Coalition is pushing for action among 43 pharmaceutical pricing bills currently before Congress
Increased transparency that lets consumers see prices charged by hospitals, physicians, and clinical laboratories in advance of service is an important goal of healthcare policymakers and self-insured employers. But greater transparency has yet to affect how prescription drugs are first priced, marked up, and charged to the final purchasers.
Now a group within the pharmaceutical industry has issued a call for greater transparency in the pricing of prescription drugs. A number of smaller Pharmacy Benefit Managers (PBMs) have formed a coalition against the often confusing and overly complex pricing of prescription drugs in hopes that their efforts will give healthcare consumers more clarity when it comes to comparison shopping for pharmaceuticals.
Calling itself Transparency-Rx, the newly-formed coalition “will push for changes to the PBM model … [such as] a ban on spread pricing as well as reforms to the rebate model that include the impact of group purchasing organizations,” Fierce Healthcare reported.
Traditional PBMs act as a third-party to connect pharmacies and drug companies with healthcare payers. This new alliance of “Transparent” PBMs claims that traditional PBMs need to be reformed, and that is what Transparency-Rx is advocating.
According to a press release, Transparency-Rx is working with both political parties in Congress and the current administration to bring “critical reforms to a costly and misaligned drug pricing market.”
The group is seeking:
A 100% pass-through model.
A ban on spread pricing.
National reporting and disclosure requirements for the industry and its consultants.
Delinking provisions that will require PBMs to be paid by a flat, disclosed fee.
Technology that empowers actionable data and information to be shared with patients, plans, pharmacists, and physicians, throughout the drug supply-chain.
“In an industry that has opposed meaningful drug reform, Transparency-Rx seeks to inject common-sense, change, and clarity into a complex environment,” the coalition stated in its press release.
This is consistent with the wider goal of healthcare policymakers to achieve fully-transparent prices for all healthcare services so that buyers—self-insured employers, patients, and others—can easily compare prices of prescription drugs.
“The notion that transparency is a dangerous idea, to us is sort of a little absurd—it’s already working,” Transparency-Rx founder, President, and Managing Director Joseph Shields, JD, (above) told Fierce Healthcare. “The question is, can Congress help empower it and take it to scale for a variety of different plans?” (Photo copyright: Transparency-Rx.)
Transparency-Rx Members
In a press release announcing S.4293—the Pharmacy Benefit Manager Transparency Act of 2022—Senator Chuck Grassley stated, “Today, three PBMs control nearly 80% of the prescription drug market. They serve as middlemen, managing every aspect of the prescription drug benefits process for health insurance companies, self-insured employers, unions, and government programs. They operate out of the view of regulators and consumers—setting prescription costs, deciding what drugs are covered by insurance plans and how they are dispensed—pocketing unknown sums that might otherwise be passed along as savings to consumers and undercutting local independent pharmacies. This lack of transparency makes it impossible to fully understand if and how PBMs might be manipulating the prescription drug market to increase profits and drive-up drug costs for consumers.”
The act was reintroduced as S.127 to the next Congress in 2023.
According to PharmaNewsIntelligence, “Vertical integration within the market has resulted in most PBMs being owned by the largest insurers in the country. The ACMA [Accreditation Council for Medical Affairs] estimates that CVS Caremark, Express Scripts, and OptumRx control approximately 89% of the market share.”
Transparency-Rx represents more than 14 million people in all 50 states, the press release notes. Founding transparent PBM members include:
“The founding members are companies that are looking to have a voice in the drug pricing debates and reform efforts,” Joseph Shields, JD, founder, President, and Managing Director of Transparency-Rx, told Fierce Healthcare.
Transparency-Rx’s efforts will “likely ruffle feathers at the industry’s biggest companies,” Fierce Healthcare surmised.
“As a counterweight to the status-quo, Transparency-Rx confronts stale and dated ideas, takes on corporate monopolies, and especially big PBMs and the insurance lobby,” Transparency-Rx states on its website. “For too long, these special interests have been the lone and loudest voice fighting against real policy changes on drug pricing and health care, protecting a broken system which hides profits and inflates prescription costs, harming the interests of diverse communities, working families, and seniors.”
