A&B Healthcare Week in Review, December 2, 2016

I. Regulations, Notices, & Guidance

• On November 21, 2016, the Center for Medicare & Medicaid Services (CMS) issued a final rule entitled, Medicaid and Children’s Health Insurance Programs: Eligibility Notices, Fair Hearing and Appeal Processes for Medicaid and Other Provisions Related to Eligibility and Enrollment for Medicaid and CHIP. The final rule implements provisions of the Affordable Care Act (ACA) that expand access to health coverage through improvements in Medicaid and coordination between Medicaid, Children’s Health Insurance Program (CHIP), and Exchanges. The final rule finalizes most of the remaining provisions from the “Medicaid, Children’s Health Insurance Programs, and Exchanges: Essential Health Benefits in Alternative Benefit Plans, Eligibility Notices, Fair Hearing and Appeal Processes for Medicaid and Exchange Eligibility Appeals and Other Provisions Related to Eligibility and Enrollment for Exchanges, Medicaid and CHIP, and Medicaid Premiums and Cost Sharing; Proposed Rule” that CMS published in the January 22, 2013, Federal Register. The final rule continues CMS’ efforts to assist states in implementing Medicaid and CHIP eligibility, appeals, and enrollment changes required by the Affordable Care Act. The final rule is effective on January 20, 2017.
• On November 21, 2016, CMS issued a proposed rule entitled, Medicaid and Children’s Health Insurance Programs: Eligibility Notices, Fair Hearing and Appeal Processes for Medicaid and Other Provisions Related to Eligibility and Enrollment for Medicaid and CHIP. The proposed rule proposes to implement provisions of the Medicaid statute pertaining to Medicaid eligibility and appeals. The proposed rule continues CMS’ efforts to assist states in implementing Medicaid and CHIP eligibility, appeals, and enrollment changes required by the Affordable Care Act. Comments are due by January 23, 2017.   
• On November 22, 2016, the Food and Drug Administration (FDA) issued a guidance entitled, Contract Manufacturing Arrangements for Drugs: Quality Agreements.  The guidance describes the FDA's current thinking on defining, establishing, and documenting manufacturing activities of the parties involved in contract drug manufacturing subject to current good manufacturing practice (CGMP) requirements. In particular, the FDA describes how parties involved in contract drug manufacturing can use quality agreements to delineate their manufacturing activities to ensure compliance with CGMP. Comments may be submitted at any time.
• On November 22, 2016, the FDA issued a final rule entitled, Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications. The FDA is amending its nonprescription (over-the-counter or OTC) drug regulations. The final rule supplements the time and extent application (TEA) process for OTC drugs by establishing timelines and performance metrics for the FDA’s review of non-sunscreen TEAs, as required by the Sunscreen Innovation Act (SIA). The final rule also amends the existing TEA process to include filing determination and withdrawal provisions to make the TEA process more efficient. The final rule is effective on December 23, 2016.
• On November 23, 2016, the FDA issued a notice entitled, Request for Nominations on the Blood Products Advisory Committee. The FDA is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Blood Products Advisory Committee for the Center for Biologics Evaluation and Research (CBER) notify the FDA in writing. The FDA is also requesting nominations for a nonvoting industry representative(s) to serve on the Blood Products Advisory Committee. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations are due by December 23, 2016.
• On November 23, 2016, the FDA issued a draft guidance entitled, Submission of Quality Metrics Data. The revised draft guidance describes the FDA's plans for an initial, voluntary phase of a quality metrics reporting program. The FDA expects that this voluntary phase will allow the Agency to learn more about a limited set of quality metrics and associated analytics, and to help inform future FDA decision making about its quality metrics program. The revised draft also provides an opportunity to gain additional perspectives from industry participants on the future use of quality metrics data. Comments are due by January 24, 2017.  
• On November 23, 2016, the FDA issued a guidance entitled, Safety Testing of Drug Metabolites. According to the FDA, the guidance provides recommendations to industry on when and how to identify and characterize drug metabolites whose nonclinical toxicity needs to be evaluated. The safety of drug metabolites may need to be determined in nonclinical studies because these metabolites are either identified only in humans or are present at disproportionately higher levels in humans than in any of the animal species used during standard nonclinical toxicology testing. The guidance applies to small molecule nonbiologic drug products. The guidance does not apply to some cancer therapies where a risk-benefit assessment is considered.
