Cancer-Free Medicare Recipients Received Fentanyl Indicated for Cancer Pain

 Some doctors have been prescribing opioids to Medicare Part D drug plan beneficiaries to relieve their cancer pain -- even though they didn't actually have cancer, according to a report from the Office of Inspector General

opens in a new tab or window (OIG) at HHS.

The report noted 7,552 prescription fills for transmucosal immediate-release fentanyl (TIRF) dispensed to 810 beneficiaries who did not have a cancer diagnosis in their Medicare claims history to support a medically accepted indication for use. And for 65 of those beneficiaries, the plans kept approving the prescriptions even after they had been disallowed.

"As a result, plan sponsors paid $86.2 million in unallowable Medicare Part D total costs," the authors wrote in the report, which was issued last month.

Another few thousand prescriptions were questionable, such as the 2,023 prescription fills for TIRF drugs for 176 beneficiaries whose most recent cancer diagnosis in their Medicare claims history was more than 1 year before the drugs were dispensed -- totaling $19.7 million in paid claims. "Although we did not determine these [prescription drug events] to be unallowable, they were at high risk of being unallowable," the report said.

In its introduction, the OIG noted that it has been tracking opioid use in the Medicare program during the opioid crisis "and has identified providers with questionable prescribing practices and beneficiaries at serious risk of misuse or overdose of opioids." Because improper off-label drug use can harm beneficiaries, it audited Medicare Part D plan sponsors' data on prescription drug events (PDEs, i.e., prescription fills) submitted to the Centers for Medicare & Medicaid Services (CMS) to determine compliance with Medicare requirements.

The audit included 45,776 prescriptions for TIRF drugs dispensed to 5,034 beneficiaries from July 2015 through December 2019, for which the Medicare Part D total cost was $513.9 million. In addition to examining whether the patients receiving the drugs had a cancer diagnosis, the researchers also "selected a judgmental sample of 51 beneficiaries who did not have a cancer diagnosis in their Medicare claims history and reviewed plan sponsor documentation to determine why TIRF drugs were approved."

They also scrutinized medical records from 28 of those patients' other providers who did not prescribe TIRF drugs, trying to find any evidence for a cancer diagnosis.

The investigators found that TIRF prescriptions were approved for patients without a cancer diagnosis "because plan sponsors' prior authorization processes were not adequate. Specifically, these authorization processes did not always require verification of the diagnosis or followup to confirm that the beneficiaries had a cancer diagnosis. In addition, during its assessments, CMS determined PDEs to be allowable for beneficiaries who did not have a cancer diagnosis because CMS relied on plan sponsors' prior authorization documentation."

Approving TIRF prescriptions for patients without a cancer diagnosis can lead to substance abuse, the report authors warned. "During our audit period, 446 beneficiaries who did not have a cancer diagnosis to support the use of TIRF drugs had at least one Medicare claim indicating an opioid overdose or opioid misuse during the time they were receiving TIRF drugs."

The authors made five recommendations to address this problem:

• Delete the PDEs related to the $86,247,325 of unallowable Medicare Part D total costs
• Identify and delete any unallowable PDEs related to the $19,704,602 of Medicare Part D total costs for beneficiaries whose most recent Medicare claim with a cancer diagnosis was for services provided more than 1 year before the TIRF drugs were dispensed
• Ensure that plan sponsors obtain sufficient information during the prior authorization process so that TIRF drugs are dispensed only to beneficiaries with a medically accepted indication of breakthrough cancer pain
• Expand the required PDE data elements to include diagnosis codes to enable plan sponsors to confirm that TIRF drugs are prescribed for a medically accepted indication
• Conduct data analysis and follow up on information that is inconsistent between the Medicare claims data and prior authorization information obtained for TIRF drug prescriptions

However, CMS didn't agree with most of the OIG recommendations, the authors noted. "CMS stated that it did not concur with our first and second recommendations because our determination of the amount of unallowable costs was not based on the applicable statute, regulations, or guidance."

