A&B Healthcare Week in Review, February 6, 2016

I. REGULATIONS, NOTICES, & GUIDANCE

• On February 5, 2016, the Substance Abuse and Mental Health Administration (SAMHSA) issued a proposed rule entitled, “Confidentiality of Substance Use Disorder Patient Records.” This proposed rule addresses changes to the Confidentiality of Alcohol and Drug Abuse Patient Records regulations. This proposal was prompted by the need to update and modernize the regulations. These laws and regulations governing the confidentiality of substance abuse records were written out of great concern about the potential use of substance abuse information against an individual, preventing those individuals with substance use disorders from seeking needed treatment. Under this proposed rule, SAMHSA seeks to ensure that patients with substance use disorders have the ability to participate in, and benefit from new integrated health care models without fear of putting themselves at risk of adverse consequences.
• On February 2, 2016, the Centers for Medicare and Medicaid Services (CMS) published a notice entitled, “Medicaid Program; Final FY 2013 and Preliminary FY 2015 Disproportionate Share Hospital Allotments, and Final FY 2013 and Preliminary FY 2015 Institutions for Mental Diseases Disproportionate Share Hospital Limits.” This notice announces the final federal share disproportionate share hospital (DSH) allotments for federal fiscal year (FY) 2013 and the preliminary federal share DSH allotments for FY 2015. This notice also announces the final FY 2013 and the preliminary FY 2015 limitations on aggregate DSH payments that states may make to institutions for mental disease and other mental health facilities. In addition, this notice includes background information describing the methodology for determining the amounts of states' FY DSH allotments.
• On February 5, 2016, the CMS Center for Consumer Information and Insurance Oversight (CCIIO) issued guidance entitled, “Application of the Market Reforms and Other Provisions of the Affordable Care Act to Student Health Coverage.” This Bulletin provides guidance on the application of certain provisions of the Affordable Care Act (ACA) to premium reduction arrangements offered in connection with student health plans and provides temporary transition relief from enforcement by the Departments of the Treasury, Labor, and Health & Human Services (HHS) in certain circumstances.
• On February 4, 2016, CMS and the Administration for Community Living (ACL) published an interim final rule entitled, “State Health Insurance Assistance Program (SHIP).” This rule implements a provision enacted by the Consolidated Appropriations Act of 2014 and reflects the transfer of the State Health Insurance Assistance Program (SHIP) from CMS to ACL. The previous regulations were issued by CMS under the authority granted by the Omnibus Budget Reconciliation Act of 1990 (OBRA `90), Section 4360.
• On February 3, 2016, the Food & Drug Administration published notices to announce the availability of several guidance documents. Topics of the guidance documents include: (1) List of Highest Priority Devices for Human Factors Review; (2) Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices; (3) Applying Human Factors and Usability Engineering to Medical Devices; and (4) Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development.
• On February 2, 2016, the FDA published a notice entitled, “Regulatory Site Visit Training Program.” In this notice, the FDA’s Center for Biologics Evaluation and Research (CBER) announces an invitation for participation in its Regulatory Site Visit Training Program (RSVP). This training program is intended to give CBER regulatory review, compliance, and other relevant staff an opportunity to visit biologics facilities. These visits are intended to allow CBER staff to directly observe routine manufacturing practices and to give CBER staff a better understanding of the biologics industry, including its challenges and operations. The purpose of this document is to invite biologics facilities to contact CBER for more information if they are interested in participating in this program.
• On February 4, 2016, CMS published a notice entitled, “Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-October Through December 2015.” This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from July through September 2015, relating to the Medicare and Medicaid programs and other programs administered by CMS.
• On February 4, 2016, the HHS Office of the National Coordinator (ONC) for Health Information Technology published a notice of new tool availability entitled, “Notice of Availability: 2015 Edition Test Tools and Test Procedures Approved by the National Coordinator for the ONC Health IT Certification Program.” This notice announces the availability of test tools and test procedures approved by the National Coordinator for Health Information Technology for the testing of Health IT Modules to the 2015 Edition health IT certification criteria under the ONC Health IT Certification Program. The approved test tools and test procedures are identified on the ONC website.
• On February 2, 2016, CMS published a notice entitled, “Request for Information: Certification Frequency and Requirements for the Reporting of Quality Measures Under CMS Programs; Extension of Comment Period.” This document extends the comment period for the December 31, 2015 request for information entitled “Request for Information: Certification Frequency and Requirements for the Reporting of Quality Measures Under CMS Programs” (80 FR 81824) (referred to as the “December 31 RFI”). The comment period for the December 31 RFI, which would have ended on February 1, 2016, is extended for 15 days.
• On February 4, 2016, the National Institutes of Health (NIH) published a notice entitled, “The National Heart, Lung, and Blood Institute (NHLBI) Strategic Visioning: Draft Strategic Research Priorities; Request for Comments.” he National Heart, Lung, and Blood Institute (NHLBI) is soliciting comments from the public on its Draft Strategic Research Priorities, which will help inform Institute-solicited research activities over the next decade. The draft document is available through the NHLBI Strategic Visioning website.
• On February 5, 2016, CMS published a notice of information collections. Topics for the proposed information collections include: (1) the Medicare Probable Fraud Measurement Pilot; and (2) the Medicare Prior Authorization of Home Health Services Demonstration. On the same day, CMS also published information collection request notices on: (1) the Reapplication Submission Requirement for Qualified Entities under ACA Section 10332; and (2) the Fiscal Soundness Reporting Requirements for Medicare Advantage Organizations (MAOs).
• On February 5, 2016, the Centers for Disease Control & Prevention (CDC) issued a notice entitled, “Vaccine Information Materials for Hepatitis A and Hepatitis B Vaccines; Revisions.” Under the National Childhood Vaccine Injury Act, the CDC develops vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. HHS/CDC seeks written comment on the proposed updated vaccine information statements for hepatitis A and hepatitis B vaccines.
• On February 2, 2016, the FDA published information collection notices the following topics: (1) General Licensing Provisions for Biosimilar Applications; (2) Establishment and Operation of Clinical Trial Data Monitoring Committees; (3) Drug Supply Chain Security Act Implementation; and (4) Application of 30-Month Stays on Approval of Abbreviated New Drug Applications Certifying That a Patent Claiming a Drug Is Valid or Will Not Be Infringed.
• On February 3, 2016, the FDA published information collection notices on the following topics: (1) Biosimilar User Fees; and (2) Post-Marketing Adverse Drug Experience Reporting.

