​A new study from the Partnership for Part D Access confirms that the Medicare Part D protected classes policy is an essential pillar of protection for beneficiaries with complex health conditions. Yet, the research also highlights that Medicare prescription drug plans (PDPs) are increasingly limiting access to medications — even for patients with complex, chronic conditions. The study, performed by Avalere Health, a leading strategic advisory company, provides new insights into the various steps Medicare Part D plans are taking to manage utilization of medications covered under Medicare’s six protected classes policy. The protected classes policy is designed to ensure that Medicare beneficiaries with some of the most serious health conditions — cancer, HIV, epilepsy, mental illness, and those at risk of organ rejection, among others — have access to the full range of medicines recommended by their physician.

​For Medicare beneficiaries who need a specific medication that their doctor believes is necessary and most appropriate, the six protected classes policy is intended to ensure they can get it. However, even with these protections, this new research demonstrates that patients must often overcome layers of restrictive financial and administrative barriers put in place by plans intended to inhibit access to these essential medications.
 
According to the Avalere analysis, Part D plans are leveraging formularies and utilization management tools for Medicare beneficiaries across drugs in the protected classes. For example, in 2019, the most recent year for which data is available, plans covered just 54% of drugs across the protected classes — a decrease of nearly 20% since 2016 when the coverage rate was 67%.  For covered drugs, nearly two-thirds of all medications in the six protected classes were placed in a non-preferred or specialty category, with 89% of branded products categorized as non-preferred or specialty and 37% of generics also subject to placement on the higher tiers. In aggregate, Part D plans placed drugs from the protected classes on high tiers (non-preferred or specialty) 64% of the time.
 
These coverage limitations are particularly concerning because of the negative impact they have on patients and their quality of life. If a patient does not receive the best treatment option, it opens the door for complications resulting in emergency department visits, physician visits, hospitalization, or other types of care that increase overall Medicare costs. Moreover, because standalone Part D Prescription Drug Plans (PDPs) are not liable for the cost incurred under Medicare Part A and Part B or Medicaid, research shows that they do not work as hard as commercial plans to ensure they offer a robust formulary. That is why Congress explicitly created fundamental patient protections — including the six protected classes policy — which are unique to Medicare and recognize the unique needs of seniors and persons with disabilities who rely on Medicare. 

30 advocacy groups as part the Federal AIDS Policy Partnership (FAPP) are urging Health and Human Services (HHS) Secretary-designee Xavier Becerra to rescind a policy change from the Trump administration that would severely weaken access to life-saving HIV treatments. Their letter echoes a recent flood of complaints triggered by the new Center for Medicare and Medicaid Innovation (CMMI) Part D Payment Modernization (PDM) Model, concluding that impending changes to the Medicare Part D ‘six protected classes’ policy would exacerbate the difficulties experienced by the HIV/ AIDS community.
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​The letter explains that the six protected class policy has allowed those living with HIV to avoid the burdens of step therapy to access needed medications, as patients often require more complex treatments due to comorbidities and resistance to other antiretrovirals. Stripping away access to these medications would also leave patients vulnerable to discrimination by Part D plan sponsors. Not only is a rollback of these protections harmful to patients, it is also inconsistent with federal HIV treatment guidelines.
 
“The changes move in the wrong direction for particularly vulnerable Medicare beneficiaries, and in direct opposition to what Congress intended when it established the statutory two drugs per class requirement and the six protected classes,” the letter states.  “We again request that you rescind these policy changes to the PDM model.”
 
Signatories include: AIDS Healthcare Foundation (AHF), AIDS Action Baltimore, AIDS Alabama, AIDS Alliance for Women, Infants, Children, Youth & Families, AIDS Foundation Chicago, AIDS United, American Academy of HIV Medicine, APLA Health, Center for Health Law and Policy Innovation, Community Access National Network (CANN), Community Education Group, Community Research Initiative, Inc. (CRI), Georgia Equality, HealthHIV, HIV+Hepatitis Policy Institute, HIV Dental Alliance, HIV Medicine Association, iHealth, National Alliance of State and Territorial AIDS Directors (NASTAD), NMAC, Positive Health Solutions of the University of Illinois, Positive Women's Network-USA, Prevention Access Campaign, Rural Health Service Providers Network, San Francisco AIDS Foundation, SisterLove, Inc., The AIDS Institute, Vivent Health
 
The letter can be read here. 

Nine leading pharmacy stakeholder groups penned a letter to the Acting Director of the Center for Medicare and Medicaid Innovation (CMMI) Amy Bassano urging the Biden administration to rescind the Trump administration’s last-minute attempt to weaken Medicare’s six protected classes policy.

