A&B Healthcare Week in Review, May 13, 2016

I. REGULATIONS, NOTICES, & GUIDANCE

• On May 13, 2016, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a final rule entitled, “Nondiscrimination in Health Programs and Activities.” This final rule implements Section 1557 of the Affordable Care Act (ACA). Section 1557 prohibits discrimination on the basis of race, color, national origin, sex, age, or disability in certain health programs and activities. The final rule clarifies and codifies existing nondiscrimination requirements and sets forth new standards to implement Section 1557, particularly with respect to the prohibition of discrimination on the basis of sex in health programs other than those provided by educational institutions and the prohibition of various forms of discrimination in health programs administered by HHS and entities established under Title I of the ACA. In addition, the Secretary is authorized to prescribe the Department’s governance, conduct, and performance of its business, including, here, how HHS will apply the standards of Section 1557 to HHS-administered health programs and activities. This rule is effective July 18, 2016.
• On May 13, 2016, the Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled, “Medicare Program; Obtaining Final Medicare Secondary Payer Conditional Payment Amounts via Web Portal.” This final rule specifies the process and timeline for expanding CMS' existing Medicare Secondary Payer (MSP) Web portal to conform to Section 201 of the Medicare IVIG and Strengthening Medicare and Repaying Taxpayers Act of 2012 (the SMART Act). The final rule specifies a timeline for developing a multifactor authentication solution to securely permit authorized users other than the beneficiary to access CMS' MSP conditional payment amounts and claims detail information via the MSP Web portal. It also requires that CMS adds functionality to the existing MSP Web portal that permits users to: notify us that the specified case is approaching settlement; obtain time and date stamped final conditional payment summary statements and amounts before reaching settlement; and ensure that relatedness disputes and any other discrepancies are addressed within eleven business days of receipt of dispute documentation. The rule is effective June 13, 2016.
• On May 10, 2016, CMS issued a notice entitled, “Part C Medicare Advantage Reporting Requirements and Supporting Regulations; Reporting Requirements for States Under Transitional Medical Assistance (TMA) Provisions; Cooperative Agreement to Support Navigators in Federally-facilitated and State Partnership Exchanges." CMS notes that Medicare Advantage Organizations (MAOs) must have an effective procedure to develop, compile, evaluate, and report to CMS, to its enrollees, and to the general public, at the times and in the manner that CMS requires, and while safeguarding the confidentiality of the doctor-patient relationship; information demonstrating that the MAO has a fiscally sound operation; and other matters that CMS may require. CMS also has oversight authority over cost plans which includes the establishment of reporting requirements. This revision would add five new data elements to the reporting section: Organization Determinations and Reconsiderations. These new data elements are needed to obtain more information about case reopenings. The revision would also suspend the Sponsor Oversight of Agents reporting section beginning 2017 so that the reporting section can be reassessed based on burden and usage. Public comments are due July 11, 2016.
• On May 10, 2016, CMS issued guidance entitled, “Guidance on Annual Eligibility Redetermination and Re-enrollment for Marketplace Coverage for 2017.” CMS will continue to build on the operational improvements made as part of the Federally-facilitated Marketplaces’ annual redetermination and re-enrollment process in 2016 to further smooth the process for enrollees and issuers. The Marketplace will continue to request updated data from the Internal Revenue Service (IRS) for all enrollees who have provided authorization to the Marketplace for purposes of annual redetermination. The Marketplace will automatically re-enroll 2016 enrollees who do not select a qualified health plan (QHP) by the last day on which a plan may be selected for coverage effective January 1, 2017.
• On May 13, 2016, CMS issued a notice entitled, “Long Term Care Hospital (LCTH) Continuity Assessment Record and Evaluation (CARE) Data Set." Beginning in FY 2014, LTCHs that fail to submit quality measure data may be subject to a two percentage point reduction in their annual update to the standard Federal rate for discharges occurring during a rate year. The LTCH CARE Data Set was developed specifically for use in LTCHs for data collection of NQF #0678 Pressure Ulcer measures beginning October 1, 2012, with the understanding that the data set would expand in future rulemaking years with the adoption of additional quality measures. Public comments are due by June 13, 2016.
• On May 13, 2016, CMS issued a notice entitled, “Medicare Credit Balance Reporting Requirements; HIPPA Eligibility Tracking System; Issuers Reporting Requirements for Selecting a Cost-Sharing Reductions Reconciliation Methodology.” CMS indicates that quarterly credit balance reporting is needed to monitor and control the identification and timely collection of improper payments. Credit balances are mainly attributable to provider billing practices and cannot be eliminated by program functions; they will continue to occur. Public comments are due by July 13, 2016.
