Biden admin says will 'follow through' on moves to ban medical debt from credit reports

 The Biden administration announced Tuesday it will be following through on plans to bar medical debt from being included on credit scores.

“One of the most significant consequences of carrying medical debt is the harm it does to a person’s credit score,” Vice President Harris said in a press briefing.

“Medical debt makes it more difficult for millions of Americans to be approved for a car loan, a home loan or a small business loans. All of which in turn makes it more difficult to just get by much less get ahead. And that is simply not fair.”

The administration said back in September it had begun looking into the potential of banning medical debt from credit scores. At the time, the Consumer Financial Protection Bureau (CFPB) said it was seeking to keep creditors from “relying on data that is often plagued with inaccuracies and mistakes.”

The CFPB has previously reported that medical debt is one of the most common forms of debt represented on credit reports. CFPB Director Rohit Chopra said on Tuesday that medical debt is unique and shouldn’t be taken into consideration when assessing someone’s credit worthiness.

“Medical debt on a consumer credit report is just so different than a mortgage, auto loan or credit card. Sometimes, like a visit to the emergency room, the debt is taken on unexpectedly and in a time of crisis. Medical bills are also frequently subject to insurance coding errors, charity care mistakes or complexities with insurance,” he said.

Chopra said that the medical debt has become a “major money-making enterprise” for agencies that buy debt from hospitals for pennies on the dollar.

“The credit reporting system is more closely resembling a weapon for debt collectors rather than a tool for lenders to assess someone’s likelihood to repay a loan,” he added.

The proposed rule will be open for comment from the public through August 12.

According to senior administration officials, this rule is “simply closing a regulatory loophole” that was left open after Congress passed the Fair and Accurate Credit Transactions Act of 2003. The bill restricts the sharing of medical information in credit reporting, but regulatory exemptions remained.

Officials said on Tuesday that the new rule, which will go into effect retroactively on past medical bills, will allow for stronger assessments of credit worthiness going forward.

Medical debt experts previously called for the rule to recognize how healthcare costs are often shifted by patients paying them off through personal loans or credit cards. Administration officials said the rule will not extend to third-party lenders as debt incurred through paying off hospital bills would be considered new debt obligations.

Advocacy groups welcomed the proposal.

“Medical debt is an unfair burden on millions of people and I am thrilled to see the CFPB taking
action” Allison Sesso, CEO of the nonprofit Undue Medical Debt, said in a statement.

“Access to necessary healthcare should have zero impact on creditworthiness and while many providers like hospitals have stopped reporting to the credit bureaus, this is still a huge achievement for the millions struggling with a depressed credit score simply because they got sick or were in an accident,” added Sesso.

“We have known for years that medical debt doesn’t predict credit defaults, nor does it accurately predict a person’s desire and willingness to pay off loans. The CFPB agrees,” said Patricia Kelmar, health care campaigns director for the consumer protections nonprofit Public Interest Research Group.

“These newly proposed rules are an important step toward implementing a fair credit system that doesn’t penalize people for life events they can’t control, such as getting sick or injured.”

https://thehill.com/policy/healthcare/4716225-biden-administration-moves-to-ban-medical-debt-from-credit-reports/mlite/

House GOP says health officials misled investigation of mpox research

 Federal health officials misled a House panel investigation into potentially risky research of the mpox virus, Republican staff of the Energy and Commerce Committee said in an interim report Tuesday. 

Over a period of 18 months, the Department of Health and Human Services (HHS), the National Institutes of Health (NIH) and the National Institute of Allergy and Infectious Diseases (NIAID) “repeatedly obstructed and misled the Committee” about the research being done by an agency scientist to alter a strain of the mpox virus, according to the report.

The committee sought information from NIH and HHS to better understand the potential risks and benefits of the experiment, first described in an interview in Science magazine, but the report said the agency largely stonewalled those requests.  

“The Committee has lost trust in the NIH and NIAID’s ability to oversee its own research on potential pandemic pathogens or enhanced potential pandemic pathogens and to fairly determine whether an experiment poses an unacceptable biosafety or public health risk,” committee staff wrote. 

Only after the committee threatened a subpoena did HHS officials admit that the agency approved the research.  

HHS maintains that even though it granted approval, the riskier research was never conducted. 

