CMS: 'Tighter price transparency enforcement, standardized requirements for hospitals to come'

 Centers for Medicare & Medicaid Services (CMS) leaders say the agency has handed out nearly 500 warnings to hospitals falling short on price transparency as of January and plans to streamline enforcement and standardize hospital reporting requirements.

Enforcement of the transparency requirements has also included more than 230 requests for corrective action plans, CMS’ Deputy Administrator and Director Meena Seshamani, M.D., and Center for Medicare Chief Transformation Officer Douglas Jacobs, M.D., wrote last week in an article for Health Affairs.

Almost 300 of the hospitals have addressed the issues spotted by CMS and are now compliant with the price transparency requirements, the CMS heads wrote. Noncompliance penalties have still only been handed out to two hospitals, Northside Hospital Atlanta and Northside Hospital Cherokee, both in Georgia.

The federal price transparency requirements went into effect Jan. 1, 2021. They require hospitals to post a comprehensive machine-readable list of their services and prices as well as a patient-friendly tool to help shop for 300 common services.

Seshamani and Jacobs said compliance with these requirements has increased substantially during the two years since enforcement began. An assessment conducted by the agency from January to February of 2021 found that among 235 randomly sampled hospitals, 66% met consumer-friendly display criteria, 30% appropriately posted machine-readable files and 27% did both.

A follow-up analysis conducted in late 2022 among 600 randomly sampled hospitals found 82% consumer-friendly display compliance, 82% machine-readable file compliance and 70% compliance in both areas. The agency heads noted that this review came after CMS’ rulemaking that increased the penalty for noncompliance from over $100,000 annually per hospital to more than $2 million annually per hospital.

“We believe the multifaceted effort that CMS has undertaken since initially implementing the regulation—including efforts to educate, monitor and enforce the regulations with increased applicable potential penalty amounts, along with heightened public interest and scrutiny—have driven this improvement,” they wrote.

CMS’ estimate is substantially more generous than other recent analyses that use different cutoffs for full compliance.

On Feb. 6, patientrightsadvocate.org released its latest semiannual review that deemed just 24.5% of 2,000 sampled hospitals to be fully compliant—up from a 5.6% rate back in July 2021. The watchdog group wrote in its latest analysis that many hospitals that had posted information were still found to be noncompliant “due to most hospitals’ files being incomplete, illegible or not having prices clearly associated with both payer and plan.”

Hospitals and other stakeholders have blamed CMS for the inconsistencies, noting that the rule provides vague guidance that can be difficult to interpret.

Seshamani and Jacobs said the issue is on CMS’ radar, writing that the agency engaged the public and stakeholders on how to improve both the consumer-facing data and machine-readable file component of the requirements.

In particular, the heads said that CMS convened last summer “a technical expert panel comprised of industry experts” for recommendations on how they could better standardize machine-readable file formats and released a template version in November that hospitals are welcome to adopt.

“The current regulations permit some flexibility related to form and format, so long as the hospital makes public its standard charges in a machine-readable file format and includes certain minimum data elements,” they wrote. “Increased standardization could help deliver on the promise of hospital price transparency to better enable third parties to develop products to make prices available to consumers. It could also help hospitals comply with the regulations and aid CMS enforcement.”

Seshamani and Jacobs added that CMS will also be looking into ways to streamline its current enforcement practices, “including expediting the timeframes by which it requires hospitals to come into full compliance upon submitting a corrective action plan.” The agency will also be taking “aggressive additional steps to identify and prioritize action” against hospitals that have yet to post any files whatsoever, they said.

“We believe that, together with members of the public, we can further unlock the collective potential of hospital price transparency and achieve greater competition in the healthcare system,” they wrote.

