A&B Healthcare Week in Review, August 5, 2016

I. Regulations, Notices, & Guidance

• On August 4, 2016, the Centers for Medicare & Medicaid Services (CMS) issued a notice entitled Medicare and Medicaid Programs: Quarterly Listing of Program Issuances: April through June 2016. This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from April through June 2016, relating to the Medicare and Medicaid programs and other programs administered by CMS.

• On August 4, 2016, CMS issued a Request for Nominations: Members for the Medicare Evidence Development and Coverage Advisory Committee; Medicare Program. This notice announces the request for nominations for membership on the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). Among other duties, the MEDCAC provides advice and guidance to the Secretary of the Department of Health and Human Services (the Secretary) and the Administrator of CMS concerning the adequacy of scientific evidence available to CMS in making coverage determinations under the Medicare program. The MEDCAC reviews and evaluates medical literature and technology assessments, and hears public testimony on the evidence available to address the impact of medical items and services on health outcomes of Medicare beneficiaries. Nominations must be received by Tuesday, September 6, 2016

• On August 3, 2016, CMS released a CMCS Informational Bulletin entitled Suggested Approaches for Strengthening and Stabilizing the Medicaid Home Care Workforce. This informational bulletin highlights steps available to states, providers, and others to strengthen the home care workforce, the term used in this document to encompass individuals furnishing home and community-based services (HCBS), consistent with advancing goals of beneficiary autonomy and self-direction of needed services.

• On August 1, 2016, the Center for Consumer Information and Insurance Oversight (CCIIO) released a Frequently Asked Questions (FAQ) on Summer/Fall 2016 Medicaid/CHIP Periodic Data Matching. The FAQ provides that in August 2016, the Marketplace will send an initial warning notice to the household contact for each consumer who is identified as being enrolled in both an applicable Exchange plan and Medicaid or CHIP, requesting that they take immediate action to respond to the notice. The notice will be mailed and will also be posted to the Marketplace account of the household contact for the affected consumer. The notice will include the names of those consumers who were identified as dually-enrolled and instructions on how to respond to the notice.

• On August 1, 2016, the Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health, and the Food and Drug Administration (FDA) issued a notice announcing the availability of a draft guidance entitled “Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs.” The purpose of this draft guidance is to assist IRB administrators, IRB chairpersons, and other institutional officials responsible for preparing and maintaining written procedures for IRBs. The draft guidance is intended for IRBs and institutions responsible for review and oversight of human subject research under the HHS or FDA regulations, or both.  Comments are requested by October 3, 2016.

• On August 3, 2016, the FDA issued a guidance on Insanitary Conditions at Compounding Facilities. FDA is issuing this draft guidance to assist compounding facilities in identifying insanitary conditions so that they can implement appropriate corrective actions, and to assist State regulatory agencies in understanding some examples of what FDA considers to be insanitary conditions. FDA is requesting comments by October 3, 2016.

• On August 2, 2016, the FDA released a notice announcing the availability of draft guidance entitled “Medical X-Ray Imaging Devices Conformance With IEC Standards.” This draft guidance describes FDA's policy regarding the regulation of medical x-ray imaging equipment that are subject to requirements in the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and FDA's regulations that apply to medical devices and electronic products. The draft guidance also provides recommendations to industry on how to comply with the applicable requirements. This draft guidance is not final nor is it in effect at this time. Comments are due by November 1, 2016.

• On August 5, 2016, the FDA released Guidance for Industry and Staff: Deciding When to Submit a 510(k) for a Change to an Existing Device and guidance entitled Deciding When to Submit a 510(k) for a Software Change to an Existing Device.  FDA is issuing these guidance documents to clarify when a change in a legally marketed medical device would require that a manufacturer submit a premarket notification (510(k)) to FDA and when a software change in a legally marketed medical device would require that a manufacturer submit a premarket notification (510(k)) to FDA.

• On August 5, 2016, the FDA issued a final rule entitled Standard Preparations, Limits of Potency, and Dating Period Limitations for Biological Products; Confirmation of Effective Date. The FDA is confirming the effective date of September 16, 2016, for the final rule on this issue, which appeared in the Federal Register of May 4, 2016. The direct final rule amends the general biological products standards relating to dating periods and removes certain standards relating to standard preparations and limits of potency. FDA is taking this action to update outdated requirements, and accommodate new and evolving technology and testing capabilities without diminishing public health concerns. This action is part of FDA’s retrospective review of its regulations in response to an Executive order.

• On August 4, 2016, CMS issued updated FAQs on the Pre-Claim Review Demonstration to address procedural and practical implications of the demonstration’s delayed start date. CMS had previously announced that, in order to allow time to resolve an administrative procedural requirement related to the Paperwork Reduction Act, implementation of the Pre-Claim Review Demonstration for Home Health Services in Illinois began on August 3, 2016.  The revised start date does not impact demonstration requirements or processes, and the demonstration will be operationalized as planned for episodes of care starting on or after August 3, 2016. CMS’ Medicare Administrative Contractors will work directly with any HHAs that submitted requests for episodes of care that began prior to August 3, 2016 and allow them to either have the requests withdrawn or processed as test requests.

• On August 3, 2016, the FDA issued a notice entitled Medical Devices: Availability of Safety and Effectiveness Summaries for Premarket Approval Applications. The FDA is publishing a list of premarket approval applications (PMAs) that have been approved. This 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 August 5, 2016, the FDA issued a notice announcing the availability of a draft guidance for industry entitled “Ulcerative Colitis: Clinical Trial Endpoints.” The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of ulcerative colitis (UC) in adult and pediatric patients. Specifically, this guidance addresses FDA’s current thinking regarding efficacy endpoints for UC clinical trials.  Comments are requested within 60 days of publication in the Federal Register, which is scheduled for August 8, 2016.

