Still Protected! Medicare's Six Protected Drug Classes Policy Survives Trump's Attack

By: Brandon M. Macsata, CEO, ADAP Advocacy Association

In the waning days of the Trump Administration, Medicare Part D once again faced a serious threat. The Centers for Medicare & Medicaid Services (CMS) had authorized a potentially harmful demonstration project, which would have limited patient access to medications covered by the six protected classes (6PC) policy. The 6PC demonstration project would have proved disastrous for patients living with chronic health conditions, such as HIV/AIDS. Fortunately, President Joseph R. Biden Jr. pumped the brakes on the proposed changes.

Photo Source: The Associate Press

In Medicare Part D, 6PC protects vulnerable seniors and low-income beneficiaries with serious and complex health conditions, while also allowing Part D insurance plans to use the tools they need to control costs. Medicines for some of the sickest patients in Part D are covered within the six protected classes, including those for cancer, epilepsy, HIV/AIDS and mental illness.  Many of these conditions require patients to attempt a variety of therapies before they and their doctor settle on the most appropriate treatment, so there is no one-size fits all medicine for these conditions.[1]

Healthcare decisions for complex health conditions should be left to patients, and their doctors. For people living with HIV/AIDS, numerous factors come into play when determining the appropriate highly active anti-retroviral therapy (HAART). And now with the advent of injectable HIV therapy, such decisions take-on an entirely new dimension.  

Earlier this year, HealthHIV's Executive Director Brian Hujdich spelled out the importance of the Medicare Part D's 6PC for the HIV-positive community: "Those medications are protected for good cause. About 25 percent of people living with HIV in the United States depend on Medicare for their antiretrovirals, care, and preventative services. These patients often require very tailored treatment regimens."[2]

The insurance industry welcomed the proposed changes, but otherwise the 6PC demonstration project was universally condemned by the pharmaceutical industry, patient advocacy groups, and numerous powerful trade associations. Said Guy Anthony: “I’m deeply concerned as someone living with HIV and Bi-polar disorder. Insurers would be allowed to institute new prior authorization or step therapy requirements – or ‘fail first’ – as community advocates commonly call it. Let’s be clear, no patient should fail before being afforded life-saving treatment.”

The latest 6PC demonstration project wasn't the first time that the Trump Administration had attempted to weaken Medicare Part D. In the end, however, patients won the day! There is an inherent value in advocacy partnerships...AGAIN!

Photo Source: Partnership for Part D Access

The effort to fight the proposed changes to Medicare’s six protected classes policy was spearheaded by the Partnership for Part D Access, which is a broad coalition of healthcare stakeholders working to ensure that Medicare continues to provide beneficiaries with access to vital medications. The ADAP Advocacy Association actively fought against the proposed changes.

“Medicare beneficiaries with the most complex, chronic conditions are breathing a sigh of relief,” said Chuck Ingoglia, President and CEO of the National Council for Behavioral Health, who serves as Executive Director of the Partnership for Part D Access. “The Biden administration’s decision demonstrates the need to maintain the six protected classes policy as an essential patient safeguard in Medicare Part D.”[3]

According to the Partnership for Part D Access,[4] it was stakeholder mobilization against the 6PC demonstration project that led to it being halted by the Biden Administration. Advocacy efforts included:

• 67 bipartisan Members of Congress signed a letter to HHS and CMS urging them to withdraw the proposal;
• several thousand patients from across the country wrote letters to the CMS comment portal;
• over 130 individual patient groups joined a letter to HHS Secretary-designate Xavier Becerra;
• nine leading pharmacy stakeholder groups penned a letter to the Acting CMMI Director Amy Bassano;
• the Center for Medicare Advocacy and Medicare Rights Center sent a letter to Acting HHS Secretary Norris Cochrane; and
• a group of 30 leading HIV groups sent a letter to HHS Secretary-designate Becerra.

Although the Biden Administration is widely viewed more favorably by the patient advocacy community, now is not the time for the HIV community to let down its guard. Much more work needs to be done to reverse other harmful policies enacted by the Trump Administration, such as drug importation and co-pay accumulator programs.

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

[1] Johnson, Juliet (2019, January 31). New Research Shows Changes to the Six Protected Classes Would Harm Most Vulnerable Patients and Are Unnecessary. ADAP Blog. Retrieved online at https://adapadvocacyassociation.blogspot.com/2019/01/new-research-shows-changes-to-six.html.

