Tag archives: HHS

COVID-19 Update: HHS Declaration Provides Liability Immunity Related to Certain COVID-19 Countermeasures

The Public Readiness and Emergency Preparedness Act provides the Secretary of HHS authority to issue a declaration providing immunity to certain individuals and entities during a public health emergency.  On March 17, 2020, the U.S. Secretary of Health and Human Services published a Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures … Continue reading

COVID-19 Update: Trump administration expands access to telehealth services for Medicare beneficiaries to combat COVID-19

On Tuesday, March 17, 2020, the Trump administration announced that it will immediately expand access to telehealth services for all Medicare beneficiaries during the COVID-19 outbreak. In coordination with this announcement, the Office for Civil Rights at the Department of Health & Human Services (HHS) released a notification stating that HHS has temporarily suspended certain … Continue reading

COVID-19 Update: US Expands Travel Restrictions After First Fatality

On Saturday, the State of Washington announced the first fatality in the United States arising from the coronavirus, with a second announced on Sunday. Washington Governor Jay Inslee has declared a state of emergency.  As of Monday March 2, 2020, there were 89,197 total confirmed cases of COVID-19 worldwide and 3,048 resulting deaths.  U.S. Secretary … Continue reading

COVID-19 Update: Over 60,000 Confirmed Cases

Earlier this week the WHO announced that COVID-19 would be the name for the disease caused by the coronavirus.  On Wednesday, China announced 14,840 new cases of the coronavirus after changing the way cases are confirmed to include where a test was negative but other methods such as symptoms and x-rays show evidence of the … Continue reading

Administration Budget Proposes to Cut U.S. Department of HHS Funding

On February 10, 2020, the Trump Administration released its budget proposal for fiscal year 2021.  While the total budget would amount to $4.8 trillion, the administration proposes to cut $9.4 billion in funding from the U.S. Department of Health and Human Services and provide for $96.4 billion in discretionary spending.   The budget contains several notable … Continue reading

HHS Memorandum Addresses Implications of Allina Decision

On November 21, an internal HHS memorandum addressed to Centers for Medicare & Medicaid Services (CMS) Principal Deputy Administrator Demetrios Kouzoukas entitled “Impact of Allina on Medicare Payment Rules” became publicly available.  The memorandum addresses the HHS Office of the General Counsel’s (OGC) “views on the impact of Azar v. Allina Health Services, 139 S. … Continue reading

Allina Update: Supreme Court holds Medicare statute requires notice and comment for DSH payment change

In a decision with potentially far reaching implications for Medicare hospital reimbursement, on June 3  the U.S. Supreme Court ruled 7-1 against the U.S. Department of Health and Human Services (“HHS”) in Azar v. Allina Health Services.   The Court affirmed the U.S. Court of Appeals for the D.C. Circuit decision that vacated a rate calculation … Continue reading

MEDICAID ALERT: Work and community engagement requirements blocked by federal court

“As Opening Day arrives, the Court finds its guiding principle in Yogi Berra’s aphorism, “It’s déjà vu all over again.”” – Judge James Boasberg, Gresham v. Azar. On March 27, United States District Court for the District of Columbia Judge James Boasberg ruled that Department of Health & Human Services Secretary Azar’s approval of work … Continue reading

Medicaid update

The Trump Administration took several steps this past week in support of its efforts to transform the Medicaid program.… Continue reading

OIG proposes to eliminate safe harbor protection for drug manufacturer rebates to PBMs; proposes two new safe harbors

On January 31, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a proposed new rule that, if finalized, would eliminate existing protection under the Anti-Kickback Statute (AKS) “discount” safe harbor (42 C.F.R. 1001.952(h)) for drug manufacturers’ rebates to plan sponsors or pharmacy benefit managers (PBMs) acting under contract with plan … Continue reading

Judge declares ACA unconstitutional

On Friday, December 14, Judge Reed O’Connor of the Federal District Court in the Northern District of Texas issued a declaratory judgment holding the shared responsibility provision (also referred to as the “Individual Mandate”), and with it, the entire Affordable Care Act (“ACA”), to be unconstitutional. The case is Texas v. United States and California … Continue reading