And regarding the third recommendation, "CMS stated that we did not determine whether prior authorizations had been obtained from prescribing providers confirming that a medication was for a medically accepted indication, nor what clinical information was provided by prescribers via the prior authorization process," the report noted.

"CMS also stated that it disagrees with the position that every Medicare Part D claim without a corresponding cancer diagnosis, or a recent cancer diagnosis, demonstrates that a TIRF drug was used for a nonmedically accepted indication," they continued. "CMS stated that, although it disagrees with our methodology, it continues to take misuse of TIRF drugs seriously and is therefore undertaking an additional TIRF audit using a methodology aligned with legal requirements for plan sponsors."

The authors said they appreciated the additional TIRF audit for prescriptions without a medically accepted indication but pushed back on CMS's response: "Our audit methodology was based on the medically accepted indication requirements as defined in the [Social Security] Act. We maintain that it is not reasonable for a beneficiary to be prescribed TIRF drugs for breakthrough cancer pain without having had a cancer diagnosis."

https://www.medpagetoday.com/painmanagement/opioids/103359

Normal Defined for Adolescent Hearts Under Cardiac MRI

 With new cardiac MRI (CMR) reference values for healthy adolescents, clinicians may have a better picture of what a normal scan looks like on this increasingly favored noninvasive imaging modality.

Reference values for anatomical and functional parameters in the heart during adolescence were based on a Spanish regional population and reported by Rodrigo Fernández-Jiménez, MD, PhD, of Centro Nacional de Investigaciones Cardiovasculares (CNIC) and Hospital Universitario Clínico San Carlos in Madrid, Spain, and colleagues.

The researchers set sex-stratified comprehensive percentile tables for various 3-Tesla cardiac MRI parameters in a paper published in eClinicalMedicine

opens in a new tab or window:

• Left and right ventricular end-diastolic indexed volumes

• Left ventricular mass

• Left and right ventricular ejection fraction

• Indexed atrial size and function parameters

• Global myocardial native T1 and T2 relaxation times

"This information is useful for clinical practice and may help to distinguish between the diseased and healthy cardiac states and in the differential diagnosis of cardiac diseases, such as cardiomyopathies and myocarditis, in adolescent populations," the authors concluded.

"[W]ith this information, physicians at any center can determine if cardiac MRI data from an adolescent's heart fall within the normal range for this age group, and prescribe closer follow-up and additional tests if needed," Fernández-Jiménez said in a press release.

These reference values fill a gap in the literature as most published MRI data from adolescents come from patients with congenital heart defects or other heart conditions. In healthy pediatric populations, most studies assessing cardiac structure and function have relied on another imaging modality, echocardiography, because of its simplicity and availability, the investigators noted.

Advances in cardiac MRI technology have contributed to its rise in recent years.

"Magnetic resonance imaging has become a very important method for studying the heart because it avoids exposing patients to radiation and provides more information, and with greater precision, than ultrasound, currently the most frequently used cardiac imaging technique," said co-investigator Valentín Fuster, MD, PhD, of CNIC and Mount Sinai Medical Center in New York City, in the press release.

Yet because of the resources required, cardiac MRI is considered a selective downstream test and not recommended for widespread routine screening. This was a point of contention early on in the COVID pandemic, when cardiac MRI scans provided evidence of lingering myocardial inflammationopens in a new tab or window and other cardiac abnormalities in COVID-19 survivors.

Reassuringly, however, problems with heart inflammation and cardiac function after COVID generally resolveopens in a new tab or window within months, reports show.

Moreover, cardiac involvement was observed in just 3.8% of professional athletesopens in a new tab or window who had COVID and systematic cardiac screening in the form of troponin testing, electrocardiography, and resting echocardiography in 2020. The prevalence of inflammatory heart disease specifically -- myocarditis being a known risk factor of sudden cardiac death -- was 0.6% in that study.

For the development of the present cardiac MRI reference values, Fernández-Jiménez and colleagues drew upon an ongoing cluster-randomized trial

opens in a new tab or window testing the effects of a school-based behavioral intervention on adolescent obesity and lifestyle.

