On June 30, 2016, Sen. Chuck Grassley of Iowa and Sen. Sherrod Brown of Ohio wrote a letter urging the Centers for Medicare and Medicaid Services (CMS) to maintain current policy requiring that Medicare prescription drug plans carry six categories of prescription drugs offered to participating beneficiaries. Senators Grassley and Brown, the sponsors of legislation requiring the maintenance of the “six protected classes,” contend that the policy is meant to “safeguard access to lifesaving medicines for vulnerable Medicare beneficiaries who rely on these classes of prescription drugs to protect them from potential challenges associated with any interruption of therapy.” The Senators go on to note that “MedPAC acknowledges ‘the degree to which plans could achieve potential savings is unclear.’ Regardless of potential savings, we maintain serious concerns with MedPAC’s recent proposal and urge CMS to maintain the six protected classes policy as it currently exists.”
On March 30, 2016, in a letter to Medicare Payment Advisory Commission (MedPAC) Executive Director Mark Miller, the Partnership for Part D Access announced its opposition to a MedPAC proposal that would remove existing protections guaranteeing Medicare beneficiaries access to the full range of anti-depressant and immunosuppressant medicines. The letter notes the detrimental impact removal of these medications from the six classes protected by federal law could have on patients suffering from serious diseases – such as epilepsy, mental illness, cancer, and HIV-AIDS. In recommending that MedPAC abandon the proposal, the Partnership explains that such a change would fail to achieve any significant cost savings for the Medicare program; hold possibly “devastating health implications” for some beneficiaries; contradict Congressional intent; and ignore the “substantial flexibility” that already exists in Part D plans to help manage costs for protected-class medicines.
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.”
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 ‘Read More’ to view the comments.
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.
The Medicare Modernization Act (MMA) tasked the Centers for Medicare & Medicaid Services (CMS) with implementing the Part D benefit. In designing the benefit to take effect in 2006, CMS took several steps to ensure that Part D plans offered a robust formulary design. For example, a Part D plan must offer at least two drugs in every category or class of drugs (unless there is only one drug in the therapeutic category or class). In designing the two-drug policy, CMS wanted to “ensure sufficient drug choice for beneficiaries.” Click "Read More" to view the final rule.
According to a report from the non-partisan Congressional Budget Office (CBO), even among drugs approved to treat the same condition, some drugs in a class may be more effective than others for different patients. In many therapeutic classes, substitution between a brand name drug and a chemically different generic drug is not medically appropriate, particularly when the generic “substitute” is not the Food and Drug Administration (FDA)-approved generic equivalent of the specific brand medicine originally prescribed by the physician. The CBO concluded that “even among drugs approved to treat the same condition, important differences can exist. Some drugs in a class may be more effective than others, at least for some members of the population. Certain subpopulations—for example, people with liver or kidney disease—may need a specific brand-name drug in a class. In addition, some drugs in a class may have harmful side effects for different patients. […] Finally, physicians’ clinical experience with their patients may lead them to conclude that certain patients respond better to a particular drug from a given class.” Click below to view the report.
Under the Affordable Care Act (ACA), after reiterating the requirement that Part D plans cover “all” drugs in a protected class, Congress provided the Secretary of Health and Human Services (HHS) with authority to “identify, as appropriate, categories and classes of drugs for which the Secretary determines are of clinical concern.” Congress gave no indication, in the text of the ACA or in the accompanying body of legislative history, that it intended section 3307 be used to weaken the protected classes policy. A reading of section 3307 in the historical context of the policy’s initial enactment and subsequent endorsement in MIPPA, less than two year prior to the passage of the ACA, can only conclude that the provision was a continuation of Congress’ strong support for the protected classes policy. Furthermore, Congress enacted section 3307 without modifying the Part D non-discrimination requirement in any way. The clear intent of Congress was for the six identified classes of medications to maintain protected status. Click the below to view the law.
During implementation of the Medicare Modernization Act (MMA), which created the Medicare Part D drug program in 2003, CMS (at the urging of Congress) issued sub-regulatory guidance directing prescription drug plans (PDPs), through contract provisions, to cover “all or substantially all” medications within six therapeutic classes and categories that the agency identified. CMS explained that it “instituted this policy because it was necessary to ensure that Medicare beneficiaries reliant upon these drugs would not be substantially discouraged from enrolling in Part D plans and to mitigate the risks and complications associated with an interruption of therapy for these vulnerable populations.” Consistent with that rationale, the policy protected access to: anticonvulsants (for epilepsy); antidepressants; antineoplastics to treat cancer; antipsychotics; antiretrovirals for HIV/AIDS; and immunosuppressants to prevent rejection of transplanted organs. Click below to view the guidance.
In 2008, under Section 176 of the Medicare Improvements for Patients and Providers Act (MIPPA), Congress strengthened the so-called protected classes policy by codifying it in the Part D statute. In a strong congressional affirmation of the ongoing importance of these protections, MIPPA required Medicare Part D drug plans to include in their formularies access to all or substantially all drugs in the six identified categories of priority. MIPPA also specified two statutory criteria that CMS had to use in identifying additional classes of clinical concern: (1) restricted access to the drugs in the class would have major or life-threatening clinical consequences for individuals with a disease or disorder treated by drugs in such class; and (2) there is a significant need for such individuals to have access to multiple drugs within a class due to unique chemical actions and pharmacological effects of the drugs within a class. Click ‘Read More’ to view the law.
On December 8, 2003, the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) was signed into law by former President George W. Bush. Prior to the enactment of the MMA, Medicare prescription drug coverage was very limited, and was generally only available for physician-administered drugs, drugs necessary for the effective use of durable medical equipment such as inhalers, and a handful of drugs listed specifically in the statute. When Congress established the Medicare Part D prescription drug benefit, it recognized that certain drug classes were vital to the beneficiaries whose lives, in many cases, depended on those drugs, and that their prescribers needed access to the full range of treatment options. For example, Congress expressed significant concern regarding the needs of Medicare beneficiaries with mental illness, as illustrated in the Conference Report that accompanied the MMA. The MMA corrected a major gap in Medicare coverage, adding a new Part D to the program and provided coverage for FDA-approved drugs that had not previously been covered. Click "PLAW 108 Published 173' to view the law.
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