Each summer in recent years, the U.S. Department of Justice (DOJ) and associated fraud enforcement partners have indicted many health care defendants, in multiple cases across the country. This summer continued the tradition.

The surveys the DOJ’s 2024 summer sweep, involving criminal charges against 193 defendants, including 76 doctors, nurse practitioners, and other licensed medical professionals in 32 federal districts across the United States, for their alleged participation in various health care fraud schemes involving approximately $2.75 billion in intended losses and $1.6 billion in actual losses, by DOJ estimations.

The that it took adverse administrative actions in the prior six months against 127 medical providers for their alleged involvement in health care fraud. (The CPI/CMS actions, which include payment suspensions and billing privileges revocations, are not routinely reported by CMS or available to the public on any CMS database, and so it is not possible to ascertain their alignment with the DOJ actions identified above.) As noted in the CPI/CMS announcement, the summer enforcement action “is the direct result of close coordination among the Health Care Fraud Unit, U.S. Attorneys’ Offices across the country, State Attorneys General, Medicaid Fraud Control Units, and our law enforcement agency partners…including the U.S. Department of Health and Human Services Office of the Inspector General (OIG), FBI, Drug Enforcement Administration, and Homeland Security Investigations.”  

The claims against the defendants are broadly based and do not seem to be overly focused on any health care sector or advocate for a prevailing legal theory. Nonetheless, in looking at DOJ’s and their history, there are “repeat occurrences” reflected among the DOJ-identified alleged misconduct. The cases provide some insight into DOJ’s workloads and priorities and may help providers identify areas of risk.

• Medical necessity is once again a popular enforcement theme. While there is a statutory requirement to support most claims for Medicare items or services, a failure to establish medical necessity can be a difficult theory to prove, often involving costly disputes among experts and wide variances in opinions. Indeed, in the civil False Claims Act context, appellate courts have dismissed cases where experts have disagreed about this issue. See, e.g., United States of America v. AseraCare Inc., 938 F.3d 1278 (11^th Cir. 2019).
• Commercial insurance is identified as the victim entity in multiple actions. Other “non-traditional” alleged victims in the summer takedown include Amtrak and the Department of Energy. This focus is a reminder that providers should review and be confident in the integrity of their billing to all payers, not just to federal health care programs.
• Kickbacks to Medicaid patients are alleged in a few cases. DOJ and OIG appear to be continuing to analyze and distinguish those cases where intent is easier to prove (criminal) and those where intent is less obvious (civil monetary penalties or CMPs). For an interesting discussion of OIG’s views of the difference between the anti-kickback authorities (AKS) and the CMP relating to beneficiary inducements, see
• Adderall prescribing is the subject of several actions in California resulting from allegedly improper prescribing of this controlled substance. Some of the allegations relate to the use of telehealth — a continued additional focus of both DOJ and HHS. 
• Lack of physician order for items or services, or lack of a physician–patient relationship, confirm the view of enforcement agencies that a physician or authorized equivalent must be demonstrated as a sufficiently involved gatekeeper to support Medicare coverage for claimed items and services. With health care evolving toward a more patient-empowered model (e.g., with patients identifying and requesting their own lab tests from commercially available test menus for tests that by law still require a clinician order), this theory is likely to continue as a lucrative area of focus for DOJ.
• Marketing alleged as kickbacks underscores that providing remuneration (directly or indirectly) for referrals continues to grab summer takedown headlines. It remains good practice to be certain that provider marketing arrangements meet AKS safe harbor elements.
• Patient protection, including in actions relating to drug diversion and “substandard care,” remains a top area of focus for both DOJ and HHS, both of which are on record as making patient protection an enforcement priority. 

What Should Providers Do with This Information? As providers act on OIG’s Compliance Guidance to reexamine their risk assessment practices, the focus areas in DOJ’s summer sweep may suggest additional areas of risk to consider or address. 

Want To Learn More?

• HHS OIG: New “General Compliance Program Guidance” Provides Voluntary Steps Towards Increased Effectiveness
• “Let’s Talk Compliance”: OIG’s General Compliance Program Guidance: How to Refresh Compliance Programs

Â鶹´«Ă˝â€™s seasoned team of Health Care and Government Enforcement Defense & Investigations attorneys are monitoring the evolving and dynamic landscape of health care regulatory, criminal, and civil enforcement.