• On November 25, 2016, the FDA issued a notice entitled, Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments. The notice is the FDA’s report on the status of the studies and clinical trials that applicants have agreed to, or are required to, conduct. A supplemental report containing additional information and analyses on the status of postmarketing requirements (PMRs) and postmarketing commitments (PMCs) is available on the FDA’s Web site.
• On November 28, 2016, the FDA issued a guidance entitled, Providing Postmarketing Periodic Safety Reports in the International Council for Harmonisation E2C(R2) Format (Periodic Benefit-Risk Evaluation Report). The guidance is intended to inform applicants of the conditions under which the FDA will exercise its waiver authority to permit applicants to submit an International Council for Harmonisation (ICH) (formerly International Conference on Harmonisation) E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER) in place of the ICH E2C(R1) Periodic Safety Update Report (PSUR), U.S. Periodic adverse drug experience report (PADER), or U.S. Periodic adverse experience report (PAER), to satisfy the periodic safety reporting requirements in the FDA regulations. The guidance describes the steps applicants can take to submit the PBRER, and discusses the format, content, submission deadline, and frequency of reporting for the PBRER. Comments may be submitted at any time.
• On November 28, 2016, the FDA issued a guidance entitled, Mitigating the Risk of Cross-Contamination From Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes; Guidance for Industry and Food and Drug Administration Staff. The guidance highlights the cross-contamination risk associated with day-use of irrigation systems used with flexible gastrointestinal endoscopes; clarifies terminology used to describe these devices; and outlines strategies to mitigate the risk of cross-contamination between patients during these procedures. Comments may be submitted at any time.
• On November 28, 2016, the FDA issued a final rule entitled, Submission of Food and Drug Administration Import Data in the Automated Commercial Environment. The final rule establishes requirements for the electronic filing of entries of the FDA-regulated products in the Automated Commercial Environment (ACE) or any other electronic data interchange (EDI) system authorized by the U.S. Customs and Border Protection Agency (CBP), in order for the filing to be processed by CBP and to help the FDA in determining admissibility of that product.
• On November 30, 2016, the Office of Personal Management (OPM) issued a proposed rule entitled, Removal of Eligible Family Members from Existing Self and Family Enrollments. The proposed rule would amend Federal Employees Health Benefits (FEHB) Program rules. The intended effect of the proposed rule is to allow certain eligible family members to be removed from self and family or self plus one enrollments. Comments are due by January 30, 2017.
• On November 30, 2016, OPM issued a proposed rule entitled, Federal Employees Health Benefits Program: Removal of Ineligible Individuals from Existing Enrollments. The proposed rule would amend FEHB regulations to provide a process for removal from FEHB enrollments of certain identified individuals who are found not to be eligible as family members. Comments are due by January 30, 2017.
• On December 1, 2016, OPM issued an interim final rule entitled, Federal Employees Health Benefits and Federal Employees Dental and Vision Insurance Programs’ Coverage Exception For Children of Same-Sex Domestic Partners. The interim final rule amends the rule to create a regulatory exception that allows children of same-sex domestic partners living overseas to maintain their FEHB and Federal Employees Dental and Vision Program (FEDVIP) coverage until September 30, 2018.
• On December 1, 2016, the FDA issued a draft guidance entitled, Physiologically Based Pharmacokinetic Analyses--Format and Content. The draft guidance recommends to drug sponsors the format and content for submitting physiologically based pharmacokinetic (PBPK) analyses to the FDA to enable efficient and consistent review. Comments are due by January 31, 2017.
• On December 2, 2016, the FDA issued a guidance entitled, Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products--Content and Format. The guidance is one of a series of guidance documents intended to assist applicants in complying with FDA regulations on the content and format of labeling for human prescription drug and biological products. The guidance describes the recommended information to include in the CLINICAL PHARMACOLOGY section of labeling that pertains to the safe and effective use of human prescription drug and biological products. Comments may be submitted at any time.

