A&B Healthcare Week in Review, March 4, 2016

I. REGULATIONS, NOTICES, & GUIDANCE

• On February 29, 2016, the U.S. Department of Health and Human Services (HHS) issued a final notice entitled, “Final HHS Notice of Benefit and Payment Parameters for 2017.” This final rule sets forth payment parameters and provisions related to the risk adjustment, reinsurance, and risk corridors programs; cost-sharing parameters and cost-sharing reductions; and user fees for Federally-facilitated Exchanges. It also provides additional amendments regarding the annual open enrollment period for the individual market for the 2017 and 2018 benefit years; essential health benefits; cost sharing; qualified health plans; Exchange consumer assistance programs; network adequacy; patient safety; the Small Business Health Options Program; stand-alone dental plans; third-party payments to qualified health plans; the definitions of large employer and small employer; fair health insurance premiums; student health insurance coverage; the rate review program; the medical loss ratio program; eligibility and enrollment; exemptions and appeals; and other related topics.
• On February 29, 2016, the Centers for Medicare & Medicaid Services (CMS) issued the final 2017 Letter to Issuers in the Federally-facilitated Marketplaces. This Letter provides issuers seeking to offer qualified health plans (QHPs), including stand-alone dental plans (SADPs), in the Federally-facilitated Marketplaces (FFMs) or the Federally-facilitated Small Business Health Options Programs (FF-SHOPs) with operational and technical guidance to help them successfully participate in any such Marketplace in 2017.
• On February 29, 2016, CMS issued frequently asked questions (FAQs) on the 2017 Moratorium on Health Insurance Provider Fee. These FAQs provide guidance on how the moratorium is expected to affect 2017 rate filings for single risk pool plans in the individual and small group market.
• On February 29, 2016, CMS issued final key dates in 2016 for QHP Certification in the FFM; Rate Review; Risk Adjustment, Reinsurance and Risk Corridors. This document summarizes key dates for calendar year 2016 regarding these activities and policies as outlined in other documents such as 2017 Letter to Issuers in the Federally-facilitated Marketplaces and the HHS Notice of Benefit and Payment Parameters for 2017.
• On February 29, 2016, CMS issued a final guidance entitled, “Timing of Submission and Posting of Rate Filing Justifications for the 2016 Filing Year for Single Risk Pool Coverage.” This guidance establishes the uniform deadline under 45 CFR 154.220(b) for health insurance issuers to submit the Rate Filing Justification for proposed rates for single risk pool coverage in the individual and small group markets. It also establishes the uniform posting deadline under 45 CFR 154.301(b)(1)(i) for a State with an Effective Rate Review Program to provide public access to information regarding proposed rate increases that are subject to review.
• On February 29, 2016, CMS issued a letter entitled, “Availability of HITECH Administrative Matching Funds to Help Professionals and Hospitals Eligible for Medicaid EHR Incentive Payments Connect to Other Medicaid Providers.” This letter updates guidance about the availability of federal funding at the 90 percent matching rate for state expenditures on activities to promote health information exchange (HIE) and encourage the adoption of certified Electronic Health Record (EHR) technology by certain Medicaid providers.
• On February 29, 2016, CMS issued a change request entitled, “April 2016 Update of the Hospital Outpatient Prospective Payment System (OPPS).” The change request is intended for providers and suppliers who submit claims to Medicare Administrative Contractors (MACs), including Home Health and Hospice (HH&H) MACs, for services provided to Medicare beneficiaries paid under the Outpatient Prospective Payment System (OPPS).
• On February 29, 2016, the HHS Office of the National Coordinator for Health Information Technology issued a notice of proposed rulemaking entitled, “ONC Health IT Certification Program: Enhanced Oversight and Accountability.” The proposed rule proposes to establish processes for ONC to directly review health IT certified under the Program and take action when necessary, including requiring the correction of non-conformities found in health IT certified under the Program and suspending and terminating certifications issued to Complete EHRs and Health IT Modules.
• On March 1, 2016, the HHS Office of the National Coordinator for Health Information Technology issued notice entitled, “Consumer Health Data Aggregator Challenge; Requirements and Registration.” The Consumer Health Data Aggregator Challenge is intended to spur the development of third-party, consumer-facing applications that use open, standardized Application Programming Interfaces (APIs) to help consumers aggregate their data in one place and under their control. This challenge will focus on solving the problem that many consumers have today the ability to easily and electronically access their health data from different health care providers using a variety of different health IT systems.
• On March 1, 2016, the Food and Drug Administration (FDA) issued a proposed order entitled, “General and Plastic Surgery Devices: Blood Lancets; Reclassification.” FDA is identifying proposed special controls for these types of blood lancets that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness.