Participants were 123 adolescent boys and girls with no known cardiovascular disease who were enrolled in one of seven schools in the Madrid area. They agreed to undergo a non-contrast 3-Tesla CMR scan between March 2021 and October 2021.

The cohort averaged 16 years of age and 52% were girls. Over one in five had at least one parent born outside Spain.

"This study reports reference values of CMR parameters based in a relatively large adolescent sample based in Spain and has some limitations. The impact of race/ethnicity on CMR reference values could not be assessed and the geographical limitation of the sample could compromise external validity," Fernández-Jiménez and co-authors acknowledged.

They recommended that centers check the reference mapping values with their own local data.

Disclosures

The study was funded by Instituto de Salud Carlos III with support from Spain's la Caixa Foundation.

Fernández-Jiménez declared no conflicts of interest; one study co-author is a Philips Healthcare employee.

Primary Source

EClinicalMedicine

Source Reference: opens in a new tab or windowReal C "Magnetic resonance imaging reference values for cardiac morphology, function and tissue composition in adolescents" EClinicalMedicine 2023; DOI: 10.1016/j.eclinm.2023.101885.

https://www.medpagetoday.com/cardiology/prevention/103379

MedPAC Eyes Reference Pricing, Other Ideas to Cut Part B Drug Costs

 Congress will need to use a multipronged approach to bring down prescription drug costs in the Medicare Part B program, members of the Medicare Payment Advisory Commission (MedPAC) agreed at their March meeting on Thursday.

MedPAC members discussed three draft recommendations being considered for inclusion in the commission's June report to Congress. The recommendations addressed rising drug costs in Medicare Part B, which covers, among other things, the cost of drugs administered in a physician's office. The three proposed recommendations were:

• Give the HHS secretary the authority to cap the cost of Medicare Part B drugs that were approved under FDA's accelerated approval program, provided the drugs meet certain criteria
• Give the HHS secretary the authority to establish a single average sales price (ASP)-based payment rate for drugs and biologics with similar health effects
• Direct the HHS secretary to reduce add-on payments for Part B drugs paid based on ASP to improve financial incentives, and to eliminate add-on payments for Part B drugs based on wholesale acquisition costs

Members were generally supportive of the first recommendation. "I love it; I'm fully supportive of it as is," said Commissioner Stacie Dusetzina, PhD, of Vanderbilt University School of Medicine in Nashville. But some members raised concerns about the criteria that the accelerated approval drugs would have to meet to qualify for the price cap, including any one of the following:

• The drug's sponsor didn't complete the postmarketing confirmatory trials by the deadline established by the manufacturer and the FDA
• The drug offers a clinical benefit that is not confirmed in the postmarketing trials
• The drug is covered under a "coverage with evidence development" policy
• The drug has a price that is excessive relative to the upper bound estimates of value

"I'm very worried about [the fourth] bullet," said Commissioner David Grabowski, PhD, of Harvard Medical School in Boston. "What is value? ... I'm also worried beyond just the squishiness of the issue, about the potential drag on innovation."

The commissioners also discussed ways to reduce the add-on payments under Part B; for most drugs, doctors are paid an additional fee of 6% of the ASP to cover their administrative costs. However, concerns have been expressed that this formula gives clinicians an incentive to prescribe a higher-priced drug. Commission staff proposed a three-part structure for dealing with this issue, in which clinicians would be paid, for example, an add-on fee of 6%, 3% + $24, or $220, whichever is less.

Commission Vice-Chair Amol Navathe, MD, PhD, of the Perelman School of Medicine at the University of Pennsylvania in Philadelphia, liked that idea. He added that while he is "very, very supportive" of the recommendation, "it is very broad in the sense that we're saying, 'Reduce the ASP add-on.' And I wonder if that's insufficient -- that doesn't quite get us there because reducing the ASP add-on could just mean moving from the ASP plus 6% to ASP plus 5% or 3%, or something else like that."