• On May 9, 2016, the Office of Management and Budget (OMB) received a proposed rule for review entitled, “CY 2017 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System and Quality Incentive, Durable Medical Equipment, and DMEPOS Competitive Bidding Programs.” According to OMB, this annual proposed rule would update the bundled payment system for ESRD facilities by January 1, 2017. The rule would also update the quality incentives in the ESRD program.
• On May 9, 2016, OMB received a final rule for review entitled, “Conditions of Participation for Home Health Agencies.” According to OMB, when the final rule is issued, it is expected to revise the existing Conditions of Participation that Home Health Agencies (HHA) must meet to participate in the Medicare program. The new requirements will focus on the actual care delivered to patients by HHAs, reflect an interdisciplinary view of patient care, allow HHAs greater flexibility in meeting quality standards, and eliminate unnecessary procedural requirements.
• On May 10, 2016, HHS National Institute on Disability, Independent Living, and Rehabilitation Research issued a final rule entitled, “National Institute on Disability, Independent Living, and Rehabilitation Research.” This rule implements the Workforce Innovation and Opportunity Act of 2014 and reflects the transfer of the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR) from the Department of Education to HHS. The previous regulations were issued by the Department of Education. The rulemaking consolidates the NIDILRR regulations into a single part, aligns the regulations with the current statute and HHS policies, and provides guidance to NIDILRR grantees. These final regulations are effective July 1, 2016.
• On May 9, 2016, OMB received a proposed rule for review entitled, “CY 2017 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model; and Home Health Quality Reporting Requirements.” According to OMB, this annual proposed rule would update the 60-day national episode rate based on the applicable home health market basket update and case-mix adjustment. It would also update the national per-visit rates used to calculate low utilization payment adjustments (LUPAs) and outlier payments under the Medicare prospective payment system for home health agencies. These changes would apply to services furnished during home health episodes beginning on or after January 1, 2017.
• On May 13, 2016, OMB received a proposed rule for review entitled, “CY 2017 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B.” According to OMB, this annual proposed rule would revise payment policies under the Medicare physician fee schedule, and make other policy changes to payment under Medicare Part B. These changes would apply to services furnished beginning January 1, 2017.
• On May 11, 2016, HHS issued a notice entitled, “Announcement of Re-Establishment of the Physical Activity Guidelines Advisory Committee and the Secretary’s Advisory Committee on National Health Promotion and Disease Prevention Objectives.” HHS announced the reestablishment of the Physical Activity Guidelines Advisory Committee and the Secretary’s Advisory Committee on National Health Promotion and Disease Prevention Objectives. Both committees have been established to perform single, time-limited tasks that will assist with furthering the mission of the HHS.
• On May 9, 2016, HHS Office of the National Coordinator for Health Information Technology (ONC) issued a notice entitled, “Requirements and Registration: Move Health Data Forward Challenge.” The Move Health Data Forward Challenge aims to incentivize participants to create an application programming interface (API) solution that utilizes the implementation specifications developed by the HEART Workgroup to enable individuals to securely authorize the movement of their health data to destinations they choose. Submissions for Phase 1 are due by September 8, 2016.
• On May 9, 2016, CMS issued a notice entitled, “Announcement of Requirements and Registration for A Bill You Can Understand Design and In-novation Challenge: Help Patients Understand Their Medical Bills and the Financial Aspect of Health.” This notice announces a challenge to engage those in the health care community working on medical bill issues, as well as new players from other industries, such as human-centered design and digital technology, to help in redesigning the “Medical Bill” or the “Medical Billing Process.” Submissions are due by August 10, 2016.
• On May 9, 2016, the Food and Drug Administration (FDA) issued a guidance entitled, “Technical Considerations for Additive Manufactured Devices.” FDA has developed this draft guidance to provide FDA's initial thoughts on technical considerations specific to devices using additive manufacturing, the broad category of manufacturing encompassing 3-dimensional (3D) printing. Specifically, this draft guidance outlines technical considerations associated with additive manufacturing processes, and testing and characterization for final finished devices fabricated using additive manufacturing. Public comments are due by August 9, 2016.
