Alston & Bird Healthcare Week in Review, May 13, 2017

Regulations, Notices, & Guidance

• On May 9, 2017, the Food and Drug Administration (FDA) issued a notice entitled, Draft Revisions to the Food and Drug Administration Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioids. The notice announces the availability of draft revisions to the “FDA Blueprint for Prescriber Education for Extended Release and Long-Acting Opioid Analgesics" (Blueprint). The Blueprint is part of the FDA approved risk evaluation and mitigation strategy (REMS) for extended release (ER) and long-acting (LA) opioid analgesic medications (ER/LA Opioid Analgesics REMS). The FDA is seeking comment on the draft revisions to the Blueprint. Comments are due by July 10, 2017.
• On May 9, 2017, the Department of Health and Human Services (HHS) issued a notice entitled, Nerve Agents and Certain Insecticides (Organophosphorus and/or Carbamate) Countermeasures. The notice announces that the Secretary is issuing a declaration pursuant to section 319F-3 of the Public Health Service Act to provide liability protections consistent with that authority for medical countermeasures against nerve agents and organophosphorus insecticides that result in organophosphorus poisoning and carbamate insecticides that result in carbamate poisoning.
• On May 9, 2017, the Department of Veterans Affairs (VA) issued a notice entitled, Use of Medicare Procedures to Enter Into Provider Agreements for Extended Care Services. The VA published a notice of proposed rulemaking in the Federal Register on February 13, 2013, that proposed amending its regulations to allow the VA to enter into provider agreements to obtain extended care services for Veterans from community providers. According to the VA, since publication of that proposed rule, further review has led the VA to conclude the VA cannot achieve the proposal’s goals without a statutory change. For this reason, the VA withdraws the proposed rule.
• On May 10, 2017, HHS issued a notice entitled, Request for Nominations to the Advisory Council on Alzheimer's Research, Care, and Services. The notice announces that HHS is soliciting nominations for seven (7) new non-Federal members of the Advisory Council to replace the seven members whose terms will end September 30th, 2017. Nominations are due by June 16, 2017.
• On May 10, 2017, the Centers for Disease Control and Prevention (CDC) issued a notice entitled, World Trade Center Health Program; Petition 015--Neuropathy; Finding of Insufficient Evidence. According to the CDC, on November 25, 2016, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 015) to add neuropathy to the List of WTC-Related Health Conditions (List). The notice announces that upon reviewing the scientific and medical literature, including information provided by the petitioner, the Administrator has determined that the available evidence does not have the potential to provide a basis for a decision on whether to add neuropathy to the List.
• On May 11, 2017, the Office of Management and Budget (OMB) received a final rule from the Centers for Medicare & Medicaid Services (CMS) entitled, Changes to the Medicaid Eligibility Quality Control and Payment Error Rate Measurement (PERM) Programs in Response to the Affordable Care Act. The final rule updates the Medicaid Eligibility Quality Control and PERM programs based on the changes to Medicaid and Children’s Health Insurance Program eligibility under the Affordable Care Act (ACA) of 2010. The rule also implements various other improvements to the PERM program.
• On May 12, 2017, the FDA issued a guidance entitled, Three-Month Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule. The guidance is intended to assist persons who manufacture, package, sell, offer to sell, distribute, or import for sale and distribution within the United States newly regulated tobacco products, roll-your-own tobacco, and cigarette tobacco in complying with the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act, and FDA regulations. Comments may but submitted at any time.
• On May 12, 2017, the CDC issued a notice entitled, Request for Nominations of Candidates to Serve as Members of the Community Preventive Services Task Force (CPSTF). The notice announces the opening of the nomination period for individuals qualified to serve as members of the CPSTF to serve 5-year terms starting in 2018 or 2019. Nominations are due by July 3, 2017.
• On May 12, 2017, the CDC issued a notice entitled, Interagency Committee on Smoking and Health: Notice of Charter Renewal. The notice announces that the Interagency Committee on Smoking and Health, Department of Health and Human Services, has been renewed for a 2-year period through March 20, 2019.

