Home2019-01-17T20:58:16-05:00

On Point With POs: Visioning The Future: It’s Time To Address Public Health Crises

By EWA MATUSZEWSKI
My mind keeps going to the word community when I reflect on the past year and a half. Initially, as the pandemic broke out, many of us were in a community of one, two or three, confined to our homes for all but the most essential trips. Then, for those in the healthcare community, there was a call to action, an immediate need to get our own acts together from a public health perspective to treat those afflicted with COVID-19, those who had pressing medical needs not related to the pandemic, and others whose emotional well-being was overwhelmed by the stress the virus added to already fragile lives. Ultimately, we figured it out; with virtual care, drive- through clinics, and in-person care, as necessary. (Indulge me here for a shout out to our organization’s Master of Public Health team members, who provided much of the direction for the pop-up clinics.)

The pandemic is not over in the United States, but it’s easing. Perhaps we can all take a bit of credit for that, whatever our roles – even if just to follow the recommended health guidelines out of concern for ourselves, our families, and our neighbors. For most, especially as we head into summer, [Read More]

COMPLIANCE CORNER: Disciplinary Action Against Providers Decreases During Pandemic

By JESSE A. MARKOS, ESQ.
Wachler & Associates, P.C

Disciplinary actions against healthcare providers have decreased significantly during the past year according to figures provided by the U.S. Department of Health and Human Services. This development may be evidence of a general easing of heavy-handed enforcement in state licensing disciplinary proceedings and hospital professional review actions based on technical violations during the Covid-19 pandemic and the result of an increased appreciation for providers serving on the front lines of the crises.

Prior to the outbreak of COVID-19, the United States was already facing a shortage of healthcare providers. A report by the Association of American Medical Colleges projected a shortage of between 46,900 and 121,900 physicians by 2032. Moreover, the healthcare system will also likely face a shortage of tens of thousands, if not hundreds of thousands, of other healthcare providers such as nurse practitioners and registered nurses.

The outbreak of COVID-19 has stretched the staffing resources of the healthcare system to unprecedented levels. Adding to the demand for already scarce providers, hospitals have scrambled to find additional frontline workers like emergency medicine physicians and nurses. During this period of mounting shortage, disciplinary actions against physicians have dropped significantly according to figures published by the U.S. Department of [Read More]

LEGAL LEANINGS: Update to the ALJ Backlog for Medicare Appeals

By EMMA TRIVAX
Dickinson Wright

For the majority of the 2010s, the Medicare appeals process had become extremely backlogged. The Office of Medicare Hearings and Appeals (“OMHA”) is in charge of administering the Administrative Law Judge (“ALJ”) hearing program for appeals arising from Medicare claims and disputes. Pursuant to 42 U.S.C. § 1395ff(d)(1)(A), an ALJ is statutorily required to provide an appellant a hearing within ninety (90) days of the hearing being requested. However, due to a large backlog of appeals, appellants would end up waiting three (3) to five (5) years for that hearing. This caused much concern because disputed payments were being recouped from providers and suppliers during that waiting period, yet they were being deprived of defending themselves in a timely matter. Having Medicare payments recouped for 90 days is often not detrimental for provider and supplier businesses. However, being recouped for 3 to 5 years can have a significantly detrimental impact to provider and supplier businesses.

Due to the backlog, a slew of litigation ensued. The most common claim was one for a temporary restraining order (“TRO”) and preliminary injunction against the Department of Health and Human Services (“HHS”), ordering them to stay recoupments until the ALJ hearing occurred. Providers and suppliers would [Read More]

LANSING LINES

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

Providers For Injured Auto Wreck Victims Shutting Down; Berman Drops Bill
The president of a West Michigan-based home health care provider said he’s personally aware of nine Michigan facilities that will close their doors for good as of July 2 in reaction to the 2019 auto insurance law designed to cut rates for drivers.

Frantic families are calling Kris Skogen, president of AdvisaCare, and his team about availability at his facilities for their catastrophically injured loved one after they received a 30-day notice from their current provider that they’ll be ending service.