Event Notices

• February 24, 2016: The CDC’s Advisory Committee on Immunization Practices will hold a meeting from 8:00 a.m. to 6:00 p.m. in the CDC’s Tom Harkin Global Communications Center, 1600 Clifton Rd NE, Bldg. 19, Atlanta, GA 30329. More information about this meeting may be found here.
• February 24-25, 2016: The FDA and the Arthritis Foundation will hold a joint workshop concerning “Accelerating Osteoarthritis Clinical Trials,” from 8:00 a.m. to 5:30 p.m. on February 24th and 8:00 a.m. to 2:00 p.m. on February 25th. This workshop will be held at the Atlanta Airport Hilton, 1031 Virginia Ave, Atlanta, GA 30354. More information on this workshop may be found here.
• March 3, 2016: The Presidential Commission for the Study of Bioethical Issues, in conjunction with HHS, will hold a teleconference meeting from 2:00 p.m. to 4:00 p.m. to discuss ongoing development of pedagogical materials to facilitate the integration of bioethics into education in a range of traditional and non-traditional settings. More information on this meeting may be found here.

II. CONGRESSIONAL LEGISLATION & COMMITTEE ACTION

U.S. Senate

• On February 4, 2016, the Senate Committee on Finance held a hearing entitled, “Hearing to Consider the Nominations of Mary Katherine Wakefield, Andrew LaMont Eanes, Elizabeth Ann Copeland, and Vik Edwin Stoll.” Among the other pending nominees being considered during the hearing, the Committee considered the nomination of Mary Wakefield for Deputy Secretary of HHS. Wakefield previously served as the Administrator of the Health Resources & Services Administration (HRSA) and currently serves as the Acting Deputy Secretary of HHS. Committee Chairman Orrin Hatch (R-UT) expressed hope that there will be a confirmation vote as soon as possible on Wakefield’s nomination.
• On February 3, 2016, Senator Brian Schatz (D-HI) was joined by Senators Roger Wicker (R-MS), Mark Warner (D-VA), Thad Cochran (R-MS), John Thune (R-SD), and Ben Cardin (D-MD) in introducing draft legislation entitled, the “Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act.” Among other things, the legislation would allow telehealth and remote patient monitoring (RPM) to be used by qualifying participants in alternative payment models (APMs) without having to meet stringent existing Social Security Act requirements for Medicare coverage of telehealth and RPM services. The CONNECT for Health Act would also allow telehealth and RPM to be basic benefits under Medicare Advantage (MA). Additional information on the draft legislation may be found here.

