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CAPITOL PERSPECTIVES CMS Guts Patient Protections In Part D T he Obama Administration welcomed in the new Administration in 2009 and enactment of the Affordable year by releasing a proposed rule that would Care Act in 2010 did not change this two-part test or change eliminate patient access protections for Medicare the six protected classes. beneficiaries in three therapeutic classes: anti-depressants, Thus, it was a surprise to patients and pharmaceutical anti-psychotic, and immunosuppressive. manufacturers alike that CMS chose to fundamentally deny Currently, Medicare Part D plans must cover "substantially critical beneficiary protections that have been entwined all" drugs in six protected classes, which ensures benefi- into the fabric of the program for eight years. Although Part ciaries can continue to take particular drugs that work for D cost growth has declined from 3 percent to 1 percent in them. The Center of Medicare and Medicaid Services (CMS) the three most recent years data is available, CMS said the proposal would eliminate these protections immediately policy change is necessary to provide plans with additional for anti-depressants and immunosuppressants and lift the tools to constrain costs and deter overutilization. protections for anti-psychotic medications in 2015. Unfortunately, the Obama Administration's approach to Patient groups have reacted with outrage. Ron Honberg, this issue is entirely consistent with its implementation director of policy and legal affairs for the National Alliance of its philosophy of healthcare "reform" — its misguided of the Mentally Ill said, "By undoing one of fixation on constraining costs trumps patient Medicare's signature protections for persons access. with mental illness, the rule disregards scienMillions of enrollees in Affordable Care Act tific understanding that psychiatric medica(ACA) plans are now painfully discovering tions are not interchangeable. A medication that their provider networks are more akin to that works for one person does not necessarily Medicaid than to the commercial plans they work for another person. Prescribing decisions may be more accustomed to. A December 2013 must be individualized, based on clinical hisMcKinsey study of 20 metropolitan areas found tory, side effects, and personal history." that two-thirds of ACA plans had "narrow" or John McManus, Although the six protected classes were not "ultra-narrow" networks, with at least 30 percent The McManus Group created in statute, the Bush Administration of the top 20 hospitals excluded. The median jmcmanus@mcmanusgrp.com premium was 26 percent lower for these plans used its administrative authority to establish the patient protections for these drugs at the than comparable benefit packages with broad outset of the program, recognizing that many dually eli- networks. gible beneficiaries were enrolling from state Medicaid plans For example, Blue Shield of California asked providers that generally did not restrict access to these products. In to accept a 30 percent discount for its ACA plan, but disaddition, the Administration understood that while patient covered that 40 percent of the doctors and 25 percent of adherence may increase the Part D spend — something its hospitals that participate in its commercial offerings contrary to the economic incentives of a free-standing pre- declined to participate in its Obamacare network. scription drug plan — it could substantially reduce overall If the CMS proposal goes through, only anti-retroviral, antihealthcare costs to Medicare. neoplastics, and anti-convulsants will retain the protected In 2008, the Democrat-controlled Congress enacted a status that has been critical to patient access and optimal cliniMedicare law, overriding President Bush's veto, which cre- cal outcomes. Patients with severe mental illnesses or organ ated a two-part test to identify protected classes. The class transplants will lose access protections to products that may of drug must be one which: be critical to their unique physiological needs. 1. Restricted access would have a major or life-threatenThe good news is that the Obama Administration's proing clinical consequence; and posed abandonment of this core beneficiary protection is 2. Beneficiaries have significant need for multiple drugs. not final — yet. Patient and disease group advocates and Importantly, that law neither explicitly affirmed the cur- other stakeholders have until March 6 to make their case, rent six protected classes nor suggested that they were provide clinical evidence, and exert political pressure to get inappropriate. In addition, rulemaking by the Obama the Obama Administration to reverse this dangerous policy. 10 LifeScienceLeader.com February 2014