By MICHAEL R. LOWE, Esq.
What do they say about the weather in Florida? If you don't like it, wait 5 minutes and it will change. Health care and health care laws are exactly the same and will experience even more rapid and dynamic changes in 2018 from what we have been experiencing in Florida these past several years. Here are 10 of the top health care law areas that will affect physicians and providers in 2018:
- HIPPA/Business Associate Agreements/Privacy/Security/Data Breaches and Cybersecurity.
Ransomware, phishing, hacking and other forms of intrusion continued to be paramount issues for physicians, group practices and providers. It is important for all covered entities to ensure that they have appropriate business associates agreements and privacy and security measures in place to prevent, detect and respond to breaches and cyber-security threats. Expect increased enforcement and investigation activity from HHS/OCR in 2018 and start now in developing an effective compliance program including appropriate private and security safeguards and breach prevention and response components which should include purchasing appropriate cyber liability insurance coverage for your group practice or entity.
- Private Equity Investment Within the Physician Health Care Provider.
2017 saw a huge uptake in private equity investment in the health care arena. With hedge fund and private equity managers having less options to invest in income stream producing investments and assets, they are looking more and more to health care entities as investments. These types of transactions are complex and require corporate and health care regulatory expertise in order to properly structure them. We anticipate further activity in the private equity/health care marketplace throughout 2018.
- The Opioid Crisis.
With the opioid crisis in national headlines on a weekly basis, physicians and providers need to be cautious about prescribing any narcotic pain medications for their patients. There are a whole host of potential legal issues from professional liability/medical malpractice claims to professional licensure and federal government investigations to criminal action which can arise if a physician or provider is accused of misprescribing or facilitating the trafficking of opioids. Pain management, medications, contracts are an area of particular focus and concern for physicians treating chronic pain patients.
- The Amazon/JP Morgan/Birkshire Hathaway Joint Venture.
Recently announced the plans by these 3 mega-giants in the corporate and financial world could change the entire face and structure of the health care delivery and payment system. Although in its infancy, this joint venture should be monitored closely by all physicians, providers, facilities and other players in the health care delivery system as contractual relationships, structure of health care networks, and the way in which providers are reimbursed for the provision of health care goods and services could all rapidly change over the next several years depending on the implementation and outcome of this joint venture.
- Medicare Access and Chip Reauthorization Act of 2015 (MACRA) and Merit-based Incentive Path (MIPS).
Physicians and providers need to understand what financial opportunities and pitfalls would result from the application of MACRA, particularly with regards to physician compensation for employed physicians. Significantly, CMS recently announced the launch of its New Bundled Payments for Improved Advanced Model in an attempt to address Advance Alternative Payment Model issues which have risen with the initial implementation of MACRA, while the Medicare Payment Advisors Commission ("MedPAC") decided last month to ask Congress that it repeal and replace MIPS with more of a voluntary participation model. Both Part A and B providers should continue to monitor MACRA for the remainder of 2018.
- Ancillary Services (i.e. diagnostic imaging, labs, physical therapy, dispensing practitioners)/Acquisition of Them by Physicians and Providers/Stark Law Reform and Considerations.
On January 17 of this year, CMS announced that it would be establishing an inter-agency group to review the current Stark Law in particular referral by physicians for designated health services such as diagnostic imaging procedures, labs and physical therapy. While we do not expect any short-term changes to the Stark Law, CMS has signaled that it is going to look at long-term sweeping changes in particular changes to the existing regulatory exceptions. Therefore, until newer amended legislation is officially signed into law, physicians and health care organizations providing designated health services should ensure any current or future transactions in which they are involved, fit squarely within the parameters at least within one (1) of the Stark Law exceptions. Physicians and providers should consider having existing transactions and potential future transactions reviewed by competent and experienced health care regulatory counsel in order to ensure compliance with the Stark Law.
- Clinically Integrated Networks and Accountable Care Organizations.
We continue to see consolidation in the health care world and continued growth of clinically integrated networks and accountable care organizations. These types of entities implicate not only corporate, tax and business, but also detailed health care regulatory law considerations involving Stark Law, the federal Anti-Kickback Statute, and a number applicable Florida laws as well. Physicians and providers are well served to obtain financial, legal, and business advice before agreeing to enter into one of these types of entities.
- What's the Future of 60-day Overpayment Rule.
Physicians and providers that submit claims to and receive payment from the Medicare and/or Medicaid programs need to be familiar with the 60-day overpayment rule and how it is triggered, when the government will consider that a provider knew that they had an overpayment, and the steps to take to report and refund the overpayment in order to avoid federal false claims act investigation and/or proceeding. It is critical to understand the time frames involved in an overpayment situation and when the 60-day deadline begins to run, as well as how to respond to a correct/address an overpayment in order to avoid federal False Claims Act issues.
- Peer Review Re-Engineered/New Paradigms for Employed Physicians and Value-Based Purchasing Within the Employment of Them by Hospitals.
With the continuing emphasis on value based reimbursement in health care, many hospitals and facilities are incorporating value-based principles in internal peer review analysis. This is a relatively new phenomenon, and as it progresses it will involve defining and distinguishing adverse peer review incidents from simple economical credentialing, as well as the careful analysis of how value-based peer review situations must comply with applicable Federal and Florida health care regulatory laws. The physicians and medical staff would be well served to work with hospitals and facilities to develop value-based peer review criteria and programs, as the current peer review landscape adverse incident reporting and discovery environment in Florida will present significant hurdles for the cooperative development of value-based peer review.
- Increased Enforcement and Scrutiny by the Florida Agency for Health Care Administration of Licensed Providers and Facilities and the Florida Department of Health of Licensed Professionals.
While these are 10 of the top health care law areas that will affect physicians and providers in 2018, they are not all of the health care law areas that will affect physicians and providers and are by no means exclusive. If you are facing issues in these areas or issues in other health care law areas, please consult with an attorney.
Michael R. Lowe, Esquire is a board-certified health law attorney at Forster, Boughman, Lefkowitz & Lowe. The firm regularly represents providers, physicians and other licensed health care professionals, and facilities in a wide variety of health care law matters.
For more information regarding those health care law and such matters please visit our website www.FBL-Law.com