Demands for access to the drug are loud and insistent, despite federal regulators' recent warning against using the drug to treat COVID.

This article was published on Monday, November 8, 2021 in Kaiser Health News.

By Blake Farmer, Nashville Public Radio 

When state senators in South Carolina held two hearings in September about COVID-19 treatments, they got an earful on the benefits of ivermectin — which many of the lawmakers echoed, sharing experiences of their own loved ones.

The demands for access to the drug were loud and insistent, despite federal regulators' recent warning against using the drug to treat COVID.

Ivermectin is a generic drug that has been used for decades to treat river blindness, scabies and even head lice. Veterinarians also use it, in different formulations and dosages, to treat animals for parasites like worms.

At one of the South Carolina hearings, Pressley Stutts III reminded the panel that his father, a prominent GOP leader in the state, had died of COVID a month earlier. He believed ivermectin could have helped him. But doctors at the hospital wouldn't discuss it.

"I went every bit as far as I could without getting myself thrown in jail trying to save my father's life," he told the panel, as lawmakers offered condolences.

"What is going on here?" he asked, with the passion in his voice growing. "My dad's dead!"

The pleas to public officials have been building. And now politicians are beginning to act, largely to satisfy their conservative constituents.

After the pandemic began, scientists launched clinical trials to see if ivermectin could help as a treatment for COVID. Some are still ongoing. But providers in mainstream medicine have rejected it as a COVID treatment, citing the poor quality of the studies to date, and two notorious "preprint" studies that were circulated before they were peer-reviewed, and later taken off the internet because of inaccurate and flawed data.

On Aug. 26, the Centers for Disease Control and Prevention advised clinicians not to use ivermectin, citing insufficient evidence of benefit and pointing out that unauthorized use had led to accidental poisonings. Vaccination, the CDC reiterated, is still the best way to avoid serious illness and death from the coronavirus.

But many Americans remain convinced ivermectin could be beneficial, and some politicians appear to be listening to them.

"If we have medications out here that are working — or seem to be working — I think it's absolutely horrible that we're not trying them," said Republican state Sen. Tom Corbin in South Carolina. He questioned doctors who had come to the Statehouse to counter efforts to move ivermectin into mainstream use.

The doctors challenged the implied insult that they weren't following best practices: "Any implication that any of us would do anything to withhold effective treatments from our patients is really insulting to our profession," said Dr. Annie Andrews, a professor at the Medical University of South Carolina who has cared for COVID patients throughout the pandemic.

Instead of listening to the medical consensus, some politicians in states like South Carolina seem to be taking cues from doctors on the fringe. During one September hearing, state senators patched in a call from Dr. Pierre Kory.

Last year, Kory started a nonprofit called the Front Line COVID-19 Critical Care Alliance, which promotes ivermectin. He said he's not making money by prescribing the drug, though the nonprofit does solicit donations and has not yet filed required financial documents with the IRS.

Kory acknowledged his medical opinions have landed him on "an island."

He first testified about ivermectin to a U.S. Senate committee in December. That video went viral. Although it was taken down by YouTube, his Senate testimony prompted patients across the country to ask for ivermectin when they fell ill.

By late August, outpatient prescriptions had jumped 24-fold. Calls to poison control hotlines had tripled, mostly related to people taking ivermectin formulations meant for livestock.

Kory said he has effectively lost two jobs over his views on ivermectin. At his current hospital in Wisconsin, where he runs the intensive care unit two weeks a month, managers called him to a meeting in September, where he was informed he could no longer prescribe ivermectin. He'd been giving it to "every patient with COVID," he said.

"After the pharma-geddon that was unleashed, yeah, they shut it down," he told the South Carolina lawmakers. "And I will tell you that many hospitals across the country had already shut it down months ago."

Framing the ivermectin fight as a battle against faceless federal agencies and big pharmaceutical corporations appealed to Americans already suspicious of the science behind the pandemic and the approved COVID vaccines.

Kory suggests success stories with COVID treatments in other parts of the world have been suppressed to instead promote the vaccines.

In an interview with NPR, Kory said he regrets the flashpoint he helped ignite.

"I feel really bad for the patients, and I feel really bad for the doctors," he told NPR. "Both of them — both the patients and doctors — are trapped."

Patients are still demanding the treatment, but doctors sympathetic to their wishes are being told by their health systems not to try it.

Now conservatives in elected office are sensing political payoff if they step in to help patients get the drug. State legislatures, including those in Tennessee and Alaska, are debating various ways to increase access to ivermectin — with proposals such as shielding doctors from repercussions for prescribing it, or forcing pharmacists to fill questionable prescriptions.

The Montana State News Bureau reported that the state's Republican attorney general dispatched a state trooper to a hospital in Helena where a politically connected patient was dying of COVID. Her family was asking for ivermectin.