Â鶹´«Ă˝ is here to help you address the short and long-term impacts in the wake of regulatory and litigation changes. We have the resources to help you navigate these and other important legal considerations related to business operations and industry-specific issues. Please reach out to the authors, your Â鶹´«Ă˝ relationship partner, or to our Health Care Practice GroupĚý˛ą˛Ô»ĺĚýGovernment Enforcement Defense & Investigations Practice Group with any questions.

The Office of Inspector General (OIG) recently issued a new favorable regarding patient assistance programs (PAP) for 12 specific disease funds. PAPs help patients pay high cost-sharing obligations for medications. The OIG has previously recognized the importance of PAPs to mitigate the increasing cost of prescription drugs as long as these PAPs do not implicate the federal anti-kickback statute, the civil monetary penalties law, or other laws. Previously, the OIG has stated that PAPs must be independent of pharmaceutical manufacturer influence and must not act as merely cover for a pharmaceutical manufacturer to make payments to patients for choosing their products.

Factual Background of this PAP

A non-profit (Non-Profit) organization operates each of the 12 disease funds, but each fund is financed by a single pharmaceutical manufacturer (Donor). Donors that fund the 12 PAPs also manufacture or market drugs that treat the same disease as those PAPs. The Non-Profit publicizes these PAPs throughout the community and a patient may apply to the PAPs for financial assistance. Additionally, a patient’s eligibility for the PAP is not contingent on the selection of a particular treating physician or pharmacy and the Non-Profit does not solicit information regarding the type of drug or treatment the patient may need besides the general out of pocket cost to the patient. Finally, the PAPs are open to all patients including those that may be enrolled in federal health care programs.

Key Laws

The anti-kickback statute prohibits anyone from knowingly and willfully offer, pay, solicit, or receive any remuneration to induce, or in return for, the referral of an individual for any item or service. Additionally, the OIG may impose Civil Monetary Penalties (CMPs) against any person who offers or transfers remuneration to a Medicare or state health care program beneficiary that the person knows or should know is likely to influence the beneficiary’s selection of a particular provider, practitioner or supplier.

Key Takeaway of this Opinion

The OIG notes that the arrangement implicates the federal anti-kickback statute but not CMPs. The arrangement implicates the anti-kickback statute because Donors, through the Non-Profit, provides remuneration to patients who may be federal health care program beneficiaries who have been diagnosed with diseases that can be treated by a drug that the Donor manufacturers. Conversely, the arrangement does not implicate the CMP because a patient’s eligibility for a PAP does not impact the patient’s selection of a physician or pharmacy. As a result, the remuneration from the PAP does not sway a beneficiary’s choice of drug or provider.

Despite the implication of the anti-kickback statute, the OIG announced it would exercise its enforcement discretion and not impose administrative sanctions for this arrangement. First, although the disease funds vary substantially and a Donor may support a fund that provides assistance for a large proportion of its own drug, the arrangement included many features the OIG has previously highlighted as reducing the risk of fraud and abuse. These include:

• Defining Disease Funds based on established disease states;
• Awarding assistance without regard to the treatment regimen prescribed for a particular patient;
• Limitations on the sharing of information with donors; and
• Application of a financial eligibility process.

Second, the funds only provide financial assistance with rare diseases. In these cases, PAPs can provide life-changing assistance for these patients. Additionally, a portion of the fund’s assistance is spent on non-drug cost sharing items and services.

Importantly, the OIG notes that this advisory opinion is only effective through December 31, 2026, and starting January 1, 2027, this opinion will no longer effective. It is highly unusual for the OIG to limit the effective period of an advisory opinion. In this case, OIG did this because Congress recently enacted legislation restructuring the cost sharing obligations of Medicare Part D enrollees and caping the enrollees’ out of pocket costs at US$2,000. The OIG noted that the reduction in Part D enrollee’s cost sharing obligations could change its assessment of the fraud and abuse risks in this arrangement. Because of the changing landscape, this opinion will no longer be effective two years after the legislation is enacted. This two-year grace period is to ensure that the Non-Profit has sufficient time to collect data supporting the need for these PAPs even after the legislation changes have been enacted.

Non-profit organizations, drug manufacturers, and other actors that may offer PAPs should take note of this opinions and the factors that the OIG emphasized in reducing risk of fraud and abuse. Although the effectiveness of this opinion is limited, it provides important insight in how the OIG evaluates and analyzes fraud and abuse risks in PAPs.

