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July 10, 2013September 10, 2014 by Duane Morris

IRS Publishes Notice Providing Transition Relief in Response to ACA Delay

As outlined in our prior Alert, the Obama administration recently announced a one-year delay in the effective date of three key provisions of the Patient Protection and Affordable Care Act (ACA): (1) the annual information reporting requirements applicable to insurers, self-insuring employers and certain other providers of minimum essential coverage, (2) the annual information reporting requirements applicable to large employers (i.e., those with 50 or more full-time equivalent employees); and (3) the employer shared responsibility provisions. These provisions of the ACA will now be fully effective for 2015.

Click here to read the full Alert, which provides highlights from the IRS Notice 2013-45.

July 3, 2013September 10, 2014 by Duane Morris

Obama Administration Delays ACA Employer Reporting and Penalties for 2014

In a July 2, 2013, blog posting on the U.S. Department of the Treasury website titled “Continuing to Implement the ACA in a Careful, Thoughtful Manner” the Obama administration announced that it will provide an additional year before the Patient Protection and Affordable Care Act’s (ACA) mandatory employer and insurer reporting requirements begin. These reporting requirements, which were originally scheduled to go into effect on January 1, 2014, will now be delayed until January 1, 2015. More significant is the fact that the Obama administration acknowledges that the delay in the reporting requirements will make it impractical to determine which employers owe shared responsibility payments for 2014. Therefore, the employer shared responsibility provisions will also not be applicable until 2015.

Click here to read the full Alert.

June 27, 2013September 10, 2014 by Duane Morris

Duane Morris Co-Hosted “The 2013 mHealth Prognosis: Converging Business and Legal Trends”

Duane Morris, in conjunction with the Wharton Health Care Management Alumni Association and Locust Walk Partners, presented a networking reception and panel discussion of the key legal and business issues for mHealth app developers and entrepreneurs on Wednesday, June 26, 2013, at the University of Pennsylvania’s Bodek Lounge. Panelists discussed topics including healthcare industry trends and mHealth growth; investment and business trends; legal and regulatory issues; and healthcare IT and reimbursement issues.

Click here to see pictures of the event.

June 12, 2013September 10, 2014 by Duane Morris

State Medicaid Fraud Control Units’ Data Mining Likely to Increase Through Federal Funding

Effective June 17, 2013, state Medicaid fraud control units (MFCU) will be permitted to use federal matching funds to pay for data mining activities to detect potentially fraudulent utilization and billing patterns. Historically, MFCUs have been prohibited from using federal matching funds to pay for the cost of data mining. Given the financial constraints facing MFCUs, this funding is likely to result in a substantial increase in activities by MFCUs across the United States. While this rule in and of itself is noteworthy, it is likely to have a more significant impact on healthcare providers when coupled with the regulation implementing the Patient Protection and Affordable Care Act (ACA) that requires states to suspend all Medicaid payments to a provider upon credible allegation of fraud during, or triggering, a Medicaid investigation.

Click here to read the full Alert.

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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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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