In a statement, St. Peter's Hospital said doctors and nurses were "harassed and threatened by three public officials."

"These officials have no medical training or experience, yet they were insisting our providers give treatments for COVID-19 that are not authorized, clinically approved, or within the guidelines established by the FDA and the CDC," the statement added.

On Oct. 14, the Republican attorney general in Nebraska addressed the controversy, issuing a nearly 50-page legal opinion arguing that doctors who consider the "off-label" use of ivermectin and hydroxychloroquine for COVID are acting within the parameters of their state medical licenses, as long as the physician obtains appropriate informed consent from a patient.

Some patients have filed lawsuits to obtain ivermectin, with mixed success. A patient in Illinois was denied. But other hospitals, including one in Ohio, have been forced to administer the drug against the objections of their physicians.

Even as they gain powerful political supporters, some ivermectin fans say they're now avoiding the healthcare system — because they've lost faith in it.

Lesa Berry, of Richmond, Virginia, had a friend who died earlier this year of COVID. The doctors refused to use ivermectin, despite requests from Berry and the patient's daughter.

They know better now, she said.

"My first attempt would have been to keep her out of the hospital," Berry said. "Because right now when you go to the hospital, they only give you what's on the CDC protocol."

Berry and her husband have purchased their own supply of ivermectin, which they keep at home.

This story is from a partnership that includes NPR, Nashville Public Radio and KHN.

Blake Farmer, Nashville Public Radio: bfarmer@wpln.org, @flakebarmer

Tamping down drug expenses has been a longtime rallying cry for consumers beset by rapidly rising prices.

This article was published on Friday, November 5, 2021, in Kaiser Health News.

By Michael McAuliff  

The Medicare prescription drug pricing plan Democrats unveiled this week is not nearly as ambitious as many lawmakers sought, but they and drug policy experts say the provisions crack open the door to reforms that could have dramatic effects. 

Tamping down drug expenses has been a longtime rallying cry for consumers beset by rapidly rising prices. Although people in private plans had some protections, those on Medicare often did not. They had no out-of-pocket caps and frequently complained that federal law kept them from using drugmakers' coupons or other cost-cutting strategies.  

A plan offered earlier this year by House Democrats — which included robust negotiation over drug prices in Medicare — was blocked by a handful of moderates who argued that the price curbs would stifle innovation. The legislation also was on a course to hit roadblocks among senators. 

The moderates favored more limited negotiation over drugs only in Medicare Part B — those administered in doctors' offices and hospitals. Most people in Medicare get their drugs through Part D, which covers medicine dispensed at a pharmacy. 

When it appeared that the bill to fund President Joe Biden's social agenda would move forward without a drug pricing proposal, the pressure built, intense negotiations were held, and a hybrid proposal was unveiled. It includes identifying 100 of the most expensive drugs and targeting 10 of them for negotiations to bring those costs down beginning in 2025. It will also place inflation caps on prescription drug prices for all insurance plans, restrict copays for insulin to no more than $35, and limit Medicare beneficiaries' annual out-of-pocket drug costs to $2,000. 

"There was a sense that the government had its hands tied behind its back. Now a precedent is being set," said Senate Finance Committee Chairman Ron Wyden (D-Ore.), who led the talks for the senators. "There's going to be negotiation on the most expensive drugs: cancer drugs, arthritis drugs or the anticoagulants. And that's a precedent, and once you set a precedent that you can actually negotiate, you are really turning an important corner."

Drugmakers say the changes could stymie consumers' options. "Under the guise of 'negotiation,' it gives the government the power to dictate how much a medicine is worth," Stephen Ubl, CEO of the trade group PhRMA, said in a statement, "and leaves many patients facing a future with less access to medicines and fewer new treatments." 

But how, exactly, will the changes be felt by most Americans, and who will be helped?  

The answers vary, and many details would still have to be worked out by government agencies if the legislation passes. House members warned some minor changes were still being made Thursday night, and it all has to pass both chambers. 

Controlling Insulin Costs 

One of the most obvious benefits will go to those who need insulin, the lifesaving drug for people with Type 1 diabetes and some with Type 2 diabetes. Although the drug has been around for decades, prices have risen rapidly in recent years. Lawmakers have been galvanized by nightmarish accounts of people dying because they couldn't afford insulin or driving to Canada or Mexico to get it cheaper. 

Under the bill, starting in 2023, the maximum out-of-pocket cost for a 30-day supply of insulin would be $35. The benefit would not be limited to Medicare beneficiaries. 

That cap is the same as one that was set in a five-year model program in Medicare. In it, the Centers for Medicare & Medicaid Services estimated that the average patient would save about $466 a year. 