Hospitals’ price transparency issues have been a frequent presence in the headlines since 2021, but payers got their turn last year with their own mandate to release pricing data. That process has also been bumpy, with a Georgetown University report from last month calling for reforms to whittle down and organize the massive data troves payers have shared to date.

https://www.fiercehealthcare.com/providers/cms-tighter-price-transparency-enforcement-standardized-requirements-are-horizon

Costly discharge delays highlight need for more downstream care options in NY

 Rampant discharge delays last spring cost New York hospitals an average of $168,000 per inpatient case and $18,000 per day in the emergency department, much of which was not reimbursed by payers, according to hospital data from the Healthcare Association of New York State (HANYS).

The data collection pilot, published Tuesday, pulled information from 52 New York hospitals from April 1 to June 30, 2022.

Among these, HANYS found 1,115 patients who “for circumstances largely outside hospitals’ control” couldn’t be discharged from the ED for at least four days or from an inpatient unit for 14 days. These patients collectively represented about 60,000 days of “avoidable” delays, according to the pilot.

“These numbers are astounding, and they only represent a sliver of the crisis,” Bea Grause, president of HANYS, said in a release. “The current system is failing thousands of patients annually, their loved ones and hospitals’ healthcare professionals who, despite their best efforts and intentions, lack the resources and robust system needed to ensure these individuals are in the most appropriate care setting for their unique needs.”

The average ED discharge delay among the sample lasted nearly two weeks, according to the report, while the average inpatient discharge delay spanned two months. HANYS found that children and older adults with medically complex and/or behavioral health conditions experienced discharge delays more often and more frequently.

Nearly half of all delay days were caused by difficulties finding another care setting that could accept a patient due to, for instance, mental illness, infection status or other medical care needs such as dialysis.

Behind placement setting declinations were other issues such as insurance or financial coverage, guardianship and “extended administrative processes” related to agency referrals and eligibilities, per the report.

Altogether, the 1,115 patient delays cost the 52 hospitals an estimated $169 million, which HANYS said is likely a “conservative” guess by the participating hospitals. The group also noted that the total number of discharge delays among those hospitals is likely higher than their tally, as patients who met the inclusion criteria but had not yet been discharged by the end of the sample period were not included in the pilot.

HANYS paired its results with a framework for cutting down on delays across New York, which has between 160 to 220 hospitals “depending on the definitions used.” At the top level, these included recommendations to prevent unnecessary hospitalizations, intervene early when patients at higher risk of delay first arrive at a hospital, reimburse hospitals for the “extraordinary” costs incurred delivering care during discharge delays and better visibility and documentation of care delays.

“Our complex case discharge delay data collection pilot’s results demonstrate tremendous care gaps for individuals with complex care needs,” the group wrote. “The healthcare system must be designed for individuals with these care needs as the expectation, not the exception. The need for change is urgent.”

Patient backlogs and frequent ED boarding issues extend beyond New York. Hospital groups from states such as Washington and Minnesota have warned of discharge delays harming care access and costing hospitals millions.

In November 2022, a coalition of 33 provider groups penned a joint letter to President Joe Biden warning that “gridlocked” hospital EDs were threatening patients’ lives and the well-being of healthcare workers alike. About a month later the American Hospital Association floated discharge delays as a key driver of hospital length-of-stay and expenses in a plea to Congress for temporary financial support.

https://www.fiercehealthcare.com/providers/costly-discharge-delays-highlight-need-more-downstream-care-options-ny-groups-analysis

Cingulate Announces Positive Top-Line Results from ADHD Study

 Primary Endpoints Demonstrate CTx-1301 Can be Taken With or Without Food

CTx-1301 is Designed as a True, Entire Active-Day Treatment for ADHD

Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today announced positive top-line results from the CTx-1301-003 study assessing the effect of food on absorption of its lead candidate CTx-1301. CTx-1301 is a novel, investigational, trimodal, extended-release tablet formulation of dexmethylphenidate, a compound approved by the U.S. Food and Drug Administration (FDA) for the treatment of attention deficit/hyperactivity disorder (ADHD).

