November 29, 2018

New USPSTF Recommendations May Compel Insurers to Cover PrEP

Last October, the Centers for Disease Control (CDC) estimated that 1.2 Americans are at sufficiently high risk of HIV that they could benefit from using PrEP. They noted that, in 2016, “although black men and women accounted for approximately 40% of persons with PrEP indications…nearly six times as many white men and women were prescribed PrEP as were black men and women”. Data from 2017 published by the Annals of Epidemiology suggests that “less than 10% of the 1.2 million individuals [in the US] indicated for PrEP were using it” and that the “PrEP to Need (PnR) ratio for women was less than one-fifth the PnR for men”.

Against this background, the United States Prevention Services Task Force (USPSTF) released new draft guidance on PrEP last week that gives it “an A rating” for HIV prevention. Established by Congress in 1984, the USPSTF is supported by DHHS staff and made up of 16 volunteer members (most of them practicing clinicians) who work in the fields of preventive medicine, primary care in prevention, and evidence-based medicine.

According to AJMC, USPSTF task force member Seth Landefeld, MD said that “To make a difference in the lives of people at high risk for HIV, clinicians need to identify patients who would benefit and offer them PrEP.” AIDS United also observed that, “While not yet final, these recommendations bode well for the future accessibility of PrEP”, adding that they could also help to ensure that insurance plans were required to cover the medication at no cost to those who meet the USPSTF definition of high risk.

CMS Promotes Reducing Access to “Protected Classes” of Drugs

Last Monday, the Centers for Medicare and Medicaid Services (CMS) announced its proposal to give Medicare Part D and Medicaid Advantage insurance plans “the option to limit coverage of drugs” in the six protected drug classes, Politico reports.  The New York Times’ coverage notes that currently “approximately 45 million people have outpatient drug coverage through Part D of Medicare”.

This revision was featured in the Administration’s “DHHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs”, a document issued for public comment last May (see WA column from 7/12/18).  The commentary submitted by the Academy is available online here.

CMS proposes that the reduction start in 2020 and that insurance plans be allowed to cover some, rather than all, of the drugs in the six protected categories which includes all cancer medicines, antidepressants and HIV drugs, among others. In the agency’s plan, at least two drugs would remain available in each category. Insurers under contract with Medicare would be allowed to exclude coverage of protected class drugs if their prices rises more than inflation or if the drugs are new products that differ only slightly from older products. CMS also wants to allow Medicare-contracted insurance plans to make greater use of step therapy and prior authorization, the Times added.

CMS’ plan moves toward actualizing the Blueprint issued by the White House last May. It is energetically opposed by pharmaceutical industry leaders as well as by advocates for the rights of people living with HIV and in the other protected classes. At present, the cost of all Medicare Part D drugs comprise about 15% of Medicare spending and Part B accounts for 3%. CMS predicts that cutting back the protected class drugs would save Medicaid almost $2 billion in drug costs between 2020 and 2029 and that Medicare enrollees would save $692 million in out-of-pocket drug costs in that time.

Public comments on this proposal are being accepted until January 25, 2019. Directions for submitting comments are at the bottom of the first page of the document available here.

More Election Repercussions Affecting Medicaid Expansion and Work Requirements

Midterm election results continue to trigger controversy in some states regarding Medicaid policy:

Idaho’s ballot initiative to expand Medicaid was approved by over 60% of voters. Opponents immediately mounted a challenge to block its implementation. According to the Idaho Statesman, the Idaho Freedom Foundation (IFF) is filing the suit on the grounds that the initiative, “cedes too much control to the federal government and the Idaho Department of Health and Welfare.” On their own website, IFF states that they want “the Idaho state Supreme Court [to recognize] Prop 2 for what it is: a gross misallocation of power from one branch of government to another that must be struck down.”

Kansas’ election produced a Democratic Governor but the majority of the legislature is still conservative. Last year, outgoing Governor Sam Brownback vetoed the bi-partisan Medicaid expansion bill presented to him by Democratic and moderate Republican legislators. The Associated Press reports that, while Democrat Laura Kelly will be the state’s new Governor, conservatives in the midterm “gained at least half a dozen seats in the House and might replace the chamber’s majority leader, a moderate, with someone who leans further to the right.” Kelly, a veteran state senator is dedicated to developing a bipartisan plan. “I’m not exactly sure what it will look like yet” Kelly told the AP. “I’m a fiscal realist, and I need to make sure whatever we present is doable.”

Wisconsin may also find Medicaid expansion difficult to achieve due to the composition of the legislature. Tony Evers, a Democrat, defeated Republican Scott Walker in the governor’s race and is committed to Medicaid expansion. That may be hard to achieve, though, with a legislature that is still Republican controlled. Wisconsin may also become the fourth state to implement work requirements for Medicaid recipients unless the new Governor is able to cancel the waiver application submitted by Governor Walker and approved by CMS immediately before the election (see WA 11/8/18 for more information).

View the latest Policy Update here.