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AHA, BCBSA Urge CMS To Ditch ‘Conflicting’ Requirements In Prior Authorization Reform Proposal

August 9, 2023 By Jay Baldauf

Lobbying groups representing different camps of the healthcare industry have come together to urge the Centers for Medicare & Medicaid Service (CMS) to reconsider “conflicting regulatory proposals” that require different electronic standards for electronic data exchanges during prior authorization.

The American Hospital Association, the American Medical Association and the Blue Cross Blue Shield Association’s joint letter to CMS Administrator Chiquita Brooks-LaSure addresses proposed rule-making released by the agency in December 2022.

It will require payers and states to streamline prior authorization processes and improve the electronic exchange of health data by 2026, including through the use of a Fast Healthcare Interoperability Resources (FHIR) application programming interface (API) able to handle electronic prior authorization. The proposed rule also contains incentives for hospitals and physicians to adopt electronic prior authorization.

The provider and payer groups told the administrator that, while they appreciate the push to reduce administrative burden and reform prior authorization, the administration must not move forward with the proposed current prior authorization standards provisions that “create the very same costly burdens that administrative simplification seeks to alleviate.”

One proposed rule regarding electronic prior authorization information exchange (CMS-0057-P) requires federally regulated health plans to offer Health Level 7 (HL7) FHIR-based APIs, while another (the prior authorization attachment standards provisions) requires all health plans under the HIPAA regulatory pathway to use a combination of HL7 standards and the X12 standard.

“We are concerned by the conflicting provisions of these NPRMs that would establish two different sets of standards and corresponding workflows to complete the PA process, depending on the type of health plan,” the groups wrote. “Moreover, for federally regulated plans, this would require cross-walking the two standards for no discernable benefit.”

The end result, they wrote, would be “widespread industry confusion” and major expenses for plans and providers needing to implement the conflicting technologies to meet the proposed rules’ requirements.

“For these reasons, our organizations strongly advise against adoption of standards for PA attachments as proposed in this rule,” they wrote.

Hundreds of federal legislators from both sides of the aisle have pushed CMS to more quickly finalize its proposed updates to prior authorization, which, in its current form, lawmakers and other critics have characterized as a costly and overwrought administrative burden. They also called for the agency to go further and shorten delays by shortening the window for a response to an expedited prior authorization request and to include a mechanism enabling real-time decisions for routine approvals.

Filed Under: ACA, Doctors, Drugs, Employer Benefits, Federal Government, General Health, hospital, Medi-Cal, Medicare, Reform Tagged With: Administrator, AHA, AMA, BCBSA, CMS, conflicting, ditch, FHIR, lobbying groups, NPRMs, prior authorization, proposal, reform, requirements, urge

CMS Again Pauses Out-Of-Network Billing Arbitration After Judge Sides With Providers

August 9, 2023 By Jay Baldauf

The Centers for Medicare & Medicaid Services (CMS) has again suspended arbitration of out-of-network payment disputes between providers and payers due to a court order that the agency’s implementation of the No Surprises Act had run afoul of proper notice-and-comment procedure.

The decision stems from a Texas Medical Association (TMA) complaint filed in the U.S. District Court for the Eastern District of Texas back in January. The provider group argued that an increase in administrative fees from $50 to $350 that was implemented earlier that month was “arbitrary and capricious” and would curtail certain physician organizations’ ability to contest a health plan’s reimbursement offer.

The No Surprises Act gives payers and providers 30 days to settle any disputes on an out-of-network charge. If an agreement can’t be reached, both parties submit a preferred amount to a third-party arbitrator, which then chooses one—a process referred to as Independent Dispute Resolution (IDR).

CMS said its fee increase was necessary to cover expenses related to the arbitration process.

Additionally, TMA took issue with CMS’ updated requirement that joint consideration of multiple disputed items and services, a process referred to as “batching,” must be billed under the same or comparable code. The change, which CMS said was made to enable greater efficiency, would force providers to submit for multiple IDR processes, which, combined with the price hike would be prohibitive for certain providers, TMA argued.

In an order signed Aug. 3, Judge Jeremy Kernodle granted-in-part TMA’s motion for summary judgment. The court struck the higher fee and vacated and remanded three portions of the rule outlining the IDR process.

