First and foremost, there is a mountain of clinical research supporting the efficacy of nutritional supplements in helping alleviate a variety of medical conditions. Doctors are also using supplements in conjunction to patient lifestyle modification and standard pharmaceutical treatments. With the changes in healthcare over the last few years combined with rising overhead, doctors are looking for new avenues to generate additional revenue. The medical community in general is finding patients are looking more and more for “natural” or “homeopathic” treatments and physicians are in the position to help educate patients on the use of these supplements.

How do doctors evaluate a potential supplement to recommend in their practice? Many medical professionals tend to recommend products that have science to support claims. Those nutritional products that have science to support the efficacy of their product will be the ones that doctors tend to gravitate to for their patients aliments. Make sure to review products that offer benefits supported by science rather than marketing tactics!

Below are some findings from two published reports. The findings come from a report compiled by ChangeWave Research called “Preventive Care and Wellness Trends” and a survey done by the Nutrition Business Journal.
ChangeWave Research Observations

• 41% of doctors recommend that patients take vitamins/nutritional supplements
• 31% of doctors report increased patient interest in preventive care and wellness. Those changes were driven by lifestyle changes but also included supplementation as a means to avoid illness
• Doctors rated Vitamins/Nutritional Supplements as the safest products in the marketplace, even more safe than prescription drugs and over-the-counter drugs
• 29% of doctors recommended nutraceutical products to their patients with the top 3 recommendations being Fish/Omega oils, Probiotics, and Fruits and Vegetables/Whole grain/Organic products
Nutrition Business Journal Report
• 76% of practitioners sell supplements in their offices
• 70% of practitioners reported being “very knowledgeable” about supplements and how they can be used to support their patients health (growing trend on physician education on nutrition)
• Prediction that the healthcare practitioner channel of distribution is going to be “one of the most vibrant and fastest-growing sales channels in the nutrition industry for the next 10 years”.
Based on these findings you can see that practices are becoming more involved in the sale of nutritional supplements.

Practices are adopting creative ways to incorporate supplements into their practice without the need to carry any inventory. Some physicians are creating websites, treatment plans, etc. to help encourage patients to use alternative care therapies. Some practices have the physician “recommend” the product and the staff “sells” it. The practices are using the additional revenue to cover increased overhead. Offices often use the revenue to pay for employee raises and incentives. Consider introducing supplementing into your practice today.

Staff Writer, Great Healthworks

CMS has issues revised and clarified POS coding instructions. They give multiple examples, including one where a Medicare patient receives MRI services at a hospital. The hospital bills the technical component . The physician is to submit a claim showing the professional component POS as his/her office (code 22), since that is where the physician performed the covered service, not the MRI center at the hospital. The Instructions describe the proper use of POS modifiers and are invaluable in avoiding liability to Medicare.

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What does all this mean to doctors? Simple: VERIFY REGULARLY. If you assign to any person or entity the right to bill for your services, you MUST routinely check to see if they are billing correctly. The fact that some person or entity may bill wrongfully, even fraudulently, without your direct knowledge, will not protect you from liability. Make sure (1) you have written agreements for all arrangements that involve any person or entity billing for your services, and (2) those contracts contain indemnification provisions in case you have to hire a lawyer or pay anything to the government for their wrongdoing.

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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.

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View the bill in it’s entirety HERE

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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.

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The Council for Urological Interests (CUI) is a national organization of physician-owned joint ventures.  As many readers know, for instance “under arrangement” lithotripsy services, for instance, are a common joint venture type business for urologists to be engaged in.  The CUI filed suit in response to 2008 changes to the Stark Law, which would have interfered with certain urology-centered joint venture businesses, but the lower court dismissed the suit because the CUI was first required to go through “administrative review” required by the Medicare Act.  The appellate court disagreed and agreed to hear the CUI suit.  The case should make it easier to file legal challenges in response to regulatory changes, like Stark Law developments.

The case is also important because the Stark Law change in 2008 (effective in 2009) made it difficult (impossible in some instances) for physicians to act as service providers to hospitals.  These “under arrangement” transactions were ok because the hospitals billed for the “designated health services,” not the doctors.  The Stark Law change, effective in October, 2009, interfered with such relationships (between physicians and hospitals) by determining that the “under arrangement” providers were actually providing the service (even though the hospital, not the doctor entity, billed for the service).

Though the jury is still out on the substance of the CUI lawsuit (whether the Stark changes are unlawful), the case will pave the way for more legal challenges of this type.