Transparent PBMs Focus on Congress
“Congress should know patients, employers, and plans can thrive in a transparent, competitive, and efficient PBM market,” LeAnn Boyd, PharmD, CEO and founding partner at Liviniti, told Fierce Healthcare. “We embrace critical reforms to a costly and misaligned drug pricing market. In fact, most of these reforms are already reflected in the business and innovations of transparent PBMs.”
Clinical laboratory managers and pathologists may be surprised to learn that 43 bills are currently pending in Congress. Each of these bills focuses on changing the prescription pricing policy for both public and commercial healthcare sectors. The number of pending bills on this topic signals that many in Congress consider the long-standing and complex pricing structure of prescription drugs to be a major issue that needs a solution.
“The coalition is working with lawmakers on both sides of the aisle as well as with the Biden administration, according to the announcement,” Fierce Healthcare reported.
“Just as transparency offers a better way to managing prescription drug benefits, Transparency-Rx represents a step forward to sound policy solutions, galvanizing true affordable prices,” Transparency-Rx claims.
“We’re not naive in terms of where we are in the conversation. We’re looking to scale up and play a meaningful role,” Shields told Fierce Healthcare.
Transparency-Rx’s progress is worth following because it’s a group of smaller PBMs forming a coalition to advocate for more transparency in the prices of prescription drugs. Currently, it’s nearly impossible to understand the way drugs are priced and how rebates are passed along the reimbursement chain. That complexity is what is causing transparent PBMs to organize.
How big is this problem? For 2022, prescription drug spending was $405.5 billion, according to government data. That is about four times the amount spent annually in the United States for clinical laboratory and anatomic pathology testing.
Healthcare industry watchdog Group Leapfrog says that if CMS suppresses the data “all of us will be in the dark on which hospitals put us most at risk”
For some time, hospitals and clinical laboratories have struggled with transparency regulation when it comes to patient outcomes, test prices, and costs. So, it is perplexing that while that Centers for Medicare and Medicaid Services (CMS) pushes for more transparency in the cost of hospital care and quality, the federal agency also sought to limit public knowledge of 10 types of medical and surgical harm that occurred in hospitals during the COVID-19 pandemic.
And even though the CMS announced in its August 1 final rule (CMS-1771-F) that it was “pausing” its plans to suppress data relating to 10 measures that make up the Patient Safety and Adverse Events Composite (PSI 90), a part of the Hospital-Acquired Condition (HAC) Reduction Program, it is valuable for hospital and medical laboratory leaders to understand what the federal agency was seeking to accomplish.
According to USA Today, medical complications at hospitals such as pressure ulcers and falls leading to fractures would be suppressed in reports starting next year. Additionally, CMS “also would halt a program to dock the pay of the worst performers on a list of safety measures, pausing a years-long effort that links hospitals’ skill in preventing such complications to reimbursement,” Kaiser Health News reported.
The proposed rule’s executive summary reads in part, “Due to the impact of the COVID-19 PHE on measure data used in our value-based purchasing (VBP) programs, we are proposing to suppress several measures in the Hospital VBP Program and HAC Reduction Program … If finalized as proposed, for the FY 2023 program year, hospitals participating in the HAC Reduction Program will not be given a measure score, a Total HAC score, nor will hospitals receive a payment penalty.”
In a fact sheet, CMS noted that its intent in proposing the rule was neither to reward nor penalize providers at a time when they were dealing with the SARS-CoV-2 outbreak, new safety protocols for staff and patients, and an unprecedented rise in inpatient cases.
“We want the public to have complete trust in the data and will only be providing data we have determined has a high confidence of credibility and accuracy,” said CMS Chief Medical Officer Lee Fleisher, MD (above), Director of the CMS Center for Clinical Standards and Quality in a statement, Axios reported. Clinical laboratory leaders would find it more difficult to compare the performance of their hospitals against peer hospitals, should this proposed rule take effect as written. (Photo copyright: Lee Fleisher.)
Groups Opposed to the CMS Proposal
Like healthcare costs, quality data need to be accessible to the public, according to a health insurance industry representative. “Cost data, in the absence of quality data, are at best meaningless, and at worst, harmful. We see this limitation on collection and publication of data about these very serious safety issues as a step backward,” Robert Andrews, JD, CEO, Health Transformation Alliance, told Fortune.