“In sum, the Court holds that the Departments improperly bypassed the [Administrative Procedure Act]’s notice-and-comment requirement in issuing the Fee Guidance and the September Rule’s batching regulations,” Kernodle wrote in the order. “The Court finds that vacatur of these rules is the proper remedy.”

TMA had also sought a refund of previously paid fees and an extension of the IDR deadline, though the judge ruled that the plaintiffs had not done enough to demonstrate that these were warranted under his court’s jurisdiction.

“While the court declined to provide deadline extensions and certain other requested relief, we remain pleased with the overall outcome,” TMA President Rick Snyder, M.D., said in a Friday release. “Yesterday’s decisions on batching rule provisions and administrative fees will aid in reducing barriers to physician access to the law’s arbitration process, which is vital to both patient access to care and practice viability.”

As a result of the decision, CMS wrote in an online notice that it has “temporarily suspended the Federal IDR process, including the ability to initiate new disputes until the Departments can provide additional instructions,” effective immediately.

Fierce Healthcare has reached out to CMS for additional comment on the temporary suspension and what avenue the agency may pursue to restore it.

Implementation of the IDR process has so far been a headache for CMS. TMA has taken the process to task in four different lawsuits, two of which Kernodle ruled in the provider group’s favor while the third, filed in November and taking issue with the contentious method used to determine a “qualifying payment amount,” is still up for grabs.

Kernodle’s judgments had already forced CMS to put the whole process on hold for several weeks earlier this year, marking the second time CMS had been forced to amend the IDR process.

Those hiccups have earned derision from lawmakers disappointed with the staccato rollout of the No Surprises Act. In the administration’s defense, Department of Health and Human Services Secretary Xavier Becerra told legislators in March that the government had received “more than 10 times the number of claims than anyone ever expected,” and noted that most of the disputes appeared to be frivolous due to the low barrier of entry for arbitration claim submissions.

“These arbitrators are swamped,” Becerra told Congress.

Filed Under: ACA, Doctors, Drugs, Employer Benefits, Federal Government, General Health, hospital, Medi-Cal, Medicare, Reform Tagged With: arbitration, billing, CMS, IDR, Judge, out of network, pauses, Providers, sides, texas, TMA, US district Court

Nearly 4 Million In U.S. Cut From Medicaid, Most For Paperwork Reasons

August 9, 2023 By Jay Baldauf

The notice arrived in an envelope stamped “important information,” telling Kristin Fortner she needed to prove that she and her husband still deserved Medicaid. She filled out the form within a week of receiving it this past winter and mailed it back. So she was perplexed by a phone call almost three months later from the Arkansas Department of Human Services alerting her that she had neglected to renew the couple’s Medicaid and, unless she sent the paperwork, their health insurance would end.

Fortner quickly resubmitted the same form, this time in person. Except Arkansas already had cut them off. She discovered in May that her insurance had vanished as she tried to pick up a prescription for Suboxone, the medicine that helps her stay off opioids, from a Walgreens near her Fayetteville, Ark., home. Suddenly, she owed $380. Her Medicaid coverage, the pharmacy’s records showed, had expired April 30.

A 33-year-old waitress earning $3 an hour plus tips, Fortner walked out of the drugstore without the pills. She is among nearly 4 million Americans who have been lopped off Medicaid since the end of a pandemic-era promise that people with the safety-net health coverage could keep it, requiring every state to begin a herculean undertaking of sorting out who still belonged on the rolls. The 3.8 million — the most thorough tally — is an undercount, reflecting only people who have lost coverage so far in 38 states that have voluntarily made public their data from this sorting process, known as the Medicaid unwinding.

Most of those people have been dropped from Medicaid for reasons unrelated to whether they actually are eligible for the coverage, according to KFF, a health-policy organization, which has been compiling this data. Three-fourths have been removed because of bureaucratic factors. Such “procedural” cutoffs — prompted by renewal notices not arriving at the right addresses, beneficiaries not understanding the notices, or an assortment of state agencies’ mistakes and logjams — were a peril against which federal health officials had cautioned for many months as they coached states in advance on how best to carry out the unwinding.

Fortner’s experience attests to the bureaucratic maze ensnaring some people — and the damage being done to their well-being. The Arkansas Medicaid agency, one of the nation’s first to launch the unwinding, has repeatedly insisted that Fortner needs to provide different documents. Her husband, Ryan, has stopped making physical therapy appointments for a herniated disk. As for her Suboxone, Fortner felt like she was going through withdrawal when she skipped it for two weeks, and now, after paying for a partial order with a drug discount card, stretches the supply by cutting the pills in half.

