Interim Final Rule Released Allowing HRSA to Exempt Religious Employers From Covering Contraception

Interim final regulations released on August 3, 2011 by the Department of Health and Human Services, the Department of the Treasury and the Department of Labor (DOL) give the Health Resources and Services Administration (HRSA) the discretion to exempt religious employers that offer insurance to their employees from the requirement to cover contraception. These regulations amended the previous interim final regulations addressing coverage of preventive services by new insurance plans. The Interim Final Rule sets forth a definition of “religious employer” based on the most commonly used definition in those states that exempt religious employers from state law requirements to cover contraception. HHS is accepting comments on this definition.

To read the Interim Final Rule, please go to: http://www.gpo.gov/fdsys/pkg/FR-2011-08-03/pdf/2011-19684.pdf.

New Guidelines Require New Insurance Plans to Provide Preventive Services to Women at No Additional Cost

On August 1, 2011, the U.S. Department of Health and Human Services (HHS) announced guidelines requiring new health insurance plans to provide certain preventive services to women without cost-sharing. The guidelines were developed by the Institute of Medicine. The preventive services that will no longer be subject to any co-payment, co-insurance or deductible include well-woman visits, screening for gestational diabetes, HPV testing for women 30 years of age and older, sexually-transmitted infection counseling, HIV screening and counseling, contraception and contraception counseling, breastfeeding support, and domestic violence screening and counseling. New health insurance plans must comply for plan years starting on or after August 1, 2012.

To read more about this announcement, please go to http://www.hhs.gov/news/press/2011pres/08/20110801b.html.

CMS and HHS Release Final Rules Affecting Payment to Inpatient Rehabilitation Facilities and Skilled Nursing Facilities

On August 1, 2011, the Centers for Medicare & Medicaid Services (CMS) and the U.S. Department of Health and Human Services (HHS) released a Final Rule updating the prospective payment rates for inpatient rehabilitation facilities (IRFs). The rule also establishes a program that reduces the annual increase factor by 2 percent for failure to report quality data to HHS starting in 2014. The Final Rule implements section 3004 of the Affordable Care Act and will become effective on October 1, 2011.

The Final Rule affecting IRFs was published in the Federal Register on August 5, 2011 and can be found here: http://www.gpo.gov/fdsys/pkg/FR-2011-08-05/pdf/2011-19516.pdf.

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CMS Transmittal Clarifies that Critical Access Hospitals are Included in CMS Laboratory Demonstration Project

On July 29, 2011, CMS issued Transmittal 78 clarifying that critical access hospitals (CAH) are included in CMS’ laboratory demonstration project for certain complex diagnostic tests. Under standard rules, payment made for tests provided by a laboratory working under arrangement with a hospital or CAH would ordinarily be in the form of a bundled payment to the hospital or CAH, and not directly to the laboratory. However, the Affordable Care Act requires that CMS conduct a demonstration project that will allow laboratories to receive a separate, direct payment for certain complex tests. The demonstration project begins January 1, 2012 and continues for two years or until the $100 million in funding is exhausted. Transmittal 78 rescinds and replaces Transmittal 74 dated July 15, 2011.

To read Transmittal 78, please go to https://www.cms.gov/transmittals/downloads/R78DEMO.pdf.

$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.

New Public-Private Partnership To Focus on Improving Quality, Safety and Affordability of Health Care

On April 12, 2011, The U.S. Department of Health and Human Services (HHS) announced its intentions to form a public-private partnership with stakeholders such as patient advocates, healthcare providers and leaders at major hospitals. Called Partnership for Patients, this national initiative was created to improve quality and safety in health care, while also substantially reducing health care costs. HHS estimated that the partnership could save up to $35 billion in health care costs. Under the authority of the Affordable Care Act, HHS will invest $1 billion dollars towards this endeavor.

The two main goals will be to assist hospital patients by (1) preventing injury and further illness and (2) eliminating or mitigating complications that would adversely affect patient recovery. To learn more about the Partnership for Patients, please visit HealthCare.gov.

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.

CMS Releases Long-Awaited Proposed Rule on Accountable Care Organizations

On March 31, 2011, the Centers for Medicare & Medicaid Services (CMS) and Health and Human Services (HHS) unveiled the long-awaited federal rule on accountable care organizations. This proposed rule would implement section 3022 of the Affordable Care Act, which allows service providers and suppliers to continue receiving traditional Medicare fee-for-service payments under Parts A and B, and to be eligible for additional payments based on meeting specified quality and savings requirements.

To view the proposed rule, please visit the Office of the Federal Register website.

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.

Civil Money Penalties for Nursing Homes

On March 18, 2011, the U.S. Centers for Medicare and Medicaid Services (CMS) and the Department of Health and Human Services (HHS) issued this regulation, implementing section 6111 of the Affordable Care Act. Section 6111 gives CMS authority to impose and collect civil monetary penalties (CMPs) against nursing homes. The penalties are reserved for nursing homes that fail to comply with federal participation requirements outlined in section 6111. Although penalties for noncompliance existed before the Affordable Care Act was promulgated, this regulation revises and expands CMS’s authority to impose and collect CMPs. The final rule is effective January 1, 2012.

For additional information about this new regulation, please visit the Office of the Federal Register website.

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The opinions expressed on this blog are those of the author and are not to be construed as legal advice.

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