Interest in, and acceptance of, telehealth services continues to grow. Federal and state legislators are under pressure to codify the flexibilities granted in response to the COVID-19 pandemic that increased access to telehealth services. Meanwhile, increased use of telehealth has put a much greater focus on the potential for fraudulent behavior and increased enforcement activity
The New Jersey Department of Health (the “Department”) recently finalized regulations initially proposed in April 2020 that will now require all telehealth organizations providing telemedicine services to patients located in New Jersey to register their business with the Department before October 15, 2021, and annually thereafter. In addition to annual registrations, telehealth companies will also be required to submit annual reports on activity and encounter data.
Continue Reading Navigating New Jersey’s Telemedicine Business Registry
On June 21, 2021, Florida Governor Ron DeSantis signed into law a bill requiring genetic counselors to be licensed by the Florida Department of Health (“FLDOH”). The new law, known as the Genetic Counseling Workforce Act (“GCWA”), became effective on July 1, 2021. FLDOH has announced a 90 day enforcement moratorium to allow counselors time to become appropriately licensed in the State. Florida now joins a growing number of states that regulate the work of genetic counselors.
Continue Reading Florida Joins a Growing Number of States Requiring Licensure of Genetic Counselors
On May 26, 2021, the Department of Justice (“DOJ”) announced a coordinated law enforcement action against 14 telehealth executives, physicians, marketers, and healthcare business owners for their alleged fraudulent COVID-19 related Medicare claims resulting in over $143 million in false billing. This coordinated effort highlights the increased scrutiny telehealth providers are facing as rapid…
The Illinois Coalition to Protect Telehealth, a coalition of more than thirty Illinois healthcare providers and patient advocates, announced its support for a bill that would, among other things, establish payment parity for telehealth services and permanently eliminate geographic and facility restrictions beyond the COVID-19 pandemic. Like many states, Illinois issued an executive order at the outset of the pandemic temporarily lifting longstanding barriers to consumer access to telehealth via commercial health plans and Medicaid. The executive order expanded the definition of telehealth services, loosened geographical restrictions on physician licensing requirements, and barred private insurers from charging copays and deductibles for in-network telehealth visits.
Now, House Bill 3498 seeks to make permanent some of those temporary waivers by aligning coverage and reimbursement for telehealth services with in-person care. If enacted, it would also establish that patients could no longer be required to use an exclusive panel of providers or professionals to receive telehealth services, nor would they be required to prove a hardship or access barrier in order to receive those services. The bill does not include a provision that would permanently allow out-of-state physicians or health care providers to provide services in the state beyond the pandemic.
In the Coalition’s announcement of support for this bill, it states that the use of telehealth over the last year has shown an increased adherence to patient care plans and improved chronic disease management. “In recent surveys, over 70% of Illinois hospital respondents and 78% of community-based behavioral healthcare respondents reported that telehealth has helped drive a reduction in the rates at which patients missed appointments. Surveys of Illinois physicians, community health centers, and specialized mental health and substance use disorder treatment providers have also revealed similar dramatic reductions in missed appointments.”…
This Diagnosing Health Care episode examines the fraud and abuse enforcement landscape in the telehealth space and considers ways telehealth providers can mitigate their enforcement risks as they move into the new year. Hear how the uptick in enforcement warrants close consideration by telehealth providers, especially those that are new to the space and have…
On March 17, 2020, the Office for Civil Rights’ (“OCR”) announced that—for the duration of the COVID-19 emergency—it would exercise enforcement discretion and waive any potential penalties for HIPAA violations relating to health care providers’ use of “everyday communications technologies” in the provision of services via telehealth (the “HIPAA Waiver”). This move has resulted in a drastic increase in the number of telehealth encounters. The HIPAA Waiver has enabled many providers to immediately leverage these technologies to render services via telehealth for the first time, without the need to expend significant resources to quickly ramp up a HIPAA-compliant telehealth platform. A summary of the HIPAA Waiver can be found in a recent blog post. While the HIPAA Waiver applies only temporarily, it is likely that the increased reliance on telehealth evidenced over the past three months is here to stay.
