Purdue Pharma pleads guilty to federal criminal charges related to nation’s opioid crisis

https://www.cnn.com/2020/11/24/us/purdue-pharma-oxycontin-guilty-plea/index.html?fbclid=IwAR2DM1jxDtKxFaCW1o-HJ45Tuh1-HOVw5DjNx_ncuhfajyjdkvP9wnMHUMg

Purdue Pharma, the maker of OxyContin, pleaded guilty Tuesday to three federal criminal charges related to the company’s role in creating the nation’s opioid crisis. Purdue Pharma board chairman Steve Miller pleaded guilty on behalf of the company during a virtual federal court hearing in front of US District Judge Madeline Cox Arleo.

The counts include one of dual-object conspiracy to defraud the United States and to violate the Food, Drug, and Cosmetic Act, and two counts of conspiracy to violate the Federal Anti-Kickback Statute.

The plea deal announced in October includes the largest penalties ever levied against a pharmaceutical manufacturer, including a criminal fine of $3.544 billion and an additional $2 billion in criminal forfeiture, according to a Department of Justice press release.

The company, which declared bankruptcy last year, will be dissolved as a part of the plea agreement, and its assets will be used to create a new “public benefit company” controlled by a trust or similar entity designed for the benefit of the American public.

The Justice Department has said Purdue Pharma will function entirely in the public interest rather than to maximize profits. Its future earnings will go to paying the fines and penalties, which in turn will be used to combat the opioid crisis.

In pleading guilty to the criminal charges, the company is taking responsibility for past misconduct, Purdue Pharma said in a statement to CNN Tuesday.”Having our plea accepted in federal court, and taking responsibility for past misconduct, is an essential step to preserve billions of dollars of value for creditors and advance our goal of providing financial resources and lifesaving medicines to address the opioid crisis,” the statement said. “We continue to work tirelessly to build additional support for a proposed bankruptcy settlement, which would direct the overwhelming majority of the settlement funds to state, local and tribal governments for the purpose of abating the opioid crisis.”

According to the US Centers for Disease Control and Prevention, about 70,000 Americans died of drug overdoses in 2018, just one year of the opioid crisis, and about 70% of those deaths were caused by prescription or illicit opioids like OxyContin. In that year, an estimated 10.3 million Americans 12 and older misused opioids, including 9.9 million prescription pain reliever abusers and 808,000 heroin users, according to the US Department of Health and Human Services Substance Abuse and Mental Health Services Administration.

The Sackler family, and other current and former employees and owners of the company, still face the possibility that federal criminal charges will be filed against them. The court did not set a date for a sentencing hearing.

Appeals court sides with hospitals in latest challenge of DSH payment calculations

lady justice

A federal appeals court upheld a ruling that would allow hospitals to calculate their disproportionate share hospital (DSH) payments using Medicaid patients as well as patients eligible for treatment under experimental Medicaid “demonstration projects” approved by the Department of Health and Human Services (HHS).

The opinion, issued Friday, upheld the decision of a lower court that sided with 10 Florida hospitals seeking to include days of care funded by Florida’s Low Income Pool, an approved Medicaid demonstration project. Through the pool, the state and federal governments jointly reimbursed hospitals for care provided to uninsured and underinsured patients.

HHS argued against allowing the hospitals to include those patients in their Medicaid fraction on the ground that the patients were treated out of charity rather than as designated beneficiaries of a demonstration project.

“The district court found the Secretary’s arguments to the contrary unpersuasive. The Secretary argued the text of the regulation allows hospitals to include days of care provided under a demonstration project only if the project entitles specific patients to specific benefit packages,” the judges said (PDF). “As the court noted, however, this is not what the regulation says. Rather, a patient must have been ‘eligible for inpatient services,’ meaning the demonstration project enabled the patient to receive inpatient services, regardless whether the project gave the patient a right to these services or allowed the patient to enroll in an insurance plan that provided the services.”

DSH payments have traditionally been calculated using the costs incurred to treat Medicaid and uninsured patients. However, the Centers for Medicare & Medicaid’s 2017 rule says costs incurred treating other patients are applicable. For example, a dually eligible patient who’s admitted to the hospital will likely have their stay paid for by Medicare, the agency said, as Medicaid is treated as the “payer of last resort.” As such, those costs would be eligible to be subtracted from DSH payouts.

