A&B Healthcare Week in Review, January 15, 2016

I. REGULATIONS, NOTICES, & GUIDANCE

• On January 8, 2016, the Office of Management and Budget (OMB) received for review a proposed rule from the Department of Veterans Affairs (VA) entitled Advanced Practice Registered Nurses. The VA is proposing to amend its medical regulations to permit the full practice authority of all VA advanced practice registered nurses (APRNs) when they are acting within the scope of their VA employment. This rulemaking would increase veterans’ access to VA health care by expanding the pool of qualified health care professionals who are fully authorized to provide comprehensive primary health care and other related health care services to veterans. This rule would permit VA to use its health care resources more effectively and in a manner that is consistent with the non-VA health care sector, while maintaining the patient-centered, safe, high quality health care that veterans receive from VA.
• On January 15, 2016, the Centers for Disease Control and Prevention (CDC) issued a Notice of Proposed Rulemaking on Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review of the List of Select Agents and Toxins and Enhanced Biosafety Requirements. CDC has reviewed the list of biological agents and toxins that have the potential to pose a severe threat to public health and safety and proposes to amend and republish the list. Specifically, CDC is proposing to remove six biological agents; add provisions to address the inactivation of select agents; add specific provisions to the section of the regulations addressing biosafety; and clarify regulatory language concerning security, training, incident response, and records.
• On January 15, 2016, the CDC also issued a Request for Information on development of a Performance Test Protocol for Closed System Transfer Devices that Incorporate Air-Cleaning Technology to Provide Worker Protection During Pharmacy Compounding and Administration of Hazardous Drugs. This RFI seeks information from the public regarding the feasibility of developing a protocol applicable to CSTDs using air cleaning or filtration technologies and to request information from stakeholders on this topic. Electronic or written comments should be received on or before March 8, 2016.
• On January 15, 2016, the Food and Drug Administration (FDA) announced a Meeting of the Arthritis Advisory Committee. The meeting will be held on February 9, 2016, from 7:30 a.m. to 5 p.m. The committee will discuss biologics license application (BLA) 125544, for CT-P13, a proposed biosimilar to Janssen Biotech Inc.'s REMICADE (infliximab), submitted by Celltrion, Inc.
• On January 15, 2016, the FDA announced a meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee. The meeting will be held on March 15 and 16, 2016, from 8 a.m. to 6 p.m. The committee will discuss, make recommendations, and vote on information related to the premarket approval application for the Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System sponsored by Abbott Vascular. The Absorb GT1 BVS System is a temporary scaffold that will fully resorb over time and is indicated for improving coronary luminal diameter in patients with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 millimeters (mm)) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. On March 16, 2016, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the AngelMed Guardian System sponsored by Angel Medical Systems, Inc. The AngelMed Guardian System is an implantable cardiac monitor intended to alert patients to ST segment shifts indicating coronary ischemia. The AngelMed Guardian System is intended for use in patients with prior acute coronary syndrome events, and at risk for recurrent events, to ST segment changes indicating cardiac ischemia.
• On January 15, 2016, the FDA issued a Request for Nominations to the Technical Electronic Product Radiation Safety Standards Committee. FDA is requesting any industry organizations interested in participating in the selection of voting industry representatives to serve on the Technical Electronic Product Radiation Safety Standards Committee for the Center for Devices and Radiological Health to notify FDA in writing. FDA is also requesting nominations for voting industry representatives to serve on the Technical Electronic Product Radiation Safety Standards Committee. A nominee may either be self-nominated or nominated by an organization to serve as a voting industry representative. Nominations will be accepted for current vacancies effective with this notice. Nominations are due February 18, 2016.
• On January 15, 2016, the National Institutes of Health (NIH) issued an Announcement of Requirements and Registration for the “Pill Image Recognition Challenge”. Through this Challenge, the National Library of Medicine (NLM), part of NIH, seeks algorithms and software to match images of prescription oral solid-dose pharmaceutical medications (pills, including capsules and tablets). The objective of the Challenge is the development and discovery of high-quality algorithms and software that rank how well consumer images of prescription pills match reference images of pills in the authoritative NLM RxIMAGE database. NLM may use all or part of any Challenge entry (i.e., algorithm and software) to create a future software system and a future API (Application Programming Interface) for pill image recognition; the system will be freely usable and the API will be freely accessible. The submission period will run from April 4, 2016 to May 31, 2016. The judging period will run from June 6, 2016 to July 15, 2016. Winners will be announced August 1, 2016
