A&B Healthcare Week in Review, September 9, 2016

I. Regulations, Notices, & Guidance

• On September 8, 2016, the National Institutes of Health (NIH), made an announcement entitled, “Requirements and Registration for Antimicrobial Resistance Rapid, Point-of-Need Diagnostic Test Challenge.” Through the “Antimicrobial Resistance Rapid, Point-of-Need Diagnostic Test” Challenge (the “Challenge”), the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA) of the Office of the Assistant Secretary for Preparedness and Response (ASPR) are searching for novel and innovative in vitro diagnostic tests that would rapidly inform clinical treatment decisions and be of potential significant clinical and public health utility to combat the development and spread of antibiotic resistant bacteria. Tests of interest will provide novel, innovative solutions for use in inpatient and/or outpatient settings.
• On September 8, 2016, the Centers for Medicare & Medicaid Services (CMS) finalized a rule entitled, “Medicare and Medicaid Programs; Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers.” The rule establishes national emergency preparedness requirements for Medicare- and Medicaid-participating providers and suppliers to plan adequately for both natural and man-made disasters, and coordinate with federal, state, tribal, regional, and local emergency preparedness systems. Additionally, the rule assists providers and suppliers in adequately preparing to meet the needs of patients, residents, clients, and participants during disasters and emergency situations. These standards must be adopted by November 2017.
• On September 8, 2016, CMS announced the new single payment amounts for the competitive bidding program and began sending contract offers to successful bidders for Medicare’s Round 1 2017 Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program.
• On September 9, 2016, the Food and Drug Administration (FDA) issued a draft guidance entitled, “E17 Principles for Planning and Design of Multi-Regional Clinical Trials.” The draft guidance describes general principles for planning and designing multi-regional clinical trials (MRCT).
• On September 9, 2016, the FDA announced a draft guidance entitled, “510(k) Third Party Review Program.” The draft guidance provides a comprehensive look into FDA’s current thinking regarding the 510(k) Third Party (TP) Review Program authorized under section 523 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
• On September 7, 2016, the Medicare-Medicaid Coordination Office (MMCO) announced that the National Enrollment/Disenrollment Guidance for State and Medicare-Medicaid Plans was updated. The guidance will go into effect as of January 1, 2017.
• On September 7, 2016, CMS announced a call for nominees for a Technical Expert Panel related to MACRA CMS Quality Measure Development Plan. CMS is currently soliciting nominations for technical expert panel members to support the CMS Quality Measure Development Plan (MDP) project. The panel will consist of representatives of stakeholder organizations, including physician and non-physician practitioners, especially those with clinical expertise in any of the following specialties:  Mental health and substance use conditions, oncology, orthopedic surgery, palliative care, pathology, and radiology.  In addition, CMS seeks nominations of patients and families/caregivers, consumer advocates, and technical experts in quality measurement and health information technology, among other areas of knowledge. The call is open from August 26 through September 15, 2016.
• On September 6, 2016, CMS announced that it will pilot a program requiring consumers who want to use a special enrollment period to complete an eligibility determination before signing up for coverage.

On September 2, 2016, the Office of Management and Budget (OMB) received the following for review:

• HHS’s proposed rule entitled, “Fire Safety Requirements for Certain Dialysis Facilities.”
• HHS’s notice of guidance entitled, “340B Program Omnibus Guidelines.” The guidance addresses key policy issues raised by stakeholders for which HHS does not have statutory rulemaking authority.