• On May 9, 2016, CMS issued a transmittal entitled, “Quarterly Healthcare Common Procedure Coding System (HCPCS) Drug/Biological Code Changes - July 2016 Update.” The HCPCS code set is updated on a quarterly basis. This instruction informs the contractors of updating specific drug/biological HCPCS code. Beginning on July 1, 2016, the following HCPCS codes will be established: Q9981 rolapitant, oral, 1mg; Q9982 flutemetamol f18 diagnostic; Q9983 florbetaben f18 diagnostic; Q5102 Inj., infliximab biosimilar.
• On May 6, 2016, CMS issued a change request (CR) entitled, “Shared Savings Program (SSP) Accountable Care Organization (ACO) Qualifying Stay Edits." This CR is to allow the processing of Skilled Nursing Facility (SNF) claims without having to meet the 3-day hospital stay requirement for a select number of facilities that have a relationship with an SSP ACO.
• On May 10, 2016, CMS issued a notice entitled, “Attending Physician's Certification of Medical Necessity and Supporting Documentation Requirements; Durable Medical Equipment Medicare Administrative Contractors (MAC) Regional Carrier, Certificate of Medical Necessity and Supporting Documentation; Data Collection for Medicare Beneficiaries Receiving NaF-18 Positron Emission Tomography (PET) to Identify Bone Metastasis in Cancer.” The certificates of medical necessity (CMNs) collect information required to help determine the medical necessity of certain items. CMS requires CMNs where there may be a vulnerability to the Medicare program. Each initial claim for these items must have an associated CMN for the beneficiary. Public comments are due June 11, 2016.
• On May 12, 2016, HHS Office of the Inspector General (OIG) issued a notice entitled, “Modification of OIG Advisory Opinion 10-07.” This notice modifies OIG Advisory Opinion 10-07 which concerned a nonprofit, tax-exempt, charitable organization's proposal to provide assistance with cost-sharing obligations to financially needy individuals, including Medicare and Medicaid beneficiaries, diagnosed with certain specified diseases, and its first modification at Modification of OIG Advisory Opinion 10-07 to reflect guidance issued on May 21, 2014 in the Supplemental Special Advisory Bulletin regarding Independent Charity Patient Assistance Programs.
• On May 11, 2016, CMS issued an informational bulletin entitled, “Maternal Depression Screening and Treatment: A Critical Role for Medicaid in the Care of Mothers and Children." The bulletin discusses the importance of early screening for maternal depression and clarifies the pivotal role Medicaid can play in identifying children with mothers who experience depression and its consequences, and connecting mothers and children to the help they need. State Medicaid agencies may cover maternal depression screening as part of a well-child visit. In addition, states must cover any medically necessary treatment for the child as part of the Early and Periodic Screening, Diagnostic and Treatment (EPSDT) benefit.
• On May 12, 2016, the National Institutes of Health (NIH) issued a request for information (RFI) entitled, “Requests for Information: Developing the National Cancer Moonshot Initiative.” The initiative, led by Vice President Joe Biden, aims to make more therapies available to more patients, while also improving NIH’s ability to prevent cancer and detect it at an early stage. Additional details of the National Cancer Moonshot Initiative are available here. Public comments are due by July 1, 2016.
• On May 12, 2016, FDA issued a notice entitled, “Charter Renewals: Pulmonary-Allergy Drugs Advisory Committee." FDA announced the renewal of the Pulmonary-Allergy Drugs Advisory Committee by the Commissioner of FDA. The Commissioner has determined that it is in the public interest to renew the Pulmonary-Allergy Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until May 30, 2018.
• On May 12, 2016, FDA issued a draft guidance entitled, “Infectious Disease Next Generation Sequencing-Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers.” This draft guidance provides recommendations to assist the industry in designing studies to establish the analytical and clinical performance characteristics of infectious disease next-generation sequencing- based diagnostic devices for microbial identification and detection of antimicrobial resistance and virulence markers. Public comments are due by August 13, 2016.
• On May 13, 2016, FDA issued a guidance entitled, “Considerations for Use of Histopathology and Its Associated Methodologies to Support Biomarker Qualification." This guidance is intended to assist submitters of a biomarker for a qualification that conduct nonclinical biomarker qualification studies in which histopathology is used as a reference or truth standard. The recommendations in this guidance are intended for confirmatory studies in nonclinical biomarker qualification that justify the proposed context of use, where scientifically rigorous evaluation of biomarker performance in relation to histopathologic changes is essential.
• On May 13, 2016, FDA issued a guidance entitled, “Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act.” The guidance is intended to assist manufacturers of devices subject to section 522 postmarket surveillance orders by providing an overview of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), information on how to fulfill section 522 obligations, and recommendations on the format, content, and review of postmarket surveillance plan submissions.

