The latest healthcare marketing prosecution in the Florida laboratory space came when criminal charges were filed against Mr. John Skeffington on December 6th. The case is unique because it involves (a) purely commercially insureds (no governmental patients), (b) it is aimed entirely at marketing practices, and (c) is seems to target (the allegedly illegal contract was not attached) pure incentive compensation (percentage based in this case). The case will certainly get a lot of attention, since it may be signaling enhanced federal enforcement of purely commercial payer arrangements sources, marketing activities, lab marketing relationships and percentage based compensation arrangements.
The Florida Health Care Clinic License (HCCL) law was created in 2001 to create accountability of healthcare businesses that are not owned by certain healthcare providers (e.g. physicians). The legislative thinking behind the law was that laypeople who acquire healthcare businesses that bill insurance companies have nothing to lose by “getting it (anything) wrong.” By attaching the license requirement to the lay owned business, those business people have to pay close attention to regulatory details, or they risk losing their HCCL and the ability operate their business. Accountability!
The U.S. Food and Drug Administration (FDA) has issued new guidance for regenerative medicine manufacturers and healthcare providers. At the core of the guidance are two central interpretations: 1) the FDA’s current interpretation of the minimal manipulation and homologous use criteria set forth in 21 CFR Part 1271; and 2) the FDA’s current view on the same surgical procedure exception under 21 CFR 1271.15(b). Additionally, the FDA issued a notice to all interested stakeholders that the FDA intends to initiate increased discretionary enforcement over the next 36 months for human cell and tissue-based products. Given these developments, healthcare companies and providers impacted by this guidance are strongly encouraged to ensure compliance with the FDA’s new interpretations.
Medicare beneficiaries are generally entitled to coverage for care received by a home health agency. However, home health providers can expose themselves to large overpayment demands from Zone Program Integrity Contractors (ZPIC audit) if the face-to-face (FTF) encounter requirements for home health certification are not strictly followed. On an increasing basis, FTF encounters have been the target of ZPIC review. Providers view this position as an effort to use home health agencies to police the industry. On the other hand, contractors see this as part of their mission to identify cases of suspected fraud and recoup inappropriate payments. Thus, it is imperative that home health providers fully understand the requirements in order to withstand contractor scrutiny.
Before doing business in Florida, an entity providing substance abuse marketing services must be licensed by Florida’s Department of Agriculture and Consumer Protection. This includes includes either telephone solicitation from a location in Florida or solicitation from other states or nations for substance abuse and addiction treatment centers located in Florida.
As of November 27, 2017, only the following entities are licensed by the State of Florida to provide marketing services to substance abuse and addiction treatment centers:
A Way and a Means, LLC (Delray Beach, Florida)
Addiction International Holdings, LLC d/b/a The Addiction Advisor d/b/a The Recovery Miracle (Boca Raton, Florida)
Advanced Recovery Systems, LLC (Winter Park, Florida)
Bandwidth Interactive Company d/b/a Local Management (Boca Raton, Florida)
Delphi Behavioral Health Group, LLC (Fort Lauderdale, Florida)
Freedom From Addiction, LLC (Miami Beach, Florida)
Infoworx Direct, LLC d/b/a Addiction Hope and Help Line (Boca Raton, Florida)
Invigorate Solutions, LLC d/b/a Local Management (Boca Raton, Florida)
Meridian Treatment Solutions, LLC (Lauderdale by the Sea, Florida)
NPA Consulting Group, LLC (Pompano Beach, Florida)
Palm Partners, LLC (Palm Springs, Florida)
Parent Team, LLC (Santa Rosa, California)
Pryme Time Media, LLC (Sunrise, Florida)
R360, LLC (Fort Lauderdale, Florida)
Redwood Recovery Solutions, LLC d/b/a com (Riviera Beach, Florida)
Ring2Media, LLC (Westport, Connecticut)
Rybchinskiy Inc. (Boynton Beach, Florida)
Sober Network, Inc. (Delray Beach, Florida)
The Addiction Network, LLC (North Miami, Florida)
True Choice Health Group Limited Liability Company (Pompano Beach, Florida)
United Addiction Specialists, LLC (Hollywood, Florida)
USR Holdings, LLC (Coconut Creek, Florida)
It is a third degree felony for: any person to work for an entity that does not have a current and valid license; or for any entity to invite telephone calls or other communications with a substance abuse marketer who is soliciting clients without a current and valid substance abuse marketing license; or for any person or entity to solicit without a license; or for any person who otherwise violates the law requiring licensure either directly or indirectly. Any person who is convicted of a second or subsequent violation commits a felony of the second degree.