Event Notices

• December 14, 2016: The Department of Defense (DoD) announced a meeting of the Federal Advisory Committee meeting of the Defense Health Board (DHB) Health Care Delivery Subcommittee. The purpose of the meeting is for the Health Care Delivery Subcommittee members to receive public comments concerning pediatric health care services during an open forum. The Subcommittee is examining opportunities to improve the overall provision of health care and related services for children of members of the Armed Forces to better promote the health of this beneficiary population and potentially realize cost savings for the Military Health System.
• December 16, 2016: The Physician-Focused Payment Model Technical Advisory Committee (the Committee) announced their next meeting. The Committee will continue discussions about the process by which physician focused payment model proposals will be received and reviewed by the Committee based on the criteria established by the Secretary for physician-focused payment models. The Committee will also discuss the role of non-physician stakeholders including beneficiaries and employers in payment models and in the Committee’s processes.
• January 12-13, 2017: The Department of Health and Human Services (HHS) announced a meeting of the Chronic Fatigue Syndrome Advisory Committee (CFSAC). The meeting will cover the most recent and pressing topics surrounding Myalgic Encephalomyelitis/Chronic Fatigue Syndrome.
• March 15, 2017: The FDA announced a public advisory committee meeting of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee. The committee will discuss strategies, approaches, and challenges in the model-informed drug development (MIDD) with specific focus on two areas.

II. Congressional Legislation & Committee Action

U.S. Senate

• On November 30, 2016, the Senate Special Aging Committee held a hearing entitled, Trust Betrayed: Financial Abuse of Older Americans by Guardians and Others in Power. The witnesses included Ms. Kathryn Larin, Acting Director, Forensic Audit and Investigative Services Team, Government Accountability Office (GAO); Ms. Cate Boyko, Manager, Conservator Account Auditing Program; Ms. Jayne Martin, Executive Director, Legal Services for the Elderly; and Ms. Jessica Kruse, Attorney, Ozarks Elder Law.

• On November 30, 2016, the House Energy and Commerce Health Subcommittee held a hearing on the United States Preventative Task Force Transparency and Accountability Act of 2016. The witnesses included Kirsten Bibbins-Domingo, Chairwoman of the United States Preventive Services Task Force (USPSTF); Dr. John Lynch, Member, American Urological Association (AUA), Chairman and Professor, Department of Urology, Georgetown University; and Dr. John Meigs, Jr., President of the American Academy of Family Physicians (AAFP).
• On November 30, 2016, the House Oversight and Government Reform Government Operations Subcommittee held a hearing entitled, Federal Long-Term Care Insurance Program: Examining Premium Increases. The witnesses included Michael Doughty, President General Manager John Hancock Insurance; Mr. John O’Brien, Senior Advisor for Health Policy, U.S. Office of Personnel Management (OPM); Ms. Laurel Kastrup, Chair of the Health Financial Reporting and Solvency Committee, American Academy of Actuaries (AAA); Mr. Richard G. Thissen, National President, National Archive and Retired Federal Employees Association (NARFE); and Mr. Marc A. Cohen, Ph.D., Clinical Professor of Gerontology, University of Massachusetts – Boston.
• On November 30, 2016, the House passed R. 34, the 21^st Century Cures Act by a vote of 392-26. 