In backing the hospitals on the DSH dispute, the judges pointed to a similar case considered by the Fifth Circuit last year in which the agency sought to exclude from the Medicaid fraction days of care funded through an “uncompensated care pool” created by a demonstration project. That pool reimbursed hospitals in Mississippi for services provided to uninsured patients affected by Hurricane Katrina but did not entitle specific patients to specific services.

In that case, the Fifth Circuit held “plain regulatory text demands that such days be included—period.”

“We see no flaw in Judge Collyer’s analysis and therefore embrace the district court’s opinion as the law of this circuit,” the judges said.

Los Angeles hospital can force Anthem to cover ER visits, court rules

https://www.beckershospitalreview.com/legal-regulatory-issues/los-angeles-hospital-can-force-anthem-to-cover-er-visits-court-rules.html?utm_medium=email

Innovating in Emergency Medicine: CMS Launches ET3 — A New Treatment Model  for EMS | by StartUp Health | StartUp Health

A federal appellate court recently ruled that Anthem is required to pay Martin Luther King Jr. Community Hospital in Los Angeles for about 75 emergency room visits from covered patients, according to Bloomberg Law

The appeal centered on whether Anthem was required to cover services MLK Jr. Community Hospital rendered to employees of Budco Group, an Ohio company, when the hospital was assigned the patients’ benefit payments. Anthem is the administrator of Budco’s Employee Retirement Income Security Act plan, and the employees who received services at the hospital were beneficiaries of the plan. 

Between 2015 and 2017, Budco employees visited MLK Jr. Community Hospital’s emergency room at least 75 times and assigned their benefits under the company’s ERISA plan to the hospital as a condition of receiving care. Instead of paying MLK Jr. Community Hospital, which was out of Anthem’s network, the insurance company paid the beneficiaries, forcing the hospital to attempt to recover payment from the beneficiaries. The Budco employees deposited payment into their personal accounts and did not send any of the benefit payments to the hospital. 

The hospital sued Anthem and Budco in 2016, seeking benefit payments and declaratory relief. The district court granted summary judgment in favor of the hospitals, and Anthem and Budco appealed. 

On appeal, Anthem argued the case was blocked by a provision in its health plan that prevented patients from assigning their rights to third parties such as MLK Jr. Community Hospital, according to Bloomberg Law. The hospital argued that the “anti-assignment” provision did not bar assignments in this case. 

In an unpublished split decision filed Oct. 2, the U.S. Court of Appeals for the Ninth Circuit ruled in favor of the hospital, holding that the language cited by Anthem allowed assignments to healthcare providers, including those that were out of network. 

“The provision lists three entities other than the beneficiary that Anthem may pay directly. Providers are included among those entities,” the court stated. “In the same paragraph, and only two sentences later, the anti-assignment provision forbids beneficiaries from assigning benefits to ‘anyone else.’ This sentence restricting assignment must be read consistently with the entire paragraph, which concerns benefit payments to entities other than the beneficiary. Thus, we interpret the anti-assignment provision’s reference to ‘anyone else’ to permit assignments to those entities, including ‘providers.'”

Alternatively, the appellate court held that the anti-assignment provision is not part of the health plan documents. 

“The anti-assignment provision is plainly not a benefit, and therefore the district court correctly determined it should not be incorporated as a description of the plan’s benefits,” the appellate court held. 

In his dissenting opinion, Judge Daniel Collins said the anti-assignment provision is an express term of the documents that govern the Budco plan. He also disagreed with the majority’s alternative conclusion that the language of the anti-assignment provision did not bar the assignments that plan beneficiaries made to MLK Jr. Hospital. 

Drug payment cuts to 340B hospitals spur debate on best path forward

https://www.healthcarefinancenews.com/news/drug-payment-cuts-340b-hospitals-spur-debate-best-path-forward

340B hospitals breathing easier under Dem-controlled House

Hospitals say revenue from the 340B program is essential, while others contend the original law is being abused.

On August 3, an federal appeals court ruled that 340B hospitals will now be subject to Medicare cuts in outpatient drug payments by nearly 30%, reversing an earlier ruling calling those cuts illegal. The 2-1 decision by the U.S Court of Appeals for the District of Columbia Circuit essentially gives the Trump Administration and the Department of Health and Human Services the legal authority to reduce payment for Medicare Part B drugs to 340B hospitals.

