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 !!!
Via @USAToday
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.
Full Story Here: http://content.usatoday.com/communities/theoval/post/2012/06/Supreme-Court-rules-on-Obama-health-care-plan-718037/1#.T-xqPhd5F9E
(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.”
To request a service list or for any other firm information, call Autumn Piccolo at 888-455-7702 or visit the firm’s website at www.nationalhealthcarelawfirm.com or www.floridahealthcarelawfirm.com
* * *
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.
Clinical Research Organizations (CROs) in Florida have to be careful about ensuring compliance with state and federal patient consent requirements.
To begin with, let’s agree on the following language.
FEDERAL LAW
Federal law contains the following for effective informed consent:
Under federal law, informed consent is not required if, before the test is conducted, the Investigator and a physician who is not participating in the trial certify in writing:
i. Subject is confronted by life-threatening condition necessitating use of the test article; AND
ii. Informed consent is not possible due to inability to communicate with, or obtain legally effective consent from, the Subject; AND
iii. There is not enough time to obtain consent from the Subject’s legal representative; AND
iv. There is available no alternative method of approved or generally recognized therapy that provides at least as good of a chance of saving the Subject’s life.
If the Investigator feels that all items above are true, but the Investigator does not have time to obtain determination by an independent physician prior to administering the Article, the Investigator can obtain determination by an independent physician within five working days after administering the Article to the Subject. Certifications must be submitted to the IRB within five working days after administering the Article to the Subject.
When informed consent is required, it must be documented.
IRB will sometimes waive the requirement that informed consent be documented for some or all Subjects. This waiver only concerns documentation. Informed consent must still be obtained. IRB itself can issue such a waiver if the trial presents a minimal risk of harm, and does not involve any procedures for which written consent customarily would be required in ordinary, non-trial, healthcare delivery, or if emergent circumstances justify such a waiver. If documentation is waived, informed consent must still be obtained verbally.
FLORIDA LAW
Current Florida law does not regulate the clinical trials research process. The investigational drug program and the Florida Drug Technical Review Panel were repealed by the Florida Legislature in 2000. Instead, clinical trials research is regulated entirely by federal law.
That said, clinical trials in Florida are subject to applicable state law, including the Florida Medical Consent Law (Section 766.103) and the health care surrogate provisions (Section 765).
The seminal law in Florida regarding patient consent is Section 766.103, F.S., the Florida Medical Consent Law. It precludes recovery in any court action based on a claim of failure to obtain informed consent, in essence, if:
The failure to meet the above does not violate any law. Rather, meeting the above essentially precludes any successful lawsuit based on the claim that there was a failure to obtain informed consent.
Relatedly, Section 381.026, the Florida Patient’s Bill of Rights and Responsibilities state—“Every individual has the basic human right to be informed about the medical treatment or procedure that is being proposed to them.” under this state law, the key principles that comprise Informed Consent are:
CROs have a lot of ground to cover to ensure patients understand the risks and benefits associated with participating in clinical research. They have to be particularly astute regarding not only federal law, but also the law of the state where the research is performed.
By: David W. Hirshfeld, Esq.
When the text of the new PIP law became public, our jaws went slack. The new law imposed incongruous effective dates that would seemingly put many providers out of the PIP business for six months. How could the insurance industry’s best and brightest have screwed this up?
The new law requires providers to be licensed as “clinics” in order to receive PIP payments, unless an exclusion to that licensing requirement applies. The incongruity arises because the provision requiring licensure seems to become effective July 1, 2012; but the provision creating the exclusions from that licensure requirement do not seem to become effective until January 1, 2013. Many providers are rightly concerned that they must either: become licensed as a clinic in order to receive PIP payments, or stop treating PIP patients from July 1, 2012 through January 1, 2013 when an appropriate exclusion will exist.
Thank goodness for Stuart Williams, AHCA’s General Counsel. In his May 8, 2012 memorandum, Mr. Williams artfully reasons that the statute could and should be interpreted so that both the licensure requirement and its applicable exclusions become effective January 1, 2013. Now most providers can continue to treat PIP patients without interruption. Whew!!!
We hope and expect that Florida’s Office of Insurance Regulation will adopt Mr. Williams’ reasoning and educate the PIP insurers.
Physicians with Florida medical practices that provide physical therapy must feel at times they are playing “Whack a Mole,” given the many changes to the applicable rules and regulations, especially those that pertain to Medicare patients. Is it ok for a physical therapy assistant (PTA) to provide the services? Can the practice provide PT to people who are not patients of the practice? Does a physician have to be on premises when PT is provided? It’s just complex.
