A&B Healthcare Week in Review, August 7, 2015

I. REGULATIONS, NOTICES, & GUIDANCE

• On August 3, 2015, the Centers for Medicare and Medicaid Services (CMS) published the Quarterly Listing of Program Issuances, April-June 2015. This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from April through June 2015, relating to the Medicare and Medicaid programs and other programs administered by CMS.
• On August 3, 2015, the Government Accountability Office (GAO) released a call for nominations for the Medicaid and CHIP Payment and Access Commission for the January 2016 through September 2015 term. The Children’s Health Insurance Program Reauthorization Act of 2009 (CHIPRA) established the Medicaid and CHIP Payment and Access Commission (MACPAC) to review Medicaid and CHIP access and payment policies and to advise Congress on issues affecting Medicaid and CHIP. CHIPRA gave the Comptroller General of the United States responsibility for appointing MACPAC’s members. For appointments to MACPAC that will be effective January 1, 2016, GAO is announcing the following: Letters of nomination and resumes will be accepted through September 16, 2015 to ensure adequate opportunity for review and consideration of nominees prior to appointment of new members. More information may be found here.
• On August 3, 2015, CMS published a proposed information collection activity for public comment, entitled “Initial Plan Data Collection to Support Qualified Health Plan (QHP) Certification and Other Financial Management and Exchange Operations”. Each Exchange must assume responsibilities related to the certification and offering of Qualified Health Plans (QHPs). To offer insurance through an Exchange, a health insurance issuer must have its health plans certified as QHPs by the Exchange. A QHP must meet certain minimum certification standards, such as those pertaining to essential community providers, essential health benefits, and actuarial value. In order to meet those standards, the Exchange is responsible for collecting data and validating that QHPs meet these minimum requirements as described in the Exchange rule under 45 CFR parts 155 and 156. Based on experience with the first three years of data collection, CMS requests the continuation of data collection and propose revisions to data elements being collected and the burden estimates for years four, five, and six. Comments are due October 2, 2015.
• This week the Centers for Disease Control and Prevention (CDC) announced that it is seeking nominations for membership on the Breast and Cervical Cancer Early Detection and Control Advisory Committee. The committee provides advice and guidance to the Secretary, HHS, and the Director, CDC, regarding the early detection and control of breast and cervical cancer. The committee makes recommendations regarding national program goals and objectives; implementation strategies; program priorities, including surveillance, epidemiologic investigations, education and training, information dissemination, professional interactions and collaborations, and policy. The next cycle of selection of candidates will conclude in the fall of 2015, for selection of potential nominees to replace members whose terms will end on March 31, 2016. Nominations should be submitted ((postmarked or received)) by September 25, 2015. More information may be found here.
• On August 3, 2015, the Food and Drug Administration (FDA) announced the availability of a document entitled ‘‘Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation; Guidance for Industry.’’ The guidance document provides recommendations to submitters and FDA reviewers in preparing and reviewing premarket notification submissions (hereafter referred to as ‘‘510(k) submission’’ or ‘‘510(k)’’) for HLA in vitro diagnostic (IVD) device test kits. The guidance applies specifically to nucleic acid-based HLA test kits used for the matching of donors and recipients in making your submission to FDA, you will have to pay the higher standard fee. Please note that the establishment registration fee is not eligible for a reduced small business fee. As a result, if the establishment registration fee is the only medical device user fee that you will pay in FY 2016, you should not submit a FY 2016 Small Business Qualification and Certification request. This document provides information on how the fees for FY 2016 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.
• On August 4, 2015, the Office of Management and Budget (OMB) began review of a rule entitled “Covered Outpatient Drugs” (CMS-2345-F). According to a summary on OMB’s website, “This final rule revises requirements pertaining to Medicaid reimbursement for covered outpatient drugs to implement provisions of the Affordable Care Act. This rule also revises other requirements related to covered outpatient drugs, including key aspects of Medicaid coverage, payment, and the drug rebate program.”
• On August 5, 2015, the FDA announced the availability of a guidance for industry entitled "Over-the-Counter Pediatric Oral Liquid Drug Products Containing Acetaminophen." The guidance is intended to help drug manufacturers, packagers, and labelers minimize the risk to consumers of acetaminophen-related liver damage associated with the use of nonprescription, also known as over-the-counter or OTC, pediatric oral liquid acetaminophen drug products. This guidance provides recommendations regarding acetaminophen concentration, container labels, carton labeling, and packaging of such products, as well as for any associated delivery devices. FDA's recommendations are designed to encourage safer use of these products by minimizing the potential for acetaminophen overdosing due to medication errors or accidental ingestion.
• On August 6, 2015, the FDA announced the reissuance of a revised draft guidance for industry (Revision 2) entitled “Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs.” FDA is reissuing the revised draft guidance to incorporate animal prescription drugs. This reissued revised draft guidance, when finalized, will assist manufacturers, packers, and distributors (firms) of human prescription drugs, including biologics, and animal prescription drugs, with meeting the brief summary requirement for prescription drug advertising and the requirement that adequate directions for use be included with promotional labeling for prescription drugs when print materials are directed toward consumers. Comments are due within 60 days.
• On August 7, 2015, the Department of Veterans Affairs published a notice entitled “Publication of Wait-Times for the Department for the Veterans Choice Program”. In keeping with its commitment to improve transparency, the Department of Veterans Affairs’ (VA) publishes wait-times for the scheduling of appointments in each VA facility for primary care, specialty care, and mental health services twice each month. VA also publishes a Federal Register Notice every 90 days with the address of the website where this wait-time data can be accessed. This Notice announces the availability of the data on that website.
• On August 5, 2015, the FDA released a final order classifying the internal tissue marker into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the internal tissue marker’s classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. More information may be found here.
• On August 6, 2015, the Administration for Children and Families released the “Implementation of Executive Order 13559 Updating Participation in Department of Health and Human Services Programs by Faith-Based or Religious Organizations and Providing for Equal Treatment of Department of Health and Human Services Program Participants”. The United States Department Health and Human Services (HHS) proposes to amend its general regulations regarding the equal treatment of religious organizations in HHS programs and the protection of religious liberty for HHS social service providers and beneficiaries. Specifically, this proposed rule would: clarify the definition of direct and indirect financial assistance, replace the term “inherently religious activities” with the term “explicitly religious activities,” require faith-based organizations administering a program supported with direct HHS financial assistance to provide beneficiaries with a written notice informing them of their religious liberty protections, including the right to a referral to an alternative provider if the beneficiary objects to the religious character of the organization providing services, and add a provision stating that decisions about awards of Federal financial assistance must be free from political interference and based on merit. Comments are due within 60 days.

