Alston & Bird Healthcare Week in Review, May 5, 2017

I. Regulations, Notices, & Guidance

• On May 2, 2017, the Drug Enforcement Agency (DEA) issued a temporary scheduling order entitled, Schedules of Controlled Substances: Temporary Placement of 4-Fluoroisobutyryl Fentanyl into Schedule I. The DEA is issuing the temporary scheduling order to schedule the synthetic opioid, N-(4-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)isobutyramide(4-fluoroisobutyryl fentanyl or parafluoroisobutyryl fentanyl), and its isomers, esters, ethers, salts and salts of isomers, esters, and ethers, into schedule I pursuant to the temporary scheduling provisions of the Controlled Substances Act.
• On May 2, 2017, the Centers for Disease Control and Prevention (CDC) issued a notice entitled, Issuance of Final Guidance Publications. The notice announces the availability of the following final 5 Skin Notation Profiles: Acrylic acid [CAS No. 79-01-7], Dichlorvos [CAS No. 62-73-7], Morpholine [CAS No. 110-91-8], Ethyl p-nitrophenyl phenylphosphorothioate (EPN) [CAS No. 2104- 64-5], Dioxathion [CAS No. 78-34-2]. The documents may be obtained here.
• On May 4, 2017, the Centers for Medicare & Medicaid Services (CMS) issued a notice entitled, Medicare and Medicaid Programs; Quarterly Listing of Program Issuances— January through March 2017. The quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from January through March 2017, relating to the Medicare and Medicaid programs and other programs administered by CMS.
• On May 4, 2017, the Agency for Healthcare Research and Quality (AHRQ) issued a notice of delisting entitled, Patient Safety Organizations: Voluntary Relinquishment from the Healogics Patient Safety Institute. The notice announces that a patient safety organization (PSO) can be "delisted" by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO’s listing expires. AHRQ has accepted a notification of voluntary relinquishment from the Healogics Patient Safety Institute of its status as a PSO, and has delisted the PSO accordingly. The Healogics Patient Safety Institute submitted this request for voluntary relinquishment after receiving a Notice of Preliminary Finding of Deficiency.

• May 31, 2017: the CDC announced a meeting of the National Center for Chronic Disease Prevention and Health Promotion, Interagency Committee on Smoking and Health (ICSH). The topic of the meeting is “Increasing the Impact of Evidence-Based Tobacco Treatment” and the objective of the meeting is to identify federal actions to increase the reach and effectiveness of efforts to help smokers quit.
• June 5, 2017: the Physician-Focused Payment Model Technical Advisory Committee (PTAC) announced its next meeting. The Committee will hear presentations by PTAC members on proposals for Medicare physician-focused payment models submitted by members of the public. Presentations will be followed by public comments and Committee deliberation and voting on recommendations.
• June 14 – 15: the CDC announced the next meeting of the Community Preventive Services Task Force. The matters proposed for discussion, include: Diabetes prevention: Diabetes Prevention and Control (Effectiveness of Mobile Phone Applications to Improve Glycemic Control (HbA1c) in the Self-management of Diabetes); Obesity Prevention and Control (Economics of School-based Interventions for Obesity Prevention Availability of Healthy Food and Beverage (AHFB) and Snack Food and Beverage (SFB)); Physical Activity (Effectiveness of Activity Monitors for Increasing Physical Activity in Adults with Overweight or Obesity); Nutrition (Telehealth Methods to Deliver Dietary Interventions in Adults with Chronic Disease); and Women’s Health (Effectiveness of Interventions for the Primary Prevention of Intimate Partner Violence and Sexual Violence Among Youth).
• June 27, 2017: the Department of Health and Human Services (HHS) announced the next federal 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. The Committee will advise the Secretary on the Healthy People 2030 mission, vision, framework, and organizational structure. The Committee will provide advice regarding criteria for identifying a more focused set of measurable, nationally representative objectives.
• June 29, 2017: the National Institutes of Health (NIH) announced a meeting of the National Toxicology Program (NTP) Board of Scientific Counselors (BSC). The BSC will provide input to the NTP on programmatic activities and issues. Preliminary agenda topics include: reports from the National Institute of Environmental Health Sciences/NTP Director and NTP Associate Director, and presentations on programmatic activities including issues related to studying mixtures, an evaluation of the zebrafish model for toxicology, a state of the science evaluation of transgenerational inheritance of health effects, and the new Integrated Chemical Environment database.
• July 12, 2017: the NIH announced a meeting of the National Cancer Institute Clinical Trials and Translational Research Advisory Committee. An agenda will be posted when available here.

