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Waller | February 2021

Virginia is now the first state in the nation to enact permanent COVID-19 workplace safety and health standards. In late January, the Virginia Department of Labor and Industry (DOLI) adopted the Virginia Occupational Safety and Health (VOSH) Program. The program promulgates a new standard that supersedesVirginia’s Emergency Temporary Standard from July 2020 ...

Waller | February 2021

WHAT IS A CON? A Certificate of Need (CON) is a permit authorizing the establishment, modification, or construction of a healthcare institution, facility, or service at a designated location. Obtaining a CON is a prerequisite to obtaining licensure from the State of Tennessee for certain enumerated health services and facilities. The Health Services and Development Agency (HSDA) regulates the healthcare industry in Tennessee through the CON program ...

Waller | February 2021

To the extent that there is such a thing as a “HIPAA Day,” it’s coming up soon. And, no, it’s not a HIPAA Holiday. Instead, March 1 is the deadline to report all HIPAA breaches of fewer than 500 affected individuals. HIPAA requires all breaches to be reported to the Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services (HHS) ...

Waller | February 2021

Given the upheaval and intense focus on the Department of Justice (DOJ) during the last four or more years and the recent events in Washington, D.C., the Biden administration is inheriting a host of thorny legal issues. So, what can the Nashville business community expect from the DOJ on a national and local level for the next four years? In short, increased enforcement ...

Waller | January 2021

Tennessee state Rep. Bob Ramsey has introduced state legislation that makes delivery of alcoholic beverages by restaurants, hotels and other liquor by the drink licensees “permanent” — at least for three years. Download a copy of the legislation here ...

Waller | January 2021

Tennessee’s urban centers continue to be attractive markets for investment in residential, office and mixed-use developments. While most sophisticated real estate developers and investors are aware of land use and zoning requirements associated with projects in heavily regulated urban centers, many may not be aware of certain environmental issues that can derail a project.  “Urban soil” is different ...

Waller | January 2021

The second HIPAA settlement of 2021 is the first traditional enforcement action of the year. And, it’s a big one. Traditionally, OCR enforcement has been triggered by breaches. In 2020, however, we saw a significant increase in a sub-set of Privacy Rule enforcement arising out of the U.S. Department of Health and Human Services’ Office for Civil Rights’ (OCR) patient “Right of Access” initiative ...

Waller | January 2021

The U.S. Department of Health and Human Services (HHS) just announced that Provider Relief Fund Program (PRF) recipients will now be required to submit reports regarding their use of these funds later than previously announced. The previous deadline was February 15, 2021. Currently, a specific new timeline was provided, but HHS is encouraging providers to register to receive updates ...

Waller | January 2021

The regulatory change proposed by the Department of Health and Human Services (HHS) in the recent HIPAA Notice of Proposed Rulemaking (NPRM) is another step toward HHS’s objective to encourage a patient-centric healthcare environment. The HIPAA NPRM proposes to tilt the balance of protecting privacy and facilitating the availability of information toward loosening restrictions on disclosures of patient information ...

Waller | January 2021

The most recent changes to the Stark Physician Self-Referral Law (Stark) and the Anti-Kickback Statute (AKS), described previously here, create a new lexicon and framework to guide healthcare providers from payment for volume-based services to payment for value-based healthcare. These value-based rules go into effect on January 19, 2021 ...

Waller | January 2021

As part of the new omnibus stimulus bill, Congress passed, and President Trump signed into law, the “Economic Aid to Hard-Hit Small Businesses, Nonprofits, and Venues Act” (the “Act”) which makes substantial changes to the popular Paycheck Protection Program ...

Waller | December 2020

Tennessee Gov. Bill Lee has extended the executive order allowing carryout and delivery of beer, wine and spirits for restaurants. Restaurants, limited-service restaurants and wine-only restaurants can continue to sell carryout and deliver alcoholic beverages and beer. There is no additional license or permission needed to deliver. Lee extended the privilege through to 11:59 pm February 27, which brings welcome certainty to an industry battered by the pandemic ...

