Every day, millions of Americans rely upon their Medicare drug benefit to help manage their health conditions, including mental illness, organ transplants, epilepsy, Parkinson’s Disease, lupus, cancer and HIV. Because patients with these illnesses react differently to different medicines, access to the full range of effective medications is a crucial component of successful treatment and recovery. Medicare’s “Six Protected Class” policy has long stood as a guarantee to patients that their access to all available medications would never be in doubt.
Unfortunately, recent proposals that have emanated from Washington could potentially undermine Medicare's vial 'protected classes' policy. As an essential patient safeguard in Part D, the protected classes stand as a guarantee to the patients with the most complex conditions will have access to the full spectrum of medications under Part D.
In January of 2021, for example, the outgoing Trump Administration announced a new proposal that would allow Medicare Part D plans that participate in the Center for Medicare and Medicaid Innovation’s (CMMI) Part D Payment Modernization (PDM) Model to limit the drugs they cover, including denying patients access medications in the protected classes. Similarly, a November 2018 proposal fromthe Centers for Medicare and Medicaid (CMS) proposed changes that would have advanced a much more extensive set of exceptions to the protected classes policy than Congress has previously allowed. Fortunately, in May 2019, the agency issued a final rule that made no changes to the current six protected classes policy — completely eliminating the potentially damaging changes included in a proposed rule released several months earlier. Additionally, in January 2014, CMS proposed changes that would have removed the protected status of antidepressants and immunosuppressants for the 2015 coverage year, and antipsychotics in 2016. In response to strong congressional and stakeholder opposition, CMS eventually announced that the agency would not finalize the proposal to eliminate protected class status, although they acknowledged that they may look to advance these proposed changes “in future years.” If proposals to alter the “Six Protected Classes” ever goes into effect, these changes could result in a drastically reduced set of drug options for Medicare beneficiaries and people who are dually enrolled in Medicare and Medicaid. Patients who have been stabilized for years on a drug regimen could be forced to switch their medications - resulting in health setbacks, hospitalizations, or worse. And for enrollees newly diagnosed with these conditions, additional regulatory barriers could prevent them from accessing the most appropriate, clinically indicated medication selected by their provider.
Threats to the Six Protected Classes
CMMI's January 2021 Demonstration Proposal
On their final day in office, the outgoing Trump Administration, through the Centers for Medicare and Medicaid Services (CMS), announced a new proposal that would undermine key patient protections in Medicare's prescription drug program. Indeed, policy outlined in a new Request for Applications (fact sheet) would allow Medicare Part D plans that participate in the third year of the Center for Medicare and Medicaid Innovation’s (CMMI) Part D Payment Modernization (PDM) Model to limit the drugs they cover, including denying patients access medications used to manage complex conditions such as cancer, mental illness, HIV-AIDS, epilepsy, Parkinson’s, and organ transplantation. The Biden Administration will have authority to determine whether the new policy is ultimately implemented.
There are two key flexibilities that are being offered to participating plans beginning in CY 2022:
plans would be permitted to cover only one drug per therapeutic class, rather than two under the current requirements; and
plans could treat five of Medicare’s six protected classes as if they were any other class of drug, no longer requiring coverage of “all or substantially all” of the drugs in those classes. CMS says that the sixth protected class — antiretrovirals — will also be treated as any other class for CY 2023.
This hasty, deeply misguided program would severely jeopardize Medicare beneficiary access to medications used to manage complex conditions such as cancer, mental illness, HIV-AIDS, epilepsy, Parkinson’s, and organ transplantation. In response, the Partnership has launched a national grassroots campaign to urge the Biden administration to swiftly rescind this dangerous program. To support this effort, we encourage you to visit our dedicated comment portal to send a letter encouraging the Biden administration to reverse this proposal.
CMS' NOVEMBER 2018 PROPOSED RULE
As part of a broad proposed rule on Medicare prescription drug policies, in November 2018 the Centers for Medicare and Medicaid Services (CMS) proposed to weaken Medicare’s “protected classes” policy, which was created to ensure patients with the most challenging medical conditions have access to the full range of treatment options under Medicare Part D. Among their proposals, CMS suggested allowing Part D plans to implement new utilization management tools on the six protected classes, including broader prior authorization and more restrictive step therapy policies. Additionally, CMS proposed allowing plans to exclude protected class drugs whose prices rise more quickly than inflation.