Detailed analyses of the proposals were not yet available, so it is unclear what the fiscal impact or savings would be for patients outside of Medicare. 

Limiting Out-of-Pocket Spending 

Another obvious benefit for Medicare beneficiaries is the $2,000 cap on out-of-pocket costs for prescription drugs. Currently, drug costs for people in the Part D prescription drug plans are calculated with a complicated formula that features the infamous "doughnut hole," but there is no limit to how much they might spend.  

That has led to consumers with serious diseases such as cancer or multiple sclerosis paying thousands of dollars to cover their medication, a recent KFF analysis found. Under current law, when an individual beneficiary and her plan spend $4,130 this year on drugs, the beneficiary enters the doughnut hole coverage gap and pays up to 25% of the price of the drug. Once she has spent $6,500 on drugs, she is responsible for 5% of the cost through the end of the year.  

Limiting that expense is an especially big deal for people who get little low-income assistance and have expensive illnesses, said Dr. Jing Luo, an assistant professor of medicine at the University of Pittsburgh's Center for Research on Healthcare. "The patient pays 5% of all drug costs, and 5% of $160,000 is still a lot of money," he said. 

The legislation would alleviate that fear for consumers. "Rather than having a bill at the end of the year, like over $10,000, maybe their bill at the end of that year for that very expensive multiple myeloma treatment is $2,000," he said. 

Negotiating Drug Prices 

Medicare price negotiation is probably the highest-profile provision in the legislation — and the most controversial. According to the bill, the Department of Health and Human Services would be responsible for identifying the 100 high-cost drugs and choosing the 10 for price negotiations. That effort wouldn't start until 2023, but the new prices would go into effect in 2025. Another 10 drugs could be added by 2028. No drugs have been identified yet. 

To meet the concerns of some lawmakers, the legislation lays out specific provisions for how HHS would select the drugs to be included. Only drugs identified as one of a kind or the only remedy for a specific health problem would be included. 

The list would also be limited to drugs that have been on the market beyond the period of exclusivity the government grants them to be free from competition and recoup costs. For most regular drugs, the exclusivity can last nine years. For the more complicated biologic drugs, the period would be 12 years. Using the exclusivity timing allowed lawmakers to skirt the issue of whether the drugs were still under patent protection. 

The measure allows for prices to be negotiated to a lower level for older drugs chosen for the program. So, for example, the negotiated price for a non-biologic drug that has been available for less than 12 years would be 75% of the average manufacturer price. That would fall to 65% for drugs that are 12 to 16 years past their initial exclusivity, and 40% for drugs more than 16 years past the initial exclusivity. 

Drugs from smaller companies with sales under $200 million are excluded because lawmakers were afraid tamping down their prices would harm innovation. 

Some experts questioned whether the negotiated prices would be directly felt by consumers. 

"It helps Medicare, without question, to reduce their expenditures," said William Comanor, a professor of health policy and management at the UCLA Fielding School of Public Health. "But how does that affect consumers? I bet Medicare doesn't change the copay." 

Yet, he added, the copayment is less of an issue if a consumer's prescription expenses are capped at $2,000. 

Linking Prices to Inflation 

Under the bill, manufacturers would have to report their prices to the HHS secretary, and if the prices increase faster than inflation, the drugmakers would have to pay a rebate to the government. Manufacturers that don't pay the rebate would face a civil penalty of 125% of the value of the rebate. 

The provisions would apply to drugs purchased through Medicare and non-Medicare plans.  

Over the long term, the idea is to slow the overall inflation of drug prices, which has exceeded general inflation for decades. 

Drug prices would be pegged to what they were in March, and the system would go into effect in 2023, so there would be little immediate impact. (Some lawmakers had hoped to peg the program to prices from several years ago — which might produce a bigger effect — but that was changed in the negotiations over the weekend.) The long-term impact is also hard to judge, because under the current complicated system, many people who pay for drugs get assistance from the drug companies, and most generics in the U.S. are relatively inexpensive, Comanor said. 

Over the long haul, though, savings are expected to be substantial for the government, as well as for consumers who don't qualify for other programs to help pay drug expenses and need high-end medication. 

At the very least, the legislation would move the U.S. in the direction of the rest of the world. 

"The longer the drug is on the market, the lower the price," said Gerard Anderson, a professor of health policy at Johns Hopkins' medical school. "In every other country, the price goes down over time, while in the United States, it is common for prices to increase." 

Michael McAuliff: @mmcauliff ‏

About 21% of the patients who contracted COVID in the hospital from April to September last year died. In contrast, nearly 8% of other Medicare patients died in the hospital at the time.

This article was published on Thursday, November 4, 2021 in Kaiser Health News.

By Christina Jewett

They went into hospitals with heart attacks, kidney failure or in a psychiatric crisis.