• June 6, 2017: The CDC announced a meeting of the Advisory Board on Radiation and Worker Health (ABRWH). The agenda for the conference call includes: Reporting Final SEC Petition Vote Count from March ABRWH Meeting for Rocky Flats Plant SEC petition (Golden, CO) and Carborundum Company SEC petition (Niagara Falls, NY); Follow-up on ABRWH March Meeting Discussion on General Steel Industries Site Profile Review; Work Group and Subcommittee Reports; Status of SEC Petitions Update; Plans for the August 2017 Advisory Board Meeting; and Advisory Board Correspondence. The agenda is subject to change as priorities dictate.
• June 6 – 7, 2017: HHS announced a meeting of the National Advisory Council on Migrant Health. The agenda includes an overview of the Council’s general business activities. The Council will also hear presentations from Federal officials and experts on agricultural worker issues, including the status of agricultural worker health at the local and national levels.
• June 6 – 7, 2017: The National Institutes of Health (NIH) announced a meeting of the National Advisory Environmental Health Sciences Council. An agenda will be posted before the meeting and can be found here.
• June 21 – 22, 2017: The CDC announced a meeting of the Prevention Advisory Committee on Immunization Practices. The agenda will include discussions on: meningococcal vaccine; influenza; hepatitis vaccines; herpes zoster vaccine; varicella; yellow fever vaccine; mumps disease and vaccine; Dengue virus vaccines; Human Papillomavirus; Anthrax vaccine workgroup; Vaccine Adverse Event Reporting System and vaccine supply. A recommendation vote is scheduled for hepatitis vaccines and influenza. A Vaccines for Children vote is scheduled for hepatitis vaccines.

II. Congressional Legislation & Committee Action

• On May 10, 2017, the Senate Health, Education, Labor and Pensions Committee held a markup of S. 1028, the "Recognize, Assist, Include, Support, and Engage (RAISE) Family Caregivers Act"; and S.934, the "Food and Drug Administration Reauthorization Act." S. 1028 was reported favorably by a voice vote and S. 934 was reported favorably by a vote of 21-2.
• On May 11, 2017, the Senate Appropriations Military Construction, Veterans Affairs and Related Agencies Subcommittee held a hearing on the Veterans Healthcare Choice Program Reform. The witnesses present at the hearing were The Honorable David Shulkin, M.D., Secretary, VA and Dr. Baligh R. Yehia, Deputy Under Secretary for Health for Community Care in the Veterans Health Administration (VHA).

• The House has adjourned and will reconvene on May 16, 2017.

• On May 16, 2017, the Senate Finance Committee will hold a hearing entitled, Examining Bipartisan Medicare Policies that Improve Care for Patients with Chronic Conditions. The hearing will take place at 10:00 a.m. in 215 Dirksen. The witnesses are TBD.
• On May 17, 2017, the Senate Special Aging Committee will hold a hearing entitled, Aging With Community: Building Connections that Last a Lifetime. The hearing will take place at 9:30 a.m. in 562 Dirksen. The witnesses are TBD.
• On May 17, 2017, the Senate Veterans Affairs Committee will hold a hearing on pending veterans' health care and benefits legislation. The hearing will take place at 2:30 p.m. in 418 Russell. The witnesses are TBD.

• On May 17, 2017, the House Appropriations Labor, Health and Human Services, Education and Related Agencies Subcommittee will hold a hearing entitled, Advances in Biomedical Research. The hearing will take place at 10:00 a.m. in 2358 Rayburn. The witnesses are TBD.
• On May 17, 2017, the House Energy & Commerce Health Subcommittee will hold a hearing on examining initiatives to advance public health, including: H.R.767, the "SOAR to Health and Wellness Act of 2017"; H.R.931, the "Firefighter Cancer 5 Registry Act of 2017"; and H.R.1876, the "Good Samaritan 5 Health Professionals Act of 2017." The hearing will take place at 10:15 a.m. in 2322 Rayburn.
• On May 18, 2017, the House Ways & Means Health Subcommittee will hold a hearing entitled, The Current Status of the Medicare Program, Payment Systems, and Extenders. The hearing will take place at 2:00 p.m. in 1100 Longworth. The witnesses are TBD.

• N/A.

Other Health Policy News

• On May 9, 2017, CMS released an informational bulletin announcing the extension of transition period for compliance with home and community based settings (HCBS) criteria. CMS will extend the transition period for compliance until March 17, 2022 for state Medicaid programs to meet the HCBS settings requirements for settings operating before March 17, 2014. According to CMS, the extension is in response to states’ request for more time to demonstrate compliance with the regulatory requirements and ensure compliance activities are collaborative, transparent, and timely.
• On May 9, 2017, the Senate confirmed Scott Gottlieb by a vote of 57-42.
• The Congressional Budget Office and the Joint Committee on Taxation anticipate releasing the projected savings and coverage losses of the House-passed American Health Care Act (AHCA) early in the week of May 22.

V. ACA Repeal News

• On May 9, 2017, Senators Cory Gardner (R-CO) and Mike Rounds (R-SD) said discussions are ongoing about beefing up the funding for invisible risk pools from the amount in the AHCA to help low-income and disabled individuals afford health coverage.