A&B Healthcare Week in Review, November 18, 2016

I. Regulations, Notices, & Guidance

• On November 14, 2016, the Center for Medicare & Medicaid Services (CMS) issued an interim final rule with comment period entitled, Medicaid Program; Covered Outpatient Drug; Delay in Change in Definitions of States and United States. The Covered Outpatient Drug final rule with comment period was published in the February 1, 2016 Federal Register. As part of that final rule with comment, CMS amended the regulatory definitions of “States” and “United States” to include the U.S. territories (American Samoa, the Northern Mariana Islands, Guam, the Commonwealth of Puerto Rico, and the Virgin Islands) beginning April 1, 2017. The interim final rule with comment period delays the inclusion of the territories in the definition of “States” and “United States” until April 1, 2020. Comments are due by January 17, 2017.
• On November 14, 2016, the Department of Health and Human Service (HHS) issued a notice entitled, Federal Financial Participation in State Assistance Expenditures; Federal Matching Shares for Medicaid, the Children’s Health Insurance Program, and Aid to Needy Aged, Blind, or Disabled Persons for October 1, 2017 through September 30, 2018. The notice provides the Federal Medical Assistance Percentages (FMAP), Enhanced Federal Medical Assistance Percentages (eFMAP), and disaster-recovery FMAP adjustments for Fiscal Year 2018. The percentages will be effective from October 1, 2017 through September 30, 2018.
• On November 14, 2016, the Office of Management and Budget (OMB) received a final rule from CMS entitled, Program Integrity Enhancements to the Provider Enrollment Process. The final rule revises various Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) provider enrollment provisions to address specific program integrity issues.  The changes enhance CMS's efforts to prevent fraud, waste, and abuse in the Medicare and Medicaid programs and CHIP.
• On November 14, 2016, the Federal Trade Commission (FTC) issued a proposed consent agreement entitled, Valeant Pharmaceuticals International, Inc. The consent agreement in this matter settles alleged violations of federal law prohibiting unfair methods of competition. The attached Analysis to Aid Public Comment describes both the allegations in the complaint and the terms of the consent order – embodied in the consent agreement – that would settle these allegations. Comments are due by December 7, 2016.
• On November 15, 2016, the Food and Drug Administration (FDA) issued a notice entitled, Site Visit Training Program for Office of Pharmaceutical Quality Staff. The notice announces the 2017 Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality (OPQ) Staff Experiential Learning Site Visit Program. Additionally, the notice invites pharmaceutical companies interested in participating in this program to submit a site visit proposal to CDER’s OPQ. Proposals are due by January 17, 2017.
• On November 17, 2016, the FDA issued a notice entitled, Medical Devices Regulated by the Center for Biologics Evaluation and Research. The notice makes available a list of premarket approval applications (PMAs) that have been approved by the Center for Biologics Evaluation and Research (CBER). The list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the Agency's Division of Dockets Management.
• On November 17, 2016, the FDA issued a guidance entitled, Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices. The guidance provides a detailed description of the information that should be included in a premarket notification for a magnetic resonance diagnostic device (MRDD). Comments may be submitted at any time.
• On November 17, 2016, the FDA issued a guidance entitled, Revised Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products Who Have Received Human-Derived Clotting Factor Concentrates. The guidance provides establishments that make donor eligibility (DE) determinations for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps) with information on infectious disease risks related to receipt of FDA licensed human-derived clotting factor concentrates (HDCFCs). The guidance explains that FDA no longer considers FDA licensed HDCFCs as a risk factor for human immunodeficiency virus (HIV), Hepatitis B virus (HBV), or Hepatitis C virus (HCV). As such, receipt of FDA licensed HDCFCs, or sex with a person who has received FDA licensed HDCFCs, should not be considered a risk factor when determining eligibility of a donor of HCT/Ps. Comments may be submitted at any time.
• On November 17, 2016, the FDA issued a guidance entitled, Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments. The guidance provides updated answers to common questions from the generic drug industry and other interested parties involved in the development and/or testing of generic drug products regarding GDUFA user fees and finalizes the revised version of the guidance. Comments may be submitted at any time.
• On November 17, 2016, the FDA issued a draft guidance entitled, Bacillus Calmette-Guerin (Bcg)--Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs And Biologics For Treatment. The purpose of the draft guidance is to assist sponsors in the development of drugs and biologics to treat patients with a high-risk form of bladder cancer. According to the FDA, the draft guidance will help overcome some of the obstacles in conducting the studies needed to establish efficacy of drugs and biologics for these patients with an unmet medical need. Comments are due by February 16, 2017.
• On November 17, 2016, the FDA issued a final rule entitled, Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements. The final rule amends the current good manufacturing practice (CGMP) and labeling regulations regarding medical gases. The FDA is requiring that portable cryogenic medical gas containers not manufactured with permanent gas use outlet connections have gas-specific use outlet connections that cannot be readily removed or replaced except by the manufacturer. The FDA is also requiring that portable cryogenic medical gas containers and high-pressure medical gas cylinders meet certain labeling, naming, and color requirements. According to the FDA, these requirements are intended to increase the likelihood that the contents of medical gas containers are accurately identified and reduce the likelihood of the wrong gas being connected to a gas supply system or container. The FDA is also revising an existing regulation that conditionally exempts certain medical gases from certain otherwise-applicable labeling requirements in order to add oxygen and nitrogen to the list of gases subject to the exemption, and to remove cyclopropane and ethylene from the list. The final rule is effective on January 17, 2017.
• On November 17, 2016, CMS issued a guidance entitled, Excluding Abuse-Deterrent Formulations From the Definition of Line Extension. The purpose of the guidance is to clarify how CMS intends to verify if a drug is an abuse-deterrent formulation, and thus be excluded from the definition of line extension for purposes of the Medicaid Drug Rebate (MDR) program.
• On November 18, 2016, CMS released a proposed rule entitled, The Use of New or Increased Pass-Through Payments in Medicaid Managed Care Delivery Systems. According to CMS, the proposed rule addresses changes, consistent with the CMCS Informational Bulletin (CIB) concerning “The Use of New or Increased Pass-Through Payments in Medicaid Managed Care Delivery Systems,” published on July 29, 2016, to the pass-through payment transition periods and the maximum amount of pass-through payments permitted annually during the transition periods under Medicaid managed care contract(s) and rate certification(s). The changes prevent increases in pass-through payments and the addition of new pass-through payments beyond those in place when the pass-through payment transition periods were established in the final Medicaid managed care regulations. Comments appear to be due by December 22, 2016.