Instead, "we're perhaps less worried about whether it's $220 or $50 or 3% or 4%," Navathe said. "What we're more interested in is mitigating this ASP-plus-6% way of pricing that is inducing this distortion. And I think that's not currently captured in the language of the recommendation."

Commission member Greg Poulsen, MBA, of Intermountain Healthcare in Salt Lake City, Utah, agreed. "I have experienced the perversion that [ASP + 6%] creates among clinicians, and I would love to get rid of it," he said. Noting that more expensive drugs often have higher inventory and other costs associated with them than cheaper drugs, Poulsen said he'd prefer to offer only the percentage-plus-flat-fee alternative, but "if we decide not to go down that path, and stick with the language and the examples that we have, I would still say that's a big step in the right direction."

However, he added, "I don't think that the recommendations here will materially change our United States position relative to other countries ... It doesn't fix the problem. I think that we're going to have to pick up the very unpleasant and unpopular idea of looking to international comparisons at some point in the future, and there's no reason we should be paying X dollars more for a new drug than is paid in Sweden, Switzerland, Great Britain, France, or Japan."

Commissioner Lawrence Casalino, MD, PhD, of Weill Cornell Medical College in New York City, agreed. "I don't believe that the U.S. needs to finance the cost of pharmaceutical innovation for the world. And to a considerable extent, that's what we're doing," he said. "And I do think it's true that if the pharmaceutical companies couldn't make quite as much on the price side of it, they would be tougher in their negotiations with other countries, with some success." He recommended including the "rest of the world" issue in the June report.

Commission member Marge Ginsburg, BSN, MPH, of Sacramento, California, said she was "troubled" by the second recommendation in support of reference pricing for drugs and biologics. "I really do think it's a problem, because I think every drug manufacturer will find variations in the health effects of their drug that will make reference pricing almost impossible," she said. "I love the concept of reference pricing and I'd love to see if there's a way it can be applied here, but I have to admit I'm really cynical about whether that is going to work in this whole area of medical care."

https://www.medpagetoday.com/publichealthpolicy/medicare/103385

Surgeries That Made the Sharpest Turns to Outpatient Setting After COVID

 Some common general surgeries had the biggest migrations to the outpatient setting during the first year of the COVID-19 pandemic, a retrospective cohort study confirmed.

Compared with the previous few years, calendar year 2020 saw disproportionately more outpatient cases of mastectomy for cancer, minimally invasive adrenalectomy, thyroid lobectomy, breast lumpectomy, minimally invasive ventral hernia repair, minimally invasive sleeve gastrectomy, parathyroidectomy, and total thyroidectomy.

And absolute increase in outpatient volumes from 2016 to 2020 was deemed clinically significant for the following four procedures:

• Mastectomy for cancer: 9.2% to 28.6%
• Thyroid lobectomy: 43.2% to 57.9%
• Minimally invasive ventral hernia repair: 58.8% to 69.4%
• Parathyroidectomy: 51.8% to 61.8%

Driving the accelerated transition to outpatient surgeries was the need to simultaneously meet the needs of the massive influx in patients, a result of the COVID-19 pandemic, while still accepting and treating patients in need of non-urgent surgery, according to Cornelius Thiels, DO, MBA, surgical oncologist at the Mayo Clinic in Rochester, Minnesota, and coauthors, writing in JAMA Network Open

opens in a new tab or window.

As U.S. hospitals were beginning to buckle under limited resources and the need to mitigate SARS-CoV-2 exposure, the American College of Surgeons (ACS) and other organizations published elective case triage guidelinesopens in a new tab or window in early 2020.

"These guidelines recognize that postoperative inpatient admission uses key hospital resources that need to be allocated toward the care of acutely unwell patients with COVID-19 and exposes patients undergoing routine surgery to the risk of nosocomial COVID-19 infection," Thiels and colleagues noted.