Medicaid, the country’s largest public insurance program, is a legacy of the 1960s’ War on Poverty. The federal government provides most of the money, lays down basic rules and supervises states, which set eligibility standards and handle applications and renewals.

Beneficiaries typically must renew Medicaid every year, but that stopped in 2020 when the coronavirus arrived. With no one leaving the program, the number of Americans on Medicaid swelled to 85 million by this April, when the unwinding began in phases, with five states starting to terminate people. By July, every state except one had started removing some people from the program. Oregon will begin removing people in the fall. The government wants states to spread the undertaking over a year, although a few have chosen to do it faster — none more rapidly than Arkansas.

Health and Human Services Secretary Xavier Becerra has made clear his displeasure with the high rates at which low-income people are being severed from Medicaid without knowing whether they still qualify.

“[I]t is critically important to ensure that individuals do not lose coverage due solely to administrative processes,” Becerra admonished in a June letter to the nation’s governors in which he urged states to improve their renewal methods.

Some health-policy advocates and Democrats on Capitol Hill contend that HHS is partly to blame, saying federal health officials should exert a heavier hand with states that have been performing poorly.

“They have to be more assertive,” said Rep. Frank Pallone Jr. (N.J.), the top Democrat on the House Energy and Commerce Committee, which oversees Medicaid. Pallone said in an interview that the Centers for Medicare and Medicaid Services should explore whether some Republican-led states are deliberately winnowing their Medicaid rolls so they will have fewer low-income people to insure. Last year, Congress gave CMS the power to order states to draft plans to correct the problem and pause removing beneficiaries for procedural reasons — and to fine states that persist in mishandling cases.

During the unwinding’s first few months, CMS refused to disclose how many states were violating federal guidelines and how often federal officials were intervening.

In recent days, the agency has pivoted, portraying itself as stepping in when it discovers that a state is performing badly. According to Daniel Tsai, CMS’s Medicaid director, the agency has ordered a half-dozen states he did not identify to pause the removal of people for paperwork reasons and to reinstate some whose coverage had been denied — up to tens of thousands of people, depending on the state. The agency is conferring with about a dozen other states regarding potential violations.

Tsai said some states are failing to follow a federal requirement that they rely when possible on electronic data — such as wage records from food stamps or other benefits programs — to check people’s eligibility automatically and avoid the burden of renewal notices.

“Make no mistake, where we have found problems or violations of federal requirements, we are taking action to ensure that states correct the issue immediately,” CMS Administrator Chiquita Brooks-LaSure said during a recent news briefing.

CMS has been collecting states’ unwinding data monthly but said it could not release its first state-by-state snapshot before the end of July because federal officials needed time to check the accuracy of that data. Many health-care advocates say CMS should have been providing this unwinding picture sooner.

On Friday, the agency issued the first official unwinding data based on 18 states that began the process relatively early. The report evaluated what happened with 2.2 million beneficiaries whose status was scheduled to be reviewed. It found that 46 percent remained on Medicaid or the Children’s Health Insurance Program, 32 percent were removed from the program, and 22 percent of the reviews had not been completed. Of those removed, 79 percent were for procedural reasons.

Spanning just two months, the federal snapshot is less complete than the data compiled by KFF and separate tracking of 20 states by Georgetown University’s Center for Children and Families. Still, all three sources show considerable variation in how many people have been cut off — and the rate at which people lose coverage for paperwork reasons. Michigan and Pennsylvania are doing comparatively well, with most beneficiaries who have come up for renewal remaining on Medicaid. The KFF and Georgetown tallies show that, in both states, 3 in 5 cases removed from the rolls were dropped because of ineligibility.

Florida has severed the second-most people, after Texas — slightly more than 300,000, two-thirds for procedural reasons. And CMS says Florida has been the only state unwilling to discuss with the agency how to minimize removing people for the wrong reasons.

“We are alarmed by the data,” a coalition of more than 50 health-care and other advocacy groups wrote this spring to Florida Gov. Ron DeSantis (R), calling on the governor to pause the unwinding until the state improved its methods.

Rep. Kathy Castor (D-Fla.) and the seven other Democrats in the state’s congressional delegation also wrote to DeSantis, saying the disenrollment rate “is incredibly concerning” and echoing the call for a pause. “I’m very concerned too many Floridians are going to be lost in the shuffle,” Castor said in an interview.