III. Reports, Studies, & Analyses 

• On November 23, 2016, the Office of Inspector General (OIG) released a report entitled, North Carolina Improperly Claimed Federal Reimbursement for Some Medicaid Nonemergency Transportation Services. The report found that the North Carolina Department of Health and Human Services (State agency) claimed Federal Medicaid reimbursement for some nonemergency medical transportation (NEMT) services that did not comply with Federal or State requirements. Of the 200 sample items, 82 complied with Federal and State requirements, but 118 did not. Of the 118 items, 48 contained more than 1 deficiency. On the basis of the OIG’s sample results, OIG estimated that the State agency improperly claimed at least $18.7 million ($12 million Federal share) for unallowable NEMT services for the audit period. The State agency also improperly claimed $20 million in NEMT administrative expenditures at North Carolina's Federal medical assistance percentage (FMAP) rate, instead of the 50-percent administrative rate, which resulted in excess Federal reimbursement of $3.1 million.
• On November 28, 2016, the OIG released a report entitled, The Minnesota Marketplace Misallocated Federal Funds and Claimed Unallowable Costs. The report found that the Minnesota marketplace did not always allocate costs for establishing a health insurance marketplace and expend establishment grant funds in accordance with Federal requirements. Specifically, it: (1) allocated $1.8 million to the establishment grants and Medicaid on the basis of a cost allocation methodology that used outdated, estimated data instead of updated, better estimated data that were available, thereby misallocating $346,000 in costs to the establishment grants instead of allocating these costs to its State-based public health care programs; (2) did not appropriately authorize $930,000 for additional marketing work or execute a contract amendment until after the contractor completed the work; (3) reimbursed a contractor twice, resulting in an unallowable payment of $4,000; and (4) did not create or maintain complete and accurate inventory records for equipment purchased with establishment grants in accordance with Federal requirements.
• On November 28, 2016, the Government Accountability Office (GAO) released a report entitled, Food Safety: FDA’s Efforts to Evaluate and Respond to Business Concerns Regarding the Produce Rule. The report discusses the FDA’s efforts to evaluate and respond to business concerns regarding the Produce Rule.
• On November 28, 2016, the Congressional Budget Office (CBO) released a report entitled, Direct Spending and Revenue Effects for H.R. 34, The 21^st Century Cures Act. The report provides the direct spending and revenue effects for H.R. 34, The 21^st Century Cures Act from 2017 to 2026. The CBO issued an updated report on H.R. 34, as amended, the following day,
• On November 30, 2016, the OIG released a report entitled, Semiannual Report to Congress. The semiannual report provides Congress and the Secretary with OIG’s significant findings and recommendations. 

IV. Other Health Policy News

• On November 21, 2016, the FDA issued Questions and Answers on the Generic Drug User Fee Amendments of 2012. The Question and Answer document answers questions related to the user fee assessments.
• On November 28, 2016, CMS issued and informational bulletin entitled, Section 1115 Demonstration Opportunity to Allow Medicaid Coverage to Former Foster Care Youth Who Have Moved to a Different State. According to CMS, the purpose of the bulletin is to inform states how they can pursue a Medicaid demonstration project under section 1115 of the Social Security Act (the Act) to continue to provide Medicaid coverage to former foster care youth who aged out of foster care under the responsibility of another state (and were enrolled in Medicaid while in foster care), and are now applying for Medicaid in the state in which they live.
• On November 30, 2016, CMS issued an informational bulletin entitled, Coverage of Blood Lead Testing for Children Enrolled in Medicaid and the Children’s Health Insurance Program. The information bulletin provides an overview of coverage of blood lead testing for children enrolled in Medicaid and CHIP.
• On November 30, 2016, CMS released a Biweekly Enrollment Snapshot of weeks 3 and 4 of Open Enrollment for the Health Insurance marketplace for 2017. According to CMS, Over 2.1 million people have selected plans using the HealthCare.gov platform since Open Enrollment began on November 1, including over half a million new consumers and 1.6 million consumers renewing their coverage. Enrollments for these two weeks represent an increase of 167,000 plan selections versus the third and fourth weeks of Open Enrollment last year. In addition, the total number of plan selections at this point exceeds last year by over 97,000, even though this year’s totals include two fewer days. In addition to national data, this snapshot includes state-by-state plan selection estimates for those states using HealthCare.gov.
• On December 1, 2016, CMS issued a joint informational bulletin entitled, Opportunities to Improve HIV Prevention and Care Delivery to Medicaid and CHIP beneficiaries. The informational bulletin informs state Medicaid agencies about important advances in HIV prevention, care and treatment that have occurred in the five years since CMCS outlined opportunities available to provide Medicaid coverage to individuals living with HIV in a letter to State Medicaid Directors (SMD) entitled, Coverage and Service Design Opportunities for Individuals Living with HIV. Additionally, the informational bulletin highlights opportunities available to state Medicaid programs to drive improvements in the accessibility, quality, cost, and population-level impact of HIV prevention and care services available to Medicaid beneficiaries.
• On December 2, 2016, CMS released the 2015 National Health Expenditures. In 2015, per-capita health care spending grew by 5.0 percent and overall health spending grew by 5.8 percent, according to a study by the Office of the Actuary at CMS.