Event Notices

• June 9, 2016, CMS announced that the Agency is inviting health plans and issuers that have found particular success in serving the new Marketplace population to present their insights and innovations at a forum entitled, “Improving the Marketplace through Innovation.” At the forum, presenters will describe strategies around consumer engagement, provider contracting, and care coordination models tailored by population data. CMS noted that everyone will have the opportunity to discuss novel techniques that may help companies offer better health care coverage at lower cost. This discussion will also help CMS work towards a vibrant Marketplace that drives high-value, high-quality health care. To join the forum on June 9, please watch a live stream at www.HHS.gov/live.  
• June 10, 2016, FDA announced a public meeting to gather stakeholder input on the potential development of a user-fee program for nonprescription (over-the-counter or OTC) monograph drugs. A user-fee program would provide funding to supplement congressional non-user-fee appropriations, and would support timely and efficient FDA review of the efficacy and safety of ingredients included in or proposed for inclusion in a monograph. FDA invites public comment on a potential OTC monograph user-fee program and also invites suggestions regarding the features a user-fee program should include.
• June 30, 2016, the FDA announced a public workshop regarding clinical trial design considerations for malaria drug development. FDA is interested in discussing the scientific challenges pertaining to malaria drug development and malaria parasite detection methods used as endpoints in clinical trials. This public workshop is intended to provide information for and gain perspective from health care providers, other U.S. government agencies, public health organizations, academic experts, and industry on various aspects of the design of clinical trials evaluating new drugs to treat malaria. The input from this public workshop will also help in developing topics for future discussion.
• July 18, 2016, CMS announced a public meeting to establish payment amounts for new or substantially revised HCPCS codes being considered for Medicare payment under the clinical laboratory fee schedule (CLFS) for 2017. This meeting also provides a forum for those who submitted certain reconsideration requests regarding final determinations made last year on new test codes and for the public to provide comment on the requests.

II. CONGRESSIONAL LEGISLATION & COMMITTEE ACTION

U.S. Senate

• On May 10, 2016, the Senate Health, Education, Labor, and Pensions (HELP) Committee convened a hearing on “Understanding Dyslexia: The Intersection of Scientific Research & Education.” The witnesses included Dr. Sally Shaywitz, Co-Director, Yale Center For Dyslexia And Creativity, Yale University School of Medicine; Mr. Ameer Baraka, Author/Actor; Dr. Guinevere Eden, Director, Center For The Study Of Learning, Georgetown University Medical Center; Mr. David Boies, Chairman, Boies, Schiller, & Flexner, LLP; Dr. Mark Mahone, Director, Department Of Neuropsychology, Kennedy Krieger Institute; and Ms. April Hanrath, Parent.

