Alston & Bird Healthcare Week in Review, June 17, 2017

I. Regulations, Notices, & Guidance

• n June 12, 2017, the Centers for Medicare & Medicaid Services (CMS) issued a proposed notice entitled, Medicare and Medicaid Programs: Application from the American Osteopathic Association / Healthcare Facilities Accreditation Program (AOA-HFAP) for Continued CMS Approval of its Ambulatory Surgical Center Accreditation Program. The proposed notice acknowledges the receipt of an application from the American Osteopathic Association / Healthcare Facilities Accreditation Program (AOA-HFAP) for continued recognition as a national accrediting organization for Ambulatory Surgical Centers that wish to participate in the Medicare or Medicaid programs. Comments are due by July 13, 2017.
• On June 12, 2017, the National Institutes of Health (NIH) issued a notice entitled, Notice of Charter Renewal. The notice announces that the Charter for the Advisory Committee to the Director, was renewed for an additional two-year period on May 31, 2017.
• On June 12, 2017, the NIH issued a notice entitled, Government-Owned Inventions; Availability for Licensing. The notice announces that human and veterinary cancer therapeutic agent utilizing anthrax toxin-based technology is available for licensing. According to the NIH, due to the disorganized nature of blood vessels that run through tumors, chemotherapeutic agents often fail to penetrate tumors and kill cancer cells at the tumor’s center. This can lead to ineffective chemotherapeutic treatments, because tumors can quickly grow back if the entire tumor is not destroyed. NIH researchers have developed a therapeutic agent that solves this problem facing current chemotherapy treatments.
• On June 13, 2017, the Food and Drug Administration (FDA) issued a notice entitled, Determination of Regulatory Review Period for Purposes of Patent Extension; HETLIOZ. The notice announces that the FDA has determined the regulatory review period for HETLIOZ and is publishing the notice of that determination as required by law. The FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product. Comments are due by August 14, 2017.
• On June 13, 2017, the FDA issued a notice entitled, Determination of Regulatory Review Period for Purposes of Patent Extension; NEUROPACE RNS SYSTEM. The notice announces that the FDA has determined the regulatory review period for HETLIOZ and is publishing the notice of that determination as required by law. The FDA has made the determination because of the submission of an application to the Director of the USPTO, Department of Commerce, for the extension of a patent which claims that human drug product. Comments are due by August 14, 2017.
• On June 13, 2017, the FDA issued a notice entitled, Request for Nominations on Device Good Manufacturing Practice Advisory Committee. The FDA is requesting that any industry organization interested in participating in the selection of a nonvoting industry representative to serve on the Device Good Manufacturing Practice Advisory Committee (DGMPAC) in the Center for Devices and Radiological Health notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative to serve on DGMPAC. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for the upcoming vacancy effective with this notice. Nominations are due by July 14, 2017.
• On June 13, 2017, the FDA issued a notice entitled, Request for Nominations of Voting Members on a Public Advisory Committee; National Mammography Quality Assurance Advisory Committee. The FDA is requesting nominations for voting members to serve on the National Mammography Quality Assurance Advisory Committee in the Center for Devices and Radiological Health. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups. Nominations are due by August 14, 2017.
• On June 14, 2017, the FDA issued a notice entitled, Request for Nominations for Voting Members on a Public Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee. The FDA is requesting nominations for members to serve on the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC) in the Center for Devices and Radiological Health. Nominations are due by August 14, 2017.
• On June 14, 2017, the FDA issued a notice entitled, Request for Nominations for Individuals and Consumer Organizations for Advisory Committees. The FDA is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify the FDA in writing. The FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. Nominations are due by July 17, 2017.
• June 14, 2017, the FDA issued a notice entitled, Determination of Regulatory Review Period for Purposes of Patent Extension; NATPARA. The notice announces that the FDA has determined the regulatory review period for HETLIOZ and is publishing the notice of that determination as required by law. The FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product. Comments are due by August 14, 2017.
• On June 14, 2017, the Office of Management and Budget (OMB) received a proposed rule from CMS entitled, Medicaid Disproportionate Share Hospital (DSH) Allotment Reductions. The proposed rule outlines the Medicaid DSH allotment reductions.

