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Articles Posted in Health Law

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Primer on Provider Requirements under the No Surprises Act (Part I)

Effective January 1, 2022 under the No Surprises Act, healthcare providers, facilities, and providers of air ambulance services will be subject to new requirements that generally apply to items and services provided to individuals enrolled in group health plans, group or individual health insurance coverage, and Federal Employees Health Benefit…

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HHS Proposes to Repeal Rules that Limit Its Authority

The Department of Health and Human Services (HHS) recently proposed to repeal two rules implemented under the Trump Administration to moderate the power of the agency. The rules HHS seeks to repeal are the Good Guidance Rule and the Civil Enforcement Rule. Public comments on the proposal are due by…

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CMS Proposes Repeal of Breakthrough Devices Medicare Coverage Rule

The Centers for Medicare & Medicaid Services (CMS) recently announced a proposal to repeal the Medicare Coverage of Innovative Technology (MCIT) rule that has been delayed several times. The latest news in the MCIT saga comes from a CMS announcement expressing concerns with the final rule, specifically that it will…

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Court Ruling Shows Limits on FDA Authority to Regulate Medical Devices

On July 6, 2021, the U.S. Court of Appeals for the D.C. Circuit issued a 2-1 opinion in Judge Rotenberg Education Center v. FDA that overturned the Food and Drug Administration’s (FDA) ban on the use of electric shock medical devices for particular purposes because the FDA is prohibited from…

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Sale of Goods in Physician Offices

The sale of goods in physicians’ offices can afford patients greater accessibility to healthcare products while simultaneously enhancing quality of care. However, these transactions may pose ethical dilemmas for physicians along with the potential to negatively affect the physician-patient relationship. Physicians should be aware of these potential pitfalls. Specifically, both…

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A Primer on Corporate Practice of Medicine

The Corporate Practice of Medicine refers to the practice of medicine by a corporate entity, rather than an individual practitioner. That is, the corporate entity employs physicians. Many states prohibit the corporate practice of medicine or otherwise regulate what types of entities may employ physicians. The rationale is often a…

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CMS Delays Rule on Breakthrough Devices …Again.

Recently, the Centers for Medicare & Medicaid Services (CMS) announced another delay of the implementation of the new rule for Medicare Coverage of Innovative Technology (MCIT) and discussed several concerns it had with the new rule, raising doubts that CMS would ever implement the new rule without significant changes. The…

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Are COVID-19 Liability Waivers by Patients Enforceable?

In general, liability waivers can be a useful tool for businesses and individuals to avoid personal injury lawsuits and liability. Typically, liability waivers are associated with participating in a dangerous activity, such as skiing, boating, gym classes, or school activities. The individual participating in the activity signs the waiver, acknowledging…

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A Peak Inside the $1.9 Trillion COVID-19 Relief Bill

On March 11, 2021, President Biden signed  the $1.9 trillion American Rescue Plan, a legislative package to help fund vaccinations, provide immediate relief to families during the COVID-19 pandemic, increase COVID-19 testing and identify new and emerging strains of COVID-19.  The final bill includes several sources of funding for COVID-19…

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COVID Testing Providers Face Hurdles for HRSA Reimbursement

As part of the response to the COVID-19 pandemic, Congress provided funding for testing of patients without health insurance. To receive this reimbursement for testing, providers must attest that the patient is uninsured. However, it is not clear how providers must gather this information, exposing providers to risk of enforcement…

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