HHS Secretary Alex Azar said the action means patients – particularly those who live in vulnerable areas – will pay less out-of-pocket for drugs in the Medicare Part B program. But providers, including the American Hospital Association, the Association of American Medical Colleges and America’s Essential Hospitals, said the 340B decision will hurt hospitals and patients in these vulnerable areas.

Hospitals that serve large numbers of Medicaid, Medicare and uninsured patients were getting the drugs for a discounted price, but, getting reimbursed at the higher price, HHS pays all hospitals for Medicare Part B drugs. The hospitals, many of which are in the red or operating on thin margins, were using the pay gap in the price difference to cover operational expenses. HHS deemed it inappropriate that these facilities would use Medicare to subsidize other activities and initiatives, and the appeals court agreed.

As per the original 340B legislation, discounts on drugs can range from 13% to 32% off the average retail price for participating providers, but Medicare Part D sets reimbursement in an entirely different way, leading to the significant reimbursement discrepancies – until the ruling, which furthered HHS’ push to narrow the spread between acquisition price and reimbursement.

THE DEBATE

“The opportunity to exploit this buy/sell differential probably has something to do with the explosive growth there’s been in the number of participating institutions in 340B,” said Michael Abrams, cofounder and managing partner of Numerof and Associates. “According to the data I came across, discounted 340B purchases grew 23% from 2018 to 2019, and currently make up about 8% of the total of the U.S. drug market. So from my perspective this looks like a loophole that’s been used by a small number of large institutions, who in many cases don’t serve that many disadvantaged patients, but nonetheless serve enough to qualify for the 340B program and to purchase the drugs they buy at the discounted rate.”

Groups representing U.S. hospitals would disagree with that assessment, and, in fact, when the appeals court handed its ruling, the AHA, AAMC and America’s Essential Hospitals said 340B hospitals and their patients would “suffer lasting consequences.”

“The decision conflicts with Congress’ clear intent and defers to the government’s inaccurate interpretation of the law, a point that was articulated by the judge who dissented from the opinion,” the groups wrote in a statement. “For more than 25 years, the 340B program has helped hospitals stretch scarce federal resources to reach more patients and provide more comprehensive services. Hospitals that rely on the savings from the 340B drug pricing program are also on the front-lines of the COVID-19 pandemic, and today’s decision will result in the continued loss of resources at the worst possible time.”

President and CEO of 340B Health Maureen Testoni also lamented the appeals court’s decision, calling the cuts “discriminatory.”

“These cuts of nearly 30% have caused real and lasting pain to safety-net hospitals and the patients they serve,” she said earlier this month. “Keeping these cuts in place will only deepen the damage of forced cutbacks in patient services and cancellations of planned care expansions. These effects will be especially detrimental during a global pandemic.

Abrams contends that much of the confusion and legal wrangling can be attributed to the vagueness of the original 340B legislation, the stated goal of which was to “enable participating institutions to stretch scarce financial dollars.” With little else to go on in terms of the language, those on each side of the issue were able to interpret it in their own way, with participating institutions saying it’s within the bounds of the law to use that revenue stream to enhance their mission – another phrase that’s open to wide interpretation.

“There’s no question this is being put to uses that were never intended,” said Abrams, adding that the profits generated by the buy/sell differential often disappear into balance sheets with little to no accountability.

Hospitals, for their part, feel they’re under siege by HHS at a critical time for the healthcare system’s financial viability. Even before the COVID-19 pandemic, hospitals saw the migration of lucrative inpatient procedures, such as hip and knee replacements, to freestanding outpatient facilities, which in some cases are not owned by the hospital. That represents a significant loss of revenue. Factor in the lost revenue from cancelled or delayed elective procedures due to the coronavirus, as well as patients who are too cautious to enter the healthcare system, and hospitals are hurting. AHA President and CEO Rick Pollack said in July that half of all U.S. hospitals will likely be in the red by the end of the year.

A COMPLICATED PICTURE

Actions by the pharmaceutical industry are also adding to the complication. A recent statement from America’s Essential Hospitals alleges that recent actions by pharmaceutical manufacturers “hinder access to affordable medications for millions of people who face financial hardships and defy clear statutory requirements that they provide drugs to 340B Drug Pricing Program covered entities.”

