A new study shows proposed changes by the Trump administration to Medicare Part D would have a significantly negative impact on people living with HIV and on the healthcare system, including 7,200 additional deaths, 6,750 new HIV infections and $1.08 billion more than is currently allocated.
The alarming new statistics are detailed in a research study by Precision Health Economics in California, a scientific think-tank that conducts advanced health economics research that addresses the most challenging problems in healthcare, including diseases like HIV/AIDS.
According to the study, the new standards set by U.S. Department of Health and Human Services Secretary Alex Azar would allow expanded use of “step therapy” and “prior authorization” from insurance companies, resulting in delays in more efficacious and better-tolerated treatment and therapies.
“This research brief shows that the proposed rule would not only be a source of increased costs, but it would cause substantial harm to those living with HIV who rely on Medicare Part D for their life-saving medications,” said James Baumgardner, lead researcher on the study.
“This proposed rule would impact access to antiretroviral prescriptions drugs. Limiting access to medication for people living with HIV would lead to reduced survival, an increased number of serious and adverse events, and allow more people to contract HIV — leading to greater costs to the healthcare system in the long run.”
The proposed rule change to Medicare is titled “Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses.” But what the change actually would do is radically alter protections extended to the six classes of drugs currently protected by Medicare Part D and Medicare Advantage. These drug classes are antidepressants, antipsychotics, anticonvulsants, immunosuppressants (to prevent transplant rejection), antiretrovirals (the key class of drugs for HIV/AIDS) and antineoplastics (to prevent tumors). The proposed change would seriously affect millions of people living with complex and often deadly conditions, including cancer, schizophrenia, epilepsy and HIV/AIDS.
In its research study, PHE assessed what the impact of the proposed changes would be on people living with HIV. The study compared the new rule’s guidelines to existing policy with no restrictions to antiretroviral treatment for the period 2020-2029. The research brief was an in-depth investigation into what Azar’s insistence on “step therapy” and “prior authorization” would mean for patients, and also estimated the implications of the proposed rule’s impact on drug formulation and drug pricing provisions.
The study found thousands of people with HIV/AIDS would be affected. The most alarming projections were the increase in deaths and new infections.
If HIV patients were subjected to step therapy and prior authorization, it could result in 7,200 additional all-cause deaths; 84,000 more renal and bone adverse events related to tumors; $1.08 billion in additional costs due to these adverse events; and 6,750 new HIV infections, which would contribute to significant additional costs, considering estimates of the lifetime cost associated with managing HIV infection is more than $330,000 per infection.
The use of prior authorization and step therapy is meant to reduce drug costs by forcing patients to start a less-expensive treatment before they can access more expensive drugs, which are often more effective and have fewer side effects. Step therapy and prior authorization could delay or interrupt people living with HIV from accessing treatment that would result in viral load suppression, which is essential in preventing the transmission of HIV.
In addition to these complications, drug formulation and drug-pricing provisions and restrictions could result in more than 8,000 additional deaths and 7,600 new HIV infections.
Written into Azar’s proposal is this salient fact for people with HIV: Provisions could eliminate drugs from a formulary if that drug didn’t meet certain requirements. This could prevent patients from accessing, for example, single-drug regimens, which are more effective and better tolerated but also more expensive than multi-drug regimens. It also could restrict people with HIV from accessing more effective medicines or those with fewer serious side effects.
Medicare Part D was created in 2006 to help older Americans as well as chronically ill and disabled people access affordable, life-saving drugs for their serious, chronic and — in the case of HIV — infectious health conditions.
According to the Kaiser Health Foundation, the number of Medicare beneficiaries with HIV has tripled since the 1990s, rising from 42,520 in 1997 to 150,000 in 2017. Approximately 25 percent of people with HIV receiving care get their health-insurance through Medicare.
Medicare spending for HIV also has increased and the program is now the single largest source of federal financing for HIV care and treatment. Most people with HIV on Medicare are under age 65 and qualify because of HIV-related disability.
The majority of Medicare beneficiaries with HIV are dually eligible for both Medicare and Medicaid and receive low-income subsidies under Part D. Medicare recipients with HIV are younger — under 65 — disproportionately male (74 percent vs. 45 percent), black (43 percent vs. 10 percent) and dually eligible for Medicare and Medicaid (69 percent vs. 21 percent) than other Medicare recipients.
They also have higher rates of certain co-morbidities. For example, 21 percent of HIV-positive beneficiaries are co-infected with viral hepatitis (types A-E) compared to 1 percent of the overall Medicare population, while 34 percent have depression compared to 17 percent of the overall Medicare population.
All of these factors mean the proposed changes to Medicare Part D could not only harm people with HIV, but also contribute to new infections, as the best treatments for HIV lower the viral load and make the disease less transmissible.