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Potential Pitfalls of Telehealth Prescribing

May 31, 2022 | Blog | By Lara Compton, Ellen Janos, Cassandra Paolillo

As we’ve previously covered, while Congress has acted to extend certain COVID-era telehealth flexibilities (mostly related to Medicare coverage) beyond the Public Health Emergency (PHE), the future of prescribing controlled substances via telehealth is uncertain.  Although the American Telemedicine Association and other industry groups continue to advocate for changes to allow telehealth providers to prescribe controlled substances in certain circumstances, without further action by Congress or the Drug Enforcement Administration (DEA), telehealth providers who prescribe controlled substances will need to conduct an in-person examination of the patient once the PHE ends. 
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Last week saw a lot of great news in the world of telehealth. On March 15, President Biden signed into law H.R. 2471, the “Consolidated Appropriations Act, 2022”, which extends many of the Medicare telehealth flexibilities put in place during the COVID-19 pandemic for a period following the end of the Public Health Emergency (“PHE”). The same day, the OIG issued a report highlighting the positive impact telehealth had on increasing access for beneficiaries during the first year of the pandemic. Then, during a press conference on March 18, HHS Secretary Xavier Becerra said that HHS will seek to sustain and expand access to telehealth services after the public health emergency ends. While these developments signal the continued expansion of telehealth, there is still some uncertainty surrounding coverage, reimbursement and licensure flexibilities that have allowed telehealth to flourish for the past two years.
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Telehealth Update: New Bill Could Provide Much Needed Certainty to Providers and Patients

February 10, 2022 | Blog | By Ellen Janos, Cassandra Paolillo

On Monday, February 7, 2022, U.S. Senators Catherine Cortez Masto, D-Nevada, and Todd Young, R-Indiana, introduced the Telehealth Extension and Evaluation Act, which if passed, would extend several of the telehealth waivers for two years after the end of the federal public health emergency (PHE). See our previous coverage of telehealth during the COVID-19 pandemic. The PHE was most recently renewed for an additional 90 days on January 16, 2022. Since January 2020, providers who pivoted to telehealth in order to deliver care to their patients during the pandemic have had to closely monitor the status of the PHE, which the Secretary of HHS is only authorized to extend for 90 days at a time. Passage of the proposed legislation would provide some much-needed certainty and would give providers time to transition back to in-person care where necessary. It would also further the growth and expansion of telehealth services and continued integration into our health care delivery system.
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Last week, CMS announced its final Physician Fee Schedule Payment Policies (the “Final Rule”), which will become effective January 1, 2022. The Final Rule included several updates to Medicare coverage of telehealth services, including a number of COVID-19 related changes that will be extended or be made permanent. As previously covered, while temporary orders allowing expanded use of telehealth have increased access to care across the country during the public health emergency (“PHE”), the regulatory environment for telehealth has always been somewhat unsettled. The changes in the Final Rule described below signal a move towards increased access to telehealth for Medicare beneficiaries as regulators acknowledge the potential benefits of these alternate methods of delivering care.
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Five Takeaways from DOJ’s Latest National Enforcement Action, Including Continued Focus on Opioids and Telemedicine