Event Notices

• November 18, 2016: the FDA announced a public advisory committee meeting of the Blood Products Advisory Committee. The Committee will meet to discuss strategies to manage iron deficiency associated with blood donation. The Committee will also discuss proposed procedures for assuring donor safety for collections of blood from female donors.
• November 1, 2016: the FDA announced a public advisory committee meeting of the Science Advisory Board (SAB) to the National Center for Toxicology Research (NCTR). The NCTR Director will provide a Center-wide update on scientific initiatives and accomplishments during the past year. The SAB will be presented with an overview of the Division of Bioinformatics and Biostatistics Subcommittee and the Subcommittee Site Visit Report and a response to this review.
• September 27, 2016: CMS announced it will hold a Virtual Office Hours session entitled, “2015 PQRS Feedback Reports,” regarding PQRS feedback reports for program year 2015 results. Topics to be discussed in this session include information about how the 2017 PQRS negative payment adjustment is assessed and how and where to access 2015 PQRS feedback reports depicting payment adjustment results. Additionally, this PQRS VOH session will allow stakeholders an opportunity to ask a CMS representative questions about the 2017 PQRS negative payment adjustment and the 2015 PQRS feedback reports.
• September 20, 2016: CMS will hold a Virtual Office Hours series entitled, “2016 PQRS Reporting: Measures Overview (session 2 of 3),” regarding 2016 Physician Quality Reporting System (PQRS) quality measures. Topics to be discussed in this session include an overview of the 2016 PQRS measures, a live walkthrough of the 2016 PQRS Measures List, the 2016 PQRS Individual Claims/Registry Measure Specification Supporting Documents, and the new web-based measure search tool.
• September 16, 2016: The Physician-Focused Payment Model Technical Advisory Committee (PTAC) will hold its next meeting on September 16, 2016. Though previously announced, the PTAC has now formally noticed this meeting in the Federal Register and a detailed agenda and draft recommendations are now available here.
• September 15, 2016: The Medicaid and CHIP Payment and Access Commission (MACPAC) will hold its next meeting on September 15, 2016. An agenda and additional information can be found here.
• September 14, 2016: CMS announced they will hold a webinar on Accountable Health Communities Models. The webinar will address a new funding opportunity for Track 1 of the Accountable Health Communities Model.

II. Congressional Legislation & Committee Action

U.S. Senate

• On September 7, 2016, the Senate Veterans’ Affairs Committee held a meeting entitled, “VHA (Veterans Health Administration) Best Practices: Exploring the Diffusion of Excellence Imitative.” The hearing will be held at 2:30 p.m. at 418 Russell Bldg. The witnesses are Deputy Under Secretary of Veterans Affairs for Health for Organizational Excellence Carolyn Clancy, accompanied by Shereef Elnahal, senior advisor to the Under Secretary for Health for Best Practices Kimberly Garner, associate director for Education and Evaluation for VISN 16 in the Central Arkansas Veterans Healthcare System Geriatric Research Education and Clinical Center in Little Rock, Arkansas Scott Bryant, innovation specialist and chief of Quality, Safety, and Value at the Chillicothe VA Medical Center in Chillicothe, Ohio.

House of Representatives

• On September 7, 2016, the House Budget Committee held a hearing entitled, “Center for Medicare and Medicaid Innovation: Scoring Assumptions and Real-World Implications.” The witnesses included Mark Hadley, deputy director of the Congressional Budget Office, Joseph Antos, scholar at the American Enterprise Institute, Ted Okon, executive director of the Community Oncology Alliance, and Mark Madden, orthopedic surgeon for OrthoVirginia.
• On September 7, 2016, the House Veterans’ Affairs Committee held a hearing entitled, “From Tumult to Transformation: The Commission on Care and the Future of the VA Healthcare System.” The witnesses included Nancy Schlichting, chairperson of the Commission on Care and Delos Cosgrove, vice chairperson of the Commission on Care.
• On September 7, 2016, the House Ways and Means Health Subcommittee held a hearing entitled, “The Evolution of Quality in Medicare Part A.” The witnesses included Barbara Gage, Associate Research Professor, George Washington University (GWU), Center for Healthcare Innovation and Policy Research; Elisabeth Wynn, Senior Vice President, Health Economics and Finance, Greater New York Hospital Association (GNYHA); Steve Guenthner, President, Almost Family; and Gregory Worsowicz, MD, President, American Academy of Physical Medicine Rehabilitation.
• On September 8, 2016, the House Energy and Commerce Health Subcommittee held a hearing on H.R.1192, the "National Diabetes Clinical Care Commission Act"; H.R.1717, the "Sober Truth on Preventing Underage Drinking Reauthorization Act"; H.R.1807, the "Sickle Cell Disease Research, Surveillance, Prevention and Treatment Act of 2015"; H.R.3119, the "Palliative Care and Hospice Education and Training Act"; and H.R.3952, the "Congenital Heart Futures Reauthorization Act of 2015.” The witnesses included Sonja L Banks, President and COO, Sickle Cell Disease Association of America, Inc., General Arthur Dean, Chairman and CEO, Community Anti-Drug Coalitions of America, Dr. Jonathan Leffert, President-Elect, American Association of Clinical Endocrinologists, Dr. Brad Marino, Chair, Pediatric Congenital Heart Association, and Dr. R. Sean Morrison, Director, National Palliative Care Research Center.
• On September 9, 2016, the House Energy and Commerce Health Subcommittee held a hearing entitled, “An Examination of Federal Mental Health Parity Laws and Regulations.” The witnesses included Ms. Pamela Greenberg, President and CEO, Association for Behavioral Health and Wellness, Mr. Matt Selig, Executive Director, Health Law Advocates, Inc., and Dr. Michael A. Trangle, Senior Medical Director, Behavioral Health Division, HealthPartners Medical Group.