• On March 2, 2016, CMS issued a joint informational bulletin with the Health Resources and Services Administration (HRSA) entitled, “Coverage of Maternal, Infant, and Early Childhood Home Visiting Services.” This Bulletin is intended to assist states in designing a benefit package to provide home visiting services for pregnant women and families with young children. The bulletin encourages state agencies such as Medicaid, Maternal and Child Health programs, and others to use this information to improve access and service delivery for beneficiaries.
• On March 2, 2016, CMS issued a final rule correcting amendment entitled, “Medicare Program: Comprehensive Care for Joint Replacement Payment Model for Acute Care Hospitals Furnishing Lower Extremity Joint Replacement Services; Corrections and Correcting Amendments.” In the November 24, 2015 Federal Register (80 FR 73274), CMS published a final rule to implement a new Medicare Part A and B payment model under section 1115A of the Social Security Act, called the Comprehensive Care for Joint Replacement (CJR) model, in which acute care hospitals in certain selected geographic areas will receive retrospective bundled payments for episodes of care for lower extremity joint replacement (LEJR) or reattachment of a lower extremity. The effective date was January 15, 2016. This correcting amendment corrects a limited number of technical and typographical errors identified in the November 24, 2015 final rule.
• On March 3, 2016, CMS issued a change request entitled, “Skilled Nursing Facility (SNF) Prospective Payment System and Consolidated Billing; Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biologicals; Establishment of Exchanges and Qualified Health Plans; Establishment of an Exchange by a State and Qualified Health Plans.” CMS is requesting public comments on the SNF payment system, the submission of ASP data as well as the establishment of exchanges. Public comments are due April 4, 2016.
• On March 3, FDA issued a technical amendment entitled, “Unique Device Identification System: Editorial Provisions; Technical Amendment.” FDA is amending the Unique Device Identification (UDI) System regulation to make editorial changes. This technical amendment updates the email address associated with FDA’s UDI system, which allows FDA to obtain information and offer support and assistance on medical devices through their distribution and use.
• On March 3, 2016, FDA issued an information collection request (ICR) entitled, “Medical Devices: Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing Performed by Third-Party Entities and Original Equipment Manufacturers.” FDA is announcing the establishment of a docket to receive information and comments on the medical device industry and healthcare community that refurbish, recondition, rebuild, remarket, remanufacture, service, and repair medical devices, including radiation-emitting devices subject to the electronic product radiation control (EPRC) provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). FDA is taking this action, in part, because various stakeholders have expressed concerns about the quality, safety, and continued effectiveness of medical devices that have been subject to one or more of these activities that are performed by both original equipment manufacturers (OEM) and third parties, including health care establishments. FDA is seeking comments by May 3, 2016.
• On March 3, 2016, FDA issued an ICR entitled, “Nonclinical Study Data Reviewer's Guide Template.” FDA is seeking public comment on the use of the PhUSE Nonclinical SDRG template for regulatory submissions. Public comments are due May 4, 2016.
• On March 3, 2016, FDA issued an ICR entitled, “Notice of Special Enrollment Rights under Group Health Plans.” This ICR seeks to extend PRA authority for the Notice of Special Enrollment Rights under Group Health Plans information collection.
• On March 3, 2016, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a notice entitled, Announcement of Requirements and Registration for the Opioid Overdose Prevention Challenge. SAMHSA has issued a challenge to developers to help support patients in recovery who are receiving medication assisted treatment for opioid use disorder with an innovative app that provides features and information that support their recovery.
• On March 4, 2016, the FDA issued a notice announcing the availability of guidance on Clinical Considerations for Investigational Device Exemptions for Neurological Devices Targeting Disease Progression and Clinical Outcomes. This guidance is intended to assist sponsors who plan to submit an IDE to the FDA to conduct clinical trials on medical devices targeting neurological disease progression and clinically meaningful patient centered outcomes. This draft guidance is not final nor is it in effect at this time. Comments will be accepted for up to 90 days following publication of this notice in the Federal Register.
• On March 1, 2016, the Office of Management and Budget (OMB) received for review a proposed rule entitled Medicare Program: Changes to the Medicare Claim, Organization Determination, and Coverage Determination Appeals Procedures. This proposed rule would make changes to procedures for Medicare fee-for-service claim appeals, managed care organization determination appeals, and prescription drug plan coverage determination appeals to increase administrative efficiencies and set forth procedures that will help position the administrative appeals process to address the increasing number of appeals in a manner that is responsive to appellants needs for timely determinations on Medicare coverage and payment, while maximizing the efficiencies in administering the appeals programs.

