A&B Healthcare Week in Review, February 26, 2016

I. REGULATIONS, NOTICES, & GUIDANCE

• On February 24, 2016, the Centers for Medicare & Medicaid Services (CMS) issued a guidance entitled, “Special Enrollment Confirmation Process” that will enhance program integrity and contribute to a stable rate environment and affordability for consumers. CMS issued a fact sheet and will institute a verification process for consumers who enroll or change plans using a special enrollment period (SEP) in 2016. The Special Enrollment Confirmation Process is modeled after approaches used by the Internal Revenue Service. CMS will review documents to ensure consumers qualify for a SEP and will follow up with consumers if there is a question or problem. Consumers need to be sure to provide sufficient documentation. If they don’t respond to CMS’ notices, they could be found ineligible for their SEP and could lose their insurance.
• On February 25, 2016, CMS issued a proposed rule entitled, “Program Integrity Enhancements to the Provider Enrollment Process (CMS-6058-P).” This proposed rule is part of CMS’s ongoing and continuous effort to prevent questionable providers and suppliers from entering the Medicare program and enhance the Agency’s ability to promptly identify and act on instances of improper behavior. CMS is proposing new regulations that implement additional provider enrollment provisions of the Affordable Care Act to help make certain that entities and individuals who pose risks to the Medicare program and beneficiaries are kept out of or removed from Medicare for extended periods.
• On February 25, 2016, CMS issued a final rule entitled, “Basic Health Program; Federal Funding Methodology for Program Years 2017 and 2018.” This document provides the methodology and data sources necessary to determine Federal payment amounts made in program years 2017 and 2018 to states that elect to establish a Basic Health Program under the Affordable Care Act to offer health benefits coverage to low-income individuals otherwise eligible to purchase coverage through Affordable Insurance Exchanges. These regulations are effective on January 1, 2017.
• On February 25, 2016, the Office of Management and Budget (OMB) received a proposed rule for review entitled Part B Drug Model (CMS-1670-P). It is widely anticipated that this proposed rule will outline the parameters of the Part B drug reimbursement demonstration that CMS inadvertently communicated to Medicare contractors on February 5, 2016.
• On February 25, 2016, OMB completed review of the final rule entitled “CY 2017 Notice of Benefit and Payment Parameters (CMS-9937-F).” This rule sets forth payment parameters and provisions related to the risk adjustment programs; cost sharing parameters and cost-sharing reductions; and user fees for Federally-facilitated Exchanges. It also provides additional standards for several other Affordable Care Act programs.
• On February 26, 2016, the U.S. Department of Health and Human Services (HHS) issued a HIPAA guidance entitled, “Individuals’ Right under HIPAA to Access their Health Information 45 CFR § 164.524.” The guidance states that patients have the right to send their health information to anyone they want, including entities that want to use their data for research. White House science adviser John P. Holdren said the new guidance, which also clarifies when and to what extent fees can be charged for access, is a pivotal step in “liberating patient data” that will allow patients to collect their records across multiple providers and donate their data to support efforts like President Barack Obama's Precision Medicine Initiative.
• On February 26, 2016, HHS issued a notice entitled “Request for Information on Updates to the ONC Voluntary Personal Health Record Model Privacy Notice.” The Office of the National Coordinator for Health Information Technology (ONC) seeks comments on the scope and content of the voluntary Personal Health Record Model Privacy Notice (MPN) developed by ONC and published in 2011. In response to stakeholder requests for an electronic means to inform consumers about how health technology products store, use, and share health information (especially products of health technology developers not covered by the Health Insurance Portability and Accountability Act of 1996, Pub. L. 104-191), HHS has initiated a process to update the MPN to better align with the current consumer health technology landscape.