• On January 14, 2016, the Internal Revenue Service (IRS) issued a correction to final regulations, Minimum Value of Eligible Employer-Sponsored Plans and Other Rules Regarding the Health Insurance Premium Tax Credit; Correction. This document contains corrections to final regulations (TD 9745) that were published in the Federal Register on Friday, December 18, 2015 (80 FR 78971). The final regulations are on the health insurance premium tax credit enacted by the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010, as amended by the Medicare and Medicaid Extenders Act of 2010, the Comprehensive 1099 Taxpayer Protection and Repayment of Exchange Subsidy Overpayments Act of 2011, and the Department of Defense and Full Year Continuing Appropriations Act, 2011.
• On January 14, 2016, the FDA issued a Notice of Agency Information Collection Activities; Proposals, Submissions, and Approvals: Information to Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements. This notice solicits comments on information to accompany humanitarian device exemption (HDE) applications and the collection of information regarding the annual distribution number (ADN). Comments are due by March 15, 2016.
• On January 14, 2016, the FDA issued Notice of a Meeting: How Should Liver Injury and Dysfunction Caused by Drugs Be Measured, Evaluated, and Acted Upon in Clinical Trials? This conference will be cosponsored with the Critical Path Institute (C-Path). The purpose of the conference is to discuss, debate, and share views among stakeholders in academia, patient groups, regulatory bodies, and the health care and pharmaceutical industries on how best to measure, evaluate, and act upon liver injury and dysfunction caused by drugs used during clinical trials. This public conference will be held on March 23, 2016, from 8 a.m. to 6 p.m., and on March 24, 2016, from 8 a.m. to 4 p.m.
• On January 14, 2016, the FDA issued a Notice of Public Workshop, Navigating the Center for Drug Evaluation and Research -- What You Should Know for Effective Engagement. The purpose of this public workshop is to help the public and patient advocacy groups gain a better understanding of how to effectively engage CDER. The public workshop will be held on March 31, 2016, from 8:30 a.m. to 5 p.m.
• On January 13, 2016, the FDA released Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products. The guidance document provides blood collecting establishments and manufacturers of plasma derivatives with comprehensive recommendations intended to minimize the possible risk of transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) from blood and blood products. The guidance amends the guidance document entitled “Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products” dated May 2010 (2010 guidance) by finalizing and incorporating the recommendations from the draft document entitled “Draft Guidance for Industry: Amendment to 'Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products'” dated June 2012 (2012 draft guidance). Submit either electronic or written comments on Agency guidances at any time.
• On January 13, 2016, the FDA released a Notice of Meetings: Patient and Medical Professional Perspectives on the Return of Genetic Test Results and Interpretations; Public Workshop. The public workshop will be held on March 2, 2016, from 8 a.m. to 4 p.m. The purpose of this public workshop is to understand patient and provider perspectives on receiving potentially medically relevant genetic test results. The topic(s) to be discussed will focus on better defining the specific information patients and providers prefer to receive, with an emphasis on the type(s) and amount of evidence available to interpret the results for medical purposes, how those results should be returned, and what information is needed to understand the results in the event that they could effectively aid in medical decision making. Submit either electronic or written comments on the public workshop by March 31, 2016.
• On January 12, 2016, the FDA released a Notice entitled Clinical Outcome Assessment Compendium, announcing the establishment of a docket to receive suggestions, recommendations, and comments from interested parties (including academic institutions, regulated industry, and patient groups) on FDA’s pilot “Clinical Outcome Assessment Compendium” (COA Compendium). FDA has developed a Web site that describes the purpose of the pilot COA Compendium and provides background information. Comments received on the pilot COA Compendium during its pilot phase will help FDA determine its utility, and may assist FDA in developing future iterations of the COA Compendium and identifying best methods for conveying COA Compendium information on FDA’s Web site. Comments are due March 15, 2016.
• On January 12, 2016, the NIH released a Notice of Agency Information Collection Activities; Proposals, Submissions, and Approvals on Cancer Genomics Cloud Pilots Survey. The Center for Biomedical Informatics and Information Technology (CBIIT), in collaboration with the Center for Cancer Genomics at the National Cancer Institutes (NCI) in the NIH, is coordinating a program to develop three Cancer Genomics Cloud Pilots to help meet the research community’s needs to access and analyze high quality, large-scale cancer genomic data and associated clinical information. The goal of this effort is to develop an innovative, cost-effective model for computational analysis of biological data and provide broader yet secure access to genomic data that NCI generates. Cloud computing will be a valuable tool to support studies related to the mechanisms of cancer. This capability will be equally valuable to other NCI scientific areas, including clinical trials and other types of patient-focused research. In order to understand the utility and value of the tools being developed, the NCI has developed a survey instrument to capture feedback from the cancer research community. The information collected as part of this survey process will be used exclusively by the NCI to determine future funding of cloud technology projects. Comments regarding this information collection are “best assured of having their full effect if received within 60 days of the date of this publication.”
