The indictments and regulatory activities that took place on April 9th were just the tip of the iceberg when it comes to the crackdown on DME fraud, telemarketing and telemedicine operations.
In the weeks and months that have followed ‘Operation Brace Yourself’, healthcare providers (such as DME suppliers and telehealth physicians) and telemarketers allegedly involved in these activities have been subjected to a wide range of penalties from suspension of Medicare billing privileges to civil penalties and/or criminal charges. Here are some of the more serious recent DME, telemarketing and telemedicine related civil and criminal regulatory enforcement actions:
Monday, April 29, 2019, the Florida House and Senate came to agreement on a new Telehealth bill (HB 23). If signed by Governor DeSantis, the bill will become effective July 1, 2019.
The bill creates two new statutes: Section 456.47 and Section 627.42396, and amends Section 641.31.
Section 456.47 sets forth the standards of practice for telehealth providers, authorizes the use of telehealth encounters for patient evaluations, and allows certain providers to prescribe certain controlled substances in limited circumstances. The bill also allows non-physician providers to use telehealth without being deemed to be practicing medicine without a license. Further, the bill sets forth record keeping requirements and registration for out-of-state telehealth providers. It authorizes the Department of Health to establish rules for telehealth, including exemptions from registration requirements, and to set up disciplinary action against telehealth providers that violate the law or rules.
Via justice.gov – One of the largest health care fraud schemes investigated by the FBI and the U.S. Department of Health and Human Services Office of the Inspector General (HHS-OIG) and prosecuted by the Department of Justice resulted in charges against 24 defendants, including the CEOs, COOs and others associated with five telemedicine companies, the owners of dozens of durable medical equipment (DME) companies and three licensed medical professionals, for their alleged participation in health care fraud schemes involving more than $1.2 billion in loss, as well as the execution of over 80 search warrants in 17 federal districts. In addition, the Center for Medicare Services, Center for Program Integrity (CMS/CPI) announced today that it took adverse administrative action against 130 DME companies that had submitted over $1.7 billion in claims and were paid over $900 million. Read on…
Pursuant to Section 456.44(3)(a), Florida Statutes, and Rule 64B-9.013(3)(a), Florida Administrative Code, a practitioner must evaluate a patient by taking a complete medical history and performing a physical examination prior to prescribing a controlled substance to a patient. The aforementioned statute and rule do not specifically rule out a patient evaluation taking place via a telemedicine visit. However, under current Florida law, only controlled substances used to treat psychiatric disorders may be prescribed using telemedicine technology, that is audio and video technology commonly referred to as telepsychiatry. Specifically, Rule 64B8-9.0141(4) states, “controlled substances shall not be prescribed through the use of telemedicine except for the treatment of psychiatric disorders.” Psychiatric disorders include Substance Use Disorders since the DSM-V classifies addiction as a mental health condition. Although the Standards for Telemedicine Practice under Rule 64B-9.0141, Florida Administrative Code, allows licensed practitioners to prescribe controlled substances for psychiatric disorders via telehealth technology, the federal law has lagged somewhat behind.
Improving patient outcomes while maintaining physician decision making and practice efficiency is key to success in the growing health care arena. Innovation is the ability to see change as an opportunity to create new value, instead of a threat to what we find comfortable. It is clear that the Center for Medicare and Medicaid Services (CMS) is embracing the importance of innovation in the way we deliver health care.
In November 2018, the 2019 Physician Fee Schedule and Quality Payment Program was released by CMS with changes effective January 1, 2019. This is the time for providers to definitely keep their eyes open to utilizing mHealth, and telehealth services. mHealth is also known as mobile health, and is a general term for the use of mobile phones and other wireless technology in medical care to educate consumers about preventive healthcare services as well as for disease surveillance, chronic disease management, treatment support, epidemic outbreak tracking. The release of the program is a sign that the agency is in favor of expanding the implementation of technology in providing medical care. The updated mHealth codes are:
Regulatory compliance is a mandatory investment for any healthcare business owner looking to stay out of serious and personal legal peril, let alone one hoping to keep their company viable.
Yet there is seemingly an onslaught of providers that blatantly run afoul of many of these regulations, knowingly or not, or those that believe they may have found a loophole.
Concerning the latter, there is an important mantra that such DME and pharmacy providers should remember and live by: “[W]hat a provider cannot do directly, it cannot do indirectly through an intermediary.”
Marketing for DME – What exactly am I talking about?
DME providers enrolled with CMS (should) know they cannot solicit or ‘cold call’ Medicare Part B beneficiaries, per the Federal Anti-Solicitation Statute, and that they cannot offer anything of value to a potential patient that could induce them to utilize them as a provider, in accordance with the Beneficiary Inducement Statute.
A new law has been passed in Florida that pertains to prescribing and dispensing controlled substances. On March 19, 2018 Governor Scott signed HB21, which becomes effective July 1, 2018. Intended to address the growing nationwide opioid epidemic that has also greatly affected Floridians, among other requirements, the new regulations establish:
Healthcare practitioners are excited about the expansive geographic scope of practice in Telemedicine. A licensed Florida physician can provide services in other states provided the physician is also licensed in the state where the patient is receiving the services. There are no geographical limitations if the delivery platform of technology provides voice and vision and where necessary videos for the Telemedicine/Telehealth visit.
As more and more physicians practice and contract to provide Telemedicine visits, one of the legal challenges we are facing is how to draft a restrictive covenant. The traditional reasonableness standards used to evaluate non-compete agreements just do not apply. What are you trying to restrict when the physician lives in Florida but has telemedicine practice with patients 500 miles away?
Attorney Karina Gonzalez will present this live lunch n’ learn webinar for attendees interested in learning more about the billing and reimbursement issues related to Telehealth/Telemedicine. She will cover various aspects, from compliance with Medicare regulations to claims denials and commercial plans as well.
Telemedicine law is driven at the federal level, but mostly at the state level, since the developing areas of law are more dynamic at the state level than they are at the federal level. For instance, the Florida Telehealth Advisory Council is recommending that telehealth capabilities be expanded and that insurance reimbursement for telehealth services be compelled. If the Council’s recommendations are adopted by Florida legislators, it will be the most forward moving telehealth law in the country.
We are committed to advising teleheatlh providers and related vendors of all kinds, both within Florida and around the country. Given our extensive experience and exclusive focus on healthcare law, we see where healthcare is headed; and we are working closely with many around the country who have caught the wave of telehealth.
Floridians are all too familiar with the business and logistical hurdles bad tropical weather can create. However, even less expected are the everyday human errors such as an overzealous backhoe operator digging above a fiber optic cable and inadvertently cutting a data connection. The reality is that disruption can happen anytime, not just during hurricane season. The good news is that recent developments in technology provide a new way to both augment the practice of medicine and insulate a business against downtime. Telemedicine or telehealth is rapidly becoming an inexpensive and secure way to interact with patients and medical professionals just short of the tactile response from pressing flesh during an introductory handshake.
Granted, telemedicine and telehealth are generic terms that incorporate layers of many technologies. For simplicity’s sake we’ll discuss some of the most popular options for video conferencing, cloud based technology and virtualization. If that sounds intimidating just look past the buzzwords you may hear in commercials mentioning a certain character from a Sir Arthur Conan Doyle novel. It’s all elementary. See what I did there?
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.