[2] Hujdich, Brian (2021, February 26). President Biden must rescind a last-minute Trump rule that could leave people with HIV on the hook for thousands in prescription costs. HIV Plus Magazine. Retrieved online at https://www.hivplusmag.com/opinion/2021/2/26/trumps-parting-shot-hiv-patients.

[3] The Partnership for Part D Access (2021, March 16). Patient Advocates Applaud Biden Administration for Maintaining Medicare's Six Protected Classes Policy. Retrieved online at http://www.partdpartnership.org/newsroom/patient-advocates-applaud-biden-administration-for-maintaining-medicares-six-protected-classes-policy.

[4] The Partnership for Part D Access (2021, March 16). Patient Advocates Applaud Biden Administration for Maintaining Medicare's Six Protected Classes Policy. Retrieved online at http://www.partdpartnership.org/newsroom/patient-advocates-applaud-biden-administration-for-maintaining-medicares-six-protected-classes-policy.

An Inherent Value in Advocacy Partnerships...AGAIN! CMS Backs Down on Medicare Part D's Six Protected Drug Classes

By: Brandon M. Macsata, CEO, ADAP Advocacy Association

In a blog posted last summer we highlighted why advocacy partnerships are so important to the HIV/AIDS community, and how these partnerships advance public policies designed with patients' interests in mind. Last week, we were reminded...AGAIN...why there is an inherent value in advocacy partnerships. The Centers for Medicare & Medicaid Services ("CMS") released its Final Rule on Medicare Part D, which did not include potential harmful changes to its six protected drug classes ("6PC").

Photo Source: indystar.com

The 6PC "protects vulnerable seniors and low-income beneficiaries with serious and complex health conditions, while also allowing Part D insurance plans to use the tools they need to control costs. Medicines for some of the sickest patients in Part D are covered within the six protected classes, including those for cancer, epilepsy, HIV/AIDS and mental illness. Many of these conditions require patients to attempt a variety of therapies before they and their doctor settle on the most appropriate treatment, so there is no one-size fits all medicine for these conditions."[1]

The current Administration had proposed to weaken these drug class protections, but their attempt was met with fierce opposition from the pharmaceutical industry, patient advocacy groups, and numerous powerful trade associations. Fortunately, in the end, CMS decided to walk back from their short-sighted proposal.[2]

The ADAP Advocacy Association discussed the issue at its recent HIV/AIDS Fireside Chat retreat in California, we all as endorsed numerous national sign-on letters and continually Tweeted to @CMSGov about the potential harm to people living with HIV/AIDS.

Reaction to the news was universally positive!

"The epilepsy community spoke up loudly against this proposal and we are grateful that the Administration heard us," said Philip M. Gattone, M.Ed., president and CEO of the Epilepsy Foundation. "For people living with epilepsy, there is no 'one-size-fits-all' anticonvulsant, and treatment is highly individualized. People with epilepsy need access to the full range of anticonvulsants so that they — along with their healthcare provider — can identify and remain on the medication(s) that helps them achieve seizure control. Preserving this important policy will enable that to happen."[3]

Altha Stewart, M.D., President of the American Psychiatric Association, said, "With adherence to medications already a challenge, this proposal would have added additional utilization management burden which contributes to burnout for clinicians, as well as confusion for patients trying to navigate an already complex system. This rule protects patients by ensuring they receive lifesaving medications through the protected classes."[4]

“Medicare beneficiaries with the most complex, chronic conditions are breathing a sigh of relief,” said Chuck Ingoglia, executive director of the Partnership for Part D Access, a coalition of drug makers and patient advocacy organizations that also opposed the proposal. “This rule cements Medicare’s protected classes policy as an essential patient safeguard in Medicare’s prescription drug program.”[5]

In 2014, like this year, advocacy partnerships also squashed attempts by the previous Administration to weaken Medicare Part D's 6PC. It demonstrates that stakeholders can from time to time, unite behind common goals. In the case of the 6PC proposals in 2014 and 2019 it was patient protections that won the day.

CMS's Final Rule also prohibits the use of step therapy for patients who are stable on their current treatment.[6] Yet another win for patients, which was achieved by different stakeholder groups uniting against the dangers of step therapy.

Advocacy partnerships prove that stakeholders don't have to agree on everything, yet can come together to advance (or protect) common interests. What happened last week with the CMS announcement shows that people living with HIV/AIDS are well-served by such collaboration. Chalk one up for us, finally!