The manufacturers have threatened punitive actions – including withholding 340B drugs to contract pharmacies – for failing to comply with reporting requirements that Essential Hospitals call “arbitrary.”

“These data requests have no clear link to program integrity,” the group said. “Rather, they seem to be little more than a fishing expedition.”

A concrete example can be found in AstraZeneca’s decision to refuse 340B pricing to hospitals with on-site pharmacies for any drugs that will be dispensed through contract pharmacies. In a statement this week, Testoni of 340B called this action an “attack” on the 340B program that will hurt healthcare institutions as well as low-income and rural Americans.

“We believe that refusing to offer discounts that the 340B statute requires is a violation of federal law,” said Testoni. “We are calling on Health and Human Services Secretary (Alex) Azar to exercise his authority to stop these overcharges before they cause permanent damage to the healthcare safety net.”

Abrams sides more with the appeals court decision, saying that requiring the pharmaceutical industry to sell drugs at a discount comes with significant regulation to ensure they do so – a stark contrast to the lack of regulation around the resulting revenue. Though another appeal certainly isn’t out of the question, Abrams expects participation in the program to shrink back to a level reflecting the size of the target populations.

“This is about helping disadvantaged patients get their drugs, and that should be the driving activity of the program,” he said. “I’m fine with HHS taking this problem on, because it was an abuse that was never intended in the original legislation. It just seems to me that HHS really wants the healthcare sector to deliver care that is more accountable both for efficient use of resources and outcomes.”

One person who disagrees is Circuit Judge Cornelia Pillard, who wrote the dissenting opinion in the appeals court decision.

“The challenged rules took a major bite out of 340B hospitals’ funding,” she said. “Often operating at substantial losses, 340B hospitals rely on the revenue that Medicare Part B provides in the form of standard drug-reimbursement payments that exceed those hospitals’ acquisition costs. 340B hospitals have used the additional resources to provide critical healthcare services to communities with underserved populations that could not otherwise afford these services.”

 

 

 

 

Payers win again, court rules Admininistration violated law in axing ACA cost-sharing payments

https://www.healthcaredive.com/news/payers-win-again-court-rules-trump-admin-violated-law-in-axing-aca-cost-sh/583565/?utm_source=Sailthru&utm_medium=email&utm_campaign=Issue:%202020-08-17%20Healthcare%20Dive%20%5Bissue:29123%5D&utm_term=Healthcare%20Dive

Payers win again, court rules Trump admin violated law in axing ...

Dive Brief:

  • A federal court ruled Friday that insurers are owed subsidies mandated by the Affordable Care Act to help them cover people with low incomes in the exchanges and the Trump administration violated the law when it halted the payments in 2017.
  • In a separate but related ruling, the same court found that payers that were able to raise premiums to offset the loss of those payments in 2018, however, should not receive the entire unpaid amount.
  • The judges with the U.S. Court of Appeals for the Federal District in their decision relied on a recent ruling in favor of insurers from the U.S. Supreme Court on a separate cost-sharing program in the ACA. “We see no sufficient basis for reaching a different conclusion,” they wrote.

Dive Insight:

The Affordable Care Act took into account that payers participating in the exchanges it created would be somewhat flying blind when setting premium rates for a new population. To safeguard them, multiple programs were established to help manage the inherent risk.

One of them was the risk corridors program, which was supposed to redistribute some of the profits insurers received in the exchanges to other companies seeing losses. But far more companies reported losses than profits, and the program quickly ran out of funds to pay out.

The Trump administration argued the ACA does not properly appropriate the funding anyway. 

The high court, however, ruled in April those insurers are owed about $12 billion from the program and that the language indeed creates what is called a money-mandating provision.

The decisions released Friday use that precedent for one of the other risk programs, which provided the subsidies for coverage of people with low-incomes, called cost-sharing reduction payments.

HHS abruptly stopped making the payments in October 2017, making the argument that the money had not been appropriated. But litigation of the issue goes back farther. Republicans in Congress sued HHS in 2014 making the same claim.

In 2018, with the payments still halted, payers increased their premium rates to help account for the lack of cost-sharing reduction payments, and thus received additional premium tax credits (a practice known as silver loading). The judges Friday said that although they agreed with a February 2019 decision from the U.S. Court of Federal Claims that the payers were owed the payments, they disagreed that insurers should be reimbursed in full despite the 2018 premium adjustments.