• On February 26, 2016, HHS issued a notice entitled “Health IT Policy Committee and Health IT Standards Committee: Schedule and Recommendations.” This notice fulfills obligations under the Health Information Technology for Economic and Clinical Health (HITECH) Act, Title XIII of Division A and Title IV of Division B of the American Recovery and Reinvestment Act of 2009 (Pub. L. 111–5), which amended the Public Health Service Act (PHSA).
• On February 19, 2016, CMS issued a guidance entitled, “Physician Quality Reporting System (PQRS) 2014 Reporting Year and 2016 Payment Adjustment for Rural Health Clinics (RHCs), Federally Qualified Health Centers (FQHCs), and Critical Access Hospitals (CAHs).” The guidance is intended for Rural Health Clinics (RHCs), Federally Qualified Health Centers (FQHCs), and Critical Access Hospitals (CAHs) who submit claims to Medicare Administrative Contractors (MACs) for services furnished to Medicare beneficiaries.
• On February 22, 2016, CMS issued a notice entitled, “Medicare Fee-for-Service Provider & Supplier Lists.” CMS released two public data sets regarding the availability and use of services provided to Medicare beneficiaries by ground ambulance suppliers and home health agencies, as well as a list of Medicare fee-for-service (FFS) providers and suppliers currently approved to bill Medicare. This was part of an effort to improve care delivery, data sharing, and transparency.
• On February 23, 2016, the Centers for Disease Control and Prevention (CDC) issued a notice entitled, “Unintentional Drug Overdose Reporting System (SUDORS).” The notice asks for information that is currently not collected on death certificates such as whether the drug(s) causing the overdoses were injected or taken orally, decedent toxicology report, if available, and risk factors for fatal drug overdoses including previous drug overdoses, decedent's mental health, and whether the decedent recently exiting a treatment program. Public comments are due March 25, 2016.
• On February 23, 2016, CMS released a final notice entitled, “Continued Approval of the American Association for Accreditation of Ambulatory Surgery Facilities Rural Health Clinic Accreditation Program.” This final notice announces CMS’ decision to approve the American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF) for continued recognition as a national accrediting organization for Rural Health Clinics (RHCs) that wish to participate in the Medicare or Medicaid programs.
• On February 19, 2016, the Food and Drug Administration (FDA) issued a notice entitled, “Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices.” FDA is extending the comment period from March 28th to April 28, 2016.
• On February 23, 2016, CMS released a notice for a change request entitled, “Reclassification of Certain Durable Medical Equipment HCPCS Codes Included in Competitive Bidding Programs (CBP) from the Inexpensive and Routinely Purchased Payment Category tot he Capped Rental Payment Category.” The notice is intended for suppliers and Home Health Agencies (HHAs) submitting claims to Durable Medical Equipment Medicare Administrative Contractors (DME MACs) or Home Health & Hospice MACs for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) provided to Medicare beneficiaries.
• On February 23, 2016, CDC issued a notice entitled, “Workplace Health In America.” The notice is a request for public comments on whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; how to enhance the quality, utility, and clarity of the information to be collected. Public comments are due March 25, 2016.
• On February 23, 2016, CDC issued a notice entitled, “Insurance Coverage, Employment Status, and Copayments/Deductibles Faced by Young Women Diagnosed with Breast Cancer.” The notice is to request public comment to address: (1) What are young, female breast cancer survivors experiencing after their diagnosis in terms of (a) continuation of insurance coverage, access to care, and quality of care; (b) changes in employment status after breast cancer diagnosis; and (c) out-of-pocket medical costs? (2) What factors affect young breast cancer survivors' access to comprehensive, high quality care? CDC is sponsoring a study to collect information from breast cancer survivors. Public comments are due on March 25, 2016.
• On February 24, 2016, the National Institutes of Health (NIH) issued a notice entitled, “National Physician Survey of Precision Medicine in Cancer Treatment.” The notice is a request for public comment to investigate the current practice of precision medicine in cancer treatment among medical oncologists in the U.S. Public comments are due on March 24, 2016.

