Alston & Bird Healthcare Week in Review, October 13, 2017

I. Regulations, Notices, & Guidance

• On October 6, 2017, The Centers for Medicare and Medicaid Services (CMS) issued a guidance entitled, Addressing Enforcement of Section 1303 of the Patient Protection and Affordable Care Act. Section 1303 of the Patient Protection and Affordable Care Act (PPACA) has applied certain prohibitions, restrictions, and requirements with respect to coverage of certain abortion services by qualified health plans (QHPs) offered through the individual market exchanges. The section prohibits the use of certain Federal funds to pay for coverage by QHPs of abortions for which payment would not be permitted under the Hyde Amendment. Thus, QHP issuers may not use premium tax credits of cost-sharing reductions (CSRs) to pay for such services. This Bulletin discusses section 1303 restrictions in detail and sets forth guidance for how these restrictions are to be enforced beginning in plan year 2018.
• On October 6, 2017, the Internal Revenue Service, Department of the Treasury; Employee Benefits Security Administration, Department of Labor; and CMS and HHS issued interim final rules with request for comments entitled, Religious Exemptions and Accommodations for Coverage of Certain Preventive Services Under the Affordable Care Act. According to the agencies, the interim final rules expand exemptions to protect religious beliefs for certain entities and individuals whose health plans are subject to a mandate of contraceptive coverage through guidance issued pursuant to the Patient Protection and Affordable Care Act. These rules do not alter the discretion of the Health Resources and Services Administration (HRSA), a component of HHS, to maintain the guidelines requiring contraceptive coverage where no regulatory recognized objection exists. These rules also leave the “accommodation” process in place as an optional process for certain exempt entities that wish to use it voluntarily. These rules do not alter multiple other Federal programs that provide free or subsidized contraceptives for women at risk of unintended pregnancy. The interim final rules and temporary regulations are effective October 6, 2017. Comments must be received by December 5, 2017.
• On October 6, 2017, the Internal Revenue Service, Department of the Treasury; Employee Benefits Security Administration, Department of Labor; and CMS and HHS issued interim final rules with request for comments entitled, Moral Exemptions and Accommodations for Coverage of Certain Preventive Services Under the Affordable Care Act. According to the agencies, the interim final rules expand exemptions to protect moral convictions for certain entities and individuals whose health plans are subject to a mandate of contraceptive coverage through guidance issued pursuant to the Patient Protection and Affordable Care Act. These rules do not alter the discretion of the Health Resources and Services Administration, a component of the United States Department of Health and Human Services, to maintain the guidelines requiring contraceptive coverage where no regulatory recognized objection exists. These rules also provide certain morally objecting entities access to the voluntary “accommodation” process regarding such coverage. These rules do not alter multiple other Federal programs that provide free or subsidized contraceptives for women at risk of unintended pregnancy. The interim final rules and temporary regulations are effective October 6, 2017. Comments must be received by December 5, 2017.
• On October 6, 2017, CMS issued a notification entitled, Place of Service Codes. This notification updates the descriptors for place of service (POS) codes 32 and 54 to align them with the descriptors in the National POS Code Set. This CR updates outdated language related to individuals with intellectual disabilities. Unless otherwise specified, the effective date is April 2, 2018.
• On October 6, 2017,  CMS issued a notification entitled, Changes to the Laboratory National Coverage Determination (NCD) Edit Software for January 2018. The notification announces changes that will be included in the January 2018 quarterly release of the edit module for clinical diagnostic laboratory services. This Recurring Update Notification applies to Chapter 16, Section 12.02, Publication 1000-04. Unless otherwise specified, the effective date is January 2, 2018.
• On October 6, 2017, CMS issued a notification entitled, CMS Approved Review Topics for Durable Medical Equipment, Prosthetic, Orthotics, Supplies (DEMPOS). The CMS Approved Review Topics list (CART) is a menu of items designed to focus and direct contractors to effectively use medical review resources, while also reducing appeals and provider burden. This CART lists DEMPOS. Unless otherwise specified, the effective date is November 6, 2017.
• On October 6, 2017, the Food and Drug Administration (FDA) issued a final order entitled correction entitled, Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Cardiovascular Status Indicator; Correction. The FDA is correcting a final order that appeared in the Federal register of July 28, 2017. The final order was published with an incorrect statement in the preamble about whether FDA planned to exempt the device from premarket notification requirements. This document corrects that error.