Â鶹´«Ă˝ is here to help you address the short- and long-term impacts in the wake of regulatory changes. We have the resources to help you navigate these and other important legal considerations related to business operations and industry-specific issues. Please reach out to the authors, your Â鶹´«Ă˝ relationship partner, our Health Care & Life Science Sector, or to our Health Care Practice Group with any questions.

Recent federally qualified health center (FQHC) litigation highlights the impact state Medicaid agencies have on FQHC reimbursement. The important decisions summarized below all involve FQHC disputes over state Medicaid agency decisions designed to limit coverage and reimbursement. Although not every outcome favored FQHCs, the cases demonstrate that FQHCs have viable state and federal causes of action to challenge state interpretations that improperly undermine the special protections afforded to FQHCs under the federal Medicaid statute.

In Arizona Alliance for Community Health Centers, a group of Arizona FQHCs and their association successfully challenged the Arizona Medicaid agency and its director. The plaintiffs alleged that Arizona violated federal law and Ninth Circuit precedent when it failed to reimburse the plaintiff FQHCs for services provided by dentists, podiatrists, optometrists, and chiropractors. At issue was the Medicaid requirement for states to “cover [FQHC] services . . . and any other ambulatory services offered by a [FQHC] and which are otherwise included in the [state Medicaid] plan.” 42 U.S.C. § 1396d(a)(2)(C). The defendants argued that states need cover only those FQHC services included in the state Medicaid plan, which in Arizona did not encompass certain services provided by dentists, podiatrists, optometrists, and chiropractors.  

Although acknowledging the case involved “uncommonly complex issues,” the court rejected Arizona’s limited reading of its Medicaid obligations. It reasoned that states must cover all “FQHC services”—a defined term in the law—regardless of whether they are included in the state Medicaid plan. Because the definition of “FQHC services” extends to services provided by dentists, podiatrists, optometrists, and chiropractors, the court held that Arizona could not categorically exclude such services, although it remanded for further consideration of whether Arizona could impose limitations on them.

In Family Health Centers of Southwest Florida, an FQHC successfully challenged the Florida State Medicaid Secretary in federal court after the State rejected the plaintiff’s request to increase its reimbursement rate to account for its growing workforce. The central issue hinged on the interpretation of Medicaid’s requirement to adjust FQHC reimbursement rate for “any increase or decrease in the scope of such services furnished by the [FQHC] during that fiscal year.” 42 U.S.C. § 1396a(bb)(3). Although Florida provided that the rate may be adjusted based on “[a]n increase or decrease in the scope of service(s),” it defined this condition as “the addition of a new service not previously provided by the FQHC” or “the elimination of an existing service provided by the FQHC.”

The plaintiff argued that Florida’s definition was too narrow, citing the Centers for Medicare & Medicaid Services’ (CMS) broader interpretation of a change in the “scope of services” as “a change in the type, intensity, duration and/or amount of services.” The court agreed with plaintiff and held that Florida’s interpretation was inconsistent with an “unambiguously clear” federal law. The court’s order granting plaintiff’s motion for summary judgment is under appeal.  

In Community Health Center Alliance for Patient Access, a coalition of FQHCs and their association contested the implementation of California’s Medi-Cal Rx Program, unsuccessfully arguing that California’s transition to a fee-for-service reimbursement methodology for pharmacy services—which eliminated managed care reimbursement of medications purchased by FQHCs at discounted 340B prices—deprived them of their right to full FQHC reimbursement under federal Medicaid law. The plaintiffs filed suit against the administrator of CMS under Administrative Procedure Act causes of action and the director of California’s Medicaid agency under 42 U.S.C. § 1983.

The court ultimately dismissed the FQHC claims, primarily because of the elective nature of fee-for-service pharmacy reimbursement; the court emphasized that notwithstanding the Medi-Cal Rx Program, FQHCs remained entitled to their prospective payment system (PPS) reimbursement rate if they chose to “carve in” pharmacy services under the FQHC reimbursement methodology approved in California’s state plan. The court rejected various additional arguments, including the contention that PPS reimbursement for pharmacy services itself did not comply with federal requirements, as well as preemption arguments and assertions that the approval of Medi-Cal Rx conflicted with the purpose of Medicaid. The court’s order granting defendants’ motion to dismiss is under appeal.