They left with COVID-19 — if they left at all.

More than 10,000 patients were diagnosed with COVID in a U.S. hospital last year after they were admitted for something else, according to federal and state records analyzed exclusively for KHN. The number is certainly an undercount, since it includes mostly patients 65 and older, plus California and Florida patients of all ages.

Yet in the scheme of things that can go wrong in a hospital, it is catastrophic: About 21% of the patients who contracted COVID in the hospital from April to September last year died, the data shows. In contrast, nearly 8% of other Medicare patients died in the hospital at the time.

Steven Johnson, 66, was expecting to get an infection cut out of his hip flesh and bone at Blake Medical Center in Bradenton, Florida, last November. The retired pharmacist had survived colon cancer and was meticulous to avoid contracting COVID. He could not have known that, from April through September, 8% of that hospital's Medicare COVID patients were diagnosed with the virus after they were admitted for another concern.

Johnson had tested negative for COVID two days before he was admitted. After 13 days in the hospital, he tested positive, said his wife, Cindy Johnson, also a retired pharmacist.

Soon he was struggling to clear a glue-like phlegm from his lungs. A medical team could hardly control his pain. They prompted Cindy to share his final wishes. She asked: "Honey, do you want to be intubated?" He responded with an emphatic "no." He died three days later.

After her husband tested positive, Cindy Johnson, trained in contact tracing, quickly got a COVID test. She tested negative. Then she thought about the large number of hospital staffers flowing into and out of his room — where he was often unmasked — and suspected a staff member had infected him. That the hospital, part of the HCA Healthcare chain, still has not mandated staff vaccinations is "appalling," she said.

"I'm furious," she said.

"How can they say on their website," she asked, "that the safety precautions 'we've put into place make our facilities among the safest possible places to receive healthcare at this time'?"

Blake Medical Center spokesperson Lisa Kirkland said the hospital is "strongly encouraging vaccination" and noted that it follows Centers for Disease Control and Prevention and federal and state guidelines to protect patients. President Joe Biden has called for all hospital employees to be vaccinated, but the requirement could face resistance in a dozen states, including Florida, that have banned vaccine mandates.

Overall, the rate of in-hospital spread among Medicare and other patients was lower than in other countries, including the United Kingdom, which makes such data public and openly discusses it. On average, about 1.7% of U.S. hospitalized COVID patients were diagnosed with the virus in U.S. hospitals, according to an analysis of Medicare records from April 1 to Sept. 30, 2020, provided by Dr. James Kennedy, founder of CDIMD, a Nashville-based consulting and data analytics company.

Yet the rate of infection was far higher in 38 hospitals where 5% or more of the Medicare COVID cases were documented as hospital-acquired. The data is from a challenging stretch last year when protective gear was in short supply and tests were scarce or slow to produce results. The Medicare data for the fourth quarter of 2020 and this year isn't available yet, and the state data reflects April 1 through Dec. 31, 2020.

A KHN review of work-safety records, medical literature and interviews with staff at high-spread hospitals points to why the virus took hold: Hospital leaders were slow to appreciate its airborne nature, which made coughing patients hazardous to roommates and staff members, who often wore less-protective surgical masks instead of N95s. Hospitals failed to test every admitted patient, enabled by CDC guidance that leaves such testing to the "discretion of the facility." Management often failed to inform workers when they'd been exposed to COVID and so were at risk of spreading it themselves.

Spread among patients and staffers seemed to go hand in hand. At Beaumont Hospital, Taylor, in Michigan, 139 employee COVID infections were logged between April 6 to Oct. 20 last year, a hospital inspection report shows. Nearly 7% of the Medicare patients with COVID tested positive after they were admitted to that hospital for something else, the federal data shows. A hospital spokesperson said tests were not available to screen all patients last year, resulting in some late diagnoses. He said all incoming patients are tested now.

Tracking COVID inside health facilities is no new task to federal officials, who publicly report new staff and resident cases weekly for each U.S. nursing home. Yet the Department of Health and Human Services reports data on COVID's spread in hospitals only on a statewide basis, so patients are in the dark about which facilities have cases.

KHN commissioned analyses of hospital billing records, which are also used more broadly to spot various hospital-acquired infections. For COVID, the data has limitations. It can pick up some community-acquired cases that were slow to show up, as it can take two to 14 days from exposure to the virus for symptoms to appear, with the average being four to five days. The records do not account for cases picked up in an emergency room or diagnosed after a hospital patient was discharged.

Linda Moore, 71, tested positive at least 15 days into a hospital stay for spinal surgery, according to her daughter Trisha Tavolazzi. Her mother was at Havasu Regional Medical Center in Lake Havasu City, Arizona, which did not have a higher-than-average rate of internal spread last summer.