• On October 6, 2017, the Centers for Disease Control (CDC) issued a notice with comment period entitled, Proposed Data Collection Submitted for Public Comment and Recommendations. The notice invites comment on the Paul Coverdell National Acute Stroke Program (2015-2020) evaluation. The program is authorized to track and monitor stroke episodes. The purpose of the comment period is the evaluate program efficacy.  Comments are due November 6, 2017.
• On October 11, 2017,  HHS issued a notice for comment  on the I Can Do It, you Can Do It program evaluation. The Office of the Secretary (OS) is soliciting feedback on the I Can Do It, you Can Do It! Health promotion program that is designed to provide access and opportunities for children and adults with a wide range of physical and cognitive disabilities to lead healthy, active lives. The information collected will allow the agency and partners to assess the impact of the program and gather critical information for improvement. Comments are due December 11, 2017.
• On October 12, 2017, President Trump signed an Executive Order (EO) intended to expand choices and alternatives to the ACA individual and small group market insurance plans and to increase competition to bring down costs for consumers. The EO directs the Departments of Treasury, Labor, and Health and Human Services to review and revise existing guidance in three areas: association health plans (AHP), short term limited duration insurance (STDLI), and health reimbursement arrangements (HRAs). The EO is intended to facilitate the purchase of insurance across State lines and the development and operation of a high-quality and affordable healthcare system. The EO states that government rules and guidelines affecting the United States healthcare system should expand the availability of and access to AHP, STDLI, and HRAs, re-inject competition into healthcare markets by lowering barriers to entry, limit excessive provider consolidation, prevent abuses of market power, and improve access to and the quality of information that Americans need to make informed healthcare decisions, including data about healthcare prices and outcomes, while minimizing reporting burdens on affected plans, providers, or payers. The EO died not direct the agencies to adopt any particular rules but asks the agencies to consider access to AHPs, STDLI, and HRAs to the extent consistent with law and comments received from the public.
• On October 13,2017, HHS Acting Secretary Eric Hargan and CMS Administrator Seema Verma released a statement announcing that CSR payments will be “discontinued immediately.” Acting Secretary Hargan stated that the decision was made based on a legal opinion from the Department of Justice, which states that “Congress has the power of the purse, and it is up to Congress to decide which programs it will and will not fund… When Congress refuses to appropriate money for a program, the Executive is required to respect that decision.” Subsequently, the Justice Department interpreted the law to mean that the Executive branch cannot appropriate CSR payments. While the statement indicates legal reasons for this action, President Trump has repeatedly threatened to stop making CSP payments as a political bargaining chip.  Subsequently, the pressure is now on the Senate HELP Committee. As previously reported, Senate HELP Committee Chairman Lamar Alexander (R-TN) and Ranking Member Patty Murray (D-WA) have been working on a stabilization deal, which could include funding for CSR payments in exchange of changes to the individual and small group markets (e.g. additional flexibility for section 1332 waivers). Further, there are likely going to be legal challenges to the decision – the Attorney General for New York and California have already announced that they will be filing suits.
• On October 13, 2017, the FDA issued a final order entitled, Medical Devices; Gastroenology-Urology Devices; Classification of the Enzyme Packed Cartridge.  The FDA is classifying the enzyme packed cartridge into class II (special Controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the enzyme packed cartridge’s classification. The FDA is taking this action because it has determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness. The FDA believes the action will enhance patients’ access to beneficial innovative devices.
• On October 13, 2017,  the FDA issued a final order entitled, Medical Devices; Immunology and Microbiology Devices; Classification of the Nucleic Acid-Based Device for the Amplification, Detection, and Identification of Microbial Pathogens Directly From Whole Blood Specimens. The FDA is classifying the nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens into class II. The Special controls that apply to the device type are identified in this order and will be part of the codified language. This action was taken because the FDA believes it will provide a reasonable assurance of safety and effectiveness of the device.
• On October 13, 2017, CMS issued a notice for the public to comment on CMS’ intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any aspect of this collection of information, including necessity and utility of the proposed information collection for the proper performance of the agency’s functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Comments must be received by December 12, 2017.

