Search Results for: Final Rule

CMS issues interim final rule on SARS-CoV-2 vaccination for health care workers

The Centers for Medicare and Medicaid Services (CMS) has published an interim final rule that changed the conditions of participation in Medicare and Medicaid to require vaccination of certain healthcare workers. The rule, title “Omnibus COVID-19 Health Care Staff Vaccination Rule” was published in the Federal Register on November 5, 2021. The rule requires all … Continue Reading

FDA clarifies evidence and knowledge requirements in intended use final rule

On August 2, 2021, the U.S. Food and Drug Administration (“FDA”)  published a final rule amending existing regulations (21 C.F.R. § 201.128 and 21 CFR § 801.4) that describe the types of evidence relevant to determine a drug or device’s intended use under the Food, Drug and Cosmetic Act (“FDCA”).  See 86 Fed. Reg. 41,384–85. … 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

Final Rules Modernizing Stark Law and Anti-Kickback Statute Released

The Department of Health and Human Services (HHS) released complementary rules this past Friday, November 20, 2020, to modernize and clarify the regulations that interpret the Physician Self-Referral Law (the Stark Law) and the federal Anti-Kickback Statute. As we wrote when the proposed rules were released last autumn (see client alerts here and here), the … 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

Final rules modernizing Anti-Kickback Statute and Stark Law under review by OMB: anticipating the future of value-based care

The much-anticipated final rules modernizing the safe harbors under the Anti-Kickback Statute (AKS) and the physician self-referral exceptions under the Stark Law are officially under review by the Office of Management and Budget (OMB). The Department of Health and Human Services (HHS) anticipates publishing the final rules in August 2020, although that target date is … 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

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

Controversial CMS Final Rule Requires Hospitals to Disclose Payer-Specific Charge Data; New Proposed Rule Would Impose Health Plan Transparency Requirements

The Centers for Medicare & Medicaid Services (CMS) finalized a “price transparency” rule that requires hospitals to make detailed charge data – including payer-specific negotiated charges – available for all inpatient and outpatient services.  Additionally, the final rule mandates that hospitals make “consumer-friendly” charge information available for at least 300 “shoppable” services.  While CMS deferred … Continue Reading

CMS Issues Final Rule to Streamline Medicare, Medicaid Provider Requirements

The Centers for Medicare & Medicaid Services (CMS) has issued an “omnibus burden reduction” rule that finalizes a September 20, 2018 proposed rule intended to streamline various Medicare and Medicaid regulatory requirements, in alignment with the Administration’s “Patients over Paperwork” initiative.  The omnibus regulation also finalizes a November 4, 2016 proposed rule on fire safety … Continue Reading

CMS Issues Final Rule Repealing the Prohibition on the Use of Pre-Dispute Binding Arbitration Agreements

On July 18, 2019, the Centers for Medicare & Medicaid Services (CMS) issued a final rule repealing the agency’s ban on the use of pre-dispute arbitration agreements in the long-term care (LTC) setting.1 This final rule follows CMS’s proposed rule, issued on June 8, 2017, reversing course on CMS’s initial ban on pre-dispute, binding arbitration … Continue Reading

FY 2019 Medicare Inpatient Rehabilitation Facility Payments to Rise by $105 Million under Final Rule

The Centers for Medicare & Medicaid Services (CMS) expects Medicare payments to inpatient rehabilitation facilities (IRFs) to increase by 1.3% ($105 million) in fiscal year (FY) 2019 under the final IRF prospective payment system (PPS) rule.  For FY 2019, the IRF PPS update factor is 1.35%, based on an IRF market basket update of 2.9%, … Continue Reading

Interim Final Rules Expand Contraceptive Coverage Exemption Based on Religious/Moral Beliefs

The Trump Administration has issued interim final rules to make it easier for employers and health insurance plans to qualify for an exemption from ACA rules mandating coverage of contraceptive services without cost sharing on the basis of religious or moral objections. The extent to which group health plans must cover contraceptive services in cases … 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

Price, Verma Taking a Fresh Look at Obama Administration’s EPM/CJR Final Rule; Changes Pushed Back to at Least October 1, 2017

HHS Secretary Thomas Price and CMS Administrator Seema Verma have signaled that the Trump Administration is eyeing changes to one of the last major Medicare policies issued by the Obama Administration.  Specifically, CMS is delaying a January 3, 2017 final rule that established mandatory Medicare episode payment models (EPM) for acute myocardial infarction, coronary artery … Continue Reading

HRSA Publishes Final Rule on 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties

The Health Resources and Services Administration (HRSA) has published a final rule to implement civil money penalty (CMP) provisions added to section 340B of the Public Health Service Act under the Affordable Care Act.  In particular, the final rule addresses:  (i) the calculation of the 340B “ceiling price” that may be charged to covered entities; … Continue Reading

OIG Issues CMP, Anti-kickback Safe Harbor Final Rules

The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) has published a final rule amending the safe harbors to the Anti-Kickback Statute (AKS) and the Civil Monetary Penalty (CMP) rules to protect certain payment practices and business arrangements from criminal prosecution or civil sanctions under the AKS (Final Rule). … Continue Reading

CMS Publishes Final Rule Updating 2017 Medicare Physician Fee Schedule Rates and Policies

The Centers for Medicare & Medicaid Services (CMS) has issued its final Medicare physician fee schedule (MPFS) for calendar year (CY) 2017.  In addition to updating MPFS rates and policies, the final rule makes numerous other Medicare policy changes, including updates to Stark Law regulations related to unit-based compensation and new enrollment requirements for providers and … Continue Reading

CMS Corrects FY 2017 Medicare IPPS/LTCH Final Rule

CMS has corrected a series of technical and typographical errors in its final rule updating the Medicare acute hospital inpatient prospective payment system (IPPS) and long-term care hospital (LTCH) prospective payment system (PPS) payments and policies for fiscal year (FY) 2017. Among other things, CMS is making changes to the budget neutrality factors, uncompensated care … Continue Reading

SAMHSA Final Rule on Medication Assisted Treatment for Opioid Use Disorders Reporting Requirements

On September 27, 2016, the Substance Abuse and Mental Health Services Administration (SAMHSA) published a final rule establishing annual reporting requirements for certain practitioners who prescribe buprenorphine-based medication-assisted treatment for opioid disorders under the Controlled Substances Act. As previously reported, SAMHSA published a rule on July 8, 2016 that expanded from 100 to 275 the … Continue Reading

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