• On January 12, 2016, the Center for Consumer Information & Insurance Oversight (CCIIO) released an Updated 2016 FFM Web-broker List. This list contains the names of web-brokers who have completed FFM registration (including execution of the required agreements) for the 2016 plan year. This list is current as of January 6, 2016 and CMS anticipates updating the information on a monthly basis.
• On January 11, 2016, the Department of Justice (DOJ) issued a Notice of Agency Information Collection Activities; Proposals, Submissions, and Approvals on Annual Reporting for Manufacturers of Listed Chemicals. This information collection permits the DEA to monitor the volume and availability of domestically manufactured listed chemicals. These listed chemicals may be subject to diversion for the illicit production of controlled substances. This information is required by law. Comments are due by March 14, 2016.
• On January 11, 2016, the FDA announced a public workshop entitled "Next Generation Sequencing-Based Oncology Panels." The purpose of this workshop is to obtain feedback on analytical and clinical validation approaches for next generation sequencing (NGS)-based oncology panels. Comments and suggestions generated through this workshop will help guide the development of appropriate regulatory standards for evaluation of NGS-based oncology panels in cancer patient management. The public workshop will be held on February 25, 2016, from 8:30 a.m. to 5 p.m. Submit either electronic or written comments on the public workshop by March 28, 2016.
• On January 11, 2016, the CDC issued a Notice of Agency Information Collection Activities; Proposals, Submissions, and Approvals: Employer Perspective of an Insurer-Sponsored Wellness Grant. The proposed project addresses three priority goals of the NIOSH Total Worker HealthTM Program: (1) investigate the costs/benefits associated with comprehensive, coordinated work-based health protection/health promotion interventions, (2) improve the understanding of how the work environment influences the effectiveness of health programs and identify opportunities for workplace interventions to prevent, control, recognize and manage common chronic conditions, and (3) conduct scientific research that more holistically investigates organizational and worker health and safety outcomes associated with emerging issues and addresses gaps in knowledge in the health protection/health promotion field. Comments are due February 10, 2016.
• On January 11, 2016, the Health Resources and Services Administration (HRSA) issued a Notice of Agency Information Collection Activities; Proposals, Submissions, and Approvals: Information Collection Request Title: Telehealth Resource Center Performance Measurement. In order to evaluate existing programs, data are obtained from the Performance Improvement Measurement system (PIMs). The data are used to measure the effectiveness of the technical assistance. This revised request proposes changes to existing measures. After compiling data from the previous tool over the last 3 years, the Office conducted an analysis of the data and compared the findings with the program needs. Based on the findings, the measures were revised to better capture information necessary to measure the effectiveness of the program. Comments are due March 14, 2016.
• On January 11, 2016, HRSA issued a notice on Meetings: Centers for Disease Control and Prevention/Health Resources and Services Administration Advisory Committee on HIV, Viral Hepatitis and Sexually Transmitted Diseases Prevention and Treatment. The next meeting will take place on February 3, 2016, from 3:00 p.m.-4:00 p.m. (EST). The agenda includes a discussion and vote on the “Resolution relative to increasing federal funding for innovative HIV, STD, and viral hepatitis prevention and care programs in the context of continued Affordable Care Act implementation.” Agenda items are subject to change as priorities dictate.
• On January 11, 2016, the Department of Health and Human Services (HHS) announced a Meeting of the Physician-Focused Payment Model Technical Advisory Committee, on Monday, February 1, 2016. In accordance with its statutory mandate, the Committee is to review physician-focused payment model proposals and prepare recommendations regarding whether such models meet criteria that will be established through rulemaking by the Secretary of the Department of Health and Human Services (DHHS) (the Secretary). The Committee is composed of 11 members appointed by the Comptroller General with staggering terms of 1, 2, and 3 years as specified in the authorizing legislation. The Committee will receive information about MACRA implementation and about payment models currently being tested by the Center for Medicare & Medicaid Innovation within CMS. The meeting will be held in Room 5051 of the Wilbur J. Cohen Federal Building, 330 Independence Ave SW, Washington, DC, 20201. The public may attend the meeting in-person or listen via audio teleconference. Space is limited and registration is required. Registration may be completed at www.regonline.com/PTACommitteeMeetingRegistration.  

