By JEREMY BELANGER
On Oct. 24, 2018, the Eliminating Kickbacks in Recovery Act (EKRA) was enacted. Broadly speaking, EKRA prohibits soliciting, receiving, paying, or offering “any remuneration (including any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind,” for referring or to induce a referral to a recovery home, clinical treatment facility, or laboratory, as those terms are defined in EKRA. While modeled after the federal Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b), EKRA applies more broadly to any public or private plan or contract providing medical benefits, items, or services. EKRA is a criminal statute enforced by the U.S. Attorney General. A violation of EKRA may result in a fine of $200,000, up to 10 years imprisonment, or both for each violation.

EKRA contains several statutory exceptions. Among them are:

[A] payment made by an employer to an employee or independent contractor (who has a bona fide employment or contractual relationship with such employer) for employment, if the employee’s payment is not determined by or does not vary by–
(A) the number of individuals referred to a particular recovery home, clinical treatment facility, or laboratory;
(B) the number of tests or procedures performed; or
(C) the amount billed to or received from, in part or [Read More]

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

MDHHS: Masks No Longer Needed At Schools, Indoors

Department of Health and Human Services officials announced that it is dropping the suggestion that masks be worn in schools or indoors as COVID-19 cases continue to fall.

The health department reported 4,271 new cases and 312 new deaths of COVID-19 over a two-day period this month. The two-day average of cases was 2,136, marking a decline in new cases across the state.

The report prompted the health department to revise guidance for wearing masks indoors to prevent the spread of the virus.

“This is good news for Michigan,” Gov. Gretchen Whitmer said. “While Michigan hasn’t had statewide mask policies since last June, this updated guidance will underscore that we are getting back to normal. Let’s keep working together to build on our momentum so we can keep our kids learning in person.”

The guidance would not be dropped for nursing homes, homeless shelters, jails, prisons and other health care facilities. Officials also still recommended masks for people in isolation or quarantine after exposure to COVID-19.

Health department officials stated that school administrators and other organizations should continue working with county health departments to determine local risk for school.

Michigan [Read More]

This story courtesy of MIRS, a Lansing-based news and information service.

The U.S. Supreme Court stopped the President Joe Biden administration’s vaccination-or-testing requirement on the nation’s largest employers.

The court allowed, however, the administration’s mandate for most health care workers at federally funded health care facilities to continue.

Chief Justice John G. Roberts Jr. and Justice Brett M. Kavanaugh were the only two justices in the majority on both orders while liberal Justices Stephen G. Breyer, Sonia Sotomayor and Elena Kagan would have allowed the workplace requirements to continue.

In the blistering dissent, the justices said, “When we are wise, we know not to displace the judgments of experts, acting within the sphere Congress marked out and under Presidential control, to deal with emergency conditions.

“Today we are not wise,” they wrote. “In the face of a still-raging pandemic, this Court tells the agency charged with protecting worker safety that it may not do so in all the workplaces needed. As disease and death continue to mount, this Court tells the agency that it cannot respond in the most effective way possible.”

In September, Biden signed an executive order mandating that federal employees would need to be vaccinated as a way to control COVID-19 spread, and that companies with 100 or more employees would be required to ensure their employees are vaccinated or test [Read More]

By LAUREN WEBER & PHIL GALEWITZ
The surge driven by the extremely infectious omicron variant helped push the South Florida hospital with 206 licensed beds to 250 patients. The rise in cases came as the hospital struggled with severe staff shortages while nurses and other caregivers were out with COVID.

The challenge is finding room to safely treat all the COVID patients while keeping staffers and the rest of patients safe, said Dr. Scott Ross, chief medical officer.

“It’s not a PPE issue,” he said, referring to personal protective equipment like masks, “nor an oxygen issue, nor a ventilator issue. It’s a volume issue and making sure we have enough beds and caregivers for patients.”

