Category Archives: Healthcare Law

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Lack of Timely Action and Knowledge of Risk Results in $3.2 Million Civil Monetary Penalty for HIPAA Violations

Children’s Medical Center of Dallas (Children’s) was hit with a $3.2 million civil penalty from the U.S. Department of Health and Human Services, Office for Civil Rights (OCR) for failing to take steps to properly protect patient medical information. The civil penalty is the result of two data breaches caused by a lack of encryption and what was described as … Continue Reading

Potential Implications to the ACA Under the Incoming Republican Administration – Part IV: Pharmacies

The Affordable Care Act (ACA), as a whole, did not have a significant impact on pharmacy services per se. However, a complete repeal would likely impact certain areas of pharmacy services including the drug benefit for the exchange plans, the donut hole for Medicare Part D, states’ necessary Medicaid rebates, and certain recipients of 340B drugs.… Continue Reading

Potential Implications to the ACA Under the Incoming Republican Administration – Part III: Hospitals

President Trump has been clear in his intention to repeal the ACA. In fact, among President Trump’s first executive orders was one seeking to “minimize the economic burden” associated with the Patient Protection and Affordable Care Act (ACA). In addition to calling for its prompt repeal, he calls upon the executive branch to minimize the regulatory burdens of the ACA … Continue Reading

Potential Implications to the ACA Under the Incoming Republican Administration – Part II: Physicians

In contemplating the ways in which physicians may be affected by the possible repeal of the Affordable Care Act (ACA)—and certain features of any legislation that may replace it—a good place to start is with the person selected by President Trump to be the Secretary of the Department of Health and Human Services (HHS) – Representative Tom Price of Georgia, … Continue Reading

The AHA’s Letter to Santa Claus

The American Hospital Association, after having been “nice” all year, penned its letter to Santa Claus with its wish list for Christmas. Its four page letter (actually addressed to President-Elect Donald Trump at 1717 Pennsylvania Avenue, not Santa at the North Pole) advised the incoming President of its own public policy priorities and their vision for healthcare reform. Some of … Continue Reading

Are Recommendations of the White House Task Force on Behavioral Health Parity Trumped by the Election?

Recently the White House Behavioral Health Parity Task Force issued guidance on the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act (Parity Law). The Task Force could not have known, though, that on November 8th, the election may have changed the direction of the Task Force report and subsequent implementation. … Continue Reading

HHS Publishes a New Rule to Protect Dialysis Patients From Being “Steered” into Private Coverage for the Benefit of Dialysis Centers

On implementing significant, new requirements for Medicare-certified dialysis facilities that make payment of premiums for individual health coverage, on December 14, 2016, the Department of Health and Human Services (HHS) published an Interim final rule with comment period. The regulations become effective 30 days after the date of publication – January 13, 2017, and comments regarding the interim must be … Continue Reading

Recent CyberSecurity Incidents Emphasize Importance of Cyberinsurance

As the threat of cyberattacks continues to pose daily threats to businesses large and small, more companies have turned to cyber insurance products to shore up protection against these disruptive threats. A spate of recent incidents has highlighted the importance of taking steps to prepare for and mitigate possible damages. As such, healthcare entities have begun exploring Cyberinsurance as a … Continue Reading

The Florida Agency for Health Care Administration Releases an Invitation to Negotiate for a Vendor to Provide an All Payor Claims Database to Florida Consumers

The Florida Agency for Health Care Administration (AHCA) released ITN 003-16/17 (the “ITN”) to select a vendor to provide All Payer Claims Database (APCD) services pursuant to section 408.05(3)(c), Florida Statutes. The ITN, published on September 26, 2016, contains a tight time-frame for the submission and evaluation of responses to it. While written inquiries regarding the ITN must be … Continue Reading

The Changing Meaning of Healthy: FDA Seeks Public Input About Healthy Foods

In the 1990s, food had to be low in fat in order to be considered healthy. Those were the days of Snack-Wells cookies and fat-free salad dressings. How times have changed. Now health professionals consider many higher-fat foods such as almonds, avocado, eggs, and salmon to be healthy. Conversely, some low-fat but artificial, processed foods are no longer deemed healthy.… Continue Reading

CMS Postpones Pre-Claim Review Demonstration for Home Health Services

The Centers for Medicare & Medicaid Services (CMS) announced that it would postpone the initiation of the CMS Pre-Claim Review Demonstration for Home Health Services (the “Demonstration”) in Florida, which was scheduled to begin in October 2016. The start dates for Texas, Michigan and Massachusetts, which are also part of the Demonstration, have not yet been announced, but were originally … Continue Reading