In Family Health Centers of San Diego, an FQHC successfully appealed the California Medicaid agency’s denial of reimbursement for the costs of outreach and education activities aimed at Medi-Cal-eligible patients. The California Supreme Court rejected the agency’s view that the salaries and benefits of the FQHC’s outreach workers were categorically nonreimburseable advertising costs.

The court noted that the Medicare reasonable cost regulations governing the appeal were general in nature and could not “directly answer the question whether an FQHC’s cost of outreach and education” are reimbursable costs related to patient care. It also analyzed the more specific instructions related to advertising in the Medicare Provider Reimbursement Manual, while cautioning that the manual is informal guidance only. In concluding that reimbursement for outreach and education is not prohibited, the court noted that the FQHC presented “extensive evidence” demonstrating how its outreach activities related to patient care, and that outreach and education activities are mandated “primary health services” FQHCs must provide—not the type of advertising uniformly deemed nonreimbursable in Medicare guidance. It remanded to the Medicaid agency to re-evaluate whether the FQHC’s costs should be recognized under the appropriate standard.

In Clinicas Del Camino Real, an FQHC unsuccessfully challenged a California Medicaid agency decision denying a reimbursement rate adjustment for a change in scope of services. The substantive dispute revolved around whether the FQHC’s increased costs related to the acquisition and use of data analytics software qualified as a triggering event for a new ratesetting. The FQHC purchased the data analytics software—which helps identify patient care gaps by analyzing medical records—to fulfill obligations under its managed care contract and its certification as a patient centered medical home.

Despite express statutory authority for a change in scope of services due to a change in applicable technology and medical practice, the court interpreted Medi-Cal’s change-in-scope-of-services statute to require that an FQHC’s increased costs are “attributable to an increase or decrease in the FQHC’s scope of services as defined in federal law.” It viewed this scope primarily to include physicians’ services and incident-to services. Under its interpretation, the court found that the FQHC’s new software costs, although associated with improved professional consultations, did not constitute an increase in the scope of physician services or incident to services, and therefore did not meet the qualifying conditions. In an ancillary issue, the court rejected the FQHC’s alternative argument that it qualified for a rate adjustment due to an increase in service intensity attributable to changes in the types of patients served because the FQHC had not raised this ground until it appealed the Medicaid agency’s initial denial of its request. As a result, there were no agency findings to review. The case was remanded for consideration of elements related to the software’s use not previously addressed by the agency.

Want To Learn More?

• Five Tips for Contracting with Federally Qualified Health Centers
• FQHCs: Four Reimbursement Traps for the Unwary
• FQHCs: The Nuts and Bolts of Medicaid Reimbursement
• FQHCs: Practical Impacts of Governance Requirements
• What FQHCs Need to Know about Telehealth After the PHE

Â鶹´«Ă˝ is here to help you address the short and long-term impacts in the wake of regulatory changes. We have the resources to help you navigate these and other important legal considerations related to business operations and industry-specific issues. Please reach out to the authors, your Â鶹´«Ă˝ relationship partner, or to our Health Care Practice Group with any questions.

This year will see a continued proliferation of enforcement against health-care fraud, with old and new theories. Some hot spots for enforcement will involve cases about new technologies; data outliers; entities perceived as exploiting ambiguous requirements; patient data safeguards; allegations of kickbacks, lack of medical necessity, and services not provided; and Covid-1 9-related cases.

Some types of entities seem particularly vulnerable to enforcement these days: companies operating in the managed care space, digital health providers, telemarketers related to health-care services, innovative labs and diagnostics companies, pharmaceutical companies, nursing homes, hospice providers, and companies owned by private equity.

For each hot spot, there are actions entities can take to reduce exposure.

New Technologies

Technologies such as those using artificial intelligence, digital medicine, or remote patient monitoring present novel compliance challenges, which in turn draw enforcement attention.

The Biden administration in October issued an executive order directing agencies, including the Department of Health and Human Services, to develop plans for responsible AI use.

Health-care industry participants can’t let the excitement of deploying technological advances outpace their compliance programs.

Data Outliers

The federal government and many states have devoted extensive resources to data mining and are getting better at identifying outliers based on several metrics, including provider prescribing tendencies, diagnosing habits, and use trends.