Let’s start with a couple fundamentals: first, medical practices that comply with the so called “group practice” exceptions (under both state and federal law) are permitted to provide PT to their own patients. They are more accurately known as the “In Office Ancillary Services Exception,” but most refer to them as described above. These exceptions dictate, for instance, the form of the practice and how much time each physician has to spend practicing through the group. For instance, if the practice does not have at least two of the following, it does not meet the group practice requirements: physician owner; physician W-2 employee. Second, PT falls under both the state and the federal definitions of “designated health service” (DHS). DHS are services that are regulated by the Stark Law and also (at the state level) by the Florida Patient Self Referral Act of 1992 (FPSRA). They are very similar laws, but with some key differences. Where many physicians go wrong is to ensure compliance with federal laws but not state or vice versa.
Why is it important to know that this discussion is confined to Florida “group practices” providing PT to Medicare patients? First, because the laws that apply to group practices are different that those that apply to reference PT businesses. Businesses that only provide PT are not nearly as regulated as medical practices (especially those in Florida) that provide both medical services and PT to their own patients. For instance, the issue of “outside referrals” does not arise with respect to reference PT businesses. Second, because when Medicare patients are involved, both state and federal law come into play. While state law applies to all services provided in Florida, federal law only comes into play when federal or state healthcare program dollars are involved.
Medical practices in Florida that provide DHS (like PT) to their Medicare patients have to comply with both state and federal law. And those laws are different. For instance, while federal law allows up to 25% of the time of doctors in a group practice to be spent providing services outside the group, state law is not so clear. For instance, federal law allows a practice to provide DHS to a certain amount of patients who are not patients of that group practice (“outside patients), but Florida law allows that sort of flexibility only for “diagnostic imaging services” (up to 15%). If, for instance, a Medicare patient from Dr. Smith down the street comes to your office only to get the PT your practice provides to its patients (i.e. they are not a patient of your practice), that patient will be turned away. Isn’t it ok for a Florida medical practice to provide just PT to someone else’s Medicare patient? No, because state law does not allow it.
Similarly, under federal law, a physician complies with certain supervision requirements if he or she is in the building where the medical practice is located while a Medicare patient receives DHS. In Florida, the physician in a group practice is required to be in the office (not just the building) when a Medicare (and every other) patient receives DHS in order to comply with the stricter “direct supervision” requirement applicable to patients in Florida that receive DHS (all DHS, not just PT) from a group practice.
Once a physician clears those regulatory hurdles, how can a doctor bill for PT? Essentially, there are two ways: under the provider number of the physical therapist or under the provider number of the supervising physician. The situation gets even more complex when a physical therapy assistant (PTA) gets involved.
Can a Florida medical practice bill under the provider number of a supervising MD for PT provided by a PTA to a Medicare patient? No. While applicable law requires an MD or DO to be on premises when a Medicare patient receives PT from the group practice, services provided by a PTA are considered by CMS to be included as part of the covered service under Section 220 and 230 of the Medicare Benefit Policy, Chapter 15. A Florida doctor may not lawfully supervise the services of a PTA, since PTAs (under federal law) that provide services in a medical practice must be directly supervised by an RPT.
There are also state laws that need to be followed, they differ based on physician specialty. For instance, a PTA employed by a physician other than a board certified orthopedist, physiatrist or chiropractor certified in physiotherapy must be under the onsite supervision of an RPT. Though inapplicable to Medicare, there is no provision in Florida law that allows a chiropractor to supervise a PTA.
What about if the PT services are provided by a registered physical therapist (RPT)? Though CMS does not recognize the term RPT, it does allow the services of a “qualified professional,” which includes a licensed physical therapist, to be billed either under the physical therapist’s provider number or “incident to” the services of the supervising MD or DO. “Incident to” services are services that are so integral to the services provided personally by the physician that they can be billed to Medicare as though the physician provided the service, even when the physician didn’t provide them. To comply with the rule (and for the doctor to be able to bill for it as though he or she did provide the service), the services must be:
1. An integral though incidental part of the physician’s service in diagnosing or treating an illness or injury,
2. Commonly furnished without charge or included in the physician’s bill;
3. Commonly furnished in a physician’s office or clinic;
4. Furnished under the physician’s direct supervision (e.g. physical presence in the office);
5. Furnished by the physician, practitioner with an incident to benefit or auxiliary personnel.
Though the incident to services rule is materially different from the Florida “direct supervision” requirement under the FPSRA, its effect is very similar: an MD or DO must be physically present on the premises of the office when a patient receives DHS and it is billed under the provider number of the supervising physician. One might argue that the PT’s services could be billed under the PT when the MD or DO is not on premises, but this conflicts with the direct supervision requirement of the FPSRA.