Nationally, COVID cases and hospitalizations are at their highest levels since the pandemic began. Yet, unlike previous COVID surges, large portions of the patients with COVID are coming to the hospital for other reasons. The infections are exacerbating some medical conditions and making it harder to reduce COVID’s spread within hospital walls, especially as patients show up at earlier, more infectious stages of the disease.

Although the omicron variant generally produces milder cases, adding the sheer number of these “incidental” hospitalizations to COVID-caused hospitalizations could be a tipping point for a health care system that is [Read More]

By PAUL NATINSKY
Many recent articles appearing in mainstream conservative newspapers and magazines have bemoaned the unfair persecution of people who choose not to be vaccinated. Many authors find vindication in the shifting nature of virus variants, COVID’s growing footprint as an endemic virus and the highly contagious but less severe omicron variant currently dominating headlines.

What has been left out of many such reports are a few salient facts and included have been some curious policy rationales.

Case in point—The nation’s 17 million healthcare workers must be vaccinated, but not its 80 million workers as the Supreme Court split the baby of the latest federal bill on the subject. As increasing numbers of providers miss work for illness, they are not afforded the very same protections shielding their patients.

Its also been widely reported that two-thirds of COVID hospitalization cases are comprised of the unvaxxed as Michigan hospitals make public appeals for judicious emergency room use and increased vaccinations—the same hospitals that have had to call in federal manpower help as cases surge and caregivers increasingly sicken.

It’s one thing for opinion mills—on the right and left—to take a righteous, one-sided view of almost every news story. It’s quite another for heretofore responsible newspapers and magazines—yes, there still [Read More]

By EWA MATUSZEWSKI

A recent Wall Street Journal article was entitled “The New Trend in Healthcare – Do it Yourself.” My immediate reaction was, “Is this what we’ve come to as community of healthcare professionals – encouraging a DIY approach to primary care?” But reading the article, which had an excellent balance of what patients should and should not be doing on their own, made me realize we’ve been leading up to this point for years. After all, isn’t the patient-centered medical home a partnership model between patient and physician where we’ve encouraged patients to take control of their health? Now, through remote medical monitoring devices, over the counter tests, and mobile apps we are much better positioned to do so. I think we have to look at this development as tremendous progress on the healthcare continuum and that care coordination may finally become reality.

Pivoting from DIY healthcare to its polar opposite, I want to say a few words about vaccine pop-up clinics. After hosting more than 200 clinics and administering more than 5,000 vaccines with first and second dose, booster shoots, or all three, my belief in the value of community-based care has never been stronger. The connections made, the health education information shared, and [Read More]

By STEPHEN SHAVER & CHRISTIAN IERACI
Wachler & Associates P.C.

When a Medicare provider or supplier receives an overpayment demand that they believe is in error, the provider or supplier has a strategic and practical choice to make: let Medicare recoup the money while the appeal is pending or follow certain procedural steps to stop recoupment during the appeal. Either option may have unforeseen consequences and a new court case may offer some tools to providers and supplier caught in this situation.

A Medicare overpayment demand letter kickstarts the lengthy process of appeals and collection attempts, which can be costly and span several years. A demand letter will explain the reason for and the amount of the overpayment, the payment and interest accrual timeline (the provider generally has 30 days before accrual of interest begins), and the provider’s right to appeal the determination. The demand letter will also give the provider options for repayment, which include the immediate payment of the overpayment or recoupment. Recoupment is a process where the applicable Medicare Administrative Contractor (MAC) will recover the overpayment amount by withholding future Medicare payments until the full overpayment amount is recovered.

If the provider files their appeal within a certain timeframe, usually 30 days, it can generally [Read More]

By CHRISTOPHER J. RYAN & GREGORY W. MOORE
Since last year, certain providers (e.g., anesthesiologists, radiologists, surgeons, etc.) in Michigan have had to navigate Michigan’s Surprise Medical Billing Law (Michigan Act). Starting Jan. 1, 2022, those same providers have also had to comply with the Federal No Surprises Act (Federal Act). Generally, both statutes prevent nonparticipating providers from balance billing patients when the patient’s insurance company pays less than the nonparticipating provider’s usual and customary charge. The Federal Act defines “nonparticipating providers” as those who do not have a contractual relationship with a plan/insurance company.