“It’s a real thing. It’s a mess out here,” he said.

The comments come a day after Rep. Ryan Berman (R-Commerce Twp.) introduced HB 4992 to change reimbursement rates for providers based on regional market averages as calculated by the Michigan Department of Insurance and Financial Services.

The current law mandates providers charge auto insurers 55% of what they’re currently charging for care for those injured in auto insurance. The other option is to charge 200% of what Medicare would charge.

The problem, Skogen said, is Medicare doesn’t cover hourly home care, a service provided in Michigan due to the coverage through its unique lifetime [Read More]

‘Comprehensive’ Tracker Shows MI At 54% Vaccinated

It turns out Michigan is a lot closer to hitting the first milestone of Gov. Gretchen Whitmer’s Vacc to Normal plan than what the state data had been indicating.

The state released a Vacc to Normal tracker tonight that shows 54% of Michiganders have initiated their vaccinations. When the state hits 55%, Whitmer said in-person work would again be allowed for all sectors of business after two weeks have passed.

The state said its usual dashboard, which as of May 7 shows 51.5% had begun vaccinations, “slightly undercounts the true number of doses” given to Michigan residents.

The new tracker includes Michigan residents who were vaccinated out-of-state as well as in-state to get at a more “comprehensive” look at the state’s inoculation rate.

The newest tracker, based on the Centers for Disease Control and Prevention data, includes Michiganders vaccinated by providers not currently reporting to the state’s usual dashboard, such as Veterans Affairs, Department of Defense, Bureau of Prisons, and most out-of-state providers.

The inclusion of out-of-state data in the Vacc to Normal campaign comes after several GOP lawmakers representing border counties asked the governor to do just that.

Whitmer had predicted April 29 the state could reach the 55% mark by May 7. At the time, the percentage of those [Read More]

COVID Testing Has Become A Financial Windfall

By JAY HANCOCK & HANNAH NORMAN
Pamela Valfer needed multiple COVID tests after repeatedly visiting the hospital last fall to see her mother, who was being treated for cancer. Beds there were filling with COVID patients. Valfer heard the tests would be free.

So, she was surprised when the testing company billed her insurer $250 for each swab. She feared she might receive a bill herself. And that amount is toward the low end of what some hospitals and doctors have collected.

Hospitals are charging up to $650 for a simple, molecular COVID test that costs $50 or less to run, according to Medicare claims analyzed for KHN by Hospital Pricing Specialists. Charges by large health systems range from $20 to $1,419 per test, a new national survey by KFF shows. And some free-standing emergency rooms are charging more than $1,000 per test.

Authorities were saying “get tested, no one’s going to be charged, and it turns out that’s not true,” said Valfer, a professor of visual arts who lives in Pasadena, California. “Now on the back end it’s being passed onto the consumer” through high charges to insurers, she said. The insurance company passes on its higher costs to consumers in higher premiums.

As the pandemic enters its second [Read More]

ON POINT WITH POs: Vaccination Pop-up Clinics Bring Community-Sensitive COVID Response

By EWA MATUSZEWSKI
Many readers know I’m an avowed foodie. Pre-COVID, I was always game to try the newest restaurant and have long been a devoted fan of Detroit’s eclectic food scene. Tell me about a pop-up restaurant and I’m first in line. The latter concept has appropriately grown during the pandemic, as leading chefs seek safe yet fun ways to feed and entertain their followers–while eking out a living for themselves and their workers in the process.

So for me, the idea of pop-up vaccination clinics may have been preordained. As a CDC approved vaccination distributor, our team, either directly or through partner relationships, has vaccinated 3,000 people as of this writing with either the Moderna, Pfizer or J&J vaccine. While we started out (and continue) vaccinating in traditional settings, as well as drive throughs in physician office parking lots, we quickly branched out to pop-up clinics that targeted the need to increase vaccination rates among Greater Detroit’s Asian community. Meeting at cultural centers and houses of worship, we have conducted pop-up clinics for the Filipino, Korean, Chinese, Hmong, Thai and Vietnamese communities.