Event Notices

• August 20, 2015: The Department of Defense published a notice on August 4th announcing that the Department will convene a meeting of the Defense Health Board (DHB). The purpose of the meeting is to conduct a decision briefing for deliberation and provide progress updates on specific taskings before the DHB. In addition, the DHB will receive information briefings on current issues or lessons learned related to military operational programs, health policy, health research, disease/injury prevention, health promotion, and healthcare delivery. More information may be found here.
• August 21, 2015: The FDA, in collaboration with the University of Maryland’s Center of Excellence in Regulatory Science and Innovation and the Critical Path Institute, is announcing a public workshop entitled ‘‘Evidentiary Considerations for Integration of Biomarkers in Drug Development.’’ The purpose of the meeting is to discuss current scientific approaches to biomarker development, acceptance, and utility in drug and biologic (hereafter referred to as therapeutic product) development programs. The meeting will be held on August 21, 2015, from 9 a.m. to 5 p.m.
• August 26, 2015: The CMS Advisory Panel on Clinical Diagnostic Laboratory Tests will convene a meeting on August 26th in Baltimore, Maryland, at 9:00 AM ET. The Panel will specifically recommend crosswalks for new laboratory codes, recommend an appropriate coding structure for drugs of abuse testing, and recommend crosswalks for such drugs of abuse testing.
• August 27, 2015: The Health Resources and Services Administration (HRSA) will convene an Advisory Committee meeting on Heritable Disorders in Newborns and Children on August 27th from 9:00 AM to 5:00 PM. The meeting will be held in-person in Rockville, Maryland, and by webinar. More information may be found here.
• September 28, 2015: The FDA is announcing a public workshop entitled ‘‘Surrogate Endpoints for Clinical Trials in Kidney Transplantation.’’ The purpose of the public workshop is to discuss potential surrogate endpoints for clinical trials for drugs and therapeutic biologics used in kidney transplantation, with a focus on endpoints in conditions that represent unmet medical needs. This public workshop is intended to provide information and gain perspective from health care providers, academia, and industry on the role of various laboratory, histologic, and other endpoints used to evaluate patient and allograft outcome in clinical trials for kidney transplantation. The public workshop will be held on September 28, 2015, from 8 a.m. to 6 p.m. in Arlington, Virginia.