II. Congressional Legislation & Committee Action

• There were no healthcare-related hearings this week.

• On May 2, 2017, the House Energy and Commerce Health Subcommittee held a hearing on "Examining Improvements to the Regulation of Medical Technologies," including H.R.1652, the "Over-the-Counter Hearing Aid Act of 2017"; H.R.1736, to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device; H.R.2009, the "Fostering Innovation in Medical Imaging Act"; and H.R.2118, the Medical Device Servicing and Accountability Act." The witnesses included Dr. Jeffrey Shuren, Director, Food and Drug Administration (FDA), Center for Devices and Radiological Health; Dr. Thomas Powers, Powers Consulting, LLC; Dr. Frank Lin, Associate Professor of Otolaryngology – Head and Neck Surgery, Geriatric Medicine, Mental Health and Epidemiology, Johns Hopkins University; Mr. Joe Robinson, Senior Vice President, Health System Solutions, Philips North America; Mr. Robert Kerwin, General Counsel, International Association of Medical Equipment Remarketers and Servicers; and Patricia Shrader, Vice President, Global Regulatory Affairs, Medtronic.
• On May 2, 2017, the House Energy and Commerce Oversight and Investigations Subcommittee held a hearing entitled, Combating Waste, Fraud, and Abuse in Medicaid's Personal Care Services Program. The witnesses included Christi Grimm, Chief of Staff Office of Inspector General (OIG), HHS; Timothy Hill, Deputy Director of the Center for Medicaid and CHIP Services, CMS; and Katherine Iritani, Director of Health Care at the GAO.
• On May 3, 2017, the House Rules Committee voted along party lines, 8-3 to adopt the MacArthur and Upton Amendments to H.R. 1628, the AHCA. The MacArthur amendment offered by Rep. Thomas MacArthur (R-NJ)  establishes a permissible state waiver, allowing states to: increase the age rating ratio above the 5:1 ratio; specify the essential health benefits that are required to be covered; and implements a health status rating for states operating a risk mitigation program or participating in a Federal Invisible Risk Sharing Program. The Upton amendment offered by Rep. Fred Upton (R-MI) provides an additional $8 billion over five years to offset or reduce premiums or other out-of-pocket costs for certain individuals with pre-existing conditions.
• On May 4, 2017, the House of Representatives, by a vote of 217-213, passed H.R. 1628, the American Health Care Act (AHCA). While the bill was previously pulled from consideration on the House floor on March 24, 2017 before a vote was taken, negotiations continued. A final bill, as amended following a House Rules Committee hearing on May 3, 2017, received further floor consideration and was passed. Even though the bill passed, 20 Republican members voted against the measure, including: Andy Biggs (AZ); Mike Coffman (CO); Barbra Comstock (VA); Ryan Costello (PA); Charlie Dent (PA); Dan Donovan (NY); Brian Fitzpatrick (NY); Jamie Herrera Beutler (WA); Will Hurd (TX); Walter Jones (NC); David Joyce (OH); John Katko (NY); Leonard Lance (NJ); Frank LoBiondo (NJ); Thomas Massie (KY); Patrick Meehan (PA); Dave Reichert (WA); Ileana Ros-Lehtinen (FL); Chris Smith (NJ); and Michael Turner (OH).

Upcoming Congressional Floor and Committee Action U

U.S. Senate

• On May 10, 2017, the Senate Health, Education, Labor and Pensions Committee will hold 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." The hearing will take place at 10:00 a.m. in G-50 Dirksen.
• On May 10, 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 2:30 p.m. in 562 Dirksen. The witnesses are TBD.
• On May 11, 2017, the Senate Appropriations Military Construction, Veterans Affairs and Related Agencies Subcommittee will hold a hearing on the Veterans Healthcare Choice Program Reform. The hearing will take place at 10:30 a.m. in 124 Dirksen. The witnesses are TBD.