“The experiment referenced by the committee was never conducted, which the committee knows. HHS remains committed to ensuring the safety of biomedical research,” an HHS spokesperson said.  

“The committee is looking for an issue where there isn’t one. HHS and its divisions, including NIH, follow strict biosafety measures as our scientists work to better understand and protect the public from infectious diseases — like mpox,” the spokesperson added. 

But the report noted “no documentation or any other evidence has been produced to substantiate the claim.” 

The committee argues that the NIH approved the study in 2015 and only revoked the clearance once the committee began asking questions. 

“This deliberate, prolonged effort to deceive the Committee is unacceptable and potentially criminal,” the staff report said. “The Committee needs additional evidence from HHS, the NIH, or NIAID to have confidence that the experiment did not occur.” 

NIH scientist Bernard Moss said in a 2022 Science article that he planned work to understand the mpox virus’s severity by inserting genes from a more lethal version of the virus into a less deadly strain. 

The committee alleges the experiments were “gain of function” research, which has become a flashpoint among Republicans amid investigations into the origins of the coronavirus pandemic and the potential for the virus to have come from a Chinese lab. 

A second GOP aide said the Energy and Commerce Committee is planning a hearing in “the coming weeks” on COVID-19 and laboratory safety 

The interim report is part of an investigation into the NIH’s research practices the committee first launched in 2022, with a particular focus on mpox and Moss’s experiments.  

“The plan is to continue the investigation, because there’s so much in the way of information and documents that we’re still waiting on … to get an accounting of what actually happened here,” a GOP committee staff member said. 

“We’re just pushing as hard as we can and they’re hardly giving us anything,” the staffer said. “And that is a shattering of norms in which the Congress and NIH have previously engaged.” 

https://thehill.com/policy/healthcare/4716544-house-gop-mpox-research-investigation-health-officials-misled/

Texas, Montana sue Biden administration over LGBTQ health protections

 Texas and Montana are suing the Biden administration over a new rule that would prohibit state Medicaid programs from banning gender-affirming care. 

The lawsuit from Texas Attorney General Ken Paxton (R) and Montana Attorney General Austin Knudsen (R), filed Monday, asks a federal court to vacate a sweeping final rule aimed at bolstering health care protections against discrimination for gay and transgender people. 

“Through a sweeping new rule promulgated under the Affordable Care Act (ACA), those who do not conform to the Biden Administration’s gender-ideology regime stand to lose all federal healthcare funds, including Medicaid and Medicare dollars,” the lawsuit states. 

The lawsuit argues the rule is an unconstitutional attempt to override state law, and that the ACA never authorized the U.S. Department of Health and Human Services (HHS) or any government agency to compel institutions to perform or pay for gender-affirming treatment.  

The complaint centers on Section 1557 of the ACA, which prohibits discrimination on the basis of race, color, national origin, sex, age and disability in certain health programs and activities.  

Section 1557 has been subject to a wave of litigation in the past decade, as advocacy groups and lawmakers have fought over how the policy should be interpreted.  

The Obama-era rule interpreted sex nondiscrimination protections to include gender identity and sex stereotyping (among other identities) but not sexual orientation. The Trump administration removed those protections, but the Biden administration then moved to reinstate and expand them by adding sexual orientation. 

The Biden administration’s final rule, which was released at the end of April, said organizations receiving federal health funding and health insurers that do business through government plans cannot refuse to provide gender-affirming care services that would be provided to an individual for other purposes.  

In addition, the rule categorically prohibited exclusions of gender-affirming care. 

For example, if a covered entity would perform a hysterectomy for the purpose of treating uterine cancer, it must also be willing to remove a healthy uterus for the purpose of facilitating a gender transition. 

The Biden administration made it clear in the rule that federal protections for religious freedom and conscience still apply. Those protections say health providers are not engaging in discrimination if they decline to provide abortion or any other care if it conflicts with a “sincerely-held belief.”  

But the rule makes clear that Section 1557 preempts state laws that prohibit access to gender-affirming care. 

