Georgia 6-Week Abortion Law Is Void Ab Initio

By Amy Fouts and Claire Bass on November 18, 2022 Posted in Alert

Pregnant woman talking a break while working in Roastery

On Nov. 15, the Superior Court of Fulton County issued an order finding that two sections of the Georgia LIFE Act (the Act) – Sections 4 and 11 – were void ab initio. Section 4 of the Act criminalized abortions after the detection of a heartbeat (typically around six weeks into the pregnancy), with exceptions only for certain medical emergencies and in cases of rape or incest where a police report was filed. Section 11 required any physician who performed an abortion after detecting a fetal heartbeat to report to the Georgia Department of Public Health the exception under Section 4 of the Act that applied to justify the otherwise illegal procedure. Spokespersons for the state reported that the state has filed a notice of appeal.

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Allergan Win in Medicaid Drug Rebate Statute

By Lee H. Rosebush, Stephen E. Ruscus and Laura Macherelli on October 21, 2022 Posted in Medicaid

RX pharmacy prescription bottle of pills on a pile of $100 dollar bills and a USA outline Medicaid Drug Rebate

The United States Court of Appeals for the Fourth Circuit decision in US ex rel. Sheldon v. Allergan Sales, LLC, a qui tam False Claims Act (FCA) suit, affirms the complexity of pricing and Medicaid rebates under the Medicaid Drug Rebate Statute, emphasizes the need for government guidance in complex regulations, and further confirms the importance of documenting intentions and reasonable assumptions with respect to the Rebate Statute. The Court was evenly split in upholding the dismissal of the suit brought by a former employee alleging Forest Laboratories LLC committed Medicaid fraud by violating the Medicaid Drug Rebate Statute and unjustly profiting from it.

Federal Judge Blocks Idaho from Enforcing Abortion Ban in Emergencies

By Amy Fouts, Gregory Tanner and Claire Bass on September 1, 2022 Posted in Post-Dodds

On Aug. 24, the United States District Court for the District of Idaho issued a preliminary injunction blocking the enforcement of Idaho’s new abortion law. The law was set to take effect on Aug. 25, 2022. As previously reported, the U.S. Department of Justice (DOJ) filed suit on Aug. 2 against the state of Idaho, seeking to block the recently passed state abortion law. The DOJ alleged the Idaho law violates the federal Emergency Medical Treatment and Labor Act of 1986 (EMTALA) because it does not provide any exceptions for stabilizing treatment in emergency medical situations.

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HHS Proposes Rule Strengthening Section 1557 Protections Against Nondiscrimination in Health Activities

By Justin Chavez and Vimala Devassy on August 8, 2022 Posted in Healthcare

On Aug. 4, the Department of Health and Human Services (HHS) published its proposed rule, Nondiscrimination in Health Care and Activities (Proposed Rule), to revise its regulations pertaining to Section 1557 of the Affordable Care Act (ACA). The aim of Section 1557 is to ensure access to health care and coverage in certain health programs or activities. The Proposed Rule aims to realign the scope of Section 1557 — which has been subject to several regulatory changes, interpretations and litigation throughout several presidential administrations — with the underlying statutory and regulatory intent, after the 2020 Final Rule regarding Section 1557 was limited in its reach following challenges to the regulation in litigation.

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DOJ Alleges Idaho Abortion Law Violates EMTALA

By Amy Fouts, Claire Bass and Gregory Tanner on August 4, 2022 Posted in Healthcare

On Aug. 2, the U.S. Department of Justice (DOJ) filed suit against the state of Idaho to block a state abortion law set to take effect on Aug. 25, claiming that it violates the federal Emergency Medical Treatment and Labor Act of 1986 (EMTALA).

Under EMTALA, a hospital that receives Medicare funds must provide treatment to patients who present to the hospital’s emergency department with an “emergency medical condition.” The DOJ explains that “emergency medical conditions” under EMTALA “include not just conditions that present risks to life but also those that place a patient’s ‘health’ in ‘serious jeopardy’ or risk ‘serious impairment to bodily functions’ or ‘serious dysfunction of any bodily organ or part.’”