The COVID-19 pandemic’s impact on the regulatory landscape of telehealth was the topic of a June 17, 2020 hearing before the Senate Health, Education, Labor & Pensions Committee. As Chairman Lamar Alexander acknowledged during his opening statement, the health care sector and government “have been forced to cram 10 years’ worth of telehealth experience into just the past three months.” Indeed, this “cramming” has resulted in thirty-one temporary changes to telehealth policy at the federal level. Of these temporary changes, Chairman Alexander included the OCR enforcement discretion / HIPAA waiver as one of the three changes he considers most important. However, of the three changes the Chairman views as most important, he declined to include the enforcement discretion in the temporary changes he believes should be made permanent, and instead called upon his colleagues to consider whether to extend the HIPAA waiver.…
The FDA has issued the Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency. The Prescription Drug Marketing Act of 1987 (PDMA) describes manufacturers’ drug sample storage, handling, and recordkeeping obligations as well as the written request and receipt requirements for prescribers.
Many manufacturers utilize their field sales representatives to deliver drug samples directly to, and collect written receipts from, prescribers at prescriber offices during sales calls. The COVID-19 crisis has disrupted field sales representatives’ ability to have face to face visits with prescribers, preventing them from delivering samples and collecting required receipts. In addition, as a result of the crisis, many prescribers are providing telehealth services from their homes, impacting prescribers’ ability to receive, store and distribute samples at their offices.
Continue Reading FDA PDMA Guidance in Response to COVID-19 Pandemic
On March 13, 2020, President Trump issued a proclamation that the novel coronavirus (“COVID-19”) outbreak in the United States constituted a national emergency. Following this proclamation, pursuant to section 1135(b) of the Social Security Act, the Secretary of the Department of Health and Human Services (“HHS”), Alex Azar, invoked his authority to waive or modify certain requirements of titles of the Act as a result of the consequences of the COVID-19 pandemic, to the extent necessary, as determined by the Centers for Medicare & Medicaid Services (“CMS”), to ensure that sufficient health care items and services are available to meet the needs of individuals enrolled in the Medicare, Medicaid, and Children’s Health Insurance Programs (“CHIP”). This authority took effect on March 15, 2020, with a retroactive effective date of March 1, 2020 and will terminate at the conclusion of the public health emergency period. Pursuant to this authority, HHS announced a number of nationwide blanket waivers, including a waiver related to telehealth, in order for providers to respond to the COVID-19 public health emergency.
Separate from and in addition to the blanket waivers, the Secretary’s authority under Section 1135 also allows CMS to grant Section 1135 waivers to states that request CMS to temporarily waive compliance with certain statutes and regulations for its Medicaid programs during the time of the public health emergency. So far, many states have requested these additional flexibilities in order to focus their resources on combatting the outbreak and providing the best possible care to Medicaid enrollees in their states. CMS has been rapidly approving these Section 1135 waiver requests, but it is important to recognize that not all state requests are created equal with respect to utilizing telehealth / telemedicine services during the public health emergency. Based on a review of the publicly available state request letters, it is clear that some states have prioritized use of telehealth in order to respond to COVID-19, while other states have not, or have not yet requested similar flexibilities related to provision of telehealth services. Examples of states that have prioritized greater use of telehealth include:
- California: The state requested flexibility for telehealth and virtual communications to make it easier for providers to care for people in their homes. Specifically, California requested flexibility to allow telehealth and virtual/telephonic communications for covered State plan benefits, such as behavioral health treatment services, and waiver of face-to-face encounter requirements for Federally Qualified Health Centers and Rural Health Clinics, among others. The state also sought reimbursement of virtual communication and e-consults for certain providers. CMS approved this waiver request on March 23, 2020.
- Illinois: The Illinois Department of Healthcare and Family Services waiver request, approved on March 23, 2020 by CMS, sought flexibility of documentation requirements, including the lack of documentation of consent for a telehealth consult. Like several other states, Illinois also requested CMS to allow providers to use non-HIPAA compliant telehealth modes from readily available platforms, such as Facetime, WhatsApp, Skype, etc., to facilitate a telehealth visit or check-in at the location of the patient, including the patient’s home.
On March 17, 2020 the Department of Health and Human Services, Office for Civil Rights (“OCR”) announced that it would “exercise its enforcement discretion and will waive any potential penalties for HIPAA violations” for health care providers who are serving patients using “everyday communications technologies.” The OCR issued this guidance to ensure providers could make…