As a Polish immigrant who came to the United States as an infant with my parents, I am bi-lingual and bi-cultural and have always [Read More]

COMPLIANCE CORNER: Recent Michigan Law Bars Surprise Medical Billing

By KAITLIN A. NUCCI, ESQ
On Oct. 22, 2020, the Michigan Legislature enacted Enrolled House Bills 4459 and 4460 to protect consumers from surprise medical billing. The legislation creates limitations on out-of-network provider payments, requires providers to afford certain disclosures to patients regarding the costs of services and, overall, protects patients from excessive balance medical billing. Balance billing occurs when a healthcare provider first submits a claim to a patient’s insurer, and subsequently bills the patient for the outstanding balance that the patient’s insurance company did not cover.

To prevent surprise balance billing, House Bill 4460, now Public Act No. 235, requires out-of-network providers administering care to non-emergency patients to make the following disclosures to the patient:

• That the patient’s health insurance may not cover all services the out-of-network provider is scheduled to provide;
• A good faith estimated cost of services to be provided to the patient; and
• That the patient may ask the services to be performed by an in-network provider.

These disclosures must be provided in a written format with at least 12-point font. MCL § 333.24509 provides sample language that providers may use for their disclosures. An out-of-network provider must also obtain the patient’s signature on its disclosure form. This disclosure must be provided [Read More]

LEGAL LEANINGS: DOJ Increases Focus On COVID 19 Fraud

By ANDREW SPARKS
In March 2020, Congress passed the Coronavirus Aid, Relief and Economic Security (CARES) Act, which provided $2.2 trillion in economic relief. The Act was designed to quickly get money to millions of Americans suffering from the pandemic. Unfortunately, this relief provided ample opportunity for fraud. As the COVID pandemic begins to ease, the Department of Justice’s efforts to prosecute this COVID-19 fraud is intensifying. To date, the Department has charged nearly 500 defendants with criminal offenses for attempted fraud in excess of $550 million. The focus of the prosecutions have been schemes targeting the Paycheck Protection Program, Economic Injury Disaster Loan program, Unemployment Insurance programs, and relief funds for health care providers.

Anticipating that fraudsters would attempt to profit from the pandemic, the Department created multiple initiatives to combat theft. According to Attorney General Merrick Garland, “[t]he Department of Justice has lead an historic enforcement initiative to detect and disrupt COVID-19 related fraud.” This initiative includes, among other law enforcement techniques, using data analysis capabilities to identify potential areas of fraud. To date, the Department has focused on a handful of key programs:

• Paycheck Protection Program. Over 120 people have been charged nationwide for PPP fraud, including business owners who have inflated payroll [Read More]

In My Opinion: Social Justice

By ALLAN DOBZYNIAK, MD
At a recent meeting of the Wayne County Medical Society Editorial Board it was mentioned that today’s Wayne State University medical students have a greater interest in the idea of “social justice.” I initially assumed this was a positive change for the profession. But later I became unsure why this might be the case. Without a clear definition of “social justice” it is impossible to conclude whether this should be understood as something new, something positive or even possibly negative. This then raises the questions of how this unclear and undefined concept might apply to healthcare and its present and future physicians. Further, if “social justice” has not existed the question is why. Are we left then to conclude that “social injustice” is what has been culturally dominant?

The concept of justice has been credibly debated for eons by philosophers and thinkers such as Aristotle, Plato, Thomas Aquinas, and David Hume as it might relate to politics, economics and religion. To conclude in a general sense, a biblical sense and specifically as it relates to our Constitutional Republic, justice is equal treatment for all individuals by law. Clearly, “social justice” is not the same as “justice.” If this was the case, the term [Read More]

LANSING LINES

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

Shirkey Shows His Work On COVID Immunity Calculations
Senate Majority Leader Mike Shirkey (R-Clarklake) explained his calculation that Michigan residents are already at 70% immunity to COVID, if you’re counting “broad-based community immunity” rather than just shots in arms, in an interview with WRFH radio this week.

The state reports that more than 660,000 Michiganders have had the disease and recovered.