What’s the Analysis?
To comply with the State and Federal supervision requirements, group practices in Florida that provide PT to their Medicare patients must ask themselves at least the following questions:
1. Does my practice comply with the state and federal “group practice” requirements? and
2. Is an MD or DO in the office when the patient receives PT? If not, the PT may not be provided at all, since all PT in Florida group practices require direct supervision by a physician.
What are the Penalties?
At the very least, doctors who fail to comply with the supervision requirements for DHS risk (1) AHCA licensure actions; (2) having to repay the money received when they did not comply; (3) having to pay stiff fines, and in some instances (4) criminal prosecution. There have been many reported cases of physicians being investigated and fined for failing to meet the supervision requirements. And there have been numerous instances of physicians being prosecuted for failing to meet the “incident to services” rule.
If you provide PT to your patients, you must be clear about (1) the “group practice” exception provisions that allow you to provide DHS to your patients, and (2) the State and federal supervision requirements. There is simply too much at stake not to. Additionally, physicians ought to develop clear and easy to use written guidelines for compliance.
This is a great article published by CNN this morning.
View it in it’s entirety Here
(CNN) — On Monday, the U.S. Supreme Court takes on a political, social, economic and medical hot potato: the health care reform law that was signed into law two years ago.
For six hours during each of the next three days, attorneys will argue and justices will consider legal questions about the constitutionality of the Affordable Care Act’s individual mandate and issues surrounding federal versus state powers.
Read a transcript of Monday’s Supreme Court arguments
Many of the law’s major aspects have been the topic of much discussion. But are you aware that deep within the sweeping law’s 2,700 pages are many lesser known changes that could affect your life in unexpected ways?
CNN Explains: Health care reform1. How many goodies your doctors get
Is your doctor prescribing you certain drugs because those are the best for your condition or because of a pharmaceutical company’s influence? Here’s one way you can find out.
The Physician Payment Sunshine Act under health care reform requires drug, device or medical supply companies to report annually certain payments or things of value that they’ve given physicians and teaching hospitals. This could be speaking fees, consulting fees, meals and travel. So, you can find out which and how much companies pay doctors or health care workers. The companies are obligated to report annually about physician ownership and their financial investments.
Continue Reading Here
So many questions, so few answers. But the answers are coming! Here are some of our favorite stories out right now:
Via Yahoo News, Liz Goodwin, The Lookout
Could President Obama’s sweeping health care reform law survive if the court strikes down the requirement that all Americans buy insurance?
The short answer is yes — but insurance companies certainly won’t be happy about it.
Both Justice Department lawyers and their challengers agree that the individual mandate is not “separable” from the rest of the law, which means the rest of the law can’t survive if the individual mandate is surgically removed by the court.
The lower courts have been split on the question, but one of them, the 11th Circuit Court of Appeals, ruled in August that only the mandate should be struck down, leaving the rest of the law’s provisions — including an expansion of Medicaid to cover all low-income people and federal subsidies for lower-income and middle-class people to buy insurance — in place.
That decision no doubt sent shivers down the spines of some insurance executives. Striking down the mandate could be a nightmare scenario for the health insurance industry, since the rest of the law compels them to accept sick customers and to not charge higher premiums based on a customer’s health, age or gender. Sick customers would flood the insurance market and drive up costs, while young, healthy uninsured people would take their chances and not buy coverage, in what insurers worry would be a “death spiral” of rising costs.
Via The Associated Press, Boston Herald
DONALD B. VERRILLI JR.
Verrilli is solicitor general of the United States, the government’s official representative in front of the Supreme Court. He was confirmed to his position last June as the replacement for Justice Elena Kagan after serving as associate deputy attorney general and an associate White House counsel in the Obama administration. A graduate Columbia Law School, where he served as editor-in-chief of the Columbia Law Review, he was a law clerk for Justice William J. Brennan, Jr. and a partner at Jenner & Block, where he co-chaired the firm’s Supreme Court practice. He has argued more than a dozen times before the Supreme Court, and worked as an adjunct professor at Georgetown University Law School from 1992 through 2008. In 1994, as special counsel to President Bill Clinton, he assisted in the confirmation process for Justice Stephen Breyer.
