Healthcare providers often have more than one relationship with each other. For instance, a physician may be employed by a hospital and also provide that hospital with medical director services. Or a healthcare consultant may also be a healthcare provider’s landlord. Oftentimes, these types of relationships are each memorialized in one or several contracts between the parties. And while, on their face, these contracts may seem to be compliant with applicable healthcare laws, when examined together, compliance and other contract issues may arise.
Miami resident Adrian Abramovich certainly wasn’t laughing on Thursday May 10th, 2018 when the Federal Communications Commission (“FCC”) levied a $120 MILLION dollar fine on him for his alleged involvement in an illegal robodialing campaign. FCC Chairman Ajit Pai stated that Abramovich did not dispute that he had placed more than 96 million telemarketing robocalls over a three month period in 2016 without the recipient’s consent. Furthermore, Chairman Pai stated that Abramovich’s telemarketing campaign utilized caller ID “spoofing” which masks the calling party’s true phone number and causes the recipient’s caller ID to indicate that the call was being made by a local number. Abramovich’s telemarketing activities allegedly violated a variety of state and federal regulations; caller ID spoofing, for example, is expressly prohibited by the Florida Telemarketing Act, § 501.616(7).
With the record-breaking fine imposed on Abramovich, the FCC is sending a loud and clear message that it will not tolerate those individuals or entities that violate telemarketing laws. Any person or business engaged in telemarketing (be it a healthcare provider with a single telephonic sales representative or a business devoted to telemarketing with a 100 person call center) must heed the FCC’s unsubtle hint that enforcement activity of telemarketing laws is only heating up.
Like it or not, telemarketing is a huge component of American businesses, and the healthcare industry is no exception. Many insurance companies, physicians, medical equipment and pharmacy providers heavily rely on telemarketing to expand their client base.
Take a moment to reflect – are you engaged in telephonic marketing or sales? Be it a healthcare businesses’ own internal based sales team or a third party providing such services, many individuals and entities are telemarketing and don’t even realize. If conducting telephonic sales either out of a Florida based location, or if calling into Florida, then listen up! There is a Florida telemarketing law that requires all such marketers to register for a telemarketing license or file for an exemption therefrom. While it’s not a new regulation, it’s one that is often overlooked and one that carries serious consequences for non-compliance.
What am I talking about?
Florida Statute Title XXXIII, Ch. 501 §§ 501.601 through 501.626, or more colloquially known as The Florida Telemarketing Act.
BEFORE doing business, The Florida Telemarketing Act requires individuals or entities looking to conduct telemarketing activities within the State to either (1) obtain a Commercial Telephone Seller Business License, as well as to license its individual sales representatives, or (2) have an approved exemption from such licensure on file. For the purposes of the Florida Telemarketing Act, this includes individuals/entities calling either into or calling out of the State! Unwanted telemarketing calls are one of the largest sources of consumer complaints in America; an individual or entity engaged in telemarketing will not “fly under the radar.” A called party will inevitably file a grievance with the state or federal government over telemarketing calls. If the activity falls under Florida’s jurisdiction, regulators will investigate and will penalize those persons or businesses involved if they are not adhering to the regulations outlined in the Florida Telemarketing Act. So what’s required to become licensed or exempted?
The license or exemption is issued by the Florida Department of Agriculture and Consumer Services – Division of Consumer Services (“FDACS”). A commercial telephone seller must obtain a license from FDACS, in accordance with §501.605, or have an exemption from such licensure on file, in accordance with §501.604.
Option 1 – Apply for the Commercial Telephone Seller Business License
Physicians and practitioners are ordinarily required to submit claims on behalf of Medicare beneficiaries when payment may be made for items and services provided by the physician or practitioner. However, in today’s health care environment, more and more physicians and practitioners are considering opting out of Medicare. For those professionals facing this decision, there are a few things to consider.
Is the Physician or Practitioner Eligible to Opt-Out?
First, determine if you are eligible to opt out of providing services to Medicare patients. Not every physician or practitioner is eligible to opt out of Medicare. For purposes of opting out of Medicare, “physician” is limited to: doctors of medicine; doctors of osteopathy; doctors of dental surgery or medicine; podiatrists; and optometrists; licensed by the state in which they practice (this could be multiple states). The term practitioner, for opt-out purposes, is limited to: PAs, ARNPs, Clinical Nurse Specialists, CRNAs, Certified Nurse Midwife, Clinical Psychologist, Clinical Social Worker, Registered Dietitian and Nutrition Professional. What is omitted from the definition of physician and practitioner are chiropractors, and physician therapists and occupational therapists in independent practice. Consequently, a chiropractor may not opt out of Medicare; neither may PTs or OTs in independent practice, but it seems PTs or OTs working in a physician’s office may be eligible to opt out.