“The rule will wreak financial havoc on Montana’s medical system as the state receives around two-billion dollars in federal financial aid administered by HHS every year. This new rule places unlawful strings on that aid, penalizing Montana for attempting to protect its citizens from harmful medical procedures and for declining to insure those procedures in its health plans,” Knudsen said in a statement.  

https://thehill.com/policy/healthcare/4716768-texas-montana-sue-biden-administration-lgbtq-health-protections/

Federal judge blocks Biden’s Title IX transgender protections

A federal judge in Texas halted President Biden’s proposed changes to the interpretation of Title IX on Tuesday, which added protections for transgender students. The changes are the subject of multiple lawsuits from GOP attorneys general nationwide.

The Education Department in April unveiled a final set of sweeping changes to Title IX, the civil rights law preventing sex discrimination in schools and education programs that receive government funding. The new rule, which was slated to take effect Aug. 1, covers discrimination based on sexual orientation and gender identity for the first time.

Texas Attorney General Ken Paxton (R) sued the federal government after the guidance was first proposed a year ago.

District Judge Reed O’Connor ruled with Paxton, explaining that the federal government “engaged in unlawful agency action taken in excess of their authority, all while failing to adhere to the appropriate notice and comments requirements when doing so.”

The administration’s Title IX revamp would also bolster nondiscrimination protections for pregnant students and change how schools handle claims of sexual harassment and assault.

Paxton and conservative groups commonly file suits in the Northern District of Texas, hoping to be assigned O’Connor, a nominee of former President George W. Bush. He was the judge who ruled in 2018 that the Affordable Care Act was unconstitutional and ruled in multiple cases that later became landmark Supreme Court decisions, including the 2015 Obergefell v. Hodges decision, which enshrined the right to gay marriage.

O’Connor has ruled against Democratic presidents’ attempts to expand Title IX before. In 2016, he went against the Obama administration when it gave guidance that colleges and universities could not discriminate by sex, in a similar attempt to expand protections to transgender students. An appeal to his decision was rescinded when former President Trump came to office.

The judge’s reasoning in Tuesday’s ruling, that the Biden administration went beyond its authority and did not allow correct time for comment, is the same as his explanation for the Obama administration decision.

O’Connor chastised the Biden administration, saying its guidance would “functionally rewrite” Title IX and “shockingly transforms American education and usurps a major question from Congress.” 

“That is not how our democratic system functions,” the judge wrote.

Paxton hailed the decision as a victory against government overreach.“Joe Biden’s unlawful effort to weaponize Title IX for his extremist agenda has been stopped in its tracks,” he said in a statement. “Threatening to withhold education funding by forcing states to accept ‘transgender’ policies that put women in danger was plainly illegal. Texas has prevailed on behalf of the entire Nation.”

The Biden administration has yet to finalize a separate rule governing athletics eligibility. The proposal unveiled by the Education Department last year would prohibit schools from enacting policies that categorically ban transgender student-athletes from sports teams that match their gender identity, with some exceptions.

The Hill has reached out to the Department of Education for comment.

https://thehill.com/regulation/court-battles/4716699-federal-judge-blocks-joe-biden-title-ix-transgender-protections/

Biden’s plan to save money on Medicare drugs risks leaving shelves empty, pharmacists say

 Months into a new Biden administration policy intended to lower drug costs for Medicare patients, independent pharmacists say they’re struggling to afford to keep some prescription drugs in stock.

“It would not matter if the governor himself walked in and said, ‘I need to get this prescription filled,’” said Clint Hopkins, a pharmacist and co-owner of Pucci’s Pharmacy in Sacramento, California. “If I'm losing money on it, it’s a no.”

A regulation that took effect in January changes prescription prices for Medicare beneficiaries. For years, prices included pharmacy performance incentives, possible rebates, and other adjustments made after the prescription was filled. Now the adjustments are made first, at the pharmacy counter, reducing the overall cost for patients and the government. But the new system means less money for pharmacies that acquire and stock medications, pharmacists say.

Pharmacies are already struggling with staff shortages, drug shortages, fallout from opioid lawsuits, and rising operating costs. While independent pharmacies are most vulnerable, some big chain pharmacies are also feeling a cash crunch — particularly those whose parent firms don’t own a pharmacy benefit manager, companies that negotiate drug prices between insurers, drug manufacturers, and pharmacies.

A top official at the Centers for Medicare & Medicaid Services said it’s a matter for pharmacies, Medicare insurance plans, and PBMs to resolve.