II. CONGRESSIONAL LEGISLATION & COMMITTEE ACTION

U.S. Senate

• The Senate Health, Education, Labor and Pensions (HELP) Committee was scheduled to convene a review of several healthcare bills on August 6th. The executive session was postponed on Wednesday August 5th, and has not been rescheduled. Before adjourning for recess, the HELP Committee favorably reported to the Senate floor the nomination of Karen DeSalvo to be Assistant Secretary of HHS.
• This week Senators Barbara Mikulski (D-MD) and Kelly Ayotte (R-NH) introduced a Senate companion to House legislation (introduced last week by Representatives Renee Ellmers (R-NC) and Debbie Wasserman Schultz (D-MD)), which would place a two-year moratorium on controversial USPSTF draft breast cancer screening recommendations, which gave a “C” rating to regular, biennial screening before age 50 and an “I” or “Incomplete” rating to screening for women ages 75 and older. The Protect Access to Lifesaving Screenings (PALS) Act (S. 1926) would ensure free mammograms for women aged 40 and older during the two year moratorium period.
• The Senate adjourned for August recess this week, and is expected to resume regular legislative business on September 8th. The Senate calendar may be accessed here.

House of Representatives

• The House adjourned last week for the August recess, and is expected to resume regular legislative business on September 8th. The House of Representatives calendar may be accessed here.
• On August 4, 2015, a bipartisan group of 33 House Members urged CMS to drop its proposal to create single billing codes for biosimilars that reference the same brand biologics. In the letter, Members write that in the proposal, “…CMS treats biosimilars as if they are generic drugs. As a primary matter, it is important to recognize that traditional small-molecule pharmaceuticals and biologics are fundamentally different in their development, manufacture and chemical makeup. A biologic is a large, complex molecule, which is grown in living systems such as a microorganism, a plant or animal cell”.
• On August 6, 2015, the House Energy & Commerce Committee released a report entitled, “Information Security at the Department of Health and Human Services.” According to a Committee press release, the report, which follows the committee’s yearlong investigation, details “…serious structural flaws at HHS and its operating divisions, including the Food and Drug Administration and the National Institutes of Health, which have led to poor information security. These problems have left HHS vulnerable to cyber attacks, which the report outlines have been numerous the past few years.” Committee Chairman Fred Upton (R-MI) and Oversight and Investigations Subcommittee Chairman Tim Murphy (R-PA) said, “While it is impossible to fully protect against cyber attacks, we have a responsibility to approach these issues with necessary foresight and diligence to minimize vulnerabilities and maximize security. We look forward to working with HHS, FDA, NIH, and others to develop solutions to better protect this information. Unfortunately, the bar has been set low and we have nowhere to go but up.”

III. REPORTS, STUDIES, & ANALYSES

• On August 5, 2015, the HHS Office of Inspector General (OIG) released a report entitled “Providers Terminated from One State Medicaid Program Continued Participating in Other States”. Prior to passage of the Patient Protection and Affordable Care Act (ACA), if a State terminated a provider’s participation in its Medicaid program, the provider could potentially participate in another State’s Medicaid program, leaving the second State’s program vulnerable to fraud, waste, or abuse committed by that provider. To prevent this from happening, the ACA requires States to terminate a provider’s participation in their respective State Medicaid programs if that provider is terminated for cause (i.e., for reasons of fraud, integrity, or quality) from another State Medicaid program. OIG’s review found that despite the ACA requirement for States to terminate any providers already terminated for cause in another State, continued participation from such providers in other States’ Medicaid programs was found. Specifically, OIG found that 12 percent of providers (295 of 2,539) terminated for cause in 2011 were still participating in other States’ Medicaid programs in January 2014. These Medicaid programs paid $7.4 million to 94 providers for services performed after each provider’s termination for cause by the initial State. The challenges that States face in meeting the intent of the ACA legislation include not having a comprehensive data source for identifying all terminations for cause and difficulty differentiating such terminations from other administrative actions that a State reports. Further complicating States’ ability to terminate providers is that, of the 41 States that used managed care to deliver Medicaid services, 25 States did not require providers who participated via managed care to be directly enrolled with the State Medicaid agency. OIG recommend that CMS (1) work with States to develop uniform terminology to clearly denote terminations for cause, (2) require that State Medicaid programs enroll all providers participating in Medicaid managed care, and (3) furnish guidance to State agencies that termination is not contingent on the provider’s active licensure status. CMS concurred with our recommendations.

IV. OTHER HEALTH POLICY NEWS

• On August 7, 2015, a federal district court judge ruled that Amarin Pharma Inc. can promote its drug Vascepa to healthcare professionals for off-label uses (Amarin Pharma Inc. v. FDA). United States District Judge Paul Engelmayer concludes in the ruling that “Amarin may engage in truthful and non-misleading speech promoting the off-label use of Vascepa, and… such speech may not form the basis of a prosecution for misbranding…Based on the information presently known, the combination of statements and disclosures that Amarin proposes to make to doctors relating to the use of Vascepa to treat persons with persistently high triglycerides…is truthful and non-misleading”.