Eleventh Circuit Declares Individual Mandate Provision in Health Reform Law Unconstitutional

On Friday, August 12, 2011, the U.S. Court of Appeals for the Eleventh Circuit held that the individual mandate provision in the Patient Protection and Affordable Care Act (“Act”) is an unconstitutional exercise of Congress’ power under the Commerce Clause of the United States Constitution. However, the court refused to hold the entire Act unconstitutional, ruling instead that the individual mandate provision is severable from the rest of the Act. The decision creates a circuit split because it conflicts with the recent decision by the U.S. Court of Appeals for the Sixth Circuit, which rejected a challenge to the individual mandate provision’s constitutionality.

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$71.3 Million in Federal Funding to Expand Nursing Workforce

On July 29, 2011, the U.S. Department of Health and Human Services (HHS) announced that it would provide a total of $71.3 million in grant funding to expand the education and training of nurses and nursing diversity. The monies will be distributed among six types of awards: Nurse Education, Practice, Quality and Retention; Nursing Workforce Diversity; Nurse Faculty Loan Program; Advanced Nursing Education Program; Advanced Education Nursing Traineeships; Nurse Anesthetist Traineeships. Monies from these awards will support all levels of education from entry-level nursing to advanced traineeships, increase opportunities for individuals from disadvantaged backgrounds, and provide partial loan-forgiveness for nursing faculty.

To read more about this announcement and see details of each of the awards, please go to http://www.hhs.gov/news/press/2011pres/07/20110729a.html.

FTC and DOJ Propose Enforcement Policy for Healthcare Antitrust Laws

The Federal Trade Commission and the U.S. Department of Justice have jointly issued a proposed enforcement policy for the application of the antitrust laws to healthcare collaborations among otherwise independent providers and provider groups that seek to participate as accountable care organizations (ACOs) under the Medicare Shared Savings Program. The agencies seek public comments until May 31, 2011, on the proposed enforcement policy and the new antitrust “safety zone” it would create.

For more information and the proposed antitrust policy, please visit the FTC and DOJ’s Proposed Statement.

A Summary of Medicare Shared Savings Program and ACO Proposed Regulations

On March 30, 2011, the Centers for Medicare and Medicaid issued the long-awaited, proposed regulations for the Medicare Shared Savings Program, including details of the requirements for qualifying as an accountable care organization (ACO), such as:

  • Eligible legal entities
  • Criteria for shared governance
  • Assignment of beneficiaries to ACOs
  • Different types of risk contracts
  • Benchmarks and calculations of savings
  • Shared savings, antitrust issues and policies, Medicare anti-kickback, and other regulatory requirements as applied to ACOs

The full text of the summary is available as a Duane Morris Alert.

12 Proposed Recommendations for Accreditation of Patient-Centered Medical Homes

On March 8, 2011, a coalition comprised of physicians representing the American Academy of Family Physicians, the American Academy of Pediatrics, the American College of Physicians, and the American Osteopathic Association, announced its completion of 12 new recommendations for accreditation organizations to use when developing and implementing standards for the patient-centered medical homes (PCMHs). The PCMHs are a central component of the Patient Protection and Affordable Care Act (ACA). The coalition developed the guidelines in anticipation of accreditation organizations, such as the Joint Commission, building upon its recommendations to establish updated standards for the PCMHs.

For additional information, please refer to the coalition’s guidelines.

$750 Million More in Prevention Funding

On February 9, 2011, the Department of Health and Human Services (HHS) announced that the Prevention and Public Health Fund would make an additional $750 million available to fund prevention initiatives throughout the United States for FY2011. Last fiscal year, the Prevention and Public Health Fund made $500 million available to states. This year, the $750 million will be distributed to states and local communities to address community prevention, clinical prevention, public health infrastructure, and research and tracking. This investment demonstrates the importance of prevention initiatives in improving the nation’s health. For additional information regarding this announcement, please go to http://www.hhs.gov/news/press/2011pres/02/20110209b.html.

$12 Million More in Electronic Health Record Funding

On February 8, 2011, the Office of the National Coordinator for Health Information Technology announced the availability of an additional $12 million in grant funding for the adoption and implementation of electronic health records (EHRs) by critical access and rural hospitals throughout the United States. The purpose of the additional grant funding is to help hospitals implement and adopt EHRs such that they meet “meaningful use” requirements. For additional information regarding this announcement, please go to http://www.govhealthit.com/newsitem.aspx?nid=76202.

Federal Judge in Florida Strikes Down the Health Reform Law

On January 31, 2011, a United States District Court in Florida held that the individual mandate provision in the Patient Protection and Affordable Care Act (“Act”) is an unconstitutional exercise of Congress’ power under the Commerce Clause of the United States Constitution. The court also held that “[b]ecause the individual mandate is unconstitutional and not severable, the entire Act must be declared void.” The court reasoned that “[i]f [Congress] has the power to compel an otherwise passive individual into a commercial transaction with a third party merely by asserting—as was done in the Act—that compelling the actual transaction is itself ‘commercial and economic in nature, and substantially affects interstate commerce’ . . . it is not hyperbolizing to suggest that Congress could do almost anything it wanted.” In concluding its decision, the court emphasized that the ruling only addressed a constitutional issue and that it was not about whether the Act was good or bad legislation.

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OIG Solicits Proposals for New Anti-Kickback Safe Harbors and Special Fraud Alerts

On December 28, 2010, the Office of the Inspector General published a notice of intent to develop regulations in the Federal Register soliciting recommendations for modifications to the safe harbors under the anti-kickback statute and suggestions for new safe harbors and OIG Special Fraud Alerts. The solicitation was published in accordance with Section 205 of the Health Insurance Portability and Accountability Act of 1996, which requires HHS to publish this formal solicitation annually. The notice lists the criteria that HHS will consider in reviewing the proposals submitted and recommends that proposals be accompanied by supporting data and/or justifications.

To read the notice published in the Federal Register, please go to: http://www.gpo.gov/fdsys/pkg/FR-2010-12-28/pdf/2010-32705.pdf.

CMS Transmittal Released on Waiving Copayments and Deductibles for Preventative Services Provided at Rural Health Clinics

On December 21, 2010, CMS released Transmittal 2122 providing instructions for waiving coinsurance and deductibles for certain preventative services provided in Rural Health Clinics, as provided for in Section 4104 of the Affordable Care Act. Qualifying preventative services are those recommended by the United States Preventive Services Task Force with a grade of A or B. The transmittal is effective for services provided on or after January 1, 2011.

To read Transmittal 2122, please go to: http://www2.cms.gov/transmittals/downloads/R2122CP.pdf.