“We cannot interfere in the negotiations that occur between the plans and pharmacy benefits managers,” Meena Seshamani, director of the Center for Medicare, said at a conference on June 7. “We cannot tell a plan how much to pay a pharmacy or a PBM.”

Nevertheless, CMS has reminded insurers and PBMs in several letters that they are required to provide the drugs and other benefits promised to beneficiaries.

Cutting back on brand names

Several independent pharmacists told KFF Health News they’ll soon cut back on the number of medications they keep on shelves, particularly brand-name drugs. Some have even decided to stop accepting certain Medicare drug plans, they said.

As he campaigns for reelection, President Joe Biden has touted his administration’s moves to make prescription drugs more affordable for Medicare patients, hoping to appeal to voters troubled by rising health care costs. His achievements include a law, the Inflation Reduction Act, that caps the price of insulin at $35 a month for Medicare patients; caps Medicare patients’ drug spending at $2,000 a year, beginning next year; and allows the program to bargain down drug prices with manufacturers.

https://finance.yahoo.com/news/biden-plan-save-money-medicare-094500431.html

Akero Starts Phase 3 in Cirrhosis (F4) Due to MASH

 Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today announced initiation of the SYNCHRONY Outcomes study, a Phase 3 trial evaluating the efficacy and safety of efruxifermin (EFX) in patients with compensated cirrhosis, fibrosis stage 4 (F4) due to metabolic dysfunction-associated steatohepatitis (MASH).

https://www.globenewswire.com/news-release/2024/06/11/2896641/0/en/Akero-Therapeutics-Announces-Initiation-of-Phase-3-SYNCHRONY-Outcomes-Trial-of-Efruxifermin-in-Patients-with-Compensated-Cirrhosis-F4-Due-to-MASH.html

Urgent plea for type O blood after London cyberattack'

 An appeal has been launched for blood donors across England to come forward in the wake of the cyberattack which has disrupted hospitals and GP practices in London, now thought to be the work of a Russian criminal network.

NHS Blood and Transplant is asking eligible people with type O blood to come forward so there are plentiful supplies while the ransomware attack is resolved.

Type O blood, either negative or positive, can be widely used for transfusions. Around 8% of the UK population is O-negative and 35% O-positive.

O-negative in particular is desired because it can be given to just about any recipient and is known as the universal donor blood, while O-positive is usable in around three-quarters of patients – anyone who also has a positive blood type.

The cyberattack on pathology services provider Synnovis has impaired the ability of the affected hospitals to carry out crossmatching tests to make sure that donated blood is safe for patients to receive. The crossmatch is used to detect the presence of antibodies in the recipient against the red blood cells of the donor.

That process requires two separate tests, a belt-and-braces approach to make sure the recipient does not receive an unmatched donation that could lead to serious consequences.

With IT and other systems currently compromised by the ransomware attack, hospitals are now forced to use a manual testing approach that is slower and more cumbersome, contributing to the delays in treatment. A ready supply of type O blood will help patients get care more quickly, according to the NHS.

The attack a week ago has impacted patient care at Guy’s and St Thomas’ and King’s College Hospital NHS Foundation Trusts, as well as GP services in southeast London, by disconnecting the hospitals from servers operated by Synnovis. The Royal Brompton and the Evelina London Children’s Hospital were affected along with GP services in Bexley, Greenwich, Lewisham, Bramley, Southwark and Lambeth.

The incident led to the postponement of non-emergency patient care and the transfer of operations requiring blood transfusion to other unaffected hospitals.

Qilin (also known as Agenda), a Russian cybercriminal organisation that has been involved in a string of other ransomware incidents in the last couple of years, is believed to have been behind the London attack.

Former National Cyber Security Centre chief executive Ciaran Martin told the BBC last week that it was financially motivated and follows a “double extortion” tactic of encrypting data and threatening to publish it if a ransom is not paid.

Other cyberattacks have been levelled at NHS targets over the past year, including a data breach affecting Barts Health NHS Trust last July – which has been attributed to the ALPHV/BlackCat network – and a ransomware raid on NHS Dumfries and Galloway by INC Ransom earlier this year, according to an SC Media report.

https://pharmaphorum.com/news/urgent-plea-type-o-blood-after-london-cyberattack