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HHS and DOJ Issue Joint Guidance on Nondiscriminatory Telehealth Practices

By Vimala Devassy and Justin Chavez on August 3, 2022 Posted in Healthcare

To coincide with the 32nd anniversary of the Americans with Disabilities Act (ADA), the Department of Health and Human Services Office for Civil Rights (OCR) and the Department of Justice’s Civil Rights Division (CRT) jointly issued Guidance on Nondiscrimination in Telehealth: Federal Protections to Ensure Accessibility to People with Disabilities and Limited English Proficient Persons (Guidance) on July 29, 2022, as part of their continued commitment to ensuring that telehealth is accessible in a nondiscriminatory manner.

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HHS, DOL and Treasury Say Limiting Birth Control Coverage Violates Federal Law

By Amy Fouts and Claire Bass on August 2, 2022 Posted in Healthcare

Woman taking out a morning after pill from her handbag

Authored by: Amy E. Fouts (Partner) and Claire M. Bass (Associate)

On July 28, U.S. Department of Health and Human Services (HHS), alongside the Department of Labor (DOL) and the Department of Treasury, warned that limiting coverage of contraceptives following the U.S. Supreme Court ruling in Dobbs violates the Affordable Care Act (ACA).

HHS Letter to Healthcare Providers About Emergency Medical Care

By Amy Fouts and Claire Bass on July 12, 2022 Posted in Healthcare

On Monday, July 11, 2022, the secretary of Health and Human Services (HHS) issued a letter to healthcare providers regarding the Emergency Medical Treatment and Active Labor Act (EMTALA), indicating that when a state law prohibits abortion and does not provide an exception that aligns with EMTALA’s emergency medical condition definition, that state law is preempted.

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Please visit the BakerHostetler Post-Roe Resource Center or contact the BakerHostetler Dobbs Decision Task Force for ongoing updates and information.

Stark and AKS Rules Cross the Finish Line of HHS Regulatory Sprint

By Kristen McDermott Woodrum and Kimberly Ruark on November 25, 2020 Posted in Healthcare

With a bold finish, the Department of Health and Human Services (HHS) crossed the finish line of its race to modernize and clarify the regulations interpreting the federal physician self-referral law (Stark) and anti-kickback statute (AKS) through final rules released Nov. 20, 2020. With one exception, the Stark and AKS rules, based on October 2019 proposals, are effective on Jan. 19, 2021 – the day before the presidential inauguration. A separate AKS rule released the same day revises the discount safe harbor and creates new safe harbors focused on pharmaceutical distribution models. This rule follows a February 9, 2019 proposed rule and a July 24, 2020 Executive Order directing that HHS complete the rulemaking.

Through its Regulatory Sprint to Coordinated Care, HHS has acted to support innovative arrangements to improve quality outcomes, produce health system efficiencies, lower costs and promote care coordination, with an overarching goal of transforming the healthcare system into one that better pays for value. The Centers for Medicare & Medicaid Services (CMS) and the Office of the Inspector General (OIG) coordinated closely on the rules, which finalize proposed protections for value-based arrangements, with some modifications, and also clarify and revise existing Stark and AKS requirements that are viewed as barriers to coordinated and value-based care or that simply cause undue confusion and burden. The OIG additionally acknowledged that these “[f]lexibilities to engage in new business, care delivery and digital health technology arrangements with lowered compliance risk may assist industry stakeholders in their response to and recovery from the current public health emergency resulting from the [COVID-19] pandemic.” Continue Reading

Capitol Hill Healthcare Update

By Adam Higgins on March 9, 2020 Posted in Healthcare

CORONAVIRUS WORRIES CONTINUE AFTER EMERGENCY FUNDING BILL

Congressional approval last week of emergency spending to address the coronavirus hasn’t allayed Capitol Hill’s concerns about preparedness and response as the impact of the virus in the United States rapidly escalates.

Two lawmakers – Sen. Ted Cruz, R-Texas, and Rep. Paul Gosar, R-Ariz. – announced this weekend that after interacting with an individual last week who later tested positive for COVID-19, they were taking precautionary measures and would not be in Washington this week. The No. 3 elected House Republican, Rep. Liz Cheney, R-Wyo., was absent from a GOP retreat in Maryland this weekend because she wanted to limit participation in nonessential gatherings.