Event Notices

• January 21, 2016: CMS has announced a National Training Program Webinar, “Getting Started: New to CMS Programs?” This webinar will provide an introduction to Medicare, Medicaid, the Children’s Health Insurance Program (CHIP), the Federally-facilitated Health Insurance Marketplace and key resources for these programs.
• January 28 - 29, 2016: The Medicaid and CHIP Payment and Access Commission (MACPAC) will convene a meeting. An agenda is not yet available.
• March 25, 2016: CMS has announced a public conference to discuss potential improvements to the HHS Risk Adjustment methodology for the 2018 benefit year and beyond. More information on the announcement may be found here.

II. CONGRESSIONAL LEGISLATION & COMMITTEE ACTION

Senate

• On Wednesday, January 20, the Senate HELP Committee will hold a hearing on Improving the Federal Response to Challenges in Mental Health Care in America at 10:00 AM in 430 Dirksen Senate Office Building. The Committee will hear from the following witnesses: Brian M. Hepburn, MD, Executive Director of the National Association of State Mental Health Program Directors (Alexandria , VA); Penny Blake, RN, CCRN, CEN, Staff RN Emergency Department, Emergency Nurses Association (North Palm Beach , FL); William W. Eaton, PhD, Professor with the Department of Mental Health, Johns Hopkins Bloomberg School of Public Health (Baltimore , MD); and Hakeem Rahim, EdM, MA, CEO, Live Breathe LLC, Let’s Talk Mental Illness, National Alliance on Mental Illness (Hempstead , NY).
• On Thursday, January 21, the Senate Finance Committee will convene a hearing entitled “CO-OPs: A Review of the Financial and Oversight Controls,” to examine the management failures of Obamacare’s Consumer Operated and Oriented Plans (CO-OPs) and its impact on consumers, patients and taxpayers. The hearing, will take place at 10:00 a.m. in Room 215 of the Dirksen Senate Office Building. The sole witness is Andy Slavitt, Acting Administrator of CMS.
• On January 12, 2016, the Senate Health Education Labor and Pensions (HELP) Committee voted by voice vote to send to the Senate floor Dr. Califf’s nomination to serve as FDA Commissioner. A video of the Executive Session is available here.

House

• On January 26, 2016, the House Oversight and Government Reform Committee is planning to hold a hearing to examine the increasing prices of prescription drugs, according to a letter sent to Martin Shkreli, former CEO of Turing Pharmaceuticals. Additional details are not yet available.
• On January 15, 2016, House Ways and Means Committee Chairman Kevin Brady (R-TX) and House Energy and Commerce Committee Chairman Fred Upton (R-MI) wrote to HHS Secretary Sylvia Burwell seeking information about the Administration’s decision to fund the Basic Health Program (BHP) for more than six months without a congressional appropriation. In their letter, the Chairmen detail HHS’s record of refusing to provide information to the Committees for their investigation and state that, because of HHS's ongoing obstruction in this investigation, if the Department does not produce the requested documents by January 28, 2016, the Chairmen will have no choice but to consider issuing a subpoena.
• On January 12, 2016, the House Judiciary Committee passed by voice vote the Comprehensive Justice and Mental Health Act of 2015 (H.R. 1854). Congressman Bob Goodlatte (R-Va.), Chairman of the House Judiciary Committee, released the following statement on the bill: “As we seek to reform our nation’s criminal justice system, it’s important that we improve the way the mentally ill are treated while in jail and the Comprehensive Justice and Mental Health Act of 2015 does just that. This bill ensures that law enforcement officers are equipped to interact with the mentally ill and also provides those with mental health conditions access to the care and treatment they need. The resources provided in this bill will go a long way towards saving lives, stewarding taxpayer dollars, and enhancing public safety. I thank Congressmen Collins and Scott for their work on this legislation.” A video of the markup is available here.
• On January 13, 2016, Republican Members of the Energy and Commerce Subcommittee on Health, chaired by Rep. Joseph Pitts (R-PA), issued a release saying they are still waiting for answers from CMS to several dozen questions sent to CMS Deputy Administrator Vikki Wachino following her testimony at a July 8, 2015, hearing that examined the Medicaid program, now in its 50th year. The series of questions were submitted on July 27 with a requested response date of August 10. Over five months later, not one member has received a response to a single question. In a letter to Wachino, the committee members with unanswered questions write, “We appreciated your time and effort preparing and delivering testimony before the Subcommittee, but we are troubled that the agency has yet to respond to substantial Subcommittee interest and key oversight questions. Accordingly, we are resending you our questions and respectfully request every effort be made to respond in an expeditious manner.”
• On January 13, 2016, Republican leaders of the House Energy and Commerce Committee requested the Government Accountability Office (GAO) to examine CMS role in assisting states transitioning from a state-based information technology (IT) system to the federal program. “With nearly $5.5 billion in Obamacare grants already awarded to states, committee leaders are concerned whether states will be able to financially sustain their marketplace IT systems, putting further taxpayer dollars at risk.”
• On January 11, 2016, Rep. Lloyd Doggett (D-TX) and over 50 other lawmakers issued a letter urging the U.S. Department of Health and Human Services, urging the National Institutes of Health (NIH) to use its statutory authority to help mitigate the rising cost of prescription drugs. Specifically, the letter calls on NIH to issue guidance around “march-in rights”, which are available under the Bayh-Dole Act when “action is necessary to alleviate health and public safety needs which are not being reasonably satisfied” or when the benefits of the patented product are not “available to the public on reasonable terms.”