• July 10 – 11, 2017: The FDA announced a public workshop entitled “Data and Methods for Evaluating the Impact of Opioid Formulations with Properties Designed to Deter Abuse in the Postmarket Setting: A Scientific Discussion of Present and Future Capabilities.” The purpose of the public workshop is to host a scientific discussion with expert panel members and interested stakeholders about the challenges in using the currently available data and methods for assessing the impact of opioid formulations with properties designed to deter abuse on opioid misuse, abuse, addiction, overdose, and death in the postmarket setting.
• August 1, 2017: CMS announced a public meeting to receive comments and recommendations (including accompanying data on which recommendations are based) from the public on the appropriate basis for establishing payment amounts for new or substantially revised Healthcare Common Procedure Coding System (HCPCS) codes being considered for Medicare payment under the clinical laboratory fee schedule (CLFS) for calendar year (CY) 2018.
• August 1, 2017: CMS announced a public meeting of the Advisory Panel on Clinical Diagnostic Laboratory Tests. During the 2017 CLFS Public Meeting, the public, along with the Panel, will hear and pose questions to presenters concerning cross walking and gap filling for new and reconsidered CDLTs for calendar year CY 2018. Following the opening remarks of the Panel Meeting, the Panel will address any issues relating to the CY 2018 CLFS new and reconsidered laboratory codes.
• October 24, 2017: The NIH announced an Interagency Autism Coordinating Committee (IACC or Committee) meeting. The purpose of the IACC meeting is to discuss business, agency updates, and issues related to autism spectrum disorder (ASD) research and services activities.

II. Congressional Legislation & Committee Action

• On June 13, 2017, the Senate Health, Education, Labor and Pensions Committee held a hearing entitled, The Cost of Prescription Drugs: How the Drug Delivery System Affects What Patients Pay. The witnesses included Dan Mendelson, President Avalere Health; Allan Coukell, Senior Director of Health Programs, Pew Charitable Trusts; Dr. Paul Howard, Senior Fellow and Director of Health Policy, Manhattan Institute; and Dr. Gerard Anders, Professor of Medicine, Johns Hopkins University School of Medicine.
• On June 13, 2017, the Senate Indian Affairs Committee held a hearing on S.1250, to amend the Indian Health Care Improvement Act to improve the recruitment and retention of employees in the Indian Health Service, restore accountability in the Indian Health Service, improve health services; S.1275, to improve the housing conditions and promote useful land uses within tribal communities; and legislation on "HUD/VA Veterans Affairs Supportive Housing."
• On June 14, 2017, the Senate Veterans’ Affairs Committee held a hearing entitled, FY 2018 Budget for Veterans’ Programs and FY 2019 Advance Appropriations Requests. The witnesses included Dr. David Shulkin, VA Secretary; Mr. Carl Blake, Associate Executive Director, Government Relations, Paralyzed Veterans of America; Mr. LeRoy Acosta, Assistant National Service Director, Disabled American Veterans; Mr. Carlos Fuentes, Director Of The National Legislative Service, Veterans of Foreign Wars; and Mr. John Rowan, National President, Vietnam Veterans of America.
• On June 15, 2017, the Senate Appropriations Labor, Health and Human Services, Education and Related Agencies Subcommittee held a hearing on the Department of Health and Human Services’ (HHS) FY 2018 budget proposal. The sole witness will be Tom Price, Secretary of HHS.

• There were no health care-related hearings in the House this week.

