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Thursday, August 10, 2023

'Seniors’ medical debt soars to $54 billion in unpaid bills'

 Seniors face more than $50 billion in unpaid medical bills, many of which they shouldn’t have to pay, according to a federal watchdog report.

In an all-too-common scenario, medical providers charge elderly patients the full price of an expensive medical service rather than work with the insurer that is supposed to cover it. If the patient doesn’t pay, the provider sends the bill into collections, setting off a round of frightening letters, humiliating phone calls and damaging credit reports.

That is one conclusion of a recent report titled Medical Billing and Collections Among Older Americans, from the Consumer Financial Protection Bureau.

The report recounts a horror story from a patient in southern Pennsylvania over a hospital visit, which should have been covered by insurance.

“I never received a bill from anyone,” the patient said in a 2022 complaint. Then came a phone call from a collection agency. “The woman on the phone started off aggressively screaming at me,” saying the patient owed $2,300.

“I told her there must be some mistake, that both Medicare and my supplement insurance would have covered it. It has in the past. She started screaming, very loud, ‘If you don’t pay me right now, I will put this on your credit report.’ I told her, ‘If you keep screaming at me, I will hang up.’ She continued, so I hung up.”

Nearly 4 million seniors reported unpaid medical bills in 2020, even though 98 percent of them had insurance, the report found. Medicare, the national health insurance program, was created to protect older Americans from burdensome medical expenses.

Total unpaid medical debt for seniors rose from $44.8 billion in 2019 to $53.8 billion in 2020, even though older adults reported fewer doctor visits and lower out-of-pocket costs in 2020.

Medical debt among seniors is rising partly because health care costs are going up, agency officials said. But much of the $53.8 billion is cumulative, they said, debt carried over from one year to the next. Figures for 2020 were the latest available.

Millions of older Americans are covered by both Medicare and Medicaid, a second federal insurance program for people of limited means. Federal and state laws widely prohibit health care providers from billing those patients for payment beyond nominal copays.

Yet, those low-income patients are more likely than wealthier seniors to report unpaid medical bills. The agency’s findings suggest that health care companies are billing low-income seniors “for amounts they don’t owe.” The findings draw from census data and consumer complaints collected between 2020 and 2022.

Many complaints depict medical providers and collection agencies relentlessly pursuing seniors for payment on bills that an insurance company has rejected over an error, rather than correcting the error and resubmitting the claim.

“Many of these errors likely are avoidable or fixable,” the report states, “but only a fraction of rejected claims are adjusted and resubmitted.”

When a patient points out the error, the creditors might agree to fix it, only to ignore that pledge and double down on the debt collection effort.

An Oklahoma senior recounted a collection agency nightmare that followed a hospital stay. After paying all legitimate bills, the patient discovered new charges from a collection agency on a credit report. In subsequent months, additional charges appeared.

The patient assembled billing statements and correspondence, hoping to clear the bogus charges. “I then proceeded to spend every weekday, all day, for two weeks on the phone, trying to find out who was billing me and why,” the patient said in a 2021 complaint.

The Oklahoman eventually paid the bills, “even though I don’t owe them.” Then, more charges appeared.

“Nice racket they have going,” the patient quipped.

As anyone with health insurance knows, medical providers occasionally charge patients for services that should have been covered by the insurer. Someone forgets to submit the claim, or types the wrong billing code or omits crucial documentation. Some providers charge patients more than the negotiated rate, a discounted fee set between the provider and insurer.

Americans spend hours of their lives disputing such charges. But many seniors aren’t up to the task.

“It’s tiring to have multiple conversations, sitting on the phone for an hour, chasing representatives,” said Genevieve Waterman, director of economic and financial security at the National Council on Aging.

“I think technology is outpacing older adults,” she said. “If you don’t have the digital literacy, you’re going to get lost.”

Older adults are more likely than younger people to have multiple chronic health conditions, which can require more detailed insurance documentation and face greater scrutiny, yielding more billing errors and denied claims, the federal report says.

