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Ripple Effects of Supreme Court’s TCPA Decision Still Developing for Companies Using Auto-Dialers
Dinsmore & Shohl LLP, June 2021

If you work in the Telephone Consumer Protection Act (TCPA) space, you are certainly aware of the landmark unanimous decision by the United States Supreme Court in Facebook v Duguid[1], in which the Court narrowed the definition of an automatic telephone dialing system (ATDS) to equipment that has the capacity to either store or produce numbers using a random or sequential number generator. On its face, this decision seemed benign (the definition of an ATDS is unchanged)...

Supreme Court: Schools Are Limited in Regulation of Off-Campus Speech
Dinsmore & Shohl LLP, June 2021

On Wednesday, June 23, 2021, the United States Supreme Court issued its decision in Mahanoy Area School District v. B.L., a much-anticipated decision regarding schools’ regulation of off-campus speech. The Court held that while schools may discipline students for some off-campus speech, their ability to do so is much more limited than for on-campus speech. B.L. was a student at Mahanoy Area High School and cheered on the junior varsity team during her freshman year...

DOL Proposes 30-Minute Cap for Tipped-Wage Side Work, Seeks to Reinstate 80/20 Rule
Dinsmore & Shohl LLP, June 2021

On June 21, 2021, the Department of Labor (DOL) proposed a new rule to restrict the amount of non-tip-producing work a tipped employee can perform when an employer is taking a tip credit. The proposed rule clarifies that if an employee performs work that directly supports tip-producing work for a substantial amount of time — at least 20 percent of the hours worked in a workweek or at least 30 continuous minutes — the worker must be paid the standard minimum wage...

FCA Allegation That Surgeons Let Residents and PAs Obtain Patient Consent for Procedures Fails Materiality Test
Dinsmore & Shohl LLP, June 2021

Guided by the materiality standard from Escobar, a key safeguard for FCA defendants, the Western District of Pennsylvania found the Zaldonis relator failed to show the alleged fraud “would have any effect on the government’s decision to pay a claim.” Five years after the Supreme Court decided it, Escobar thus continues to set a high hurdle for plaintiffs...

US Department of Education Interprets Title IX to Protect Against Discrimination Based on Sexual Orientation and Gender Identity
Dinsmore & Shohl LLP, June 2021

On Wednesday, June 16, 2021, the U.S. Department of Education’s Office for Civil Rights (OCR) released a Notice of Interpretation, explaining how it interprets Title IX to prohibit discrimination on the basis of sexual orientation or gender identity...

OSHA Issues COVID-19 ETS for Health Care Employers, Updated Prevention Guidance for All Other Sectors
Dinsmore & Shohl LLP, June 2021

Last week, the Occupational Safety and Health Administration (OSHA) issued a COVID-19 Emergency Temporary Standard (ETS) for employers only in the health care sector in response to President Joe Biden’s January Executive Order on Protecting Worker Health and Safety. The ETS becomes effective on the date it is published in the Federal Register, which is yet to be determined. In addition, OSHA promulgated new non-binding guidance for employers in all other sectors...

Medicare Coverage of Innovative Technology Program Breakthrough Devices Delayed
Dinsmore & Shohl LLP, June 2021

On May 14, 2021, the Centers for Medicare and Medicaid Services (CMS) issued a new final rule that will further delay the effective date of the Medicare Coverage of Innovative Technology (MCIT) and Definition of Reasonable and Necessary Final Rule (the Final Rule) until no earlier than Dec. 15, 2021...

ESG Principles at Work in Diversifying Governance
Dinsmore & Shohl LLP, June 2021

Dinsmore's Richik Sarkar was published in Bank Director this week discussing the need for diversity and inclusion within governance structures. Read an excerpt below...

