HIV Medical Providers Strongly Oppose Proposed Changes To Medicare Drug Plan’s “Protected Classes”

HIV Medical Providers Strongly Oppose Proposed Changes To Medicare Drug Plan’s “Protected Classes”

Washington, DC – The American Academy of HIV Medicine (AAHIVM), an independent organization of HIV specialists and other care providers dedicated to promoting excellence in HIV care, came out in strong opposition to portions of a proposed rule (Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out of Pocket Expenses) issued by the Centers for Medicare and Medicaid Services (CMS) that would change the way HIV drugs are covered under the Medicare Prescription Drug Benefit, or “Part D.”

Since Medicare Part D was launched in 2006, CMS has identified six classes of prescription drugs, wherein all (or nearly all) drugs in those classes are required to be covered by the Part D plans. One of those protected classes (along with cancer drugs, mental health treatments and others) is antiretroviral drugs that are used to treat HIV. This class is also currently protected from any prior authorization, step therapy or other utilization management techniques that would affect patient access.

The proposed rule would allow plans to exclude certain drugs in those protected classes, including antiretrovirals, and would also allow prior authorization (going through coverage and utilization review prior to prescribing the preferred regimen) and step therapy (starting on a less expensive treatment regimen and requiring the patient to “fail” one or more plan drugs prior to moving to the prescriber’s chosen regimen). The aim of the rule change is to hypothetically lower drug prices in these classes. Since about a quarter of people living with HIV in the US receive their medical benefits from Medicare, this rule has the potential to seriously impact treatment options for many Americans living with the disease.

“The Protected Classes are important to my HIV patients with Medicare coverage because there is no ‘one-size-fits-all’ approach to treating HIV,” stated AAHIVM board chair, Dr. Margaret Hoffman-Terry, an HIV Specialist practicing at Lehigh Valley Hospital in Pennsylvania. “Many important considerations, including the person’s adherence to medications, drug resistance, drug-drug interactions, concomitant medical conditions and side effect profiles are taken into account when choosing the best regimen,” she continued. “It’s medically crucial to have all options on the table when prescribing and to be able to start those drugs quickly, with no barriers to access.”

“We’ve seen how health plans, managers and payers often ignore guidelines and best practices when no rules are in place to protect HIV treatment,” said AAHIVM Deputy Executive Director Bruce Packett. “Barriers are put in place to drive patients onto potentially less well-tolerated or less effective medications with possible long-term health implications,” he added. “Considering the overall medical costs of complications that can arise from being on certain HIV drugs long term, or from treatment failure, the savings the administration is hoping for may in fact not be there at all.”

AAHIVM Public Policy Director Anna Forbes also looked at the rule from a public health perspective: “We’ve come so far in the fight against the epidemic, and we now have the tools to see it to the end,” she said. “But to do so, we have to listen to the science and make sure that medical providers have all the options available to treat and prevent HIV disease. We know that people living with HIV cannot transmit it to others if they have viral levels so low that they are undetectable. And the only way to reach this goal is for patients to be on the right regimen for them,” she concluded.

AAHIVM and the HIV Medicine Association (HIVMA) teamed up to encourage their respective members, which include providers treating patients with or at risk for HIV, to offer their perspective on the proposed rule during the public comment window, which is open now until January 25, 2019. They are also encouraging providers to reach out to their congressional representatives to indicate their support for the protected classes in Part D, and, where appropriate, to submit op-eds to their local media.

For more information on how to comment on the proposed CMS rule, please visit to read a joint statement from AAHIVM and HIVMA including ways to voice your opinion on this issue.


The American Academy of HIV Medicine is a professional organization that supports the HIV practitioners and promotes accessible, quality care for all Americans living with HIV disease. Our membership of HIV practitioners and credentialed providers give direct care to more than three-fourths of HIV patients in the US.