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In a vote of 89-10, the Senate passed an amended version of the House payroll tax bill that the lower chamber approved earlier this week. The legislation from Senate Majority Leader Harry Reid (D-Nev.) and Minority Leader Mitch McConnell (R-Ky.) (PDF)—which extends a payroll tax holiday for two months—provides no payment update in Medicare reimbursement levels for the nation’s doctors in January and February 2012, which prevents a 27.4% cut that was scheduled to tax effect on Jan. 1.

Meanwhile, the bill also extends for two months a host of Medicare and health-related provisions that would otherwise have expired by year’s end. These measures include reimbursement raises for ambulance services, mental health reimbursements, the Qualifying Individual (QI) program, the outpatient “hold harmless” provision, and transitional medical assistance, which provides Medicaid benefits for low-income families who are transitioning from welfare to work.

In a statement, American Medical Association President Dr. Peter Carmel said waiting until the final week of the legislative session to address an issue Congress knew about all year is no way to conduct business for the country.

Read more: Senate OKs two-month freeze on doc pay – Healthcare business news and research | Modern Healthcare http://www.modernhealthcare.com/article/20111217/NEWS/312179947#ixzz1gzkQmEcy
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Medical Equipment Companies

Enrollment Abuses

The OIG has discovered a pattern of improper enrollment among supplier of durable medical equipment, prosthetics, orthotics and supplies (DMEPOS). The OIG is looking to Medicare contractors (carriers and intermediaries) to be more scrutinizing in the enrollment of DMEPOS suppliers. The contractors will be assessed on their use of enrollment screening mechanisms and post enrollment monitoring activities to find companies that may pose fraud risks. It is, therefore, important for DMEPOS suppliers to make sure all applications for enrollment and even those for change of ownership are completed accurately and thoroughly.

Payments for High Priced Equipment

Additionally, the OIG will be undertaking a heightened review of the appropriateness of payments to DMEPOS suppliers for “high ticket” items such power mobility devices, oxygen and hospital beds. The medical equipment industry has always been the target of potential abuse. The OIG confirms this stating that there continues to be wide spread abuse of DME not ordered by physicians, not delivered or not needed. The OIG will focus on geographic areas with high volumes of “high ticket” reimbursements and review for compete records demonstrating that the services are “reasonable and necessary for the diagnosis and treatment of the illness or injury.” For frequently replaced supplies such as CPAP and respiratory supplies, the OIG will review compliance with the requirements that a Certificate of Medical Necessity must specify the type of supplies needed and the frequency with which they must be replaced used or consumed.

Diabetic Testing Supplies

The OIG will also review Medicare claims for diabetic testing strips and lancets (diabetic testing supplies) to identify questionable billing. Medicare has utilization guidelines for the amount of diabetic testing supplies (DTS) that beneficiaries may receive. To receive reimbursement from Medicare, suppliers must maintain documentation demonstrating that their DTS claims meet all Medicare coverage, coding, and medical necessity requirements. DTS claims with certain characteristics (e.g., DTS provided to a beneficiary at irregular intervals) may indicate improper supplier billing.

Physicians

Some highlights of physician’s services that are going to be under review include the following:

Place-of-Service Errors

The OIG will be reviewing physicians’ coding practices on Medicare Part B claims for services performed in ambulatory surgical centers and hospital outpatient departments to determine whether they properly coded the places of service. The OIG will particularly pay attention to this as there is evidence of physicians coding for services at the higher non-facility rate when the services were actually performed in an ASC or outpatient setting. Medicare pays a physician higher amounts for serviced performed in a non-facility setting such as the physician’s office.

Incident-To Services

“Incident-to” services will also be reviewed. This is a new initiative on the part of the OIG and therefore, should garner lots of attention. The OIG will try to determine whether payment for such services had a higher error rate than that for non-incident-to services. We will also assess CMS’s ability to monitor services billed as “incident-to.” One of the main focuses of this review is to cut down the amount of billings for incident to services performed by non-physicians without the required direct physician supervision. The OIG has found that unqualified non-physicians performed 21 percent of the services that physicians did not perform personally. Incident-to services represent a potential abuse for the Medicare program in that they do not appear in claims data and can be identified only by reviewing the medical record.

