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.
A 2018 Department of Justice civil settlement involving a Florida interventional pain physician was a cliff hanger when it surfaced, especially vis a vis the issue of the so-called Company Model, where anesthesiologists and referring physicians jointly owned an anesthesia provider. The Daitch settlement involved interventional pain specialists who settled the case for $2.8 Million. There, the government claimed that a mass of urine drug tests weren’t reasonable or medically necessary. But the issue buried in the settlement call the issue of intertwined medical businesses and the Company Model into question.
The so-called Company Model involves the formation of a company that provides anesthesia services. It’s jointly owned by anesthesiologists and referring physicians. Theoretically, on a Monday, the anesthesiologists own the anesthesia practice and bill for all anesthesia services performed at a GI lab or ASC. On a Tuesday, however, the new company (jointly owned by the same anesthesiologists and the referring physicians) steps in and starts billing for the anesthesia services, thus indirectly sharing a part of the profits with the physicians who are generating the anesthesia referrals.
CMS recently published a white paper entitled “Healthcare Payer Strategies to Reduce the Harms of Opioids.” The white paper was prepared by the Healthcare Fraud Prevention Partnership (“HFPP”), which is a voluntary public-private partnership between the federal government, state agencies, law enforcement, private health insurers, employer organizations and fraud units to reduce fraud, waste and abuse. The white paper gives information and provides insight on the way payors view addiction treatment.
HFPP identified five actions that should be considered for implementation by all payors as quickly as possible.
Train providers on Centers for Disease Control and Prevention guidelines for prescribing opioids for chronic pain;
Promote access to and usage of Medication Assisted Treatment (MAT);
Promote the availability of Naloxone;
Encourage use of cross-payor data to identify fraudulent, wasteful or abusive practices associated with opioids in order to target corrective actions; and
Identify and disseminate effective practices across the healthcare sector.
For many years, medical providers and regulators have wrestled with whether Advance Registered Nurse Practitioners (“ARNPs”) and Physician Assistants (“PAs”) should be able to prescribe controlled substances. This past legislative session, several bills were signed into law allowing ARNPs and PAs to prescribe controlled substances subject to several limitations and restrictions. This article will set forth a broad overview of the bills. However, if your practice intends to use ARNPs or PAs to prescribe controlled substances, we strongly recommend that each practitioner is educated about the boundaries set forth in the new law. For instance, there are restrictions on prescribing certain controlled substances in certain circumstances, prescribing controlled substances within a pain management clinic, and prescribing controlled substances for persons under age 18. It is important that all practitioners are properly educated prior to engaging in prescribing or dispensing any controlled substances.
Advance Registered Nurse Practitioners
ARNPs may prescribe or dispense Schedule II, III or IV controlled substances if they have graduated from a program leading to a master’s or doctoral degree in a clinical nursing specialty area with training in specialized skills and have completed 3 hours of continuing education on the safe and effective prescription of controlled substances. ARNPs must limit their prescriptions of Schedule II controlled substances to a 7-day supply. However, this restriction does not apply to psychiatric ARNPs who are prescribing psychiatric medications. read more
“Shoot, ready, aim” might be the right approach in many situations—like in war or when your kid runs into the street. But the approach never makes much sense in the context of law making. The best law making involves careful analysis, ensuring public protection and basically doing the best for the most (people). The issue of medical marijuana seems, however, to be driven by self interest and seems lacking in balanced and serious concern for the public. Reader caution: this article isn’t intended to subliminally advertise this law firm. It’s just venting, plain and simple.