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

• On May 1, 2017, the GAO released a report entitled, Medicaid Managed Care: Compensation of Medicaid Directors and Managed Care Organization Executives in Selected States in 2015. The report found that Medicaid directors earned less than most top paid managed care organization (MCO) executives in 2015 in the states the GAO selected for its review. Under managed care arrangements, states contract with MCOs to provide certain services to beneficiaries. Spending for Medicaid managed care has grown significantly, representing over one-third of federal spending on Medicaid in 2014. In 2015, Medicaid directors' salaries in the 10 selected states ranged from $103,020 to $260,088, with an average of $152,439 and a median of $141,000. The 2015 salaries paid to 133 top paid MCO executives in seven states that met the GAO's selection criteria and provided data ranged from $108,598 to $796,732, with an average of $236,007 and a median of $229,442.
• On May 2, 2017, the GAO released a report entitled, Medicaid Personal Care Services: More Harmonized Program Requirements and Better Data Are Needed. The report found that A growing number of people rely on Medicaid personal care services for help with daily tasks like bathing and eating. However, these types of services are at high risk for fraud and abuse (g., services that were paid for but never provided). Moreover, the report found that Medicaid needs better data to oversee personal care service programs.
• On May 3, 2017, the GAO released a report entitled, Medicaid Demonstrations: Federal Action Needed to Improve Oversight of Spending. The report found that over the last decade, federal spending under Medicaid section 1115 demonstrations, which allow states flexibility to test new approaches for delivering Medicaid services, has increased significantly. The GAO found inconsistencies in CMS’ monitoring process.  For example, CMS did not consistently require selected states to report the information needed to assess compliance with demonstration spending limits.
• May 4, 2017, the OIG released a report entitled, CMS Validated Hospital Inpatient Quality Reporting Program Data, But Should Use Additional Tools to Identify Gaming. The report found that for payment year 2016, CMS met its regulatory requirement by validating sufficient IQR data, which are used to adjust payments on the basis of quality. Almost 99 percent of hospitals that CMS reviewed passed validation, and CMS took action against the six that failed, including reducing their Medicare payments. CMS and CDC offer training to hospitals to help improve the accuracy of the quality data hospitals report. However, CMS’ approach to selecting hospitals for validation for payment year 2016 made it less likely to identify gaming of quality reporting (i.e., hospitals' manipulating data to improve their scores). Furthermore, CMS did not include any hospitals in its targeted sample on the basis of their having aberrant data patterns.

• On May 3, 2017, CMS announced that it has assessed the results of the 2015 benefit year HHS-Operated Risk Adjusted Data Validation (HHS-RADV) pilot and received feedback from issuers and their initial validation audit (IVA) entities suggesting the need for an additional transition year to ensure the successful implementation of risk adjustment data validation. Therefore, CMS announced that it is converting 2016 benefit year HHS-RADV to a second pilot year, forgoing payment adjustments until 2017 benefit year HHS-RADV, and implementing process refinements that will reduce the burdens of HHS-RADV.
• On May 5, 2017, the Internal Revenue Service issued a revenue procedure that provided the 2018 inflation adjusted amounts for Health Savings Accounts.

• On May 3, 2017, the House Rules Committee voted along party lines, 8-3 to adopt the MacArthur and Upton Amendments to H.R. 1628, the AHCA. The MacArthur amendment offered by Rep. Thomas MacArthur (R-NJ)  establishes a permissible state waiver, allowing states to: increase the age rating ratio above the 5:1 ratio; specify the essential health benefits that are required to be covered; and implements a health status rating for states operating a risk mitigation program or participating in a Federal Invisible Risk Sharing Program. The Upton amendment offered by Rep. Fred Upton (R-MI) provides an additional $8 billion over five years to offset or reduce premiums or other out-of-pocket costs for certain individuals with pre-existing conditions.
• On May 4, 2017, the House of Representatives, by a vote of 217-213, passed H.R. 1628, the American Health Care Act (AHCA). While the bill was previously pulled from consideration on the House floor on March 24, 2017 before a vote was taken, negotiations continued. A final bill, as amended following a House Rules Committee hearing on May 3, 2017, received further floor consideration and was passed. Even though the bill passed, 20 Republican members voted against the measure, including: Andy Biggs (AZ); Mike Coffman (CO); Barbra Comstock (VA); Ryan Costello (PA); Charlie Dent (PA); Dan Donovan (NY); Brian Fitzpatrick (NY); Jamie Herrera Beutler (WA); Will Hurd (TX); Walter Jones (NC); David Joyce (OH); John Katko (NY); Leonard Lance (NJ); Frank LoBiondo (NJ); Thomas Massie (KY); Patrick Meehan (PA); Dave Reichert (WA); Ileana Ros-Lehtinen (FL); Chris Smith (NJ); and Michael Turner (OH).