Those with the greatest risk of exposure from data mining are providers of health-care services, entities operating in the managed care space, and pharmaceutical companies. Being an outlier can subject companies to civil liability or criminal legal exposure.

Providers with the resources to do so may consider data mining on their own to get ahead of any potential outlier trends. Once outliers are identified, a thoughtful approach and an internal investigation may be warranted, as being an outlier doesn’t necessarily mean there has been fraud and because course-correcting any misconduct is better accomplished sooner than later.

Perceived Exploitation

To operate in the health-care industry is to face a labyrinth of rules, requirements, and directives. Underlying legal requirements are often less than clear, and questions arise about whether a defendant can have fraudulent intent—for instance, under the False Claims Act—when the defendant has misinterpreted an ambiguous directive.

Defendants have historically argued that if a requirement is ambiguous, and there’s a reasonable, but incorrect interpretation of the ambiguous requirement that would render the defendants’ conduct acceptable, they can’t have the requisite scienter under the False Claims Act.

The US Supreme Court ruled in 2023 that an ambiguous requirement doesn’t excuse a provider’s noncompliance.

It held that what matters for the purposes of scienter under the False Claims Act is the provider’s interpretation of the requirement, and that if the provider knew of a substantial and unjustifiable risk that its claims could be false, that was sufficient to meet the intent requirement of the False Claims Act, regardless of any ambiguity in the underlying legal requirement.

To help combat allegations of fraudulent intent that may later surface, entities may consider creating contemporaneous, non-privileged records regarding the reasoned basis for their interpretation of any potentially ambiguous requirement.

Patient Data Safeguards

There are many reasons for enforcers to increase their focus on health privacy. These reasons include fast-moving AI development, growing sophistication of cybercrime schemes, the expansion of telemedicine, and marketability of patient data.

Even reckless disregard for the security of patient information can result in fraud risk exposure, and providers should be careful to safeguard patient data and to use new technologies and AI carefully and responsibly.

Moreover, the Department of Justice’s Civil Cyber-Fraud Initiative, just two years ago, is still in its nascent phase in search of new targets. Pursuant to that initiative, the Department of Justice seeks to hold accountable those who put information or systems at risk by providing deficient cybersecurity products or services, misrepresenting cybersecurity practices or protocols, or violating obligations to monitor and report incidents and breaches.

As new technologies are implemented and deployed, companies should pay close attention to responsible safeguarding of patient data and appropriate reporting of breaches.

Kickbacks, Medical Necessity

We expect the steady clip of kickback allegations in a variety of contexts, and allegations related to kickbacks, lack of medical necessity, and services billed but not provided, to continue as ever. Our advice on this one? Don’t forget compliance basics.

Covid-19

We haven’t seen the end of pandemic relief fraud cases, cases related to Covid-19 testing kits, and cases related to purported treatments. When concerns are raised in any compliance area, an internal investigation and a related consideration of self-disclosure, where appropriate, should be considered.

The Covid-19 public health emergency is still very much on the mind of enforcers, and these issues remain well within statutes of limitations for fraud claims.

Looking Ahead

Health-care enforcers and their resources are plentiful. The Department of Justice recently announced its plans to add more criminal health-care fraud prosecutors. Whistleblowers and their counsel are creative at asserting liability across a host of scenarios.

To greatly reduce the risk of health-care fraud exposure, companies should ensure they’re dedicating appropriate resources to robust compliance programs that work on paper and in practice. It’s imperative that they vet business practices against the legal and enforcement environment. Health-care compliance is complex, and enforcement will continue to be red-hot.

This article originally appeared in . Reproduced with permission. Published January 2, 2024. Copyright 2024 Bloomberg Industry Group 800-372-1033. For further use please visit .

On December 7, 2023, the Biden Administration announced several new initiatives intended to “promote competition” in the health care sector. These initiatives reflect a broad range of concerns about rising costs in health care, including pointed references to “price gouging” and “profiteering” by private equity and big business. These initiatives build on the dozens of other regulatory efforts that President Biden ordered in his 2021 Executive Order on Promoting Competition in the American Economy. They also complement a number of enforcement actions, guidance statements, and rulemakings that the Federal Trade Commission (FTC), Department of Justice (DOJ), and Department of Health and Human Services (HHS) have taken over the past three years to promote competition in the health care sector, which those agencies highlighted in a issued at the same time as the White House’s announcement.