Event Notices

• March 21, 2016, HHS Board of Scientific Counselors, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry announced a teleconference to advise the Secretary of HHS on policy revisions.
• March 21 & 22, 2016: HHS National Advisory Council on the National Health Service Corps announced a public meeting to advice the Secretary of HHSS on a range issues and policy revisions.
• March 30 & 31, 2016: The Federal Advisory Committee Act (FACA) announced a meeting to be held for the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria.
• May 5, 2016: CMS will host the2016 Medicare Advantage & Prescription Drug Plan Spring Conference & Webcast. Session topics include: Building Effective Relationships with Your Account Managers; Chapter 6: The Part D Formulary Awakens; Encounter Data Update; Effective Strategies for Addressing Overutilization and Abuse of Prescription Drugs in Medicare Part D; and an Open Q & A Session. In-person registration for this event is now open but will close on Friday, April 22nd at 6pm EDT. The webcast registration will remain open until CMS reaches capacity.

II. CONGRESSIONAL LEGISLATION & COMMITTEE ACTION

U.S. Senate

• On March 2, 2016, the Senate Appropriations Subcommittee on Agriculture, Rural Development, FDA, and Related Agencies held a hearing entitled, “Fiscal Year 2017 FDA Budget.” The witnesses included Robert Califf, Commissioner, FDA; and Jay Tyler, CFO, FDA.
• On March 3, 2016, the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies held a hearing entitled, “Fiscal Year 2017 Budget for the Health and Human Services Department.” The sole witness was Secretary Sylvia Matthews Burwell of HHS.
• On March 3, 2016, the Senate Appropriations Subcommittee on Military Construction, Veterans Affairs and Related Agencies held a hearing entitled, “The Fiscal Year 2017 and Fiscal Year 2018 Budget for the Veterans Health Administration and Veterans Benefits Administration.” The witnesses included David Shulkin, Undersecretary for Health, Veterans Affairs; Danny Pummill, Acting Undersecretary for Benefits, Veterans Affairs.
• On March 3, 2016, Sens. Susan Collins (R-ME) and Claire McCaskill (D-MO) introduced a bipartisan bill – the Increasing Competition in Pharmaceuticals Act – that aims to lower drug prices by requiring FDA quickly review certain generic drug applications to increase market competition. “The sudden, aggressive price hikes for a variety of recently acquired off-patent drugs that have been used widely for decades, of which there is no generic drug competitor, also affects access to affordable prescriptions for patients and the overall cost of health care in the United States,” states the newly introduced legislation.
• On March 3, 2016, Senators Patty Murray (D-Wash.) and Elizabeth Warren (D-Mass.) introduced the National Biomedical Research Act with all of their Democratic colleagues on the Health, Education, Labor & Pensions (HELP) Committee. This bill would increase funding for targeted biomedical research initiatives through a new, reliable funding stream supporting the National Institutes of Health (NIH) and the Food and Drug Administration (FDA). This funding boost will help restore the NIH budget to its 2006 levels, adjusted for biomedical inflation.

