Articles and Blogs

This article is Part I in a five-part series discussing the federal Physician Payment Sunshine Act.  This first installment provides an overview of the major sections of the Sunshine Act and CMS’s implementing rule, with a focus on issues of importance to health product manufacturers and entities sharing an ownership structure with manufacturers.  Part II…Read More

On February 13, 2013, the Federal Trade Commission (“FTC”) released an advisory opinion approving Norman PHO’s proposed “clinically integrated” network after a review process that took roughly a year and nine months (“Norman PHO Advisory Opinion”).  This is the FTC’s latest advisory opinion discussing the merits of clinical integration programs from an antitrust perspective and…Read More

This article is Part III in a series discussing the proposed rule to revise certain Conditions of Participation, Conditions for Coverage and regulations under the Clinical Laboratory Improvement Amendments of 1998 published on February 7, 2013. This final installment provides an overview of the changes applicable to rural health care providers, including critical access hospitals,…Read More

On January 25, 2013, the Department of Health and Human Services (“HHS”) formally published its Omnibus Final Rule (“Final Rule”), which includes modifications to the HIPAA Privacy and Security Rules under the Health Information Technology for Economic and Clinical Health Act (“HITECH”) and the Genetic Information Nondiscrimination Act (“GINA”).  Because the Final Rule covers a…Read More

In support of the health IT certification program, National Institute of Standards and Technology (NIST) developed the conformance test method (test procedures, test data and test tools) to ensure compliance with the meaningful use technical requirements and standards.

Hospitals, Drug Industry Argue over Outpatient Drug Discounts On February 12, a coalition of pharmaceutical industry trade groups released a report on the 340B drug discount program.  The report questioned whether hospitals and other providers receiving the discount are doing enough to benefit patients and called for the drug discounts to be more narrowly focused.

This article is Part II in a series discussing the proposed rule to revise certain Conditions of Participation, Conditions for Coverage and regulations under the Clinical Laboratory Improvement Amendments of 1998 published on February 7, 2013. This second installment provides an overview of the changes applicable to hospitals. Part I addressed changes applicable to CLIA…Read More

Executive Summary On November 15, 2012, the Federal District Court of the District of Columbia issued a decision favorably impacting disproportionate share hospital (“DSH”) patient percentage (“DPP”) calculations.  If this decision is upheld on appeal, Medicare Advantage days may be removed from the SSI/Medicare Fraction (defined below) of the DPP calculation, thereby typically increasing the…Read More

On January 25, 2013, the Department of Health and Human Services (“HHS”) formally published its Omnibus Final Rule (“Final Rule”), which includes modifications to the HIPAA Privacy and Security Rules under the Health Information Technology for Economic and Clinical Health Act (“HITECH”) and the Genetic Information Nondiscrimination Act (“GINA”).  Because the Final Rule covers a…Read More

This article is Part I in a series discussing the proposed rule to revise certain Conditions of Participation, Conditions for Coverage and regulations under the Clinical Laboratory Improvement Amendments of 1998 published on February 7, 2013. This first installment provides an overview of the changes applicable to CLIA certified laboratories and several other changes applicable to…Read More