According to Castor’s staff, DeSantis, a candidate for the 2024 GOP presidential nomination, did not reply to the lawmakers’ letter. The governor’s office referred questions from The Washington Post to the Florida Department of Children and Families. Mallory McManus, the department’s deputy chief of staff, said the agency had developed “a thoughtful, common-sense plan … to return to normal Medicaid processes” and already uses some procedures urged by federal health officials.

Florida’s top priority is ensuring that those who are eligible for Medicaid remain enrolled,” McManus said by email.

Already, the large proportion of beneficiaries in some states tumbling into the ranks of the uninsured is starting to hurt clinics and hospitals that focus on low-income patients — especially in the poorest states, such as West Virginia, where about 1 in 3 residents have relied on Medicaid.

“It’s a total failure, this unwinding,” said Craig Robinson, the executive director of Cabin Creek Health Systems, a network of a half-dozen clinics in West Virginia. Every day, he said, people arrive for appointments or for medicine at each clinic, unaware that their Medicaid coverage has stopped.

Cabin Creek is not alone. At West Virginia Health Right, a Charleston clinic with 43,000 patients at three sites, the number covered by Medicaid fell by about 1,600 in May and June, the first two months of that state’s unwinding, according to Angie Settle, the clinics’ chief executive. The number of uninsured patients, usually fairly stable, rose by about the same number during those two months.

Settle said the unwinding is putting a strain on the staff as new people show up for medical services they can no longer afford — and a strain on finances as more people show up for medications for which no one else is paying the costs.

One of Health Right’s new patients is Heather Elkins, who lives nearby with her daughter in Dunbar, at a bend in the Kanawha River. Living on $1,100-a-month Social Security checks, Elkins, 63, had no health insurance starting in 2012, when she quit the construction work that was hurting her body, partly because of breathing lime dust on river barges. Five years later, her health deteriorating, she applied for Medicaid, which has paid for medications for her high blood pressure, high cholesterol, depression and diseased lungs.

When she went to pick up prescriptions the first week in May, Elkins said, the pharmacist told her, “Honey, you’re declined. You don’t have coverage.”

She paid out of pocket for the prescriptions, except for the Symbicort to treat her chronic obstructive pulmonary disease, because a month’s supply would have cost about $400. Instead, she headed to Health Right for it.

Elkins said she isn’t certain whether her renewal notice from the West Virginia Department of Health and Human Resources never came or was stuck in the middle of other pieces of mail. She stopped at a state office to try to find out what she needed to do. Over the next two months, she was told to bring a Social Security card, assured that would suffice, then was told she would need to start a new application. When Elkins finally brought in the completed paperwork, an employee looked in the computer, ripped up the form without examining it and said she was back on Medicaid. Stunned, Elkins asked about what she’d been told by the first worker who triggered the whole runaround — and was told he had been a new employee and did not work there any more.

According to Sarah Young, the health department’s deputy commissioner, each beneficiary receives three phone calls and written notices before a case is closed. She did not address how situations such as Elkins’ could happen but said by email, “the challenge remains how to increase the number of individuals who submit their renewal forms in a timely manner to prevent a loss of coverage.”

Some states face special obstacles. In Alaska, renewal notices do not always reach intended recipients in rural communities that lack roads or broadband internet, according to Anne Zink, the state’s chief medical officer. Some towns and villages at times lack a working postmaster, so mailbags containing the notices sometimes pile up outside shuttered post offices, Zink said.

Alaska is among 34 states, plus D.C., that have been out of compliance with at least one federal requirement for how to conduct the unwinding, a CMS tally shows. But even some states that meet all the federal rules have high rates of people being dropped from the program for paperwork reasons, mystifying state officials and patient advocates alike.

One of those states is Indiana, where 86 percent of removals were done on procedural grounds, according to the KFF and Georgetown data. In addition to sending beneficiaries a postcard, letter, renewal packet, text messages and phone calls, the state’s Medicaid agency is launching a multilingual ad campaign and has collaborated with food banks, pharmacists, clinics, school systems and child-welfare workers to spread the word, according to Michele Holtkamp, the agency’s spokeswoman.