“We are greater than 50% of eligible adults (who) have at least received one shot and then — based on studies from Yale, Stanford, Columbia, Harvard, they all have done their own independent studies suggesting that states’ numbers who have recorded cases are anywhere from two to six times underreported, ” Shirkey told Scot Bertram of Radio Free Hillsdale May 6.

Shirkey continued: “So let’s just use the multiple of two and half. Michigan has over two million people who have had the virus and recovered. They have developed their own natural immunity so it seems to me it would be a sum, the addition of those have received shots plus those who have recovered that have naturally acquired immunity. That number in Michigan is already at 70%.”

A University of Texas study also concluded [Read More]

12 Months of Trauma: More Than 3,600 US Health Workers Died in COVID’s First Year

By JANE SPENCER & CHRISTINA JEWETT
More than 3,600 U.S. healthcare workers perished in the first year of the pandemic, according to “Lost on the Frontline,” a 12-month investigation by The Guardian and KHN to track such deaths.

Lost on the Frontline is the most complete accounting of U.S. healthcare worker deaths. The federal government has not comprehensively tracked this data. But calls are mounting for the Biden administration to undertake a count as the KHN/Guardian project comes to a close.

The project, which tracked who died and why, provides a window into the workings — and failings — of the U.S. health system during the COVID-19 pandemic. One key finding: Two-thirds of deceased healthcare workers for whom the project has data identified as people of color, revealing the deep inequities tied to race, ethnicity and economic status in America’s healthcare workforce. Lower-paid workers who handled everyday patient care, including nurses, support staff and nursing home employees, were far more likely to die in the pandemic than physicians were.

The yearlong series of investigative reports found that many of these deaths could have been prevented. Widespread shortages of masks and other personal protective gear, a lack of COVID testing, weak contact tracing, inconsistent mask guidance by politicians, missteps by [Read More]

Analysis: More COVID Outbreaks Have Followed Easing Of COVID Restrictions

Gov. Gretchen Whitmer’s administration has eased numerous COVID-related restrictions on business sectors and other activities the past two months, and in many cases, the outbreaks for the corresponding sector increased since then, according to a MIRS review of weekly outbreak data reported to the state.
The outbreak categories that encompass restaurants and bars, some youth sports, retail, exercise facilities, indoor community exposures and social gatherings have all increased by various amounts since restrictions eased on those respective industries or functions.

That doesn’t include outbreaks tied to K-12 school settings, which were given the goal but not the mandate by Whitmer to resume some in-person learning by March 1. Almost all districts in the state were expected to begin some in-person instruction by that date, and school outbreaks have been steadily increasing since then.

The COVID outbreak data published by the state each week come with a number of caveats, including that the data may not capture every case outbreak in a certain setting.

Also, outbreaks associated with certain places may not mean the virus was transmitted there directly. For instance, school groups have insisted COVID outbreaks at schools aren’t happening in the classrooms directly.

It’s been established that COVID data trends in Michigan are on the rise in general, as [Read More]

IN OUR VIEW: We’re All COVID Long Haulers (and maybe that’s okay)

By PAUL NATINSKY
Not long ago, it seemed the solution to the COVID-19 pandemic was simple in concept, but daunting in execution. Wear masks, socially distance and wait for a vaccine that could be years away.

Now, with very effective vaccines widely available, we struggle with variants from across the globe that are more contagious than the original bug. We see unanticipated complications in young people, and we see long-lasting aftereffects among adults who have survived the virus’ initial ravages—the long haulers.

As this pandemic’s onion-like nature leaves increasing layers of questions in place of solid core answers, one thing is clear. Our lives have forever changed.

Much like universal precautions in the wake of the AIDS/HIV threat of the 1980s and ‘90s, and the unceasing travel and security precautions in place since the terrorist attacks of 2001, it appears that COVID-19 will have lasting effects on how we congregate, eat, greet, travel and socialize.

Likely gone forever are the handshake, the casual greeting hug-and-kiss, the incredible energy of the large close crowds at ballgames, concerts, weddings and other celebrations.