Adrian Diaz, MD, general surgery resident at The Ohio State University in Columbus, said the study's findings are consistent with his group's reported experienceopens in a new tab or window before and since the pandemic, and that the trends may continue for years.

Diaz suggested that outpatient surgery may be the preference for many patients. "Often times outpatient surgery is logistically more convenient and patients can return home and to normalcy much faster. Finally, outpatient surgery is often less resource intensive and thereby less expensive, leading to less cost to patients."

"I believe this study is further evidence that more and more surgery is moving to an outpatient setting. Although this study did not assess safety or outcomes, the trends in the study demonstrate that most providers feel comfortable performing these operations in an outpatient setting," he told MedPage Today.

The pandemic-era rise of outpatient procedures reportedly also extends to minimally invasive procedures like percutaneous coronary interventionopens in a new tab or window and transcatheter aortic valve replacementopens in a new tab or window, other groups have shown.

For the present retrospective cohort study, Thiels and colleagues analyzed case volumes for the 16 most common general surgeries in the ACS National Surgical Quality Improvement Program (NSQIP). Outpatient procedures were defined as those that had patients discharged the same day as their procedure.

Patients were split between the 823,746 who received surgery prior to the COVID-19 pandemic (January 2016 through December 2019) and the 164,690 patients who had surgery during the pandemic (January through December 2020).

The study population had an average age of 54.5 years and 58.1% were women.

Data from the ACS-NSQIP-participating hospitals may not be fully representative of the entire U.S. population, the investigators acknowledged. Another limitation was the possibility of confounding due to surgical patients during the pandemic being sicker overall.

Disclosures

This study was supported by funding from the Mayo Clinic.

No disclosures were reported.

Primary Source

JAMA Network Open

Source Reference: opens in a new tab or windowShariq OA, et al "Performance of general surgical procedures in outpatient settings before and after onset of the COVID-19 pandemic" JAMA Netw Open 2023; DOI: 10.1001/jamanetworkopen.2023.1198.

https://www.medpagetoday.com/surgery/generalsurgery/103386

CMS vastly overestimates hospital price transparency efforts

 More than two years after a federal rule required hospitals to post their actual prices, the Centers for Medicare & Medicaid Services has finally responded to public pressure about the failure of many hospitals to be transparent about what they charge for their services.

Unfortunately, CMS’s new hospital compliance report gaslights American health care consumers by claiming that most hospitals are following the rule. Its survey of a mere 600 out of 6,000 U.S. hospitals showed that 70% are complying with two key rule requirements: a machine-readable file that computer systems can read and a consumer-friendly display.

This sunny conclusion is out of step with other reports.

The results of a review conducted by PatientRightsAdvocate.org, the organization I lead, showed that only 24.5% of the 2,000 hospitals surveyed in December 2022 and January 2023 were fully complying with the rule and posting complete price information. Some of the nation’s largest medical systems, including HCA Healthcare, Tenet Healthcare, Providence, Avera, UPMC, Bon Secours Mercy Health, Christus Health, and Mercy Health, had compliance rates of zero.

Our analysis is far more in depth than CMS’s. It surveys hospitals’ machine-readable files for the completeness of the data the rule requires, including discounted cash prices and all rates negotiated by health insurer and plan

CMS’s analysis, by contrast, provides a mere surface-level look at the existence of price files and doesn’t analyze whether insurance plan prices are correctly listed. Anything less than listing complete prices in dollars and cents is obfuscation. CMS’s study even admits that it “does not include all the requirements of the Hospital Price Transparency regulation.”

Consumers need detailed price information to perform meaningful comparisons, identify the well-documented widespread price variations for the same care even within the same hospital, and avoid pervasive hospital overcharging. When prices are missing or remain hidden, hospitals can escape competition and accountability. And the dearth of information limits tech innovators from creating easy-to-use web applications such as Priceline or Kayak have done in other areas.

The findings of the PatientRightsAdvocate survey are in line with other reports on compliance with the hospital price transparency rule. Two studies published in January in the Journal of General Internal Medicine found hospital compliance rates of 19% and 35.9%, respectively. A June 2022 JAMA study determined that only 5.7% of hospitals were following the rule.