• On August 1, 2016, the Office of Management and Budget (OMB) received for review a final rule entitled Clinical Trials Registration and Results Submission.  According to OMB, this rule will prescribe procedures for registering and submitting summary results, including adverse events, of clinical trials in ClinicalTrials.gov, in accordance with section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA, Pub. L. 110-85). As previously announced, NIH intends to proceed with a single rulemaking to implement the expanded registry, results reporting, and adverse event information reporting requirements of the statute.

• On August 2, 2016, the OMB completed its review of the proposed rule entitled 340B Drug Pricing Program; Administrative Dispute Resolution Process. According to OMB, this proposed rule is required under the Affordable Care Act and would implement an enhancement to the 340B Program by establishing a required and binding administrative dispute resolution process to resolve claims raised by covered entities that they have been overcharged for drugs purchased under the 340B Program. This administrative dispute resolution process also is available to drug manufacturers.

• September 8, 2016: CMS announced that registration for CMS' Medicare Advantage & Prescription Drug Plan Fall Conference & Webcast is now open.

• September 29, 2016: CMS announced a Marketplace Technical Operations Workshop. This event will feature a mix of FFM issuer and CMS panels that explore best practices and techniques on how to improve technical operations, reduce overhead, and bolster performance while operating on the Marketplace. Registration required to participate in-person or remotely.

II. Congressional Legislation & Committee Action

• The Senate has adjourned and will reconvene on Tuesday, September 6, 2016.

• The House has adjourned and will reconvene on Tuesday, September 6, 2016.

• On August 1, 2016, the Government Accountability Office (GAO) released a report entitled Medicare Part B: CMS Should Take Additional Steps to Verify Accuracy of Data Used to Set Payment Rates for Drugs.  GAO reported that in 2014, the most recent year for which data were available, the Medicare program and its beneficiaries spent about $21 billion on approximately 46 million administrations of 551 Part B drugs paid based on average sales price (ASP). Six drugs—each exceeding $1 billion in expenditures—accounted for 36 percent of all expenditures on Part B ASP drugs, while a different 10 drugs—each administered over 1 million times—accounted for 37 percent of all administrations. Biologics (drugs made from living entities), drugs without generic versions available, and drugs made by a single manufacturer were associated with the vast majority of expenditures on Part B ASP drugs.  GAO recommends that Congress consider requiring all manufacturers of drugs paid at ASP to submit sales price data to CMS and periodically verify the data submitted by a sample of drug manufacturers by requesting source documentation. HHS agreed with GAO's recommendation and stated that CMS would take action as warranted.

• On August 1, 2016, the GAO released a report entitled Hospital Uncompensated Care: Federal Action Needed to Better Align Payments with Costs.  GAO recommends that CMS take two actions: (1) improve alignment of Medicare uncompensated care payments with hospital uncompensated care costs; and (2) account for Medicaid payments made when making Medicare uncompensated care payments to individual hospitals. In commenting on a draft of this report, HHS concurred with both recommendations.

• On August 1, 2016, the Congressional Budget Office (CBO) released a blog post entitled Spending for Social Security and Major Health Care Programs in The Long-Term Budget Outlook. CBO published its 2016 Long-Term Budget Outlook in July, describing the agency’s projections of federal spending and revenues over the next 30 years. This blog post focuses on the spending of Social Security and major health care programs.

• On August 5, 2016, the GAO issued a report entitled Patient Protection and Affordable Care Act: Information on Approval Process for State Innovation Waivers.  This report provides information on HHS’s and Treasury’s approach to (1) applying the statutory approval criteria for State Innovation Waivers and (2) coordinating the review and approval of applicable waiver proposals across HHS, Treasury, and their related agencies.

IV. Other Health Policy News

• On August 1, 2016, CMS opened the application period for practices to participate in the new nation-wide primary care model, Comprehensive Primary Care Plus (CPC+). CPC+ is a five-year primary care medical home model beginning January 2017 that will enable primary care practices to care for their patients the way they think will deliver the best outcomes and to pay them for achieving results and improving care. CPC+ is an opportunity for practices of diverse sizes, structures, and ownership who are interested in qualifying for the incentive payment for Advanced Alternative Payment Models through the proposed Quality Payment Program. CMS estimates that up to 5,000 primary care practices serving an estimated 3.5 million beneficiaries could participate in the model.

• On August 4, 2016, CMS announced the participants in the Frontier Community Health Integration Project (FCHIP) Demonstration, an effort to increase access to care for Medicare beneficiaries in areas of the country where access to health services can be limited because of distance from providers. Ten critical access hospitals (CAHs) in Montana, Nevada, and North Dakota will participate in the Demonstration, which begins this August.

• On August 4, 2016, the Veterans Affairs Department (VA) released results of The Joint Commission Special Focused Surveys on VA health care facilities. VA invited The Joint Commission to conduct unannounced, focused surveys at 139 medical facilities and 47 community-based outpatient clinics across the country to measure progress on VA access to care, quality improvements and diffusion of best practices across the system. The surveys also assessed barriers that may stand in the way of providing timely care to Veterans. Results indicate VA has made significant progress since The Joint Commission began its surveys two years ago.