Likely here to stay are social distancing, ubiquitous hand sanitizer, tests and temperature checks, plexiglass everywhere.

We’ll get used to it. Many of us already have. We’ll vaccinate, separate and hibernate when [Read More]

ON POINT WITH POs: Reactive Disaster Planning For Physician Practices? Follow These Tips

By EWA MATUSZEWSKI
Did you catch the oxymoron in the headline? Reactive disaster planning – or reactive planning of any sort – of course is not planning. But writing this so close to what we can only hope was and is the worst disaster of our lifetime, we mut be honest and admit that our responses to the myriad disasters wrought by the pandemic were rarely planned. Some of us may have been quicker to act than others, more willing to admit that indeed a crisis of heretofore unknown proportions was upon us. But still, we reacted. We had not adequately planned.

In Michigan, we were at the epicenter of our nation’s outbreak, and primary care practices in particular – with their normally busy offices of over-scheduled patient visits – were in a tizzy as the degree of the severity of this crisis came to be understood. While most primary care physicians and their practice teams did not have a basic emergency preparedness plan in place there is no excuse not to have create one now for future disasters.

First, understand that disasters take many forms beyond public health. They can be an electric grid failure, or weather-related, such as a tornado or a dam break (like the [Read More]

COMPLIANCE CORNER: OIG Announces Reviews Of Telehealth Services Provided During COVID-19 Emergency

By DUSTIN WACHLER, ESQ.
Prior to the COVID-19 public health emergency, Medicare coverage of telehealth was restricted to a limited set of services provided via interactive audio and video telecommunications systems between a healthcare provider at a “distant site” and a beneficiary at an “originating site” as defined by Medicare. In order to qualify as an “originating site,” the beneficiary was required to be in a physician office, healthcare facility, or other authorized site located in either a county outside a Metropolitan Statistical Area (MSA) or a rural Health Professional Shortage Area (HPSA) in a rural census tract. In addition to Medicare requirements, telehealth arrangements must also comply with state telemedicine rules, physician licensure laws, and other state laws based on the specifics of a given arrangement (e.g., e-prescribing).

In response to the COVID-19 public health emergency, the Centers for Medicare & Medicaid Services (CMS) significantly expanded access to telehealth services. Specifically, Medicare waived the location requirements to allow beneficiaries to receive care via telemedicine in any location, including at home. Medicare providers may now treat both new and established patients via telemedicine. CMS also drastically increased the types of services that may be provided via telemedicine, including emergency department visits, initial nursing facility and discharge visits, [Read More]

LEGAL LEANINGS: IRS Attack On ‘Zero Out’ In Recent Tax Court Cases

By RALPH Z. LEVY JR.
Taxpayer losses in two recent Tax Court cases serve as reminders that physician and other incorporated medical practice groups should take care in the “zero out” approach to the payment of compensation to the group’s owners and that success in this area may depend on whether the practice is organized as a “C” corporation or has elected to be taxed as an “S” corporation and if the practice group is owned by one or more professionals.

Regardless of whether the practice group is organized under local law as a professional corporation (PC) or a professional association (PA), is taxed as a “C” corporation or as an “S” corporation for federal tax purposes, the entity typically compensates its physicians or other licensed professional shareholders by payment of base compensation that constitutes an advance estimate of a pre-determined percentage of budgeted annual operating profits.

Once actual year-end operating results are determined (or reasonably estimated), prior to its taxable year–end, the PC or PA pays a bonus to members of the practice group based on its distributable cash using the formula adopted by the practice group members to pay annual compensation to and among its professionals. These bonuses “take into account” the amounts previously paid to [Read More]

IN MY VIEW: Another Misunderstanding

By ALLAN DOBZYNIAK, MD
So many of the organizations alleging to represent a consensus of individual physicians simply do not. The narrative that equates all physicians with the organizations that claim to represent them is just wrong. Unfortunately, this narrative has become repetitive and increasingly common.

