I. REGULATIONS, NOTICES, & GUIDANCE
- On September 11, 2014, the Department of Health and Human Services (HHS) released the “2014 Edition Release 2 Electronic Health Record (EHR) Certification Criteria and the ONC HIT Certification Program; Regulatory Flexibilities, Improvements, and Enhanced Health Information Exchange”. This final rule introduces regulatory flexibilities and general improvements for certification to the 2014 Edition EHR certification criteria. It also codifies a few revisions and updates to the ONC HIT Certification Program for certification to the 2014 Edition and future editions of certification criteria as well as makes administrative updates to the Code of Federal Regulations. The certification criteria and program updates included in the 2014 Edition Release 2 final rule were proposed earlier this year. In consideration of public comment received on the proposed rule, the 2014 Edition Release 2 final rule provides alternative certification criteria and approaches for the voluntary certification of heath IT.
- On September 9, 2014, the Drug Enforcement Administration (DEA) release a final rule entitled “Disposal of Controlled Substances”. This rule governs the secure disposal of controlled substances by registrants and ultimate users. These regulations will implement the Secure and Responsible Drug Disposal Act of 2010 by expanding the options available to collect controlled substances from ultimate users for the purpose of disposal, including: Take-back events, mail-back programs, and collection receptacle locations. These regulations contain specific language allowing law enforcement to voluntarily continue to conduct take-back events, administer mail-back programs, and maintain collection receptacles. These regulations will allow authorized manufacturers, distributors, reverse distributors, narcotic treatment programs (NTPs), hospitals/clinics with an on-site pharmacy, and retail pharmacies to voluntarily administer mail-back programs and maintain collection receptacles. In addition, this rule expands the authority of authorized hospitals/clinics and retail pharmacies to voluntarily maintain collection receptacles at long-term care facilities. This rule also reorganizes and consolidates previously existing regulations on disposal, including the role of reverse distributors. This rule is effective October 9, 2014.
- On September 10, 2014, the Food and Drug Administration (FDA) announced the availability of a guidance for industry entitled “Unique Device Identification System: Small Entity Compliance Guide” for a final rule published in the Federal Register of September 2013. This small entity compliance guide (SECG) intends to provide, in plain language, the requirements of the regulation and to help small businesses understand and comply with the regulation. More information may be found here.
- On September 12, 2014, the Centers for Medicare and Medicaid Services (CMS) released the following information collection requests for public comment: 1) State Collection and Reporting of Dental Provider and Benefit Package Information on the Insure Kids Now! Web site and Hotline; 2) Fee-for-Service Recovery Audit Prepayment Review Demonstration and Prior Authorization Demonstration; 3) National Provider Identifier (NPI) Application and Update Form and Supporting Regulations in 45 CFR 142.408, 45 CFR 162.406, 45 CFR 162.408. Comments on the proposed information collection activities are due November 12, 2014. More information may be found here.
- On September 12, 2014, FDA released a proposed “Survey of Health Care Practitioners for Device Labeling Format and Content” for public notice and comment. The purpose of this study is to compare existing device labeling from approximately six different types of medical devices with a standard content and format of the same labeling that FDA researchers will develop using the existing labeling as their source of the information. Comments on the proposed survey are due November 12, 2014.
II. LEGISLATION & COMMITTEE ACTION
- On September 9, 2014, the Senate Veterans’ Affairs Committee held a hearing on the findings of an investigation into the Department of Veterans Affairs (VA) Medical Center at Phoenix. Witnesses for the hearing included VA Secretary Robert McDonald and Acting Inspector General at VA, Richard Griffin. More information may be found here.
House of Representatives
- On September 11, 2014, the House voted 247-167 to advance the Employee Health Care Protection Act of 2013 (HR 3522), authored by Representative Bill Cassidy (R-LA). The measure would permit any health insurance issuer offering coverage in the group market in 2013 to continue to offer that coverage through 2018, even if policies do not comply with the Affordable Care Act (ACA) requirements that went into effect in 2014. The Congressional Budget Office (CBO) said the bill would increase federal revenues by $1.25 billion between 2015 and 2024. The White House issued a Statement of Administrative Policy on HR 3522 this week, indicating that the President would veto the measure if it reached his desk.
- On September 9, 2014, the House Energy and Commerce Subcommittee on Health held a hearing entitled "21st Century Cures: Examining the Regulation of Laboratory Developed Tests." Witnesses included: Jeffrey Shuren, director, Center for Devices and Radiological Health, Food and Drug Administration; Christopher Newton-Cheh, assistant professor of medicine, Harvard Medical School, and cardiologist, Massachusetts General Hospital; Andrew Fish, executive director, AdvaMed Diagnostics; Alan Mertz, president, American Clinical Laboratory Association; Charles Sawyers, immediate-past president, American Association for Cancer Research; and Kathleen Wilsey, co-founder, Coalition for 21st Century Medicine. More information on the hearing may be found here.