With the rapid growth of the regenerative medicine field, the U.S. Food and Drug Administration (FDA) is trying to strike the right balance between preventing harm to the public and fostering innovation of new treatments. In an effort to prevent potential harm, the FDA stepped up enforcement this week. In two complaints filed by the U.S. Department of Justice (DOJ) on behalf of the FDA, the FDA has sought permanent injunctions against a California and Florida stem cell clinic along with their owners and officers to prevent the marketing of stem cell products without FDA approval and for failure to correct deviations from manufacturing practice requirements.
Amid the growing focus on stem cell products by the Federal Food and Drug Administration (FDA), multiple states have proposed and passed some form of stem cell law or clinic regulation. While some center the regulation on informing prospective customers of the risks associated with these treatments others seek to protect the availability of these treatments in the form of a “right-to-try” law. Here are a few examples:
Effective January of this year, California implemented a new regulation in its Business and Professions Code aimed at clinics offering non-FDA approved stem cell treatments. The regulation requires a notice to be posted at the clinic entrance along with the requirement to provide a separate written notice to the patient prior to initiating treatment. However, this requirement does not apply if a licensed health care practitioner has obtained approval for an investigational new drug from the FDA.
A recent lawsuit seeking class action status that targeted Zone Program Integrity Contractor (ZPIC), AdvanceMed along with the U.S. Department of Health and Human Services (HHS) has been dismissed. The plaintiff, an Illinois home health agency (HHA), filed suit in federal court requesting a writ of mandamus (i.e. an order directing a party to perform a specific act) and damages based on claims of fraud and non-compliance with Medicare’s regulations. With many wanting an overhaul with regards to ZPIC authority, this case has been watched closely. What does this decision mean going forward? Consequently, this decision solidifies the formidable hurdle and requirement to exhaust all administrative remedies before challenging a ZPIC in court.
What occurred in this case is not uncommon. AdvanceMed conducted a review of a number of patient charts which led to a suspension of Medicare payment “based on reliable information that an overpayment exists or that the payments to be made may not be correct.” In response to the suspension notice, the HHA submitted a rebuttal statement with additional supporting documentation. The ZPIC later informed the HHA that the documentation had been reviewed and the Centers for Medicare & Medicaid Services (CMS) decided to continue the suspension. In subsequent discussions between the parties, an AdvanceMed representative surprising stated that it was not their policy to review rebuttals nor was it obligated to review the additional documentation. The representative further indicated that CMS concurred with their position. As a result, the HHA filed a lawsuit.
Iowa Senator Chuck Grassley issued a press release last week indicating that he sent a letter to the leadership of the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) seeking additional information regarding the investigation into U.S. Stem Cell Clinic, LLC based in Sunrise, Florida. The letter poses seven questions with a deadline of April 27th. Last November, the FDA issued new guidance regarding human cell and tissue based treatments and announced its intention to crackdown on unproven treatments. Hence, many in the industry are watching closely to see what actions if any have been taken.
In August 2017, the FDA issued a press release setting forth the details of a warning letter sent to U.S. Stem Cell Clinic, LLC. The warning letter cited manufacturing deviations, efforts to impede an investigation, and issuance of a demand for corrective action. This step was taken as a result of several people experiencing blindness after receiving stem cell injections for treatment of macular degeneration. One of the patients noted that she believed the treatment was part of a clinical trial listed on ClinicalTrials.gov.
Due to financial and regulatory constraints, many companies are merging or purchasing other healthcare companies. However, prior to closing any transaction, these companies need to first determine whether government agencies must be provided advance notice of the change of ownership (CHOW). As an example, if Medicare is involved, these companies might be required to report the CHOW.
This issue is not one to dismiss or ignore because if companies fail to comply, they face significant penalties. In a recent “MLN Connects” newsletter, the Centers for Medicare & Medicaid Services (CMS) issued a reminder to report changes in ownership. The newsletter cites to an Office of Inspector General (OIG) report from 2016 that found a substantial amount of ownership changes were not being reported.
Many DME suppliers purchase leads from marketing companies. The patients who respond to the marketing advertisements are generally not interested in travelling to their doctor’s office to obtain an order for braces, for example. This type of arrangement is seen often enough and so starts a potentially problematic arrangement with the DME company paying the marketing company. The marketing company may then use some of these dollars to pay a telehealth company. The telehealth company may then pay a telehealth physician for “telemedicine visit” with the patient. Ultimately, the telehealth/telemedicine physician issues and order for the braces or other supplies.The DME brace supplier then gets paid by Medicare Part C, or other healthcare plan for providing the supply to the patient.
The problem with this arrangement is that the sole source of the telehealth doctor’s reimbursement for the visit comes indirectly from the DME company. Essentially, the DME supplier is paying the ordering physician through the marketing company for the visit with the patient. This creates a prohibited kickback arrangement because the supplier is essentially paying the Teledoctor for the referral for braces. The telehealth company is acting as a virtual unregulated physician practice. Providers engaged in this type of practice are not in compliance with either Federal or Florida law.
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.