Consider that the American Medical Association has only a membership of around 12 percent of practicing physicians; hence, it does not represent the majority. It has unquestionably become increasingly political in its views. The organization and leadership have moved to the progressive left. Priorities such as “systemic racism,” “social justice” and “equity” have been engaged to clarify its organizational identity of “wokeness.” It has recently dismissed one of its founders with an accusation of past racism. Does anybody want to be judged only by the worst things they have done? I certainly hope that the good things I have done are taken into account when I die. By digging deeply enough into the history of anything or anyone you can always find something to pretend to be upset about, if that is your objective. Dressing up so-called policy to perpetuate an organization’s political and perceived cultural status is self-serving. Doing it dressed in the lofty robes of “morality” is pathetically transparent. [Read More]

Lansing Lines

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

Mental Health Crisis Management Program Brought To Teachers Under Bill

The Michigan Department of Education would need to create a professional development course on mental health crisis management and rapid response for educators under Sen. Sylvia Santana’s (D-Detroit) latest legislation.

Already, the MDE has advocated for the doubling—at a minimum—of funding of intermediate school districts (ISDs) for distributing mental health amenities to students. Under Santana’s SB 0321, the department would join forces with the Michigan Department of Health and Human Services in fostering a program that equips teachers for mental health challenges.

“The mental and emotional toll of this stressful time will stay with our children for the rest of their lives, and it will have a profound effect on their growth,” Santana said in her press release on the bill. “If we want all students to reach their potential, we need to ensure they’re not just physically healthy, but mentally healthy, too.”

In a study led by Daniel Whitney, a postdoctoral fellow in the Department of Physical Medicine and Rehabilitation at the University of Michigan, 17.6 percent of Michigan children and adolescents have been diagnosed with either depression, anxiety or Attention Deficit Hyperactivity Disorder [Read More]

OUR VIEW: One Year Later, COVID Brings Chaos From Unexpected Corners

By PAUL NATINSKY
In early February 2020, the news stories and warnings began to appear about a virus in China emerging from a “wet market” in a city of 11 million whose name I’d never heard. My first thought was here we go again. Just like MERS or SARS—and seemingly every winter’s inevitable exaggerated blizzard forecast—I figured it was another alarmist health scare that would never reach American shores.

In mid-March, it became clear that this time it was real—the “coronavirus” had arrived, was spreading fast and was going to wreak havoc in our lives. Even at first and amid the confusion of mixed messages and unclear science, I suspected this disease was going to infect many and have long-term consequences.

As our school district struggled along with neighboring districts about whether to close schools, I applauded Gov. Gretchen Whitmer stepping up and taking the heat off of local school boards about whether or not to shut down. The locals were under pressure keep schools open, in no small part so that parents could go to work and hot meals continued for kids who needed them.

I saw the immediate wisdom of shutting down offices, restaurants, gyms, barbers—any business that created a virus-spreading risk. I saw the wisdom in [Read More]

House Health Policy Spotlights Drug Price Hikes

The rising cost of prescription medicine was the issue of the day before the House Health Policy Committee as it took up two bills March 4, one to bar so-called copay “accumulators” and a second to require drug makers to report price increases to the state.

HB 4353, sponsored by Rep. Bronna Kahle (R-Adrian), would require all copays to count toward an insured’s deductible and out-of-pocket costs. HB 4347, by Rep. Angela Witwer (D-Delta Twp.), would require manufacturers to report price increases to the Department of Insurance and Financial Services.

The bills are reintroductions of legislation considered last term.

Sarah Procario of the Hemophilia Foundation of Michigan told the committee many patients rely on copay assistance programs run through nonprofits or the drug manufacturers themselves in order to be able to afford their medicines.

“Unfortunately, . . . a growing insurance trend is jeopardizing the benefits of copay assistance,” Procario said. “Copay accumulator adjustment programs bar all copay assistance from counting toward patients’ out-of-pocket costs making it harder for them to access their life-saving and life-enhancing medications.”