The trial demonstrated that CTx-1301 can be taken with or without food. Multiple pharmacokinetic (PK) measurements were taken and adverse events were consistent with previous findings and indicate a favorable tolerability profile.

https://www.biospace.com/article/releases/cingulate-announces-positive-top-line-results-from-fed-fast-study-of-lead-asset-ctx-1301-for-adhd/

American Cancer Society warns about potential impact of missed screenings during Covid

 When the Covid-19 pandemic brought ordinary life to a halt in 2020, routine cancer screenings fell off many people’s list of priorities. Screenings for cervical, breast, and prostate cancer all dropped in the first year of the Covid-19 pandemic, according to a new analysis from the American Cancer Society. Over the course of 2021, screening levels recovered — but the report’s authors say there’s still reason to be concerned about the impact of missed cancer screenings down the line. 

While it’s good that people are resuming their regular visits, the data suggest people haven’t been making up for the missed screens earlier in the pandemic, said Ahmedin Jemal, senior vice president of surveillance and health equity science at the American Cancer Society and the senior author on the study. “We know there was a deficit during Covid,” he said. “But [visits] should have exceeded the pre-pandemic levels to offset the Covid years, but we haven’t gotten there yet.”

The concern is that some people might have missed out on routine screenings that would have detected an early-stage cancer or precancerous lesion, Jemal said. Cancer is easiest to treat or prevent at these crucial early stages. Without a make-up visit, Jemal warned, some individuals might wait years for their next screening and then discover cancers that have advanced to later stages, when the disease is more difficult to manage.

The analysis compared the amount of breast, cervical, prostate, and colorectal cancer screenings in 2019 and 2021 using data from the U.S. government’s National Health Interview Survey. Overall, the researchers found that 57% of eligible people got breast cancer screenings in 2021, down from 60% in 2019 — an absolute difference of roughly 1.1 million individuals. For cervical cancer, 45% of eligible people received screenings, compared to 39% in 2019, a decline of about 4.4 million individuals. About 700,000 fewer people reported receiving a prostate cancer screening test, declining from 40% of the eligible pool to 36%. Colorectal screening remained the same, Jemal said, because an increase in home stool tests balanced out a drop in colonoscopies.

STAT spoke with Jemal and Jessica Star, an associate scientist at the American Cancer Society and lead author on the study, about the implications of the changes in cancer screening during the Covid-19 pandemic. This interview has been edited for length and clarity.

What was the most important finding of this analysis?

Jessica Star: Past year breast, cervical, and prostate screening all declined from 2019 to 2021. This was particularly the case for non-Hispanic Asian persons. There were declines in other groups, but non-Hispanic Asians were the only group where we saw declines in all three [categories], and we’ve been seeing the largest declines for non-Hispanic Asian persons. That’s concerning because they were already susceptible to low screening rates, based on previous literature. So, that should inform some screening campaigns to ensure groups that need screening are receiving it.

The big fear was that we would see more cancer diagnoses at later stages after the pandemic. Has that happened?

Ahmedin Jemal: It will take time to see these consequences. Progression of disease takes years, and screening at regular intervals helps cut those cancers at an early stage. For colorectal cancer and cervical cancer, you can detect lesions before they become cancer. But if you miss that window, they have time to progress to later stages, and people who skipped screening may not get another screening for several more years.

So, those missed opportunities may not turn into late-stage diagnoses in one year or two years, but there might still be cancers that weren’t picked up at the height of the pandemic that may be detected at later stages in the future. I think that’s very important. We don’t have evidence that this loss in screening led to late-stage diagnosis now, but we’ll need to monitor the stage at diagnosis over the coming years.

Why do you think screening dropped off during the pandemic?

Jemal: There were many factors contributing to that. One is financial issues — we still have close to 30 million people who are uninsured in the United States. At the height of Covid, there were high rates of unemployment, and the majority of insurance is employment-based insurance. So, a lot of people lost their insurance.

Then there’s language barriers and racial discrimination during Covid times; particularly for Asian people, there was heightened discrimination and anti-Asian hate. It’s a possibility that was partly responsible for the large decline in screening for Asian Americans, that Asian people may not have felt safe going out.