The initiatives announced on December 7 include the following:

• HHS, FTC, and DOJ are taking steps to promote the sharing of data among themselves to identify so-called “roll-up” acquisitions, such as mergers or acquisitions that may be too small to require reporting to the FTC or DOJ under the Hart-Scott-Rodino Antitrust Improvements Act, but which nevertheless can potentially create competitive issues. This announcement builds on the FTC and DOJ’s ongoing efforts to revise the federal Merger Guidelines to specifically address the issue of “serial acquisitions” that may have a cumulative effect of lessening competition, and also continue prior efforts to promote the exchange of data between HHS and antitrust enforcers.

• HHS and the Department of Commerce have released a for the exercise of “march-in” rights under the Bayh-Dole Act. In short, for pharmaceuticals, medical devices, or other inventions whose development was funded by taxpayers, the Bayh-Dole Act allows the federal government under certain circumstances to license the invention to a third party. The new proposed framework would, for the first time, allow the government to consider pricing as a factor in determining whether to exercise these so-called march-in rights.

• In the near future, the DOJ, FTC, and HHS will issue a joint Request for Information to the public, seeking information on the topic of “corporate greed in health care.” (Or, as the White House Fact Sheet somewhat more diplomatically puts it, on “how private equity and other corporations’ increasing power and control of our health care is affecting Americans.”) This Request for Information will be used to identify areas for future regulatory and enforcement activity by these agencies.

• HHS, FTC, and DOJ are creating new administrative roles within their respective organizations. HHS will appoint a new “Chief Competition Officer.” And FTC and DOJ will both appoint “Counsels for Health Care,” with responsibility for leading antitrust enforcement efforts in health care. It is not immediately clear whether these positions will replace or overlap with other existing positions, such as the Director for Health Care that already exists within the FTC’s Bureau of Competition, or the Deputy Assistant Attorney General for the Healthcare and Consumer Products Section that already exists within the DOJ’s Antitrust Division.

• Finally, the Centers for Medicare & Medicaid Services (CMS) is taking steps to increase the transparency of certain data it keeps about health care organizations. For the first time, CMS will publicize data about the ownership of Federal Qualified Health Centers and Rural Health Clinics. CMS will also explore ways to increase the transparency of data about Medicare Advantage plans and performance, starting with a request for information from the public on this topic to begin in early 2024.

Together, the new initiatives underscore the Biden Administration’s efforts to promote competition and value across the health care sector. Expect the Administration to continue highlighting these efforts as a key component of the President’s “Bidenomics” agenda in the months ahead of the 2024 election.

Â鶹´«Ă˝ is here to help you address the short- and long-term impacts in the wake of regulatory changes. We have the resources to help you navigate these and other important legal considerations related to business operations and industry-specific issues. Please reach out to the authors, your Â鶹´«Ă˝ relationship partner, or to our Health Care Practice Group with any questions.

On October 6, 2023, the Drug Enforcement Administration (DEA) released a  extending the COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications. This second extension, issued shortly after DEA’s listening session on a potential new Telemedicine Special Registration, gives practitioners and patients certainty of the DEA requirements for telemedicine prescribing through the end of 2024. 

Without this Second Temporary Rule, COVID-19 telemedicine flexibilities would expire on November 11, 2023, with respect to practitioner-patient relationships established after that date (as described in our previous blog post). This Second Temporary Rule – entitled “Second Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications” – continues the temporary extension of the “full set” of DEA’s COVID-19 waivers for prescribing controlled substances via telemedicine. Those waivers, which have been in place since March 2020, are now extended through December 31, 2024.

Key Provisions Under the DEA’s Second Temporary Rule

1. Which DEA waivers are extended under this rule?

DEA said it is again extending the “full set” of telemedicine flexibilities regarding the prescription of controlled medications, referencing the two DEA letters that authorized telemedicine waivers.

• A  â€śDear Registrant” letter signed by William T. McDermott, DEA’s then-Assistant Administrator, Diversion Control Division.
• A  â€śDear Registrant” letter signed by Thomas W. Prevoznik, DEA’s then-Deputy Assistant Administrator, Diversion Control Division.

