DEA Announces Three New Telemedicine Rules
On January 16, 2025, the Drug Enforcement Administration (DEA) announced two final rules and a proposed rule for telemedicine flexibilities. In 2024, the DEA issued a one-year extension of the COVID-era telemedicine flexibilities when it became clear there was significant industry opposition to an alleged DEA rule that was publicly leaked to the press in August 2024 (the Unpublished Rule). The Unpublished Rule reportedly proposed to (i) restrict Schedule II substances from being prescribed unless an in-person visit had occurred, (ii) permit Schedule III-V substances to be prescribed based solely on a telehealth visit, and (iii) only allow providers to do fifty percent of prescribing online or via telemedicine.
Final Rule for Expansion of Telehealth Buprenorphine Prescribing
This final rule provides patients with increased remote access to buprenorphine, a medicine used to treat opioid use disorder. Patients will be permitted to receive a six-month supply of buprenorphine through a telephone consultation with a provider. Further prescriptions of buprenorphine beyond the six-month supply will require an in-person visit to a medical provider. This rule was published in the Federal Register on January 17, 2025, and is effective February 18, 2025.
Proposed Rule for Special Registrations for Telemedicine
This proposed rule would establish three types of "special registrations" to permit patients to receive prescribed medications through telemedicine visits without an in-person medical evaluation from a medical provider. Predicated upon the level of scrutiny required for the specific prescribing practices, the special registrations would be divided as follows:
- The first special registration would apply to mid-level practitioners seeking to prescribe Schedule III-V controlled substances via telehealth.
- The second, or advanced special registration, would be for providers seeking to prescribe Schedule II controlled substances, which are considered riskier and more susceptible to diversion. This type of special registration would include additional safeguards and oversight. Specifically, this type of advanced registration would only be available to providers in certain specialties, like psychiatry, hospice and palliative care, and pediatricians. Additionally, the patient and provider must be located in the same state, and a provider with an advanced special registration could prescribe no more than half of Schedule II prescriptions via telehealth.
- The third type of special registration would regulate telemedicine platforms seeking to prescribe Schedule II-V controlled substances with the DEA.
The proposed rule would also increase prescription recordkeeping requirements and require the establishment of a national prescription drug monitoring program to help protect against abuse and the diversion of controlled substances into the illegal drug market.
This proposed rule was published in the Federal Register on January 17, 2025, and comments to this proposed rule must be submitted before March 18, 2025.
Final Rule for Continuity of Care via Telemedicine for Veterans Affairs Patients
An additional rule was finalized in consultation with the Department of Veterans Affairs (VA). This final rule exempts VA practitioners from Special Registrations requirements. Once a patient has received an in-person medical examination from a VA medical practitioner, the provider-patient relationship is extended to all VA practitioners engaging in telemedicine with the patient. This final rule was published in the Federal Register on January 17, 2025, and is effective February 18, 2025.
Reporter, Michelle Huntsman, Houston, +1 713 751 3211, mhuntsman@kslaw.com.
HHS Issues Report on Consolidation and Private Equity in Health Care Markets
On January 15, 2025, HHS released a report highlighting negative sentiments from commenters toward consolidation, private equity, and private insurers in health care markets. The comments were received in response to a joint Request for Information (RFI) issued by FTC, DOJ, and HHS in March 2024 seeking public feedback on the impact of corporate ownership of health care businesses.
Under the Biden Administration, the leadership of the FTC, DOJ, and HHS criticized private equity investment and consolidation in health care. In December 2023, the agencies announced a joint effort intended to combat health care inflation by enhancing competition within the health care sector. A virtual workshop hosted by the FTC in March 2024 titled "Private Capital, Public Impact: An FTC Workshop on Private Equity in Health Care" featured several speakers, including representatives from DOJ and HHS, who discussed criticisms of private equity investment in health care. In March 2024, the agencies issued the joint RFI seeking public comment to investigate how certain transactions in the health care market—carried out by health systems, private equity funds, private insurers, and other private investors—might lead to reduced competition, higher costs, and compromised quality of care. After reviewing more than 2,000 comments received in response to the RFI, HHS issued "HHS Consolidation In Health Care Markets RFI Response" (the Report) on January 15, 2025.
The Report states that it "is not intended to be a comprehensive summary of all topics, but instead focuses attention on evidence, trends, and policy ideas that deserve greater scrutiny and consideration." In the Report, HHS makes the following assertions: (1) provider consolidation increases prices and reduces access for patients; (2) M&A in health care services, especially in private equity funded transactions, results in process changes and quality reductions; (3) reviews from physicians that work with private equity firms are mixed; (4) there is widespread desire for transparency on private equity led transactions; and (5) there is dissatisfaction with private health insurers, especially vertically integrated insurers.
HHS also sets forth certain policy considerations in the Report, including the following:
- scrutinizing potentially harmful transactions and engaging in more vigorous antitrust enforcement to stop or reverse the trend of consolidation;
- improving health care entity ownership transparency, including expanding upon CMS's nursing home ownership transparency rule;
- enhancing health care M&A disclosure by reducing reporting thresholds, mandating review and approval, and providing relevant authorities with the necessary data and resources to review health care transactions; and
- furthering data sharing and collaboration across agencies, Congress, and state and local authorities in a comprehensive government approach to foster competition.
