By BILLEE LIGHTVOET WARD, ESQ.
One year ago, in March of 2020, the Secretary of the U.S. Department of Health and Human Services (Secretary) declared that, because of the public health emergency resulting from the number of confirmed cases of 2019 Novel Coronavirus (COVID), circumstances exist to justify the authorization by the Food and Drug Administration (FDA) of emergency use of drugs and biological products during the COVID-19 pandemic. This action followed similar declarations permitting so-called “Emergency Use Authorizations” or “EUAs” for in vitro diagnostics and for ventilators, respirators and other medical devices. Since that time, the FDA has issued hundreds of EUAs for the use of various medical products [Read More]

Lansing Lines is presented in cooperation with MIRS, a Lansing-based news and information service.

Pressure Builds On DHHS Director Confirmation Vote

Three more Republican senators urged for the rejection of the appointment of Department of Health and Human Services Director Elizabeth Hertel March 4, while Democratic legislators are beginning to rally around her confirmation.

Sens. Tom Barrett (R-Potterville), Jim Runestad (R-White Lake) and Dale Zorn (R-Ida) joined three other colleagues in urging for a vote to reject Hertel based on her support, in part, on “her absurd and blatantly unconstitutional belief” that DHHS directors can, theoretically, issue public health orders that restrict public movement “forever.”

“The Senate should decline to consent to Director [Read More]

Michigan is ranked 42nd among the states according to how much it’s reopened from COVID-19 restrictions, according to one site tracking pandemic-related restrictions on a state-by-state basis.

However, Michigan isn’t necessarily an outlier among the states when it comes to particular COVID-related restrictions, according to a MIRS review of sites tracking restrictions, such as the Kaiser Family Foundation (KFF), the National Academy for State Health Policy (NASHP), The New York Times and USA Today.

The state openness rankings compiled by Virginia-based government relations firm Multistate is based on a score derived from 11 factors, ranging from whether state residents are under a stay-at-home order, to the extent of specific restrictions on industries [Read More]

By JONEL ALECCIA
Kaitlyn Romoser first caught COVID-19 in March, likely on a trip to Denmark and Sweden, just as the scope of the pandemic was becoming clear. Romoser, who is 23 and a laboratory researcher in College Station, Texas, tested positive and had a few days of mild, coldlike symptoms.

In the weeks that followed, she bounced back to what felt like a full recovery. She even got another test, which was negative, in order to join a study as one of the earliest donors of convalescent blood plasma in a bid to help others.

Six months later, in September, Romoser got sick again, after a trip to Florida with her dad. [Read More]

Lansing Lines is presented in cooperation with MIRS, a Lansing-based news and information service.

School Outbreaks, Sports Guidance
The number of ongoing COVID outbreaks in school settings went up for the fourth week in a row, according to numbers released by the state Feb. 8.

With 32 new outbreaks among the 131 overall the first week of February, that eclipses the 105 from last week, the 70 from Jan. 25, and the 60 the week before that.

The 32 new outbreaks in schools were down from the 35 new ones reported the prior week, however. Before that, the numbers had been on the rise, up from the 26 from the week of [Read More]

By EWA MATUSZEWSKI
I hope as you are reading this that Michigan primary care physicians are vaccinating their patients against COVID-19. However, as I write this, the primary care community has been shut out of offering solution-oriented strategies for maximizing vaccinations among Michigan residents. Note, I do not include publicly traded primary care companies here, which was tapped early on by large health systems for vaccination administration assistance. If you sense irritation on my part, you are correct.

For those vaccines that do not require polar temperature refrigeration, the physician’s office should not have been overlooked. Not only are primary care physicians experienced in vaccination storage, monitoring and distribution, they know their [Read More]

By ROLF LOWE
The Department of Health and Human Services (HHS) released proposed changes to the Health Insurance and Portability Accountability Act (HIPAA) Standards for Privacy of Individually Identifiable Health Information (the Privacy Rule) on December 10, 2020. The proposed modifications to the Privacy Rule are intended to address existing standards HHS has identified as impeding the transition to value based care, while continuing to protect the privacy and security of individuals’ protected health information (PHI). HHS specifically identified obstacles currently in place hindering care coordination and case management communications among individuals and covered entities, (which include hospitals, physicians, other health care providers, payors and insurers). The proposed rule changes [Read More]

By JEREMY BELANGER
On Dec. 2, 2020, the CMS and the OIG published the rules modifying the safe harbors under the Anti-Kickback Statute and exceptions under the Stark Law . This article presents an overview of the value-based rules, which became effective on Jan. 19, 2021.

CMS and OIG coordinated many aspects of the value-based rules, and this section will align them as much as possible. It is important to remember that these rules do not protect remuneration based on ownership interests, only for compensation.
A value-based arrangement must be designed to achieve: (i) coordination and management of care; (ii) improve the quality of care; (iii) reduce the costs to, or growth [Read More]

By ANERI PATTANI
The nurses at Mission Hospital in Asheville, North Carolina, declared on March 6 — by filing the official paperwork — that they were ready to vote on the prospect of joining a national union. At the time, they were motivated by the desire for more nurses and support staff, and to have a voice in hospital decisions.

A week later, as the COVID-19 pandemic bore down on the state, the effort was put on hold, and everyone scrambled to respond to the coronavirus. But the nurses’ long-standing concerns only became heightened during the crisis, and new issues they’d never considered suddenly became urgent problems.

Staffers struggled to find masks and [Read More]

It’s not just Republicans complaining about Michigan’s COVID-19 vaccination rollout so far.

Democratic leaders of some of Michigan’s population centers – Oakland County Executive Dave Coulter and Macomb County Executive Mark Hackel – have publicly railed against the speed of the distribution so far.

Gov. Gretchen Whitmer, for her part, announced she’s now asked the feds for permission to directly purchase up to 100,000 doses. She said her letter to the feds asking for more vaccines to be released hasn’t seen a response.

“We remain ready to accelerate distribution to get doses into arms,” Whitmer said she wrote in the letter. “Toward that end, I am writing to request permission for the state [Read More]