Event Notices

• March 23, 2016, CMS will hold a meeting with the Advisory Panel on Outreach and Education (APOE) (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of the HHS and CMS on opportunities to enhance the effectiveness of Health Insurance Marketplace.
• March 31, 2016, CMS will hold a public conference to discuss potential improvements to the HHS Risk Adjustment methodology for the 2018 benefit year and beyond. The deadline to register at www.regtap.info is March 23, 2016.
• April 14 & 15, 2016, FDA will hold a public workshop entitled “Developing an Evidentiary Standards Framework for Safety Biomarkers Qualification Workshop.” The purpose of the workshop is to discuss the evidentiary standards needed to support biomarker qualification with a particular emphasis on drug safety markers. The 2-day workshop will focus on the standards relevant to the qualification of a range of safety biomarkers and examine case studies in several different organ systems. The public workshop is intended to seek input from representatives of medical device manufacturers and other stakeholders, on best practices, what has worked for them and what FDA can do to inspire quality efforts.
• April 15, 2016, FDA will hold a meeting entitled, “Medical Devices--Quality Systems Survival; Success Strategies for Production and Process Controls/Corrective and Preventative Action.”
• April 27, 2016, CMS announced a public meeting entitled, “Medicare Evidence Development and Coverage Advisory Committee (MEDCAC).” The meeting will specifically focus on obtaining the MEDCAC’s recommendations regarding the definition of treatment resistant depression (TRD) as well as to advise CMS on the use of the definition of TRD in the context of coverage with evidence development and treatment outcomes.
• May 17, 18, & 19, 2016: CMS announced the dates, time, and location of the Healthcare Common Procedure Coding System (HCPCS) public meetings for 2016 to discuss the preliminary coding and payment determinations for all new public requests for revisions to HCPCS. These meetings will focused on HCPCS Code requests for Drugs/Biologicals, Radiopharmaceuticals/Radiologic Imaging Agents.
• June 1 & 2, 2016: CMS announced the dates, time, and location of the Healthcare Common Procedure Coding System (HCPCS) public meetings for 2016 to discuss the preliminary coding and payment determinations for all new public requests for revisions to HCPCS. These meetings will focused on HCPCS Code requests for Durable Medical Equipment (DME) and Accessories; Orthotics and Prosthetics (O & P); Supplies and Other.
• July 19, 2016: NIH announced a public meeting to peer review the draft monograph on immunotoxicity associated with exposure to perfluorooctanoic acid (PFOA) or perfluorooctane sulfonate (PFOS).

II. CONGRESSIONAL LEGISLATION & COMMITTEE ACTION

U.S. Senate

• On February 23, 2016, the Senate Finance Committee held a hearing entitled, “Examining the Opioid Epidemic: Challenges and Opportunities.” The witnesses included Allan Coukell, Senior Director, Pew Charitable Trusts; Nancy Young, Director, Children and Family Futures; David Hart, Assistant Attorney-In-Charge in the Oregon Department of Justice's Civil Enforcement, Financial Fraud and Consumer Protection Section.
• On February 23, 2016, the Senate Committee on Armed Services’ Personnel Subcommittee convened a hearing entitled “Defense Health Care Reform.” Panel I Witnesses for the hearing included: Bernadette C. Loftus, Associate Executive Director and Executive-in-Charge for the Mid-Atlantic Permanente Medical Group; Dr. A. Mark Fendrick, Director of the Center for Value-Based Insurance Design and Professor in the Departments of Internal Medicine and Health Management and Policy at the University of Michigan; Mr. David J. McIntyre, Jr., President and CEO of TriWest Healthcare Alliance; and Dr. John E. Whitley, Senior Fellow at the Institute for Defense Analyses. Panel II Witnesses for the hearing included: Honorable Jonathan Woodson, Assistant Secretary of Defense for Health Affairs; Vice Admiral Raquel C. Bono, USN Director of the Defense Health Agency; Lieutenant General Mark A. Ediger, USAF Surgeon General of the Air Force; Lieutenant General Nadja Y. West, USA Surgeon General of the Army and Commanding General, U.S. Army Medical; and Vice Admiral C. Forrest Faison III, USN Surgeon General of the Navy and Chief, Bureau of Medicine and Surgery.
• On February 24, 2016, the Senate HELP Committee held a hearing entitled, “Zika Virus: Addressing the Growing Public Health Threat.” The witnesses included Anne Schuchat, Principal Deputy Director, Disease Control and Prevention; Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases; Robin Robinson, Director of the Biomedical Advanced Research and Development Authority.
• On February 24, 2016, the Senate confirmed Robert M. Califf, M.D., to lead the U.S. Food and Drug Administration. Senators voted 89-4 to confirm Dr. Califf as FDA commissioner, taking over from Acting Commissioner Dr. Stephen Ostroff, who has held the role since March, after Margaret Hamburg stepped down. Califf is currently the Agency’s Deputy Commissioner for Medical Products and Tobacco, overseeing all related units, including the Center for Drug Evaluation and Research, the Center for Devices and Radiological Health and the Center for Tobacco Products.
• On February 24, 2016, the Senate Special Committee on Aging held a hearing entitled “Opioid Use Among Seniors – Issues and Emerging Trends”. The Committee heard testimony from Sean Cavanaugh, Deputy Administrator and Director of the Centers for Medicare & Medicaid Services (CMS); Ann Maxwell, Assistant Inspector General, Department of Health & Human Services Office of Inspector General (OIG); Dr. Steven Diaz, Chief Medical Officer and Emergency Medicine Physician of MaineGeneral Health; Dr. Jerome Adams, Health Commissioner, Indiana State Department of Health; and Dr. Sean Mackey, Professor, Stanford School of Medicine.
• On February 25, 2016, Senator Tom Cotton (R-AR) sent a letter to the FDA expressing his “support for FDA’s critical role in increasing competition in the generic drug market to lower the costs of life-saving pharmaceutical treatments. Prescription drug costs in Arkansas have increased to more than to $2.5 billion in 2014, and more market competition could relieve some of this burden on hard-working Arkansans.”