A complete understanding of compliance is a necessary prerequisite for properly enforcing the price transparency rule. CMS’s rose-colored conclusions likely explain the agency’s meager enforcement so far. It has fined just two hospitals nationwide out of the thousands that aren’t following the rule. Yet even this limited response demonstrates the power of financial penalties. These two hospitals quickly came into compliance, posting exemplary price files.

Disregarding the limited CMS report and viewing the bulk of the published compliance literature, it’s clear there remains an urgent need to ramp up enforcement of the hospital price transparency rule. Ongoing noncompliance by most American hospitals suggests that robust government action is the only way to make hospitals follow the rule and disclose their actual prices.

As a first step, CMS should issue fines on the 30% of American hospitals (approximately 1,800 in total) it concludes in its own analysis are not complying with the rule. Once those hospitals post their real prices, the agency can do another sweep of hospital price disclosures using broader compliance criteria to identify another tranche that isn’t following all facets of the rule, such as posting complete prices by insurance company and plan.

Only when all hospitals post their actual, upfront prices can health care consumers benefit from choice and competition and enjoy significant health care savings. Systemwide price transparency is required to usher in a functional, competitive market that empowers patients, employers, and unions to shop for the best care at the best prices and fight medical billing overcharges, errors, and fraud.

The good news is that CMS seems to recognize the importance of price transparency and has recommitted to advancing it in its report. The bad news is that the agency doesn’t seem to understand the scope of the hospital noncompliance problem.

Cynthia A. Fisher is the founder and chair of PatientRightsAdvocate.org.

https://www.statnews.com/2023/03/02/cms-vastly-overestimates-transparency-hospital-prices/

Walgreens VillageMD Acquires Starling Physicians Primary Care

 VillageMD announced today it has acquired Starling Physicians, a leading primary care and multi-specialty group in Connecticut.

“Starling shares our vision of being a physician-led model and they provide care in a compassionate and exceptional way to all the patients they serve. By integrating primary care with specialty care, we are able to optimize access to high-quality care for our patients,” said Tim Barry, CEO and chair of VillageMD. “This is a natural extension of our growth in the Northeast, including our recent acquisition of Summit Health-CityMD. Together, we are transforming the way healthcare is delivered in the United States.”

Starling has more than 30 locations in Connecticut offering primary care and a range of specialties including cardiology, ophthalmology, endocrinology, nephrology, and geriatric care. Starling offers a coordinated approach to care and focus on building lasting relationships with their patients.

“The value-based care delivery model, coupled with our broad multi-specialty healthcare platform, will result in improved clinical outcomes for our patients and healthier local communities, while lowering the cost of care. VillageMD has had notable and repeated success delivering cost-effective high-quality care in a variety of markets and was the natural partner for Starling to realize this transformational vision in Connecticut,” said Christopher Russo, M.D., a Starling board member and chair of the board finance committee.

The transaction closed on March 1, 2023. Terms of the transaction were not disclosed. Cain Brothers, a division of KeyBanc Capital Markets, served as financial advisor and DLA Piper LLC (US) served as legal counsel to Starling. River Pines Capital, LLC also provided strategic advice to the Starling board of directors. McDermott Will & Emery served as legal counsel to VillageMD.

https://www.businesswire.com/news/home/20230303005288/en/VillageMD-Acquires-Starling-Physicians-and-Broadens-its-Footprint-in-the-Northeast

Biden had small cancerous lesion removed, White House doctor says

 President Joe Biden had a skin lesion removed on Feb. 16 during a checkup and it later was found to have been cancerous tissue, said Biden's physician, Dr. Kevin O'Connor, in a memo released Friday by the White House. The memo said all cancerous tissue was removed, no further treatment is required, and the site of the biopsy has "healed nicely."

https://www.morningstar.com/news/marketwatch/20230303613/biden-had-small-cancerous-lesion-removed-white-house-doctor-says