On August 29, 2013, the Federal Department of Justice issued a memorandum stating it will continue to rely on state and local authorities to address marijuana activity through enforcement of state narcotics laws. Nevertheless, in light of new state laws allowing for possession of a small amounts of marijuana and regulating production, processing and sale of marijuana, the Department designated eight criteria to guide state law enforcement. States must (1) prevent the distribution of marijuana to minors; (2) prevent revenue from the sale of marijuana from flowing to criminal enterprises; (3) prevent the diversion of marijuana from states where it is legal to states where it is illegal; (4) prevent marijuana activity from being used as a cover for the trafficking of other illegal drugs; (5) prevent violence and the use of firearms in the cultivation and distribution of marijuana; (6) prevent drugged driving and the exacerbation of other adverse public health consequences associated with marijuana use; (7) prevent the growth of marijuana on public lands; and (8) prevent marijuana possession or use on federal property. In the event that the Federal Government determines that States are not adhering to such criteria, the Federal Government reserves its right to challenge State laws. The Feds didn’t say how any of that was to be done. They simply said the states should do that. But Florida has apparently been looking the other way. read more
The Federal Government lists marijuana as a “Schedule I” controlled substance, meaning it has a high potential for abuse and no currently accepted medical use. 21 USC § 812(b)(1). Because there is no current accepted medical use, Federal law prohibits physician from issuing prescriptions for marijuana. 21 CFR § 1306.04(a). However, the Federal Government has traditionally deferred to the States to prosecute small-scale marijuana violations. This lack of Federal enforcement has encouraged the States to enact less stringent controls on the marijuana industry. read more
Has your practice implemented a compliance program or considered improving an existing one? Is it really necessary? Prior to the Patient Protection and Affordable Care Act (ACA), the necessity for physician practices to develop compliance plans was merely voluntary. However, the ACA will now require physician practices to have a fraud and abuse compliance plan in place as a condition of continuing to participate in Medicare or Medicaid programs. Because the government first published guidelines in the year 2000 for the voluntary use of compliance plans in physician practices and has subsequently enacted a mandate in the ACA for compliance plans, many physician practices are proactively implementing them. While this compliance plan mandate may be viewed by physicians as yet another administrative burden and expense to the practice, it can have many benefits as well. Implementing an effective compliance program can have the result of not only reducing liability risks, but can also allow a practice to reap monetary benefits. In fact, it could be more costly for the practice not to have one! read more
The drug and alcohol rehab business is especially abundant in South Florida, yet few entrepreneurs are aware of the many laws that apply. The recovery business is a highly regulated one, with great intricacy in terms of the options and also the applicable laws.
Substance abuse services in Florida are broadly regulated by Chapter 397, Florida Statutes. The applicable regulations, however, drill down with remarkable granularity. For instance—
The broadly crafted Client Rights listed in Section 397.501, like the ones applied to nursing home residents, are very open ended (requiring things like the “Right to Individual Dignity”) and yet create the basis of a lawsuit! That said, people acting “in good faith, and without negligence” can rest assured they will not be found liable.
Though some may intuitively understand the specificity and seriousness of the regulations dealing with medical detox, residential treatment and Partial Hospitalization Programs (PHPs), including the staffing, service and supervision requirements, it may not be as readily apparent with the lower intensity of service options, like Intensive Outpatient Programs (IOPs).
Even PHP requirements can, however, be confusing. For instance, it is well known that PHPs are not for people who require 24/7 residential treatment. They stand somewhere between residential inpatient and intensive outpatient programs. What is less known is that the staffing requirements are particularly detailed. For instance, each PHP has to have a paid, awake employee on premises at all times when even one client is on the premises and also must have a paid employee on call when clients are at the community housing location.
Intensive inpatient programs are required to provide detailed services, to include 14 hours of counseling each week and 20 hours of “other structured activities.” Like IOPs, staff coverage is very specific. Nursing coverage must be available 24/7. More specifically, an RN must supervise all nursing staff and an RN or LPN has to be physically present on site. Finally, a physician has to be on call 24/7.
Outpatient programs have similarly detailed requirements, including the minimum counseling requirements and staffing client ratios. Intensive Outpatient Programs (IOPs) of course have far greater service requirements (at least nine hours of services each week) and yet share the same staffing ratio as regular outpatient (50 clients per counselor).
One of the more vexing issues the recovery industry faces deals with marketing. The industry is flush with commission based marketing professionals, and yet there are very detailed state and federal regulations that threaten that practice. At the federal level, the Anti Kickback Statute, a criminal statute that criminalizes remuneration for patient referral, threatens these percentage based arrangements. State laws also strike them hard. For instance, the Florida Patient Brokering Act (PBA) is a criminal statute with serious consequences for violations. While the PBA does have an exception for federal law compliance, many entrepreneurs may find themselves hard pressed to comply.