In Arkansas, a 2021 law requires the state to sort through renewals within six months, half the time the Biden administration recommends. Gov. Sarah Huckabee Sanders (R) published an op-ed in the Wall Street Journal in May saying, “I’m proud Arkansas is leading the nation in getting back to normal.” Most Arkansans who lost jobs during the pandemic are working again, she wrote, saying, “It’s time to get them off the path of dependency.” The governor did not say how many of the reemployed have health benefits through their jobs.

Trevor Hawkins, an attorney at Legal Aid of Arkansas, said some people have been told their Medicaid cases were closed at their own request — when that was not true. As in a number of states, he said, children are being removed from coverage if their parents become ineligible, even though the children still qualify. And some people are simply being denied and told to reapply, Hawkins said, so they are uninsured while “they are just patiently waiting to be reapproved …[with] no idea how long the line is.”

Arkansas Community Organizations, a grass-roots antipoverty group, held a protest last month outside one of the Department of Human Services’ Little Rock offices. Demonstrators carried hand-lettered placards saying, “Fix the glitch!” and “This update is life or death,” and one protester staged a skit simulating depositing information into a cardboard computer and receiving a slip of paper saying, “Denied.”

Gavin Lesnick, spokesman for the state’s human services department, said Arkansas is following “a detailed plan … that is both fair and helps protect Medicaid resources for those who truly need it.” He said that just because a case is closed for a procedural reason does not necessarily mean someone failed to receive a renewal packet or did not know about the unwinding. Some people, Lesnick said, have chosen not to return renewal forms, aware that they are no longer eligible.

In Fayetteville, Fortner does not know when — or if — her Medicaid coverage will be restored. She does not understand why her 15-year-old daughter has been allowed to stay on the children’s version of Medicaid, while she and her husband, the manager of a vape shop, were cut off — without receiving a denial letter.

She takes Suboxone to stay clean from the opioid addiction she said she has struggled with since she was 14 and prescribed painkillers for whiplash from a car crash. The day this spring she could not afford the Suboxone, she said, “I felt hopeless … and pretty irritated.”

After discovering in May that her Medicaid coverage had been cut off, she went to a local branch of the human services department to find out what was going on. “I was told I would need to reapply completely,” Fortner said. By the end of that week, she took in all the requested information, including proof of her husband’s previous jobs and his current one.

“They said I was good to go,” she said, and was told the paperwork would take 30 to 45 days to process. After calling repeatedly, she returned in person in mid-June. She was told she needed to furnish evidence that she no longer worked at another waitress job she had left nearly a year before. She also was told her husband’s doctor needed to provide proof of why he was on Social Security disability. Her husband has never been on disability. She asked for a copy of the form with the disability question, but the employee said she couldn’t print it out because it had just been mailed to their home and, once it arrived, she could mail it back saying he did not have disability benefits.

“It’s very, very frustrating,” Fortner said. “I keep thinking I’ve done everything I’m supposed to do and it’s fine, but then, when I check, it’s not fine.”

Filed Under: ACA, Doctors, Drugs, Employer Benefits, Federal Government, General Health, hospital, Medi-Cal, Medicare, Reform Tagged With: 4 million, CMS, cut, HHS, KFF, Medi-cal, Medicaid, nearly, paperwork reasons, states, unwinding

CMS Proposes Updates To The Hospital Price Transparency Rule

August 9, 2023 By Jay Baldauf

On July 13, 2023, the Centers for Medicare & Medicaid Services (CMS) proposed key changes to the hospital price transparency rule. These proposed changes are meant to strengthen standards for disclosing hospital prices and provide more enforcement authority to regulators, and if finalized, will go into effect on January 1, 2024. This article provides an overview of the original rule and its implementation to date and describes the current changes being proposed by CMS.

What Is The Hospital Price Transparency Rule And Whom Does It Benefit?

In 2019, CMS enacted the hospital price transparency rule requiring hospitals to publish the following types of charges for all items and services in a machine-readable file: (1) gross charges (or “prices”), (2) discounted cash prices for self-pay patients, (3) payer-specific negotiated prices, (4) de-identified minimum and maximum negotiated rates. Additionally, hospitals are also required to publish similar information for 300 “shoppable services” in a consumer-friendly manner, such as through an online price estimating tool. The rule gives CMS authority to monitor hospital noncompliance, issue written warnings, request corrective action plans, impose monetary penalties, and make information about penalties public on a CMS website. The rule went into effect on January 1, 2021.

