On Tuesday, September 30, 2014, the Partnership for Part D Access hosted two congressional staff briefings—one on each side of the Capitol—to share patient and healthcare provider experiences that demonstrate the essential importance of protecting beneficiary access to proper care under the Six Protected Classes policy. Held before overflowing hearing room crowds, the briefings featured a pair of courageous patient advocates for the mental health and epilepsy communities, respectively, Trudy Lapin and Carlton Zeigler. The panel, which was moderated by Chuck Ingoglia of the National Council for Behavioral Health, also featured Dr. Nicole Brandt, Senior Care Pharmacist and Professor at the University of Maryland, Dr. Ray Martins, Chief Medical Officer of Whitman-Walker Health, Dr. Jeanie Tse, Associate Chief Medical Officer of the Institute for Community Living, Dr. Matthew Cooper, Director of Kidney and Pancreas Transplantation, MedStar Georgetown, and Dr. Joanne Buzaglo of the Research and Training Institute of the Cancer Support Community.
The Centers for Medicare and Medicaid Services (CMS) announced on March 10, 2014, that they would not finalize a proposal to eliminate protected class status for any drugs under Medicare Part D “at this time.” In a letter to members of Congress, CMS Administrator Marilyn Tavenner said that the agency will abandon its proposal to exclude antidepressants and immunosuppressants for the 2015 coverage year (and antipsychotics in 2016) from their status as protected drug classes. In the letter, Administrator Tavenner notes that CMS may look to advance these proposed changes “in future years.” The Partnership for Part D Access applauded CMS on their decision to withdraw this dangerous proposal. Click below to view the letter.
In a letter to the Department of Health and Human Services (HHS), key Republican leaders urged HHS to rescind a proposed rule that could threaten access to prescription drugs for seniors and people with disabilities. In the letter—spearheaded by Sen. Marco Rubio (R-FL) and signed by 15 Senate Republicans—the Senators urge CMS to retract the ruling immediately, indicating that “the most important pillars of the Part D program have been its robust competition among plans, protection from government interference in contract negotiations, and protection of access to life-saving drugs.” The Senators warn that the proposed rule could “undermine each of these pillars,” resulting in as many as 14 million seniors losing their current drug coverage. Click the document below to view the letter.
Partnership for Part D Access Submits Comments Urging CMS to Rescind Proposed Change to Six Protected Classes
On March 7, 2014, the Partnership for Part D Access filed comments urging the Centers for Medicare and Medicaid Services (CMS) to rescind the proposed rule that would eliminate protected class status for several categories of drugs under Medicare Part D. The comment letter notes that in the proposed rule, CMS fundamentally misinterprets the intent of the Affordable Care Act (ACA) by weakening the protected classes policy and transforming a legislative directive to identify classes of clinical concern into one targeting classes of alleged cost concern. The studies cited by the agency do not support its own cost savings assumptions and the rule ignores the substantial spending associated with the destabilization of patient care that it will precipitate. By using it as a tool for cutting costs at the expense of the most vulnerable Medicare beneficiaries, CMS contradicts Congress’s intent to improve and expand the protected classes policy. Click "Download File" to view the comments.
In a letter to CMS Administrator Marilyn Tavenner, House Energy & Commerce Oversight Subcommittee Chairman Tim Murphy (PA-18) questions the agency’s decision to eliminate protected access to mental health drugs on Medicare Part D plans. “The Proposed Rule fails to address the Agency’s past acknowledgement that Medicare beneficiaries require access to medications in therapeutic classes where different drugs are not interchangeable,” Rep. Murphy writes. “The CMS proposal appears not to be grounded in a concern over beneficiary health. Instead, the proposal seeks to increase profits through increased rebate-negotiating leverage for private Prescription Drug Plans Sponsors or insurers.”
On March 5, 2014, fifty members of the House Energy & Commerce and Ways & Means Committees penned a letter opposing a proposed Center for Medicare and Medicaid Services (CMS) rule that would eliminate protected class status for several categories of drugs under Medicare Part D. The lawmakers say that the rule, which will eliminate protected class status for several categories of drugs, will place harmful limits on Medicare beneficiaries’ access to necessary medications that would otherwise be covered. The group stated that Part D has “demonstrated the ability to provide access to important life-saving and life-enhancing medications for the vast majority of America’s seniors and non-elderly people with severe disabilities.” Click below to view the letter.
In a rare display of bipartisanship, the 24 members of the Senate Finance Committee sent a letter to the Centers for Medicare and Medicaid Services urging the agency to reconsider a proposal to limit protected class status for certain medications under Medicare Part D. “We are very concerned this change will lead to decreased access to medication, especially for those beneficiaries afflicted by mental health problems,” the senators wrote. “These vulnerable individuals rely on multiple medications to control and treat their illnesses. Unfortunately, over the course of treatment, certain medications may cause undesired side effects or become ineffective. As a result, certain beneficiaries must have a wide range of treatment options available. By limiting the number and type of medications offered under a Part D plan, a beneficiary may be forced to rely, if only temporarily, on medication that simply does not work or results in adverse side effects.” Click below to view the letter.
In a letter to Health and Human Services (HHS) Secretary Kathleen Sebelius and Centers for Medicare and Medicaid Services (CMS) Administrator Marilyn Tavenner, key Republican leaders question the legality of a proposed regulation which includes changes to Medicare Part D drug access. The letter was signed by Energy and Commerce Committee Chairman Fred Upton (R-MI), Ways and Means Committee Chairman Dave Camp (R-MI), and Senate Finance Committee Ranking Member Orrin Hatch (R-UT). The leaders write, “CMS is proposing to fundamentally undermine the program and jeopardize the prescription drug plans that millions of seniors rely on. […] Given the important legal questions and irreparable harm facing seniors across the country, we request that you reject these harmful changes to the Part D program and withdraw this proposed regulation. A failure to reject this rule will force Congress to evaluate all legislative options necessary to ensure seniors are protected.” Click below to view the letter.
As part of a broader proposed rule regarding Contract Year 2015 changes to Medicare Advantage and Part D programs, CMS is proposing limiting and redefining the Part D program’s protected drug classes to exclude antidepressants and immunosuppressants for the 2015 coverage year, and anti-psychotics in 2016. CMS argued that many of the drugs within these classes are interchangeable and will not cause hospitalization if patients do not immediately take them upon receiving a prescription. CMS determined that antipsychotics also fail to meet the new criteria, however, they will not immediately be excluded from protected status. Click below to view the proposed rule (fact sheet here).
A recent study from Harvard researchers published in the Journal of the American Medical Association (JAMA) found that implementation of the Medicare prescription drug program was followed by a $1,200 decrease in nondrug medical spending among those who previously had limited drug coverage. While researchers were unsure about early indications that newly insured seniors were in fact spending more on prescription drugs than previously, this study found that seniors were experiencing “reduced out-of-pocket costs, and improved medication adherence.” Medicare Part D, therefore, showed significant differential reductions in nondrug medical spending. This reduction in non-drug spending achieved approximately $13.4 billion in overall savings during the first full year of Part D.
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