POLICY BRIEFINGS


FDA Finally Decides the Issue of Nomenclature of Biosimilars ...Sort Of


In one of the most anticipated Food and Drug Administration (FDA) guidances of the year, the agency announced its position on the nonproprietary naming of non-interchangeable biosimilars. With regard to biosimilars that meet the higher standard of interchangeability, however, the FDA has not made a decision and requests public input. The guidance, “Nonproprietary Naming of Biological Products: Guidance for Industry,” was released in August and will be open for comment until October 27, 2015. Whether a biosimilar should share an International Nonproprietary Name (INN) with its brand counterpart has been hotly debated. Small-molecule generics do share an INN with their reference products, but many stakeholders believe this paradigm is inappropriate for large-molecule biologics, which are far more complex and impossible to replicate exactly. The recent guidance indicates that FDA agrees, at least partly.

Per the draft guidance, the FDA will designate a unique suffix composed of four lowercase letters to all biological products. This will distinguish the brand product from related products and any biosimilars and, as the agency notes, is intended to help prevent inadvertent substitution. While this sounds straightforward enough, the agency did pose one question for public comment: should a biosimilar that the agency deems interchangeable pursuant to the higher statutory standard share a suffix with the reference product?

In addition to the draft guidance, the FDA also issued a proposed rule to rename previously designated biologics using the process outlined in the draft guidance. Comments to the proposed rule are due by November 12, 2015. Meanwhile, Senator Bill Cassidy (R-LA) will chair a Senate Health Education Labor and Pensions Subcommittee on Primary Health and Retirement Security hearing on Thursday September 17 entitled “Biosimilar Implementation: A Progress Report from FDA.” Since the only witness is Janet Woodcock, Director of FDA’s Center for Drug Evaluation and Research, expect a lot of questions related to the recent guidance and the agency’s thinking on the naming of interchangeable biosimilars.


New Season of MedPAC Begins


The Medicare Payment Advisory Commission (MedPAC) kicked off its 2015-2016 season September 10-11, 2015, with its new chairman, Dr. Francis J. Crosson, MD. Chairman Crosson previously served on MedPAC from 2004-2010, including as vice chair from 2009 – 2010.

As part of his opening remarks, the Chairman reiterated MedPAC’s longstanding concerns regarding Medicare payments to physicians, specifically the imbalance between primary and specialty care payments, rising drug costs and its impact on the trust fund and Medicare beneficiaries, and Medicare payments for graduate medical education (GME). He further noted that hospitals can expect to face significant changes over the next decade.

Following his comments, commissioners tackled a robust agenda, which included staff presentations, analysis and discussions on a unified payment system for post-acute care, Medicare Advantage encounter data for Part B services, Medicare Advantage star ratings, Medicare drug spending, emergency department services at stand-alone facilities, and the Centers for Medicare and Medicaid Services (CMS) open payments program.

MedPAC will continue its conversation on these and other topics at its next meeting, set for October 8-9, 2015, in Washington DC.


Medicare Premiums on the Rise...For Some


The 2015 Medicare Trustees Report provides an outlook for Medicare Part B premiums in 2016. The current Part B standard monthly premium is $104.90, but some beneficiaries could see their monthly premiums rise and fall dramatically over the next two years. According to estimates from the latest trustees report, about 70 percent of Medicare enrollees can expect to pay the same amount for their Medicare Part B coverage in 2016 due to a “hold harmless” provision in law that prevents their premiums from increasing when their Social Security benefits are not increased (a cost-of-living adjustment is not expected in 2016 because of low inflation).

But the remaining 30 percent of enrollees could face a dramatic increase in their Medicare Part B premiums because Medicare premiums, in aggregate, cover 25% of total Part B costs. The Trustees Report suggests that the 2016 Part B premiums could be as high as $159.30/month, a 52 percent increase. Beneficiaries impacted could include new Medicare enrollees and beneficiaries not receiving a Social Security check, but also those enrolled in Medicaid or a Medicare Savings Program that have their premiums paid by their state. Also impacted are higher-income beneficiaries ($85,000 for individuals and $170,000 for couples) who already have their premiums income adjusted.

The opposite impact is likely in 2017 when the Social Security benefits are expected to rise by about 3 percent, resulting in 70 percent of beneficiaries (protected by the hold harmless provision in 2016) seeing increased premiums and the remaining 30 percent seeing a substantial decline.

The Centers for Medicare and Medicaid Services (CMS) will announce the actual premium amounts in October. In the meantime, some senior advocates are urging Congress to pass a one-time fix, at an estimated $10 billion cost, that would hold off the wild premium swings for everyone.



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