Texas Medical Association Sues Feds Over Surprise Billing

 The Texas Medical Association (TMA) is challenging a federal law designed to shield patients from surprise medical bills, arguing in a new lawsuit that regulators have stacked the deck against healthcare providers in their implementation of the No Surprises Act.

Essentially, TMA takes issue with the arbitration process for settling out-of-network bills, arguing that the regulation favors insurers over providers.

"This is a fight about money," said David Hyman, MD, JD, a professor of health law and policy at the Georgetown University Law Center who researches the regulation and financing of healthcare. "The providers who could use out-of-network billing strategies to get sizable additional amounts are not very happy that the legislation plus the regulation is going to clip their ability to do that far more severely than they thought it would."

The No Surprises Act, which is set to go into effect in January 2022, seeks to relieve the burden of unexpected bills on patients. Surprise billing can happen if a patient ends up with an out-of-network provider at an in-network hospital. The provider may receive only a portion of what they bill the insurance, and may pass the remainder to the patient.

Hyman said surprise billing (also called "balance billing") arose because physicians who provide one-time services learned they could be better off remaining out-of-network. "The patient is never going to go back to this provider," he said. "There's a big incentive to exploit your disparities in bargaining power, like [sending] a huge bill and balance billing for it."

In 2016, as many as 42.8% of emergency department visits resulted in an out-of-network bill, and these have gotten more costly over time. According to one study, emergency physicians recovered a higher portion of what they charged for services for likely surprise bills compared to other cases. The Kaiser Family Foundation showed that two-thirds of Americans reported being worried about unexpected medical bills.

Under the No Surprises Act, patients would only pay the amount they would have for an in-network copay or deductible. Then, the provider and insurer must agree on the rest of the cost. If they can't agree on an amount, they can engage in arbitration, where a third-party -- an "independent dispute resolution" or IDR entity -- steps in to resolve the dispute for them. Each side must propose an amount, and the arbitrator then determines which of the two is the fairest for the insurer to pay the out-of-network provider.

But TMA takes issue with the HHS rules for the IDR, which they say are different from what Congress intended when they passed the law. While TMA's president, E. Linda Villarreal, MD, said in a press release that the organization "supports the patient protection intent of the No Surprises Act," their lawsuit argues the HHS interim final rule gives insurers an unfair advantage, which would have outsize consequences for Texas providers.

In particular, they point to using a "rebuttable presumption" of the Qualifying Payment Amount (QPA), or the insurance plan's median contracted rates, to determine payment. That is, arbitrators should presume first that the insurance plan's median in-network payment for a given medical service is appropriate.

In their lawsuit, TMA states that the law doesn't allow for regulatory agencies to dictate how arbitrators decide cases. They add that the rules "will unfairly skew IDR results in the payors' favor, granting them a windfall they were unable to obtain in the legislative process."

"This is a big change from the status quo, and it may be a financial loss to some practices," said Erin Duffy, PhD, a research scientist at the USC Schaeffer Center for Health Policy and Economics and a scholar with the USC-Brookings Schaeffer Initiative for Health Policy. "So I'm not surprised to see legal challenges."

Staff from the TMA's general counsel wrote in an email to Medpage Today, via a public relations representative, "TMA's request under the lawsuit is that the court strike the rebuttable presumption from the rule and to, instead, restore the fair, balanced dispute resolution process that Congress created."

TMA argues that the independent arbitrators should consider equally -- instead of prioritizing the median rate -- all factors that might influence the price of medical services. These include the level of training or expertise of the provider, the market share of the provider in the area, the "acuity" of the patient or how difficult it was to provide the service, the status of the facility that provided the service, and previous efforts made by the provider to enter into a network agreement.

Wrapped up in the lawsuit is a larger debate over the cost of healthcare, and who should determine the price tag. With balance billing or surprise bills, providers can, and are, paid more for a service than they would in-network, because the patient ends up covering the difference.

The new law, which removes the patient from the equation, leaves providers to battle it out with insurers or turn to arbitration. Using the QPA to establish the price marks "a substantial shift in the payment landscape for ancillary physicians and emergency medicine physicians," said Duffy.

Regulators argue that by emphasizing the QPA, out-of-network rates will become more predictable over time, which will ultimately discourage the use of the arbitration process. But TMA says the rules "undermine providers' ability to obtain adequate reimbursement for their services" at a time when they are "facing strained resources as they battle the virus."

The TMA also argues that emphasis on qualifying payment amounts "will make it harder for patients to access care by driving down reimbursement rates and encouraging insurance companies to continue narrowing their networks."