Official biography: http://www.justice.gov/osg/meet-osg.html
___
PAUL CLEMENT
Clement is a former solicitor general, having served in that position for President George W. Bush. When confirmed, he was the youngest solicitor general in 115 years at age 38. Clement graduated magna cum laude from Harvard Law School one year behind Obama, and clerked for Justice Antonin Scalia. He has argued more than 55 cases at the Supreme Court, and served as the chief counsel of the U.S. Senate Subcommittee on the Constitution, Federalism and Property Rights. A partner at Bancroft PLLC, he is a Georgetown University law professor and a former partner at King & Spalding. He resigned from there after the firm decided not to continue its representation of the U.S. House of Representatives in its attempt to defend the Defense of Marriage Act. Clement was one of the lawyers who made the successful argument in front of the 11th U.S. Circuit Court of Appeals in Atlanta that would strike down the law’s core requirement that individuals carry health insurance or pay a penalty
Official biography: http://www.bancroftpllc.com/professionals/paul-d-clement/
___
MICHAEL A. CARVIN
Another former Justice Department official, Carvin’s most famous argument was delivered to the Florida Supreme Court on behalf of soon-to-be President George W. Bush in the Florida recount controversy during the 2000 presidential election. A graduate of George Washington University’s law school in 1982, Carvin has worked as deputy assistant attorney general in the Justice Department’s Office of Legal Counsel, which is responsible for legal opinions that are binding on the Executive Branch, deputy assistant attorney general and special assistant to the assistant attorney general in the department’s civil rights division. He will be representing the National Federation of Independent Businesses, which was a party to the lawsuit in the 11th U.S. Circuit Court of Appeals in Atlanta that struck down the law’s core requirement that individuals buy health insurance or pay a penalty.
Official biography: http://www.jonesday.com/macarvin
Richard Wolf, USA Today, via the Pensacola News Journal
WASHINGTON — Health coverage for more than 30 million people. The power of Congress to regulate interstate commerce. President Obama’s re-election chances. The reputation of the Supreme Court and the legacy of its chief justice.
And to hear some tell it: liberty.
All that and more could be at stake today when the Supreme Court begins a historic three days of oral arguments on the 2010 health care law that has become a symbol of the nation’s deep political divide.
All that and more could be at stake today when the Supreme Court begins a historic three days of oral arguments on the 2010 health care law that has become a symbol of the nation’s deep political divide.
Not since the court confirmed George W. Bush’s election in December 2000 — before 9/11, Afghanistan and Iraq, Wall Street’s dive and Obama’s rise — has one case carried such sweeping implications for nearly every American.
STAY TUNED!
When the Stark II (Phase III) regulations were released in August, 2007, they clarified that when a hospital recruits a physician to a medical practice, the employment agreement between the medical practice and the newly recruited physician may contain practice restrictions as long as they do not “unreasonably restrict the recruited physician’s ability to practice medicine within the recruiting hospital’s service area. This stymied many medical practices which were reluctant to hire a new physician without a noncompete and nonsolicitation provision. A 2011 CMS Advisory Opinion (No. CMS-AO-2011-01) changed this.
The Advisory Opinion involved a pediatric orthopedist who was recruited by a hospital to a medical practice. The medical practice wanted to hire the new doctor, but was not willing to do so without a noncompetition provision and other restrictive covenants. The practice asked CMS for guidance because the Stark regs suggested that perhaps a noncompete could not be contained in the employment agreement of a physician recruited by a hospital to join a local medical practice. In fact, a prior version of the Stark regs was clear that noncompetes were not permitted in the employment agreements of physicians recruited by hospitals.
Hospital recruitment transactions involve bringing a physician into a new area and funding the start up period (usually a year). The nice thing for a medical practice is that the dollars given by the hospital to the practice (the difference between salary and benefits and collections) can run into the hundreds of thousands of dollars! The down side was that the medical practice could not tie the recruited physician’s hands with a noncompete or other similar restriction. The Advisory Opinion is, however, a game changer because it allowed the medical practice to impose a noncompete on the recruited physician.
As mentioned, the practice would not hire the recruited physician without the noncompete. The noncompete had a 25 mile radius, and the Opinion cited the following relevant facts:
1.The recruited doctor would remain on one of five hospitals within the 25 mile zone;
2.The recruiting hospital’s service area extended beyond the 25 mile zone, in which there were at least three other hospitals within a one hour driving range;
3.The noncompete complied with applicable state law.