• On June 12, the Office of Inspector General (OIG) released a report entitled, Medicare Market Shares of Mail Order Diabetes Test Strips From October Through December 2016. The report found from October through December 2016, sampled suppliers provided 19 types of diabetes test strips via the Medicare National Mail-Order program. The top 2 strip types accounted for 53 percent of the Medicare mail-order market, and the top 10 strip types accounted for 97.5 percent.
• On June 12, 2017, the OIG released a report entitled, Review of Wisconsin Medicaid Managed Care Program Potential Savings With Minimum Medical Loss Ratio. The report found that the Wisconsin Medicaid program could have saved $16.2 million (approximately $9.6 million Federal share) in 2014 if Wisconsin (1) required its Medicaid managed care plans to meet the minimum medical loss ratio (MLR) standard similar to the Federal standards for certain private insurers and Medicare Advantage plans and (2) required remittances when Medicaid managed care plans did not meet the MLR standard. Specifically, of the 11 managed care plans that we reviewed, we calculated MLRs for 4 plans that were less than 85 percent (the minimum MLR standard for large private insurers) during calendar year 2014.
• On June 12, 2017, the OIG released a report entitled, Medicare Paid Hundreds of Millions in Electronic Health Record Incentive Payments That Did Not Comply With Federal Requirements. The report found that CMS did not always make electronic health record (HER) incentive payments to eligible professionals (EPs) in accordance with Federal requirements. On the basis of the OIG’s sample results, the OIG estimated that CMS inappropriately paid $729.4 million (12 percent of the total) in incentive payments to EPs who did not meet meaningful use requirements. These errors occurred because sampled EPs did not maintain support for their attestations. Furthermore, CMS conducted minimal documentation reviews, leaving the self-attestations of the EHR program vulnerable to abuse and misuse of Federal funds.
• On June 13, 2017, the OIG released a report entitled, 2016 Performance Data for the Senior Medicare Patrol Project. The report found that in 2016, the 53 Senior Medicare Patrol (SMP) projects had a total of 6,126 total active team members who conducted a total of 26,220 group outreach and education events, reaching an estimated 1.5 million people. In addition, the projects had 195,386 individual interactions with, or on behalf of, a Medicare beneficiary. For 2016, the projects reported $163,904 in cost avoidance on behalf of Medicare, Medicaid, beneficiaries, and others. Savings to beneficiaries and others totaled $53,449. Expected Medicare recoveries totaled $2,672. Further, two projects provided information to Federal prosecutors that resulted in settlements totaling an additional $9.2 million in expected Medicare recoveries. There were no expected Medicaid recoveries.
• On June 13, 2017, the Government Accountability Office (GAO) released a report entitled, Improper Payments: Additional Guidance Could Provide More Consistent Compliance Determinations and Reporting by Inspectors General. The report found that five years after the implementation of the Improper Payments Elimination and Recovery Act of 2010 (IPERA), 15 of the 24 Chief Financial Officers Act of 1990 (CFO Act) agencies were reported by their inspectors general (IG) as noncompliant under IPERA for fiscal year 2015. The programs associated with these 15 agencies accounted for $132 billion (or about 96 percent) of the reported $136.7 billion government-wide improper payment estimate for fiscal year 2015. In addition, the inconsistent IG compliance determinations in the IGs' fiscal year 2015 IPERA compliance reports may present potentially misleading information. Specifically, certain IGs reported compliance based on the presence or absence of the required analysis or reporting, regardless of whether the IGs identified flaws, whereas certain other IGs reported agencies as noncompliant based on their performance of some degree of evaluative procedures to determine whether the analysis or reporting that the agency produced was substantively adequate. While the severity of the IGs' findings may have resulted in the IGs reporting noncompliance for some agencies, similar findings were identified for both the compliant and noncompliant agencies. IPERA and Office of Management and Budget (OMB) guidance does not specify what, if any, evaluative procedures should be conducted as part of the IGs' compliance determinations. The Council of the Inspectors General on Integrity and Efficiency (CIGIE), which represents the IGs, has also not issued such guidance.
• On June 15, 2017, the Congressional Budget Office (CBO) issued a cost estimate of S. 934, the FDA Reauthorization Act of 2017. The cost estimate found that implementing S. 934 would require increased funding for a variety of FDA activities, but most of the increase in FDA spending would be offset by additional fees that would be collected under the bill and used to reduce the need for discretionary appropriations. The CBO estimates that net discretionary spending (primarily by the FDA) would increase by about $740 million over the 2017–2022 period, assuming appropriation actions consistent with the bill. The CBO also estimates that enacting S. 934 would increase direct spending by $13 million and decrease revenues by $2 million over the 2017-2027 period; therefore, pay-as-you-go procedures apply. Taken together, the CBO estimates that enacting S. 934 would increase budget deficits by $15 million over the 2017-2027 period. The CBO estimates that enacting S. 934 would not increase net direct spending or on-budget deficits by more than $5 billion in any of the four consecutive 10-year periods beginning in 2028.