The March 25 letter addressed two waiver exceptions: one related to DEA registrations in individual states; and one related to the in-person evaluation requirement. It stated, in relevant part:

• DEA-registered practitioners are not required to obtain additional registration(s) with DEA in the additional state(s) where the dispensing (including prescribing and administering) occurs, for the duration of the public health emergency declared on January 31, 2020, if authorized to dispense controlled substances by both the state in which a practitioner is registered with DEA and the state in which the dispensing occurs. Practitioners, in other words, must be registered with DEA in at least one state and have permission under state law to practice using controlled substances in the state where the dispensing occurs.
• Under the Controlled Substances Act (CSA), a prescription for a controlled substance issued by means of the Internet must generally be predicated on an in-person medical evaluation. See 21 U.S.C. § 829(e)(1). This requirement does not apply, however, when a practitioner is practicing telemedicine as defined by the CSA. The CSA’s definition of the practice of telemedicine includes multiple different categories of telemedicine. For several of these categories, the CSA specifically requires a practitioner to have a DEA registration in the state in which the patient is located. See, e.g., 21 U.S.C. § 802(54)(A), (B). But the practice of telemedicine during a public health emergency pursuant to 21 U.S.C. § 802(54)(D) does not include this requirement. On March 16, 2020, the Secretary of the United States Department of Health & Human Services, with concurrence of the Acting DEA Administrator, designated that the telemedicine allowance under section 802(54)(D) applies to all schedule II-V controlled substances in all areas of the United States.

The March 31 letter extended waivers with respect to prescribing of buprenorphine. It stated, in relevant part:

• DEA notes that practitioners have further flexibility during the nationwide public health emergency to prescribe buprenorphine to new and existing patients with opioid use disorder (OUD) via telephone by otherwise authorized practitioners without requiring such practitioners to first conduct an examination of the patient in person or via telemedicine.

On May 11, 2023, Â鶹´«Ă˝ received confirmation from the DEA’s Section Chief of its Diversion Regulatory Draft and Policy Support Section (Scott Brinks) that the registration policy outlined in the  letter is being extended. Thus, the PHE policy on single-state DEA registrations will continue during the duration of the flexibilities as outlined in the May 10^th  Temporary Rule and extended in this Second Temporary Rule as well.

2. What time period does this Second Temporary Rule cover?

The Second Temporary Rule extends the COVID-19 PHE DEA telemedicine flexibilities through December 31, 2024. As stated in the Second Temporary Rule, the DEA has removed the distinction between new and previously seen patients outlined in the initial extension:

• This extension authorizes all DEA-registered practitioners to prescribe schedule II-V controlled medications via telemedicine through December 31, 2024, whether or not the patient and practitioner established a telemedicine relationship on or before November 11, 2023. In other words, the grace period provided in the First Temporary Rule is effectively subsumed by this Second Temporary Rule, which continues the extension of the current flexibilities for all practitioner-patient relationships – not just those established on or before November 11, 2023 – until the end of 2024.

3. Does this rule shed any light on when DEA may issue new proposed rules on this topic?

Yes. In the Second Temporary Rule, DEA stated:

• DEA is working to promulgate new standards or safeguards by the fall of 2024.

If that estimated time frame is accurate, and a new substantive proposed rule is issued in fall of 2024, that is not much time before this second extension expires. It almost seems certain that a third extension would be necessary. Time will tell.

Conclusion

This Second Temporary Rule lengthens the runway for telemedicine companies planning for changes until the end of 2024. While both expected and necessary, it remains to be seen what DEA’s proposal will look like in 2024 and whether it will include a special telemedicine registration. Stay tuned. We will continue to monitor for updates.

Want to Learn More?

• DEA: Potential New Telemedicine Special Registration for Controlled Substances Prescribing to be Discussed in Special Listening Sessions
• DEA Extends Telemedicine Flexibilities for Prescribing of Controlled Medications
• Â鶹´«Ă˝ & Lardner Comment Letter on DEA Telemedicine Controlled Substance Proposed Rule

Â鶹´«Ă˝ is here to help you address the short- and long-term impacts in the wake of regulatory changes. For more information on telemedicine, telehealth, virtual care, remote patient monitoring, digital health, and other health innovations, including the team, publications, and representative experience, visit Â鶹´«Ă˝â€™s Telemedicine & Digital Health Industry Team or our Health Care Practice Group.