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On April 17th, Crowell & Moring’s Government Affairs and Health Care Groups hosted speakers from Capitol Hill, federal agencies, and national trade groups during a thought-provoking half-day Long Term Care Policy Update forum (“LTC Forum”).  The LTC Forum was spearheaded by James Flood and Scott Douglas, who recently joined the firm from the Government Affairs division at Omnicare, a leader in the long-term pharmacy industry. 

The LTC Forum focused on overall policy affecting the long-term care industry, which the Centers for Medicare & Medicaid Services (CMS), the Department of Health and Human Services (HHS) Office of the Inspector General (OIG), Congress, and other government agencies have consistently scrutinized.  Throughout the day, LTC Forum participants discussed the challenges and opportunities present in the long-term care industry that will only increase as payment reforms become the norm in Medicare. 

Of note, Sarah Johnson, the Legislative Assistant for U.S. Senator Rob Portman (R-OH) gave a timely overview of the negotiations that led up to the ultimate passage and signing of the Medicare Access and CHIP Reauthorization Act (MACRA).  MACRA repealed the Sustainable Growth Rate (SGR) formula for Medicare payments to physicians and phases in a new Merit-Based Incentive Payment System and other alternative payment models over the next ten years.  But MACRA partially funds these payment reforms with reductions to market basket updates for post-acute care providers, which creates increased concern from the industry about sustainability of long-term care providers under health reform initiatives.  According to one audience comment, there is concern that “in the long-term care industry, [stakeholders] are going to lose sight of overall health care industry shifts.”  

Continue Reading Crowell’s Long-Term Care Policy Update—Recapping the Discussions and Debates

On December 23, 2014, FDA Commissioner Margaret A. Hamburg announced that the agency favors supplanting the outright ban on blood donations from men who have sex with men (MSM) with a new policy that would prohibit donations from men who have engaged in homosexual activity in the previous 12 months. This shift for MSM would comport with the mandatory deferral period for other men and women at higher risk for HIV. It would also align with other countries’ policies including Australia, Japan, and the U.K.

“Over the past several years, in collaboration with other government agencies, the FDA has carefully examined and considered the available scientific evidence relevant to its blood donor deferral policy for men who have sex with men,” Hamburg said in her statement. The FDA also cited the recommendation of the U.S. Department of Health and Human Services Advisory Committee on Blood and Tissue Safety and Availability, an independent expert advisory panel. But when, exactly, this policy shift will take effect remains uncertain. According to the FDA’s announcement, the agency “intends to issue a draft guidance recommending this proposed change in policy in 2015, which will also include an opportunity for public comment.”

As noted in an earlier post, gay rights advocates, the American Red Cross, and other groups have long condemned the indefinite ban—enacted during the emergence of the AIDS epidemic—as discriminatory. They also have argued that it is medically and scientifically unjustified. Yet they are far from satisfied with the result of their advocacy efforts to change the ban. According to Gay Men’s Health Crisis, a prominent nonprofit dedicated to HIV/AIDS prevention, care, and advocacy, “This new policy does not require heterosexual blood donors to be celibate for one year. Some may believe this is a step forward, but in reality, requiring celibacy for a year is a de facto lifetime ban.”