Alston & Bird Healthcare Week in Review, April 1, 2017

I. Regulations, Notices, & Guidance

• On March 29, 2017, the Agency for Healthcare Research and Quality (AHRQ) within the Department of Health and Human Services (HHS) issued a notice entitled, Supplemental Evidence and Data Request on Physiologic Predictors of the Need for Trauma Center Care: A Systematic Review. The AHRQ is seeking scientific information submissions. Scientific information is being solicited to inform the AHRQ’s review of Physiologic Predictors of the Need for Trauma Center Care: A Systematic Review, which is currently being conducted by the AHRQ’s Evidence-based Practice Centers (EPC) Program. Comments are due by May 1, 2017.
• On March 30, 2017, the Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled, Medicaid Program; Disproportionate Share Hospital Payments – Treatment of Third Party Payers in Calculating Uncompensated Care Costs. According to CMS, this final rule addresses the hospital-specific limitation on Medicaid disproportionate share hospital (DSH) payments under Medicaid, and the application of such limitation in the annual DSH audits, by clarifying that the hospital-specific DSH limit is based only on uncompensated care costs. Specifically, this rule makes explicit in the text of the regulation, an existing interpretation that uncompensated care costs include only those costs for Medicaid eligible individuals that remain after accounting for payments made to hospitals by or on behalf of Medicaid eligible individuals, including Medicare and other third party payments that compensate the hospitals for care furnished to such individuals. As a result, the hospital-specific limit calculation will reflect only the costs for Medicaid eligible individuals for which the hospital has not received payment from any source. These regulations are effective 60 days after the date of publication in the Federal Register – scheduled for April 3, 2017.

• April 6 – 7, 2017: The Medicare Payment Advisory Commission (MedPAC) announced their next public meeting. The agenda for April’s meeting can be found here.
• April 27, 2017: HHS announced an advisory committee meeting regarding the development of national health promotion and disease prevention objectives for 2030. The Committee will discuss the nation’s health promotion and disease prevention objectives and will provide recommendations to improve health status and reduce health risks for the nation by the year 2030.
• May 12, 2017: The Food and Drug Administration (FDA) announced a public workshop entitled, Roadmap for Engaging with FDA’s Center for Drug Evaluation and Research (CDER).  The purpose of this workshop is to help the public learn how to successfully engage with CDER.

II. Congressional Legislation & Committee Action

• On March 29, 2017, the Senate Special Aging Committee held hearing entitled, The Arch of Alzheimer's: From Preventing Cognitive Decline in Americans to Assuring Quality Care for those Living with the Disease. The witnesses present included Maria Shriver, Mother, Journalist and Founder the Women’s Alzheimer’s Movement; Dr. Kristine Yaffee, Scola Endowed Chair And Vice Chair; Professor, Department Of Psychiatry, Neurology, and Epidemiology And Biostatistics; And Chief, Neuropsychiatry University of California, San Francisco; and San Francisco VA Medical Center; Dr. Christopher Callahan; Direct and Investigator, Indiana University Center for Aging Research and Regenstrief Institute, Inc; and Phyllis Galagher, Family Caregiver.

• On March 28, 2017, the House Energy and Commerce Health Subcommittee held a hearing entitled, Examining FDA’s Medical Device User Fee Program. The witnesses present included, Dr. Jeffrey Shuren, Director, FDA, Center for Devices and Radiological Health; Ms. Cynthia Bens, Vice President of Public Policy, Alliance for Aging Research; Mr. Patrick Daly, President & CEO, Cohera Medical, speaking on behalf of the Advanced Medical Technology Association; Mr. Robert Kieval, Founder and Chief Development Officer, CVRx, speaking on behalf of the  Medical Device Manufacturers Association; and Ms. Diane Wurzburger, Executive, GE Healthcare, Regulatory Affairs U.S. & Canada, Global Strategic Policy & Programs, speaking on behalf of the Medical Imaging & Technology Alliance.
• On March 29, 2017, the House Appropriations Labor, Health and Human Services, Education, and Related Agencies Subcommittee held a budget hearing on the Department of Health and Human Services. The sole witness present was the Honorable Tom Price, HHS Secretary.
• On March 29, 2017, the House Oversight and Government Reform Committee held a hearing entitled, Federally Funded Cancer Research: Coordination and Innovation. The witnesses present included Dr. Mary Beckerle, Ph.D., Chief Executive Officer and Director, Huntsman Cancer Institute, University of Utah Medical School; Dr. Elizabeth Jaffee, M.D., Deputy Director, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University; Dr. Tyler Jacks, Ph.D., Director, Koch Institute for Integrative Cancer Research, Massachusetts Institute of Technology; and Ms. Tammi Carr, Mother of Chad Carr, The ChadTough Foundation.