Waller | December 2020

Apparently, the OCR has a different concept of the holiday spirit than many others do. On December 22, OCR announced the 13th settlement agreement related to its Right of Access Initiative. This time, the provider settled for $36,000 and agreed to enter into a corrective action plan. This latest matter involved Peter Wrobel, M.D., P.C., d/b/a Elite Primary Care ("Elite"). The situation follows a very familiar pattern: a patient requested records but did not receive them ...

Waller | December 2020

The Paycheck Protection Program (the “PPP”) was passed into law by Congress as part of the CARES Act earlier this year in response to the COVID-19 pandemic. While considered a relative success at its intended goal of temporarily preserving jobs during the pendency of the pandemic, the PPP ended its initial run with tens of billions of dollars left on the table and frustrated borrowers and lenders because of opaque and frequently changing rules and regulations ...

Waller | December 2020

  In light of the Food and Drug Administration’s approval of new COVID-19 vaccines, the Equal Employment Opportunity Commission (EEOC) has issued new guidance on the legal implications of the COVID-19 vaccine under federal anti-discrimination laws.  Employers should carefully consider these points when making decisions about employee vaccinations. 1. Employers can require employees to receive a COVID-19 vaccination ...

Waller | December 2020

2020 was already expected to be a challenging year for the retail industry and the worldwide pandemic only intensified the underlying troubles. Heading into the year, one estimate projected that 12,000 major chain stores would close in 2020. Today, a number of high-profile brands are in bankruptcy and tenants and landlords alike are struggling to recover from COVID-19 related closures ...

Waller | November 2020

The Department of Health and Human Services (HHS) released a Special Fraud Alert from the Office of Inspector General (OIG) highlighting the fraud and abuse risks associated with the offer, payment, solicitation, or receipt of remuneration related to speaker programs sponsored by healthcare companies ...

Waller | November 2020

The Department of Health and Human Services (HHS) further codified the shift to a value-based care model with the first major overhaul of both the Stark Law and Anti-Kickback Statute since they were first introduced three decades ago. Earlier this week, the White House completed the final review of the changes, and on Friday, Nov ...

Waller | November 2020

The White House has completed the final review to clear a path for the Department of Health and Human Services (HHS) to publish the final rule to modernize and clarify regulations promulgated for the Stark Law and Anti-Kickback Statute. In June 2018, HHS Deputy Secretary Eric Hargan announced a regulatory reform initiative entitled the “Sprint to Coordinated Care ...

Waller | November 2020

Last week, Waller kicked off its multi-part series examining the near- and medium-term impact of President-elect Biden on the financial services industry with Part I of a discussion analyzing the likely direction of financial services regulatory reform under the Biden administration. Part II continues the discussion and incorporates emerging information regarding Biden’s financial regulatory platform ...

Waller | November 2020

As the end of 2020 mercifully approaches and the presidential election is now in the rearview mirror, Waller’s Financial Services Industry Team is looking forward to 2021 to bring you its insight into what the future may hold for participants in the financial services industry ...

Waller | October 2020

It is the time of year for a good scare– but not all a welcome treat! The U.S. Department ofHealth and Human Services(HHS)published a cyber-threat advisory that comes as no great surprise to healthcare providers. As all healthcare providers are focused on continuing to provide excellent care during this COVID-19 pandemic, it is unfortunate that cyber-criminals see this as an opportunity for healthcare targeted ransomware attacks ...

Waller | October 2020

The Federal Deposit Insurance Corporation (“FDIC”) Advisory Committee of State Regulators (“Committee”) recently announced a new technology initiative designed to transition to real-time financial reporting and to modernize the collection of data ...

Waller | October 2020

The Federal Deposit Insurance Corporation (“FDIC”) Advisory Committee of State Regulators (“Committee”) held its inaugural meeting on October 14, 2020. During the meeting, the Committee emphasized the importance of financial inclusion within the banking industry and the recent efforts to foster inclusion undertaken by the FDIC and applicable state regulators ...

Waller | October 2020

The Securities and Exchange Commission (SEC) recently adopted rules to update the statistical disclosures that bank holding companies, banks, savings and loan holding companies, and savings and loan associations (Financial Institutions) provide to the market. The rules will eliminate Guide 3 and will replace it with new Subpart 1400 of Regulation S-K. The rules primarily streamline former Guide 3 disclosures and eliminate disclosures that overlap with SEC rules and U.S ...

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