FTC Investigating the Competitive Effects of Certificates of Public Advantage

The Federal Trade Commission has issued orders to five health insurers and two health systems requiring them to provide information that will assist the FTC in studying the competitive effects of certificates of public advantage (COPAs) with respect to prices, quality, access and innovation in healthcare. The orders were sent on October 21 to Aetna, Anthem, Blue Cross Blue Shield of Tennessee, Cigna, United Healthcare, Ballad Health and Cabell Huntington Hospital.

COPAs are state laws that allow healthcare providers to enter into cooperative arrangements that might otherwise raise competitive concerns, in circumstances where state regulators have determined that the likely benefits of the arrangement outweigh any potential competitive harm. When subject to a COPA, merging healthcare providers are exempt from federal antitrust scrutiny (typically by the FTC) pursuant to the “state action” doctrine. Continue Reading

Direct Patient Billing Can Create Provider Liability in Florida

By William J. Spratt, Jr. on October 21, 2019 Posted in Healthcare Law, Healthcare Litigation, Hospitals & Health Systems, Physicians

To bill or not to bill, that is the question. Or, more appropriately, who to bill and when to bill, that is the question. Providers who bill patients under the circumstances described below may face liability. What is a provider to do?

A patient was injured in the course of her employment in December 2013 and applied for workers’ compensation benefits. As part of her treatment for her injury under workers compensation, she had a preoperative chest x-ray taken in October of 2014, and a clinical laboratory provided medical testing. She received bills for these services from the providers. The patient alleged that the providers knew she was a workers’ compensation patient and thus not responsible for paying the medical bills. Despite this knowledge, the providers continued to send bills demanding payment over a period of many months. In June of 2015, the patient received a bill from a collection agency on behalf of one of the providers. In response, the patient’s workers’ compensation carrier contacted the provider to inform it that the patient was not responsible for payment and warned that billing the patient was a violation of the Workers’ Compensation Law (WCL). Despite this warning, the provider sent yet another bill to the patient in July of 2015. The second provider, a clinical laboratory company, billed the patient twice for what the patient alleged was an illegitimate debt. Continue Reading

Addressing Acute Mental Health Concerns: Parkland’s Legacy – Florida’s Red Flag Law

By Kirk S. Davis on October 10, 2019 Posted in Healthcare Law, Healthcare Litigation, Hospitals & Health Systems

We are all too aware of the horrors of the Parkland shooting. In response to that awful day, the Florida Legislature enacted Florida Statute Section 790.401 in 2018, “the Marjory Stoneman Douglas High School Safety Act.” Part of this new law is the “red flag” provision which allows courts to proactively remove firearms from individuals who pose a significant danger to themselves or others upon proper petitions by law enforcement agencies. (Called Risk Protection Orders (RPO’s)). The law is being frequently used in Florida. At the Florida Bar’s September 13, 2019 Masters Class presentation on “Legal Issues with Mental Health and Substance Abuse,” it was mentioned that the RPO’s had been “used about 2,500 times in the State of Florida in the past year and a half. That’s about five times a day.” Undoubtedly, what are “red flags” to some will not be to others. The application of the law in the present case, though, aids in clarifying the concept of “Red Flags.” Continue Reading

Healthcare Providers Must Remember HIPAA Before Responding to Online Reviews

By Elizabeth F. Hodge on October 8, 2019 Posted in Healthcare Law, HIPAA, Privacy, and Data Security, Hospitals & Health Systems

The latest HIPAA resolution agreement by the U.S. Department of Health and Human Services Office for Civil Rights (OCR) is a reminder that healthcare providers must take the high road when responding to unflattering online reviews by patients. While it is tempting to respond to a bad and perhaps untrue online review, healthcare providers need to take care to not disclose patient protected health information (PHI) when defending their reputation.

A Texas dental practice agreed to pay $10,000 and enter a two-year corrective action plan to settle potential violations of the HIPAA Privacy Rule arising from allegations that the practice responded to a patient’s online Yelp review by disclosing the patient’s last name and details of the patient’s health condition. The practice did not have authorization from the patient to disclose his/her protected health information in the online forum. As a result of its investigation, OCR learned that the practice had disclosed the PHI of multiple patients in the course of responding to comments on the practice’s Yelp review page. In announcing the settlement, OCR Director Roger Severino said, “Doctors and dentists must think carefully about patient privacy before responding to online reviews.” Continue Reading

Possible Relief for Hospitals in the Protection of PSO Information?