Seniors are also more likely to rely on more than one insurance plan. As of 2020, two-thirds of older adults with unpaid medical bills had two or more sources of insurance.

Multiple insurers means a more complex billing process, making it harder for either patient or provider to file a claim and see that it is paid. With Medicaid, “you have 50 states, plus the territories,” said one official from the federal agency, speaking on condition of anonymity. “They each have their own billing system.”

In an analysis of Medicare complaints filed between 2020 and 2022, the agency found that 53 percent involved debt collectors seeking money the patient didn’t owe. In a smaller share of cases, patients reported that collection agents threatened punitive action or made false statements to press their case.

The complaints “illustrate how difficult it is to identify an inaccurate bill, learn where it originated, and correct other people’s mistakes,” the report states. “Some providers refuse to talk to consumers because the account has already been referred to collections. Even when providers seem willing to correct their own mistakes, debt collectors may continue attempting to collect a debt that is not owed and refuse to stop reporting inaccurate data.”

Rather than carry on a fight with collection agents over multiple rounds of calls and correspondence, many seniors become ensnared in a “doom loop,” the report says, convinced their appeal is hopeless. They pay the erroneous bill.

“I think some people get to the point where they just throw up their hands and give up a credit card number just to make the problem go away,” said Juliette Cubanski, deputy director of the Program on Medicare Policy at KFF.

Debt takes a toll on the mental and physical health of seniors, research has shown. Older adults with debt are more prone to a range of ailments, including hypertension, cancer and depression.

As the Oklahoma patient said, recalling a years-long battle over unpaid bills, “It nearly sent me back to the hospital.”

https://thehill.com/policy/healthcare/4146137-seniors-owe-54-billion-unpaid-medical-bills/

CymaBay starts Phase 3 Biliary Cholangitis trial

 CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on developing and providing access to innovative therapies for patients with liver and other chronic diseases, today announced the initiation of its 52-week, placebo-controlled, randomized, Phase 3 study — "Intended to Determine the Effects of seladelpar on normalization of Alkaline phosphatase (ALP) Levels in subjects with Primary Biliary Cholangitis (PBC)" (IDEAL).

The IDEAL study aims to enroll 75 patients with PBC who have an incomplete response or intolerance to ursodeoxycholic acid (UDCA), in each case with ALP greater than the upper limit of normal (ULN) but less than 1.67xULN, and total bilirubin less than or equal to 2xULN. Patients will be randomly assigned using a 2:1 ratio to oral, once daily seladelpar 10 mg or placebo. The primary outcome measure is the normalization of ALP at 52 weeks.

Additional key outcomes evaluating efficacy include the percent change from baseline in ALP at 52 weeks and the level of self-reported pruritus (itch) at 6 months for patients with moderate to severe symptoms at baseline, assessed by a numerical rating scale (NRS) and recorded by electronic diary.

https://www.biospace.com/article/releases/cymabay-initiates-ideal-a-phase-3-placebo-controlled-randomized-study-of-seladelpar-in-patients-with-primary-biliary-cholangitis-and-incomplete-control-of-alkaline-phosphatase/

UroGen: Record JELMYTO Quarterly Sales and Recent Corporate Developments

 

  • Both ENVISION and ATLAS Phase 3 trials of UGN-102 met primary endpoints in treating low-grade intermediate-risk non‐muscle‐invasive bladder cancer (LG-IR-NMIBC).
  • Reported record JELMYTO® net product revenues in Q2 2023 of $21.1 million, an increase of ~27% from the same period last year
  • Significantly strengthened balance sheet via $120 million private placement of ordinary shares and pre-funded warrants

FDA approves Johnson & Johnson's blood cancer therapy

 Johnson & Johnson said on Thursday the U.S. Food and Drug Administration had approved its antibody-based therapy for patients with a difficult-to-treat type of blood cancer.

The therapy, talquetamab-tgvs branded as Talvey, belongs to a class of treatments called bispecific antibodies designed to bring a cancer cell and an immune cell together so the body's immune system can kill the cancer.

