Alston & Bird Healthcare Week in Review, May 26, 2017

Regulations, Notices, & Guidance

• On May 23, 2017, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a notice entitled, Call for Nominations for the Non-Federal Members of the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC). The notice announces that SAMHSA is seeking nomination of non-federal members of the ISMICC. Nominations for non-federal public members are encouraged, and self-nominations are permitted as well. Only one nomination per individual is required. Multiple nominations for the same individual will not increase likelihood of selection. Nominations are due by June 2, 2017.

• On May 24, 2017, SAMHSA issued a notice entitled, Protecting Our Infants Act Report to Congress: Summary of Public Comment and Final Strategy. The notice announces the release of the “Protecting Our Infants Act: Final Strategy” in response to sections 3(a)(2) and 3(b) of the Protecting Our Infants Act of 2015 (POIA).

• June 13, 2017: SAMHSA announced a meeting of the Drug Testing Advisory Board (DTAB). The Board will meet in open session to provide updates on the Mandatory Guidelines for the Federal Workplace Drug Testing Program.
• June 19, 2017: The National Institutes of Health (NIH) announced a joint meeting of the National Cancer Advisory Board (NCAB) and National Cancer Institute (NCI) Board of Scientific Advisors (BSA).
• June 21, 2017: The Food and Drug Administration (FDA) announced a public advisory committee meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. On June 21, 2017, information will be presented to gauge investigator interest in exploring potential pediatric development plans for three products in various stages of development for adult cancer indications. The subcommittee will consider and discuss issues concerning diseases to be studied, patient populations to be included, and possible study designs in the development of these products for pediatric use. The products under consideration are: (1) APX-005M, presentation by Apexigen, Inc.; (2) PMO1183 (lurbinectedin), presentation by PharmaMar USA Inc.; and (3) ASP2215 (gilteritinib), presentation by Astellas Pharma Global Development, Inc.
• July 28, 2017: The FDA announced a public advisory committee hearing of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). On July 28, 2017, the VRBPAC will meet in an open session to discuss and make recommendations on the safety and efficacy of a Hepatitis B Vaccine manufactured by Dynavax. The FDA intends to make background material available to the public no later than 2 business days before the meeting.
• August 21 – 22, 2017: The Centers for Medicare & Medicaid Services (CMS) announced the annual meeting of the Advisory Panel on Hospital Outpatient Payment for 2017. The agenda for the August 21 through August 22, 2017 Panel meeting will provide for discussion and comment on the following topics as designated in the Panel’s Charter: (1) addressing whether procedures within an APC group are similar both clinically and in terms of resource use; (2) evaluating APC group structure; (3) reviewing the packaging of OPPS services and costs, including the methodology and the impact on APC groups and payment; (4) removing procedures from the inpatient-only list for payment under the OPPS; (5) using single and multiple procedure claims data for CMS’ determination of APC group weights; (6) addressing other technical issues concerning APC group structure; (7) recommending the appropriate supervision level (general, direct, or personal) for individual hospital outpatient therapeutic services.

II. Congressional Legislation & Committee Action

• On May 25, 2017, the Senate Homeland Security and Government Affairs Committee held a hearing entitled, Stopping the Shipment of Synthetic Opioids: Oversight of U.S. Strategy to Combat Illicit Drugs. The witnesses included Gregory Thome, Director of the Office of Specialized and Technical Agencies in the Bureau of International Organization Affairs at the State Department; Robert Cintron, Vice President of Network Operations Management in the United States Postal Service; Robert Perez, Acting Executive Assistant Commissioners for Operations Support, Customs and Border Protection in the Homeland Security Department; Tammy Whitcomb, Acting Inspector General for the United States Postal Service in the OIG; Norman Schenk, Vice President of Global Customs Policy and Public Affairs at the United Parcel Service; Thomas Synan, Police Chief, Newton, Ohio; Thomas Gilson, Cuyahoga County Medical Examiner in Cleveland, Ohio; and Terry Horton, Chief of the Division of Addiction Medicine and Medical Director of Project Engage at Christiana Care Health Services in Wilmington, Delaware.

• On May 23, 2017, the House Energy & Commerce Oversight and Investigations Subcommittee held a hearing entitled, S. Public Health Response to the Zika Virus: Continuing Challenges. The witnesses included Dr. Timothy Persons, Chief Scientist, Government Accountability Office; Dr. Lyle R. Petersen, Director, Division of Vector-Borne Diseases, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention; Dr. Luciana Borio, Acting Chief Scientist, Food and Drug Administration; Dr. Anthony Fauci, Director, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH); and Dr. Rick A. Bright, Director, Biomedical Advanced Research and Development Authority (BARDA), Deputy Assistant Secretary, Office of the Assistant Secretary for Preparedness and Response, Department of Health and Human Services (HHS).
• On May 24, 2017, the House Appropriations Interior, Environment, and Related Agencies Subcommittee held a hearing on the Indian Health Service Budget. The witness was Rear Admiral Chris Buchanan, Acting Director of the Indian Health Services.
• On May 24, 2017, the House Ways & Means Committee held a markup of H.R. 2372, “Veterans Equal Treatment Ensures Relief and Access Now Act;” H.R. 2579, “to amend the Internal Revenue Code of 1986 to allow the premium tax credit with respect to unsubsidized COBRA continuation coverage;” and H.R. 2581, the “Verify First Act.” All the bills were reported favorably.
• On May 25, 2017, the House Appropriations Agriculture, Rural Development, FDA, and Related Agencies Subcommittee held a hearing on the Food and Drug Administration’s (FDA) budget. The witness was FDA Commissioner, Scott Gottlieb.