By Kirk S. Davis on September 10, 2019 Posted in Healthcare Law, Healthcare Litigation, Hospitals & Health Systems

Last Thursday, September 5, 2019, Judge James Moody, Jr. of the United States District Court for the Middle District of Florida issued a positive ruling for hospitals dealing with patient safety organization (PSO) data. The opinion can be reviewed here. Note, while this decision is not binding on state courts, it is persuasive authority. It may be used to argue against the production of adverse incident materials.

Federal Judge Moody commented regarding some specific issues:

Subject Matter Jurisdiction

The Plaintiff, Tampa General Hospital (TGH), was facing daily monetary sanctions pursuant to federal law in a state court action if it knowingly disclosed patient safety data. The federal statutory penalty is expressed in mandatory terms in both the Patient Safety Act and the Administrative Rules. Since the U.S. Department of Health and Human Services (HHS) had refused to assure TGH it would not be penalized if TGH produced the Patient Safety Work Product (PSWP), the court had to act.

Pre-Emption

Both TGH and HHS agreed that the Patient Safety Act expressly preempts Florida Amendment 7. Judge Moody states that the language in the Patient Safety Act clearly is an express preemption clause. The key point, in this particular case, is that the documents that TGH maintained, were made for and submitted to, a PSO. They were therefore not subject to forced disclosure in the state court medical malpractice action.

The federal court addressed the Florida Supreme Court’s opinion in Charles v. S. Baptist Hosp. of Fla., Inc., 209 So. 3d 1199 (Fla. 2017). The distinct difference is that the documents in Charles had not been submitted to a PSO. Preemption therefore was not directly at issue. Continue Reading

Long Delayed CVS/Aetna Merger Finally Gains Court Approval

By James M. Burns on September 5, 2019 Posted in Antitrust, Government Affairs, Licensure & Regulatory, Healthcare Law, Healthcare M&A, Joint Ventures, Transactions & Health Ventures

Concluding one of the longest merger reviews in history, on September 4, Judge Richard Leon, District Judge for the District of Columbia, issued his final ruling in United States v. CVS Health, approving the proposed settlement of the United States’ challenge to CVS’s merger with Aetna. The ruling concludes Judge Leon’s eleven month review of the proposed settlement, during which he repeatedly questioned whether the proposed settlement was “in the public interest” – the test for approval of the proposed settlement set forth under the Tunney Act (15 USC 16(e)(1)). To make that determination, Judge Leon conducted the first-ever live hearing in a Tunney Act proceeding, at which he heard testimony from those for and against the proposed settlement. The decision grants final approval of a merger that combines the nation’s largest pharmaceutical chain (CVS) with the nation’s third largest health insurance company. Both entities are also among the largest providers of insurance in the individual Medicare Part D prescription drug plan market, and the settlement requires CVS to divest Aetna’s Medicare Part D business to WellCare. Continue Reading

FDA’s Safe Importation Action Plan May Give Florida’s Drug Import Program a Pathway to Approval

By Martin R. Dix on August 23, 2019 Posted in Pharmacy, Drugs, Medical Devices & Equipment

At both the federal level and within Florida, there are the beginnings of the seeds of change regarding drug importation policies. President Trump and Governor DeSantis have both been HUGE supporters of drug importation as a mechanism to reduce prescription drug prices.

First, at the federal level, as a result of the President’s interest, in June 2018, DHHS Secretary Azar was directed by the FDA to establish a Working Group on Drug Importation to Address Price Spikes. Following on the working group’s efforts, earlier this month, the FDA announced its “Safe Importation Action Plan” (the Plan) to allow the importation of prescription drugs. The Plan has two options or Pathways, as they are referenced in the Plan. Continue Reading

Florida Board of Pharmacy Initiates Work on International Export Pharmacy Permit Application and Rules

By Martin R. Dix on July 23, 2019 Posted in Healthcare Law, Pharmacy, Drugs, Medical Devices & Equipment

International export pharmacies took another step forward towards a separate, distinct licensure in Florida as the Florida Board of Pharmacy held a specially called Rules Sub-Committee Meeting on June 27, 2019, to address the Board’s responsibilities under House Bill 19, which went into effect on July 1, 2019. Section 465.0157, FS, establishes an “international export pharmacy” permit as part of the governor’s initiative to try to bring less expensive drugs from Canada to Florida residents. An international export pharmacy is a pharmacy located outside of the United States that holds an active and unencumbered permit under Chapter 465, FS [The Florida Pharmacy Practice Act], to export prescription drugs from their location into this state under the program. These pharmacies will also need to be registered as exporters with the Department of Business and Professional Regulation, Division of Drugs, Devices, and Cosmetics before they can export drugs into this state.