Medicaid update: CMS again approves Kentucky HEALTH Medicaid demonstration

On November 20, 2018, the Centers for Medicare & Medicaid Services (“CMS”) again approved the Kentucky HEALTH 1115 demonstration.  Kentucky HEALTH  was the first Section 1115 demonstration that CMS approved with a work and community engagement requirement as a condition of eligibility for coverage under Medicaid.  The demonstration requires certain Medicaid beneficiaries to engage in … Continue reading

OIG considers new safe harbors and other incentives to promote coordinated care

As part of the Health and Human Services Department’s (“HHS”) “Regulatory Sprint to Coordinated Care” efforts aimed at alleviating unnecessary regulatory barriers to coordinated care while protecting against fraud and abuse, the Office of Inspector General (“OIG”) issued a Request for Information (“RFI”) on August 27, 2018, requesting public input on the following items: Care … Continue reading

CMS issues final rule to adopt risk adjustment methodology for 2017

CMS has issued a Final Rule to adopt the risk adjustment methodology for the 2017 benefit year.  The rule was issued without a notice and comment period and will become effective upon publication in the federal register.  The risk adjustment program is a premium stabilization program established by Congress in section 1343 of the Affordable … Continue reading

CMS suspends 2017 benefit year risk adjustment payments

On Saturday, July 7, 2018, the Centers for Medicare & Medicaid Services (CMS) announced the suspension of risk adjustment payments for the 2017 benefit year until the resolution of risk adjustment litigation following the decision in New Mexico Health Connections v. United States Department of Health and Human Services et al., in the United States … Continue reading

HHS requests comments on healthcare innovation and investment workgroup

A Request for Information (RFI) published in the June 7 Federal Register seeks comments on the structure of a workgroup to increase innovation and investment in the healthcare industry.  The Immediate Office of the Secretary of HHS seeks comments on how to structure the workgroup  in order to “spur investment, increase competition, accelerate innovation and … Continue reading

OCR proposes to share HIPAA data breach settlements with victims

The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) plans to issue an advance notice of proposed rulemaking this November on potentially sharing HIPAA breach settlements with victims. The notice would solicit public opinion on creating a process for sharing a percentage of any penalty or settlement with those harmed … Continue reading

Congressional hearings held on the Trump administration’s FY 2019 budget request and health care industry consolidation

On February 14, 2018, the Centers for Medicare & Medicaid Services (CMS) announced projections that national health care spending is expected to increase an average of 5.5% a year between 2017 – 2026 and will account for almost 20% of Gross Domestic Product by 2026.  This announcement provides context for the continued focus on controlling … Continue reading

HHS OCR issues cyber extortion newsletter

This week, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) published a January 2018 newsletter focusing on “cyber extortion.” Cyber extortion often involves an attacker gaining access to an organization’s computer system, stealing sensitive information, and threatening to publish the information. Healthcare and public health organizations are often the … Continue reading

DOJ charges 412 individuals in largest healthcare fraud takedown in US history

On Thursday, the DOJ announced charges against 412 individuals for their alleged participation in healthcare fraud schemes involving approximately $1.3 billion in false billings.  This marks the largest national healthcare fraud takedown in U.S. history—topping the DOJ’s announcement of charges against 301 individuals in June 2016. The enforcement actions spanned across 41 federal districts and … Continue reading

Government agencies finalize updates to Common Rule to protect human research subjects

On January 19, the U.S. Department of Health and Human Services (HHS) and 15 other government agencies published a final rule updating regulations governing the protection of human research subjects, which is commonly referred to as the “Common Rule.” As described in our September 4 post, these revisions are intended to enhance the current system … Continue reading

No monetary penalties for manufacturer providing physicians with free vaccine refrigeration storage system

In an Advisory Opinion issued on September 23, 2016, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) announced that  it would not impose administrative sanctions against the manufacturer of a vaccine refrigeration system (the “Requestor”) for providing the devices to physicians without charge.  This development comes at a critical time … Continue reading
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