The timing of the Report is notable, as it was issued in the final days of the outgoing Biden Administration. It remains to be seen whether private equity investment in health care will continue to be an area of focus for the agencies under the second Trump Administration. Under the first Trump Administration, the FTC challenged a number of proposed deals involving large health systems and insurers, but transactions involving private equity sponsors were not subject to the same level of scrutiny. However, there are signs of growing bipartisan support to scrutinize private equity's role in health care. Earlier this month, the Senate Budget Committee chaired by Senators Sheldon Whitehouse (D-RI) and Charles Grassley (R-IA) issued a bipartisan staff report criticizing private equity's impact on the U.S. health care system.
The full text of HHS's Report is available here.
Reporter, Jenna M. Anderson, Los Angeles, +1 213 443 4328, janderson@kslaw.com.
OIG Issues Favorable Opinion Regarding a Program to Provide Patients with Free Access to a Pharmaceutical Product
On January 10, 2025, OIG posted a favorable advisory opinion approving a proposed program (Program) to provide patients who meet certain financial need criteria with free access to a pharmaceutical product that has limited coverage by Federal health care programs.
Background
Under the Program, the requestor (Requestor) would provide certain patients who meet specified financial need eligibility criteria with free access to a product intended to treat an undisclosed disease and is intended for initiation in patients with mild cognitive impairment or mild disease-related dementia and confirmed presence of amyloid pathology.
When covered by Medicare, the product is covered as a Part B outpatient infusion therapy, and reimbursement is made for both the product and its administration, where the standard 20 percent coinsurance applies for Part B fee-for-service enrollees once they meet their deductible. All state Medicaid programs also cover the product, with cost-sharing requirements varying by state.
Patients would receive the product via intravenous infusions once every other week for approximately one hour in an outpatient setting. The Requestor certified that that there are no known barriers to switch or discontinue the product if a patient desired to do so. To receive the product for free, patients must meet the following eligibility criteria:
- Reside in the United States;
- Be at least 18 years old;
- Be prescribed the product for an on-label indication;
- Be uninsured, insured but with no insurance coverage for the product, or have Medicare coverage for the product but attest they are unable to afford their out-of-pocket costs associated with the product; and
- Have a household income equal to or below 500 percent of the Federal Poverty Level.
The Requestor certified that eligibility determinations for the Program are made without regard to a patient's insurer or insurance plan, physician, or infusion provider and are not contingent on past, present, or future purchases of the product. Additionally, the Requestor certified that patients who are part of the Program are free to change physicians or infusion providers at any time. The Requestor also certified that the providers—i.e., the treating physician or the site where the product will be administered—do not purchase or get reimbursed for the free product.
OIG's Determination
OIG concluded that the Program implicates the AKS because receiving the free product constitutes remuneration that might induce patients, including Federal health care program enrollees, to continue using the product after it becomes reimbursable by the applicable insurer, including Federal health care programs. OIG also stated that the AKS is implicated as to administering providers because they have an opportunity to receive remuneration via administration fees they earn when such fees are billable to a Federal health care program. OIG concluded that while no AKS safe harbor applies to the Program, it would not impose sanctions for the following few reasons.
First, OIG reasoned that the Program is unlikely to inappropriately increase costs to Federal health care programs because no product provided under the Program would be billed to Federal health care programs and that the only cost that could be billed is the administration fee for the infusion, which is only billed if a patient cannot afford cost sharing associated with the product. OIG recognized the risk that the Program might function as a seeding program if a patient's insurer begins to cover the product; however, OIG believed this risk to be low since the Requestor certified that there is no barrier to patients to switch products.
Second, OIG concluded that the Program would be unlikely to interfere with clinical decision-making because treating physicians do not have a financial incentive to order the product when patients qualify for the Program since treating physicians must certify that they will not submit a request for payment for the product and will not seek payment from the patient. Additionally, OIG reasoned that the Program poses low risk of fraud and abuse because administering providers lose potential profits when patients receive the product through the Program. While the administering provider can charge the administration fee for Medicare patients who cannot afford the cost-sharing amount for the product, OIG concluded that the risk is "low that this fee would induce a treating physician to select the [p]roduct over a competing product (particularly where the existing competing products are also infused drugs with a billable administration fee)."
Third, OIG reasoned that the Program posed a low risk of steering patients to any particular provider or plan because the Requestor certified that eligibility determinations for the Program are a reasonable, uniform, and consistent assessment of financial need without regard to the providers or plans selected by the patient. Moreover, patients are allowed to switch providers at any time throughout the Program.
In addition, OIG concluded that the Program would not implicate the Beneficiary Inducements CMP because it is not likely to influence any Federal health care program enrollee's selection of a particular provider, practitioner, or supplier since the product will be available without regard to a patient's selection of provider.
OIG's Advisory Opinion 25-01 is available here.
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SAMHSA Releases Updated National Behavioral Health Crisis Care Guidance
SAMHSA released two finalized documents, the 2025 National Guidelines for a Behavioral Health Coordinated System of Crisis and 2025 Model Definitions for Behavioral Health Emergency, Crisis, Crisis-Related Services, as well as a draft guide focused on Mobile Crisis Team Services. The guidance focuses on enhancing access to behavioral health care crisis care with the goal that everyone should have someone to contact, someone to respond, and a safe place for help. SAMHSA is accepting comments on its their draft Mobile Crisis Team Services. The updated guidance documents are available here.
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