HHS Releases Pandemic Influenza Plan

The U.S. Department of Health and Human Services (HHS) released its updated Pandemic Influenza Plan last week. The report was scheduled to be released in late 2016. HHS identifies seven domains on which to focus over the next decade: Surveillance, Epidemiology, and Laboratory Activities; Community Mitigation Measures; Medical Countermeasures: Diagnostic Devices, Vaccines, Therapeutics, and Respiratory Devices; Health Care System Preparedness and Response Activities; Communications and Public Outreach; Scientific Infrastructure and Preparedness; and Domestic and International Response Policy, Incident Management, and Global Partnerships and Capacity Building.

Grassley Asks FDA to Increase Access to Generics

Senate Judiciary Committee Chairman Chuck Grassley (R-Iowa) is urging the Food and Drug Administration (FDA) to expand access to generic drugs as a part of the agency’s efforts to reduce prescription drug costs. In a letter to FDA Commissioner Scott Gottlieb, Sen. Grassley highlights two pieces of legislation specifically. S. 974, the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, would give generics manufacturers more access to brand drug samples for testing. S. 124, the Preserve Access to Affordable Generics Act, would limit “pay-for-delay” arrangements in which generics companies agree not to enter the market for a period of time.

Bipartisan 340B Legislation Introduced

Lawmakers have introduced legislation that would allow rural and cancer hospitals to obtain 340B discounts on certain prescription drugs. H.R. 2889, the Closing Loopholes for Orphan Drugs Act, was introduced last week by Reps. Peter Welch (D-Vt.) and Gregg Harper (R-Miss.). The 340B drug-discount program currently includes an exemption for orphan drugs. This bill would limit the 340B program’s orphan drug exclusion to apply only when drugs are used to treat the rare diseases they were developed to treat. H.R. 2889 would allow 340B drugs to be discounted when they are used for a wider indication.

Lawmakers Push for Unimplemented OIG Recommendations

Republican leadership of the House Energy and Commerce Committee is urging the Centers for Medicare and Medicaid Services (CMS) to act on unimplemented recommendations from the U.S. Department of Health and Human Services (HHS) Office of the Inspector General (OIG). The recommendations are in regard to Medicare Parts A, B, and D, and the Medicaid program, and date back to almost 30 years ago. In their letter, Chairman Greg Walden (R-Ore.), Oversight and Investigations Subcommittee Chairman Tim Murphy (R-Pa.), and Health Subcommittee Chairman Michael C. Burgess, M.D. (R-Texas) attached a list of 12 HHS OIG unimplemented recommendations. “We believe that implementing these regulations – all of which appear to be low cost and uncontested by CMS – within a year is an achievable goal,” the lawmakers write. They also request that CMS prioritize the top 25 unimplemented recommendations including increasing surveyor efforts for hospices, rejecting prescription drug event records for Schedule II drugs when the prescriber ID is invalid, and reinforcing Medicaid requirements that prohibit adding unallowable room-and-board costs to States’ reimbursement payments for Home and Community Based Services (HCBS).

Budget Resolution Committee Vote Possible this Week

Less than 45 legislative days remain until the end of the fiscal year (FY) on September 30. A 2018 budget resolution continues to be negotiated among House Republicans. Budget Appropriations Chair Diane Black (R-Tenn.) is in talks with the House Freedom Caucus, which is pushing to make tax reform contingent on a high level of entitlement cuts. According to Freedom Caucus and Budget Committee member Mark Sanford (R-S.C.), a Committee vote could be held as early as this week. Work on health care reform prevents a floor vote on a new budget resolution, which is necessary to move annual appropriations bills. Once Congress passes a FY’18 budget resolution, it will void the FY’17 budget resolution that is currently being used as a vehicle for passing the Affordable Care Act (ACA) repeal through reconciliation. There has been some talk of canceling the month-long August recess in order to provide more time to mark up individual appropriations bills through regular order, but the idea doesn’t appear to be gaining traction with Majority Leader Mitch McConnell (R-Ky.).

PACHA Sees Six Resignations

Six members of the Presidential Advisory Council on HIV/AIDS (PACHA) abruptly resigned last week, citing the President’s lack of understanding or concern for public health issues, including the HIV/AIDS epidemic. In an op-ed for Newsweek, the council members outline the impact that the American Health Care Act (AHCA) would have on people living with HIV. They criticized the President for bringing a prominent abstinence-only sex education advocate into the Administration, and for failing to include the Council’s input in policy decision-making. They vow to continue to work independently on issues related to HIV/AIDS. Fifteen members of the council remain following the resignations.

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