Reform | - Part 2

Senate Finance Committee Advances PBM Reform Bill

August 2, 2023 By Jay Baldauf

A key Senate committee on Wednesday advanced bipartisan legislation aimed at regulating pharmacy benefit managers, the intermediaries in the prescription drug supply chain who negotiate discounts with drug companies on behalf of insurance plans.

The Senate Finance Committee approved the measure by a vote of 25-1, showing the broad bipartisan interest in PBM reform. Only Sen. Ron Johnson (R-Wis.) voted no, arguing the bill would add more layers of government interference.

While other committees have also passed PBM reform bills, the Finance Committee has jurisdiction over Medicare and Medicaid, which make up a large portion of U.S. health spending. Still, all the separate bills in the House and Senate will need to be combined into one floor-friendly package.

Committee Chairman Ron Wyden (D-Ore.) said he has been talking with Majority Leader Charles Schumer (D-N.Y.) about the bill, but did not give any more details.

Among other provisions, the legislation would delink PBM compensation from the price of the drug, which would remove an incentive for PBMs to favor higher priced drugs.

The legislation would also ban spread pricing, which is when a PBM charges Medicaid more for prescription drugs than they pay.

Wyden and ranking member Sen. Mike Crapo (R-Idaho) noted that additional proposals on PBMs that didn’t make it into the bill on Wednesday could be added over the August recess.

PBMs decide which drugs will be on a covered list of drugs, called a “formulary,” and how much a patient will have to pay for them. Three PBMs dominate the U.S. market: CVS Health’s Caremark, UnitedHealth’s OptumRx and Cigna’s Express Scripts.

The U.S. spends more than $4 trillion annually on health care, and Wyden said too much of that is being “frittered away on outdated middlemen practices.”

“The incentives of PBMs are just wrong. They win when prices are higher, not lower. Today’s proposals will flip that on its head,” Wyden said.

Drugmakers blame PBMs for the high costs of prescription drugs, though the PBM industry says their role is misunderstood and executives point fingers at the manufacturers.

PBMs collect rebates from drug manufacturers in exchange for coverage by a health plan.

The PBMs argue they can negotiate with insurers and manufacturers for lower drug costs and larger discounts for medications. They pass savings on to insurance plans, resulting in lower premiums for consumers.

Lawmakers have long been critical of PBMs, though the industry is not solely responsible for the high drug prices.

Sen. Sheldon Whitehouse (D-R.I) cautioned that members shouldn’t lose sight of the larger issue of drug manufacturers being responsible for setting their own prices.

“I for one want to make darn sure this committee is not turned into the tool of the pharmaceutical industry” and only focuses on PBMs, Whitehouse said.

Filed Under: ACA, Doctors, Drugs, Employer Benefits, Federal Government, General Health, Medi-Cal, Medicare, Reform Tagged With: advances, bipartisan, finance committee, Legislation, Medicaid, Medicare, PBM, reformbill, Senate

Quest Diagnostics Launches Alzheimer’s Blood Test For Consumers

August 2, 2023 By Jay Baldauf

Quest Diagnostics (DGX.N) on Monday launched the first direct-to-consumer blood test to detect abnormal levels of beta amyloid, a key Alzheimer’s disease protein that can appear years before dementia symptoms arise.

The $399 test, called AD-Detect, uses the same technology as a blood test the company began selling for use by doctors in early 2022.

“One of the advantages of having an amyloid test is that it lets you know, potentially years in advance of even being symptomatic, that you are at risk for Alzheimer’s,” said Dr. Michael Racke, Quest’s medical director of neurology.

The announcement follows U.S. regulatory approval earlier this month of Leqembi, a drug from Eisai (4523.T) and partner Biogen (BIIB.O) that removes amyloid from the brain and has been shown to slow the advance of Alzheimer’s in early-stage patients.

A similar treatment from Eli Lilly (LLY.N) called donanemab is under review by the U.S. Food and Drug Administration.

