Hart Health Strategies provides a comprehensive policy briefing on a weekly basis. This in-depth health policy briefing is sent out at the beginning of each week. The health policy briefing recaps the previous week and previews the week ahead. It alerts clients to upcoming congressional hearings, newly introduced bills, regulatory announcements, and implementation activity related to the Patient Protection and Affordable Care Act (PPACA) and other health laws.
THIS WEEK'S BRIEFING - AUGUST 29, 2016
- EpiPen Price Hikes Draw Significant Attention
- Zika Update
- Medical Device User Fee Deal Announced
- CMS Releases 2015 ACO Data
- Upcoming Congressional Hearings and Markups
EpiPen Price Hikes Draw Significant Attention
The pharmaceutical company Mylan has come under scrutiny by lawmakers on both sides of the aisle for the price of it’s EpiPen Auto-Injector, used in emergency treatment of life-threatening allergic reactions. Since Mylan acquired EpiPen in 2007, the price of two injectors has risen over 400 percent and now totals approximately $500. A bipartisan group of senators have written to the Food and Drug Administration (FDA) asking for an explanation about why EpiPens don’t have more competition in the United States. The lawmakers point out that there are generic alternatives available in other countries, where the prices for the devices are significantly lower. The letter was signed by Chuck Grassley (R-Iowa), Amy Klobuchar (D-Minn.), Ron Johnson (R-Wis.), Patrick Leahy (D-Vt.), and Richard Blumenthal (D-Conn.). Rep. Elijah Cummings (D-Md.), the ranking member of the Committee on Oversight and Government Reform, called for a hearing in September to examine the controversial price increase. The Senate Special Aging Committee has also asked to meet with Mylan staff for a briefing within the next two weeks on the issue. The company drew criticism from Democratic presidential nominee Hillary Clinton, who called on the company to immediately reduce the price of the injections. Mylan’s pricing decisions have also been criticized by the American Medical Association (AMA), which urged Mylan to do all it can to rein in the “exorbitant costs.” In response to the uproar, Mylan announced that it would provide a savings card worth up to $300 for people who had been paying the full price for the EpiPen out of pocket. The move would effectively reduce the cost of the device by 50 percent. The company will also make it easier to qualify for its patient assistance program, which eliminates out of pocket costs for uninsured and underinsured people altogether. This decision did not mollify most policymakers, however, who characterized the coupons as more of a PR strategy than a comprehensive response to the problem.
Following the emergence of five cases of Zika in Miami Beach, the Centers for Disease Control and Prevention (CDC) has warned that pregnant women should avoid traveling there. It was also announced last week that the U.S. Department of Health and Human Services (HHS) would begin funding the development of a Zika diagnostic test for use in physician offices. The lateral-flow serological test being developed by Chembio Diagnostic Systems, Inc. could provide a Zika diagnosis for patients in less than thirty minutes in a health care provider’s office. Serological tests look for antibodies produced by the immune system in response to a virus, which become present two weeks after infection and up to three months later. Because most people infected with the Zika virus do not develop symptoms and are therefore unlikely to seek testing while the virus is still present in their blood, this test could be critical in determining whether a person has recently acquired the Zika virus. The Biomedical Advanced Research and Development Authority (BARDA) will provide $5.9 million over the next year for the continued development, manufacturing, and clinical trial evaluation of the test.