Is Hope Ahead? Paths to Defeating a Rash of Anti-Trans Legislation
Dinsmore & Shohl LLP, June 2021

Dinsmore real estate associate Sam Brinker was recently published in Bar Briefs, the Louisville Bar Association's monthly publication. He wrote on his experience as a transgender man and what paths may be considered to defeat the many pieces of anti-trans legislation circulating the country. Read an excerpt below...

EEOC Issues Guidance on COVID-19 Vaccinations, Incentives and Confidentiality
Dinsmore & Shohl LLP, May 2021

On May 28, 2021, the U.S. Equal Employment Opportunity Commission (EEOC) released updated and expanded guidance on the COVID-19 pandemic’s interactions with federal equal employment opportunity (EEO) laws. The majority of the new guidance is directed at inquiries regarding vaccination status, vaccine incentives, and accommodations...

HRSA Says Drug Manufacturers Violated 340B Program Statute
Dinsmore & Shohl LLP, May 2021

On May 17, 2021, the United States Health Resources and Services Administration (HRSA) publicly disclosed letters which were sent to six major pharmaceutical manufacturers. HRSA’s letters expressly state that each manufacturer is currently in violation of the Federal 340B Program statute as a result of policies restricting contract pharmacies and covered entities from access to 340B Program discounted medication...

CDC: Masks Are No Longer Required in Most Settings for Vaccinated People
Dinsmore & Shohl LLP, May 2021

On Thursday, May 13, 2021, the Centers for Disease Control (CDC) announced new guidance stating it is safe for fully vaccinated people to not wear masks or physically distance in any non-health care setting.1 Per this guidance, fully vaccinated people can now resume most activities without wearing a mask or physically distancing...

CMS Announces Revisions to Long-Term Care Facility COVID-19 Testing Requirements
Dinsmore & Shohl LLP, May 2021

On April 27, 2021, the Center for Medicare & Medicaid Services (CMS) announced revised guidance for Interim Final Rule, CMS-3401-IFC related to Long-Term Care Facility Testing Requirements and the COVID-19 Focused Survey Tool. CMS published the initial interim final rule with comment period on Aug. 25, 2020...

CMS: Long-Term Care Providers Must Report Weekly COVID-19 Vaccine Data
Dinsmore & Shohl LLP, May 2021

On May 11, 2021, the Center for Medicare & Medicaid Services (CMS) announced a new rule that will require long-term care facilities and residential facilities serving clients with intellectual disabilities to educate and offer COVID-19 vaccines to residents, clients and staff. This new requirement will closely align with current requirements for influenza and pneumococcal vaccines in long-term care facilities...

CMS Announces Revisions to COVID-19 Nursing Home Visitation Guidance
Dinsmore & Shohl LLP, May 2021

On April 27, 2021, the Center for Medicare & Medicaid Services (CMS) announced revised guidance for Nursing Home Visitation. CMS issued its initial guidance in March 2020, via memorandum QSO-20-14-NH. Under this memorandum, all visitation by visitors and non-essential health care personnel was restricted, except for situations involving compassionate care, such as end-of-life...

New OIG Advisory Opinion Establishes Guideposts for ASC Investors in Venture Involving System-Employed Physicians
Dinsmore & Shohl LLP, May 2021

The Office of Inspector General (OIG) has issued a favorable advisory opinion addressing an investment in an ambulatory surgery center (ASC) made by a health system, certain physicians employed by the same health system, and a management company. OIG Advisory Opinion No. 21-02 is the first advisory opinion since 2009 to provide guidance on ASC investments and related safe harbors to the Anti-Kickback Statute...

New DOL Repeals Trump-Era Independent Contractor Test
Dinsmore & Shohl LLP, May 2021

On May 5, 2021, the U.S. Department of Labor (DOL) officially withdrew from the Trump-era rule for classifying workers as independent contractors. This withdrawal has been anticipated since President Joe Biden assumed his role, and was official on May 6. The DOL is expected to publish a Final Rule in the Federal Register within the coming days. Trump-Era Independent Contractor Test Contrary to FLSA Purpose and Intent On Jan...