Although the two statutes largely apply to the same providers, those providers need to pay attention to which law applies and take steps to carefully abide by the rate setting process unique to each. Generally speaking, both laws apply to situations where the patient is not able to control whether their treatment team consists of participating or nonparticipating providers.

Michigan’s Surprise Medical Billing Law

The Michigan Act typically applies to three types of treatment rendered by nonparticipating providers:

(1) Treatment of all emergency patients;
(2) Services to non-emergency patients in participating hospitals where the patient does not have the opportunity to choose a participating provider (or the patient has not been provided with prior disclosure); and
(3) [Read More]

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

COVID-19 Surge Likely To Peak In Late Jan.-Early Feb.

The ongoing COVID-19 surge isn’t likely to reach its peak until the end of January or early February, according to coronavirus scenario hubs viewed by Michigan health officials.

Amongst the most cynical predictions for Michigan, COVID-19 hospitalizations could peak at 8,000 – more than a 90% increase from when the state broke the hospitalization record with 4,191 in late November of 2021.

Slide from the Michigan Department of Health and Human Services during Jan. 11 media briefing.

While an optimistic forecast shows hospitalizations not experiencing much of an increase – similar to where the state is now – Dr. Natasha Bagdasarian, the state’s chief medical executive, said, “We don’t think that is likely to be reflective of our next few weeks here in Michigan.”

“These are ensemble models utilizing information and scenarios put together from top academic institutions around the country, funded by the (Centers for Disease Control and Prevention (CDC) and very similar to CDC models…they’re showing that we will likely peak between the end of January to early February, and then after that things will start coming down,” Bagdasarian said.

At this morning’s media briefing, Bagdasarian [Read More]

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

Schools Should Mandate Mask Wearing When Classes Resume, Doctor Says

Schools should make mask wearing mandatory for students when they return to the classroom next month, Dr. Matthew Sims, director of Infection Prevention Research for Beaumont Health, said Aug. 10 in an online press conference.
“It’s just a danger that there is no reason to take the risk of making this optional,” Sims said.

He was speaking during an online press conference hosted by Beaumont Health.

Dr. Sandy Patel, pediatrician at Beaumont, said the hospital system has been admitting two to three COVID-positive pediatric patients each week for the past few months. Likewise, the system is seeing one to two mothers each week who are testing positive for COVID while preparing to deliver a newborn.

Children under 12 currently are not eligible for COVID vaccinations, they noted. Sims was asked if schools should mandate mask wearing.

“I really believe they should. We have this entire population of people who cannot be protected by the vaccine and they are going to make masking optional in a place where they can’t keep social distancing? Kids, as you know, are much more likely to hug and touch, get together at [Read More]

By LAREN WEBER
The day after Missouri Gov. Mike Parson finished his bicentennial bus tour to drum up tourism to the state in mid-July, Chicago issued a travel advisory warning about visiting Missouri.

Earlier this summer, as covid-19 case counts began to tick up when the highly transmissible delta variant took hold in the state, the Republican-majority legislature successfully enacted laws limiting public health powers and absolving businesses from covid legal exposure.

The state health officer post has sat vacant since Dr. Randall Williams resigned suddenly in late April — leaving Missouri without a permanent leader as the covid numbers grew. And Brian Steele, a mayor in the Springfield area, which is at the epicenter of swelling cases, faces a recall vote for his masking mandate that ended in April.

Hospitals in southwestern Missouri are overflowing. As of July 19, Centers for Disease Control and Prevention data show Missouri is worst in the nation for covid case rates over the past week, and in the bottom 15 states for vaccinations against the potentially deadly virus. Though cases are not even half of what they were during the winter spike, they continue to rise rapidly, sending a warning to other states with low vaccination rates about the havoc the coronavirus’s [Read More]

By ELISABETH ROSENTHAL
The drugmaker Pfizer recently announced that vaccinated people are likely to need a booster shot to be effectively protected against new variants of covid-19 and that the company would apply for Food and Drug Administration emergency use authorization for the shot. Top government health officials immediately and emphatically announced that the booster isn’t needed right now — and held firm to that position even after Pfizer’s top scientist made his case and shared preliminary data with them last week.

