Healthcare Compliance

News & Analysis as of

Health Care E-Note - November 2015

With medical device related acquisitions at all-time highs, and regulatory interest intense from the Federal Trade Commission, the Food and Drug Administration, the Securities and Exchange Commission, and the Office of...more

OCR Expected to Strengthen HIPAA Enforcement in 2016

Two recent reports issued by the Office of Inspector General (“OIG”) for the U.S. Department of Health and Human Services (“HHS”) recommended that HHS’s Office for Civil Rights (“OCR”) should fully implement a permanent audit...more

CMS Proposes Rules Requiring LTC Facilities to Implement Compliance and Ethics Programs

Under proposed rules issued by the Centers for Medicare and Medicaid Services (CMS), long term care (LTC) facility operators would be required to develop, implement and maintain a comprehensive compliance and ethics program...more

OIG Guidance Addresses Compliance Risks of Emerging Trends in the Healthcare Industry

The Office of Inspector General of the U.S. Department of Health and Human Services (OIG) recently released new compliance guidance to help healthcare governing boards, attorneys, compliance officers and internal auditors...more

CMS Makes Significant Changes to Stage 2 Meaningful Use and Finalizes Stage 3

On October 16, 2015, the Centers for Medicare & Medicaid Services (CMS) published a final rule (Final Rule) that streamlines Stage 2 and finalizes Stage 3 of the Medicare and Medicaid electronichealth record (EHR) Incentive...more

Recent Amendments to Security Breach Notification Laws Further Complicate Breach Notification for Employers

It is not a matter of "if" but "when" an employer will be required to notify employees of a security breach.  Forty-seven states require employers to notify employees when defined categories of personal information, including...more

Developments in Long-Term Care Q2 2015

The following summary highlights key federal court developments and administrative decisions involving skilled nursing facility survey and related issues during the second quarter of 2015....more

EPA'S Hazardous Waste Pharmaceuticals Rules May Impose Significant Burdens on Health Care Facilities - Comment Period Runs Until...

The Environmental Protection Agency (EPA) has promulgated its proposed regulation of “hazardous waste pharmaceuticals,” i.e., pharmaceutical residues discarded from health care facilities which also meet EPA’s long-standing...more

OIG Hospital Compliance Audits: Is Your Number Up? Are You Ready?

In its Work Plan for Fiscal Year 2012, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) announced it would begin reviews of Medicare payments to hospitals to determine compliance...more

HELP! FTC Staff Steps Up to the Plate with Guidance for State Officials on Regulating Occupational Boards

Answering the call from state officials seeking advice regarding antitrust compliance for state boards responsible for regulating occupations, Federal Trade Commission (FTC) Staff have stepped up to answer two questions...more

Preparing for the Approaching ACA Reporting Deadlines

With ACA reporting deadlines quickly approaching, many employers should be preparing to address the various reporting requirements in order to avoid the significant fines and penalties associated with non-compliance. As of...more

Alphabet Soup and Data Security

In the span of two days, mobile device users learned of two data breaches that could compromise their personal data. In one, Experian (a credit reporting agency) reported that it was hacked, potentially putting 15 million...more

OCR portal designed for medical mobile app developers

The Office for Civil Rights (OCR) of the Department of Health and Human Services has launched a web based portal so medical mobile app developers can ask their “burning” questions about HIPAA compliance....more

Meaningful Use Audits: Proactive Tips for Success

For health care professionals who began accepting Meaningful Use incentive money at the outset of availability under the Medicare option in 2011, the year 2015 is an important year. If the provider has met all core...more

Privacy, Security, Risk: What You Missed At IAPP Conference

Earlier this month, privacy and security professionals from around the globe gathered for “Privacy. Security. Risk. 2015”—the second joint conference between the International Association of Privacy Professionals and the...more

HIPAA Fine Underscores OCR’s Focus on Physician Group Compliance

The U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) recently announced a $750,000 fine and resolution agreement, including a Corrective Action Plan (CAP), for Cancer Care Group, P.C. (CCG), a...more

Bristol-Myers Squibb Pays $14 Million to SEC to Resolve China FCPA Offenses

On October 5, the SEC announced a settlement with Bristol-Myers Squibb to resolve allegations that the pharmaceutical company’s Chinese joint venture, BMS China, gave cash, jewelry, and other benefits to health care providers...more

Is Your HIPAA Compliance Program Ready for the FTC?

Everyone in healthcare knows that the next round of HIPAA audits is coming. Covered entities and business associates have long been advised to review and update their HIPAA security risk analyses, have business associate...more

Four Clear Messages from Bristol Meyers Squibb FCPA Enforcement Action

The SEC’s FCPA enforcement action for $14.6 million against Bristol Meyers Squibb (“BMS”) in China provides a textbook example of how things can go wrong in China. For the compliance practitioner (as well as CEO and...more

OIG report spurs OCR to announce phase 2 audits

On September 29, it was revealed that the HHS Office for Civil Rights (OCR) will commence Phase 2 of its HIPAA audit program in “early 2016.” OCR’s revelation regarding the Phase 2 audits, which had been the subject of...more

USDOL "Companionship", "Live-In Domestic" Enforcement Coming

The U.S. Labor Department has now announced that, beginning on November 12, it will start enforcing its revised regulations governing the Fair Labor Standard Act's Section 13(a)(15) "companionship" exemption and Section...more

New Licensing and Regulatory Requirements for Pharmacy Benefit Managers in Ohio

House Bill 64 recently amended Ohio Revised Code Chapter (ORC) 3959. The relevant code sections amended by House Bill 64 are ORC 3959.111 and ORC 3959.12 and these changes took effect on September 29, 2015. Pursuant to...more

EXPECT FOCUS: Onboard Technology, NAIC Cybersecurity, DOL, ACA Litigation, SEC Regulation (Vol. III, Summer 2015)

In This Issue: IN THE SPOTLIGHT - - Your Data Breach Collided With My Personal Injury Coverage LIFE INSURANCE - - Phantom Injury Dooms “Shadow Insurance” Case - Latest NAIC Cybersecurity News - A...more

Justice Department Recovers Nearly $6 Billion From False Claims Act Cases in 2014

The U.S. Department of Justice (DOJ) obtained a record $5.69 billion in settlements and judgments from civil cases involving fraud and false claims against the government in fiscal year 2014. This marks the first time the DOJ...more

Supreme Court Denies Further Stay of Department of Labor's Home Care Rule; Effective Date is Imminent

On August 21, 2015, the U.S. Court of Appeals for the D.C. Circuit upheld the U.S. Department of Labor’s (DOL) Home Care Rule and reversed the lower court’s decisions vacating the new rule. On October 6, 2015, the U.S....more

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