September 27, 2021 | Blog | By Sarah Beth Kuyers, Brian Dunphy, Karen Lovitch

The U.S. Department of Justice (DOJ) recently announced its latest national enforcement action related to health care fraud (National Enforcement Action) in which DOJ filed criminal charges against 142 defendants. The National Enforcement Action, which alleges losses of $1.4 billion due to false or fraudulent billings, follows similar DOJ “take downs” over the last several years in that it focuses on telemedicine providers and the opioid crisis. This post provides five takeaways from the National Enforcement Action.
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As we’ve previously covered, the COVID-19 pandemic has brought about a major increase in the prevalence of telehealth services, due in large part to regulatory flexibilities at the federal and state levels. Beginning in March 2020, state Medicaid programs across the country loosened requirements for coverage of telehealth services provided to Medicaid beneficiaries, reducing barriers by allowing audio-only services and covering a broader scope of services delivered via telehealth. The increase in telehealth has resulted in improved access to behavioral health services in particular, but according to an OIG report issued earlier this week, state Medicaid programs will need to increase their oversight of these services if the telehealth flexibilities become permanent.
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As previously discussed, many of the telehealth flexibilities in place during the COVID-19 pandemic are set to expire at the end of the federal Public Health Emergency (PHE), unless federal and state legislators act to make the changes permanent. A recent bill introduced by Representative Robin Kelly (D-IL) suggests that Congress is interested in expanding access to telehealth services for Medicare and Medicaid beneficiaries if the benefits of increased access to telehealth can be demonstrated. According to a press release issued by Representative Kelly’s office, “Telehealth has the potential to help equalize healthcare access for underserved populations. However, we need data to understand utilization, cost, fraud, privacy and how to serve those left behind by the digital divide.”
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Telehealth Update: States Move to Permanently Expand Access to Telehealth

March 30, 2021 | Blog | By Cassandra Paolillo, Ellen Janos

Over the past year the telehealth landscape has been a patchwork of temporary waivers and regulations, expanding access during the COVID-19 pandemic but leaving providers and patients uncertain about whether the positive coverage and reimbursement changes and relaxation of pre-pandemic restrictions would continue in the future. In recent weeks, we have seen a number of state actions making permanent changes to expand access to telehealth. These changes suggest a positive trend towards making telehealth an integral part of the care delivery system, although the complicated regulatory frameworks still present challenges to providers seeking to treat patients via telehealth.
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Health Care Enforcement Kept the DOJ Fraud Section Busy in 2020

March 8, 2021 | Blog | By Eoin Beirne, Grady Campion

On February 24, 2021, DOJ’s Criminal Division Fraud Section published its annual year-end summary. The Fraud Section focuses on prosecuting white-collar crime. The report summarizes enforcement activity in the past year and discusses notable cases from the Fraud Section’s three litigation units: (1) the Health Care Fraud (HCF) Unit; (2) the Foreign Corrupt Practices Act (FCPA) Unit; and (3) the Market Integrity and Major Frauds (MIMF) Unit. In summarizing the Fraud Section’s main achievements from 2020, the report also provides valuable insights on what lies ahead for the Fraud Section in 2021. This post focuses on the health care enforcement portion of the Fraud Section’s report.
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As COVID-19 infection rates continue to rise in areas of the country, telehealth continues to play an important role in the delivery of healthcare, especially to those most vulnerable to the virus. Existing telehealth waivers continue in effect under the Public Health Emergency, and new legislation seeks to expand telehealth access through home health services. Plus, join us for a webinar on the future of telehealth.
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On August 4, CMS posted a proposed rule on CY 2021 Payment Policies, which included important updates about the expansion of Medicare covered telehealth services due to the COVID-19 pandemic. Here, we cover this and other important developments related to telehealth access during the pandemic and beyond.
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Massachusetts Adopts Permanent Telehealth Policy for the First Time

July 1, 2020 | Blog | By Sarah Beth Kuyers, Ellen Janos

Last Thursday, the Massachusetts Board of Registration in Medicine (BORIM) approved its first permanent telehealth policy. The Board had previously approved this policy on an “interim” basis in response to the COVID-19 pandemic on March 16, 2020. This policy is an important step for the Massachusetts BORIM as it had previously hesitated to provide any formal guidance on the practice of telehealth.
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In an interview yesterday, CMS administrator Seema Verma expressed support for permanently expanding access to telehealth services after the COVID-19 public health emergency resolves. Here, we explore the nature and duration of the temporary executive and regulatory orders, emergency legislation, and sub-regulatory guidance, which have resulted greater access to telehealth while leaving a fair amount of uncertainty as to what the future of telehealth looks like.
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FTC Comments on New Medicare Rule in Support of Expanded Telehealth Services