Event Notices

• None.

II. Congressional Legislation & Committee Action

U.S. Senate

• The Senate is in recess through next week for the Thanksgiving holiday.

House of Representatives

• The House is in recess through next week for the Thanksgiving holiday.

III. Reports, Studies, & Analyses  

• On November 17, 2016, the Government Accountability Office (GAO) released a report entitled, Youth with Autism: Roundtable Views of Services needed During the Transition into Adulthood. The report found that youth with Autism Spectrum Disorder (ASD) transitioning to adulthood may need a wide range of services and supports to help them achieve their goals, according to a panel GAO convened in March 2016. ASD is a highly individualized condition with characteristics that vary in degree and type from person to person. Autism characteristics may hinder or help youth achieve their goals—such as postsecondary education and community integration. For each goal, the panel described services and supports that youth (ages 14-24) with ASD transitioning to adulthood may need to address autism characteristics and other health conditions that affect their ability to attain the goal. GAO grouped these services into 14 broad categories.
• On November 17, 2016, the GAO released a report entitled, Drug Compounding: FDA Has Taken Steps to Implement Compounding Law, but Some States and Stakeholders Reported Challenges. The report found that the GAO’s survey of state pharmacy regulatory bodies found that drugs are compounded in a variety of health care settings, and some data are collected on the number of entities that compound drugs (drug compounders), but not the volume of compounded drugs. In addition to pharmacies, drug compounding settings include physicians’ offices and outsourcing facilities—a new type of facility established by law in 2013, which can compound sterile drugs without patient-specific prescriptions and register with and are inspected by the FDA. While the FDA and some states collect data on drug compounders, only one state reported collecting data on the number of prescriptions or the volume of compounded drugs. In addition, States the GAO surveyed and stakeholders GAO interviewed did not collect data specific to the extent of compounding performed by non-pharmacists, such as physicians.

IV. Other Health Policy News

• On November 14, 2016, CMS released an updated Medicare and Medicaid drug spending dashboard. According to CMS, in an effort to provide additional information on, and increase transparency with respect to the cost of prescription drugs, they are updating the Medicare Drug Spending Dashboard to include information for 2015. The online dashboard presents information for three categories of Medicare prescription drugs for both Part B and Part D: drugs with high spending on a per user basis, drugs with high spending for the program overall, and drugs with high unit cost increases in recent years.
• On November 16, 2016, CMS posted the second annual release of the Referring Provider Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Public Use File (PUF) with data for 2014. The Referring Provider DMEPOS PUF presents summarized information on physicians and other healthcare professionals who referred DMEPOS products and services, such as wheelchairs, walkers and diabetes supplies for Medicare beneficiaries. It contains information on utilization, payment (allowed amount, Medicare payment and Medicare standardized payment), and submitted charges organized by National Provider Identifier (NPI), Healthcare Common Procedure Coding System (HCPCS) code and supplier rental indicator. The updated 2014 data and supplemental information can be accessed here.
• On November 16, 2016, CMS released a Biweekly Enrollment Snapshot of weeks one and two of Open Enrollment for the Health Insurance marketplace for 2017. According to CMS, over a million people selected plans using the Healthcare.gov platform since Open Enrollment began on November 1, including about 250,000 new consumers and over 750,000 consumers renewing their coverage.
• On November 17, 2016, CMS issued a handbook entitled, Coordination of Benefits and Third Party Liability (COB/TPL) in Medicaid 2017. The handbook provides guidance on many COB/TPL subjects and also contains five training presentation on major COB/TPL topics.
• On November 17, 2016, CMS launched a new online tool to make the Quality Payment Program easier for clinicians. In October, CMS released the Quality Payment Program website, an interactive site to help clinicians understand the program and successfully participate. According to CMS, today’s release, commonly referred to as an Application Program Interface (API), builds on that site by making it easier for other organizations to retrieve and maintain the Quality Payment Program’s measures and enable them to build applications for clinicians and their practices.
• The regulatory agenda has been updated for Fall 2016 and can be accessed here.