House of Representatives

• On February 24, 2016, the House Energy and Commerce Subcommittee on Health held a hearing entitled, “The Fiscal Year 2017 HHS Budget.” The hearing took place at 10:00 a.m. in 2123 Rayburn. The sole witness was Sylvia Mathews Burwell, Secretary of HHS.
• On February 25, 2016, the House Appropriations Subcommittee on Labor, Health & Human Services, Education & Related Agencies held a hearing entitled, “The Department of Health and Human Services Budget.” The hearing took place at 10:00 a.m. in 2358-C Rayburn. The sole witness was Sylvia Mathews Burwell, Secretary of HHS.
• On February 25, 2016, the House Oversight and Government Reform Subcommittee on Health Care, Benefits, and Administrative Rules held a hearing entitled “Affordable Care Act CO-OPs Review.” The purpose of the hearing was to question CMS about factors leading to the failure of over half of Consumer Operated and Oriented Plans (CO-OPs) and examine whether the remaining Affordable Care Act (ACA) CO-OPs are viable. The witnesses included Dr. Mandy Cohen, Chief Operating Officer and Chief of Staff, Centers for Medicare and Medicaid Services, U.S. Department of Health and Human Services; and Mr. Al Redmer, Jr., Commissioner, Maryland Insurance Administration.
• On February 25, 2015, the chairs of the House Task Force on Health Care Reform – the Chairmen of the House Ways & Means Committee, Energy & Commerce Committee, Education & the Workforce Committee, and Budget Committee – released the Task Force’s mission statement. To achieve the best outcomes and get results for the American people, this task force will follow key principles of patient-centered health care: Empower every American with the ability to gain access to coverage that is affordable and portable; Provide Americans with more choices, not mandates, so they have the freedom to pick plans and providers that best fit their unique health care needs; Protect the quality of care for all patients – including those with pre-existing conditions; Promote innovation to improve competition, harness the power of new technologies, lower prices, and foster better cures and treatments for patients; and Save Medicare and Medicaid to strengthen health care security for seniors and America’s most vulnerable. To that end, the Chairmen of the respective Committees will hold hearings to advance real patient-centered reforms, including:
  • Innovations in employer-provided health care coverage
  • Health tax expenditures
  • Reforming broken insurance markets
  • Increasing state flexibility and sustainability in the Medicaid program
  • Saving and strengthening Medicare