House of Representatives

• On February 2, 2016, the House of Representatives failed to secure the 2/3rd majority vote needed to override President Obama’s veto of H.R. 3762, the “Restoring Americans’ Healthcare Freedom Reconciliation Act of 2015.” The final vote count on the veto message was 241 in favor to 186 opposed. The legislation would have repealed a number of key components of the ACA, including the so-called “individual mandate” and “employer mandate” provisions, the tax credit subsidies for Health Insurance Exchange coverage, the Medicaid expansion provisions, and a variety of tax provisions that help to finance the ACA’s coverage expansion. The legislation was vetoed by President Obama on January 8th, after passing the House earlier in the week, and previously passing through the Senate in December 2015 by a 52-47 simple majority vote under the budget reconciliation process.
• On February 4, 2016, the House Committee on Oversight & Government Reform held a hearing entitled, “Developments in the Prescription Drug Market.” The purpose of the hearing was to discuss methods and reasoning behind recent drug price increases; to discuss the role of pharmacy benefit managers in negotiating drug prices, and address concerns about the lack of transparency in pricing contracts; and to discuss impediments to a timely review and approval of generic drug applications, and how the government can improve the efficiency and competitiveness in the market. Witnesses included: Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER), FDA; Howard Schiller, Interim Chief Executive Officer, Valeant Pharmaceuticals International, Inc.; Martin Shkreli, Former Chief Executive Officer, Turing Pharmaceuticals LLC; Nancy Retzlaff, Chief Commercial Officer, Turing Pharmaceuticals LLC; and Mark Merritt, President and Chief Executive Officer, Pharmaceutical Care Management Association (PCMA). Widely considered to be a focal point for the hearing, Shkreli declined to answer questions after asserting his Fifth Amendment rights against self-incrimination and was quickly dismissed from the proceedings.
• On February 4, 2016, the House Energy & Commerce Subcommittee on Health held a hearing entitled, “Examining Implementation of the Biologics Price Competition and Innovation Act.” Witnesses for this hearing included: Sean Cavanaugh, Deputy Administrator and Director of the Center for Medicare, CMS; and Janet Woodcock, Director of CDER, FDA. At the hearing, Members from both parties expressed concerns over FDA and CMS decisions in implementing the approval pathway for biosimilars pricing of Medicare payments for biosimilar products.
• On February 4, 2016, the House Committee on the Budget held a hearing entitled, “CBO’s Budget and Economic Outlook.” The sole witness for this hearing was Keith Hall, Director, Congressional Budget Office (CBO).
• On February 5, 2016, House Energy & Commerce Committee Chairman Fred Upton (R-MI) and Energy & Commerce Subcommittee on Health Chairman Joe Pitts (R-PA) issued a request for stakeholder input concerning so-called “site-neutral” payment policies for hospital outpatient services. Under the Bipartisan Budget Act of 2015, Congress established a moratoria on the ability for new “off-campus” hospital outpatient department facilities to bill under Medicare’s Outpatient Prospective Payment System (OPPS). Instead, beginning in 2017, these facilities would be required to bill under other, lower-paying, payment systems such as the Medicare Physician Fee Schedule (MPFS), the Ambulatory Surgical Center Prospective Payment System (ASC PPS), or the Clinical Laboratory Fee Schedule (CLFS). Off-campus hospital outpatient facilities that were billing under OPPS prior to November 2, 2015 will be considered “grandfathered” and allowed to continue billing under OPPS in 2017 and future years. Chairmen Upton and Pitts request input from stakeholders on whether clarifications to the “site-neutral” policy need to be made, whether additional grandfathering exceptions should be allowed, or whether the grandfathering policy should be eliminated and the OPPS billing prohibition should apply to all off-campus hospital outpatient facilities.

III. REPORTS, STUDIES, & ANALYSES

• On February 4, 2016, Health Affairs, in conjunction with the Robert Wood Johnson Foundation, released an issue brief entitled, “High-Deductible Health Plans.” Among other things, the issue brief indicates that forecasts project that by 2018, 16 percent of employers offering health benefits would have at least one health plan that would exceeds $10,200 in annual costs for individual coverage (the threshold at which the ACA’s so-called “Cadillac Tax” on high-cost employer sponsored coverage was originally supposed to apply), and employer-sponsored plans could increasingly turn to high-deductible health plans as a lever for controlling health care cost growth.
• On February 4, 2016, CMS issued a report entitled, “Evaluation of the Initiative to Reduce Avoidable Hospitalizations among Nursing Facility Residents: Final Annual Report Project Year 3.” The report indicates that CMS’s Initiative to Reduce Avoidable Hospitalizations among Nursing Facility Residents was successful in its second year in reducing Medicare expenditures relative to the initiative’s comparison group, as all seven of the initiative’s pilot sites demonstrated a decline in all-cause hospitalizations and avoidable hospitalizations.

IV. OTHER HEALTH POLICY NEWS

• On February 4, 2016, HHS announced updated enrollment figures for the 2016 Open Enrollment Period for Qualified Health Plan (QHP) coverage on Health Insurance Exchanges established under the ACA. HHS data suggests that 12.7 million consumers successfully enrolled in new QHP coverage or renewed existing QHP coverage by January 31, 2016, the deadline for the Open Enrollment Period. In the announcement, HHS noted that 9.6 million of the 12.7 million consumers enrolled in plans through the federal HealthCare.gov web portal, while the majority of the remaining consumers had enrolled through State-Based Exchanges.