The Leapfrog Group, a Washington, DC-based non-profit watchdog organization focused on healthcare quality and safety, urged CMS to reverse the proposal. The organization said on its website that it had collected 270 signatures on letters to CMS.
“Dangerous complications, such as sepsis, kidney harm, deep bedsores, and lung collapse, are largely preventable yet kill 25,000 people a year and harm 94,000,” wrote the Leapfrog Group in a statement. “Data on these complications is not available to the public from any other source. If CMS suppresses this data, all of us will be in the dark on which hospitals put us most at risk.”
Leah Binder, Leapfrog President/CEO, told MedPage Today she is concerned the suppression of public reporting of safety data may continue “indefinitely” because CMS does not want “to make hospitals unhappy with them.”
AHA Voices Support
Meanwhile, the American Hospital Association noted that the CMS “has made this proposal to forgo calculating certain hospital bonuses and penalties due to the impact of the pandemic,” Healthcare Dive reported.
“We agree with CMS that it would be unfair to base hospital incentives and penalties on data that have been skewed by the unprecedented impacts of the pandemic,” said Akin Demehin, AHA Senior Director, Quality and Safety Policy, in a statement to Healthcare Dive.
Though CMS’ plans to limit public knowledge of medical and surgical complications have been put on hold, medical laboratory leaders will want to stay abreast of CMS’ next steps with this final rule. Suppression of hospital harm during a period of increased demand for hospital transparency could trigger a backlash with healthcare consumers.
The Joint Commission opposed the Medicare proposal, and patient advocate groups say rescinding it is a setback for hospital transparency
Powerful interests arrayed against greater transparency in the performance of hospitals, physicians, and medical laboratories have stopped a proposed Medicare program that would have allowed the public to see the results of hospital inspections.
Stopped in its tracks was an effort by the Centers for Medicare and Medicaid Services (CMS) to make hospital accreditation inspection reports available for public viewing. Opposition to this program led CMS to withdraw its plan for heightened transparency.
CMS originally called the proposal “groundbreaking” in a National Public Radio (NPR) article. That’s because it would have enabled consumers to view reports that private accreditation organizations, such as The Joint Commission, complete after each inspection. Inspection reports contain information on errors and problems found during hospital surveys. CMS’ push for more transparency in hospital inspections is consistent with the healthcare industry’s trend toward open sharing of healthcare quality, price, and other data.
“We are proposing changes relating to transparency of accrediting organizations survey reports and plans of correction of providers and suppliers,” CMS officials wrote in a proposed rule published on April 28.
CMS Pulls Back Proposal to Make Hospital Survey Reports Public
But it was not to be. After receiving comments, CMS officials stated in early August that the agency had pulled back the proposal.
“CMS is committed to ensuring that patients have the ability to review the findings used to determine that a facility meets the health and safety standards required for Medicare participation. However, we believe further review, consideration, and refinement of this proposal is necessary to ensure that CMS establishes requirements, consistent with our statutory authority, that will inform patients and continue to support high quality care,” noted a CMS fact sheet.
Agencies Find Problems in Hospitals That Accreditors Do Not, CMS Declares
It’s against federal law for CMS to release data related to hospital inspections, Becker’s Hospital Review reported. And, as part of the Clinical Laboratory Improvement Amendments (CLIA), clinical laboratories must participate in inspections to ensure they qualify for Medicare and Medicaid payments. However, the inspection reports of the nation’s medical laboratories are not made public.
So, what motivated CMS to make healthcare organizations’ inspection information public? CMS noted that private accreditation organizations miss serious provider problems that state inspectors find in follow-up visits to hospitals, ProPublica explained.
In fact, state agency reviews of 103 hospitals in 2014 found 41 serious deficiencies, including 39 missed by the accreditors, noted the NPR article.
The chart above based on Johns Hopkins research was compiled by the National Center for Health Statistics and reported by The Washington Post. It shows that medical errors are now the third leading cause of death in the US. (Photo copyright: The Washington Post.)
