Health law is the federal, state, and local law, rules, regulations and other jurisprudence among providers, payers and vendors to the healthcare industry and its patient and delivery of health care services; all with an emphasis on operations, regulatory and transactional legal issues.
I recently wrote an article titled The Top Five Legal Concerns When Developing a Healthcare App, and I received some follow up questions, including technical queries about encryption and data sharing. To answer these questions, it is important to understand the current Healthcare App state of affairs. Various reporters, governmental agencies and privacy watchdogs have installed and monitored the flow of data from Healthcare Apps installed on smart phones. These journals, articles and enforcement actions taken together provide a roadmap for Do’s and Don’ts for the sharing of data.
Almost all Healthcare Apps are free and have some disclosures about how they share your data, and both iOS and Android require the user to give permission to the newly installed App, but who really pays attention to that? Almost no one. However, this doesn’t mean that an App developer shouldn’t embrace best practices to avoid liability and bad press. read more
In the beginning of June, 2020, the Department of Justice (“DOJ”) revised its Evaluation of Corporate Compliance Programs Guidance Document. The Document is designed to assist prosecutors in making informed decisions as to whether, and to what extent, the company’s compliance program is effectivefor purposes of determining, when a compliance violation has occurred, the appropriate form of any resolution or prosecution and monetary penalty. It also guides a prosecutor as to the company’s compliance obligations contained in any criminal resolution. The Document has been revised on three occasions since 2017, telegraphing the DOJ’s intent to prosecute those businesses without compliance plans, or without effective compliance plans, more harshly than those taking steps to identify and remedy risks.
A healthcare business’ failure to have in place a compliance program designed to detect and respond to potential fraud and security risks places it at a serious risk of civil and criminal liability. When a compliance issue is investigated, charged and resolved, DOJ prosecutors are instructed to consider whether the business has invested in and improved its corporate compliance program and internal controls systems. They must also determine whether those improvements have been tested to demonstrate that they would prevent or detect similar misconduct in the future. According to the DOJ, there are three fundamental questions that a prosecutor should ask when determining whether a business’ compliance plan is sound:read more
In March, the Florida Legislature passed multiple bills that would allow advanced practice registered nurses (APRN) to practice independently of physicians in the delivery of primary care practice. The law, however, went into full effect on July 1. Still, the law did not automatically grant autonomous practice to all nurse practitioners. Rather, an application process is still needed, as well as final regulations governing the new law.
In June, the Florida Board of Nursing voted to move forward with the drafting of rules and the application process to be designated as an independent practice Nurse Practitioner. This process usually takes three months to complete before it is open for practitioners to apply. The Board also voted to define “primary care practice” to include “health promotion, disease prevention, health maintenance, counseling, patient education, and diagnosis and treatment of acute and chronic illnesses in a variety of healthcare settings.”
Until final rules are decided, a nurse practitioner will at least need to meet the following requirements: read more
On March 31, 2020 the Florida Division of Workers’ Compensation (DWC) clarified that physicians are permitted to dispense medications to injured workers, and that an injured worker shall have full and free choice to utilize their physician for medication dispensing, as well as any other pharmacy or pharmacist.
It was declared by the DWC that it is not appropriate for employers/carriers to deny authorization or reimbursement for prescription medication solely because the medication is dispensed by the treating physician who is a licensed Florida dispensing practitioner instead of a pharmacist.
What Led to the DWC Bulletin?
A Florida dispensing practitioner was denied reimbursement for drugs dispensed out of their office to an injured worker in a recent reimbursement dispute claim. The physician asserted the claims administrator denied reimbursement for the dispensed medications because the physician was not authorized to dispense prescription medications. The Florida Department of Financial Services (DFS) ruled in favor of the physician – DFS Case No.: 20180824-007-WC – and subsequently issued DWC Bulletin DWC-01-2020 on March 31, 2020.
Thinking About Selling Your Practice? Preparation is key and the difference between a successful sale and seller’s regret.
Step 1: Call Your Financial Planner
Be sure that you can afford to leave the business
Most buyers will require a comprehensive non-compete and you should be certain that you are financially prepared to retire, sell, or move before signing any restrictions.
You will also want to ensure that you are planning for the income you are about to receive. Are there vehicles in place or options that are best to ensure the purchase price is put to its best use for you.
Consider post sale options if not retirement – are you going to be employed by the buyer? Are you selling to an associate and will phase out? Are you just moving and will need to find new employment/open a practice?
Step 2: Visit Your Accountant
Your business is only worth as much as can be defined on paper.
If a potential buyer cannot make sense of your accounts and assets, you may leave significant value on the table.
Get your financial history in order by reviewing tax returns, profit statements, AR reports, and payroll history for prior 3-4 years.
Clean up creative bookkeeping – you will have to promise the buyer that your financial statements are true and accurate.
Have your accountant help value assets of your business – or use an appraiser if necessary.
Discuss company structure – there may be restructuring needs or you may need to transition to a different structure for tax purposes.
