Duane Morris Health Law

June 12, 2013September 10, 2014 by Duane Morris

Final HIPAA Wellness Program Regulations Issued Under Affordable Care Act

On June 3, 2013, the U.S. Department of Labor, Department of Health and Human Services, Internal Revenue Service, Employee Benefits Security Administration and Department of the Treasury published in the Federal Register final guidance regarding nondiscriminatory wellness programs under employer-sponsored group health plans. This final guidance was issued in the form of much-anticipated joint final regulations on such wellness programs (the “Final Regulations”). It is important to note that the Final Regulations will apply to wellness programs offered under all group health plans [regardless of whether the plan is “grandfathered” under the Patient Protection and Affordable Care Act (the “Affordable Care Act”)]. Moreover, these Final Regulations will be effective for plan years beginning on or after January 1, 2014.

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May 16, 2013September 10, 2014 by Duane Morris

Increased Spotlight on Emergency Department Facility Coding by CMS, HHS and DOJ

Although the professional component of coding for evaluation and management services (“E&M Services”) has been scrutinized over the years, until recently, little attention has been given to coding practices for the facility component of these services—including emergency department facility services. In a September 24, 2012, letter written by Kathleen Sebelius, Secretary, U.S. Department of Health and Human Services (HHS); and Eric Holder, Jr., Attorney General, U.S. Department of Justice, to hospital leadership throughout the United States, HHS and the Justice Department expressed their concern that hospitals may be inappropriately coding E&M Services. Specifically, the letter notes that “CMS is initiating more extensive medical reviews to ensure that providers are coding evaluation and management services accurately.” In light of the recent attention on emergency department facility component coding practices, an area that so far has largely been overlooked by the regulators, any facility that has not reviewed its coding practices for the facility component of E&M Services may want to consider doing so at this time.

Click here to read the full Alert.

April 19, 2013September 10, 2014 by Duane Morris

HIPAA Marketing and Sale Provisions: Legal Potholes for Providers, Payors, Advertisers, Data Aggregators, Market Researchers and Others

The 2013 HIPAA Amendments directly apply to healthcare providers, plans and clearinghouses as “covered entities,” as well as their subcontractors and vendors as “business associates” (including their downstream subcontractors and agents). However, it is not just covered entities and business associates that need to understand the 2013 Amendments. Advertisers, data aggregators, market researchers and others that want access to PHI, even data that appear to be de-identified, will be impacted.

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April 3, 2013September 10, 2014 by Philip H. Lebowitz

Increased Government Scrutiny of Physician-Owned Device Distributorships

On March 26, 2013, the Office of Inspector General of the U.S. Department of Health and Human Services (OIG) increased its scrutiny of and pressure on physician-owned entities (particularly medical device distributorships) by issuance of a Special Fraud Alert. Although there is nothing specifically new or different from positions taken previously by the OIG regarding physician-owned distributorships (PODs), the Special Fraud Alert clarifies that the “OIG is concerned about the proliferation of PODs.” In other words, the position previously adopted by the OIG has not prevented physicians and medical device companies from designing arrangements that trouble the OIG.

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March 13, 2013September 10, 2014 by Duane Morris

What the New HIPAA Rules Say About Health Information Technology for Users, Developers and Investors

HIPAA-covered entities and many of their vendors—among them are HIO and EHR consultants, data analytic firms, data transmission facilitators, software vendors and device vendors—rely on health information technology (HIT) to accomplish their purposes. Large data companies, small entrepreneurs and investors are participating in the growth of HIT.

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March 6, 2013September 10, 2014 by Duane Morris

Research-Related Payments and the Physician Payment Sunshine Act: How Reporting Works and What Applicable Manufacturers Should Consider

The Centers for Medicare & Medicaid Services on February 1, 2013, published long-awaited rules (the “Rules”) detailing manufacturers’ and group purchasing organizations’ reporting requirements under Section 6002 of the Patient Protection and Affordable Care Act, otherwise known as the Physician Payment Sunshine Act. This Alert is the second in Duane Morris’ series of Alerts on the new Sunshine Act reporting requirements, and addresses the unique reporting requirements for applicable manufacturers’ making payments or transfers of value related to clinical research and pre-clinical research. The Rules contain different reporting requirements for these research-related payments, so applicable manufacturers may want to analyze their relationships now in preparation for the August 1, 2013, data collection start date.

Click here to read more about the Rules and what every applicable manufacturer should know about reporting research-related payments.

February 25, 2013September 10, 2014 by Duane Morris

New HIPAA Rules Regarding Genetic Information Affect Employers, Group Health Plans, Health Insurers and Healthcare Providers

Because HIPAA includes employer-sponsored group health plans under the definition of insurers, employers that sponsor plans are also affected by the GINA amendments to the HIPAA Privacy Rule (“the GINA amendments”). In addition, the GINA amendments will have applicability beyond the insurance industry because they draw distinctions between permissible and impermissible uses of “genetic information” in connection with the diagnosis of a medical condition. Click here to read more about how the new HIPAA rules regarding genetic information affect employers, group health plans, health insurers and healthcare providers.

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February 22, 2013September 10, 2014 by Duane Morris

Employers Take Note: Final HIPAA Rules Mandate New Obligations for Group Health Plans

Employers that sponsor group health plans for their employees should pay careful attention to the newly announced final omnibus rule amending HIPAA in accordance with the HITECH Act of 2009. This final rule under the HITECH Act, issued on January 17, 2013, impacts group health plans in two significant ways. Group health plan sponsors should act now to make changes to existing plan documents, including HIPAA procedures and business associate agreements, in response to the Final Rule.

Click here for an overview of how HIPAA generally applies in the context of employer-sponsored group health plans and these significant changes impacting group health plans.

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February 11, 2013September 10, 2014 by Duane Morris

HIPAA Minimum Necessary Standard Should Be Key Component of Policies and Procedures, Now More Than Ever

The HIPAA Rules require that when a HIPAA-covered entity (a provider, plan or clearinghouse) or a business associate of a covered entity uses or discloses protected health information (“PHI”), or when it requests PHI from another covered entity or business associate, the covered entity or business associate must make “reasonable efforts to limit protected health information to the minimum necessary to accomplish the intended purpose of the use, disclosure, or request.”

Click here to read more about the HIPAA “minimum necessary” standard—one of the most essential, yet vague, aspects of the HIPAA Rules.

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February 8, 2013September 10, 2014 by Duane Morris

Duane Morris Partner Susan Kayser Is Quoted in McKnight’s Long-Term Care News & Assisted Living Article

Duane Morris partner Susan Kayser is quoted in the McKnight’s Long-Term Care News & Assisted Living article, “Falsified Records Mean Legal Woes for Adminstrator, Aide,” in which she discusses the alteration of records in a long-term care setting, in light of two recent cases that landed a nursing home administrator and a nurse aide in legal hot water.

Click here to read the article and Susan’s comments on this long-term care and assisted living issue.