Only drugs that meet FDA standards relating to safety, effectiveness, misbranding and adulteration, and ones that do not violate U.S. patent laws can be imported. Even then, not all prescription drugs may be imported. The law excludes: Continue Reading

Owner of Medical Marketing Company Found Guilty in $2 Million Medicare Fraud Scheme…Again!

By William J. Spratt, Jr. on July 15, 2019 Posted in Fraud & Abuse & False Claims Act, Healthcare Law, Medicare & Medicaid

The Department of Justice announced on June 27, 2019 that David Brock Lovelace, the owner of DBL Management LLC, was found guilty by a federal jury in the U.S. District Court for the Middle District of Florida of conspiracy to pay healthcare kickbacks and structuring currency transactions to avoid reporting requirements. According to the evidence at trial, Lovelace was paid by a clinical laboratory company for each DNA swab he arranged to be referred to the laboratory. To obtain DNA swabs, the evidence indicated that Lovelace paid kickbacks and bribes to medical clinics located in Miami, Florida in exchange for the referral of swabs obtained from Medicare beneficiaries, without regard to medical necessity. According to the Department of Justice, the clinical laboratory billed the Medicare program over $2.2 million in claims and paid Lovelace a percentage of the Medicare reimbursement it received. Mr. Lovelace is expected to be sentenced on October 2, 2019.

Mr. Lovelace had been convicted previously, in December of 2015, of healthcare fraud, wire fraud, and money laundering, according to an announcement by the Department of Justice dated March 7, 2016. Trial evidence showed that he and co-conspirators paid illegal kickbacks in exchange for access to Medicare patients and Medicare patient information used in the fraud scheme, used forged and falsified documents in the Medicare enrollment process to enroll medical clinics, and billed Medicare for services that had not been rendered by physicians. Lovelace was sentenced to 14 years in prison and ordered to pay $2.5 million in restitution. Continue Reading

Paper Prescription Pads to go the Way of the Horse and Buggy as Prescribers Will Soon Be Required to Electronically Transmit Prescriptions – Sometimes

By Martin R. Dix on July 1, 2019 Posted in Electronic Health Records & Medical Records, Healthcare Law, Pharmacy, Drugs, Medical Devices & Equipment

Governor Desantis recently signed House Bill 831, which will require certain healthcare practitioners to “electronically transmit prescriptions”. Unfortunately, the legislature left this term undefined, creating some ambiguity as to what the law requires. While the legislature likely intended this law to require “electronic prescribing,” the statute does not say that, and therefore the term “electronically transmit prescriptions” could also be interpreted to include the common practice of faxing prescriptions and possibly (encrypted) e-mailing as well.

Florida law had already defined the term “electronic prescribing” in Section 408.0611, FS. Electronic prescribing is defined as:

at a minimum, the electronic review of the patient’s medication history, the electronic generation of the patient’s prescription, and the electronic transmission of the patient’s prescription to a pharmacy. Section 408.0611, FS.

The requirement that practitioners electronically transmit prescriptions only applies to healthcare practitioners licensed by law to prescribe (MDs, DOs, APRNs, PAs, podiatric physicians, dentists, and optometrists) and who:

Maintain an electronic health records (EHR) system; or
Prescribe medicinal drugs as an owner, employee or contractor of a licensed health care facility or practice that maintains an EHR system

This requirement will apply to practitioners at hospitals, healthcare clinics, ambulatory surgical centers, and other licensed facilities which have EHR systems. It is less clear when it applies to practitioners in unlicensed locations with EHR systems (such as exempt healthcare clinics) as well as other entities that may or may not qualify as a “practice.” Clearly, practitioners that use paper medical record systems only will not have to comply. Continue Reading