Archives: Department of Health and Human Services

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Federal Court stays repeal of “On the Basis of Sex” definition in recent nondiscrimination final rule one day before regulations take effect

With only one day left before the final rule scaling back nondiscrimination regulations took effect, the U.S. District Court for the Eastern District of New York (EDNY) issued an order staying the repeal of certain parts of the former regulations. On June 19, 2020, the Department of Health and Human Services’ (HHS) Office for Civil … Continue Reading

“Contrary to the Public Interest”: CMS invokes retroactive-rulemaking authority to escape consequences of Allina

Earlier this month and with little fanfare, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would invoke CMS’s rarely used retroactive-rulemaking authority to essentially ensure that, despite the Supreme Court’s adverse rulemaking decision in Azar v. Allina Health Services, 139 S. Ct. 1804 (2019), CMS will apply the same Medicare … Continue Reading

HHS releases final rule and fact sheet to clarify Part 2: Standards for Substance Use Disorder Record Protection, Disclosure, and Registry

After nearly a full year of public comment consideration, last week, the U.S. Department of Health and Human Services (HHS) Substance Abuse and Mental Health Services Administration (SAMHSA) announced and published a Final Rule and Fact Sheet addressing 42 C.F.R. Part 2 (Part 2). Generally speaking, Part 2 affords privacy protections to patient records pertaining … Continue Reading

Reliance on telehealth ramps up during COVID-19, and may be here to stay

As technology has advanced over the years, there has been a corresponding push for virtual visits with health care providers.  In fact, many state boards of medicine and other regulatory agencies have sought to amend regulations and guidances to make telehealth a reality for patients across the U.S.  However, despite the technical allowance for telehealth, … Continue Reading

Office for Civil Rights issues final rule scaling back nondiscrimination requirements for health care covered entities as Supreme Court broadens discrimination protections

A final rule published by the Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) and the Centers for Medicare & Medicaid Services (CMS) significantly scales back nondiscrimination regulations first released in 2016. The final rule, which was published in the Federal Register on June 19, 2020, implements Section 1557 of the … Continue Reading

CARES Act Relief Funds: HHS continues rolling updates to FAQs and extends attestation deadline by another 45 days

On May 21, 2020, the U.S. Department of Health and Human Services (HHS) issued additional guidance, by again updating its FAQs, for Medicare providers and suppliers (collectively, providers) receiving relief from the Public Health and Social Services Emergency Fund. Of the $175 billion appropriated by Congress, HHS has allocated $50 billion for general distribution to … Continue Reading

HHS Delays Compliance for Sweeping Interoperability and Information Blocking Rules

Following more than a month of silence from the U.S. Department of Health and Human Services (HHS) on the publication of its widely anticipated companion interoperability and information blocking final rules to the Federal Register, HHS’s Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare & Medicaid Services (CMS), … Continue Reading

HHS expands access to telehealth services in response to COVID-19

As discussed in our client alert, recent legal developments have greatly expanded funding for and access to telehealth services during the COVID-19 crisis. Among the changes instituted by HHS are expanded Medicare coverage and payment for services, reduced or waived cost-sharing obligations for physicians, and loosening of the HIPAA enforcement policies for covered entities (which … Continue Reading

HHS waives requirements for health care providers under section 1135 in response to COVID-19

Shortly after President Trump declared a national emergency related to COVID-19, CMS issued blanket waivers under section 1135 of the Social Security Act that are intended to ensure there are sufficient health care items and services available to meet the increased need, as well as reduce related administrative burdens on health care providers. Our comprehensive … Continue Reading

HHS Finalizes Healthcare Interoperability and Information Blocking Rules

The U.S. Department of Health and Human Services (HHS) issued eagerly anticipated and hotly debated companion interoperability and information blocking final rules that are expected to transform the way in which certain health care providers, health information technology (IT) developers, and health plans share patient information.  The two rules, issued by the HHS Office of … Continue Reading

CDC Offers Guidance to Health Providers on ICD-10 Coding for Coronavirus/COVID-19 Encounters

The Centers for Disease Control and Prevention (CDC) recently released official diagnosis coding guidance for health care encounters and deaths related to the 2019 novel coronavirus (COVID-19), potentially in anticipation of more frequent cases in the United States. The guidance identifies specific ICD-10-CM codes to be used to code encounters. CDC advises that patients presenting … Continue Reading

Potential Tensions Lie Ahead Between Federal and State Authorities Over the Application of CDC Quarantine Powers

According to the U.S. Centers for Disease Control and Prevention (CDC), although there have been imported cases of Covid-19 detected in the United States, “at this time, the virus is NOT currently spreading in the community in the United States.”[1]  However, on Tuesday, February 25, 2020, Nancy Messonier, the CDC’s Director of National Center for … Continue Reading

Medicare/Medicaid Policy Provisions in Trump Administration’s FY 2021 Budget Proposal

