthcare equation. AHDI is a member of The Key Family of Companies.

AHDI utilizes information provided by the employer including medical claims data, eligibility records and pharmacy as the source data. The AHDI data warehouse utilizes very sophisticated software to analyze the variances, cost drivers, cost trends and other significant clinical and financial factors that influence the costs of a health plan. Ordinary claims data is transformed into powerful, actionable intelligence.
http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0056z nonez none
81
Hofford, Roger
https://www.carilionclinic.org/providers/roger-hofford-md
Program Director, Family Medicine Residencyhttp://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0002z nonez none
82
Cook, Loranz nonez nonehttp://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0003z nonez none
83
Anonymousz nonez nonehttp://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0004z nonez none
84
Herman, Marguerite
http://www.wyohistory.org/authors/marguerite-herman

https://www.linkedin.com/pub/marguerite-herman/a/245/7b3

Marguerite Herman has worked in education, communication and advocacy for many years and maintains an interest in all three. She reported for The Associated Press in Columbia, S.C., and later in Cheyenne, and is author of A Look at Wyoming Government (League of Women Voters, 2006.) She has been the federal legislative chair for the Wyoming PTA and is the legislative lobbyist for League of Women Voters in Wyoming. She lives in Cheyenne.http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0005z nonez none
85
Savoy Associates
http://www.savoyassociates.com/
Savoy Associates (SA) is a regional general agency with over 40 true GA contracts, offering comprehensive employer services consulting, in the NY, CT, NJ, PA, and DE markets. SA delivers the complete spectrum of new products and consulting services, technology, service and support so brokers can be successful today – and in the future.http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0006z nonez none
86
State of Hawaii
https://portal.ehawaii.gov/
Hawaii ( i/həˈwaɪ(j)i/ hə-WY-(y)ee, or, locally, [həˈwɐɪʔi]; Hawaiian: Hawaiʻi [hɐˈvɐiʔi]) is the 50th and most recent U.S. state to join the United States, having joined the Union on August 21, 1959. It is the only U.S. state located in Oceania and the only one made up entirely of islands. It is the northernmost island group in Polynesia, occupying most of an archipelago in the central Pacific Ocean.
http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0007z nonez none
87
American Staffing Association
https://americanstaffing.net/
The American Staffing Association is the voice of the U.S. staffing, recruiting, and workforce solutions industry. ASA and its affiliated chapters advance the interests of staffing and recruiting firms of all sizes and across all sectors through legal and legislative advocacy, public relations, education, and the promotion of high standards of legal, ethical, and professional practices. http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0009z nonez none
88
National Family Planning & Reproductive Health Association (NFPRHA)
http://www.nationalfamilyplanning.org/
The National Family Planning & Reproductive Health Association also known as NFPRHA is a membership organization made up of family planning and reproductive health care providers. NFPRHA lobbies for the concerns of family planning providers in Washington D.C. and provides trainings for its members all across the nation.http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0011z nonez none
89
Anonymousz nonez nonehttp://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0012z nonez none
90
Quinlan, Casey
https://www.linkedin.com/in/mightycasey
Co-Founder at Patients for Clinical Researchhttp://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0013z nonez none
91
Carevoyance
http://carevoyance.com/
We provide actionable data on every provider in the United States, sourced from hundreds of federal, state and private databases.http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0014z nonez none
92
School-Based Health Alliance
http://www.sbh4all.org/site/c.ckLQKbOVLkK6E/b.7453519/k.BEF2/Home.htm
The School-Based Health Alliance is a nonprofit 501(c)3 organization that was founded in 1995. We are the national voice for school-based health care. We serve the school-based health care field by providing technical assistance, resources, and trainings so they can provide the best-quality health care to their patients. In addition, we advocate for policies on the local, state, and federal level that strengthen school health. We support our technical assistance and advocacy work—and the entire school-based health care field—through quality research and evaluation.http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0015z nonez none
93
Catchings, Sue
http://www.schoolhealthathcs.org/explore.cfm/contactus/administrativeoffices/bio
Sue Catchings has been the Chief Executive Officer of Health Centers in Schools (HCS) since 1994. In her tenure, the organization has doubled the number of school-based health centers (from 4 to 7); HCS successfully contracts with the Louisiana Office of Public Health, East Baton Rouge Parish School System, Recovery District Schools, Charter Schools, and others. Health Centers in Schools coordinates all health services across ninety school campuses in East Baton Rouge Parish public schools and serves approximately 45,000 children and youth.