Out of network physician owned specialty hospitals are unique in that there are less stringent legal requirements on the facility, but patient care obligations remain the same. This means that patient care must be prioritized over profits and all actions taken by the hospital and any physician investor must showcase that order of priority.
Given the amount of scrutiny placed in physician owned specialty hospitals in the past two decades, these facilities are well served to identify and implement a process to remedy compliance concerns. Even when a facility does not submit claims to any Federal health insurance provider and is out of network with all commercial insurance companies, it is still required to follow the laws of the state where it is located.
The best plan for surviving scrutiny in such situations is to have a plan. Proactively seek out applicable laws and regulations, and determine how your hospital will abide by them. Compliance can be tailored to fit your facility.
Overutilization and Self-Referrals
A physician who shares ownership in a hospital may have a financial incentive to refer patients for services if he or she receives a percentage of the revenue generated. Laws including the Federal Stark Law and Anti-Kickback Statute were promulgated to combat unnecessary referrals. A 2003 study by the Department of Health and Human Services concluded that physician-investor referrals to hospitals in which they have an investment interest are similar to those physicians without investment interests. Nevertheless, the fear of overutilization and unnecessary self referral remains at the forefront of the regulators’ minds at both the State and Federal level. read more
The debate over the pro’s and con’s of physician-owned hospitals has been raging for decades. Physician-owners say their hospitals are more patient-focused, provide higher quality care, obtain better outcomes and therefore receive higher patient satisfaction scores. They also point out their convenience and efficiency.
Opponents argue that physician-ownership leads to overutilization and cherry-picking of only the best patients. The less-desirable patients (both clinically and financially) are then left to be taken care of by the community hospitals. For those reasons, both the American Hospital Association and the Federation of American Hospitals remain strongly opposed to physician-owned hospitals.
Federally, the Stark Law includes an exception which allows a physician to refer patients to a hospital in which the physician has an ownership interest, so long as the ownership interest is in the entire hospital, and not just a subdivision of the hospital. However, in 2010, the federal government weighed in again on the issue, and passed the Affordable Care Act (ACA), which includes provisions which (i) restrict physician referrals to hospitals in which they hold an ownership interest; (ii) restrict any increases in physician-ownership of a hospital; and (iii) restrict expansion of physician-owned hospital facilities. CMS has granted exceptions to these restrictions, but those have been limited to rural hospitals and high Medicaid hospitals, and attempts to amend the law have failed. read more
Florida may become the “next Texas” on the issue of physician owned specialty hospitals. “Next Texas,” since there are a number of examples where the concept launched (and also flopped). Done right, such facilities could be a better fit for many patients, depending of course on patient co morbidity issues. In theory, they would be the perfect bridge between surgery centers and regular acute care hospitals. But the ability of such specialty focused care suggests a better staffing model and more targeted and efficient overhead, instead of the broad-based overhead of an acute care hospital at is spread out aver all cases, including those where overhead allocation is viewed as “just an expense.” read more
When COVID-19 passes and the world begins to return to normal, you can be guaranteed that many of your old “friends” will come to visit you. To minimize future liability, pain and time, you should be preparing today for tomorrow’s visitors:
The Lawyers. Lawyers come in many flavors, and can bring good or bad news. Depending on your initial reaction to the pandemic, and your subsequent actions as the panic started to die down you may see three types of lawyers: (1) Those that represent past or present employees who have lost their job or contracted COVID-19; (2) Those that represent patients who claim malpractice based on the care that you did or did not deliver, and also those patients who assert that they contracted COVID-19 at your office; and finally (3) Those that represent creditors or debtors of your practice. The actions you should take today are many and varied and beyond the scope of this overview, however, you should be asking the following questions of yourself: (i) did you file a claim for business interruption despite the fact that your insurance broker said you were wasting your time? (ii) does your malpractice carrier cover you for liability outside of the normal scope of providing care? (iii) are your documenting your actions throughout the pandemic to demonstrate that you were acting reasonably at a time when you did not have all the facts? (iv) did you look at your business insurance policies for coverage for employee claims, or workers comp claims, or OSHA claims? (v) did you research what other similarly situated companies are doing, as you will most likely be held to the same standards? (vi) did you follow guidance from State and Federal entities? and (vii) did you provide notice during the pandemic to debtors or other parties who have breached their obligations? read more
State Surgeon General, Scott A. Rivkees, M.D., issued Emergency Order (“EO”) 20-009, which extends EO 20-002 and continues to allow out-of-state MDs, DOs, APRNs and PAs, to provide telehealth services to persons in Florida. EO 20-009 is set to expire June 30, 2020, unless otherwise extended.
Further, EO 20-009 continues to allow Florida licensed controlled substance prescribers (MDs, DOs, APRNs, PAs) to issue renewal prescriptions of controlled substances for non-malignant pain for existing patients. Additionally, EO 20-009 extends until June 30, 2020, a qualified physician’s ability to recertify an existing qualified and certified patient’s continued use of medical marijuana by using telehealth services. read more