The hospital implemented "rigorous health and safety protocols to protect all of our patients" during the pandemic, said hospital spokesperson Corey Santoriello, who would not comment on Moore's case, citing privacy laws.

Moore was airlifted to another hospital, where her condition only declined further, her daughter said. After the ventilator was removed, she clung to life fitfully for 5½ hours, as her daughter prayed for her mother to find her way to heaven.

"I asked her mom and her dad and her family and prayed to God, 'Please just come show her the way,'" Tavolazzi said. "I relive it every day."

When Tavolazzi sought answers from the hospital about where her mom got the virus, she said, she got none: "No one ever called me back."

Two Negative COVID Tests, Then 'Patient Zero'

As the second surge of COVID subsided last September, doctors from the prestigious Brigham and Women's Hospital published a reassuring study: With careful infection control, only two of 697 COVID patients acquired the virus within the Boston hospital. That is about 0.3% of patients ― about six times lower than the overall Medicare rate. Brigham tested every patient it admitted, exceeding CDC recommendations. It was transparent and open about safety concerns.

But the study, published in the high-profile JAMA Network Open journal, conveyed the wrong message, according to Dr. Manoj Jain, an infectious-disease physician and adjunct professor at the Rollins School of Public Health at Emory University. COVID was spreading in hospitals, he said, and the study buried "the problem under the rug."

Before the virtual ink on the study was dry, the virus began a stealthy streak through the elite hospital. It slipped in with a patient who tested negative twice ― but turned out to be positive. She was "patient zero" in an outbreak affecting 38 staffers and 14 patients, according to a study in Annals of Internal Medicine initially published Feb. 9.

That study's authors sequenced the genome of the virus to confirm which cases were related ― and precisely how it traveled through the hospital.

As patients were moved from room to room in the early days of the outbreak, COVID spread among roommates 8 out of 9 times, likely through aerosol transmission, the study says. A survey of staff members revealed that those caring for coughing patients were more likely to get sick.

The virus also appeared to have breached the CDC-OK'd protective gear. Two staff members who had close patient contact while wearing a surgical mask and face shield still wound up infected. The findings suggested that more-protective N95 respirators could help safeguard staff.

Brigham and Women's now tests every patient upon admission and again soon after. Nurses are encouraged to test again if they see a subtle sign of COVID, said Dr. Erica Shenoy, associate chief of the Infection Control Unit at Massachusetts General Hospital, who helped craft policy at Brigham.

She said nurses and environmental services workers are at the table for policymaking: "I personally make it a point to say, 'Tell me what you're thinking,'" Shenoy said. "'There's no retribution because we need to know.'"

CDC guidelines, though, left wide latitude on protective gear and testing. To this day, Shenoy said, hospitals employ a wide range of policies.

The CDC said in a statement that its guidelines "provide a comprehensive and layered approach to preventing transmission of SARS-CoV-2 in healthcare settings," and include testing patients with "even mild symptoms" or recent exposure to someone with COVID.

Infection control policies are rarely apparent to patients or visitors, beyond whether they're asked to wear a mask. But reviews of public records and interviews with more than a dozen people show that at hospitals with high rates of COVID spread, staff members were often alarmed by the lack of safety practices.

Nurses Sound the Alarm on COVID Spread

As COVID crept into Florida in spring 2020, nurse Victoria Holland clashed with managers at Blake Medical Center in Bradenton, where Steven Johnson died.

She said managers suspended her early in the pandemic after taking part in a protest and "having a hissy fit" when she was denied a new N95 respirator before an "aerosol-generating" procedure. The CDC warns that such procedures can spread the virus through the air. Before the pandemic, nurses were trained to dispose of an N95 after each patient encounter.

When the suspension was over, Holland said, she felt unsafe. "They told us nothing," she said. "It was all a little whisper between the doctors. You had potential COVIDs and you'd get a little surgical mask because [they didn't] want to waste" an N95 unless they knew the patient was positive.

Holland said she quit in mid-April. Her nursing colleagues lodged a complaint with the Occupational Safety and Health Administration in late June alleging that staff "working around possible COVID-19 positive cases" had been denied PPE. Staff members protested outside the hospital in July and filed another OSHA complaint that said the hospital was allowing COVID-exposed employees to keep working.

Kirkland, the Blake spokesperson, said the hospital responded to OSHA and "no deficiencies were identified."

The Medicare analysis shows that 22 of 273 patients with COVID, or 8%, were diagnosed with the virus after they were admitted to Blake. That's about five times as high as the national average.

Kirkland said "there is no standard way for measuring COVID-19 hospital-associated transmissions" and "there is no evidence to suggest the risk of transmission at Blake Medical Center is different than what you would find at other hospitals."