“The complexity of the process cannot obscure the underlying economic reality that the government is paying at least some of the increased costs that the insurers incurred as a result of the government’s failure to make cost-sharing reduction payments,” they wrote.

The judges remanded the case back to the Court of Federal Claims to determine the amount Maine Community Health Options is owed, and instructed them to take into account what amount of silver loading can be attributed to the loss of the payments.

Montana Co-op is owed $1.23 million for missed 2017 payments and Sanford Health Plan is owed $360,254.

 

 

 

 

Appeals court upholds nearly 30% payment cut to 340B hospitals

https://www.fiercehealthcare.com/hospitals/appeals-court-upholds-nearly-30-payment-cut-to-340b-hospitals?mkt_tok=eyJpIjoiWkRReFlqRmpaamRtWVdabSIsInQiOiJFTEp3SjQ3NG01NXcwRTg3Z0hCZkdTRlwvOURSeEVlblwvRlFUWlZcL09ONjZGNVEybzl3ekl3VFd2ZEgxSjY2NGQ0TkFIRFdtQ0ZDWUx0ak96NU15d09qMWcrdm9BMFUxOSszcVI0T21rak5raEN0aE5Kb0VUUGFcL254QnBjMjdCbzkifQ%3D%3D&mrkid=959610

In court filing, AHA says HHS should make 340B hospitals 'whole ...

A federal appeals court has ruled the Trump administration can install nearly 30% cuts to the 340B drug discount program.

The ruling Friday is the latest legal setback for hospitals that have been vociferously fighting cuts the Department of Health and Human Services (HHS) announced back in 2017.

340B requires pharmaceutical manufacturers to deliver discounts to safety net hospitals in exchange for participation in Medicaid. A hospital will pay typically between 20% and 50% below the average sales price for the covered drugs.

HHS sought to address a payment gap between 340B and Medicare Part B, which reimburses providers for drugs administered in a physician’s office such as chemotherapy. There was a 25% and 55% gap between the price for a 340B drug and on Medicare Part B.

So HHS administered a 28.5% cut in the 2018 hospital payment rule. The agency also included the cuts in the 2019 payment rule.

Three hospital groups sued to stop the cut, arguing that HHS exceeded its federal authority to adjust the rates to the program.

A lower court agreed with the hospitals and called for the agency to come up with a remedy for the cuts that already went into effect.

But HHS argued that when it sets 340B payment amounts, it has the authority to adjust the amounts to ensure they don’t reimburse hospitals at higher levels than the actual costs to acquire the drugs.

If the hospital acquisition cost data are not available, HHS could determine the amount of payment equal to the average drug price. HHS argued that hospital cost acquisition data was not available and so HHS needed to determine the payment rates based on the average drug price.

The court agreed with the agency’s interpretation.

“At a minimum, the statute does not clearly preclude HHS from adjusting the [340B] rate in a focused manner to address problems with reimbursement rates applicable only to certain types of hospitals,” the ruling said.

The court added that the $1.6 billion gleaned from the cuts would go to all providers as additional reimbursements for other services.

340B groups were disappointed with the decision.

“These cuts of nearly 30% have caused real and lasting pain to safety-net hospitals and the patients they serve,” said Maureen Testoni, president and CEO of advocacy group 340B Health, which represents more than 1,400 hospitals that participate in the program. “Keeping these cuts in place will only deepen the damage of forced cutbacks in patient services and cancellations of planned care expansions.”

This is the latest legal defeat for the hospital industry. A few weeks ago, the same appeals court ruled that HHS had the legal authority to institute cuts to off-campus clinics to bring Medicare payments in line with physician offices, reversing a lower court’s ruling.

The groups behind the lawsuit — American Hospital Association, American Association of Medical Colleges and America’s Essential Hospitals — slammed the decision as hurtful to hospitals fighting the COVID-19 pandemic. But the groups didn’t say if it would appeal the decision.

“Hospitals that rely on the savings from the 340B drug pricing program are also on the front-lines of the COVID-19 pandemic, and today’s decision will result in the continued loss of resources at the worst possible time,” the groups said in a statement Friday.

