Healthcare Compliance

News & Analysis as of

OCR announces launch of Phase 2 of HIPAA audits

Although the Office for Civil Rights (OCR) has indicated in the past that it would start its next round of HIPAA audits, apparently it means business now. In the wake of an Inspector General report that the OCR was merely...more

Reporting for ACA Mandates: Final Forms and Additional Guidance

The IRS has finalized the 2015 forms and instructions for reporting under the individual and employer mandates and issued additional guidance on these new reporting requirements. The following forms are now available...more

Recent Cases Involving 60-Day Overpayment Rule Should Put Healthcare Providers on Alert

Two recent federal court cases show that the federal government intends to vigorously enforce the so-called “60-day Rule” for the return of overpayments enacted as part of the Affordable Care Act (the “ACA”) even though the...more

ACA Compliance Requirements and Opportunities for the Small Employer

Small employers should be aware of certain changes and continuing small employer opportunities relating to the Affordable Care Act (aka, ObamaCare). Starting in 2016, the ACA expands the small group market to include...more

HHS Issues Proposed 340B Program Omnibus Guidance: Five Things to Watch

The 340B Drug Pricing Program (340B Program), established by Section 602 of the Veterans Health Care Act of 1992, is administered by the Health Resources and Services Administration (HRSA) of HHS. The 340B Program requires...more

Companionship Rule Is on Course to Go Into Effect October 13, 2015

The D.C. Circuit Court of Appeals has declined to stay its recent revival of the Final Rule eliminating the companionship and live-in domestic services exemptions for third-party providers. As we previously reported in a...more

It’s About Time! 10 Key (Needed) Changes Proposed to the Human Subjects Protection “Common Rule”

The world has changed drastically since 1991 when Operation Desert Storm was underway; the USSR crumbled; Prince Charles and Princess Diana separated; the World Wide Web was born; gas cost $1.14; and the Dow peaked at 3168....more

Evolving Litigation of Data Breach Claims

An Illinois circuit court judge has dismissed five of six claims in a consolidated class action against Advocate Health and Hospital Corporation arising from a data breach in July 2013. The judge’s dismissal with prejudice...more

State Data Breach Notification Requirements Specifically Applicable to Insurers

Almost all U.S. states and territories have enacted breach notification laws requiring private and/or government entities to notify individuals when their personal information is compromised....more

HHS Proposes Rules for Nondiscrimination in Health Care

On September 8, 2015, the U.S. Department of Health and Human Services (“HHS”) proposed new regulations implementing Section 1557 of the Patient Protection and Affordable Care Act (“ACA”). Section 1557 prohibits...more

Illinois Enacts Patient Notification Requirement for Observation Stays

Illinois joins a growing number of states to pass laws requiring that hospitals provide notice to patients who are placed under observation status. 210 ILCS 86/6.09b As with the recent federal NOTICE Act, the laws respond to...more

Don’t Wait for It; Recent HIPAA Enforcement Action Signal More to Come in Phase 2 Audits

Officials at the U.S. Department of Health and Human Services Office of Civil Rights (HHS OCR) have recently selected a vendor to conduct the second wave of HIPAA audits. These so-called “Phase 2 Audits” are set to commence...more

Practices, Optics and Implications: A Cautionary Tale from the North Broward Hospital District Settlement

The $69.5 million settlement by North Broward Hospital District in Fort Lauderdale, Florida to resolve False Claims Act allegations paints a cautionary tale of the importance of hospital practices and optics in connection...more

OCR Enters into $750,000 Settlement with Physician Practice for HIPAA Violations

On September 2, the Department of Health and Human Services Office of Civil Rights (OCR) announced a settlement with Cancer Care Group, P.C., a thirteen-physician oncology practice in Indiana related to violations of the...more

Avoiding the Costly “Robo No-No”

The Telephone Consumer Protection Act (“TCPA”) was enacted to protect consumers from intrusive robocalls, but Congress probably did not foresee that it would result in a windfall for plaintiff’s lawyers. Virtually every...more

Prosecuting Doctors for Medicare Fraud

Federal prosecutors have turned their attention to physicians for Medicare fraud prosecution. Physicians who participate in the Medicare program have to be aware of the significant risks of Medicare fraud....more

OCR settlement reiterates importance of proactive security rule compliance

On September 2, 2015, the U.S. Department of Health & Human Services (HHS) announced that Cancer Care Group, P.C. (CCG), a physician practice located in Indiana, agreed to pay $750,000 as part of a settlement to resolve...more

August Whistleblower News Digest | News Your CCO Needs to Know

Morgan Stanley is in the news once again for whistleblower retaliation in a new lawsuit that mentions some of the same staff members involved in the last suit against them. Progenics was found guilty of retaliation, NuVasive...more

DOL Agrees to 30-Day Grace Period on Enforcement of the Home Care Final Rule

On Friday, the U.S. Department of Labor (DOL) announced that it will not enforce the Final Rule eliminating the companionship and live-in domestic service exemptions for “third-party” providers” until 30 days after the U.S....more

Crafting a more realistic business associate agreement

According to a recent survey by KPMG, eighty percent (80%) of health care executives report that their information technology systems have been compromised by cyber attacks. Most healthcare institutions, the survey found,...more

Focus on the TCPA: Consolidated Appeal of FCC’s TCPA Order Continues to Grow

The Federal Communications Commission’s (FCC) July 10, 2015 Declaratory Ruling and Order on the Telephone Consumer Protection Act (TCPA) was received by many in the business community with great concern. The Order’s seemingly...more

340B Guidance: Eight Key Points Covered Entities Should Consider

On August 27, 2015, the Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), released the 340B Drug Pricing Program Omnibus Guidance (Guidance). Referred to...more

Highway 61 Revisited-Tombstone Blues and Corporate Integrity Agreements

I conclude my tribute to my favorite Bob Dylan album, Highway 61 Revisited with a look at the most surreal song on the disc, Tombstone Blues. I want to use it to contrast the most excellent article that appears today as a...more

Time for a HIPAA Security Check-Up!

The 2015 HIPAA Security conference held by the National Institute of Standards and Technology (“NIST”) and the U.S. Department of Health and Human Services, Office for Civil Rights (“OCR”) kicked off last week with OCR’s...more

EPA Proposes New Rules for Pharmaceutical Hazardous Waste Management and for Other Hazardous Waste Generators

The U.S. Environmental Protection Agency (EPA) has announced two new proposed hazardous waste rules that EPA believes would clarify and simplify requirements for health care facilities and retail pharmacies to manage their...more

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