Overview of 2013 Amendments to HIPAA Privacy, Security, Breach Notification and Enforcement Rules

The 2013 Amendments include a number of sweeping changes to the HIPAA Rules, including the expansion of the definition of a business associate to include their subcontractors that handle protected health information (“PHI”); a lower threshold for determining whether a breach has occurred for reporting purposes; and restrictions on “marketing” activities and the “sale” of PHI.

Click here to read this Overview Summary of the 2013 Amendments. Duane Morris is issuing a series of Alerts on the 2013 Amendments. Please see the in-depth Alerts already distributed by the firm on changes under the 2013 Amendments to the definition of a business associate and changes to the breach notification requirements. We will continue to issue Alerts on discrete HIPAA topics.

New HIPAA Breach Notification Rule May Prove Costly for HIPAA-Covered Entities

One of the most significant changes in the final HIPAA amendments is the Breach Notification Rule, which modifies and clarifies the definition of “breach” and the risk-assessment approach required for breach notification. In light of this heightened standard, covered entities, business associates and downstream contractors should consider carefully reviewing their breach notification policies and procedures, training materials and contractual arrangements in an effort to avoid potential liability under the Breach Notification Rule.

Click here for more information on the most significant changes to the Breach Notification Rule.

Final HIPAA Amendments Expand HIPAA Net: Business Associates Now Required to Enter into Business Associate Agreements with Subcontractors

Among the most significant changes of the Final HIPAA amendments are the provisions that extend the Privacy and Security Rules’ stringent compliance obligations to business associates (BA) and expand the definition of BAs to include subcontractors of BAs. Why the changes? The HITECH Act of 2009 specifically extends direct liability to BAs and expands the list of obligations for BAs. The Department of Health & Human Services extends BA obligations even further to ensure the privacy and security of all PHI throughout the HIPAA ecosystem.

Click here to read a summary of the key provisions under the 2013 amendments, as well as factors that may be worthwhile for covered entities and business associates to consider in light of these amendments.

Antitrust Laws No Help to Excluded Physicians

When physicians are excluded from medical staff privileges because the hospital has entered into an exclusive agreement with other physicians, the element of “exclusion” often raises the suggestion that somehow the antitrust laws are implicated and competition has been adversely affected. The recent opinion of the United States Court of Appeals for the Third Circuit in Bocobo v. Radiology Consultants of South Jersey, P.A., et al. , No. 07-3142 (3d Cir. April 13, 2012)(not precedential), explains why the antitrust laws do not afford a remedy to an excluded physician when a hospital contracts with a provider group that does not include the plaintiff physician.

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HHS Releases Final Rule and Interim Final Rules on Affordable Care Act’s State Health Insurance Exchanges

On March 12, 2012, the U.S. Department of Health and Human Services (HHS) released the long-anticipated Final Rule and Interim Final Rules (the “Rules”) on the Patient Protection and Affordable Care Act’s (ACA) state health insurance exchanges (“Exchange(s)”), a key element of President Obama’s healthcare reform plan. Set to go into effect on January 1, 2014, the goals of the Exchanges are to enhance competition, improve availability of affordable health insurance options and allow small businesses the same purchasing power that large businesses currently enjoy. As described in the Rules, the Exchanges will operate as competitive marketplaces, allowing individual consumers and small businesses to directly compare pricing and quality of health insurance options, among other factors.

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Aetna Sues Surgery Centers Over Billing Practices

In a bold and seemingly unprecedented move, Aetna recently sued several California surgery centers for an alleged “fraudulent billing scheme”. The lawsuit alleges that the surgery centers induced physicians to refer patients to the surgery centers with promises that the patients would not have any financial responsibility for their coinsurance and deductibles. Aetna claims that the surgery centers then turned around and submitted charges for reimbursement that were artificially inflated driving up the cost of health insurance coverage.

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CMS Awards Loans to First Seven CO-OPs

On February 21, 2012, CMS announced its first award of repayable loans to seven Consumer Operated and Oriented Plans (CO-OPs). The awards will help CO-OPs establish private, non-profit, consumer-governed health insurance companies with the goal of expanding health insurance options for consumers and small businesses. The CO-OPs will eventually operate in each states’ health insurance exchange under the Affordable Care Act, but will also offer plans outside of the exchange. Starting on January 1, 2014, the first seven CO-OPs will become operational in eight states.

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HHS OIG Notice Seeks Comments on Safe Harbors, Special Fraud Alerts

Once a year, as required by the Health Insurance Portability and Accountability Act of 1996, the Department of Health and Human Services Office of the Inspector General (“OIG”) solicits proposals to develop new or revised anti-kickback, fraud and abuse safe harbors. The OIG published its request for proposals for new or revised safe harbors in the December 29, 2011 Federal Register. The notice also seeks comments on developing special fraud alerts.

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Proposed Physician Payment Disclosure Rule Published

The Centers for Medicare and Medicaid Services (“CMS”) released its proposed rule regarding the required reporting of device, biologics and pharmaceutical manufacturer payments to physicians on December 14, 2011. The proposed rule includes templates for physicians and manufacturers to use when logging payments and gifts.

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Don’t Just Pay the RAC

Medicare Recovery Audit Contractors (RACs) mine data using automated systems to detect and recover improper Medicare payments. RAC audits pick up billing and coding errors and deny claims based on those errors. In many instances, the service was provided and was billable. In some cases, the coding error makes no difference in reimbursement, sometimes reimbursement should be higher, sometimes lower, but still reimbursable, under some code. In some cases, the RAC’s automated systems deny claims that were properly billed, because of software coding flaws. RAC auditors don’t correct billing errors, they just take the money back.

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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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