Prior Alzheimer’s treatments have treated symptoms but did not address the underlying disease.

Quest’s consumer test is aimed at adults aged 18 and older who may have mild memory loss or a family history of Alzheimer’s and want to understand their own risk for the disease, Racke said.

Users must first pay for the test on Quest’s website. A telemedicine doctor will review the purchase to ensure it is medically necessary and place an order on their behalf. Patients can review their results online and have the option to speak to a physician at no extra cost.

If the test is positive, individuals automatically will be contacted by a doctor from an independent physician network to discuss the next steps and potentially can share the results with other physicians, the company said.

Dr. Sarah Kremen, a neurologist at Cedars-Sinai in Los Angeles, was concerned that people who test positive but have no symptoms will come in seeking further testing, possibly in hopes of accessing new treatments. But they will not qualify for more testing if they are not symptomatic.

Racke said such individuals may still benefit from lifestyle interventions, such as dieting and exercise, to reduce their risk or delay the onset of symptoms. They may also qualify for Alzheimer’s trials studying treatments in at-risk individuals who are still cognitively normal.

Quest’s lab-developed test, created and performed in a single laboratory, has not undergone any FDA review. The agency generally does not review such tests as long as they are prescribed by a healthcare provider.

Filed Under: ACA, Doctors, Drugs, Employer Benefits, General Health, Medi-Cal, Medicare, Reform Tagged With: AD-direct, Alzheimer's, beta amyloid, blood test, Consumers, donanemab, Eli lilly, FDA, launches, quest diagnostics

‘Fairly Shocking’: Secret Medical Lab In California Stored Bioengineered Mice Laden With COVID

August 2, 2023 By Jay Baldauf

Illegal lab in California carried bioengineered mice, infectious agents A monthslong investigation into a rural California warehouse uncovered an illegal laboratory filled with infectious agents, medical waste and hundreds of mice bioengineered “to catch and carry the COVID-19 virus,” according to Fresno County authorities.

Health and licensing said Monday that Prestige Biotech, a Chinese medical company registered in Nevada, was operating the unlicensed facility in Reedley, California, a small city about 24 miles southeast of Fresno. The company, according to Reedley City Manager Nicole Zieba, had a goal of being a diagnostics lab.

“They never had a business license,” Zieba told USA TODAY. “The city was completely unaware that they were in this building, operating under the cover of night.”

The Fresno County Public Health Department launched its investigation into the facility in December 2022 after a code enforcement officer saw a garden hose attached to a building that was presumed to be vacant and had no active business license, Zieba said.

Further inspection in March revealed that the facility housed various chemicals, suspected biological materials, bodily fluids and hundreds of lab mice, among other lab supplies, according to court documents.

County public health officials said they also found medical devices believed to have been developed on-site, such as COVID-19 and pregnancy tests.

“Being a small, rural town of 26,000 − walking into what we believed to be a vacant building and finding lab supplies, live white mice … was was fairly shocking,” Zieba said.

After several attempts to communicate with Prestige Biotech, Fresno County officials are accusing the company of not being forthcoming with information and failing to comply with orders, such as providing a plan for hazardous and medical waste disposal.

Fresno County Public Health staff completed biological abatement work of all the materials found in the facility by July 7, according to court documents.

CDC detected at least 20 infectious agents

Zieba said officials had to conduct a separate investigation into the warehouse for several weeks because it was private property.

After authorities discovered that people were working inside the building, Zieba said, federal, state and local agencies joined the investigation, including the county health department and the FBI. Authorities were then able to serve an inspection warrant in March.

“Certain rooms of the warehouse were found to contain several vessels of liquid and various apparatus,” court documents said. “Fresno County Public Health staff also observed blood, tissue and other bodily fluid samples and serums; and thousands of vials of unlabeled fluids and suspected biological material.”

Hundreds of mice also were found at the warehouse, where they were “kept in inadequate conditions in overcrowded cages” with no food or water, according to court documents. An associate with Prestige Biotech told investigators the mice were “genetically engineered to catch and carry the COVID virus,” the documents added.