Talvey was approved as a weekly or biweekly subcutaneous, or under-the-skin, injection to treat patients with relapsed multiple myeloma who have received at least four prior lines of treatment, the company said.

Multiple myeloma is a form of cancer that starts in the bone marrow and ultimately disrupts the production of normal blood cells.

Other treatment options available for multiple myeloma include J&J 's Carvykti and Bristol-Myers Squibb's Abecma which belong to a class called CAR-T therapies, or chimeric antigen receptor T-cell therapies. They work by harvesting a patient's own disease-fighting T-cells, genetically engineering them to target specific proteins on cancer cells, and replacing them to seek out and attack cancer.

"Although options for the treatment of multiple myeloma have expanded significantly in recent years, the disease remains incurable, and therefore, patients are in need of new treatment options," said Michael Andreini, CEO of the non-profit Multiple Myeloma Research Foundation.

The FDA also placed its strongest "boxed" safety warning on the drug's label, flagging the risk for a type of aggressive immune response or cytokine release syndrome and neurologic toxicity.

The accelerated approval is based on data from a mid-stage study, which showed 73.6% patients achieved either partial or complete disappearance of cancer from their body

https://finance.yahoo.com/news/1-us-fda-approves-j-104714008.html

Marinus Q2 update

 

  • ZTALMY® (ganaxolone) second quarter net product revenue of $4.2 million; 2023 net product revenue guidance increased to between $17 and $18.5 million

  • European Commission approved ZTALMY in CDKL5 deficiency disorder

  • Interim analysis for the Phase 3 refractory status epilepticus trial now expected Q1 2024

  • First patient dosed in MAD trial with second generation ganaxolone formulation

  • New emergency IND dosing paradigm for super refractory status epilepticus showing encouraging initial results

  • Granted a new method of use patent by USPTO for ganaxolone in tuberous sclerosis complex

  • Cash runway expected into second half of 2024 with cash, cash equivalents and short-term investments of $175.3 million as of June 30, 2023

  • Marinus to host conference call on August 10, 2023, at 8:30 a.m. ET

Participants may access the conference call via webcast on the Investor page of Marinus’ website at ir.marinuspharma.com/events-and-presentations. An archived version of the call will be available approximately two hours after the completion of the event on the website.

Aprea Q2 update

 “We continue to execute across all our programs, with notable progress in enrollment in our lead Phase 1/2a dose escalation study with ATRN-119, our ATR inhibitor for the treatment of advanced solid tumors and anticipate initial preliminary data in the fourth quarter 2023,” said Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea. “Our IND enabling studies for ATRN-1051, our WEE1 inhibitor, continue to be on track, and we continue to anticipate filing an IND by the end of the year. Our strong balance sheet continues to support our strategy and plans through our near-term milestones in both our ATR and WEE1 programs, with a cash runway into the fourth quarter of 2024. We look forward to providing more updates as we make progress throughout the rest of the year.”

https://finance.yahoo.com/news/aprea-therapeutics-reports-second-quarter-113000763.html

Bristol Myers Squibb extends bounce after $4 billion accelerated buyback agreements

 Shares of Bristol Myers Squibb Co. (BMY) got a 0.9% bump up in premarket trading Thursday, after the biopharmaceutical company announced $4 billion in accelerated share repurchase agreements. The ASR represents 3.2% of the company's market capitalization of $126.64 billion as of Wednesday's close. After the ASR is completed, the company will have $2 billion remaining is share buyback authorization. The ASR comes after the stock bounced 0.8% on Wednesday, after closing at a 19-month low of $60.16 on Tuesday. The stock has dropped 15.8% year to date through Wednesday, while the Health Care Select Sector SPDR ETF (XLV) has eased 0.7% and the S&P 500 has advanced 16.4%.

https://www.morningstar.com/news/marketwatch/20230810246/bristol-myers-squibb-stock-extends-bounce-after-announced-4-billion-accelerated-buyback-agreements