Star: I think there may also still be that element of fear about going into a physician’s office. The other thing is that community health doctors may be overburdened and burned out and required to address a lot of issues. Individuals haven’t been going back for screening, but also other preventative services as well, so I’m curious if make-up visits have been deprioritized.

What are some of the key strategies that public health can use to increase screening rates quickly and get people to make up missed screening?

Star: The finding that stool-based screening increased is really important and indicates the utility of home-based screening. It’s important to note that if you have a positive stool test, you need to go in and get a follow-up colonoscopy to complete that screening, and we’ve seen in literature that follow-up colonoscopy screening adherence has been low.

Jemal: We have a test for cervical cancer screening that’s home-based, but not been approved yet. So, the development of new home-based cancer testing is important to maintain screening and cover disruptions of the healthcare system. In particular, home-based testing went up more among Hispanic and Black individuals, so it’s important in maintaining screening of those that have been historically underserved. The American Cancer Society is also working with community health centers that work with low-income populations, so we’re working to increase screening specifically [in] those populations.

https://www.statnews.com/2023/02/23/missed-cancer-screenings/

4 e-cigarette manufacturers hit with FDA fines over unauthorized products

 The Food and Drug Administration (FDA) has fined four electronic cigarette manufacturers over their alleged sales of unauthorized products. 

The FDA said in a release on Wednesday that the agency filed a complaint against BAM Group LLC, Great American Vapes LLC, the Vape Corner Inc. and 13 Vapor Co. LLC for allegedly producing and selling certain e-liquids for its products without receiving authorization to do so. 

The release states that the FDA previously warned the companies that they were violating its premarket requirements for tobacco products and that they could face fines. The agency is seeking the maximum financial penalty of $19,192 in each of the cases against the four firms. 

The manufacturers will be able to pay the fine, enter into an agreement to settle the complaint, request an extension of time to answer the complaint or file an answer and ask for a hearing. They need to respond within 30 days after they receive the complaint to avoid the possibility of being forced to pay the entire penalty by default. 

“Holding manufacturers accountable for making or selling illegal tobacco products is a top priority for the FDA,” Brian King, the director of the FDA’s Center for Tobacco Products, said in the release. “We are prepared to use the full scope of our authorities to enforce the law—especially against those who have continued to violate the law after being warned by the agency.” 

The Hill has reached out to the four manufacturers for comment. 

The fines mark the first time the FDA has issued civil money penalty complaints against tobacco product manufacturers for violating the Federal Food, Drug and Cosmetic Act’s requirement that new tobacco products are reviewed before going to market, according to the release. 

The law grants the FDA the authority to oversee the safety of food, drugs and certain other products. 

The release states the agency has sent more than 550 warning letters since January 2021 to companies that manufacture, sell or distribute new tobacco products without being allowed. Most of the companies that receive these warnings have taken their products off the market and followed FDA regulations, the agency said.

https://thehill.com/policy/healthcare/3871432-four-e-cigarette-manufacturers-hit-with-fda-fines-over-unauthorized-products/

Toxic Wastewater From Ohio Train Derailment Headed To Texas

 Recaptured toxic wastewater that was used to extinguish a fire after a Feb. 3 train derailment in East Palestine, Ohio is now headed to a Houston, Texas suburb for disposal, according to a top official from Harris County.

"I and my office heard today that ‘firefighting water’ from the East Palestine, Ohio, train derailment is slated to be disposed of in our county," said Harris County Judge Lina Hidalgo in a Wednesday statement on Twitter. "Our Harris County Pollution Control Department and Harris County Attorney’s Office have reached out to the company and the Environmental Protection Agency to receive more information about the timing, transportation mechanisms, and contents, as well as to ensure all regulations are being met."

Further details were not provided, though Hidalgo said that her office is working closely with the mayor of Deer Park, Texas.

"I have communicated with Deer Park Emergency Management and Mayor [Jerry] Mouton and am very sensitive to the concerns that this news naturally brings to our community," Hildago's statement continues. "We will keep residents informed as we learn more."