Under an abatement warrant, the city seized the mice in April and euthanized 773 of them. Nearly 180 mice were already dead, court documents said.

Zieba said officials called in the Centers for Disease Control and Prevention after about 30 freezers and refrigerators were found, with some set to minus 80 degrees. The CDC detected at least 20 potentially infectious agents, according to court documents.

“Ultimately, what we did find is some viruses, such as HIV, COVID, chlamydia, rubella, malaria, things of that nature,” Zieba said.

What is Prestige Biotech?

Prestige Biotech had been operating the unlicensed and unregulated laboratory since October 2022, according to court documents.

Emails between city officials and Xiuquin Yao, the company president, showed that Prestige Biotech had assumed assets from the now-defunct company Universal Meditech Inc. (UMI). Prestige Biotech was a creditor to UMI and became its successor, court documents said.

The assets were then moved to the Reedley warehouse from a site in Fresno, court documents said.

Authorities were unable to find any California-based addresses associated with the company except for UMI’s Fresno location. Court documents noted that other addresses provided were either “empty offices or addresses in China that could not be verified.”

During the investigation, Zieba said the company reported it was making COVID-19 and pregnancy tests with “a goal of being a diagnostics lab.”

Filed Under: ACA, Covid19, Doctors, Drugs, Employer Benefits, Federal Government, General Health, Reform, vaccinations Tagged With: bioengineered mice, California, catch and carry, CDC, Chinese company, Covid19, Fairly Shocking, fresno, Prestige Biotech, Reedley, registered Nevada, secret medical lab, unlicensed, unregulated, USA today

Medicare Advantage Report Shows Enrollees Capitalize On Supplemental Benefits

August 2, 2023 By Jay Baldauf

Most Medicare Advantage (MA) enrollees use one or more supplemental benefits, with most health plan members using multiple benefits, according to a newly released report from the Elevance Health Public Policy Institute.

The report finds that 83% of dual-eligible and 75% of non-dual-eligible individuals used at least one supplemental benefit a year. Those figures only drop to 64% and 48%, respectively, for using at least two different supplemental benefits. It also concluded that dual-eligible enrollees were more likely to live in a food desert, so they are more likely to self-select plans with strong supplemental benefit offerings.

“Further, dual eligible utilizers have a higher average CMS-HCC risk score than non-utilizers, suggesting they could be using their supplemental benefits to help address more intensive healthcare needs,” the report said.

The analysis concludes that MA enrollees see value in plans with supplemental benefits to address personalized needs. Many enrollees use grocery cards that allow for more spending on nutritious food, particularly for people living in food deserts with limited access to quality food.

Other members sign up for transportation benefits that allow people to complete errands like shopping for groceries or going to the bank. Both dual-eligible and non-dual-eligible utilizers of transportation benefits were found to have higher risk scores—and likely greater healthcare needs.

In 2019, CMS permitted supplemental benefits beyond vision and dental to include certain nonmedical services and different cost-sharing or tailored benefits.

Private MA plans can offer supplemental benefits due to the plan’s lower costs when compared to traditional Medicare, therefore enrollees can pick a plan that best suits their other individual needs. Congress has used MA to address food insecurity, as an enrollee could select a plan that offers meal benefits.

More than half of MA beneficiaries have annual incomes less than $25,000, and more than one-third identify as racial or ethnic minorities, the report says.

MA enrollment skyrocketed by 337% from 2006 to 2022, leaving the program on a path to insolvency, experts warn. Approximately half of all Medicare beneficiaries are enrolled in MA plans.

Filed Under: ACA, Doctors, Drugs, Employer Benefits, General Health, Medi-Cal, Medicare, Reform Tagged With: capitalize, CMS-HCC, dental, Elevance, enrollees, Fitness, hearing, Medicare, Medicare adbvantage, report, supplemental benefits, Vision