IV. Other Health Policy News

• On June 12, 2017, CMS issued a guidance document entitled, Updated CMS Bulletin on Network Breadth Information for Qualified Health Plans on HealthCare.gov. According to CMS, for plan year (PY) 2018, CMS intends to continue the network breadth pilot for reporting information on the relative size of provider networks that will display in a limited number of states on HealthCare.gov. Empowering consumers to select the plan that is best for them is a priority for CMS, and the goal of the network breadth pilot is to help CMS understand how consumers make use of network breadth information in their decision-making.
• On June 12, 2017, CMS issued a guidance document entitled, Display of 2017 Quality Rating System (QRS) star ratings and Qualified Health Plan (QHP) Enrollee Experience Survey results for QHPs offered through the Health Insurance Exchanges. The guidance document announces the CMS will conduct a second year of consumer pilot testing during the 2018 individual market open enrollment period of the display of Qualified Health Plan (QHP) quality rating information1 by the Federally-facilitated Exchanges (FFEs), including FFEs where the State performs plan management functions, and State-based Exchanges on the Federal Platform (SBE-FPs). CMS intends to use the same criteria for identifying states to participate in the second year of the consumer pilot testing.
• On June 12, 2017, CMS published two reports, the Effectuated Enrollment report and The Health Insurance Exchanges Trends report. These reports show that after selecting a plan on the Exchanges during open season which ended January 31, 2017, less than two months later nearly 2 million people had not paid their insurance premium to effectuate and maintain their health coverage. This number will be adjusted for individuals who effectuate their coverage in March 2017. Exit survey data also contained in the reports indicate that cost is the top reason cited for ending their coverage. Taken together, these reports provide a better understanding of why consumers are leaving the Exchanges.
• On June 13, 2017, CMS released acounty-level map of 2018 projected Health Insurance Exchanges participation based on the known issuer participation public announcements through June 9, 2017. The map shows that insurance options on the Exchanges continue to disappear. Plan options are down from last year and, in some areas, Americans will have no coverage options on the Exchanges, based on the current data.
• On June 14, 2017, CMS’ Office of the Actuary (OACT) released state-level health care spending data for the period 1991-2014. The data shows that while most states experienced faster growth in 2014 due to Medicaid expansion and enrollment in Exchange plans, per capita health spending in Medicaid expansion and non-expansion states grew at similar rates. The report also found that the most recent economic recession, which ended in 2009, and modest recovery since then, had a sustained impact on health spending and health insurance coverage. Every state experienced slower growth in per capita personal health care spending from 2010-2013 than experienced during the period 2004-2009. The data can be accessed here.
• On June 16, 2017, CMS released Affordable Care Act Implementation FAQs (Set 38): Mental Health and Substance Use Disorder Parity Implementation and the 21^st Century Cures Act. The FAQs relate to implementation of the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA).

V. ACA Repeal News

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