Though the rule was initially enacted with the goal of helping patients shop for lower-cost, higher-value services, it is unclear how useful price transparency actually is to patients. Patients have no choice when it comes to picking providers for emergency care, and even when seeking a “shoppable,” non-emergency service, patients tend to mostly rely on referrals from trusted doctors. Studies show that patients rarely make use of online shopping tools for health care.

However, price transparency can be very useful for employers, researchers, and policymakers. Employers pay for the health care of almost 153 million (or 57 percent of) non-elderly people, and having access to information about how much local providers are charging other payers can help them push provider prices down. Policymakers and researchers concerned with rising health care prices can also make use of hospital pricing data to understand cost drivers and develop informed policy solutions.

Issues With Initial Implementation: Compliance And Data Quality

Within the first year of the hospital price transparency rule going into effect, several researchers and reporters raised alarm about hospitals not complying with the rule. A CMS assessment from early 2021 found that only 27 percent of hospitals were fully compliant. In November 2021, CMS responded to this by increasing the monetary penalty for noncompliance from $300 a day (approximately $110,000 a year) for all hospitals to $5,500 a day (over $2 million a year) for the largest hospitals (with over 551 beds). These higher penalties went into effect on January 1, 2022 and by the fall of that year, CMS found that 70 percent of hospitals had fully come into compliance. As of April 2023, CMS has issued 730 warnings, 269 requests for corrective action plans, and imposed penalties on four noncompliant hospitals.

Even as CMS has made steady progress on securing higher levels of compliance from hospitals, the bigger and more difficult issue to address has been the quality of the data that hospitals are publishing. Researchers have described the data as “messy” and “consistently inconsistent,” and even experienced researchers have found it to be “difficult, if not impossible” to use it. Reported issues with the data include:

Difficulty finding the files;
Use of varied file formats;
Lack of standardization in how payers and plans are identified;
Lack of standardization in how services are identified—hospitals sometimes use their own codes instead of more commonly used Current Procedural Terminology (CPT) or Diagnosis-related Group (DRG) codes to identify services;
Lack of standardization in how prices are reported—for example, reporting some prices per day and others per service or reporting prices for bundled services in different ways;
Lack of key contextual information necessary to interpret the pricing data, such as the setting for the service (inpatient or outpatient), or what kind of provider is providing the service (facility or professional); and,
Errors in the data

CMS has made resources available to hospitals to help them format the data and minimize errors, but hospitals are not required to use these templates and recommendations.

What CMS Is Proposing Now

In its recently proposed rule, CMS seeks to: (1) standardize the data elements required in the machine-readable file, (2) make the machine-readable file for each hospital easier to find, (3) improve enforcement of the hospital price transparency rule, and (4) gather information on the best ways to align the requirements of this rule with certain other recently enacted federal disclosure requirements.

Standardizing The Data Elements

Based on the recommendations provided by a technical expert panel convened by the Health Federally Funded Research and Development Center, CMS proposes requiring hospitals to use a standard template (available only in certain standard file formats) and adhere to accompanying technical specifications. Hospitals will also be required to attest to the “accuracy and completeness” of their data. While the original rule requires hospitals to publish the gross charges and negotiated charges for each item and service on a machine-readable file, the proposed rule additionally requires that each machine-readable file include the following standardized elements:

The hospital’s location name, address, and license number.
The file version and date of the most recent update.
Payer and plan name, as specified in contract.
Type of contracting method used to establish each charge, for example per day or per service.
Whether the charge should be interpreted as a dollar amount, and if not, an algorithm or percentage used to determine the dollar amount (for example, “50 percent of total gross charges”). When a charge can only be expressed as an algorithm or percentage, hospitals must display a consumer-friendly expected allowed amount, which is the average dollar amount the hospital expects to be paid for an item or service depending on its contract with the payer.
Description of the item or service corresponding to the charge along with information about whether it is associated with an inpatient admission or outpatient visit.
For prescription drugs, the drug unit and type of measurement.
Codes used by the hospital to identify items and services.

A hospital’s failure to display its information according to these specifications could result in a compliance action. In the proposed rule, CMS requests comments from hospitals on whether providing a validation tool to check files for compliance with formatting requirements would be useful. If the proposed rule is finalized, CMS would give hospitals a 60-day enforcement grace period, until March 1, 2024, for adoption of these technical requirements.