 

 

 

Hospitals lose legal challenge to 340B drug payment cut

https://www.healthcaredive.com/news/hospitals-lose-legal-challenge-to-340b-drug-payment-cut/582717/?utm_source=Sailthru&utm_medium=email&utm_campaign=Newsletter%20Weekly%20Roundup:%20Healthcare%20Dive:%20Daily%20Dive%2008-01-2020&utm_term=Healthcare%20Dive%20Weekender

340B Program: Important, but Weaknesses Cited - Pharmacy Practice News

Dive Brief:

  • A significant rate cut for some medications for 340B hospitals was based on a “reasonable interpretation of the Medicare statute” and can stand, the U.S. Court of Appeals for the District of Columbia ruled Friday.
  • The 2-1 ruling overturns a district court decision that HHS overstepped its bounds when it cut the reimbursement rate for a certain category of outpatient drugs by 28.5% for hospitals enrolled in the 340B drug discount program.
  • The American Hospital Association, which challenged the rate cut along with three individual hospitals, did not immediately respond to a request for comment. An advocacy group for 340B hospitals said in a statement it was disappointed in the ruling and that the rate change has “caused real and lasting pain to safety-net hospitals and the patients they serve.”

Dive Insight:

The decision is another major blow for hospitals, coming two weeks after the same court ruled HHS also acted within its authority when it reduced payments to off-campus hospital outpatient departments.

AHA said this week it is seeking to have that ruling overturned.

HHS made the cut to 340B hospital outpatient drug reimbursement in the 2018 Outpatient Prospective Payment System rule, arguing that those hospitals, which primarily serve low-income populations, get the drugs at a deep discount and thus could be incentivized to overuse them.

The cut was from 106% of the average sales price to 22.5% less than ASP. Hospitals immediately sued, but HHS retained the reduction in the 2019 OPPS. The department has said the change would save Medicare $1.6 billion in 2018.

Writing for the court, Chief Judge Sri Srinivasan said the department did indeed have the authority to make the reduction, “so as to avoid reimbursing those hospitals at much higher levels than their actual costs to acquire the drugs.”

He also called the cut “a fair, or even conservative, measure of the reduction needed to bring payments to those hospitals into parity with their costs to obtain the drugs.”

In a partially dissenting opinion, Circuit Judge Cornelia Pillard wrote that she believes the statute only allows HHS to make the change for a specific group of hospitals under a clause that requires the agency to use a certain data set it did not use.

 

 

 

 

Appeals court rules HHS has authority to implement site-neutral payments, dealing blow to hospitals

https://www.fiercehealthcare.com/hospitals/appeals-court-rules-hhs-has-authority-to-implement-site-neutral-payments-dealing-blow-to?mkt_tok=eyJpIjoiWXpGa016azRZekJqTTJZeSIsInQiOiJ6ajZGSWlYUGh1TTZqTFBDMEgwaXk3ZFZZSCtBVkdUWHNhemZ0SDJZWnhJVHlHVUpjRTdFVUlpbVBSdng4dTFXUEhhOGV2S3lRcElVVWNuZWpqakdEZE1DRmhleHRzdlY4RDRxYkxtZUNYNVI3Rmg5Kys5SVd1aGdseUR6Y1hxSCJ9&mrkid=959610

Appeals court rules HHS has authority to implement site-neutral ...

A federal appeals court ruled the Department of Health and Human Services has the authority to cut Medicare payments to off-campus clinics to bring them in line with independent physician practices, reversing a lower court’s decision.

The ruling from the U.S. Court of Appeals for the District of Columbia delivered Friday strikes a major blow to the hospital industry which has been fighting HHS over the controversial rule.

The American Hospital Association (AHA) led a lawsuit against HHS arguing it did not have the statutory authority to cut payments to the off-campus, provider-based departments. HHS made the cuts in its annual hospital payments rule and the hospitals argued they were unlawful because the cuts were not budget-neutral, a requirement of the payment rule.

But the appeals court agreed with HHS that it had the authority to make the change in the payment rule because of how the law is structured.

 

 

 

 

In blow to hospitals, judge rules for HHS in price transparency case

https://www.healthcaredive.com/news/in-blow-to-hospitals-judge-rules-for-hhs-in-price-transparency-case/580395/

UPDATE: June 24, 2020: The American Hospital Association said it will appeal Tuesday’s ruling  that upholds the Trump administration’s mandate to force hospitals to disclose negotiated rates with insurers. The hospital lobby said it was disappointed in the ruling and will seek expedited review. AHA said the mandate “imposes significant burdens on hospitals at a time when resources are stretched thin and need to be devoted to patient care.”

