Monthly Archives: July 2014

Recent OCR Reports Illustrate Past and Future Compliance and Enforcement Efforts

Posted by Ryan Blaney on July 29, 2014
HIPAA, HITECH / No Comments

Daily news stories about data breaches and enforcement actions seem to be the new norm, so it’s no surprise that people may start to believe that hackers have won the war and that no personal health information is safe. But exactly how many breaches have been reported in the last several years? And were the breaches the result of nefarious plots or just plain incompetence? About how many HIPAA investigations has the government actually launched?

Rest assured, Congress has been asking similar questions as well. The HITECH Act requires the Department of Health and Human Services Office for Civil Rights (OCR) to submit annual reports to Congress that provide contextualized information about incident rates and government action; OCR published its most recent two reports on Breaches of Unsecured Protected Health Information (Breach Report) and HIPAA Privacy, Security, and Breach Notification Rule Compliance (HIPAA Compliance Report).  In addition to including cumulative data, the reports cover relevant activities that occurred between January 1, 2011, and December 31, 2012. Continue reading…

Ryan Blaney

Ryan Blaney

Ryan Blaney joined Cozen O'Connor as a member of the firm's Health Law group. Ryan practices in the firm's Washington, D.C., office. He focuses his practice on representing clients in the health care and life sciences industries in a wide range of matters, including health care fraud and abuse, civil and criminal government investigations, qui tam and whistle-blower disputes under the False Claims Act and other federal and state laws and regulations, HIPAA privacy and data security, compliance and transactional services, and antitrust matters.

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ACOs and Pay for Value … All About the Data

Posted by Chris Raphaely on July 24, 2014
Accountable Care Organizations, Affordable Care Act, HIPAA, Privacy / No Comments

It has been over three years since the Centers for Medicare and Medicaid Services (CMS) announced its proposed rule and guidance on the development and implementation of Accountable Care Organizations.  About four million Medicare beneficiaries are now in an ACO, and over 400 provider groups are participating in ACOs.  See February 19, 2013 Health Affairs Blog. An estimated 14% of the U.S. population is being treated within an ACO. See April 16, 2014 Kaiser Health News.

By all indications, these numbers will continue to grow as the US health system moves away from the fee-for-service model to pay for value models that reward quality and cost savings and require clinical coordination among different types of providers, in many cases providers who are unrelated other than through an ACO or other similar arrangement.  The seamless sharing of data, patient information and collaboration among large, medium and small physician practices, hospitals, post-acute providers, and even private companies like pharmacy chains is critical to the success of these organizations. Continue reading…

Chris Raphaely

Chris Raphaely

R. Christopher Raphaely joined Cozen O'Connor's Philadelphia office in 2014 as co-chair of the Health Care Practice Group. Chris joins the firm from Jefferson Health System, where he served as deputy general counsel and general counsel to the system’s accountable care organization and captive professional liability insurance companies.

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We Don’t Need No Intervention: Qui Tam Relator in Omnicare Wins Big Without DOJ

Posted by J. Nicole Martin on July 23, 2014
DOJ, False Claims Act, Whistleblower / No Comments

The United States Department of Justice (DOJ) recently announced the settlement of two qui tam whistleblower lawsuits against Omnicare Inc., the largest nursing home pharmaceutical and pharmacy services vendor in the nation. The suits alleged that Omnicare gave significant discounts to skilled nursing facilities in exchange for lucrative referrals and pharmacy provider contracts. This $124.24 million settlement is the largest ever in a “swapping” case brought under the Anti-Kickback Statute.