__________
[1] Johnson, Juliet (2019, January 31). New Research Shows Changes to the Six Protected Classes Would Harm Most Vulnerable Patients and Are Unnecessary. ADAP Blog. Retrieved online at https://adapadvocacyassociation.blogspot.com/2019/01/new-research-shows-changes-to-six.html.
[2] Owermohle, Sarah, and Sarah Karlin-Smith. (2019, May 17). Patient groups, pharma cheer CMS retreat on protected class change. POLITICO. Retrieved online at https://www.politico.com/newsletters/prescription-pulse/2019/05/17/patient-groups-pharma-cheer-cms-retreat-on-protected-class-change-437838.
[3] Epilepsy Foundation. (2019, May 17). Epilepsy Advocates and Partners Successfully Preserve Medicare's Six Protected Classes Policy. Business Insider. Retrieved online at https://markets.businessinsider.com/news/stocks/epilepsy-advocates-and-partners-successfully-preserve-medicare-s-six-protected-classes-policy-1028210785.
[4] American Psychiatric Association. (2019, May 17). APA Commends CMS for Maintaining Medicare's Six Protected Classes Policy. Retrieved online at https://www.psychiatry.org/newsroom/news-releases/apa-commends-cms-for-maintaining-medicare-s-six-protected-classes-policy.
[5] Florko, Nicholas. (2019, May 16). Trump administration backs off a proposal to let Medicare plans exclude certain drugs. STAT. Retrieved online at https://www.statnews.com/2019/05/16/trump-backs-off-protected-classes/.
[6] Biotechnology Innovation Organization. (2019, May 20). Final Medicare Rule Improves Patient Rx Access, But Challenges Remain.

Bipartisan lawmakers urge Administration to rethink proposed changes to six protected classes policy

By: Tom Wilbur, Director of Public Affairs, PhRMA

Reprinted with Permission from the Pharmaceutical Research and Manufacturers of America

At the end of 2018, the Centers for Medicare & Medicaid Services (CMS) introduced a dangerous proposed rule that would weaken the Medicare Part D six protected classes policy. The six protected classes policy covers patients whose conditions – like HIV, cancer, and epilepsy among others - are treated with medicines covered under six specific drug classes. The proposed rule would weaken the six protected classes policy by allowing increased use of step therapy or utilization management, including for patients already stable on a medicine. This practice is meant to reduce drug costs by requiring patients to begin treatment with a therapy preferred by the insurer before they can access the one their doctor thinks will work best for them.

Since the proposed rule was released, patient groups and advocates — particularly those representing patients with the diseases and conditions treated by medicines in these classes— have come out strongly against the proposed rule changes. Now, Members of Congress from both sides of the aisle are expressing their concerns as well because of the potential negative impacts on patients’ health.

Last week, a bipartisan group of 73 Members of Congress, led by Congresswoman Barbara Lee and Congressman Will Hurd, sent a letter to Health and Human Services Secretary Alex Azar asking the Secretary to withdraw a proposal that would modify the Part D program protections afforded to the six classes of drugs. The Members write, “We are concerned that prior authorization and step therapy requirements could have devastating public health outcomes for those receiving treatment of HIV and the additional five protected classes. Considering the public health implications of the proposed changes to Part D protected classes related to prior authorization and step therapies – we respectfully request that you withdraw the relevant provisions of the rule.”

The bipartisan Congressional Mental Health Caucus, led by Congresswoman Grace Napolitano and Congressman John Katko, also pushed back against the rule in a letter – signed by 39 Members of Congress – to Secretary Azar. The letter states, in part, that the proposed changes are “particularly worrisome” for Medicare beneficiaries living with mental illness.

In the Senate, Senators Marco Rubio and Krysten Sinema led a bipartisan letter alongside more than a dozen Senators outlining reasons the proposed rule should be reconsidered. In the letter, they note how the rule would not just adversely affect HIV patients but also cancer patients needing “highly personalized therapies;” schizophrenia and depression patients who “often struggle to find a medicine that works for them and could risk relapse if forced to switch to alternatives;” epilepsy patients who “often find that only one treatment works for them and any disruptions in treatment could increase the likelihood of seizures;” and organ transplant patients who have “complex medical needs and should not be required to jump through hoops in order to prevent transplant rejection.”

Bipartisan lawmakers, on both sides of aisle and on both sides of the Capitol, clearly oppose this proposed rule because for over 10 years, one of the cornerstones of the Medicare Part D program has been to ensure the sickest and most vulnerable patients have access to the clinically critical medicines they rely on. Letting plans restrict access for some of the sickest and most vulnerable Part D beneficiaries would reduce adherence to those medicines, jeopardize their health, increasing their need for medical care and result in poorer health outcomes and potentially higher costs for seniors and Medicare.

Visit PrescriptionForMedicare.org to learn more.

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.