The Drug Enforcement Administration (DEA) is responsible for the monitoring of all manufacturing and distribution of controlled substances in the country. Pharmacies, medical providers (i.e., who either administer, prescribe or dispense), and distributors and manufacturers of controlled substances are required to register with the DEA. The DEA’s Diversion Control Division is tasked with reviewing applications of potential registrants and monitoring existing registrants through audits and investigations. However, the question on many registrants’ minds is what happens if violations or deficiencies are discovered? The answer is it depends. The consequences will vary based on the level of noncompliance. Thus, it is essential to be familiar with the laws that apply and most importantly, have a full understanding of the administrative process in order to act quickly to minimize potential adverse action if noncompliance is found.
Many practitioners or establishments looking to enhance their practice and offer more treatment options to their patients are considering HCT/P and Stem Cell Therapy in addition to other traditional treatment options. However, before embarking on offering HCT/P or STEM Cell Therapy, a practitioner or establishment needs to carefully consider protocol and procedure for offering HCT/Ps or STEM Cell Therapy.
The FDA defines HCT/Ps as “articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion or transfer into a human recipient.” 21 CFR 1271.3(d). HCT/Ps include bone, ligament, skin, dura mater, heart valve, cornea, hematopoietic stem/progenitor cells derived from peripheral and cord blood, manipulated autologous chondrocytes, epithelial cells on a synthetic matrix, and semen or other reproductive tissue.
Since the implementation of the ZPIC audit and RAC audit programs, healthcare providers and suppliers have experienced increased scrutiny in the pursuit of overpayments and fraud. Medicare’s most vital tool in its progressive search is the use of statistical sampling. In theory, statistical sampling offers a reliable and low cost approach to addressing large volumes of claims. However, this process gives the government a huge advantage as it places a heavy assumption on a large number of claims without actual review of the claims. Thus, it is important for providers and suppliers to understand the process and know how to challenge such studies in order to minimize potential repayment obligations and retain their revenue.
What is statistical sampling?
Statistical sampling draws a random sample from a universe of claims and extrapolates or projects the results of the sample to the entire universe of claims. In other words, the Medicare contractor will select a sample of claims to review from a look back period or examination period of typically two or three years. For this example, let’s say that the review finds a 40 percent error rate in the sample, meaning 40 percent were not found to meet Medicare requirements for payment. In this case, a contractor will apply the 40 percent finding to the entire two years’ worth of claims and deny these claims based on the sampling results.
Medicare payment suspension can place serious financial strain on a company’s operations. As a result, many companies face the risk of closing its doors when a suspension is initiated. Nevertheless, CMS is able to issue such suspensions by meeting a relatively low threshold. Additionally, suspension decisions are not appealable leaving affected providers and suppliers with little options. Therefore, it is important to understand the suspension process and how to counter if a notice of suspension is received.
CMS can suspend payments to providers and suppliers based on “reliable information” of any of the following: (1) fraud or misrepresentation; (2) when an overpayment exists but the amount has not yet been determined; (3) when reimbursement paid to a provider or supplier may be incorrect; or (4) when a provider or supplier fails to submit requested records needed to determine amounts due. Suspensions are initiated by a request to CMS’ Office of Program Integrity by either law enforcement or a Medicare administrative contractor.
By now, many clients are familiar with the process of payor audit findings resulting in an agreed on Corrective Action Plan (CAP). The latest wave of activity from Cigna shows that they are now coming back around to the facilities that entered into these CAPs to determine compliance with the agreed on terms. Internal audit activity throughout the course of operations should have been consistent in order to be meaningful and meet Cigna’s requirements. Compliance is an ongoing commitment and process, not something that can be strung together in the eleventh hour.
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.