III. REPORTS, STUDIES, & ANALYSES

• On February 22, 2016, the Government Accountability Office (GAO) released a report entitled, “Health Care Fraud: Information on Most Common Schemes and the Likely Effect of Smart Cards.” GAO's analysis found that the use of smart cards could have affected about 22 percent (165 cases) of cases GAO reviewed in which the entire or part of the case could have been affected because they included schemes that involved the lack of verification of the beneficiary or provider at the point of care.
• On February 22, 2016, the Convergence Center for Policy Resolution released a report and convened a session entitled, “Long-Term Care Financing Collaborative Press Conference.” The Long-Term Care Financing Collaborative (LTCFC) expanded on the Collaborative’s July 2015 recommendations for improving long-term care (LTC). Robert Fersh, President and Founder of Convergence Center for Policy Resolution, stated that the Collaborative is more responsive and affordable than the system we have currently. The Collaborative proposes clear public and private roles for LTC financing, a new universal catastrophic LTC insurance program, redefining Medicaid long-term services and supports (LTSS), encouraging private LTC initiatives, and increasing retirement savings and improving public education. The goal of the Collaborative is to develop pragmatic, consensus-driven recommendation for a public and private insurance-based financing system that empowers people of all incomes to receive high quality services and supports.
• On February 23, 2016, OIG released a report entitled, “HealthCare.gov: Case Study of CMS Management of the Federal Marketplace.” The problems at launch raised concerns about the effectiveness of CMS management of the Federal Marketplace. The objective of this case study was to gain insight into CMS implementation of the Federal Marketplace, focusing primarily on HealthCare.gov. OIG found that HHS and CMS made many missteps throughout development and implementation that led to the poor launch of HealthCare.gov. Most critical was the absence of clear leadership, which caused delays in decision making and a lack of clarity in project tasks. Additional missteps included devoting too much time to developing policy, which left too little time for developing the website, and failing to properly manage its key website development contract. OIG calls on CMS to continue progress in applying lessons learned from HealthCare.gov to avoid future problems and to maintain improvement across the agency.
• On February 23, 2016, OIG released a report entitled, “Not All of the District of Columbia Marketplace's Internal Controls Were Effective in Ensuring That Individuals Were Enrolled in Qualified Health Plans According to Federal Requirements.” The deficiencies that OIG identified occurred because the District marketplace did not properly oversee the identity-proofing process and did not ensure that its eligibility system was always fully functional.
• On February 24, 2016, GAO published a report entitled, “Patient Protection and Affordable Care Act: CMS Should Act to Strengthen Enrollment Controls and Manage Fraud Risk, Medicare, Medicaid, and Children's Health Insurance Programs: Program Integrity Enhancements to the Provider Enrollment Process.” GAO was asked to examine the enrollment process and verification controls of the federal Marketplace. GAO analyzed 2014 data from the Marketplace and federal agencies, interviewed CMS officials, and conducted undercover testing. GAO found CMS did not have an effective process for resolving inconsistencies for individual applicants for the federal Health Insurance Marketplace. GAO makes eight recommendations, including that CMS consider analyzing outcomes of the verification system, take steps to resolve inconsistencies, and conduct a risk assessment of the potential for fraud in Marketplace applications.
• On February 25, 2016, a University of Minnesota study of certified health-care homes in the state found they saved Medicare and Medicaid about $1 billion over the five years evaluated. The study also indicated that clinics that were part of the certified health-care homes initiative were less expensive than non-health-care homes in the areas of inpatient hospital admissions, hospital outpatient visits, skilled nursing facilities and pharmacy costs. Certified health-care homes are designed for providers, patients and caregivers to work as a team to provide and manage care.
• On February 26, 2016, GAO released a report entitled, “Patient Safety: Hospitals Face Challenges Implementing Evidence-Based Practices.” GAO was asked to review information on the implementation of patient safety practices in hospitals. The six selected hospitals in GAO's study identified three key challenges that affected their efforts to implement evidence-based patient safety practices. The three key challenges are obtaining data to identify adverse events in their own hospitals, determining which patient safety practices should be implemented, and ensuring that staff consistently implement the practices over time. Patient safety practices, such as using proper antiseptics, can reduce or eliminate adverse events, which GAO defined as events such as infections that harm patients and result from the medical care patients receive rather than patients' underlying diseases or conditions.

