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“Full Employment for CISOs in New York”: New York Proposes the Nation’s First Cybersecurity Regulation

If you’re a CISO living in New York get ready for the phone calls!!! On September 13, 2016, Governor Andrew M. Cuomo proposed the nation’s first cybersecurity regulation. Starting on September 28, 2016 there is a limited 45...more

Data Security Plays a Key Role in the Adoption and Success of Precision Medicine

The White House recently released a guidance document for those in the precision medicine community to help ensure that participants’ data and resources remain secure. The document, titled “Precision Medicine Initiative:...more

The E-Cigarettes Industry Fights Back Challenging the FDA in Federal Court

Days after the publication of the Food and Drug Administration’s controversial final rule regarding e-cigarettes (and other nicotine-delivering products), a company called Nicopure Labs LLC filed a lawsuit challenging it in...more

Heads-Up! HIPAA Phase Two Audits Begin – Business Associates Included!

The Department of Health and Human Services (HHS) Office of Civil Rights (OCR) finally announced on March 21 that it is ready to begin Phase Two of its HIPAA audit program, which will include business associates. These...more

3/24/2016  /  Covered Entities , HHS , HIPAA Audits , HITECH , OCR

Finally! CMS Publishes the 60-Day Rule for Reporting and Repaying Medicare Overpayments

After four years and 200 comments, CMS finalized the much-awaited “60-Day Rule” for reporting and repaying Medicare Part A and B overpayments (CMS issued a Final Rule related to Medicare part C and D overpayments in the May...more

Largest Criminal Health Care Fraud Takedown – 243 Charged and $712 Million in False Billings

On June 18, 2015, HHS Secretary Sylvia M. Burwell and DOJ Attorney General Loretta E. Lynch announced nationwide arrests in Medicare fraud schemes amounting to approximately $712 million in false billings. Attorney General...more

Not Much New … But a Good Reminder for Medical Director Relationships

After a significant number of settlement agreements between the U.S. Department of Health and Human Services Office of Inspector General (OIG), OIG decided to release a Fraud Alert reminding physicians, practices and...more

Another Health Plan Hit By Massive CyberAttack and Class Actions Follow

Coming fresh off the heels of the Anthem data breach Premera Blue Cross announced on March 17th that it was the victim of a “sophisticated” cyberattack that may have exposed the personal information of approximately 11...more

“It’s Not Easy to Unscramble the Eggs” … Despite the FTC’s Win at the U.S. Supreme Court, the Phoebe Putney Hospital Merger...

Nearly four years after the Federal Trade Commission (“FTC”) first challenged the combination of the only two hospitals in Albany, Georgia, the FTC, Phoebe Putney Health Systems, Inc. (“Phoebe Putney”), Hospital Authority of...more

Another Health Plan Hit By Massive CyberAttack and Class Actions Follow

Coming fresh off the heels of the Anthem data breach Premera Blue Cross announced on March 17th that it was the victim of a “sophisticated” cyberattack that may have exposed the personal information of approximately 11...more

On the Horizon … A Possible “Permanent” Cure to Medicare’s “Doc Fix”

In a historic bipartisan moment, the U.S. House of Representatives passed a nearly 300-page bill that is intended to “repeal the Medicare sustainable growth rate [“SGR”] and strengthen Medicare access by improving physician...more

Going Paperless: FDA Releases Draft Guidelines to Digitize Clinical Trials

The FDA released draft guidelines (“Guidelines”) on Monday, March 9, 2015 establishing recommendations on the use of e-media and processes to obtain informed consent for clinical investigations (trials) of medical products...more

ProMedica and the AHA Seek Guidance from SCOTUS on Hospital Consolidations and Mergers

The New Year started out with a bang in the healthcare antitrust circles with ProMedica Health Systems Inc.’s (“ProMedica”) well-publicized petition to the US Supreme Court and the American Hospital Association’s (AHA) amicus...more

Decision Alert: US Supreme Court Potentially Shifts the Balance in Healthcare Employee Benefits Litigation

Justice Clarence Thomas and a unanimous US Supreme Court decided to vacate a Sixth Circuit decision and hold that the federal courts cannot assume from silence in a union’s collective bargain agreement that retiree group...more

Time to Get Rid of Those Post-it Notes with All Your Passwords!!!

This month, Governor Chris Christie signed into law a New Jersey bill requiring health insurance carriers (e.g., insurance companies, health service corporations, hospital service corporations, medical service corporations,...more

“LoProCo”, 12,915 Complaints, and Other Lessons from OCR/NIST

12,915 complaints were reported in 2013 to the Department of Health and Human Services Office of Civil Rights (“OCR”) according to Illiana L. Peters, Senior Adviser for HIPAA Compliance and Enforcement. Cozen O’Connor...more

9/29/2014  /  Cybersecurity , Data Protection , EHR , HIPAA , NIST , OCR , PHI

CMS and ACOs: A Busy Summer and a Busier Fall

It has been a busy summer so far for the Centers for Medicare & Medicaid Services (CMS) with respect to Accountable Care Organizations (ACOs), as the agency has proposed altering the quality reporting measures under the...more

Recent OCR Reports Illustrate Past and Future Compliance and Enforcement Efforts

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...more

ACOs And Pay for Value … About the Data

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...more

The American Medical Association Releases New Telemedicine Recommendations

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...more

Is $210 Million Enough? How About $54.2 Million?

On June 25, 2014, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services Office of Inspector General (OIG) issued and certified, as required by the Small Business Jobs Act of 2010...more

Attention All Health Plans: You Must Register for an HPID. Immediately!!!

It has been 18 years in coming, and the time is finally here. All Controlling Health Plans (CHPs) must obtain a unique Health Plan Identifier (HPID). A CHP is a health plan that controls its own business activities, actions,...more

Enforcement Action – FTC Is Not Backing Down and Laboratory Company Goes After a Cyber-Intelligence Company

The Department of Health and Human Services (HHS) Office for Civil Rights (OCR) is not the only government arm that enforces data breaches. The Federal Trade Commission (FTC) has broad authority to regulate the security of...more

Data Brokers: “Off the Radar” – FTC Calls for Greater Oversight

A report recently released by the Federal Trade Commission (FTC) concludes that data brokers currently operate so far below the radar screen that most consumers are unable to exercise any real control over the collection and...more

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