Here are some of the important legal areas to keep an eye on in health care during 2018.
It's hard to believe that we are embarking on 2018! As my readers know, I usually start the year off with a watch list and 2018 is no exception.
It has been said, "[l]ife can only be understood backwards; but it must be lived forwards." In other words, learning from the past can mitigate the risk of repeating mistakes in the future. For 2018, physicians should focus on the following five areas and learn from the outcomes of various events.
1. The HITECH Act and Meaningful Use – While 2017 was not a banner year for HHS-OCR enforcement, a couple of cases were notable. First, on May 31, 2017, the U.S. Department of Justice (DOJ) announced that eClinicalWorks, an electronic health records (EHR) software vendor would pay $155 million to settle False Claims Act allegations that it misrepresented the capabilities of its EHR. Physicians should take note because there has been a series of cases alleging that providers falsely attested that they were HIPAA/HITECH Act compliant on their Meaningful Use Attestations.
The Office of the Inspector General issued a report that a potential demand for the return of meaningful use payments and the possibility of pursuing a False Claims Act case are serious actions that can adversely impact a physician or other provider's financial stability, tax liability and reputational viability.
2. HIPAA – Most of the focus on HIPAA over the past several years has been on risk assessments, business associate agreements, encryption and other Privacy and Security Rule related items. Providers should pay particular attention to 45 CFR §164.512, which some consider the law enforcement exception (even though it is broader in scope). Over the past few years, several State Supreme Courts have held that persons had a private cause of action when their protected health information was released either as discovery during the course of a non-government legal proceeding or when a law enforcement officer demanded PHI without a legitimate warrant or patient consent.
In Utah, Alex Wubbles, a nurse, was arrested for refusing to permit a law enforcement officer to draw blood from a patient. Because she refused to comply with the officer's demand, she was arrested. As a result, the arresting officer was fired from the Salt Lake City Police Department and subsequently reached a $500,000 settlement with the police department and the hospital where she was employed. The take-away for physicians is two-fold: (1) if it is a lawyer in a civil suit sending a subpoena, notify the patient and consult an attorney with expertise in HIPAA/the HITECH Act; and (2) if a police officer demands information without a warrant or other viable legal document, make sure you know when you can disclose the minimum necessary information and when a legal document is required to disclose the information.
3. The Anti-Kickback Statute (AKS) and Stark Law – These two gems should always be at the top of a physician's list. The DOJ announced on December 20th that it settled AKS violations for $210 million that a foundation was used as a conduit to pay the copayments of Medicare. United Therapeutics Corporation violated the AKS, which prohibits a pharmaceutical company "from offering or paying, directly or indirectly, any remuneration – which includes money or any other thing of value – to induce Medicare patients to purchase the company's product."
Stark and AKS should always be considered together because their safe harbor provisions are not identical. A $34 million settlement for allegations that two Missouri healthcare providers engaged in improper financial relationships with referring physicians "whose compensation was based in part on a formula that improperly took into account the value of their referrals of patients to the infusion center." For physicians, they should always have their relationships evaluated by a healthcare lawyer who understands these laws. What is permissible in other industries is illegal in the healthcare sector.
4. Tax Cuts and Jobs Act – This recently implemented law has significant ramifications for tax-exempt hospitals and other tax-exempt nonprofits alike. Physicians should consult their accountant, the text of the law and an attorney to make sure that everything is in order.
5. The ACA Individual Mandate – Starting in 2019, the Affordable Care Act's individual mandate will be eliminated. While the entire Affordable Care Act (ACA) has not been repealed, this may have significant consequences for a physician's practice revenue. The take away for physicians is to be ahead of the curve and start consulting practice managers and attending conferences on how the number of insured may decrease and how this could impact their practice.
In sum, 2018 should prove to be nothing short of dynamic on the healthcare front. Physicians need to keep abreast of all of the items above – some of which are reminders to bill properly and enter into legal contracts, while others are new frontiers. Regardless, to all of the readers, I wish you Joy and Prosperity in 2018!