If AHA seeks to have the rule stayed pending an appellate ruling, the decision on such a request “is likely to be almost as significant as this ruling is, since absent a stay, the rule will likely go into effect before the appellate court rules,” James Burns, a law partner at Akerman, told Healthcare Dive.

Dive Brief:

  • A federal judge ruled against the American Hospital Association on Tuesday in its lawsuit attempting to block an HHS rule pushing for price transparency. The judge ruled in favor of the department, which requires hospitals to reveal private, negotiated rates with insurers beginning Jan. 1.
  • U.S. District Court Judge Carl Nichols, an appointee of President Donald Trump, was swayed neither by AHA’s argument that forcing hospitals to publicly disclose rates violates their First Amendment rights by forcing them to reveal proprietary information nor by the claim that it would chill negotiations between providers and payers. The judge characterized the First Amendment argument as “half-hearted.”
  • Nichols seem convinced that the requirement will empower patients, noting in Tuesday’s summary judgment in favor of the administration that “all of the information required to be published by the Final Rule can allow patients to make pricing comparisons between hospitals.”

Dive Insight:

The ruling is a blow for hospitals, which have been adamantly opposed to disclosing their privately negotiated rates since HHS first unveiled its proposal in July 2019. AHA did not immediately reply to a request for comment on whether it planned to appeal.

The legal debate hinges on the definition of “standard charges”, which is mentioned in the Affordable Care Act, though it was left largely undefined in the text. Trump issued an executive order last year that included negotiated rates as part of that definition.

Cynthia Fisher, founder of patienrightsadvocate.com, which filed an amicus brief in support of HHS, told Healthcare Dive on Tuesday the ruling could make shopping for health services more like buying groceries or retail.

“For the first time we will be able to know prices before we get care,” she said. “This court ruling rejects every claim to keep the secret hidden prices from consumers until after we get care.”

 

 

 

 

Hospitals tell court price transparency laws violate 1st Amendment

https://www.healthcaredive.com/news/AHA-HHS-price-transparency-oral-arguments/577613/

Dive Brief:

  • In the first round of oral arguments in their lawsuit against HHS over a rule requiring hospitals to reveal the secret rates they negotiate with insurers for services, hospital groups argued the requirement exceeds the government’s authority and violates the First Amendment by compelling hospitals to publicly post confidential and proprietary information​.
  • The American Hospital Association, along with other industry groups and health systems that brought the lawsuit, argued in the U.S. District Court for the District of Columbia on Thursday that medical bills aren’t considered commercial speech and don’t fall under the same regulations that traditional advertisements, flyers and other forms of commercial speech offering or promoting services do.
  • “There’s not another market that looks like the market for hospital services,” said U.S. Department of Justice Attorney Michael Baer, who was representing HHS. A majority of patients final bills’ include the negotiated rate, information that should be available to patients, acting as consumers, prior to receiving care, he said.

Dive Insight:

Thursday’s hearing was the first step in what’s likely to be a drawn out legal fight. Negotiated rates between hospitals and insurers have long been private, and hospitals want to keep it that way. 

When HHS passed the final price transparency rule last year, the hospital groups filed a lawsuit in December, warning that requiring disclosure of negotiated rates will confuse patients, overwhelm hospitals and thwart competition. The rule would go into effect Jan. 1, 2021.

According to the lawsuit, the rule creates undue burden on hospitals and health systems, which can have more than 100 contracts with insurers. There can even be multiple contracts with an individual carrier to account for the various product lines, including Medicare Advantage, HMO or PPO.

The rule would require various pricing information, including gross charges, payer-specific rates, minimum and maximum negotiated charges and the amount the hospital is willing to accept in cash from a patient.

Some payers and employer groups have also protested the new rule, calling it wrong-headed.

When the rule initially passed last year, HHS argued that patients already see this pricing data when they receive their explanation of benefits, pushing back against the idea that it’s proprietary business information. They said this information needs to come before a procedure, not after.​

HHS maintains that the rule is intended to give patients better access to payment information so they can make informed decisions as consumers. 

“Patients deserve to know how much it’s going to cost when they get hospital care,” Baer said. “They deserve to know before they open a medical bill or before they choose where they want to receive care.”