“Right now, the public has very little information about the places where they’re putting their life on the line, and that’s just not acceptable. If [they are] a good place, what are they afraid of?” Rosemary Gibson, Senior Advisor at The Hastings Center, stated in the NPR article.
Reaction from Accreditors and Consumer Groups Differs
The Joint Commission opposed the CMS proposal. And, now, patient safety advocacy groups are disappointed about the decision by Medicare officials to rescind the proposed program.
“We believe the proposal will have significant detrimental consequences on our nation’s ability to continually improve the delivery of healthcare services,” stated Mark Chassin, MD, FACP, MPP, MPH, Joint Commission President and Chief Executive Officer, in a June letter to CMS published partially in an HCPro blog post.
HCPro, a firm that aids organizations in accreditation, credentialing, and other needs, noted the following Joint Commission concerns about publicly shared survey reports in the blog post:
Providers may be less likely to be open about opportunities for improvement;
Accreditors could struggle to create new standards;
The number of non-accredited facilities may increase;
Accreditation may be devalued; and,
Costs to providers and accreditors would likely rise.
The Center for Improvement in Healthcare Quality (CIHQ), another accreditation option for hospitals, also expressed concerns with the CMS proposal, according to the ProPublica report.
“Knowing that survey [inspection] reports are public knowledge will only incentivize hospitals and other healthcare entities to go back to the days of ‘hiding’ quality of care issues from accreditors, rather than working with us to improve the quality and safety of care rendered to patients,” CIHQ advised in the ProPublica article.
The Leapfrog Group, which bills itself as an advocate of hospital transparency, called the reversed proposal “a disappointing setback for healthcare transparency.”
In a statement, Leah Binder, President and Chief Executive Officer of The Leapfrog Group, noted, “We are disappointed to learn that the agency that runs Medicare (CMS) has reversed course on its proposal to require private accrediting organizations, such as the Joint Commission, to publicly release reports of problems they found in hospitals and other healthcare facilities. The public deserves full transparency on how the healthcare industry performs.”
So, for the time being, it appears that what is found during hospital inspections will stay within the inspection report and will not become available to the general public. However, with consumers expecting greater transparency and higher levels of service in all aspects of healthcare, the interest in public access to the quality performance of hospitals, physicians, clinical laboratories, and anatomic pathology groups will only increase.
OIG suggests better use of analytics by CMS could prevent gaming of the system by providers; clinical laboratories can help through test utilization management technology
In 2015, CMS implemented the Hospital-Acquired Condition Reduction Program (HACRP) as part of the Patient Protection and Affordable Care Act (ACA). The HACRP program incentivizes hospitals to lower their HAI rates by adjusting reimbursements according to the inpatient quality reporting (hospital IQR) data provided by the healthcare providers. Hospital IQR data is the basis on which CMS validates a hospital’s HAI rate (among other things CMS is tracking) to determine the hospital’s reimbursement rate for that year.
CMS, in 2016, met its regulatory requirement to validate inpatient quality reporting data;
It reviewed data of 400 randomly selected hospitals as well as 49 hospitals targeted for failing to report half their HAIs, or for low scores in the prior year’s validation process;
However, OIG also reported that CMS did not include hospitals that displayed abnormal data patterns in its targeted sample. Targeting those hospitals, according to the OIG, could identify inaccurate reporting.
CMS staff had identified 96 hospitals with aberrant data patterns, but did not target them for validation—even though the agency can select up to 200 targeted hospitals for review, Becker’s Hospital Review pointed out.
Dollars More Important than Deaths
According to the OIG report, Medicare excluded in its investigation dozens of hospitals with suspected HAI reporting. This is odd since the CMS and the Centers for Disease Control (CDC) apparently are aware that some healthcare providers have manipulated data to improve their quality measure scores and thus increase their reimbursement rates.
“Collecting and analyzing quality data is increasingly central to Medicare programs that link payments to quality and value. Therefore, it is important for CMS to ensure that hospitals are not gaming [manipulating data to improve scores] their reporting of quality data,” the OIG report noted.