When a Discount May be a Kickback

Healthcare providers of all kinds, as well as medical equipment suppliers, have traditionally relied upon discounts as a legitimate means of attracting patients and commercial clients without running afoul of the federal anti-kickback statute (AKS). Congress specifically created the discount “safe harbor” to the AKS years ago based on its policy of encouraging discounts that are properly disclosed as a … Continue Reading

Former Home Health Agency Owner Sentenced to 20 Years for $57MM Medicare Fraud

The US Department of Justice announced that Khaled Elbeblaswy, the former owner and manager three Miami-area home health agencies, was sentenced to 20 years in prison and ordered to pay $36.4 million in restitution for his role in a $57 million Medicare fraud scheme.… Continue Reading

The Board of Pharmacy’s 40 Hour Rule is Dead! Long live the 20 Hour Rule! Community Pharmacy Ownership Rule Change Creates new Opportunities

The Florida Board of Pharmacy (BOP) recently amended the rules regarding community pharmacy hours of operation to reduce required daily operating hours from 40 to 20 hours per week. As before, the hours have to be posted and the pharmacy must have a policy and procedure for transferring prescriptions and addressing emergency doses.… Continue Reading

11th Circuit Awards Humana Double Damages Under Medicare Secondary Payer Act

Humana Medical Plan, Inc. v. Western Heritage Insurance Co., case number 15-11436.

Liability insurers beware, as the 11th Circuit held that Medicare Advantage Organizations (MAO) are entitled to the same rights Medicare itself would have in actions against primary payers for reimbursement of conditional healthcare treatment costs. … Continue Reading

HHS Issues Final Non-Discrimination Rules for Healthcare Providers

Healthcare providers and others who receive federal financial assistance are now subject to new non-discrimination rules and notice requirements under the Affordable Care Act. The new regulation prohibits discrimination in healthcare programs and activities on the basis of race, color, national origin, age, disability and sex – including pregnancy, gender identity, and sex stereotyping. The new rule also encompasses the … Continue Reading

Brief Reprieve Before Hospitals Must Provide Medicare Patients with “Observation” Notices

Hospitals now have additional time before they must meet federal requirements to provide written notice to Medicare patients who are receiving observation services. Congress passed the Notice of Observation Treatment and Implication for Care Eligibility Act (NOTICE Act) in 2015, in response to patient confusion and complaints related to hospital observation stays. The rules were expected to be effective in … Continue Reading

What does the Escobar Decision Mean for Healthcare Providers?

Universal Health Services, Inc. v U.S. ex rel. Escobar

On June 16, 2016, the U.S. Supreme Court in Universal Health Servs., Inc. v. United States ex rel Escobar, No. 13-317, — S. Ct. — (June 16, 2016), confirmed that the implied certification theory may serve as a basis for liability under the False Claims Act (FCA), although it employed … Continue Reading

Medical Marijuana’s Florida Debut: A Process Fraught with Constraints

Florida’s limited medical marijuana program is finally almost ready to go live. For those who have been sitting on the sidelines waiting for the right moment to learn about the program, now is that moment. Recently, the Florida Department of Health (DOH) hosted a webinar highlighting some of the key features, as well as limitations of the program. The smoking … Continue Reading

Lights, Camera, Settlement: OCR says a picture is worth $2.2 million

A New York hospital has settled with the U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) for $2.2 million after allowing a TV crew for the ABC documentary series “NY Med” to film patients receiving medical treatment without obtaining prior authorization from the patients or their representatives. The estate of one those patients is also suing … Continue Reading

Florida’s Adoption of Federal Exemptions for Wholesale Drug Distribution May Benefit Pharmacies, Practitioners and Hospitals

The 2016 Florida Legislature enacted substantial legislation (Ch. 2016-212, Laws of Florida) to bring Florida’s Drug and Cosmetic Act (Ch. 499, Florida Statutes) in line with the federal Drug Supply Chain and Security Act (“DSCSA”). Since the DSCSA preempts state law, the changes were necessary to avoid confusion between the state and federal exemptions to the term “wholesale … Continue Reading

Prepare for the Unexpected with Data Storage and Retrieval

Last week, a federal court in Illinois encountered another example of unexpected events causing problematic privacy and data storage implications for a healthcare company. The non-profit organization responsible for maintaining the MetroChicago Health Information Exchange (the HIE) filed suit against its information technology support contractor and the contractor’s owner to prevent the contractor’s plan to destroy all client data after … Continue Reading

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