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.
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 a fraudulent operation that the Department of Justice calls, “unprecedented”, elderly or disabled patients nationwide were lured into providing their DNA for testing in a widespread genetic testing fraud scheme powered by a large telemarketing network. The doctors involved were paid to write orders prescribing the testing without any patient interaction or with only a brief telephone conversation.read more
In 1986 President Ronald Reagan signed the Emergency Medical Treatment and Active Labor Act (EMTALA) into law. Since then, the application of the law has been expanded and refined. It was one of the first laws giving the government the authority to dictate certain operations of a hospital. While other laws and regulations such as the Anti-Kickback Statute and the Stark Law have become more of a focus for health care providers, EMTALA remains an area of active enforcement. All providers with hospital privileges should therefore be aware of its application.
The policy behind the law is fairly straightforward. Hospitals with emergency departments should not be able to turn away patients needing care because of their inability to pay (no more “wallet biopsies” as part of triage). Likewise, hospitals should not be able to “dump” patients on other facilities for reasons other than for advanced care.
The requirements of the law are also very basic. If a patient comes to an emergency department and requests an examination or treatment for a medical condition, the hospital must provide an appropriate medical screening exam, within its capability, to determine whether or not the patient has an emergency medical condition. The screening provided goes beyond simple triage, and must be performed by a clinical provider such as a physician, nurse practitioner, or physician’s assistant. read more
On Thursday, February 11, 2016, the United States Attorneys’ Office from the Middle District of Florida announced a $10 million settlement with 4 physicians and 2 pharmacies regarding alleged abuses of Tricare program. The case against these physicians and pharmacies was prosecuted as part of the United States government’s large-scale effort to combat questionable compounding practices. Investigations revealed that patients were often prescribed compounded drugs that they never used, and that Tricare paid a mark-up cost of nearly 90% for compounded drugs over and above the pharmacy’s actual costs of making the drug. Roughly 40% of the claims submitted by the pharmacies in question were written by 4 physicians with an ownership or financial interest in the pharmacies.
Tricare is a federal health care program designed to insure active duty military service members, reservists, members of the National Guard, retirees, survivors and their families. Tricare outpatient costs have almost doubled in the last 5 years, and compound drugs have accounted for a large portion of that increase. read more
It’s that time of year. People are scrambling around, deciding what they want to give and what they want to get. Brand new packages are being wrapped up and filed away. Excitement and tension fill the air. Everyone can’t wait for the big day; but in this season that big day doesn’t happen until the first Tuesday after the first Monday in March. But it’s never too early to start getting ready, right? In fact, the Florida Legislature is currently in session, drafting and filing bills that the sponsors hope will be considered in March and will become law in 2016. And as usual, health care is on a lot of legislative wish lists. Although all of these bills are subject to significant revision, and some may never make it out of a subcommittee, here’s a sneak peek of some of the proposed health care legislation (without editorial – for now).
Scope of Practice Expansion
Three categories of health care professionals may see significant expansion of the scope of their practice.
Both Advanced Registered Nurse Practitioners and Physician Assistants would gain the right to prescribe controlled substances pursuant to Senate Bill 676. Most of the details about specific medications and dosages is left to an administrative committee, but the bill seems to anticipate broad authority. The bill also adds references to ARNPs and PAs throughout the Florida Statutes, indicating a willingness to accept these professionals into a significant role in the delivery of care. Additionally, SB 572 would add PAs and ARNPs to the list of providers who can certify that an individual meets Baker Act criteria to justify a patient’s involuntarily confinement for mental health reasons. read more
In the “good old days” (in healthcare, that means more than a week ago), it was understood that if a client didn’t accept any state or federal healthcare program dollars (e.g. Medicare, Medicaid, CHAMPUS, TriCare, Supp Plans), they would not expect to get a “knock on the door” from any federal regulatory authority. No federal or state healthcare program dollars used to mean the client would only tend to hear from state regulators or commercial payors. Those days are done!
Federal law enforcement is increasingly pursuing alleged criminal wrongdoing in the “non-government” healthcare space. One of their favorite weapons is 18 U.S.C. 1347, the Federal Healthcare Fraud Statute, which gives federal law enforcement broad enforcement authority with respect to suspected wrongdoing involving interactions between healthcare providers and commercial insurers. read more
The Office of Inspector General of the Department of Health and Human Services today issued a Special Fraud Alert pertaining to relationships between laboratories and referring physicians. Payments from labs to physicians who refer were targeted in the Alert. The Alert also reiterates their suspicion of so-called “carve out” compensation relationships where state and federal healthcare program dollars are removed from the payment formula (which was previously addressed last year in Advisory Opinion 13-03). While the Alert does not add anything new to the government’s view of such relationships, it does underscore the very suspect view the OIG has of payment relationships between labs and the physicians who refer to them. Careful compliance with the Personal Services and Management Contracts Safe Harbor continues to be a core concern.
Though it can be tempting to offer help to patients in this era of sky high healthcare costs, out-of-network physicians must remember that they should not only be collecting copayments and deductibles from their patients at the time of service and before they leave the office, but also that collecting these payments is their obligation. For physicians and other providers who engage in the practice of failing to collect payments there is a significant legal exposure under federal and state laws including civil litigation brought by commercial health plans, managed care organizations and medical benefit managers regarding routine waiver of these payments. read more
When a physician cannot bill for test results, and a company offers to give that physician those test results for free, a Florida Federal Court has ruled that the company is offering the physician prohibited remuneration. On May 5, 2014 the Middle District of Florida granted partial summary judgment on the latest motion in a contentious litigation between Ameritox Ltd. and Millennium Laboratories, Inc. Ameritox and Millennium are competitors and clinical laboratories that screen urine specimens for the presence of drugs.
Millennium provided free point of care testing cups to physicians, who use the cups for initial testing and then return the cups back to Millennium for confirmation tests. Physicians do not bill patients or insurance companies for the point of care tests. read more
Healthcare professionals and businesses are routinely barraged with people who claim to be able to generate business for them. The business of healthcare is like none other in its abhorrence of anything that even smells like payment for patient referrals, so professionals and businesses alike have to be extremely cautious and well advised in crafting marketing and related business-enhancing relationships.
The federal Anti Kickback Statute (“AKS”) is a criminal law that arises in the context of individuals and entities that pay or receive anything of value in exchange for referring a patient whose care is compensated in any way by a state or federal healthcare program. Violations of the statute are punishable by a maximum fine of $25,000 and/or imprisonment up to five years. Federal courts have applied the statute to any arrangement where even one purpose of the arrangement was to obtain money for the referral of services or an attempt to induce additional referrals. Its exceptions (“Safe Harbors”) include permissible arrangements for independent contractors and employees, both of which are elusive because of the common requirement that the arrangement not vary based on the value or volume of business between the parties. The “value or volume” aspect of the regulations flies in the face of percentage based compensation arrangements (which seem to be the rule in marketing relationships). read more