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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that the previous policy announced by the Department of Health and Human Services (HHS) on Jan. 15, 2021, was being rescinded because the new policy would have required the FDA to publish redundant information about new applications of NDAs and ANDAs...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)...

Senate Bill 57 Offers Property Tax Reduction Opportunity
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...

COVID-19 Waivers Ending for Skilled Nursing Facilities
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...

Illinois Enacts Law Limiting Use of Criminal Conviction Records When Making Employment Decisions
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...

Assignor Estoppel: Soil of the Common Law or a Strange State of Affairs?
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...

United States Supreme Court Finds Google’s Use of Oracle’s Software Was Fair Use
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...

COVID-19 Vaccines in the Workplace: 8 Considerations for Employers
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...

More Open Enrollment Changes for Nonresident Transfers
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...

CMS Announces Proposed Rate Increases and Other Changes for Skilled Nursing Providers and Hospice Providers in Fiscal Year 2022
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...

United States Supreme Court Exempts Certain Technology from the TCPA
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...

FDA Continues to Referee the CBD Market
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...

ESG In Action: Diversifying Corporate Governance
Dinsmore & Shohl LLP, March 2021

Dinsmore's Richik Sarkar was published in the American Bar Association's Business Law Today this week discussing a few lawsuits alleging that lack of board and management diversity constitutes a breach of fiduciary duty. An excerpt from the article, "ESG In Action: Diversifying Corporate Governance," is below. "While the purpose of these suits is laudable, significant threshold legal questions exist...

Finally: Clarification on ECCAT 'Issues'
Dinsmore & Shohl LLP, March 2021

Over the past couple of years, school systems have been faced with several personnel issues related to the ECCAT classification.  Several grievances were filed relating to determining seniority of the ECCAT classification, with employees mainly alleging that seniority as an Aide should serve as the seniority date as an ECCAT...

Government Enforcement for Misuse of Paycheck Protection Program and Other COVID-19 Relief Funds: What You Should Know
Dinsmore & Shohl LLP, March 2021

The new American Rescue Plan Act[1] (ARPA) as signed into law earlier this month provides for $1.9 trillion in economic stimulus, supplementing last year’s Coronavirus Aid, Relief, and Economic Security (CARES) Act[2] and its $2.2 trillion allocation, both undertaken in response to the economic impact of the COVID-19 pandemic in the United States...

ESG as the Prism For Change – the SEC Targets Proxy Voting
Dinsmore & Shohl LLP, March 2021

Over the past month, the SEC has signaled the primacy of ESG in its mission for 2021 and beyond. Seemingly daily, there have been updates regarding ESG initiatives, whether from the Division of Enforcement or the Division of Corporation Finance. This week, it was the Division of Investment Management’s turn...

2021 Open Payments (Sunshine Act) Reporting Window Closes March 31
Dinsmore & Shohl LLP, March 2021

As a reminder to our life sciences clients including drug manufacturers, medical device manufacturers, and group purchasing organizations, all Open Payments data from the 2020 program year must be reported to CMS by no later than March 31, 2021. Organizations that participate in the Open Payments program are also reminded that they must submit a final attestation that their data is timely, complete and accurate in addition to reporting data from fiscal year 2020...

More ESG Signals from the SEC
Dinsmore & Shohl LLP, March 2021

As we mentioned last week, the signals coming from the SEC on ESG matters are increasing in volume and significance. On March 15, acting SEC Chair Allison Herren Lee added two more data points. The first concerned the Division of Corporate Finance’s disclosure program...

American Rescue Plan Act Provides Additional Sick and Family Leave Credits for Employers
Dinsmore & Shohl LLP, March 2021

Last week upon final passage by Congress, President Joe Biden signed the American Rescue Plan Act (ARPA or Act) into law.[1] The $1.9 trillion economic stimulus bill provides a comprehensive package of available funds to qualifying individuals and businesses in the form of direct payments, industry-specific grants, and tax credits...

 

 

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