III. REPORTS, STUDIES, & ANALYSES

• The Medicare Payment Advisory Commission (MedPAC) convened a series of meetings on January 14 and 15, 2016. Among other things, the Commission approved a package of recommendations aimed at eliminating inequities in Medicare Advantage payments as well as a recommendation to reduce Medicare payment rates for hospitals receiving drug discounts under the 340B drug discount program.
• On January 14, 2016, the Government Accountability Office (GAO) released a report on Drug Safety: FDA Expedites Many Applications, But Data for Postapproval Oversight Need Improvement, GAO-16-192. GAO found that, from October 1, 2006, to December 31, 2014, the Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) received about 1,000 requests for fast track designation and breakthrough therapy designation—two of the agency's four expedited programs to facilitate and expedite the development and review of new drugs. Sponsors submitted more than 770 requests for fast track designation since fiscal year 2007, and FDA granted about two-thirds of these requests. Sponsors submitted more than 220 requests for breakthrough therapy designation since it was established in July 2012, and the agency denied more than half of these requests. GAO recommends that FDA develop plans to correct problems with its postmarket safety data and ensure that these data can be easily used for oversight. HHS agreed with GAO's recommendations and provided additional information on FDA's postmarket safety efforts.
• On January 13, 2016, the Federal Trade Commission (FTC) issued a report entitled Agreements Filed with the Federal Trade Commission under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003: Overview of Agreements Filed in FY 2014. The report summarizes data on patent settlements – which can arise between brand and generic drug companies – filed with the FTC and the Department of Justice during FY 2014 under the Medicare Modernization Act of 2003.
• On January 12, 2016, the Office of Inspector General (OIG) released an analysis, California Claimed Unallowable Federal Medicaid Reimbursement by Not Billing Manufacturers for Rebates for Some Physician-Administered Drugs (A-09-14-02038), which finds that the California Department of Health Care Services (State agency) did not always comply with Federal Medicaid requirements for billing manufacturers for rebates for physician-administered drugs during three selected quarters between 2008 and 2010. Of $178.6 million in claims that were billed for rebates, we reviewed $61.4 million associated with 26 National Drug Codes (NDCs) and 21 manufacturers to verify that the claims were properly billed for rebates. The entire amount was properly billed for rebates. However, the State agency did not bill for rebates for claims for physician-administered drugs totaling $58.9 million.
• On January 11, 2016, the GAO released a report on Health Care Workforce: Comprehensive Planning by HHS Needed to Meet National Needs, GAO-16-17. GAO was asked to review HHS's workforce efforts. In this report, GAO examines (1) HHS's planning efforts for ensuring an adequate supply and distribution of the nation's health care workforce and (2) the extent to which individual HHS health care workforce programs contribute to meeting national needs. GAO reviewed strategic planning documents, workforce projection reports, and other related documents obtained from HHS agencies; interviewed HHS officials; and analyzed performance measures for the largest health care workforce programs operated by HHS. GAO recommends that HHS develop a comprehensive and coordinated planning approach that includes performance measures, identifies any gaps between its workforce programs and national needs, and identifies actions to close these gaps. HHS concurred with GAO's recommendations and provided technical comments, which GAO incorporated as appropriate.
• On January 8, 2016, HRSA released an update entitled 340B Audits: News to Use in 2016. HRSA notes that covered entities that participate in the 340B Drug Pricing Program must ensure program integrity and maintain accurate records documenting compliance with all 340B Program requirements. With the start of Fiscal Year 2016, the HRSA Office of Pharmacy Affairs (OPA) is providing some news and reminders to help facilitate covered entities through the auditing process and minimize operational burden.