Making It Easier To Find The Data

CMS is proposing the adoption of certain requirements that would allow sophisticated researchers to automatically compile the machine-readable files from different hospital websites without having to navigate to each individual page and find the file. CMS is seeking comment on their proposed provisions as well as suggestions on potentially better ways to achieve this goal.

Strengthening Enforcement

Building upon its prior efforts to ramp up enforcement, CMS is seeking certain additional enforcement authorities in this proposed rule. First, it proposes requiring an authorized hospital official to certify that the information in the machine-readable file is correct and complete. CMS would be allowed to ask hospitals to submit additional documentation to help them make a determination on compliance.

Second, under the proposed rule, when hospitals receive a warning letter about noncompliance from CMS, they will be required to acknowledge receipt of this notice within a certain amount of time.

Third, when a hospital is part of a bigger health system, the proposed rule would allow CMS to notify health system leadership about any compliance actions it takes against the hospital. CMS would also be allowed to work with the health system leadership to improve compliance across all hospitals in that system.

Finally, through the proposed rule, CMS seeks to publicize on its website all CMS assessments about a hospital’s compliance and information about any related action taken.

Requesting Information

CMS is also seeking comment on the best ways to align the hospital price transparency rule’s consumer-friendly price disclosure requirements with these other federal rules, given their shared goals.

As mentioned above, the hospital price transparency rule also requires hospitals to provide price information about 300 shoppable services in a consumer-friendly format. Since this rule went into effect, the federal government has enacted other rules that also require certain disclosures to consumers about health care prices.

The insurer transparency rule, also known as the Transparency in Coverage rule, requires plans to provide consumers with personalized pricing information incorporating the consumer’s cost-sharing obligations upon request. By January 1, 2024, health plans will be required to make this pricing information available for all items and services through internet-based self-service tools.

The No Surprises Act, enacted as part of the Consolidated Appropriations Act of 2021, requires providers to give uninsured patients a good faith estimate of expected charges for health care services. For patients with insurance, providers must provide this good faith estimate to the patient’s plan, and the plan must use this estimate to provide the patients with an advanced explanation of benefits, which tells the patient what they will owe out-of-pocket for the services.

CMS is hoping to reduce the administrative burden on providers and plans by streamlining reporting requirements across these various rules and statutes.

Looking Ahead

Bringing transparency to hospital prices is a necessary, if insufficient, first step to curbing provider prices, which have made health care unaffordable for many. With these proposed changes, CMS signals its continued commitment to ensuring that hospitals release their data in ways that are useful for payers, policymakers, researchers, and patients.

Filed Under: ACA, Doctors, Drugs, Employer Benefits, General Health, hospital, Medi-Cal, Medicare, Reform Tagged With: CMS, Compliance, data elements, data quality, enforcement, hospital, information, price transparency rule, proposes, standardizing, types of charges, updates

More Than A Third Of Rural Americans Skip Needed Care Because Of Cost: Study

August 2, 2023 By Jay Baldauf

More than one third of Americans living in rural areas skipped medical care they needed due to the costs, according to a new study.

The Commonwealth Fund’s 2020 International Health Policy Survey found that 36 percent of rural Americans did not get the care they needed due to costs, which is more than double the rate for rural residents in six of the other countries the study looked at. Less than 10 percent of rural residents in the United Kingdom, Norway and Sweden reported that they did not get medical care due to costs.

The study looked at 10 other high-income countries besides the United States, including Australia, Canada, France, Germany, the Netherlands, New Zealand, Norway, Sweden, Switzerland and the United Kingdom. Out of these countries, rural residents in the U.S. were most likely to report they struggle to pay their medical bills.

The survey found that nearly 25 percent of rural Americans reported serious problems with being able to pay their medical bills or not being able to pay them at all. In nine of the other countries, less than one in 10 rural residents reported the same thing.

The survey noted that the 10 other countries looked at all had a universal health care system, which the U.S. does not have. The survey also pointed to census data that showed about 12 percent of the American rural population does not have health insurance as a reason why the U.S. fell short of what the other countries reported.

The study also pointed to the disparity in health facilities and pharmacies in rural America compared to other places in the country when talking about the differences between the U.S. and the other high-income countries. It also noted that other countries use Telehealth systems more than the U.S. does, especially in rural America where many do not have access to that technology.

“Rural Americans are more likely to report financial barriers to utilizing health care compared to rural residents in any other high-income country,” the study states. “With affordability problems preventing Americans from seeing their doctor, it is no surprise that rural Americans also are more likely to have higher rates of chronic conditions and some of the highest rates of mental health conditions.”