“There are greater requirements for what a company says about a washing machine’s performance than there is for a hospital on quality of care. And this needs to change,” stated Peter Pronovost, MD, PhD, in the Kaiser Health News article. “We require auditing of financial data, but we don’t require auditing of healthcare quality data, and that implies that dollars are more important than deaths.” Pronovost is Senior Vice President for Patient Safety and Quality at Johns Hopkins University School of Medicine.
Peter Pronovost, MD, PhD (above) testifying on preventable deaths before the Senate Subcommittee on Primary Health and Aging in 2014. He is Senior Vice President for Patient Safety and Quality at Johns Hopkins University School of Medicine in Baltimore. Pronovost told Kaiser Health News that there are no uniform standards for reviewing data that hospitals report to Medicare. (Photo copyright: US Senate Committee on Health, Education, Labor and Pensions.)
Medicare Missed Hospitals with Suspected HAI Data
CMS should have done an in-depth review of many hospitals that submitted “aberrant data patterns” in 2013 and 2014, the OIG stated in its report. According to a Kaiser HealthNews article, such patterns could include:
A rapid change in results;
Improbably low infection rates; and
Assertions that infections nearly always struck before patients arrived at the hospital.
“There’s a certain amount of blind faith that hospitals are going to tell the truth. It’s a bit much to expect that if they had a bad record they are going to fess up to it,” noted Lisa McGiffert, Director of the Safe Patient Project at Consumers Union, in the Kaiser Health News article.
CMS Needs Better Data Analytics
So, what does the OIG advise CMS to do? The agency called for “better use of analytics to ensure the integrity of hospital-reported quality data.” Specifically, OIG suggested CMS:
Identify hospitals with abnormal percentages of patients who had infections on admission;
Apply risk scores to identify hospitals with high propensity to manipulate reporting;
Use experiences to create and improve models that identify hospitals most likely to game their reporting.
CMS’ Administrator Seema Verma reportedly responded, “We will continue to evaluate the use of better analytics as feasible, based on Medicare’s operational capabilities.”
Medical Laboratory Diagnostic Testing Part of Gaming the System
A 2015 CMS/CDC joint statement noted “three ways that hospitals may be deviating from CDC’s definitions for reportable HAIs,” and two involve diagnostic test ordering. According to the OIG report, they include:
Overculturing: Diagnostic tests may be overutilized by providers in absence of clinical symptoms. Hospitals may use positive results to game their data by claiming infections that appeared days later were present on admission and thus not reportable.
Underculturing: Hospitals underculture when they do not order diagnostic tests in the presence of clinical symptoms. By not ordering the test, the hospital does not learn whether the patient truly has an infection and, therefore, the hospital does not have to report it.
Adjudication: Hospital administrative staff may inappropriately overrule those who report infections. HAIs are, therefore, not shared.
Clinical Laboratories Can Help
One in 25 people each day receives an HAI, CDC estimates. The OIG findings should be a reminder to medical laboratories and pathology groups that quality measures and patient outcomes are often transparent to media, patients, and the public.
One way medical laboratories in hospitals and health systems can help is by investing in utilization management technology and protocols that ensure appropriate lab test utilization. Informing doctors on the availability of appropriate diagnostic tests based on patients’ existing conditions, unique physiologies, or medical histories, could help prevent hospitals from inadvertently or deliberately game the system.
Clearly, transparency in healthcare is increasing. That means there will be more news stories revealing federal agencies’ failures to respond to healthcare data in ways that could have protected patients and the public. Clinical laboratories don’t want to be included in negative reporting.
An earlier Johns Hopkins study looked at diagnostic errors and determined that such errors were the leading cause of malpractice payouts. Can clinical laboratories help?
This finding has many implications for pathologists and clinical laboratory managers. Often, medical errors are associated with the failure of physicians to order correct medical laboratory tests at critical junctures. Alternatively, a medical error can result if the physician fails to take appropriate action after getting an accurate lab test result. Thus, any effort within the health system to reduce medical errors will probably bring pathologists and medical laboratory scientists into closer consultation with clinicians.
What the researchers at Johns Hopkins also learned during their study is that medical error is not reported as a cause of death on death certificates. Further, the Centers for Disease Control and Prevention (CDC) has no “medical error” category in its annual report on deaths and mortality, The New York Times (NYT) reported. (more…)