House of Representatives

• On May 11, 2016, the House Energy and Commerce Subcommittee on Health convened a hearing entitled, “Health Care Solutions: Increasing Patient Choice and Plan Innovation.” The witnesses included Scott Gottlieb, Resident Fellow at the American Enterprise Institute, Avik Roy, Senior Fellow at the Manhattan Institute, and Sabrina Corlette, Research Professor in Georgetown University's Center on Health Insurance Reforms.
• On May 11, 2016, the House Ways and Means Subcommittee on Health convened a hearing entitled, “Implementation of the Medicare Access & CHIP Reauthorization Act (MACRA) of 2015.” The sole witness was Honorable Andy Slavitt, Acting Administrator, CMS. The hearing was focused on the recently issued regulations by CMS to prepare providers for the practice reforms needed to successfully navigate the implementation of the Medicare payment reforms under MACRA.
• On May 11, 2016, the U.S. House of Representatives passed eleven Energy and Commerce Committee bills to combat the opioid epidemic. For more information on these bills, which passed the full committee on April 22, 2016, may be found here. All but two of the 11 suspension bills passed by voice vote. H.R. 1818 passed by a vote of 415 to 1, and H.R. 4586 passed by a vote of 415 to 4. The House will next vote to go to Conference with the Senate to iron out the differences between the packages of bills each chamber passed to address the epidemic.
• On May 9, 2016, House Energy and Commerce Committee Chairman Fred Upton (R-MI) released a report detailing the misleading testimony given by CMS Acting Administrator Andy Slavitt at an Oversight and Investigations Subcommittee hearing on December 8, 2015. The report details the hearing, media reporting of Slavitt’s oral testimony, and CMS’ response when committee staff inquired about the questionable figure cited in Slavitt’s remarks. Since the hearing, CMS has not chosen to revise Slavitt’s testimony.
• On May 10, 2016, Vice Chairman of the Energy and Commerce Committee and leader of the House Medicaid Task Force Brett Guthrie (R-KY) said the task force hopes to lay the foundation for Medicaid reforms in 2017, suggesting that some reforms could renew Medicare extenders or reauthorize CHIP.
• On May 12, 2016, the House Veteran’s Affairs Committee convened a hearing entitled, “Combating the Crisis: Evaluating Efforts to Prevent Veteran Suicide.” The witnesses included Maureen McCarthy, Assistant Deputy VA Undersecretary for Health for Patient Care Services, Department of Veteran Affairs (VA); Harold Kudler, Chief Consultant for Mental Health Services at the Veterans Health Administration (VHA); Caitlin Thompson, National Director for Suicide Prevention at the VHA; Jackie Maffucci, Research Director for Iraq and Afghanistan Veterans of America (IAVA); Thomas Berger, Executive Director of Vietnam Veterans of America's Veterans Health Council (VVA); Kim Ruocco, Chief External Relations Officer for Suicide Prevention for the Tragedy Assistance Program for Survivors (TAPS); and Joy Ilem, National Legislative Director for Disabled American Veterans (DAV).