In Washington, D.C., 34 Medicare COVID patients contracted the virus at MedStar Washington Hospital Center, or nearly 6% of its total, the analysis shows.

Unhappy with the safety practices ― which included gas sterilization and reuse of N95s — National Nurses United members protested on the hospital lawn in July 2020. At the protest, nurse Zoe Bendixen said one nurse had died of the virus and 50 had gotten sick: "[Nurses] can become a source for spreading the disease to other patients, co-workers and family members."

Nurse Yuhana Gidey said she caught COVID after treating a patient who turned out to be infected. Another nurse ― not managers doing contact tracing ― told her she'd been exposed, she said.

Nurse Kimberly Walsh said in an interview there was an outbreak in a geriatric unit where she worked in September 2020. She said management blamed nurses for bringing the virus into the unit. But Walsh pointed to another problem: The hospital wasn't COVID-testing patients coming in from nursing homes, where spread was rampant last year.

MedStar declined a request for an interview about its infection control practices and did not respond to specific questions.

While hospitals must track and publicly report rates of persistent infections like C. diff, antibiotic-resistant staph and surgical site infections, similar hospital-acquired COVID rates are not reported.

KHN examined a different source of data that Congress required hospitals to document about "hospital-acquired conditions." The Medicare data, which notes whether each COVID case was "present on admission" or not, becomes available months after a hospitalization in obscure files that require a data-use agreement typically granted to researchers. KHN counted cases, as federal officials do, in some instances in which the documentation is deemed insufficient to categorize a case (see data methodology, below).

For this data, whether to deem a COVID case hospital-acquired lies with medical coders who review doctors' notes and discharge summaries and ask doctors questions if the status is unclear, said Sue Bowman, senior director of coding policy and compliance at American Health Information Management Association.

She said medical coders are aware that the data is used for hospital quality measures and would be careful to review the contract tracing or other information in the medical record.

If a case was in the data KHN used, "that would mean it was acquired during the hospital stay either from a healthcare worker or another patient or maybe if a hospital allowed visitors, from a visitor," Bowman said. "That would be a fair interpretation of the data."

The high death rate for those diagnosed with COVID during a hospital stay — about 21% — mirrors the death rate for other Medicare COVID patients last year, when doctors had few proven methods to help patients. It also highlights the hazard unvaccinated staffers pose to patients, said Jain, the infectious-disease doctor. The American Hospital Association estimates that about 42% of U.S. hospitals have mandated that all staff members be vaccinated.

"We don't need [unvaccinated staff] to be a threat to patients," Jain said. "[Hospital] administration is too afraid to push the nursing staff, and the general public is clueless at what a threat a non-vaccinated person poses to a vulnerable population."

Cindy Johnson said the hospital where she believes her husband contracted COVID faced minimal scrutiny in a state inspection, even after she said she reported that he caught COVID there. She explored suing, but an attorney told her it would be nearly impossible to win such a case. A 2021 state law requires proof of "at least gross negligence" to prevail in court. 

Johnson did ask a doctor who sees patients at the hospital for this: Please take down the big "OPEN & SAFE" sign outside. 

Within days, the sign was gone.

KHN Midwest correspondent Lauren Weber contributed to this report.

Methodology

KHN requested custom analyses of Medicare, California and Florida inpatient hospital data to examine the number of COVID-19 cases diagnosed after a patient's admission.

The Medicare and Medicare Advantage data, which includes patients who are mostly 65 or older, is from the Medicare Provider Analysis and Review (MedPAR) file and was analyzed by CDIMD, a Nashville-based medical code consulting and data analytics firm. The data is from April 1 through Sept. 30, 2020. The data for the fourth quarter of 2020 is not yet available.

That data shows the number of inpatient Medicare hospital stays in the U.S., including the number of people diagnosed with COVID and the number of admissions for which the COVID diagnosis was not "present on admission." A condition not "present on admission" is presumed to be hospital-acquired. The data is for general acute-care hospitals, which may include a psychiatric floor, and not for other hospitals such as Veterans Affairs or stand-alone psychiatric hospitals.

KHN requested a similar analysis from California's Department of Healthcare Access and Information of its hospital inpatient data. That data was from April 1 through Dec. 31, 2020, and covered patients of all ages and payer types and in general, private psychiatric and long-term acute-care hospitals. Etienne Pracht, a University of South Florida researcher, provided the number of Florida COVID patients who did not have the virus upon hospital admission for all ages at general and psychiatric hospitals from April 1 through Dec. 31, 2020. KHN subtracted the number of Medicare patients in the MedPAR data from the Florida and California all-payer datasets so they would not be counted twice.

