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What Awaits in the First Year of Medicare Drug Price Negotiations? CMS Issues Guidance and Solicits Comment on the 2026 Inflation Reduction Act Part D Negotiation Process

On March 15, 2023, the Centers for Medicare & Medicaid Services (“CMS”) issued an initial guidance memorandum (“Memorandum”) describing how it proposes to implement the Inflation Reduction Act Medicare Drug Price Negotiation Program (“Negotiation Program”) for the Initial Price Applicability Year of 2026 (the “Initial Year”). In the Memorandum, CMS provides further guidance regarding (i) how it intends to select the Medicare Part D drugs and biologics for which it will negotiate a maximum fair price (“MFP”) for the Initial Year (the “Selected Drugs”), (ii) the data and evidence that manufacturers will be required to submit that will inform CMS’s initial price proposals, (iii) the structure of the negotiation process, and (iv) implementation and enforcement of the MFP.

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HHS Highlights Federal Telehealth Initiatives in Response to COVID-19

Time to Read: 4 minutes Practices: Health Care, Digital Health

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On June 5, 2020, the U.S. Department of Health and Human Services (“HHS”) released a fact sheet regarding its efforts to address COVID-19’s disparate impact on racial minorities.i Although the fact sheet did not announce any new policies or initiatives, it highlighted various actions the agency has taken in response to the pandemic, including efforts to promote and expand telehealth services. The fact sheet comes amid recent comments by administration officials that HHS is considering extending certain telehealth initiatives beyond the expiration of the COVID-19 emergency.ii

We have summarized below the telehealth initiatives noted by HHS and have provided links to related Ropes & Gray Alerts for additional information on those initiatives. If you have any questions, please contact your usual Ropes & Gray advisor.

Expanded Medicare Telehealth Coverage

In March, the Centers for Medicare and Medicaid Services (“CMS”) announced various waivers and new policies to expand Medicare coverage of telehealth services. Among other changes, CMS waived “originating site” limitations to permit beneficiaries to receive telehealth services in their homes, gave providers flexibility to reduce or waive patient cost-sharing for telehealth services, and expanded the types of applications that providers may use to provide covered telehealth services.iii

In May, CMS published an interim final rule that made various modifications to Medicare telehealth regulations. For example, the rule temporarily authorizes opioid treatment programs to provide periodic assessments via telehealth and temporarily expands the list of primary care services that can be provided by a resident, including via telehealth.iv

For additional information, please see the following Ropes & Gray alerts:

HIPAA Enforcement Discretion

In March, the Office for Civil Rights (“OCR”) announced that it will exercise enforcement discretion and not impose penalties against covered health care providers for noncompliance with HIPAA rules in connection with the good faith provision of telehealth services. Enforcement discretion applies to all telehealth services that providers, in their professional judgment, believe can be provided through telehealth during the current emergency, whether or not related to COVID-19.v

For additional information about telehealth services and HIPAA, please see the following Ropes & Gray alert: OCR Releases FAQs Clarifying Telehealth Enforcement Discretion During COVID-19 (3/24/2020).

Rural Health Clinics and Federally Qualified Health Centers

To support the provision of telehealth services by Rural Health Clinics (“RHCs”) and Federally Qualified Health Centers (“FQHCs”), CMS has published guidance on a range of topics, including new telehealth flexibilities for RHCs and FQHCs, as well as billing requirements for new telehealth payment

Telehealth Grants

The Health Resources and Services Administration (“HRSA”) has awarded grants to various entities to expand telehealth infrastructure and access. Recent grants include more than $11.5 million to Telehealth Resource Centers to provide telehealth technical assistance in rural and underserved areas, as well as $15 million to four organizations focused on maternal and child health.vii

Medicaid Substance Use Disorder Services

Although not related to the COVID-19 pandemic, CMS released an Informational Bulletin in April regarding opportunities under the SUPPORT Act to expand Medicaid beneficiaries’ access to substance use disorder services via telehealth.viii

Other Ropes & Gray Telehealth Resources

In addition to the resources noted above, the following Ropes & Gray COVID-19 alerts have discussed federal and state telehealth developments:

i HHS, HHS Initiatives to Address the Disparate Impact of COVID-19 on African Americans and Other Racial and Ethnic Minorities, posted June 5, 2020, available at

ii See White House, On-the-Record Press Call on the President’s Action to Protect Seniors with Diabetes, May 26, 2020, available at; Casey Ross, ‘I can’t imagine going back’: Medicare leader calls for expanded telehealth access after Covid-19, STAT, June 9, 2020, available at

iii CMS, Medicare Telemedicine Health Care Provider Fact Sheet, dated March 17, 2020, available at

iv 85 Fed. Reg. 27550 (May 8, 2020), available at

v OCR, Notification of Enforcement Discretion for Telehealth Remote Communications During the COVID-19 Nationwide Public Health Emergency, dated March 17, 2020, available at; OCR, FAQs on Telehealth and HIPAA during the COVID-19 nationwide public health emergency, dated March 20, 2020, available at

vi CMS, New and Expanded Flexibilities for Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) During the COVID-19 Public Health Emergency (PHE), dated April 30, 2020, available at

vii HHS, HHS Awards Nearly $165 Million to Combat the COVID-19 Pandemic in Rural Communities, April 22, 2020, available at; HHS, HHS Awards $20 Million to Combat COVID-19 Pandemic through Telehealth, dated April 30, 2020, available at

viii CMS, CMCS Information Bulletin: Rural Health Care and Medicaid Telehealth Flexibilities, and Guidance Regarding Section 1009 of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (Pub. L. 115-271), entitled Medicaid Substance Use Disorder Treatment via Telehealth, dated April 2, 2020, available at

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