- On September 10, 2014, the House Ways and Means Subcommittee on Health held a hearing on the status of ACA implementation. Witnesses for the hearing included Andy Slavitt, Deputy Principal Administrator, CMS; and John Koskinen, Commissioner, Internal Revenue Service (IRS). More information on the hearing may be found here.
- On September 10, 2014, the House Energy and Commerce Health Subcommittee held a 21st Century Cures Roundtable discussion. Participants included Sylvia Mathews Burwell - Secretary of Health and Human Services; Francis Collins, Director, National Institutes of Health; Margaret Hamburg, Commissioner, Food and Drug Administration; Michael Milken, Chairman, The Milken Institute; Dean Kamen, founder, DEKA Research and Development; William Parfet, chairman and CEO, MPI Research; and Dan Theodorescu, Director, University of Colorado Cancer Center. More information on the roundtable may be found here.
- On September 11, 2014, the House Energy and Commerce Subcommittee on Health held a hearing to examine the Trafficking Awareness Training for Health Care Act of 2014 (HR 5411). The legislation seeks to provide health care professionals the tools necessary to identify and care for victims of human trafficking. Witnesses, including Katherine Chon, of the Administration for Children and Families, discussed the role health care providers can play in helping these victims. More information on the hearing may be found here.
III. REPORTS, STUDIES, & ANALYSES
- On September 10, 2014, Avalere Health released the results of an analysis which finds that in 12 of 15 states where complete data on market share of the ACA Health Insurance Exchanges are available, WellPoint or independent Blue Cross Blue Shield plans captured the greatest percentage of covered lives. Specifically, WellPoint leads enrollment in California, Colorado, Connecticut, Indiana, and Virginia, and Blues plans have captured the greatest portion of lives in the District of Columbia, Florida, Maryland, Michigan, Rhode Island, Vermont, and Washington. Avalere also found that Consumer Oriented and Operated Plans (CO-OPs) have attracted a sizeable share of covered lives in Maine and New York. According to proposed and final rates in the 15 states analyzed, nine of the issuers that captured the most enrollment requested rate increases of nine percent or more for the 2015 plan year. Rates are final in Florida, Maryland, New York, Oregon, Rhode Island, and Washington. More information may be found here.
- On September 10, 2014, the Kaiser Family Foundation and the Health Research & Educational Trust (HRET) released the results of an annual of employers, providing a detailed look at trends in employer-sponsored health coverage, including premiums, employee contributions, cost-sharing provisions, and employer opinions. The 2014 survey included almost three thousand interviews with non-federal public and private firms. The key findings from the survey include a modest increase in the average premiums for family coverage (3%). Single coverage premiums are 2% higher than in 2013, but the difference is not statistically significant. Covered workers generally face similar premium contributions and cost-sharing requirements in 2014 as they did in 2013. The percentage of firms (55%) which offer health benefits to at least some of their employees and the percentage of workers covered at those firms (61%) are statistically unchanged from 2013. The percentage of covered workers enrolled in grandfathered health plans—those plans exempt from many provisions of ACA—declined to 26% of covered workers from 36% in 2013. More information on the findings may be accessed here.
IV. OTHER HEALTH POLICY NEWS
- On September 8, 2014, HHS announced $60 million in Navigator grant awards to 90 organizations in states with Federally-Facilitated and State Partnership Marketplaces. These awards support preparation and outreach activities in year two of Marketplace enrollment and build on lessons learned from last year. Individuals seeking to enroll in coverage through the Health Insurance Exchanges established under the ACA can receive in-person assistance through “Navigators”, non-Navigator assistance personnel, certified application counselors, as well as traditional licensed agents and brokers. A list of awardees may be found here. An HHS press release on the awards may be found here.
- On September 11-12, 2014, the Medicare Payment Advisory Commission (MedPAC) convened a series of meetings on Medicare payment policy. The agenda may be found below, and more information, including presentations and transcripts as available, may be found here:
Thursday September 11th:
- Context for Medicare payment policy
- Developing payment policy to promote use of services based on clinical evidence
- Update on Medicare Accountable Care Organizations (ACOs)
- Medicare Advantage demographics and enrollment patterns
- Beneficiary and physician focus groups
Friday September 12th:
- Hospital Short Stay Policy Issues
- Mandated Report: Impact of Home Health Payment Rebasing on Beneficiary Access to and Quality of Care
On September 12, 2014, HHS announced that the Department awarded over $295 million in ACA funds to 1,195 health centers in every U.S. State, the District of Columbia, Puerto Rico, the U.S. Virgin Islands, and the Pacific Basin to expand primary care services. These awards enable health centers to increase access to comprehensive primary health care services by hiring an estimated 4,750 new staff including new health care providers, staying open for longer hours, and expanding the care they provide to include new services such as oral health, behavioral health, pharmacy, and vision services. A list of awardees may be found here.
This advisory is published by Alston & Bird LLP’s Health Care practice area to provide a summary of significant developments to our clients and friends. It is intended to be informational and does not constitute legal advice regarding any specific situation. This material may also be considered attorney advertising under court rules of certain jurisdictions.