To calculate the rate of Medicare patients who got COVID or died, KHN relied on the MedPAR data for April through September. That data includes records for 6,629 seniors, 1,409 of whom, or 21%, died. California data for all ages and payer types from April through December shows a similar rate: Of 2,115 who contracted COVID after hospital admission, 435, or 21%, died. The MedPAR data was also used to calculate the national nosocomial COVID rate of 1.7%, with 6,629 of 394,939 COVID patients diagnosed with the virus that was deemed not present on admission.

Data on whether an inpatient hospital diagnosis was present on admission is used by Medicare for payment determinations and is intended to incentivize hospitals to prevent infections acquired during hospital care. It is also used by the U.S. Agency for Healthcare Research and Quality to "assist in identifying quality of care issues."

Whether COVID is acquired in a hospital or in the community is measured in different ways. Some nations assume the virus is hospital-acquired if it is diagnosed seven or more days after admission, while statewide U.S. data counts cases only after 14 days.

Medical coders who examine medical records for this inpatient billing data focus on the physician's admission, progress and discharge notes to determine whether COVID was present on admission. They do not have a set number of days they look for and are trained to query physicians if the case is unclear, according to Sue Bowman, senior director of coding policy and compliance at the American Health Information Management Association.

KHN tallied the cases in which COVID was logged in the data as not "present on admission" to the hospital. Some COVID cases are coded as "U" for having insufficient documentation to make a determination. Since Medicare and AHRQ consider the "U" to be an "N" (or not present on admission) for the purposes of payment decisions and quality indicators, KHN chose to count those cases in the grand total.

In 409 of 6,629 Medicare cases and in 70 of 2,185 California cases, the "present on admission" indicator was "U." The Florida data did not include patients whose "present on admission" indicator was "U." Medical coders have another code, "W," for "clinically undetermined" cases, which consider a condition present on admission for billing or quality measures. Medical coders use the "U" (leaning toward "not present on admission") and "W" (leaning toward "present on admission") when there is some uncertainty about the case.

The Medicare MedPAR data includes about 2,500 U.S. hospitals that had at least a dozen COVID cases from April through September 2020. Of those, 1,070 reported no cases of hospital-acquired COVID in the Medicare records. Data was suppressed for privacy reasons for about 1,300 hospitals that had between one and 11 hospital-acquired COVID cases. There were 126 hospitals reporting 12 or more cases of COVID that were not present on admission or unknown. For those, we divided the number of hospital-acquired cases by the total number of patients with COVID to arrive at the rate of hospital-acquired cases, as is standard in healthcare.

Christina Jewett: ChristinaJ@kff.org, @by_cjewett

Nearly two-thirds of those in the Medicaid coverage gap live in one of three Republican-controlled states: Texas, Florida, and Georgia.

This article was published on Thursday, November 4, 2021 in Kaiser Health News.

By Phil Galewitz and Andy Miller    

At least 2.2 million low-income adults — nearly all in Texas and the Southeast — would be eligible for government-funded health insurance under the Democrats' $1.75 trillion social spending and climate change plan.

That's the number of people who are eligible for Medicaid under the Affordable Care Act but have been left uninsured because they live in one of the dozen states that have not expanded coverage under the 2010 law. They are in the coverage gap — with incomes too high to qualify for Medicaid, but below the $12,880 annual federal income minimum for an individual to qualify for subsidized coverage in the insurance marketplaces created by the ACA.

An estimated 60% of those caught in that Medicaid coverage gap are Black or Hispanic, according to the Center on Budget and Policy Priorities. And nearly two-thirds of those in the gap live in one of three Republican-controlled states: Texas (771,000), Florida (415,000) and Georgia (269,000), according to a KFF analysis.

Under the plan announced by President Joe Biden after negotiations with key Democratic lawmakers in Congress, those in the gap would qualify for ACA marketplace subsidies for four years starting in January. They would get additional cost-sharing protections starting in 2023 that would bring their out-of-pocket costs close to zero.

To encourage existing Medicaid expansion states to maintain their coverage levels, the bill would raise the 90% federal matching rate for the expansion population to 93% from 2023 through 2025.

To help pay for that coverage and incentivize holdout states to expand Medicaid, starting in 2023 the plan would permanently cut billions in special federal Medicaid funding to the non-expansion states that helps hospitals with disproportionately high rates of uninsured or Medicaid patients.

Those cuts have unsettled hospital industry officials, who worry that losing those special funds would mean less money to pay for services. "We always are in favor of coverage expansion," said Beth Feldpush, senior vice president of America's Essential Hospitals, which represents hospitals that treat many poor and uninsured patients. "Our concern is it is paired with cuts to the safety net, and … that is a double-edged sword."

The American Hospital Association has estimated those funding cuts would total as much as $7.8 billion over 10 years. Industry groups say hospitals need the extra Medicaid funding to handle the more than 25 million people who would remain uninsured even after the coverage expansion.