III. REPORTS, STUDIES, & ANALYSES

• On May 9, 2016, the Government Accountability Office (GAO) released a report entitled, “Medicaid and CHIP: Increased Funding in U.S. Territories Merits Improved Program Integrity Efforts.” GAO found that despite temporary increases in Medicaid funding, there was little assurance that territory Medicaid funds are protected from fraud, waste, and abuse. GAO recommends that the Acting Administrator of CMS examine and select from a broad array of activities—such as establishing program oversight mechanisms, assisting in improving program information, and conducting program assessments—to develop a cost-effective approach to protecting territories' Medicaid programs from fraud, waste, and abuse. HHS concurred with GAO's recommendation.
• On May 12, 2016, CMS released the second annual independent evaluation reports of round two of the Health Care Innovation Awards. Overall, CMS noted that the evaluation reports show a wide range of experiences that have resulted in tangible benefits for patients and helped inform CMS in the development of new payment and service delivery models. The 39 awards are being implemented in 27 states and the District of Columbia spanning a wide range of patient populations, from children to the elderly, across the care continuum. The final awards range in value from an expected $2 million to $23.8 million over a three-year period. Each project will be monitored for measurable improvements in quality of care and savings generated.
• On May 9, 2016, GAO released a report entitled, “Medicare Advantage: Fundamental Improvements Needed in CMS's Effort to Recover Substantial Amounts of Improper Payments." GAO found that CMS' methodology does not result in the selection of contracts for an audit that has the greatest potential for recovery of improper payments. GAO made recommendations to CMS to improve its processes for selecting contracts to include in the risk adjustment data validation (RADV) audits, enhance the timeliness of the audits, and incorporate Recovery Audit Contractors (RACs) into the RADV audits. HHS concurred with the recommendations.
• On May 9, 2016, OIG released a report entitled, “OIG Advisory Opinion No. 16-06,” regarding the proposal for an entity to purchase the remaining five percent ownership interest in a group purchasing organization (GPO). The Agency concluded that, although the Proposed Arrangement could potentially generate prohibited remuneration under the anti-kickback statute if the requisite intent to induce or reward referrals of Federal health care program business were present, the OIG would not impose administrative sanctions on [names redacted] in connection with the Proposed Arrangement.
• On May 9, 2016, the Congressional Budget Office (CBO) released a report entitled, “Cost Estimate of H.R. 3680, Co-Prescribing to Reduce Overdoses Act of 2015.” H.R. 3680 would authorize the Secretary of HHS to establish a grant program to provide funds to eligible entities to develop guidelines and to provide resources for prescribing drugs that reverse opioid overdoses. CBO estimates that implementing H.R. 3680 would reduce net discretionary costs by $1 million over the 2017-2021 period.
• On May 9, 2016, CBO released a report entitled, “Cost Estimate of H.R. 4982, Examining Opioid Treatment Infrastructure Act of 2016.” H.R. 4982 would direct GAO to conduct an evaluation of the infrastructure for treating opioid and other substance abuse in the United States. The bill would require GAO to submit a report to the Congress on the evaluation no later than 24 months after the date of enactment. CBO estimates that implementing H.R. 4982 would cost less than $500,000 over the 2017-2021 period.
• On May 12, 2016, OIG released a report entitled, “U.S. Department of Health and Human Services Met Many Requirements of the Improper Payments Information Act (IPIA) of 2002 but Did Not Fully Comply for Fiscal Year 2015.” Ernst & Young (EY), LLP, under its contract with the HHS OIG, audited the fiscal year 2015 HHS improper payment information reported in the Agency Financial Report (AFR) to determine compliance with IPIA and related guidance from the Office of Management and Budget (OMB). EY concluded that HHS did not comply with several IPIA requirements. EY found HHS did not fully comply with risk assessment requirements established by OMB, did not report an error rate for the Temporary Assistance for Needy Families program, and did not perform risk assessments of payments to employees and charge card payments.
• On May 11, 2016, GAO released a report entitled, “Medicare Advantage: Action Needed to Ensure Appropriate Payments for Veterans and Nonveterans.” GAO found that the Department of Veteran Affairs’ (VA's) provision of Medicare-covered services to veterans enrolled in Medicare fee-for-service (FFS) likely resulted in lower Medicare FFS spending and, in turn, lower overall payments to Medicare Advantage plans. GAO recommends that CMS should (1) assess the feasibility of revising its methodology for determining if an adjustment to the benchmark is needed by obtaining diagnoses and utilization data from VA and (2) make any additional adjustments to MA plan payments as appropriate. HHS disagreed with the first recommendation, but agreed with the second.

IV. OTHER HEALTH POLICY NEWS

• On May 12, 2016, the U.S. District Court Judge Rosemary M. Collyer ruled the Obama Administration was improperly funding an ACA subsidy program in the case, United State House of Representative vs. Sylvia Mathews Burwell. The ruling continues to allow the subsidies for consumers with health coverage through the ACA, who may be receiving now or may be eligible for through enrollment this year, pending a decision on appeal. The Obama Administration is expected to immediately appeal the decision to the D.C. Circuit Court of Appeals.