In addition to its size, this settlement is noteworthy because DOJ had initially declined to intervene in the underlying suits and relators pursued the claims independently. That go-it-alone decision was so resoundingly vindicated in Omnicare, it is likely that this case will encourage other whistleblowers to follow a similar course of action. Relators have long had the right to continue False Claims Act litigation without governmental participation. DOJ’s decision whether to intervene or not was traditionally (although not explicitly stated) viewed as a reflection of the strength of the whistleblower’s allegations.  With the increase in whistleblower complaints, the limitations on the number of cases that DOJ can put resources on, statutory changes, the rise of a specialized qui tam bar, and big dollar victories like this may significantly increase the number of independent qui tam lawsuits. Continue reading…

J. Nicole Martin

J. Nicole Martin

J. Nicole Martin is an associate and practices in the Health Care Practice Group. Nicole assists accountable care organizations, health care systems, long term care providers, behavioral and mental health providers, medical device manufacturers, physician practices and pharmacies with their compliance, regulatory and transactional needs. Nicole’s practice includes providing clients with counsel regarding HIPAA/HITECH and state privacy and security laws, data breaches, business associate and covered entity obligations, licensure laws, Medicare, Medicaid and third-party payer matters, medical staff issues, and fraud and abuse laws. Nicole also represents clients undergoing changes of ownership and changes of control, and assists them with the transactional, regulatory and compliance requirements necessary to finalize the transactions.

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The American Medical Association Releases New Telemedicine Recommendations

Posted by Ryan Blaney on July 09, 2014
Telemedicine / No Comments

Recently, the American Medical Association (AMA) released a report on telemedicine (Report) that, among other things, (i) outlines coverage and payment rules; (ii) summarizes various specialty society practice guidelines/position statements; and (iii) presents its own position and recommendations regarding the role of telemedicine in the provision of health care. The Report provides a current overview of barriers (e.g., reimbursement and licensure) that prevent further implementation of telemedicine in the provision of health care in our society, and it also emphasizes the importance of ensuring quality of care, patient safety, and coordination of care. The AMA’s publication of this Report will hopefully continue the important dialogue regarding the promise of telemedicine.

Look for an upcoming more detailed client alert analyzing this Report, other updates concerning telemedicine, and the general role of telemedicine in our healthcare system.

Ryan Blaney

Ryan Blaney

Ryan Blaney joined Cozen O'Connor as a member of the firm's Health Law group. Ryan practices in the firm's Washington, D.C., office. He focuses his practice on representing clients in the health care and life sciences industries in a wide range of matters, including health care fraud and abuse, civil and criminal government investigations, qui tam and whistle-blower disputes under the False Claims Act and other federal and state laws and regulations, HIPAA privacy and data security, compliance and transactional services, and antitrust matters.

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Begin Preparing for Pennsylvania’s Enforcement of Act 122

Posted by J. Nicole Martin on July 02, 2014
Pennsylvania Department of Health / No Comments

The Pennsylvania Department of Health (“DOH”) Bureau of Laboratories (“Bureau”) recently announced that it will begin to phase-in enforcement of Act 122, which amended the Pennsylvania Clinical Laboratory Act (“Lab Act”), even though Act 122 became effective on December 18, 2013. The Bureau also issued additional guidance regarding Act 122 in its Frequently Asked Questions, Volume 1 and Volume 2 (“FAQs”).

According to its Senate Co-Sponsorship Memoranda, the purpose of Act 122 was to: (1) prohibit the “placing of phlebotomists or specimen collectors in physician and other health care provider offices in the Commonwealth;” and (2) afford Pennsylvania laboratories “the ability to compete on a level playing field with out-of-state labs” who had been able to place staff in providers’ offices “without fear of sanction.” However, the broad language of Act 122 will also affect laboratories’ ability to collect specimens from skilled nursing facilities (“SNFs”). Continue reading…

J. Nicole Martin

J. Nicole Martin

J. Nicole Martin is an associate and practices in the Health Care Practice Group. Nicole assists accountable care organizations, health care systems, long term care providers, behavioral and mental health providers, medical device manufacturers, physician practices and pharmacies with their compliance, regulatory and transactional needs. Nicole’s practice includes providing clients with counsel regarding HIPAA/HITECH and state privacy and security laws, data breaches, business associate and covered entity obligations, licensure laws, Medicare, Medicaid and third-party payer matters, medical staff issues, and fraud and abuse laws. Nicole also represents clients undergoing changes of ownership and changes of control, and assists them with the transactional, regulatory and compliance requirements necessary to finalize the transactions.

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