Filed Under: ACA, Doctors, Drugs, Employer Benefits, General Health, Medi-Cal, Medicare, Reform Tagged With: census data, comonwealth fund, due to cost, high income, more than one third, needed care, other countries, rural americans, skip, study

Nursing Homes Will Get A 4% Medicare Pay Bump Next Year Under CMS Final Rule

August 2, 2023 By Jay Baldauf

In what the Centers for Medicare & Medicaid Services (CMS) today described as a “parity adjustment recalibration,” the agency said it will increase payments to skilled nursing facilities by 4%, or $1.4 billion, starting in fiscal year 2024.

The payment bump will, in part, make up for a $2.2 billion underpayment to the facilities as a result of the Patient Driven Payment Model (PDPM) for SNFs that replaced the former payment system in 2020, CMS said in a fact sheet. In its final rule, the agency says that it overestimated overpayments to nursing homes, and that resulted in a 2.23% reduction in fiscal year 2023.

The final payment policy reflects a 3% SNF market basket increase plus a 3.6% market basket forecast error adjustment and less a 0.2% productivity adjustment, as well as a negative 2.3% reduction, or approximately $789 million, from the clawback related to the PDPM parity adjustment recalibration, CMS said.

The final rule updates payment policies and rates for SNFs under the new measures that aim to address staff turnover under an executive order by President Joe Biden. The implementation of the PDPM in 2020 led CMS to estimate an unintended increase to SNFs of about 5%, or $1.7 billion.

One of the reasons nursing homes were underpaid is CMS didn’t account for the Consolidated Appropriations Act’s requirement to exclude marriage and family therapist (MFT) services and mental health counselor services (MHC) from SNF billing. “Exclusion from consolidated billing allows these services to be billed separately by the performing clinician rather than being included in the Medicare Part A SNF payment,” the final rule states. “We are finalizing regulatory text changes required to codify this new legislative requirement to exclude MFT and MHC services from SNF consolidated billing for services furnished on or after January 1, 2024.”

CMS notes that the PDPM utilizes the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10), to use an individual’s primary diagnosis to assign patients to clinical categories. “In response to stakeholder feedback and to improve consistency between the ICD-10 code mappings and current ICD-10 coding guidelines, CMS is finalizing several changes to the PDPM ICD-10 code mappings,” the final rule states.

Beginning in fiscal year 2025, CMS will adopt a discharge function score when considering payments to SNFs. “This measure assesses functional status by assessing the percentage of SNF residents who meet or exceed an expected discharge function score and uses mobility and self-care items already collected on the Minimum Data Set (MDS),” the final rule states.

LeadingAge, the association of nonprofit, mission-driven providers of aging services, including nursing homes, issued a statement saying the final payment rule “does not address the reality of providers’ operating environments, and will, ultimately, limit older adults’ access to much-needed care and services.”

“Of course, our nonprofit and mission-driven members welcome any increase in payment rates, the 4% provided in this rule will surely be offset by the increasing costs of care, which will most certainly continue to rise in the coming year—on top of the expected staffing standards,” Katie Smith Sloan, president and CEO of LeadingAge, said in a statement .”We encourage Congress and HHS to ensure any proposed standards meet the provisions outlined in LeadingAge’s Get Real on Ratios proposal.”

In addition, COVID-19 continues to cast a shadow over nursing home operations, seeing as how the facilities had been the main nexuses for the disease. Beginning in fiscal year 2025, CMS will track the percentage of healthcare personnel in nursing homes who are considered up to date on their COVID vaccinations.

“The prior version of this measure reported only on whether HCP had received the primary vaccination series for COVID-19, while the modified measure requires SNFs to report the cumulative number of healthcare providers who are up to date with recommended COVID-19 vaccinations in accordance with the CDC’s most recent guidance,” the final rule states.

CMS will also begin to monitor nursing staff turnover beginning in fiscal year 2026 as part of the Biden administration’s focus to ensure adequate staffing at nursing homes.

Filed Under: ACA, Doctors, Drugs, Employer Benefits, General Health, Medi-Cal, Medicare, Reform, Senior Health Tagged With: CMS, Covid19, final rule, HCP, ICD-10, Medicare, MFT, MHC, next year, nursing homes, pay bump, PDPM, SNF

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

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