III. Reports, Studies, & Analyses 

• On September 9, 2016, the Government Accountability Office (GAO) issued a report entitled, “Key Policy and Data Considerations for Designing a Per Capita Cap on Federal Funding.” The report details considerations regarding per capita Medicaid caps. The report also outlines how the design of per capita caps in Medicaid should consider coverage and flexibility, allocation of funds over time, accountability and other issues.
• On September 8, 2016, the Congressional Budget Office (CBO) released a paper entitled, “Projecting Hospitals’ Profit Margins Under Several Illustrative Scenarios: working Paper 2016-04.” The paper analyzes how hospitals’ finances could be affected by the implementation of the Affordable Care Act (ACA). Specifically, the analysis focuses on about 3,000 hospitals that provide acute care and are subject to Medicare’s cuts in payment updates, and it thus excludes most rural hospitals.
• On September 7, 2016, the GAO issued a report entitled, “In Most States and New Exchanges, Enrollees Continued to be Concentrated among Few Issuers in 2014.” The report found that enrollment in private health insurance plans remained concentrated among a small number of issuers in most states in 2014, including in the newly established exchanges.
• On September 7, 2016, the Office of Inspector General (OIG) released a report entitled,“CMS Should Address Medicare’s Flawed Payment System for DME Infusion Drugs.” The report builds on previous OIG findings by illustrating the impact of the current payment methodology on provider reimbursement rates for two vital DME infusion drugs: pump-administered insulin and milrinon lactate.

IV. Other Health Policy News

• On September 8, 2016, CMS released a blog post by Acting Administrator Andy Slavitt the agency’s plans to provide some flexibility for Medicare providers in the first year of MACRA implementation.  Essentially, there are four options for providers in 2017: to just report some data under MIPS and experience no penalty, but also no bonus payment; to report under MIPS for a portion of the year, and be eligible for a small bonus (e., performance period starts after January 1, 2017); to report as required under MIPS for the entire year under and be eligible for the currently proposed bonus;  or to participate in an advanced APM.
• On September 8, 2016, CMS release a Request for Information (RFI), entitled,“Next Steps for the State Innovation Models Initiative.” CMS is seeking input on the following concepts related to the evolution of the SIM Initiative: Partnering with states to implement delivery and payment models across multiple payers in a state that could qualify as Advanced Alternative Payment Models (APMs) or Advanced Other Payer APMs under the proposed QPP, making it easier for eligible clinicians in a state to become qualifying APM participants and earn the APM incentive; Implementing financial accountability for health outcomes for an entire state's population; assessing the impact of specific care interventions across multiple states; and facilitating alignment of state and federal payment and service delivery reform efforts, and streaming interactions between the Federal government and sates.
• On September 7, 2016, CMS released a fact sheet entitled, “EHR Incentive Program 2017 Medicare Payment Adjustment for Hospitals.” The fact sheet discusses payment adjustments under Medicare for eligible hospitals that are not meaningful users of Certified Electronic Health Record Technology.