Evaluation and Management Services (“E/M Services”)

In 2009, Medicare paid $32 billion for E/M services. This represented nearly 20% of all Medicare Part B payments. With those dollars at stake, the OIG will be reviewing E/M claims to assure there is appropriate documentation to justify payment for the more intensive E/M codes. It is important to thoroughly document records to demonstrate the type, setting, and complexity of services provided and the patient status, such as new or established. Also under review will cases of multiple E/M services for the same providers and beneficiaries to identify electronic health records (EHR) documentation practices associated with potentially improper payments. Medicare contractors have noted an increased frequency of medical records with identical documentation across services.

Payments for Services Ordered or Referred by Excluded Providers

Medicare does not allow payment to a physician or supplier for services and items provided that were prescribed or ordered by individuals or entities excluded from the Medicare program. To combat that practice, the OIG will undertake a review of the nature and extent of Medicare payments for services ordered or referred by excluded providers (those who have been barred from billing Federal health care programs) and examine CMS’s oversight mechanisms to identify and prevent payments for such services.

There are numerous other areas of concern that will be reviewed by the OIG during 2012. To assure compliance with the items describes as well as other health care laws, the Florida Healthcare Law Firm offers a comprehensive compliance audit of your organization. For more information please contact us  at 561-455-7700

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PODs distribute various things, most commonly surgical implants and devices, that are reimbursed by insurers. A patient needs a spinal rod, a surgical implant/device company makes it and a distributor rep distributed it. Device/implant companies usually contract with distributorships to sell their products. Distributorships contract with reps who are paid commissions for sales. Surgeons who actually order the devices sometimes think “Since I’m the one doing the surgery and ordering all this stuff, why don’t I make something from the selling it?” PODs are one way for physicians to financially benefit from the sales of devices and items their patients need, but they have never been more controversial than now.

Conceptually speaking, PODs are controversial because government regulators think physicians who have an economic stake in health care items or services will tend to over utilize them. Moreover, there is a specific concern that allowing physicians to profit from the devices their patients need violates federal anti kickback laws or the Stark prohibition on compensation arrangements.

In 2006, the Office of the Inspector General of HHS and CMS expressed major concerns about PODs, and cited concerns about “improper inducements.” At that time, the OIG stopped short of prohibiting them, but called for heightened scrutiny. CMS itself has stated that PODs “serve little purpose other than providing physicians the opportunity to earn economic benefits in exchange for nothing more than ordering medical devices or other products that the physician-investors use on their own patients.”

Implantable medical devices are unusual in the way they come into use. Unlike DMEPOS, for instance, medical devices are not sold to distributors. They’re sold from the manufacture to the medical facility where the surgery will take place. So, the argument goes, physicians are not actually in a position to drive the sales volume of the implants. The counter: physicians invested in a POD can leverage their hospital admissions to influence the device choice of hospitals and surgery centers.

The biggest legal hurdle for PODs is the federal Anti Kickback Statute, which carries both criminal and civil penalties. Simply put, if even one purpose of an arrangement is to pay for patient referrals, the law is violated. So, the law is arguably violated if one purpose of the POD is to induce physicians to order implants for their patients. Looked at another way, the law is violated if one purpose of a hospital doing business with a POD is to ensure patient referrals by the physician POD investors.

A 1989 OIG Special Fraud Alert on fraudulent physician joint ventures is especially interesting on the fraud and abuse issues in pointing out that the following would indicate unlawful intent to induce patient referrals—

Investor choice. If the only investors chosen are surgeons with an opportunity to refer and if they lack any business or management expertise, the arrangement appears to be a cloaked way to incentivize unlawful referrals (i.e. ordering implants). The key question is whether the business, in selecting investors, is looking to raise capital or to lock in referral sources.

Risk. If the POD investment involves little or no financial risk, the OIG would likely take issue with it.

The bottom line seems to be that if there isn’t a real business, with real financial risk and qualified investors, a POD will likely be viewed as a suspicious arrangement based on locking in patient referrals or physician admitting pressure by physician investors.

In its June, 2011 Inquiry “Physician Owned Distributors (PODs): Overview of Key Issues and Potential Areas for Congressional Oversight,” the U.S. Senate Finance Committee Minority Staff, the Committee reports “A number of legal and ethical concerns have been identified as a result of this initial inquiry into the POD Models.” The Committee reviewed over 1,000 pages of documents and spoke with over 50 people in preparing its report. The Committee cited long-held concerns regarding PODs, and leaned heavily on the 2006 Hogan Lovells (previously Hogan & Hartson) law firm’s anti-POD analysis.

With the Committee’s call for greater OIG and CMS involvement, one thing seems clear: the future of PODs is uncertain. In this era of cost-cutting, it seems clear that PODs are gonna get a haircut and may even lose their head.

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