• October 16, 2017: 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.
• October 17 – 18, 2017: HHS announced a meeting of the Secretary’s Advisory Committee on Human Research Protections (SACHRP). The SACHRP meeting will open to the public at 8:30 a.m., on Tuesday, October 17, 2017, followed by opening remarks from Dr. Jerry Menikoff, Director, Office for Human Research Protections (OHRP) and Dr. Stephen Rosenfeld, SACHRP Chair. The Wednesday, October 18, meeting will begin at 8:30 a.m. with a presentation and discussion led by FDA staff on a recent FDA experience with IRB review under 21 CFR 50.54, and the lessons learned. Time is allotted for review of the previous day’s recommendations. The meeting will adjourn at approximately 4:00 p.m., October 18, 2017.
• October 17 – 20, 2017: HHS announced a meeting of the 2018 Physical Activity Guidelines Advisory Committee. The meeting will include subcommittee reports on the remainder of their literature review questions, discussion of overarching issues, and discussion of plans for finalizing the Committee’s report to the Secretary.
• October 18, 2017: The FDA announced a public advisory committee meeting of the Endocrinology and Metabolic Drugs Advisory Committee. The committee will discuss the safety and efficacy of new drug application (NDA) 209637 for semaglutide injection, submitted by Novo Nordisk, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
• October 19, 2017: The FDA announced a regional public meeting entitled, Health Canada and U.S. Food and Drug Administration Joint Public Consultation on International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). he purpose of this public meeting is to provide information and solicit public input on the current activities of ICH as well as the upcoming ICH Assembly Meeting and the Expert Working Group Meetings in Geneva, Switzerland, scheduled for November 11 through 16, 2017. The topics to be discussed are the topics for discussion at the forthcoming ICH Assembly Meeting in Geneva.
• October 20, 2017: The NIH announced a meeting of the NIH Clinical Center Research Hospital Board. The agenda includes discussion on the Patient Safety Racking and Reporting System; quality improvement assessment results, and IRB consolidation.
• October 20, 2017: The FDA announced a public workshop entitled, Topical Dermatological Generic Drug Products: Overcoming Barriers to Development and Improving Patient Access. The purpose of the public workshop is to provide an overview of current regulatory science initiatives related to generic topical dermatological drug products, solicit public input on scientific barriers that may limit patient access to such drug products, and discuss approaches to overcome/address any such barriers. FDA is seeking public input from a variety of stakeholders, including industry, academia, patient advocates, and professional associations.
• October 25, 2017: The National Institutes of Health (NIH) announces a meeting of the Diabetes Mellitus Interagency Coordinating Committee (DMICC). The October 25, 2017 DMICC meeting will focus on Enhancing Opportunities in Addressing Obesity and Type 2 Diabetes Disparities.
• October 30, 2017: The NIH announced a meeting of the Frederick National laboratory Advisory Committee to the National Cancer Institute. The agenda includes a discussion of ongoing and new activities at the Frederick National Laboratory for Cancer Research.
• October 27, 2017: HHS announced a meeting of the Advisory Council on Alzheimer’s Research, Care, and Services (Advisory Council). During the October meeting, the Advisory Council will welcome its new members and invite them to share their experiences and where they see the Council going over the length of their terms. The Advisory Council will also spend some time discussing the process of developing recommendations and how those recommendations relate to the National Plan. The Council will then spend much of the meeting discussing the National Research Summit on Care, Services, and Supports for Persons with Dementia and Their Caregivers, held on October 16-17.
• October 31, 2017: The FDA announced a public advisory committee meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The committees will discuss NDA 209819, buprenorphine subcutaneous injection, submitted by Indivior Pharmaceuticals, Inc., for treatment of opioid dependence.
• November 1, 2017: HHS announced that the Office of Disease Prevention and Health Promotion (ODPHP) is hosting a listening session entitled, Partnering to Prevent Hypoglycemia. he purpose of this listening session is to exchange information about the public health importance of hypoglycemia, and discuss federal efforts to reduce preventable hypoglycemia from diabetes medications.
• November 3, 2017: HHS announced that the Agency for Healthcare Research and Quality (AHRQ) in accordance with section 10(a) of the Federal Advisory Committee Act. The purpose on the meeting is to advise the HHS Secretary and the Director of AHRQ to conduct its mission including providing guidance on priorities for health care research, the field of health care research including training needs and information dissemination on health care quality.
• November 6 – 7, 2017: The FDA announced a public advisory committee meeting of the Science Advisory Board (SAB) to the National Center for Toxicological Research (NCTR). On November 6, 2017, the SAB Chair will welcome the participants, and the NCTR Director will provide a Center-wide update on scientific initiatives and accomplishments during the past year. The SAB will be presented with an overview of the Division of Systems Biology Subcommittee and the Subcommittee Site Visit Report and a response to this review. There will be updates from the NCTR Research Divisions and a public comment session. On November 7, 2017, the Center for Biologics and Evaluation and Research, Center for Drug Evaluation and Research, Center for Devices and Radiological Health, Center for Tobacco Products, Center for Veterinary Medicine, and the Office of Regulatory Affairs will each briefly discuss their center-specific research strategic needs and potential areas of collaboration.
• November 16, 2017: The FDA announced a public advisory committee meeting of the Antimicrobial Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The committee will discuss new drug application (NDA) 209367, ciprofloxacin inhalation powder, sponsored by Bayer HealthCare Pharmaceuticals, Inc., for the proposed indication of reduction of exacerbations in non-cystic fibrosis bronchiectasis (NCFB) adult patients (≥18 years of age) with respiratory bacterial pathogens.
• December 5, 2017: The NIH announced a meeting of the Muscular Dystrophy Coordinating Committee. The purpose of the meeting is to bring together the Committee members to update one another on progress relevant to the Action Plan for the Muscular Dystrophies.