​The letter calls on the administration to abandon the previous administration’s formulary flexibilities for plans that participate in the Part D Payment Modernization Model, noting that two consecutive administrations have rejected proposals to weaken coverage requirements for drugs in the six protected classes. The organizations also highlight the devastating consequences that these changes would have for minority and underserved populations.
 
“…Allowing PBMs and Part D plans under the PDM model to opt-out of covering prescribed medications in the six protected drug classes is in direct conflict with President Biden’s Executive Order ‘On Advancing Racial Equity and Support for Underserved Communities Through the Federal Government,’ to ‘pursue a comprehensive approach to advancing equity for all,’” the letter states. “Accordingly, our nation’s pharmacists strongly urge you to remove these provisions in the PDM Model that would effectively strip some of our most vulnerable patients with chronic and mental health conditions from their prescribed medications.”
 
Signatories include: The American Pharmacists Association (APhA), The American College of Clinical Pharmacy (ACCP), The Accreditation Council for Pharmacy Education (ACPE), The American Society of Consultant Pharmacists (ASCP), The College of Psychiatric and Neurologic Pharmacists (CPNP), The Hematology/Oncology Pharmacy Association (HOPA), The National Alliance of State Pharmacy Associations (NASPA), The National Community Pharmacists Association (NCPA), and The National Pharmaceutical Association (NPhA).
 
The letter in its entirety can be read here. 

Two leading Medicare beneficiary advocacy groups have joined the chorus of stakeholders calling upon the President Joe Biden to take immediate action to rescind the Trump administration’s last-minute attempt to weaken coverage requirements for drugs within the six protected classes policy. 
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Led by the Medicare Rights Center and the Center for Medicare Advocacy, the letter calls on the administration to rescind formulary flexibilities for plans that participate in the Part D Payment Modernization Model. These changes would allow plan to cover only one drug per therapeutic class, and would drop the requirement for coverage of “all or substantially all” of the drugs in five out of the six protected classes.
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In their letter, the organizations cite a June 2020 analysis by Avalere demonstrating that Medicare prescription drug plans are consistently applying utilization management tools to manage spending on prescription drugs within Part D. This analysis is consistent with the Partnership-commissioned Avalere study from 2018 that clearly demonstrates that Medicare’s existing protected classes policy is working as intended for beneficiaries with cancer, HIV, transplant recipients, epilepsy, and mental illness, among others.
 
“We encourage CMS to rescind the formulary flexibilities it recently extended to plans that participate in the Part D Payment Modernization Model,” the letter states. “As analysis of earlier proposals that relax restrictions requiring plans to cover substantially all medications in the six protected classes shows, these flexibilities are unlikely to significantly drive down costs and may greatly restrict access, above and beyond the impact of utilization management tools.”
 
The letter in its entirety can be read here. 

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. 

A recent paper in the American Journal of Managed Care confirms that patients who are prescribed medications in Medicare’s “six protected classes” are consistently utilizing lower-cost generics, despite arguments from insurance companies who have said they have limited tools to contain costs for these treatments. Indeed, the authors concluded that generic dispensing rates (GDR) in the protected classes are often much higher than their non-protected counterparts — and are at least consistent with the dispensing rates among other classes of drugs. In fact, the paper suggests that plans that dispense generics at a lower rate do so to capture larger rebates from drug manufacturers, rather than to maximize access for their beneficiaries and minimize what they would pay out-of-pocket.

​The team of researchers, composed of experts from the RAND Corporation, IQVIA, the University of Southern California, and the Schaeffer Center for Health Policy & Economics, found that GDRs for the protected classes studied are well in line with prescription drugs in general. They studied 10 classes of drugs, including three of the six protected classes — antidepressants, anticonvulsants, and antineoplastics. In 2016, standalone Part D plans (PDP) had an overall GDR of 88 percent and Medicare Advantage Prescription Drug (MAPD) plans had a GDR of 90 percent, respectively. Antidepressants, the researchers found, had GDRs of between 97 and 99 percent in most plans, antineoplastics had GDRs of between 81 percent and 88 percent, and anticonvulsants between 88 and 94 percent.
 
The variation between plans may be due to payers preferring non-generic drugs in some cases — in fact, the researchers write, the variation may strongly suggest that they are doing so to seek rebates, while patients pay cost-sharing based on the full price of the drug. It also suggests that insurers use leverage in formulary decisions to benefit themselves, not the patients they are supposed to serve. While insurers have pushed for the ability to further restrict drug formularies in the protected classes, it is clear that they already have leverage in their dispensing patterns. Ending the protected classes, as some have suggested, would simply further empower insurers to restrict access to needed medications likely harming patients.