FDA Announces Revocation of Policy on Information Related to New Drug Applications
Dinsmore & Shohl LLP, May 2021

On April 30, 2021, the U.S. Food and Drug Administration (FDA) announced it was revoking a policy related to new drug applications (NDAs) and abbreviated new drug applications (ANDAs). The FDA stated that the previous policy announced by the Department of Health and Human Services (HHS) on Jan. 15, 2021, was being rescinded because the new policy would have required the FDA to publish redundant information about new applications of NDAs and ANDAs...

Proposed Expansion to Ohio Laser Rule Advances to Public Rules Hearing
Dinsmore & Shohl LLP, May 2021

More than three years after initial publication, the State Medical Board of Ohio's proposed revisions to its light-based device (laser) rules are now advancing toward possible enactment, as the Medical Board has announced amendments to the proposal and scheduled public rules hearing for May 17, 2021...

Ohio Board of Pharmacy to Award Up to 73 New Medical Marijuana Dispensary Licenses
Dinsmore & Shohl LLP, May 2021

The Ohio Board of Pharmacy recently announced it will award up to an additional 73 dispensary licenses across Ohio. Dispensary licenses will be awarded through an application and lottery process that is expected to be finalized during the spring or summer of 2021. This expansion will bring the total number of dispensary licenses in Ohio to 130 and is expected to ameliorate patient dissatisfaction with regards to the price of medical marijuana products and lack of equal access...

HHS Advises on Fraudulent Postcard Disguised as Official OCR Communication
Dinsmore & Shohl LLP, May 2021

On April 26, 2021, the Department of Health and Human Services (HHS) Office of Civil Rights (OCR) announced on its OCR Security List Digest that OCR had been made aware of misleading postcards being sent to health care organizations.  The postcards inform recipients that they must participate in a “Required Security Risk Assessment.,” It directs them to send their risk assessment to www.hsaudit.org,  a non-governmental website marketing consulting service...

District Court Finds DOJ ‘Falls Short’ of Showing Good Cause for Late FCA Intervention
Dinsmore & Shohl LLP, May 2021

The Department of Justice (DOJ) suffered an unusual defeat when its motion for late intervention in a False Claims Act (FCA)[1] qui tam case, United States ex rel. Odom v. Southeast Eye Specialists, PLLC,[2] was rebuffed by the Middle District of Tennessee, rejecting the magistrate judge’s recommendations...

Ohio COVID-19 Indoor Air Quality Assistance Program Expands Eligible Entities and Extends Reimbursement Deadline
Dinsmore & Shohl LLP, May 2021

The Ohio COVID-19 Indoor Air Quality Assistance Program allows eligible private employers to receive reimbursement for eligible inspections, assessments, maintenance, and/or improvements to indoor heating, ventilation, and air conditioning systems to help control the spread of COVID-19. Employers are not eligible for this program if any other federal funding has been supplied for the same purposes...

CMS Proposes Increases to Hospital Reimbursement Rates and GME Residency Caps with a Focus on Rural Hospitals
Dinsmore & Shohl LLP, May 2021

As part of its 2022 Inpatient Prospective Payment System (IPPS) Proposed Rule for Acute Care Hospitals, the Centers for Medicare and Medicaid (CMS) is proposing an increase for Medicare fee-for-service payment rates to acute care hospitals by 2.8 percent, or $3.4 billion in Fiscal Year (FY) 2022.[[1]] Hospitals hoping to receive the payment increase must successfully participate in the Hospital Inpatient Quality Reporting Program and be meaningful electronic health record users...

DOL Announces Essential Workers, Essential Protections Initiative
Dinsmore & Shohl LLP, April 2021

The U.S. Department of Labor announced the Essential Workers, Essential Protections Initiative on April 26, 2021. The Initiative is designed to educate workers on the Fair Labor Standards Act (FLSA) and the Family and Medical Leave Act (FMLA)...

 

 

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