• On May 19, 2017, the Office of Inspector General (OIG) released a report entitled, Medicaid Fraud Control Units Fiscal Year 2016 Annual Report. The report found that in fiscal year (FY) 2016, Medicaid Fraud Control Units (Units) reported 1,564 convictions, over one-third of which involved personal care services attendants. Fraud cases accounted for 74 percent of the 1,564 convictions. The number of convictions related to drug diversion cases increased from FY 2015. Units reported 998 civil settlements and judgments, with settlements with pharmaceutical manufacturers making up almost half of Unit settlements. Units also reported almost $1.9 billion in criminal and civil recoveries. In FY 2016, Units continued a trend of increasing numbers of convictions, and civil settlements and judgments reached a 5-year high. The number of OIG exclusions resulting from Unit conviction referrals decreased slightly in FY 2016, as compared to the previous two FYs.
• On May 19, 2017, the OIG released a report entitled, Public Summary Report: Virginia Did Not Adequately Secure Its Medicaid Data. The summary report provides an overview of the results of an OIG audit of the information security controls over Virginia's Medicaid Management Information System (MMIS). The report does not include specific details of the vulnerabilities that the OIG identified because of the sensitive nature of the information. The OIG determined that Virginia did not adequately secure its Medicaid data and information systems in accordance with Federal requirements. Virginia had adopted a security program for its MMIS, but numerous significant system vulnerabilities remained. The findings listed in the summary report reflect a point in time regarding system security and may have changed since the OIG reviewed these systems.
• On May 22, 2017, the OIG released a report entitled, Medicare Could Save Millions by Eliminating the Lump-Sum Purchase Option for All Power Mobility Devices. The report found that from 2011 through 2014, Medicare saved an estimated $86 million by eliminating the lump-sum purchase option for standard power wheelchairs. The OIG recommends that CMS seek legislation to eliminate the lump-sum payment option for all power mobility devices. The OIG notes that if such legislation had been in place during calendar years 2011 through 2014, Medicare could have saved at least an additional $10.2 million.
• On May 23, 2017, the Congressional Budget Office (CBO) released a cost estimate of S. 652, the Early Hearing Detection and Intervention Act of 2017. The CBO estimates that implementing S. 652 would cost $127 million over the 2017-2022 period, assuming appropriation of the specified amounts. CBO also estimate that enacting S. 652 would not increase net direct spending or on-budget deficits in any of the four consecutive 10-year periods beginning in 2028.
• On May 24, 2017, the Government Accountability Office (GAO) released a report entitled, Veterans Affairs: Improper Payment Estimates and Ongoing Efforts for Reduction. The report found that for fiscal year 2016, the Department of Veterans Affairs (VA) reported improper payments estimate totaled $5.5 billion. The VA’s Community Care and Purchased Long-Term Services and Support programs accounted for reported improper payment estimates of $3.6 billion and $1.2 billion, respectively, or about 87 percent of the VA’s reported improper payment estimate for fiscal year 2016. VA’s reported improper payment estimates increased significantly from $1.6 billion for fiscal year 2014 to $5.0 billion for fiscal year 2015.
• On May 24, 2017, the CBO released a cost estimate of H.R. 1628, the American Health Care Act (AHCA) of 2017. The CBO estimates that AHCA would reduce federal deficits by $119 billion over the coming decade and increase the number of people who are uninsured by 23 million in 2026 relative to current law.
• On May 26, 2017, the OIG released a report entitled, Minnesota Disbursed Only Part of Its Civil Money Penalty Collections, Limiting Resources To Protect and Improve Care for Nursing Facility Residents. The report found that civil money penalty (CMP) collections received by the Minnesota Department of Human Services (State agency) during the OIG’s audit period totaled $592,000. However, the State agency reimbursed nursing facilities $114,000, or only about 20 percent of the amount collected, for expenditures incurred during the same time period. Although expenditures incurred during the audit period were generally allowable, the OIG identified claims of $5,000 for nursing facility staff wages and supplies that were already supported by other Federal and State funding sources.

IV. Other Health Policy News

• On May 23, 2017, President Trump released his fiscal year (FY) 2018 budget proposal. The FY 2018 budget proposal calls for $610 billion in Medicaid cuts, cuts FDA discretionary budget authority by $854 million; and cuts the NIH’s budget by $5.8 billion. The full FY 2018 budget proposal can be accessed here.
• On May 24, 2017, 195 House Democrats sent a letter to President Trump urging him to continue the Affordable Care Act’s cost-sharing reduction payments. A copy of the letter can be found here.

V. ACA Repeal News

• On May 24, 2017, the CBO released a cost estimate of H.R. 1628, the AHCA of 2017. The CBO estimates that AHCA would reduce federal deficits by $119 billion over the coming decade and increase the number of people who are uninsured by 23 million in 2026 relative to current law.