In other words, they argue that because out-of-network physicians might make less money, they'd leave the workforce (or fewer would enter it), leaving fewer physicians for patients to access. "I have not seen quantitative evidence of surprise billing laws leading to physician shortage," said Duffy, "but that is a common concern that is raised by medical associations."

In states that have implemented their own surprise billing legislation, like New York, regulatory guidance dictated that arbitrators prioritize not the QPA but the 80th percentile of charges, or the top end of what out-of-network providers would normally ask for. An arrangement like this might mean higher payment for emergency and ancillary physicians.

Lower payment for out-of-network providers is exactly what the TMA is worried about, says Hyman. In the case of California, for example, which passed a surprise billing law that sets reimbursement amounts based on insurer's average in-network rates, "there was downward pressure on payments," Hyman said. "But, you know, if your baseline is, 'I'm gouging you currently and I can't do it anymore,' that's exactly what you're trying to do, thank you very much."

https://www.medpagetoday.com/special-reports/exclusives/95406

Kids 5-11 Can Now Get Pfizer's COVID Vaccine

 Children ages 5-11 should be vaccinated against COVID-19 with the Pfizer/BioNTech vaccine, the CDC's Advisory Committee on Immunization Practices (ACIP) said on Tuesday.

ACIP voted 14-0 to recommend vaccinating this population with a two-dose regimen of 10 μg apiece, 21 days apart, citing the favorable benefit-risk association, the idea of restoring normalcy to children, and especially the extensive data presented by FDA and CDC staff.

"Today is a monumental day in the course of this pandemic and one that many of us will be very eager to see," said CDC Director Rochelle Walensky, MD, once again addressing the panel. She added that since the first vaccines were authorized for ages 16 and up, the question has been when protection might be expanded to younger children.

This is a "recommendation likely to have tremendous impact," Walensky said. She said she was eager to see how committee members "interpret what we know and acknowledge areas of uncertainty."

Walensky also said that 745 children have died of COVID during the pandemic, including 94 children ages 5-11, and over 2,300 children in this population have been diagnosed with multi-system inflammatory syndrome (MIS-C).

Many committee members spoke as parents and grandparents and explained how they have vaccinated their children and grandchildren. Consumer representative Veronica McNally, JD, got a bit choked up when talking about how she would vaccinate her child after this recommendation, and would do so to prevent "the 95th death" in a child.

In an unusual move, several liaison representatives from the American Academy of Pediatrics (AAP), the American Academy of Family Physicians (AAFP), National Association of Pediatric Nurse Practitioners (NAPNAP), and the Pediatric Infectious Diseases Society (PIDS) read statements in support of vaccination for this age group prior to the ACIP vote.

Even normally skeptical ACIP members were on the side of the vaccine. Sarah Long, MD, of Drexel University in Philadelphia, who previously expressed hesitation about risk of vaccine-associated myocarditis in other age groups, said she was "very supportive" of this recommendation, given the large amount of data presented by the FDA and manufacturer, as well as because of the lower dose.

"We have one more vaccine that saves the lives of children and we should be very confident to employ it to the maximum to do what it was meant to do without significant concerns of serious adverse events," she said.

All eyes were on one rare side effect, vaccine-associated myocarditis. CDC staff presented data on vaccine-associated myocarditis showing that it occurs less frequently in younger children, and no cases of myocarditis were observed within the clinical trial.

Matthew Oster, MD, of the CDC, noted the incidence of vaccine-associated myocarditis would be about one in every 10,000 to 20,000 individuals for this age group. McNally asked Oster point-blank if given the information today, in his medical opinion, do the benefits outweigh the risks of vaccination.

"In my opinion, yes," Oster said.

While ACIP members were united in their support for the vaccine, Matthew Daley, MD, of Kaiser Permanente Colorado in Aurora, acknowledged those who are against this recommendation.

"I feel like collectively we're stronger when we hear from dissenting voices," he said. "Of course, you only want what's best for your child. It's understandable that you have questions given" the disinformation campaign against the vaccine, Daley said.

Several ACIP members stressed the importance of talking to pediatricians about the vaccine, and pediatricians recommending the vaccine to their patients.

This interim recommendation will go into effect when Walensky signs it, which she is expected to do later tonight.