Insurance companies don’t prohibit the use of copay assistance, she explained, “but when it runs out, typically a few months into the year, the patient will still be responsible for their full deductible [Read More]

Coronavirus Deranges Immune System In Complex, Deadly Ways

By LIZ SZABO
There’s a reason soldiers go through basic training before heading into combat: Without careful instruction, green recruits armed with powerful weapons could be as dangerous to one another as to the enemy.

The immune system works much the same way. Immune cells, which protect the body from infections, need to be “educated” to recognize bad guys — and to hold their fire around civilians.

In some covid patients, this education may be cut short. Scientists say unprepared immune cells appear to be responding to the coronavirus with a devastating release of chemicals, inflicting damage that may endure long after the threat has been eliminated.

“If you have a brand-new virus and the virus is winning, the immune system may go into an ‘all hands on deck’ response,” said Dr. Nina Luning Prak, co-author of a January study on covid and the immune system. “Things that are normally kept in close check are relaxed. The body may say, ‘Who cares? Give me all you’ve got.’”

While all viruses find ways to evade the body’s defenses, a growing field of research suggests that the coronavirus unhinges the immune system more profoundly than previously realized.

Some covid survivors have developed serious autoimmune diseases, which occur when an overactive immune system attacks [Read More]

ON POINT WITH POs: The Ides of March Revisited: A Pandemic Look-back

By EWA MATUSZEWSKI
“If they close a door, go through the window. If the window is closed, check the chimney.” When faced with an obstacle, these were the words of wisdom from my mother, a native of Poland who spent time in a displaced persons’ camp after World War II. While I haven’t gone down the chimney yet, I’ve certainly gone through many windows in the past year. So now, a look back.

Mid-March 2020 adds another meaning to the famed Ides of March, which alternatively refers to the assassination of Julius Caesar, a lunar celebration in ancient history marking a new year, or simply a very bad omen – which would fittingly describe a looming pandemic. One year in, it is still with us, although it appears we have tamed the beast to a significant degree, thanks to multiple effective COVID-19 vaccination options. My mind wanders down various paths when I think of all that I have learned or observed, yet several words or phrases capture the essence of my observations: leadership, partnerships, trust, bureaucracy, and patient advocacy. I highlight key take-aways:

-Leadership: Its definition is broad and varied, but true leaders didn’t wait to be asked; they took charge. Whereas typical times may have presented bureaucratic [Read More]

COMPLIANCE CORNER: COVID-19 Testing Insurance Requirements Gain Clarity

By STEPHEN SHAVER
In an effort to increase the availability of COVID-19 testing and decrease the cost of testing to individual consumers, Congress required group health plans and commercial health insurers to provide coverage for COVID-19 testing with no cost-sharing, prior authorization, or other medical management requirements. However, months of ambiguous guidance have opened the door for inconsistent implementation and left providers, especially the clinical laboratories doing the testing, in a precarious position.

Congress’s efforts began with the Families First Coronavirus Relief Act (FFRCA), enacted on March 18, 2020. The FFCRA required group health plans and commercial insurers to provide coverage of FDA-approved tests “for the detection of SARS–CoV–2 or the diagnosis of the virus that causes COVID–19,” as well as items and services relating to a visit that results in such a test, at no cost to the beneficiary. Congress built on this requirement in the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), enacted on March 27, 2020. The CARES Act expanded the types of approved tests that were covered by the FFCRA and set the reimbursement rate for COVID-19 testing by out-of-network laboratories. Under the CARES Act, an insurer must reimburse an in-network laboratory at the negotiated rate that existed before the [Read More]

LEGAL LEANINGS: FDA Authorization of COVID Vaccines – What Does it Mean?

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 in the diagnosis, treatment or prevention of COVID. Last week, the FDA issued an EUA authorizing the use of a third vaccine for the prevention of COVID. There are now 3 COVID vaccines available for use in the prevention of COVID in Americans over 18 years of age (note that the Moderna and Janssen vaccines are authorized for individuals 18 and older, while the Pfizer vaccine is authorized for individuals 16 and older).

Americans have experienced different stages of “pandemic-life” over the past year, and are currently experiencing differing stages of opportunity in relation to the [Read More]

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