II. Congressional Legislation & Committee Action

• In recess for the week of October 9, 2017.

• On October 11, 2017 the House Energy and Commerce Oversight and Investigations Subcommittee held a hearing entitled, Examining How Covered Entities Utilize the 340B Drug Pricing Program. The witnesses present at the hearing included Sue Veer, President and CEO of Carolina Health Centers; Michael Gifford, President and CEO of the AIDS Resource Center of Wisconsin; Ronald Paulus, President and CEO of Mission Health; Charles Reuland, Executive Vice President and COO of Johns Hopkins Hospital; Shannon Banna, Director of Finance and System Controller of Northside Hospital, Inc.
• On October 11, 2017, the House Energy and Commerce Subcommittee on Health held a hearing entitled, Member Day: Testimony and Proposals on the Opioid Crisis. Over fifty members testified. The purpose of the hearing was to solicit proposals to continue to address the opioid crisis.

• On October 6, 2017, the OIG released a report entitled, Some Ohio Group Homes Did Not Always Comply With Foster Care Health and Safety Requirements. The report found that the state agency did not ensure that the group homes that received funds under Title IVE of the Act complied with State requirements related to the health and safety of children in foster case, as required by federal law. The agency determined that 19 of the 30 homes reviewed did not comply with at least one or more requirements.

IV. Other Health Policy News

• On October 11, 2017, CMS issued a Frequently Asked Questions (FAQ) Document entitled, Mental Health and Substance Abuse Disorder Parity Final Rule for Medicaid and CHIP. The document clarifies ambiguities in the Mental Health and Substance se Disorder Parity Final Rule for Medicaid and CHIP.