The Centers for Medicare and Medicaid Services' (CMS) vaccine mandate (Mandate)[1] has been preliminarily enjoined[2] on a nationwide basis due to a Nov. 30, 2021, decision by Judge Terry A. Doughty of the Western District Court of Louisiana, Monroe Division. Among other conclusions, Judge Doughty stated that mandating vaccination of health care workers should be done by Congress, not a government agency, although he also questioned whether even Congress had such authority ...
On Nov. 17, 2021, the United States Drug Enforcement Administration (DEA) released an advanced notice of proposed rulemaking (the Notice) concerning its potential development of telepharmacy regulations ...
On Oct. 19, 2021, the U.S. Food and Drug Administration (FDA) issued a proposed rule that would establish a new category of over-the-counter (OTC) hearing aids. The rule came in response to President Joe Biden’s July 9 executive order, which among other things, calls for wide availability of low-cost hearing aids in order to promote economic competition ...
In order to continue addressing the impacts of COVID-19 on nursing home residents, the Centers for Medicare & Medicaid Services (CMS) recently issued a memo updating guidance for nursing home visitation. You can read the full memo here. Early in the pandemic, CMS implemented visitation restrictions to mitigate the risk of visitors introducing COVID-19 to nursing homes. Now, CMS is updating its guidance and allowing visitation for residents at all times ...
On Nov. 10, 2021, the General Counsel’s Office of the National Labor Relations Board issued a guidance memorandum [OM 22-03] dictating employers and unions will be required to engage in decision bargaining over discretionary aspects of vaccination policies required by the OSHA Emergency Temporary Standard mandating COVID vaccinations and testing. Under the OSHA Emergency Temporary Standard (ETS), employers must create Vaccination and Testing Policies by Dec. 6, 2021 ...
On Nov. 8, 2021, the U.S. Department of Health & Human Services Office of the Inspector General (OIG) updated and renamed its Provider Self-Disclosure Protocol. Now called the Health Care Fraud Self-Disclosure Protocol (SDP), the OIG’s revisions are the first changes to the SDP since 2013. We report on the key elements of these changes below ...
Two new categories of tax-exempt bonds were created by the Infrastructure Investment and Jobs Act (H.R. 3684) (the Act) adopted by the House on Nov. 6, 2021: “Qualified Broadband Projects” and “Carbon Dioxide Capture Facilities ...
On Nov. 4, 2021, the Centers for Medicare and Medicaid (CMS) released a new Interim Final Rule (IFR) regarding staff vaccination at facilities that participate in the Medicare and Medicaid programs. The IFR requires covered employers to ensure that staff receive their first dose no later than Dec. 5, 2021 and achieve full vaccination no later than Jan. 4, 2022. The vaccine rule that was also released on Nov ...
On Nov. 4, 2021, the Occupational Safety and Health Administration (OSHA) issued its highly anticipated emergency temporary standard (ETS) mandating employers of 100 or more employees to implement a COVID-19 vaccination or testing requirement. This standard implements the policy goals announced by the Biden administration in September ...
On Oct. 29, 2021, the Wage and Hour Division of the United States Department of Labor (DOL) released its final rule regarding “dual jobs” for tipped employees under the Fair Labor Standards Act (FLSA). The final rule, which becomes effective on Dec. 28, 2021, withdraws a prior final rule from 2020 regarding dual jobs and amends regulations to distinguish between tipped occupations and non-tipped occupations ...
Questions abound as to whether HIPAA comes into play when COVID-19 vaccination information is provided to employers. Recently, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued clarifying guidance on the applicability of the HIPAA Privacy Rule in the context of COVID-19 vaccination information provided to employers ...
In her speech to the Principles for Responsible Investment and the London Stock Exchange Group, SEC Commissioner Allison Herren Lee made it clear that a climate change disclosure proposal is no longer a question of if, but when and provided some hints about what the proposal will look like. After remarking that “[c]limate change is . . ...
Last week, in the culmination of a process that began in 2016, the Federal Trade Commission (FTC) issued a Final Rule to update the Safeguards Rule promulgated under the Gramm-Leach-Bliley Act ...
About a year ago, on Nov. 20, 2020, the Department of Health and Human Services Office of Inspector General and the Centers for Medicare and Medicaid Services (CMS) issued two final rules implementing sweeping changes to the Physician Self-Referral Law (Stark Law) and the Anti-Kickback Statute regulations. For the most part, those new rules went into effect on Jan. 19, 2021 ...
On Oct. 25, 2021, the Department of Labor (DOL) issued Field Assistance Bulletin No. 2021-02 (the Bulletin). In the bulletin, the DOL revised and extended the temporary enforcement policy related to the DOL’s Fiduciary Rule/Prohibited Transaction Exemption 2020-02 (the DOL Fiduciary Rule) ...
Dinsmore construction partner Jim Boyers and commercial litigation clerk Mary-Kate Hetzel were published in The Indiana Lawyer this week discussing how building material price increases have created logistical and legal challenges during the COVID-19 pandemic. An excerpt is below ...
On Oct. 25, 2021, the Equal Employment Opportunity Commission (EEOC) updated its technical guidance for employers addressing questions regarding religious objections to employer COVID-19 vaccine requirements and how those requirements interact with federal equal employment opportunity (EEO) laws ...
It is imperative that companies with government contracts, or those receiving federal grant funding, ensure that they have adequate cybersecurity protocols in place. The announcement by the Department of Justice (DOJ) of the Cyber Fraud Initiative strongly signals its intent to be aggressive in holding government contractors with lax cybersecurity standards and controls accountable ...
The Renewed Proposal On Oct. 14, 2021, SEC Chairman Gary Gensler released a statement announcing the SEC would once more open comment on the Dodd-Frank Act rule regarding clawbacks of incentive-based compensation that had been improperly awarded due to since-corrected accounting errors. Should a company not comply or refuse to institute a compensation recovery policy, the SEC proposal goes so far as to threaten delisting ...
The only thing crystal clear about health care price transparency requirements at the moment is that the government will continue implementing new price transparency laws, regulations, and rules ...
The United States Trade Representative (USTR) announced a period for public comment on whether Section 301 product exclusions should be reinstated for certain Chinese-origin goods. The product exclusions eligible for potential reinstatement are the relatively small subset of exclusions for which the USTR had both previously granted an exclusion and an extension of the exclusion ...
Companies that have imports from China subject to List 3 and List 4a Section 301 tariffs may still have an opportunity to protect their right to seek a refund from the U.S. Government. To do so, a company would need to file a lawsuit in the Court of International Trade (CIT) challenging the List 3 and/or List 4a tariffs as unauthorized under the Trade Act of 1974 and implemented in violation of the Administrative Procedure Act ...
In late September, the SEC’s Division of Corporation Finance continued signaling the increased importance of ESG initiatives in its mission by publishing a sample comment letter similar to what it may provide to issuers when reviewing their filings ...
It seems logical that when a claimant requests that a claim be amended to include an additional condition based upon a theory of substantial aggravation, the easiest element to prove would be that the condition pre-existed the date of injury. Recently, in Houlihan v. Hamilton County, 2021-Ohio-3087, the Ohio First District Court of Appeals found that a claimant must prove a condition existed at the time of the injury before they can establish a substantial aggravation ...
On Sept. 22, 2021, the U.S. Health Resources and Services Administration (HRSA) publicly referred six matters involving drug manufacturers to the United States Department of Health and Human Services (HHS) Office of Inspector General (OIG) for possible imposition of civil monetary penalties (CMPs) ...
