Today’s Topic:Did you know that pharmacies and pharmacists continue to be a top enforcement priority for the U.S. Department of Justice and the myriad health care fraud task forces around the country?
Recent Sentencing in Compounding Pharmacy Fraud Case
This past week, a Mississippi pharmacist was sentenced to 5 years in prison for defrauding TRICARE (the government healthcare payer for the U.S. military and veterans) and some private insurance companies of $180 million through various kickback schemes. These schemes might sound familiar because they all take on common characteristics- essentially payments to someone in exchange for referral of prescriptions to boost the pharmacy’s numbers. And, more often than not, these prescriptions are medically unnecessary and driven by the greed of the people involved instead of the best interests of the patients.
This particular case became known as the “Mississippi Pain Cream Scheme” and led to three individuals who pled guilty, were sentenced to jail time and lost virtually everything. This past week’s announcement involved the sentencing of David “Jason” Rutledge, a pharmacist and co-owner of several compounding pharmacies. Two others pled guilty earlier, including a Louisiana veteran, Tommy Shoemaker, who in December was ordered to pay $1.7 million in restitution and forfeit proceeds from the sale of his luxury vehicles. And the Florida connection- Mitchell “Chad” Barrett of Gulf Breeze, was the mastermind behind this scheme as well as a larger national scheme that resulted in more than $1.5 BILLION in fraud nationwide! It’s no wonder the government is on the hunt.
Enforcement against medical device companies is not new and yet, these companies continue to engage in schemes that land them in hot water. Frequently the same schemes are repeated over and over- some form of payment by the device company to a physician who selects/recommends the device to patients. In some cases, the payment is in the form of an honorarium for speaking engagements. In others, the payment is an all-expense paid travel to attend device company-sponsored “CME” in exotic locations or consulting fees for assisting in the evaluation and design of the device.
Announced yesterday by the U.S. Department of Justice (DOJ), is the settlement of allegations against Florida-based Arthrex Inc., a medical device company that specializes in orthopedic products. Under the settlement agreement, Arthrex will pay $16 million for allegedly paying kickbacks to an orthopedic surgeon (Dr. Peter Millett) in Colorado. The “payment” in this case was structured as royalty payments purportedly to compensate the orthopedic surgeon for his “contributions” to the development of two of Arthrex’s products when in fact the “payment” was intended to induce the surgeon’s recommendation/selection of the Arthrex products. By offering the payments to the surgeon with the intent to induce purchase of Arthrex’ products which were then billed to Medicare, Arthrex violated the Anti-Kickback Statute (AKS) as well as the False Claims Act.
There’s certainly a lot of enforcement activity against compounding pharmacies these days. The ramp-up began around 2012 after a fungal meningitis outbreak that caused 64 deaths and many more infections related to the compounding activities at New England Compounding Centers. That heightened scrutiny continues to rock the compounding pharmacy world, not just from the drug quality, safety, and security standpoint, but also from the standpoint of the potential fraud and abuse inherent in the pricing of ingredients and the final compounded product as well as relationships between compounding pharmacies and the physicians who refer to them.
LATEST ENFORCEMENT ACTION
Announced yesterday by the U.S. Department of Justice (DOJ), the latest enforcement action is against Professional Compounding Centers of America Inc. (PCCA), a Houston-based supplier of wholesale compounding ingredients to other pharmacies. In many prior enforcement actions, compounding pharmacies have been charged in various schemes to defraud the federal government by filing false claims for prescriptions that were not medically necessary or not requested by patients and paying kickbacks to prescribing physicians. While similar in some ways to prior enforcement actions, this one differs because in this case, the DOJ reached back to the wholesaler of the compounding ingredients that were sold to the pharmacies that then submitted inflated claims to TRICARE. Here, the DOJ nabbed PPCA in a complaint alleging False Claims Act violations, specifically that PCCA reported fraudulent and inflated Average Wholesale Prices (AWPs) for the compounding ingredients that it sold to pharmacies. Those inflated AWPs resulted in pharmacies submitting inflated claims to TRICARE, the federal payer for military personnel and their dependents.
Has your attorney ever told you to do your best to comply with certain safe harbors to the Federal Anti-Kickback Statute, and you’ll be likely to survive scrutiny under the Florida Patient Brokering Act (the PBA)? If you’ve heard that, it’s time to re-examine that relationship. In the last month, the Patient Brokering Act has been amended, and then interpreted by a court of law in a way that affects all healthcare providers.
The Patient Brokering Act has been used in recent years to prosecute abuses in the addiction treatment industry. Other healthcare providers subject to the act have largely been uninvolved in these prosecutions. However, the PBA has been remolded 4 times in the past 5 years as a means to tailor it to allow for prosecutions of bad actors in healthcare, including addiction treatment. One item should be made clear: the PBA applies to any facility at all that is licensed by the Agency for Healthcare Administration (AHCA) or practitioner licensed by the Department of Health (DOH), including physicians, surgery centers, home health agencies, skilled nursing facilities, hospitals, DME providers, diagnostic imaging facilities, clinical laboratories, pharmacies and many other. During the legislative process, barely any healthcare industry representatives (from any provider group) showed up to any legislative workshops or produced counterbalancing input or language proposals that reflected a broader perspective.
In 2018, theGlobal Wellness Institute (GWI) released its report “Build Well to Live Well” on the global and regional wellness lifestyle real estate and communities market. The report highlighted various emerging real estate wellness living concepts that will drive future development, and create a surge in the $134 Billion dollar industry, expected through 2022, to reach $180 billion.