Throughout the consideration of these policies, the Partnership consistently highlighted how the proposal misrepresented the scope of existing authority to restrict and manage access to medications. In doing so, the Administration’s proposal to change the six protected classes policy likely overestimates the potential for savings. Given the relatively high rate of utilization management that already occurs in the protected classes, patients with the most vulnerable health conditions already often face barriers in accessing the medications that might work best for them. Moreover, Part D plans have demonstrated that they have substantial tools at their disposal to elicit rebates for medications in the protected classes that are comparable to other drugs covered under Part D, and there is little question that access to the right therapies can help reduce costs related to hospitalization. As vulnerable patients rely on these medications to manage their particularly complex health conditions, we hope the Department will consider the longstanding sentiment of Congress in supporting this policy that effectively reduces other unnecessary health complications.
Ultimately, in May 2019, CMS issued a a final rule that makes no changes to the current six protected classes policy — completely eliminating the potentially damaging changes included in a proposed rule released several months earlier. Instead, the agency finalized current practices that allow for prior authorization (PA) and step therapy (ST) to only be used within the protected classes for so-called "new starts." Also consistent with current practice, antiretrovirals remain excluded from utilization management altogether. Importantly, CMS did not finalize exceptions for new formulations of existing drugs or drugs whose prices increase faster than inflation.
MEDPAC’S JUNE 2016 RECOMMENDATION TO CONGRESS
The Medicare Payment Advisory Committee (MedPAC) reiterated CMS’ troubling proposal in their June 2016 Report to Congress, recommending that the Health and Human Services (HHS) Secretary consider eliminating antidepressants and immunosuppresants from the classes of clinical concern. While MedPAC has asserted that the package of draft Part D recommendations — including the protected-class proposal — would lead to unspecified cost savings, a recent literature review by Avalere Health illuminates the broader implications of rescinding protected-class status and calls into question any claims of reduced Medicare expenditures. The literature review found that managed care formulary restrictions, which would more adversely affect beneficiary access to protected-class medicines if MedPAC’s draft recommendation were adopted, have problematic impacts on utilization, costs, and adherence.
CMS’ JANUARY 2014 PROPOSED RULE
As part of a broader proposed rule in January 2014, the Centers for Medicare and Medicaid Services proposed to limit and redefine, based on new criteria, the Part D program’s protected drug classes to exclude antidepressants and immunosuppressants for the 2015 coverage year, and antipsychotics in 2016. In redefining the Part D protected classes policy, CMS laid out its new criteria for deciding whether a class of drugs should have protected status: 1) failure to receive the drug would result in the patient’s hospitalization within 7 days (the timeframe for the appeals process); and 2) drugs in that class are not interchangeable. The proposed criteria excluded antidepressants and immunosuppresants from protected status beginning in 2015.
The proposed regulation was met with extraordinary opposition by Congress, patient groups and others concerned with access to medications for Medicare beneficiaries. All members of the Senate Finance Committee wrote to HHS opposing the proposed redefinition of the protected classes and said they were unconvinced that cost savings would materialize. Fifty bipartisan members of the House Ways & Means and Energy & Commerce Committees wrote to oppose the proposal, saying it would “place harmful limits on Medicare beneficiaries’ access to necessary medications that would otherwise be covered.” Additionally, over 1,400 comments were submitted by patient organizations, medical guilds, and other patient-focused groups to CMS opposing the change.
Ultimately, CMS did not finalize the proposed rule, stating it “did not strike the balance among beneficiary access, quality assurance, cost containment and patient welfare” that it had hoped to achieve. Instead, in its final rule, CMS stated that categories and classes of drugs of clinical concern would continue to be the six enumerated in the ACA until such time as the agency could undertake rulemaking to establish new criteria.
Proposals to limit access to certain medications under the Part D program would have a profound impact on the patients who benefit from having access to the full spectrum of treatment options. Medicines in the six protected classes treat serious health conditions, and among these vulnerable beneficiaries — the frail, disabled or those with multiple chronic conditions -- many medicines are not interchangeable. Seemingly similar patients often respond differently to the same drug: while one patient will respond well, a similar patient will have a suboptimal response, or worse. Further, drugs in the same class often have different side effects, and patients are often better suited to one particular drug over another.
Additionally, while proposals to alter the protected classes have frequently been suggested in the context of reducing program costs, their analysis often fails to recognize the significant tangential costs associated with limiting drug access. Independent third-party analysts have frequently acknowledged that limiting beneficiary access to vital medications will drive higher costs in Medicare Part A and Part B and Medicaid by increasing the need for inpatient care and emergency visits due to the destabilization of patients’ conditions. The costs associated with this care otherwise would not be incurred by Medicare or Medicaid.