June 4, 2020 | Blog | By Evan Moore, Joseph Miller

On May 29th, the Federal Trade Commission (FTC) submitted a comment to the Centers for Medicare & Medicaid Services (CMS) in support of reducing reimbursement requirements for telehealth services. CMS accepted public comments for its new Interim Final Rule published on April 6, 2020, 85 FR 19230, which changes the Medicare payment regulations to allow for more flexible Medicare service options in response to the COVID-19 pandemic. In addition to supporting CMS’s new Interim Final Rule, FTC’s comment recommends permanent measures and further steps to take. The comment offers a valuable insight into the Commission’s stance on telemedicine in relation to health care competition.
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Telehealth Reimbursement Continues to Expand for Medicare and Medicaid

May 6, 2020 | Blog | By Sarah Beth Kuyers, Ellen Janos

Last week, the Centers for Medicare and Medicaid Services (CMS) announced additional waivers of limitations on Medicare reimbursement of telehealth services and updated its summary of COVID-19 blanket waivers. We’ve previously blogged about actions by CMS and other federal and state agencies to increase access to and encourage utilization of telehealth services during the COVID-19 pandemic through loosening of restrictions on telehealth reimbursement (see here and here). CMS is now taking additional steps to further these goals. Below is a summary of the major changes that CMS announced last week.
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The ongoing COVID-19 pandemic has introduced uncertainty and unique challenges in nearly every aspect of life. During this unprecedented time, Mintz is working to keep our clients and community informed and empowered to navigate this new world. To that end, we’ve created a number of webinars on a variety of COVID-19-related topics of interest to health care industry stakeholders. In case you missed them, here’s a highlights reel of what we’ve covered so far – just click on the links below to access the webinar recordings.
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As we’ve previously discussed on the blog, telehealth is playing a critical role in delivering care during the COVID-19 pandemic. Both Congress and states continue to take action to expand the use and reimbursement of telehealth services. The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) passed by Congress last Friday includes many provisions that further expand the use and reimbursement of telehealth during this public health emergency. Congress previously took action to start waiving certain telehealth requirements in the Coronavirus Preparedness and Response Supplemental Appropriations Act (Appropriations Act) passed on March 6, 2020, which we previously discussed here. In this post, we’ll cover the key ways that the CARES Act continues to remove barriers to telehealth, in addition to other recent federal and state actions.
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Telehealth is going to play a critical role in the delivery of care in the coming weeks and months as health care providers respond to the COVID-19 pandemic. As the CDC and other public health agencies continue to recommend social distancing and self-quarantine after exposure, telehealth is a vital tool for getting both sick and healthy individuals access to health care services they need if in-person services are not necessary. The use of telehealth services should help alleviate the ever-growing pressures on health care systems as they respond to the outbreak.  In light of these benefits, the Emergency Appropriations Bill passed by Congress last week includes provisions that allow the Secretary of Health and Human Services (HHS) to lift certain restrictions that are currently required for Medicare  reimbursement of telehealth services. 
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Practice Intro Health Care Enforcement Investigations Mintz
On August 8, 2019, FDA issued a notice on its medical device recall database that a company called Opternative, Inc. had initiated a recall for the Visibly Online Refractive Vision Test, a software application offered directly to consumers. This represents a recent example of FDA taking enforcement action against a telemedicine software company that ultimately resulted in removal of the app from commercial distribution.
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FCC Seeks Big Role in Telemedicine with New Fund

July 31, 2019 | Blog | By Russell Fox

$100 million in Federal funds may soon become available to help healthcare providers cover the costs of broadband and connected care services. Earlier this month, the Federal Communications Commission (FCC) voted on a proposal, on which it will seek public comment, for a new “Connected Care Pilot Program,” and the comment period on that proposal has now begun. The proposed program would direct money to telehealth initiatives, especially for medically underserved populations like low-income families and veterans. The money would come from the Universal Service Fund (USF), which is an existing fund of fees paid by telecommunications service providers currently used for a variety of purposes.
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