House of Representatives

• On March 1, 2016, the House Energy and Commerce Subcommittee on Health held a hearing entitled, “Long-Term Care Financing/Delivery.” The witnesses included Alice Rivlin, Co-chair of the Bipartisan Policy Center's Long-Term Care Initiative and Senior Fellow in the Brookings Institution's Economic Studies Program; William Scanlon, Consultant, West Health Institute and National Health Policy Forum; and Anne Tumlinson, CEO of Anne Tumlinson Innovations and Founder of Daughterhood.org.
• On March 2, 2016, the House Science, Space and Technology Subcommittee on Research and Technology held a hearing entitled, “Smart Health: Empowering the Future of Mobile Apps.” The witnesses included Morgan Reed, Executive Director, App Association; Bryan Shaw, Assistant Professor; Baylor University's Department of Chemistry and Biochemistry; Howard Look, President, CEO and Founder, Tidepool; Gregory Krauss, Professor of Neurology, Johns Hopkins Hospital; and Jordan Epstein, CEO and Founder, Stroll Health.
• On March 2, 2016, the House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies held a hearing entitled, “Substance Abuse/Mental Health Administration Budget.” The sole witness was Kana Enomoto, Acting Administrator of the Substance Abuse and Mental Health Services Administration (SAMHSA).
• On March 3, 2016, the House Energy & Commerce Subcommittee on Commerce, Manufacturing, and Trade convened a hearing entitled "Disrupter Series: Wearable Devices." The witnesses included Mr. Thomas D. Bianculli, Vice President, Enterprise Technologies Office, Zebra Technologies; Ms. Meg Burich, Director of Commercial Development and Marketing, Adidas Digital Sports; Mr. Suresh Palliparambil, Director of American Sales and Business Development, NXP; Mr. Scott R. Peppet, Professor of Law, University of Colorado Law School; and Mr. Doug Webster, Vice President, Service Provider Marketing, Cisco.
• The House is not in session next week.

III. REPORTS, STUDIES, & ANALYSES

• On February 29, 2016, the U.S. Government Accountability Office (GAO) released a report entitled, “Federal Health Care Center: VA and DOD Need to Address Ongoing Difficulties and Better Prepare for Future Integrations.” To conduct its study, GAO reviewed Department of Veteran Affairs (VA), Department of Defense (DOD), and the Federal Health Care Center (FHCC) documents (such as the Executive Agreement), federal standards for internal control, and other sources of related best practices, and interviewed VA, DOD, Navy, and FHCC officials, including former and current leadership and over 100 staff.
• On March 2, 2016, GAO released a report entitled, “Emerging Infectious Diseases: Preliminary Observations on the Zika Virus Outbreak.” GAO stated that because Zika virus disease cannot yet be prevented by drugs or vaccines, vector (mosquito) control remains a critical factor in preventing and mitigating the occurrence of this disease.
• On March 2, 2016, GAO released a report entitled, “Rare Diseases: Too Early to Gauge Effectiveness of FDA's Pediatric Voucher Program.” GAO found that it is too early to gauge whether the FDA pediatric voucher program has stimulated the development of drugs to treat or prevent rare pediatric diseases, and given that the typical drug development process often exceeds a decade, insufficient time has elapsed to determine whether the 3 year-old program has been effective. GAO reviewed relevant laws and documentation related to the program and its management, and identified drug sponsors who were awarded vouchers, the diseases their drugs were approved to treat, and whether the vouchers were redeemed, sold, or transferred.
• On March 3, 2016, GAO released a report entitled, “Nonemergency Medical Transportation: Updated Medicaid Guidance Could Help States.” GAO identified four types of challenges related to Medicaid NEMT and several steps taken by states to address some of these challenges. Challenges reported related to containing costs, maintaining program integrity, contracting with and overseeing vendors, and accessing NEMT. For example, states reported challenges containing NEMT costs due to increased NEMT utilization and reported implementing practices to help address these challenges. Such practices include setting fixed provider reimbursement fees that remained relatively constant in recent years. Officials from 7 of the 15 selected states and 6 stakeholders GAO interviewed reported that having information on how states administer NEMT and ways to address challenges could be helpful to states. Some of this information is available; for example, CMS reported collecting information on states' approaches through state Medicaid plans and posting this information on CMS's website. GAO recommends that the Secretary of HHS direct CMS to assess current Medicaid NEMT guidance and update it as needed. HHS concurred with our recommendation and provided technical comments which we incorporated as appropriate.
• On March 3, 2016, the Office of Inspector General (OIG) released a report entitled, “Texas Inappropriately Claimed Medicaid Balancing Incentive Payments Program and Family Planning Funding.” The Texas Health and Human Services Commission claimed $72.2 million in expenditures that were not related to eligible non-institutional long-term services and supports and inappropriately received $1.4 million in Balancing Incentive Payments Program funding. Additionally, the State agency did not calculate or return the family planning Federal share of experience rebates, which totaled $502,000.
• On March 3, 2016, America’s Health Insurance Plans (AHIP) released a report by Oliver Wyman entitled, “Proposed Cuts to Medicare Advantage Put Seniors' Coverage at Risk.” According to the report, CMS’ proposed changes from the 2017 Advance Notice and Call Letter, if finalized, would result in an estimated 0.5 to 3.9 percent cut on average to MA payments in 2017. “Such reductions, coupled with the reductions experienced in 2014 through 2016, could have a significant impact on the sustainability of Medicare Advantage Organization (MAO) program participation and the ability of MAOs to provide stable benefits and affordable premiums to their members,” the report states.

