December 2013

On December 26, 2013, President Obama signed into law H.J. Res. 59, the Bipartisan Budget Act of 2013, which includes the Pathway for SGR Reform Act of 2013 (“the Act”). In addition to establishing federal budget targets for fiscal years (FYs) 2014 and 2015, the Act includes a number of provisions impacting the Medicare and Medicaid programs. Most notably, the Act provides a short-term reprieve from a looming Medicare physician fee schedule cut while lawmakers work to finalize a longer-term solution. It also extends Medicare provider payment cuts under existing sequestration authority for two years and makes a variety of other policy changes. The Act’s major Medicare and Medicaid provisions are summarized in our full post.
Continue Reading President Signs 2-Year Funding Bill with Medicare SGR Patch, Sequestration Extension for Medicare Providers

On December 27, 2013, the Office of Inspector General and the Centers for Medicare & Medicaid Services each published, in the Federal Register, a final rule that amends regulations protecting, from the Anti-Kickback Statute and Stark law, certain arrangements related to the donation of interoperable electronic health records (EHR) software or information technology and training services related to such EHR software. Among these amended regulations was the extension of protections of the Stark law exception and the Anti-Kickback safe harbor from December 31, 2013 to December 31, 2021 (the “sunset” provisions).
Continue Reading Final Rules Issued Extending Protections of Electronic Health Record Donations

The Reed Smith Health Industry Washington Watch blog (https://www.healthindustrywashingtonwatch.com) has been updated to report on recent health policy developments, including the following:

– Regulatory Developments. CMS has issued several major Medicare payment rules for 2014, including rules updating reimbursement for hospital outpatient departments, ambulatory surgical centers, physicians and other Part B providers, end-stage renal disease facilities, durable medical equipment suppliers, and home health agencies. Other recent CMS rules and notices have addressed enrollment fees, quality ratings, and payment parameters for Affordable Care Act (ACA) exchange plans. For details, see https://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/other-cms-developments/.

– Other CMS Developments. CMS has made subregulatory announcements regarding Medicaid drug pricing policy, implementation of the Stage 3 meaningful use criteria, 2014 HCPCS codes and clinical lab rates, Medicare national coverage policies, Medicare Part B drug rates, the ACA insurance grandfathering policy, and Medicaid and CHIP integrated care models (https://www.healthindustrywashingtonwatch.com/articles/other-cms-developments-1/).

– OIG Developments. Recent OIG reports examine Medicare acute hospital outlier payments and hospitalization of nursing home patients (https://www.healthindustrywashingtonwatch.com/articles/other-oig-developments/).

– Legislative Developments. The House has approved the “Keep Your Health Plan Act.” Congressional hearings continue to focus on ACA implementation and other health policy issues. President Obama has signed several bills into law, including major drug distribution security legislation. The Senate Finance Committee is scheduled to consider Medicare physician payment reform. For more information, see https://www.healthindustrywashingtonwatch.com/articles/legislative-developments/.

– Health Industry Events. Upcoming CMS events will focus on Medicare physician quality reporting, new medical services and technologies under the Medicare hospital inpatient prospective payment system, and hospital outpatient services (https://www.healthindustrywashingtonwatch.com/articles/events/).

For details on these and other health industry developments, please visit https://www.healthindustrywashingtonwatch.com/.
Continue Reading New Postings on the Reed Smith Health Industry Washington Watch Blog

On December 10, 2013, CMS published a final rule that updates Medicare payment and other policies under the hospital outpatient prospective payment system (OPPS) and the ambulatory surgical center (ASC) prospective payment system (PPS) for calendar year (CY) 2014. Key provisions of the final rule include the following:Continue Reading CMS Issues Final Medicare OPPS, ASC Policies for 2014

On December 10, 2013, CMS published its final rule updating Medicare physician fee schedule (PFS) rates and polices for calendar year (CY) 2014, which includes a 20.1% across-the-board cut in PFS rates in 2014 (down from 24.4% projected under the proposed rule). The cuts are largely due to the statutory Sustainable Growth Rate (SGR) update formula, although lawmakers are seeking agreement on legislation to block the automatic cuts. The rule also includes a number of significant Part B policy changes, including the following highlights:
Continue Reading CMS Updates Medicare Physician Fee Schedule, Other Part B Policies for CY 2014

On November 27, 2013, President Obama signed into law H.R. 3204, the “Drug Quality and Security Act” (the “Act”), bipartisan drug distribution security legislation. Among other things, the sweeping measure: clarifies current federal law and regulatory oversight regarding pharmacy compounding; establishes a uniform, national drug tracking and tracing framework; mandates national licensure standards for wholesale distributors and third-party logistics providers; and preempts state product tracing requirements. The following is an overview of the Act and highlights of initial FDA implementation guidance.
Continue Reading Drug Distribution Security Legislation Signed into Law

On December 2, 2013, CMS published a proposed rule that would establish 2015 payment parameters and oversight provisions for federally-facilitated Health Insurance Exchanges under the ACA. The rule specifically addresses risk adjustment, reinsurance, and risk corridors programs; cost-sharing parameters and cost-sharing reductions; and user fees for federally-facilitated Exchanges. It also proposes additional standards for composite…

CMS has announced the 2014 application fee for institutional providers that are initially enrolling in the Medicare or Medicaid program or the Children’s Health Insurance Program (CHIP); revalidating their Medicare, Medicaid or CHIP enrollment; or adding a new Medicare practice location (unless a hardship exemption applies). The fee for 2014 is $542, up from $532…

On December 6, 2013, CMS announced its intention to push back implementation of the Stage 3 meaningful use criteria for the Medicare and Medicaid EHR Incentive Programs. Under the new timeline, Stage 2 will be extended through 2016 and Stage 3 will begin in 2017 (instead of 2016) for those providers that have completed at…

CMS has proposed removing 10 longstanding Medicare national coverage determinations (NCDs) under an expedited process outlined in an August 7, 2013 Federal Register notice. The NCDs under review address: Noninvasive Tests of Carotid Function, Tinnitus masking, Laser Procedures, L-DOPA,Stereotactic Cingulotomy as a Means of Psychosurgery, Carotid Sinus Nerve Stimulator, Electroencephalographic (EEG) Monitoring During Open-Heart Surgery…

Recent Congressional hearings on health policy issues have included the following, among others:

  • A House Small Business Committee hearing focused on the ACA’s Small Business Health Options Program.
  • A House Ways and Means Health Subcommittee hearing reviewed “the Challenges of the Affordable Care Act,” focusing on “immediate and long-term challenges Americans face in finding affordable,

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President Obama recently signed into law S. 330, the HIV Organ Policy Equity Act, which eliminates the restriction on acquiring HIV-positive organs in order to permit research on transplants involving HIV-positive individuals. In addition, the President has signed S. 252, the "Prematurity Research Expansion and Education for Mothers who deliver Infants Early Reauthorization…

CMS is holding a meeting on February 12, 2014 to discuss fiscal year (FY) 2015 applications for add-on payments for new medical services and technologies under the Medicare hospital inpatient prospective payment system (IPPS). CMS invites interested parties to present their comments, recommendations, and data regarding whether the FY 2015 new medical services and…