The wastewater is headed to Texas Molecular, which has a process for injecting hazardous waste into the ground for disposal. This comes on the heels of a statement by Ohio EPA officials, who said that the chemicals used to put out the fire may have seeped into the Ohio River - partially forming into a plume of chemicals that is moving downstream.

According to the Texas Commission on Environmental Quality, Texas Molecular "is authorized to accept and manage a variety of waste streams, including vinyl chloride, as part of their … hazardous waste permit and underground injection control permit," which includes vinyl chloride - one of the ingredients carried by the train when it derailed.

"Our technology safely removes hazardous constituents from the biosphere. We are part of the solution to reduce risk and protect the environment, whether in our local area or other places that need the capabilities we offer to protect the environment," Texas Molecular said in a statement to KHOU-TV.

The company will inject the water extremely deep into the earth.

"This injection, in some cases, is usually 4,000 or 5,000 feet down below any kind of drinking water aquifer," said George Guillen, the executive director of the Environmental Institute of Houston who holds a doctorate in environmental science, who says the risk to the public is minimal despite it being "very, very toxic" material.

More via The Epoch Times,

Transportation Secretary Pete Buttigieg, who visited the derailment site Thursday, has warned the railroad responsible for the derailment, Norfolk Southern, to fulfill its promises to clean up the mess just outside East Palestine, Ohio, and help the town recover.

While in East Palestine, Buttigieg, who has faced criticism for his response to the disaster, joined members of the National Transportation Safety Board. The agency released a report on Thursday about its findings.

Cleanup continues at the site of the Norfolk Southern Railway train derailment in East Palestine, Ohio. (Jeff Louderback/The Epoch Times)

The three-dozen Norfolk Southern train cars that derailed earlier this month had “11 tank cars carrying hazardous materials that subsequently ignited, fueling fires that damaged an additional 12 non-derailed railcars,” the National Transportation Safety Board said Thursday. Five of the derailed cars were carrying about 115,580 gallons of vinyl chloride, the report found.

The five cars with the toxic substance “continued to concern authorities because the temperature inside one tank car was still rising,” which could have resulted in an explosion, the report also found. When the controlled release and burn were initiated, officials forced locals in East Palestine to evacuate before allowing them to return days later.

https://www.zerohedge.com/technology/toxic-wastewater-ohio-derailment-headed-texas

Supreme Court's 'major questions' test may doom Biden student debt plan

 hanna Hayes in 2007 became the first member of her immediate family to attend college. She did not realize she was setting off on a path toward another, less-welcome family first - racking up more than $150,000 in student debt.

"At no point did I actually have that conversation," Hayes said, referring to her lack of financial planning before enrolling at New England College in New Hampshire. "And to be honest, I didn't ask."

The finances of Hayes and millions of other Americans are in the hands of the U.S. Supreme Court as it hears arguments next Tuesday in appeals by President Joe Biden's administration of lower court rulings blocking his plan announced last August to cancel $430 billion in student debt.

Legal experts said Biden's program, intended to ease the financial burden on debt-saddled college-educated Americans like Hayes but criticized by Republicans as an overreach of his authority, may be scrutinized by the court under the so-called major questions doctrine. Its 6-3 conservative majority has employed this muscular judicial approach to invalidate major Biden policies deemed lacking clear congressional authorization.

Hayes, 34, said she plans to join a rally outside the court on Tuesday supporting Biden's plan. The Alexandria, Virginia resident earned an undergraduate degree in mathematics and taught high school math before obtaining graduate degrees in higher education administration and sports management at Southern New Hampshire University, where she went on to work in various roles supporting students. She is now seeking a job promoting higher education access and equity.

The major questions doctrine is an outgrowth of an approach favored by many conservatives and business groups to curb what they call the excesses of the "administrative state." They object to what they see as accumulated power by the U.S. government's executive branch without proper checks by the courts and Congress.

https://www.yahoo.com/news/u-supreme-courts-major-questions-111056690.html