We will "end this pandemic with science leading the charge," Walensky said.

https://www.medpagetoday.com/infectiousdisease/covid19vaccine/95410

Colorado governor warns of rationed care as state hits 80% vaccination threshold

 Gov. Jared Polis (D-Colo.) on Monday warned that surging COVID-19 cases in unvaccinated people was bringing Colorado closer to rationing hospital care, even as the state has reached a partial vaccination rate of 80 percent.

“It’s the 20% who haven’t been vaccinated that are filling up our hospital wards,” said Polis at a news briefing, according to Bloomberg. “We would have none of these hospital capacity issues, or orders would be operative, if everybody was vaccinated.”

The governor said Colorado may soon have to ask the Federal Emergency Management Agency (FEMA) to assist with overrun hospitals.

Polis lamented that these problems are particularly tragic because they are "essentially entirely preventable."

On Sunday, Polis signed two executive orders in an effort to help his state's hospitals. One order allows hospitals emergency departments to turn away patients, directing them to other facilities, while the other clarifies when "Crisis Standards of Care" can be activated to ration care. Both orders are set to expire in a month, though they can be reactivated, Colorado Public Radio (CPR) reported.

As Bloomberg noted, Colorado's vaccination rates is one of the highest in the country. Its hospital bed occupancy rate, however, has been averaging around 90 percent for the past few weeks.

According to CPR, 80 percent of hospitalized COVID-19 patients are unvaccinated.

On Sunday, the Colorado Department of Public Health and Environment also issued a new health order to ease hospital capacity issues. The order instituted a pause on cosmetic procedures that can be put off for six months without causing "harm to life, limb or function."

https://thehill.com/homenews/state-watch/579634-colorado-governor-warns-of-rationed-care-as-state-hits-80-percent

Airline pilot comes to blows with flight attendant over masks

 

• USA Today reports a Southwest Airlines pilot and flight attendant were involved in an altercation at a hotel bar in San Jose, Calif., last month.
• The pilot was cited for assault and battery.
• The airline put the pilot on leave while the incident is under investigation.

A Southwest Airlines pilot was cited for assault and battery following an alleged fight with a flight attendant at a California hotel over a disagreement on COVID-19 masks, according to USA Today. 

The outlet reports the altercation occurred at a hotel bar in San Jose, Calif., last month where the crew was spending the night after a flight. 

“The event involved a disagreement over mask wearing or masks,” Sgt. Christian Camarillo, a public information officer for the San Jose Police Department, told USA Today. 

The official declined to provide additional details on what led up to the dispute. The Santa Clara County District Attorney’s Office is reportedly reviewing the case for potential charges. 

The airline put the pilot on leave while the incident is under investigation. 

Days after the dispute, Southwest executives sent a memo to pilots and flight attendants saying “Being off-duty is never an excuse to ignore the Golden Rule.”

“We realize there has been a steady drumbeat over the last 19 months about civility and respectful discourse — and that is for good reason. Many of our people have been faced with an uncomfortable situation where their beliefs are not shared by someone else, resulting in a confrontation of some kind,” the memo reportedly said. 

“And for every situation we hear about, there are dozens more for which we don’t. It is vital that we treat everyone with respect and honor our differences without pushing our ideals on someone else,” the memo said.

https://thehill.com/changing-america/well-being/579678-airline-pilot-comes-to-blows-with-flight-attendant-over-masks

Oklahoma Gov. asks Pentagon to drop vaccine mandate for National Guardsmen

 Oklahoma Gov. Kevin Stitt (R) is asking Secretary of Defense Lloyd Austin to suspend the Pentagon’s COVID-19 vaccine mandate for members of the Oklahoma National Guard.

In a letter to Austin, Stitt said Tuesday that the mandate “violates the personal freedoms of many Oklahomans, as it asks them to potentially sacrifice their personal beliefs in order to not lose their jobs.” 

“These are patriotic citizens who are willing to put their lives on the line to protect others in our communities during times of greatest need,” Stitt said.

Austin ordered all service members to “immediately” get vaccinated against COVID-19 in late August after the Food and Drug Administration (FDA) granted full approval to Pfizer-BioNTech’s two-dose vaccine.  

About 97 percent of the total force has received at least one dose of a coronavirus vaccine, Pentagon Press Secretary John Kirby said Monday.

Deadlines for the mandate differ between the military branches. The first deadline, for active duty Air Force personnel, is Tuesday, while all air National Guard members and reservists have to be vaccinated by Dec. 2. 

Meanwhile, all active duty Army troops have to be vaccinated by Dec. 15, while Army reservists and National Guard units have to be fully vaccinated by June 30, 2022.