Based on these facts, the OIG permitted a one year noncompete because it did not “unreasonably restrict the doctor’s ability to practice in the recruiting hospital’s service area. Certainly, many other medical practices can be sure to follow suit.
Physicians interested in nocompetes must be familiar with state law. Getting to the bone of the issue, noncompetes are enforceable in Florida if:
1.The geographic zone in the noncompete is reasonable. This depends on where the practice draws its patients. If patients come to the practice from just down the street, a ten mile radius is probably overbroad;
2.The duration is two years or less (though it can be longer in some limited circumstances);
3.The employer has complied with all of the terms of the employment agreement. If the employer has breached the contract that contains the noncompete, most courts will reject a claim to enforce it;
4.The employer does the type of thing that the departing employee does. If the employee is the only person performing toe surgery for instance, and the practice will not provide toe surgery services once the employee leaves, the practice probably does not have a legitimate business interest to protect by enforcing the noncompete; and
5.Stopping the ex employee from practicing in the geographic zone does not create a healthcare crisis or shortage. This is tough. Very few practice areas are in such dire straits that the departure of one doctor will adversely affect the provision of such services in the area.
Physicians should also be familiar with the practical aspects involved in noncompetes.
Mistake #1 – Racing to litigation
Going to court is a crap shoot. Once litigation begins, it takes on a life of its own and costs can be nuts, sometimes in the hundreds of thousands of dollars. You may think it’s a simple noncompete case. There rarely is such a thing. And if you sue someone on a noncompete breach, they may turn around and sue you in the same lawsuit for something. And….insurance does not cover any such claims. That means you are paying out of pocket for a lawsuit, the certainty of which can never be guaranteed and which will seem endless once you run out of patience or money for the process. Often, the reality is that noncompete litigation involves the strategy or seeing which party can outspend the other one.
If you are an employer, ask yourself the following two questions before commencing litigation:
1.Does it make good economic sense to enforce the noncompete? Is the former employee a business threat?
2.Is there a way to work out a deal with the employee, short of litigation?
In some situations, it makes no business sense to pursue a noncompete. For instance, if the employee has been employed for several months and if the patients are all referred by the employer, then the employee may not be a competitive threat to the employer. The employer will find a replacement doctor at some point and refer the business to the new doctor. Case closed.
It is also possible to work out settlements before going to court. For instance, you might avoid litigation by lowering the geographic zone or the duration. You might also negotiate a buy out of the noncompete.
If you are an employee who wants out of the noncompete, sit down with the employer and see if you can agree on a way out, so that both of you can have peace and move on.
Mistake #2 – Doing it Yourself
Noncompetes are governed by state law. There are both statutes and cases that inform lawyers about what types of noncompetes are enforceable and which are not. Do not work off of an old contract to create a new noncompete, since the laws (and the cases that construe them) change often. Do not use a friend’s noncompete, since you will not be able to tell if it will be enforceable at this time or under the circumstances that apply to you. The enforceability of noncompetes is extremely fact specific. Since noncompetes are strictly construed by courts, drafting them requires a trained eye.
The Advisory Opinion marks a significant development in the area of noncompetes for physicians recruited to medical practices by hospitals. Though some states do not allow noncompetes to be applied to physicians, many states do, including Florida. Finding a way to satisfy both the federal and state authorities will be essential for ensuring an effective and enforceable noncompete.
Investigations and successful prosecutions for violation of laws like the Anti Kickback Statute (“AKS”), the Stark Law and the False Claims Act were dramatically up in 2011 and are expected to climb still higher in 2012. For instance 13 doctors were charged in December, 2011 with violating the AKS by receiving payment for referring patients to an MRI center. Physicians and other healthcare business people MUST have any suspect arrangement closely scrutinized by highly qualified counsel. A “suspect arrangement” is any arrangement between providers of healthcare services that involve, to any degree, the exchange or payment of anything of value, including money. The AKS is a criminal statute; and the risks of enforcement are now huge.
Business and arrangements which are designed at all to lock in physician referrals carry particularly large risks and require close scrutiny. For instance, surgery centers that received referrals from non-owner physicians viewed that as a great thing. Now, referrals from unaffiliated physicians are viewed as inherently suspect. “What,” the regulator thinks, “is driving this referral? What wrongful conduct is being engaged in here?” This is especially so with any marketing arrangement as well.
Physicians and other healthcare business people would do well to recall that if even “one purpose” of the arrangement is to compensate (cash or anything of value) someone for a patient referral, the AKS is triggered. Moreover, where Safe Harbor Act compliance was recommended, many now find it necessary.