Though the term “recovery business” may seem like an oxymoron to some, it is an area of significant business opportunity that many have dug into. Knowing the regulatory minefields of the industry is, however, an important step forward in both a successful business and a stable platform of care.
Followers & Friends – BIG Announcement coming out today! If you haven’t seen our new NATIONAL platform, check it out here at www.nationalhealthcarelawfirm.com and stay tuned for our #healthcare #legal news at 2pm EST !!!
The Supreme Court upheld President Obama’s health care law today in a splintered, complex opinion that gives Obama a major election-year victory.
Basically. the justices said that the individual mandate — the requirement that most Americans buy health insurance or pay a fine — is constitutional as a tax.
Chief Justice John Roberts — a conservative appointed by President George W. Bush — provided the key vote to preserve the landmark health care law, which figures to be a major issue in Obama’s re-election bid against Republican opponent Mitt Romney.
The government had argued that Congress had the authority to pass the individual mandate as part of its power to regulate interstate commerce; the court disagreed with that analysis, but preserved the mandate because the fine amounts to a tax that is within Congress’ constitutional taxing powers.
The announcement will have a major impact on the nation’s health care system, the actions of both federal and state governments, and the course of the November presidential and congressional elections.
A key question for the high court: The law’s individual mandate, the requirement that nearly all Americans buy health insurance, or pay a penalty.
Critics call the requirement an unconstitutional overreach by Congress and the Obama administration; supporters say it is necessary to finance the health care plan, and well within the government’s powers under the Commerce Clause of the U.S. Constitution.
While the individual mandate remained 18 months away from implementation, many other provisions already have gone into effect, such as free wellness exams for seniors and allowing children up to age 26 to remain on their parents’ health insurance policies. Some of those provisions are likely to be retained by some insurance companies.
Other impacts will sort themselves out, once the court rules:
— Health care millions of Americans will be affected – coverage for some, premiums for others. Doctors, hospitals, drug makers, insurers, and employers large and small all will feel the impact.
— States — some of which have moved ahead with the health care overhaul while others have held back — now have decisions to make. A deeply divided Congress could decide to re-enter the debate with legislation.
— The presidential race between Obama and Republican challenger Mitt Romney is sure to feel the repercussions. Obama’s health care law has proven to be slightly more unpopular than popular among Americans.
(Delray Beach, FL) June 21st, 2012 – The Florida Healthcare Law Firm, one of Florida’s leading healthcare law firms, today announced a major increase in their legal practice capabilities with the official launch of the National Healthcare Law Firm, a d/b/a and new portal of the firm. The expansion to a national platform providing healthcare legal services to physicians and healthcare businesses is one that significantly increases resources for clients who lack qualified local healthcare counsel. While the Florida Healthcare Law Firm has for years assisted clients outside the state of Florida*, this new development further cements the firm’s commitment to providing ethical legal counsel in the healthcare industry.
“We are very excited about it. The fact that we serve clients all over the country has been a small secret for a while but we realized there’s a huge demand and decided to just go for it,” said Jeffrey L. Cohen, Esq. Founder and President of Florida Healthcare Law Firm.
According to Cohen, “It’s just a strange area of the law. Nearly everything in healthcare business is regulated; leases, employment agreements, compensation. Things you wouldn’t think are regulated are strongly regulated. And there are large fines and criminal penalties for getting it wrong! Our clients understand that healthcare business of any kind has serious legal risks and that they need uniquely qualified help.”
Acknowledged throughout the country for its service and excellence, Florida Healthcare Law Firm is one of the nation’s leading providers of healthcare legal services. Founded by Jeffrey L. Cohen, Esq and headquartered in South Florida, FHLF provides legal services to physicians and healthcare businesses with the right pricing responsiveness and ethics. From healthcare clinic regulation, home health agency representation and physician contracting to medical practice formation/representation and federal and state compliance matters, the Florida Healthcare Law Firm is committed to bringing knowledge and experience to a diverse group of clients.