Archives: Department of Health and Human Services

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Important updates to provider relief fund reporting requirements

On June 11, 2021, the Department of Health and Human Services (“HHS”) announced that it had released revised reporting requirements for those providers and suppliers that have received Provider Relief Fund payments during the COVID-19 pandemic. Readers may recall that HHS previously issued notices on post-payment reporting requirements starting in July 2020, and that previous … Continue Reading

HHS, acting U.S. Attorney, and California Attorney General issue joint warning of the potential consequences of charging patients for COVID-19 vaccines

On May 18, 2021, in a statement issued by the U.S. Department of Health and Human Services’ (HHS) Office of Inspector General, Acting U.S. Attorney for the Eastern District of California, Phillip Talbert, and California Attorney General, Rob Bonta (the Statement), the health care industry was reminded of the prohibition against charging individuals for COVID-19 … Continue Reading

CMS again postpones the effective date of Medicare coverage pathway to access “breakthrough” medical technologies, regulatory standard for determining whether an item or service furnished under Medicare is “reasonable and necessary”

On May 14, 2021, the Centers for Medicare & Medicaid Services (CMS) released a new final rule that further delays until December 15, 2021, the effective date of the final rule titled “Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of ‘Reasonable and Necessary’” (the January 2021 Rule), which was published in the … Continue Reading

HHS to prohibit discrimination on the basis of sexual orientation and gender identity

On May 10, 2021, the Department of Health and Human Services (“HHS”) announced that— consistent with the Supreme Court’s decision in Bostock v. Clayton County, 140 S. Ct. 1731 (2020), and Title IX of the Education Amendments of 1972—HHS’s Office of Civil Rights (“OCR”) will interpret and enforce the prohibition on discrimination on the basis … Continue Reading

CMS finalizes rule to expand and modify Comprehensive Care for Joint Replacement Model

On May 3, 2021, the Centers for Medicare & Medicaid Services (CMS) published an 81-page final rule to both extend and change the Comprehensive Care for Joint Replacement (CJR) model. We previously reported on the proposed rule here. The CJR model was initially implemented by way of notice-and-comment rulemaking in April 2016; the recent final … Continue Reading

CMS acknowledges improvement in nursing home COVID-19 response, eliminates certain blanket waivers

The 2019 Novel Coronavirus pandemic (“COVID-19”) introduced several unfamiliar hardships adversely impacting the long-term care industry, especially for nursing homes.  Acknowledging these hardships, the Centers for Medicare & Medicaid Services (“CMS”) enacted several temporary emergency blanket waivers effective March 1, 2020, lending flexibility to nursing homes in their COVID-19 response efforts.  Since that time, according … Continue Reading

Congress considers the future of telehealth in the wake of COVID-19

It is no secret that the coronavirus pandemic has driven our daily lives digital—work, education, social gatherings, and, of course, health care. Congress and CMS responded to the public health emergency by waiving limitations on reimbursement for telehealth services rendered to Medicare patients. These waivers introduced new flexibility and vastly expanded Medicare patients’ access to … Continue Reading

President Biden implements policies to expand access to health care and coverage

On January 28, 2021, the White House issued President Biden’s Executive Order on Strengthening Medicaid and the Affordable Care Act (the “Executive Order”), which seeks to increase access to affordable health insurance and strengthen Medicaid and the Affordable Care Act, particularly in light of the ongoing COVID-19 pandemic.  In addition to this Executive Order, the … Continue Reading

Department of Justice files statement of interest addressing the preemptive effect of the PREP Act

On the last full day of the Trump Administration, the Department of Justice (DOJ) submitted a statement of interest in litigation supporting the position that the Public Readiness and Emergency Preparedness (PREP) Act preempts legal claims relating to the administration or use of covered countermeasures with respect to a public health emergency and, therefore, makes … Continue Reading

Congress passes legislation impacting the Provider Relief Fund

In the evening of December 21, 2020, both Houses of Congress passed the Consolidated Appropriations Act, 2021, H.R. 133.  The sprawling, 5,593-page legislation includes the most significant health care-related provisions to be passed since the CARES Act.  The President is expected to sign the legislation shortly.  Of note, in the course of appropriating billions of … Continue Reading

HHS proposes important changes to key aspects of HIPAA Privacy Rule

The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR), the agency that enforces the Health Insurance Portability and Accountability Act of 1996 (HIPAA), is the latest federal agency to jump on the HHS rulemaking bandwagon issuing a Notice of Proposed Rulemaking (NPRM) on December 10, 2020, that proposes pivotal changes … Continue Reading

Long-Awaited issuance of Section 340B ADR final rule

In 2010, the Affordable Care Act (ACA) directed the Secretary of Health and Human Services to issue regulations to establish an administrative dispute resolution (ADR) process for certain claims between Section 340B covered entities and pharmaceutical manufacturers (e.g., claims of overcharging by manufacturers and claims of covered entities taking duplicative discounts or diverting Section 340B … Continue Reading

Marketers Beware: As COVID-19 cases increase, FDA, FTC increase efforts to crack down on fraudulent and deceptive marketing and sales of purported ‘Virus Cures’

The Food and Drug Administration (“FDA”) and the Federal Trade Commission (“FTC”) have been fighting fraudulent and deceptive advertising of health care devices, household cleaners, nutrition supplements, and other health care products promising to protect or mitigate the effects of the virus for pandemic-wary consumers since March 2020. Despite these efforts, false and misleading marketing … Continue Reading

CMS finalizes rule to ensure no-cost COVID-19 vaccine

On October 28, 2020, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule with comment period (IFR) in an effort to ensure that participants in CMS programs have no-cost access to any forthcoming Food and Drug Administration (FDA or Agency) authorized or approved COVID-19 vaccine. The IFR governs any vaccine that … Continue Reading

HHS further delays compliance for Interoperability and Information Blocking Rule

Just two business days before the first of many critical components of the new 21st Century Cures Act Interoperability, Information Blocking, and ONC Health IT Certification Program Final Rule (the “Final Rule”) were set to take effect, the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health IT (ONC) … Continue Reading

Patient access to health information at the forefront of government initiatives and scrutiny

Even amidst the chaos of a global pandemic, this year multiple U.S. Department of Health and Human Services (HHS) agencies have dialed in on promoting and enforcing patients’ rights to access their health information. In just the past month, HHS’ Office for Civil Rights (OCR), the agency that enforces the Health Insurance Portability and Accountability … Continue Reading

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
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