One benefit for hospitals and healthcare providers is that marketplace health plans generally pay higher reimbursement rates than Medicaid — but they also often come with higher deductibles that can be difficult for patients to pay and providers to collect.

The massive spending package hinges on Sen. Joe Manchin (D-W.Va.), whose support is critical. Democrats can't afford to lose one party member vote in the 50-50 Senate, where Vice President Kamala Harris would break any ties and the GOP stands firmly against any government expansion. But Manchin has not yet said whether he will vote for the package.

Consumer advocates are ecstatic that Congress may no longer wait for intransigent Republican-controlled legislatures and governors to expand Medicaid. Republican leaders have cited a host of reasons for resisting, including that their states can't afford the 10% match and that nondisabled adults don't deserve Medicaid. States could not block the coverage expansion because it falls outside of Medicaid, which is jointly funded by the federal and state governments.

"This is a big deal," said Anne Swerlick, a public interest attorney in Tallahassee who has lobbied Florida's legislature to expand Medicaid. "It would make an extraordinary difference in the quality of life for tens of thousands of Floridians caught in the gap. In many instances, it will be a lifesaver."

Sen. Raphael Warnock (D-Ga.), a key lawmaker advocating for the provision, said Congress needs "to close the coverage gap in Georgia and the 11 other states where hardworking families wake up every day without healthcare coverage their neighbors in 38 other states enjoy." But, on Wednesday, he said he and Georgia's other congressional Democrats oppose the cuts to special Medicaid funding for hospitals.

While most states expanded Medicaid in 2014, no state legislature has adopted it since Virginia's in 2018. Since 2017, six states have enacted expansion as a result of ballot initiatives, most recently Missouri.

Those that haven't adopted it are in the South, save for Wyoming, Kansas, South Dakota and Wisconsin. Wisconsin already covers adults on Medicaid up to the federal poverty level but has not expanded it to match the 138% of that federal level called for under the ACA.

In Georgia, Gov. Brian Kemp and other GOP leaders have sought federal approval for a partial Medicaid expansion, which would require work or other activities for eligibility. But the Biden administration has so far resisted this approach.

R.D. Williams, CEO of Hendry Regional Medical Center in Clewiston, Florida, said the Democrats' plan would cover about 60% of the uninsured who use his hospital, which serves one of the poorest parts of the state. "It will definitely have an impact," he said.

Expanding coverage, he said, would help many patients better manage their health by getting access to primary care doctors and specialists. Medicaid enrollees make up 25% of Williams' patients, while more than 30% have no coverage. "Our largest payer group is the uninsured," he said.

However, Williams said he was still trying to figure out how much money he might have to give up in Medicaid funding under the bill. Those cuts would occur unless Florida expands Medicaid.

Elijah Manley, 22, of Fort Lauderdale, Florida, racked up more than $2,000 in bills after going to a hospital emergency room for COVID-19 treatment last year. Without insurance, he has no way to pay and fears it will hurt his credit. He's been uninsured since he aged out of Medicaid when he turned 21.

Manley works part time in a bar and also is one of several Democrats running for a special primary election for a state House seat in January. He hopes Congress will pass a plan that gives him access to free or low-cost insurance so he doesn't have to think twice about going to the doctor. "It would be very helpful to me, as I have a couple things I want to check out," he said, noting he has a family history of diabetes.

It's been nearly a decade since the Supreme Court in 2012 narrowly upheld the ACA but made its Medicaid expansion provision optional for states.

Joan Alker, director of the Georgetown University Center for Children and Families, said the Democrats' plan should motivate states to expand Medicaid because they could do so without losing their special Medicaid funding.

"If it moves states, that would be great, but it ain't going to happen," said Chip Kahn, president of the Federation of American Hospitals, which represents for-profit hospitals.

Mississippi hospitals welcome the Democrats' plan despite concerns about funding cuts.

"Hospitals would prefer a straight-up Medicaid expansion, but at this point a thirsty man is not going to be really choosy about whether it's bottled water, mineral water or tap water," said Richard Roberson, a vice president at the Mississippi Hospital Association. "An opportunity for some coverage is better than nothing."

The Medicaid gap has contributed to the financial problems of rural hospitals in Georgia, leading to recent closures, said Sen. Jon Ossoff (D-Ga.). On people stuck in the coverage gap: "It's unfair, and folks are suffering and dying needlessly."

Anne Dunkelberg, health policy expert for the advocacy group Every Texan, said 80% of Texans in the coverage gap are in working households. "I obviously am not going to celebrate till the ink dries, but I'd be thrilled for the working poor in Texas to get coverage."

Phil Galewitz: pgalewitz@kff.org, @philgalewitz

Andy Miller: amiller@kff.org, @gahealthnews