IV. OTHER HEALTH POLICY NEWS

• On January 12, 2016, President Obama delivered his final State of the Union Address. On healthcare, the President said that “Social Security and Medicare are more important than ever. We shouldn’t weaken them; we should strengthen them. (Applause.) And for Americans short of retirement, basic benefits should be just as mobile as everything else is today. That, by the way, is what the Affordable Care Act is all about. It’s about filling the gaps in employer-based care so that when you lose a job, or you go back to school, or you strike out and launch that new business, you’ll still have coverage. Nearly 18 million people have gained coverage so far. (Applause.) And in the process, health care inflation has slowed.” The President also announced a cancer “moon shot”, to be led by Vice President Biden, saying “For the loved ones we’ve all lost, for the families that we can still save, let’s make America the country that cures cancer once and for all.”
• On January 11, 2016, CMS announced 121 new participants in Medicare Accountable Care Organization (ACO) initiatives designed to improve the care patients receive in the health care system and lower costs. With this announcement, ACOs now represent 49 states and the District of Columbia. CMS also announced today that providers and hospitals have signed up to join new types of ACOs, which in addition to being paid for positive patient outcomes will also receive penalties for negative ones. With new participants in the Shared Savings Program (SSP), the Next Generation ACO Model, Pioneer ACO Model, and the Comprehensive ESRD Care Model, there will now be: Nearly 8.9 million beneficiaries served; a total of 477 ACOs across SSP, Pioneer ACO Model, Next Generation ACO Model, and Comprehensive ESRD Care Model; and 64 ACOs in a risk-bearing track including SSP, Pioneer ACO Model, Next Generation ACO Model, and Comprehensive ESRD Care Model.
• On January 14, 2016, President Barack Obama said he will propose in his final budget that Congress make available, for states that haven't expanded Medicaid, three years of full federal funding of newly eligible beneficiaries, regardless of when the states expand the program.
• On January 14, 2016, CMS released its Health Insurance Marketplace Open Enrollment Snapshot for Week 10 (January 3rd to 9th). This week’s snapshot includes weekly and cumulative data for enrollment through HealthCare.gov, a breakdown of cumulative data for 38 states using the HealthCare.gov platform, and for the first time this Open Enrollment, cumulative data for certain local areas. In Week 10, 74,239 net plans were selected for a total of 8,682,471 cumulative selections and 11,066,884 applications since the start of open enrollment.
• Kentucky Governor Matt Bevin (R) announced this week that he has officially notified HHS of his decision to dismantle the state’s Exchange, Kynect, and shift to the Federally Facilitated-Exchange, healthcare.gov. The state exchange will cease operations "as soon as is practicable,” according to the letter, which will likely be at least a year from now and will not affect health plans sold for 2016.
• On January 12, 2016, Louisiana Governor Bel Edwards (D) signed an executive order expanding Medicaid in the state. "By July 1, we expect more than 300,000 hard-working citizens will have the comfort and security of health coverage," Edwards said. "This will not only afford them peace of mind, but also help prevent them from slipping further into poverty and give them a fighting chance for a better life."
• On January 14, 2016, Vermont submitted an application to renew its section 1115 demonstration effective January 1, 2017. The state requests a five-year extension with no programmatic changes to continue its existing demonstration initiatives with the goal of increasing access to affordable and high-quality health care, improving access to primary care, improving the health care delivery for individuals with chronic care needs, containing health care costs, allowing beneficiaries a choice in long-term services and supports and providing an array of home and community-based alternatives to institutional-based supports. The federal public comment period will be open from January 14, 2016 through February 13, 2016.