The Trump Administration’s proposed fiscal year (FY) 2021 budget calls for significant cuts to federal health spending, including a 10% decrease in Department of Health and Human Services (HHS) discretionary spending in FY 2021 and a $1.6 trillion net reduction in health entitlements over the next decade.  House Budget Committee leaders have blasted the HHS … Continue Reading

Analysis:  Navigating US federal and state rules during the novel coronavirus public health emergency

The novel coronavirus (2019-nCoV, also known as “SARS-CoV-2”) has been declared a public health emergency (PHE) by the U.S. Department of Health and Human Services (HHS).  This designation authorizes HHS to direct funding to: (1) enable the dissemination of information about the virus; (2) encourage research and development of diagnostic and treatment techniques; (3) improve … Continue Reading

January Congressional Hearings Focus on Cannabis, Opioids, Other Health Priorities 

Health policy has been the focus of several House Energy and Commerce Committee hearings this month.  Notably, the Energy and Commerce Health Subcommittee held its first legislative hearing on cannabis policy, although much of the hearing focused on the status of marijuana research under the Controlled Substances Act, as discussed in a recent Reed Smith … Continue Reading

CMS Issues Final Medicare Inpatient Psychiatric Facility Update for FY 2020

The Centers for Medicare & Medicaid Services (CMS) will increase Medicare inpatient psychiatric facility (IPF) prospective payment system (PPS) payments by 1.5%, or $65 million, in fiscal year (FY) 2020 under a recently-published final rule.  The final FY 2020 market basket increase is 2.9%, which is reduced by two statutory reductions for an IPF payment … Continue Reading

CMS Looking for More Ways to Cut Medicare & Medicaid Red Tape

As part of its continuing “Patients over Paperwork” initiative, the Centers for Medicare & Medicaid Services (CMS) has released another request for information (RFI) on regulatory or subregulatory changes the agency could make to “reduce unnecessary administrative burdens for clinicians, providers, patients and their families.”  In particular, CMS seeks new ideas for: Streamlining reporting requirements, … Continue Reading

HHS Revises Previous Penalty Structure for HIPAA Violations, Creates Annual Penalty Limits

The U.S. Department of Health and Human Services filed a Notice of Enforcement Decision on Friday, April 26, 2019, announcing a new system of annual penalty limits for HIPAA violations based on an entity’s level of culpability. The agency revised its previous interpretation of the Health Information Technology for Economic and Clinical Health Act (HITECH … Continue Reading

CMS Publishes Final CY 2019 Medicare Physician Fee Schedule Rates and Policies

The Centers for Medicare & Medicaid Services (CMS) has issued its final Medicare physician fee schedule (PFS) rule for calendar year (CY) 2019.  In addition to updating rates for physician services, the rule adopts changes to numerous other Medicare Part B policies.  Highlights of the final rule include the following: The final 2019 conversion factor … Continue Reading

CMS Finalizes Medicare OPPS, ASC Rates and Policies for 2019

The Centers for Medicare & Medicaid Services (CMS) has finalized Medicare Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) rates and policies for calendar year 2019.  Notably, CMS adopted some – but not all – of its proposed policies intended to promote more “site-neutral payments” for different types of providers. Hospital Outpatient … Continue Reading

HHS Secretary Nominee Azar to Face Senate HELP Committee after Thanksgiving

President Trump has nominated Alex Azar to be Secretary of Health and Human Services, which would fill the vacancy created when Tom Price, MD resigned the post in September.  Mr. Azar, an attorney who previously served in senior HHS positions and as a pharmaceutical industry executive, is scheduled to appear before the Senate Health, Education, … Continue Reading

CMS Finalizes IPPS/LTCH Payment and Policy Changes for FY 2018

CMS has published its final rule to update the Medicare acute hospital inpatient prospective payment system (IPPS) and long-term care hospital (LTCH) prospective payment system (PPS) for fiscal year (FY) 2018. Acute Hospital Rate & Policy Updates CMS projects that the rate and policy changes in the rule will increase total IPPS payments by about … Continue Reading

CMS Proposes Medicare Physician Fee Schedule Update for 2018

Rule Would Delay Appropriate Use Criteria Requirement until 2019, Cut Rates for Off-Campus Hospital Departments The Centers for Medicare & Medicaid Services (CMS) has published its proposed rule to update the Medicare physician fee schedule (PFS) for calendar year (CY) 2018. The proposed rule addresses numerous Medicare policies, including:  implementation of appropriate use criteria (AUC) … Continue Reading

CMS Issues Final Rule to Stabilize ACA Insurance Markets, While Emphasizing Marketplace Woes

The Centers for Medicare & Medicaid Services has published a final rule intended to help improve the risk pool and stabilize the Affordable Care Act (ACA) Insurance Exchanges for 2018 – even as CMS contends that consumers “have faced double-digit premium increases, fewer plans to choose from, and a market that continues to be threatened … Continue Reading
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