In his letter, Stitt told Austin that he estimates over 800 Oklahoma guardsmen “have not and do not plan” on getting vaccinated, representing 10 percent of the total force.

The governor said it was “irresponsible” to impose the mandate, which could “potentially limit the number of individuals that I can call upon to assist the state during an emergency.”

“I sincerely ask that you reconsider the policy of mandating COVID-19 vaccination for all national guardsmen in Oklahoma,” he continued.

The letter comes as the GOP sounds the alarm on the Pentagon’s vaccine mandate and the Biden administration’s forthcoming mandates for private employers and federal contractors.

Oklahoma Sen. James Inhofe (R), the ranking member of the Senate Armed Services Committee, wrote a letter to Austin asking him to suspend the mandate last month.

“At a time when our adversaries continue to increase their quantitative and qualitative advantage against our forces, we should seek to ensure that no policy, even unintentionally, hinders military readiness,” Inhofe said at the time.

https://thehill.com/policy/defense/579683-oklahoma-gov-asks-pentagon-to-drop-vaccine-mandate-for-national-guardsmen

Schumer announces deal to lower prescription drug prices

 Democratic lawmakers have reached a deal on legislation to lower prescription drug prices to be included in President Biden's social spending package, Senate Majority Leader Charles Schumer (D-N.Y.) announced Tuesday.  

The agreement is less far-reaching than earlier Democratic proposals, but it still represents progress on an issue the party has campaigned on for years.  

The agreement would allow Medicare to negotiate drug prices in limited instances, prevent drug companies from raising prices faster than inflation and cap out-of-pocket costs for seniors on Medicare at $2,000 per year.

Democrats scaled back their earlier sweeping measure because of concerns from a handful of moderates that it would have harmed innovation from drug companies to develop new treatments. Sen. Kyrsten Sinema (D-Ariz.) as well as Reps. Scott Peters (D-Calif.) and Kurt Schrader (D-Ore.) were among those moderates and helped lead negotiations with leadership over the compromise measure.

"It's not everything we all wanted. Many of us would have wanted to go much further, but it's a big step in helping the American people deal with the price of drugs," Schumer told reporters on Tuesday.

Sinema said in a statement that she supported the agreement.

"The Senator welcomes a new agreement on a historic, transformative Medicare drug negotiation plan that will reduce out-of-pocket costs for seniors - ensuring drug prices cannot rise faster than inflation - save taxpayer dollars, and protect innovation to ensure Arizonans and Americans continue to have access to life-saving medications, and new cures and therapeutics," Sinema's office said.

One of the key compromises leading to a deal was limiting the scope of Medicare's ability to negotiate lower drug prices, which has long been a signature Democratic proposal. Lawmakers agreed to limit Medicare's ability to negotiate to older drugs that no longer have "exclusivity," meaning the period when they are protected from competition. Earlier versions of Democratic bills would have allowed negotiation for newer drugs too.

A draft measure that circulated to lobbyists in recent days would allow negotiation for 10 drugs starting in 2025 and 30 drugs starting in 2028. 

The final deal would extend the limits on drug prices rising faster than inflation to people with private health insurance plans as well, which has been a point of debate at some points in the process.

Speaker Nancy Pelosi (D-Calif.), who had championed Democrats' earlier, more sweeping drug price bill for years, praised that provision and the agreement overall. Pelosi spoke to Sinema over the weekend to help finalize the agreement, according to Sinema's office.

“For a generation, House Democrats have been fighting to deliver real drug price negotiations that will lower costs," Pelosi said. "With today’s agreement on strong lower drug price provisions for the Build Back Better Act, Democrats have a path forward to make good on this transformational agenda for our seniors."

She said the legislative text is still being drafted.

https://thehill.com/policy/healthcare/579660-schumer-announces-deal-to-lower-prescription-drug-prices

JPMorgan to restrict trading of U.S. cannabis stocks -letter

 JPMorgan Chase & Co has told prime brokerage clients it will no longer let them buy U.S. cannabis-related securities beginning Nov. 8, according to a letter seen by Reuters.

The move follows similar actions by other prime brokerages, like Credit Suisse, aimed at reducing risk of regulatory action after the fallout from the high-profile collapses of Archegos Capital Management and Greensill Capital earlier in the year.

Cannabis remains illegal under U.S. federal law, even though many states have legalized its medical or recreational use. This represents a legal risk for investment banks working for companies that produce or trade the drug.

https://finance.yahoo.com/news/exclusive-jpmorgan-restrict-trading-u-200322715.html