The lines between home, work and leisure are less defined. Your neighbor can be your patient, your coach or your nutritionist. The millennial generation and others are focused on living where their needs for healthy and long life are considered. Many people are willing to pay out of pocket for services that contribute to their health and wellness. Medical industry groups and health services will have to catalyze in order to build these wellness communities. These communities will be created by combining medical industry companies and research organizations, high quality hospitals and health services for consumers, and holistically designed wellness focused homes and neighborhoods.
Healthcare marketing arrangements that violate the Anti-Kickback Statute (AKS) can lead to serious financial and criminal consequences. Understanding the types of marketing arrangements that courts have found to be in violation of the statute and the potential implications are critical for marketers to know in order to operate in the healthcare industry.
Under the AKS, it is a criminal offense to knowingly and willfully offer, pay, solicit, or receive any remuneration to induce referrals of items or services reimbursable by the Federal health care programs. Where remuneration is paid purposefully to induce referrals of items or services paid for by a Federal health care program, the AKS is violated. By its terms, the AKS ascribes criminal liability to parties on both sides of an impermissible transaction. An example of a highly scrutinized arrangement involves percentage compensation. For regulators, percentage compensation arrangements provide financial incentives that may encourage overutilization and increase program costs.
Monty Ray Grow was a defensive back on the Florida Gators’ football team from 1990 until 1993. He contracted to play for the Kansas City Chiefs in 1994 and then for the Jacksonville Jaguars in 1995 and 1996. On February 5, 2018, he was convicted by a federal jury in Miami for his chief role in a massive healthcare marketing scheme designed to defraud Tricare.
Tricare is a health benefit program that provides civilian benefits for U.S Armed Forces military personnel, retirees, their dependents, and some military reservists. Tricare is a Department of Defense Program.
In September 2014, Grow entered into an agreement with a compounding pharmacy in Pompano Beach, Florida, wherein the pharmacy would pay Grow’s marketing company a commission equal to fifty percent (50%) of what the pharmacy netted in Tricare reimbursement from Grow’s referral of Tricare beneficiaries to the pharmacy. (Later on, Grow became an employee of the pharmacy.) Grow then used his commission to offer and pay recruiters to convince Tricare beneficiaries to use this pharmacy. Additionally, Grow offered and paid Tricare beneficiaries themselves to use this pharmacy.
Less than a year ago that medical device developer, Olympus Corp, agreed to pay a $646 million settlement to resolve claims of illegal kickbacks to physicians and hospitals. This is considered to be the largest settlement amount in the history of violations to the Anti-kickback Statute. The federal Anti-Kickback Statute (“Anti-Kickback Statute”) is a criminal statute that prohibits the exchange (or offer to exchange), of anything of value, in an effort to induce or reward the referral of federal health care program business. Conviction for a single violation under the Anti-Kickback Statute may result in a fine of up to $25,000 and imprisonment for up to five (5) years. In addition, a conviction will result in mandatory exclusion from participation in federal health care programs. The government may also assess civil money penalties, which could result in treble damages plus $50,000 for each violation of the Anti-Kickback Statute.
Between 2006 and 2011, Olympus offered consulting deals among many other bribes to influence physicians to order and prescribe Olympus medical devices. These consulting agreements provided for large up-front payments to physicians under the guise of medical device development. Olympus failed to focus on compliance and didn’t have policies and procedures in place to prevent illegal arrangements such as these. These physicians were retained as consultants, but most provided very little consulting services; they were utilized as device promoters. Physicians have a duty to order medical devices solely on the traditional standards of quality, price, and appropriateness for the medical conditions treated. Moreover, the ordering of medical devices by a physician must never be influenced by personal financial gain.
The amount of regulation imposed upon those entering into the healthcare business arena can be staggering even for a highly experienced businessman. In the business world, buying and selling businesses is often accompanied by lawyers, documents and consultants. In the healthcare business world, buying into and selling healthcare businesses, or any portion of health care businesses, requires all of that support and much more.
Diving into a healthcare business requires many considerations that are unique to other areas of business. First, appropriate licensing bodies must be notified and/or approve any such purchase or sale. For instance, in the State of Florida:
the Department of Children and Families must be notified every time a new owner becomes a part of a licensed substance abuse treatment center and prior to taking ownership, must either submit to a level 2 background screen or provide proof of compliance with the level 2 background screening requirements.
the Agency for Health Care Administration must be notified sixty days prior to any change in ownership and will run a background check on new owners.
the Agency for Health Care Administration must be notified every time a new owner is added to an entity holding a Health Care Clinic License. Additionally, AHCA must approve any owner of more than 5% of the Health Care Clinic prior to such person becoming an owner.
Healthcare professionals and businesses are aware of the term “fee splitting,” but rarely understand what that means, and for good reason. Is there some federal law against that? No. Is there a state law? Yes, but definitions are elusive and confusing.
Florida law prohibits licensed healthcare professionals engaging in any split-fee, rebate, commission or bonus in exchange for referral of any patient. In particular, Section 456.054 states it is a violation of a state criminal statute for a “healthcare provider” to “offer, pay, solicit, or receive a kickback, directly or indirectly, overtly or covertly, in cash or in kind, for referring or soliciting patients.”
Is there a court in Florida that has interpreted that law or opined on the concept? Not exactly. The closest thing we have is the Crow decision, where the 5th District Court of Appeals affirmed a Board of Medicine handling an issue involving the concept.
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.