IV. OTHER HEALTH POLICY NEWS

• On February 22, 2016, more than 660 health care organizations sent a letter to the Congressional Appropriations Committee Leaders regarding increased funding allocation for the Labor, HHS, and Education Spending Bills. The letter states, “Despite their profound impact on health and well-being, child development, educational and skills attainment, and productivity, programs and services of the Labor-HHS spending bill continue to be short-changed in the annual appropriations process. For example, with the much-needed sequestration relief provided through the Bipartisan Budget Act of 2015, the Consolidated Appropriations Act of 2016 provided nondefense discretionary programs with a 6.9 percent increase overall, but programs in the Labor-HHS bill only received a 3.3 percent increase over 2015 levels. As a result, funding for Americans health, education, workforce, and social services programs representing more than half of all nondefense discretionary spending rose less than half as much as the nondefense average. At the same time, the Labor-HHS allocation remains about 10 percent below FY 2010 levels, adjusted for inflation.”
• On February 23, 2016, a group of hospitals lost their challenge to a Medicare reimbursement rule when a federal district court held that the Department of Health and Human Services acted reasonably in restricting the method of how reported hospital pension costs are allocated (Regents of Univ. of Cal. v. Burwell, 2016 BL 49565, D.D.C., No. 1:13-cv-00683-RDM, 2/22/16). The plaintiffs, a group of 107 hospitals and 13 additional entities that either own or operate hospitals, challenged a 2005 rule that changed the accounting method for how pension costs are allocated for purposes of the Medicare wage index, which in turn affects prospective Medicare reimbursement rates. The 2005 rule said that only accrued pension costs expected to be funded and liquidated within a specified time period should be counted in a hospital's wage cost data, similar to the treatment of other accrued costs. The hospitals said this amounted to an improper retroactive rule under the Administrative Procedure Act (APA) because they had already submitted the cost data that would be used for the fiscal years under dispute (FYs 2007 and 2008). However, the U.S. District Court for the District of Columbia said the rule wasn't retroactive because it affected only prospective payments, and it granted the HHS's motion for summary judgment.
• On February 24, 2016, a group of 39 hospitals challenged a CMS ruling that governs how certain Medicare patients are counted in determining a hospital's disproportionate share hospital payment (Berwick Hosp. Ctr. v. Burwell, D.D.C., No. 16-cv-323-ESH, filed, 2/22/16). The lawsuit filed in the U.S. District Court for the District of Columbia targets CMS Ruling 1498-R, which mandates the inclusion of certain Part A patient days in the Medicare fraction of the DSH calculation that weren't actually paid through Part A. The plaintiff hospitals argue that Ruling 1498-R's treatment of noncovered Part A days prior to October 2004 violates applicable federal appeals court precedent because it counts these noncovered Part A patients as entitled to Part A benefits. The plaintiffs also argue that Ruling 1498-R improperly divests the Provider Reimbursement Review Board of jurisdiction in appeals of DSH payments and constituted a retroactive rulemaking. DSH payments are a type of supplemental payment to hospitals serving a disproportionate share of low-income patients.
• On February 22, 2016, the OMB sent a letter to House Appropriations Chairman Hal Rodgers (R-KY) in response to his letter that suggested emergency funds designated to address the Ebola crisis should be diverted to respond to Zika virus transmission. The letter argued that, “The Administration is treating Zika like the emergency it is, just like Ebola which is still a threat. By not finishing the process of strengthening public health capacity in West Africa and the selected GHSA countries, we put this nation at risk for another situation where the United States has to provide significant support to protect American’s health security.”
• On February 22, 2016, CMS announced that the Agency has contracted with Abt Associates to evaluate the methodology for calculating the Quality of Patient Care Star Ratings that appear on the Home Health Compare website, including identifying options for improvement. As part of the process of continually evolving the rating system, CMS asks contractors to convene groups of stakeholders and experts to contribute direction and thoughtful input to the contractor for consideration in the rating system. A technical expert panel (TEP) is being convened with the objectives of reviewing the first year of data on the performance of the Quality of Patient Care Star Ratings, and gathering feedback on potential refinements to the rating system including usability of the system for patients and advocates. The TEP nomination period opens on February 24, 2016 and closes on March 18, 2016. For more information, please visit: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/TechnicalExpertPanels.html#29.