IV. OTHER HEALTH POLICY NEWS

• On March 3, 2016, CMS announced “two landmark achievements for the U.S. health care system since the passage of the Affordable Care Act. First, more than 20 million Americans have gained health insurance. The country has the lowest uninsured rate ever recorded. Second, as of January 2016, more than 30% of Medicare Part A and B payments are tied to alternative payment models. This latter milestone follows the U.S. Department of Health and Human Services’ challenge to shift the way health care is paid for, away from the quantity of services to the quality and value of care provided. CMS is proud to achieve the 30% target almost a year ahead of schedule. Moreover, true transformation of our health system cannot be done through Medicare alone, and so CMS looks forward to continuing to work with partners across the country to achieve the goals of tying 30% of spending to APMs by the end of 2016 and 50% by the end of 2018 for the entire U.S. health care system.”
• On March 2, 2016, CMS announced an initiative to bring interoperable technology to a broader universe of health care providers, including long-term care, behavioral health providers, substance abuse treatment centers, and other providers that have been slower to adopt technology. This announcement will help to bridge an information sharing gap in Medicaid by permitting states to request the 90 percent enhanced matching funds from CMS to connect a broader variety of Medicaid providers to a health information exchange than those providers who are eligible for such connections today. This additional funding will enhance the sustainability of health information exchanges and lead to increased connectivity among Medicaid providers.
• On March 3, 2016, GOP presidential candidate Donald Trump released a health care reform plan to repeal and replace the Affordable Care Act (ACA). The seven point plan would completely repeal the ACA; permit the sale of insurance across state lines; allow individuals to fully deduct health insurance premium payments from their tax returns under the current tax system; allow expanded use of Health Savings Accounts (HSAs); require price transparency from all healthcare providers; block-grant Medicaid to the states; and “remove barriers to entry into free markets for drug providers that offer safe, reliable and cheaper products,” allowing consumers access to imported, safe and dependable drugs from overseas.
• On March 3 & 4, 2016, the Medicare Payment Advisory Commission (MedPAC) held its March meeting. MedPAC convened sessions on Developing a Unified Post-Acute Care Prospective Payment System, Improving Part D, Part B Drug Payment Policy, and Improving Efficiency of Oncology Care in FFS Medicare. After the staff presentations, Commissioners held in-depth discussions on their proposed recommendations. Votes on final recommendations will take place in the April meeting and final recommendations will be published in the June report.