A trainer for the National Assembly on School-Based Health Care, the American Medical Association, and the Bureau of Primary Care, Ms. Catchings' areas of expertise are in Comprehensive Risk Assessment and in Effective Systems of Care for Prevention. She served as President of the National Assembly on School-Based Health Care (2000-2001) and is a Past-President of the Louisiana Assembly on School-Based Health Care and Past-President of the Children’s Coalition of Greater Baton Rouge Board of Directors. She was also a participant in the Baton Rouge Area Chamber’s Leadership Class of 2008.

Ms. Catchings is married and enjoys her volunteer service as a leadership council member of the American Cancer Society in Baton Rouge and teaching Sunday school at the St. Francisville United Methodist Church.
http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0016z nonez none
94
Kish, Leonardz nonez nonehttp://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0019z nonez none
95
American Diabetes Association
http://www.diabetes.org/
The American Diabetes Association (ADA) is a United States-based association working to fight the consequences of diabetes and to help those affected by diabetes.

The Association funds research to manage, cure and prevent diabetes (including type 1 diabetes, type 2 diabetes, gestational diabetes, and pre-diabetes); delivers services to hundreds of communities; provides information for both patients and health care professionals; and advocates on behalf of people denied their rights because of diabetes.
http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0020z nonez none
96
Florida Coalition Against Domestic Violence
http://www.fcadv.org/
The FCADV Foundation, Inc. is a 501 (c)(3) organization established to ensure the long-term financial sustainability of life saving services for domestic violence survivors and their children by supporting Florida’s 42 certified domestic violence centers.

http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0021z nonez none
97
American Osteopathic Association
http://www.osteopathic.org/Pages/default.aspx
The American Osteopathic Association (AOA) is the representative member organization for the 82,146 osteopathic medical physicians (D.O.s) in the United States. The AOA is headquartered in Chicago, Illinois and is involved in post-graduate training for osteopathic physicians. Beginning in 2015, it will begin accrediting post-graduate education as a committee within ACGME, creating a unified accreditation system for all DOs and MDs in the United States.

The organization promotes public health, encourages academic scientific research, serves as the primary certifying body for D.O.s overseeing 18 certifying boards, is the accrediting agency for osteopathic medical schools through its Commission on Osteopathic College Accreditation, and has federal authority to accredit hospitals and other health care facilities, through its program, the Healthcare Facilities Accreditation Program.
http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0022z nonez none
98
Community Advocates Public Policy Institute
http://communityadvocates.net/ppi/
Community Advocates established the Public Policy Institute to promote and implement evidence-based policies that will prevent and reduce poverty and improve the quality of life for individuals and families in Milwaukee and throughout Wisconsin.

The Public Policy Institute is intensely engaged in researching and advocating for policy and legislation that helps people in poverty lead better lives. In addition, the Public Policy Institute works on issues related to poverty through public health efforts and interventions that increase opportunity and wellness for low-income people.
http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0023z nonez none
99
Goodman, Elizabeth
https://www.linkedin.com/pub/elizabeth-goodman/8/621/8b6
Vice President, Public Policy and Government Affairs, WellCarehttp://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0024z nonez none
100
American Psychological Association Practice Organization
http://www.apapracticecentral.org/
Practice Central, a service of the APA Practice Organization (APAPO), supports practicing psychologists in all settings and at all stages of their career. APAPO is a companion organization to the American Psychological Association. Our mission is to advance and protect your ability to practice psychology.http://www.regulations.gov/#!documentDetail;D=CMS-2014-0152-0025z nonez none