Firm: Dinsmore & Shohl LLP
Practice Industry: All
Region: All
Country/ State: All
Tag: All

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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) ...

Dinsmore & Shohl LLP | April 2021

If the COVID-19 pandemic affected the value of your property, Ohio Senate Bill 57 (S.B. 57) may offer you (or your triple-net lease tenant) a chance to reduce your Ohio real property taxes not available under prior law. Property tax valuation complaints in Ohio counties can be filed only once in each three-year interim period, and property values are determined as of January 1 of the tax year. Because the COVID-19 pandemic in the U.S ...

Dinsmore & Shohl LLP | April 2021

On April 8, 2021, the Centers for Medicare and Medicaid Services (CMS) announced that some of the blanket waivers implemented during COVID-19 will expire on May 10, 2021.[1] The following waivers will expire: The emergency blanket waivers related to notification of resident room or roommate changes, and transfer and discharge notification requirements ...

Dinsmore & Shohl LLP | April 2021

On March 23, 2021, Governor Pritzker signed a new law (Senate Bill 1480) that makes several meaningful changes to the Illinois Human Rights Act (IHRA). One significant change under the new law states employers may not use criminal conviction records when making employment decisions unless employers consider specific factors and take certain steps before making a final employment decision ...

Dinsmore & Shohl LLP | April 2021

On April 21, 2021, the Supreme Court of the United States heard oral arguments in Minerva Surgical, Inc., v. Hologic, Inc., et al., Case No. 20-440, concerning whether to limit, abolish, or uphold the doctrine of assignor estoppel. The doctrine of assignor estoppel, generally stated, prevents an inventor who assigns his patent from later challenging its validity ...

Dinsmore & Shohl LLP | April 2021

After spending over 10 years in court, the Google vs. Oracle copyright saga has finally come to an end. The U.S. Supreme Court, ruling 6-2 in Google’s favor, found that when Google used pieces of Java software developed by Oracle to build the Android operating system, it was within the parameters of the fair use doctrine that permits the unlicensed use of copyright-protected works in certain circumstances ...

Dinsmore & Shohl LLP | April 2021

PileDriver Magazine published an article by Dinsmore's Lisa Hodgdon and Jason Lambert entitled "COVID-19 Vaccines in the Workplace: 8 Considerations for Employers" in its most recent issue. Read an excerpt below. 1 ...

Dinsmore & Shohl LLP | April 2021

On April 19, 2021, West Virginia Governor Jim Justice approved Senate Bill 375 related to county boards of education policies for open enrollment. County boards may recall changes to applicable law found in W. Va. Code 18-5-16 following the 2019 Legislative Session. Although W. Va ...

Dinsmore & Shohl LLP | April 2021

On April 8, 2021, the Center for Medicare & Medicaid Services (“CMS”) announced a proposed rate increase of 1.3 percent for skilled nursing providers in fiscal year 2022. It is estimated this will result in approximately $444 million increase in payments to skilled nursing facilities (SNF) under Medicare Part A for the fiscal year.  This increased payment rate does not incorporate the SNF Value-Based Program (VBP) reductions that CMS estimates to be $184 ...

Dinsmore & Shohl LLP | April 2021

In Facebook v. Duguid, (Case No. 19-511) on April 1, 2021, the United States Supreme Court unanimously confirmed that equipment without the capacity to randomly or sequentially store or produce numbers is not an autodialer for TCPA purposes. The Facebook ruling focuses on text messages, which many institutions are using as a primary method of customer contact, but it is also a victory for those using predictive dialers and preview dialers without random and sequential source codes ...

Dinsmore & Shohl LLP | April 2021

Those in the CBD sector should be mindful of their marketing tactics, as the FDA continues to police the industry. Manufacturers of CBD products must also evaluate their quality-control procedures to ensure safe products are hitting the marketplace. As we forecasted this past December in a previous legal alert, the U.S. Food and Drug Administration continues to referee the emerging cannabidiol (CBD) product market ...

dots