This has led to confusion. Should the nearly 60% of adult Americans who have been fully vaccinated seek out a booster or not? Is the protection that has allowed them to see loved ones and go out to dinner fading?

Ultimately, the question of whether a booster is needed is unlikely to determine the FDA’s decision. If recent history is predictive, booster shots will be here before long. That’s because of the outdated, 60-year-old basic standard the FDA uses to authorize medicines for sale: Is a new drug “safe and effective”?

The FDA, using that standard, will very likely have to authorize Pfizer’s booster for emergency use, as it did the company’s prior covid shot. The booster is likely to be safe — hundreds of millions have [Read More]

By EWA MATUSZEWSKI
I’m keeping with my community theme for this column, but this time, I’m taking it to the streets. After years of being a wish-list item, our organization is set to acquire a refurbished mobile clinic, thanks to generous grant assistance from Blue Cross Blue Shield of Michigan.

Mobile health clinics are not a new concept, and there are thousands of them in operation, but I suspect their value was somewhat diminished amid a decade of healthcare news on emerging medical technology, mega health system mergers and Wall Street takeovers of primary care. But again, we see the pandemic forcing us to reconsider how we deliver care, especially to the most vulnerable. Mobile clinics go to the heart of communities that are frequently shut off from convenient and accessible care. They also serve as a direct response to addressing the social determinants of health (SDOH). It was our organization’s immersion into SDOH issues that first piqued my interest in the mobile clinic; it was COVID-19 and the need to vaccinate the largest number of the population as we can, that moved it to the top of the list. (As an aside, I want to thank Dr. Richard Bryce, an osteopathic physician who is the Chief [Read More]

By STEPHEN SHAVER & DANIEL AYYASH
A Group Purchasing Organization (GPO) is a common structure in the healthcare industry. However, running a GPO in compliance with the Anti-Kickback Statute (AKS) involves a complex analysis of two distinct safe harbors under the AKS. A GPO is a negotiating agent that allows its members to leverage their combined buying power to obtain more favorable pricing and terms. Rather than each member negotiating with a given vendor independently, the GPO negotiates and maintains a master purchase agreement with the vendor on behalf of its members which allows the members to make purchases under the master agreement with better terms than the member could negotiate itself. A GPO is similar to other types of buying groups, but is a term of art in the realm of healthcare compliance. At its simplest, the members pay the vendor the discounted price negotiated by the GPO, the vendor pays the GPO an administrative fee, and no funds change hands between the GPO and its members.

However, both the administrative fees paid by the vendor to the GPO and the discounts offered to the members potentially implicate the AKS. The AKS prohibits remuneration in return for referrals or for purchasing, leasing, ordering, or arranging [Read More]

By KATHLEEN CAMPBELL WALKER
We owe a tremendous debt to the healthcare worker battalion, who fought, and continues to fight, to save lives globally during this pandemic. It is important to consider that while the COVID-19 pandemic has underscored the severe healthcare worker shortages globally, we are now facing an increasing percentage of burnout departures in the industry. For example, a survey conducted by the International Council of Nurses (ICN) found that, “20 percent of national nurse associations reported an increased rate of nurses leaving the profession in 2020.” The ICN estimated that 13 million nurses could be needed to fill global shortages and replace nurses who leave the profession in the next few years. In a May 11, 2021 article published regarding the global shortage of nurses, the Clinton Health Access Initiative noted that while investing in training capacity is critical for a stronger global workforce, government planning for health emergencies must support and protect health workers while also increasing capacity and strategic placement.

So what failed during the pandemic in the facilitation of entry, visa issuance, and/or work authorization of critical foreign healthcare workers? Below is a list of examples for consideration:

1. For those healthcare workers outside of the U.S. requiring visas, there was [Read More]