• On April 4, 2017, the Senate Health, Education, Labor and Pensions (HELP) Committee will hold a hearing entitled, FDA User Fee Agreements: Improving Medical Product Regulation and Innovation for Patients Part II. The hearing will take place at 10:00 a.m. in 430 Dirksen. The witnesses will include Kay Holcombe, Senior Vice President for Science Policy at the Biotechnology Innovation Organization; David Gaugh, Senior Vice President of Sciences and Regulatory Affairs at the Association for Accessible Medicines; Scott Whitaker, President and CEO of the Advanced Medical Technology Association; and Cynthia Bens, Vice President of Public Policy at the Alliance for Aging Research.
• On April 5, 2017, the Senate HELP Committee will hold a hearing on the nomination of Scott Gottlieb to be Commissioner of the FDA. The hearing will take place at 10:00 a.m. in 430 Dirksen.

• On April 5, 2017, the House Appropriations Labor, Health and Human Services, Education, and Related Agencies Subcommittee will hold a hearing entitled, Opioid Abuse Crisis Response. The hearing will take place at 10:00 a.m. in 2358-C Rayburn. The witnesses are TBD.

• On March 30, 2017, the Office of Inspector General (OIG) released a report entitled, Wisconsin Claimed Unallowable Federal Reimbursement for Some Medicaid Physician-Administered Drugs. The report found that the Wisconsin Department of Health Services (State agency) did not always comply with Federal Medicaid requirements for invoicing manufacturers for rebates for physician-administered drugs. The State agency did not invoice manufacturers for rebates associated with $3 million ($1.8 million Federal share) in physician-administered drugs. Of this amount, $2.9 million ($1.7 million Federal share) was for single-source drugs, and $165,000 ($99,000 Federal share) was for top-20 multiple-source drugs. Because the State agency's internal controls did not always ensure that it invoiced manufacturers to secure rebates, the State agency improperly claimed Federal reimbursement for these single-source drugs and top-20 multiple-source drugs. Further, the State agency did not submit the utilization data necessary to secure rebates for all other physician-administered drugs. Although the State agency generally collected the drug utilization data necessary to invoice the manufacturers for rebates associated with these claims, providers submitted claims totaling $33,000 ($20,000 Federal share) that did not have National Drug Codes (NDCs). The OIG was unable to determine whether the State agency was required to invoice for rebates for these other physician-administered drug claims that did not have NDCs in the utilization data. Furthermore, under the Medicaid drug rebate program, claims totaling $170,000 ($102,000 Federal share), which contained NDCs, could have been eligible for rebates.

IV. Other Health Policy News

• On March 27, 2017, the OIG released a resource guide entitled, Measuring Compliance Program Effectiveness. According to the OIG, the guide provides measurement options to a wide range of organizations with diverse size, operational complexity, industry sectors, resources, and compliance programs. The guide provides a list of many individual compliance program metrics.
• On March 29, 2017, Senators Al Franken (D-MN), Tammy Baldwin (D-WI), Amy Klobuchar (D-MN), Bernie Sanders (I-VT), Sheldon Whitehouse (D-RI), Sherrod Brown (D-OH), Elizabeth Warren (D-MA), Jack Reed (D-RI), Kirsten Gillibrand (D-NY), Maggie Hassan (D-NH), Dick Durbin (D-IL), Chris Van Hollen (D-MD), Jeff Merkley (D-OR), Tom Udall (D-NM), Richard Blumenthal (D-CT) and Cory Booker (D-NJ) introduced The Improving Access to Affordable Prescription Drug Act. The bill looks to address drug prices by touching on policies related to drug rebates, government monitoring of price spikes, disclosure requirements for drug marker’s research and marketing spending, cost-sharing caps on plans, awards for antibiotic development, public clinical trial funding, exclusivity cuts, and a pay-for-delay ban and drug advertising restrictions.
• On March 30, 2017, CMS issued the Spring 2017 Medicaid/CHIP Periodic DATA Matching – External FAQ. The FAQ document answers general questions about Medicaid/CHIP periodic data matching.
• On March 30, 2017, House Speaker Paul Ryan (R-WI) said that the House has no plans to drop its lawsuit against the administration over the Affordable Care Act’s cost-sharing reduction payments. However, Speaker Ryan noted that CSR’s will continue to flow to issuers as the lawsuit makes its way through the system.
• On March 30, 2017, CMS announced that it will exercise enforcement discretion until May 30, 2017, with respect to the data reporting period for reporting applicable information under the Clinical Laboratory fee Schedule (CLFS) and the application of the Secretary’s potential assessment of civil monetary penalties for failure to report applicable information.
• On March 31, 2017, CMS announced that as of April 1, 2017, the Pre-Claim Review demonstration will be paused for at least 30 days in Illinois. According to CMS, the demonstration will not expand to Florida on April 1, 2017. Furthermore, after March 31, 2017, and continuing throughout the pause, the Medicare Administrative Contractors will not accept any Pre-Claim Review requests.  During the pause, home health claims can be submitted for payment and will be paid under normal claim processing rules.

V. ACA Repeal News

• On March 29, 2017, Senators Lamar Alexander (R-TN) and Bob Corker (R-TN) introduced the Health Care Options Act of 2017. The legislation would allow consumers to buy insurance plans outside of the Affordable Care Act exchanges in areas with a lack of coverage options and would waive the individual mandate penalty for these individuals.