Dear Secretary Azar,
We, the undersigned, are deeply concerned that recent Medicare Part B proposals outlined in President Trump’s Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs and corresponding Request for Information (RFI) could have harmful consequences for patients with serious diseases. As advocates for both patients reliant on Part B medicines and the physicians and other healthcare professionals who care for them, we are alarmed that proposals to create a new Competitive Acquisition Program (CAP) in Medicare Part B and move Part B medicines under Part D coverage would place middlemen between patients and their doctors and as a result create substantial risk of impeding access to needed care, increasing costs for our nation’s sick and vulnerable patients, and creating new delays and inefficiencies in care delivery.
Part B medicines are vital to treating seniors and individuals living with conditions that require intensive management, such as cancer, rheumatoid arthritis, macular degeneration, Crohn’s disease, or primary immunodeficiency diseases. Most of the medicines used to treat these conditions are administered by a physician and have highly specialized storage, handling, and patient monitoring requirements. For example, ophthalmologists inject complex therapies for macular degeneration directly in the eyes of patients; oncologists administer infused chemotherapy to patients with cancer at infusion centers that offer important monitoring and support services; and rheumatologists, gastroenterologists and neurologists treat immune mediated conditions with infused biologics.
Due to the specialized nature of these conditions and the medicines used to treat them, many Part B patients rely on a specific treatment regimen, decided with their physician, that addresses the complexities of their disease. Often, patients must try multiple treatment options and work with their physician to identify the right medicine or combination of medicines that fit their individual needs. As a result, it is critically important that physicians have flexibility to tailor treatment to patients’ needs and that patients have prompt access to appropriate treatment as determined by their physician.
We are very worried that proposals to create a CAP and move Part B medicines under Part D coverage would restrict patient access to these needed treatments by inserting third-party middlemen between physicians and their patients. Unlike Part B, which covers all medicines that are medically necessary, Part D plans are only required to cover two medicines per class and can decide which medicines are made available to patients. Part D plans may also impose restrictions on those medicines (e.g., prior authorization, step therapy) that delay access to care.
The recent proposal by the Medicare Payment Advisory Commission to create a new competitive bidding program for Part B drugs further illustrates our concerns. Proposals like MedPAC’s pave the way for access restrictions and treatment delays, because they are designed as if patients are homogenous and treatments are commodities. In the care of patients who need physician-administered medicines, nothing could be further from the truth. In addition, experience under the previous Part B CAP program demonstrated how such programs can impede physicians’ ability to deliver and tailor treatment in a timely way. Under the original CAP, for example, physicians were required to place an order for a specific treatment with the CAP vendor in advance of the patient’s visit. This limited their ability to adjust the treatment plan if laboratory work showed a different medicine, formulation, or dosage was needed at the time of the patient’s visit.
Dosing based on weight is another example that arises with some chemotherapy treatments based on a patient’s weight – if a patient’s weight changes before their next treatment, the physician may be unable to treat the patient because they must now order these medicines in advance through a separate vendor. This could delay treatment and impact health outcomes if they need to return to the office for a second visit.
Patient access and cost sharing must be a primary concern. Proposals to move Part B medicines into the Part D program could increase out-of-pocket costs for patients or even result in a loss of coverage for certain Medicare beneficiaries. Over 80 percent of Part B beneficiaries have supplemental coverage that helps with their coinsurance. Allowing Part B medications to shift to Part D, where cost sharing for specialty medicines can reach 30, 40, or 50 percent, could significantly increase costs for those Part B beneficiaries. A recent report from Avalere Health found that average out-of-pocket costs were about 33 percent higher for Part D-covered new cancer therapies ($3,200) than for those covered in Part B ($2,400).(1) Furthermore, not all Medicare beneficiaries are currently enrolled in a Part D coverage plan, and shifting Part B medicines to Part D will result in loss of coverage for these patients.
A recent survey found that a majority of oncologists and rheumatologists are concerned about the impact proposals like these could have on treatment choices, access to care, and the administrative burden on physicians.(2) While we commend and support the administration’s efforts to lower costs for Medicare, patient access to treatment must come first. To that end, we urge the administration to reject proposals that could have a damaging impact on access and affordability of Part B medications for our most vulnerable beneficiaries.
(1) Matt Brow and Richard Kane. “Avalere Analysis Highlights Complexities of Transitioning Medicare Part B Drugs into Part D.” May 21, 2018. http://avalere.com/expertise/life-sciences/insights/avalere-analysis-highlights-complexities-of-transitioning-medicare-part-b-d?utm_source=newsletter&utm_medium=email&utm_campaign=newsletter_axiosvitals&stream=top
(2) Community Oncology Alliance. “Medicare Part B Proposals Will Harm Patients, Increase Costs and Bureaucracy.” May 16, 2018. https://www.communityoncology.org/2018/05/16/may-16-coa-physician-survey-medicare-part-b-proposals-will-harm-patients-increase-costs-and-bureaucracy/