An MIT-Sloan study finds policies in the category related to data protection affect health information sharing the most.
Policies developed by state legislatures can play a critical role in the adoption of health data sharing, which, in turn, will improve care quality, according to a new study from MIT Sloan School of Management.
The MIT Sloan researchers wanted to determine why, despite the high levels of adoption of electronic health records since the 2009 Health Information Technology for Economic and Clinical (HITECH) Act, the actual use of shared data to improve care has sputtered.
"If states want to increase the use of health information sharing in an effort to improve quality of care, we need to understand how state laws most encourage and discourage the use of HIEs, and then weigh the benefits of information sharing with other goals like the strength of privacy protections," says coauthor MIT Sloan Prof. Joseph Doyle.
Fewer than 10% of hospitals (and fewer than 20% of doctors) were using EHR before the HITECH Act, which doled out $30 billion to increase the adoption. By 2014, 97% of reporting hospitals had electronic health record technology.
Despite the big investment and adoption, the study notes that the actual use of the data and resulting improvements to healthcare quality and productivity have been tepid.
In particular, the research finds policies in the category related to data protection affect health information sharing the most.
The researchers built a database of laws from 50 states between 2000 and 2019 and tracked 12 policies area that may increase HIE use. In turn, those 12 policy areas were further divided into four main categories: clarifying HIE governance, strengthening financial stability, specifying the uses and users of an HIE, and protecting the underlying data.
MIT-Sloan looked at shifting state policies over the 20-year span and then tested whether health information sharing responds to changes in state laws. The findings identify policies can have the potential to bolster the use of digital tools to improve health and lower costs.
For example, the research shows that data protection policies affect health information sharing the most. In states that make the protection of data less costly, HIE usage increases by 18%. Enacting legislation that has patients participate by default leads to a 16% increase in usage.
"When comparing outcomes of policies that had patients 'opting in' or 'opting out' of using health information exchanges, we found that 'opt in' policies resulted in less participation and data sharing," Doyle says.
The study also found that HIE use can improve care quality. An examination of hospital discharges for heart attack patients in Florida from 2011 to 2014 found that hospitals using HIEs had lower readmission rates.
In addition, physician offices with strong HIE programs have maintained quality with 5% lower Medicare spending.
Even with those measured successes, however, surveys of HIE stakeholders show ongoing and stubborn challenges to HIEs, including financial viability, state regulations and concerns about privacy.
In a first-of-its-kind proposed action, the commission also issued an order banning the online counseling service from sharing consumers mental health data.
Online mental health provider BetterHelp Inc. will refund $7.8 million to its customers for "deceiving" them and sharing their medical data for targeting ads used by Facebook, Snapchat and other social media, the Federal Trade Commission announced Thursday.
The FTC says the proposed action – which cleared the commission on a 4-0 vote -- is its first to return money to consumers whose health data was compromised and includes a proposed order banning BetterHelp from sharing consumers health data, "including sensitive information about mental health challenges."
The agreement will be published in the Federal Registry for 30 days for public comment, after which the commission will decide whether to make the order final.
"When a person struggling with mental health issues reaches out for help, they do so in a moment of vulnerability and with an expectation that professional counseling services will protect their privacy," Samuel Levine, director of FTC's Bureau of Consumer Protection, says in a media release.
"Instead, BetterHelp betrayed consumers most personal health information for profit. Let this proposed order be a stout reminder that the FTC will prioritize defending Americans sensitive data from illegal exploitation," Levine says.
Mountain View, California-based BetterHelp did not respond Thursday to HealthLeaders' request for comment.
The company markets mental health services geared toward specific groups, such as Faithful Counseling for Christians, Teen Counseling, and Pride Counseling for LGBTQ people.
Prospective customers are required to fill out a questionnaire asking for sensitive mental health information—such as whether they have experienced depression or suicidal thoughts and are on any medications. The applicants also provide their name, email address, birth date and other personal information, after which they are matched with a counselor and pay between $60 and $90 per week for counseling, the FTC says.
Consumer Protection inspectors at FTC note that, at several points in the signup process, BetterHelp promises consumers that it will not use or disclose their personal health data except for limited purposes, such as to provide counseling services.
"Despite these promises, BetterHelp used and revealed consumers email addresses, IP addresses, and health questionnaire information to Facebook, Snapchat, Criteo, and Pinterest for advertising purposes," according to the FTCs complaint.
For example, the FTC complaint says BetterHelp "used consumers email addresses and the fact that they had previously been in therapy to instruct Facebook to identify similar consumers and target them with advertisements for BetterHelps counseling service, which helped the company bring in tens of thousands of new paying users and millions of dollars in revenue."
In addition to the refund, the FTCs proposed order will ban BetterHelp from sharing consumers personal information with certain third parties for re-targeting consumers who previously had visited BetterHelps website or used its app, including those who had not signed up for the companys counseling service.
According to the complaint, BetterHelp pressed customers for sensitive health data by repeatedly showing them privacy misrepresentations and nudging them with unavoidable prompts to sign up for its services.
"Despite collecting such sensitive information, BetterHelp failed to maintain sufficient policies or procedures to protect it and did not obtain consumers affirmative express consent before disclosing their health data," the complaint states, adding that "BetterHelp also failed to place any limits on how third parties could use consumers health information—allowing Facebook and other third parties to use that information for their own internal purposes, including for research and development or to improve advertising."
The counseling service further lied to users and the public in 2020 when it denied media reports that it shared consumers' health information with third parties, the complaint says.
Lilly's announcement puts pressure to follow suit on competitors Novo Nordisk and Sanofi.
Indianapolis-based Eli Lilly and Co., the nation's largest insulin manufacturer, says it will slash the cost of the drug by 70% and cap patient out-of-pocket costs at $35 or less per month.
“While the current healthcare system provides access to insulin for most people with diabetes, it still does not provide affordable insulin for everyone and that needs to change," Lilly Chair and CEO David A. Ricks says in a media release Wednesday.
"The aggressive price cuts we're announcing today should make a real difference for Americans with diabetes,” Ricks says. “Because these price cuts will take time for the insurance and pharmacy system to implement, we are taking the additional step to immediately cap out-of-pocket costs for patients who use Lilly insulin and are not covered by the recent Medicare Part D cap."
Specifically, Lilly says it will:
Cut the list price of its non-branded insulin, Insulin Lispro Injection 100 units/mL, to $25 a vial. Effective May 1, 2023, it will be the lowest list-priced mealtime insulin available, and less than the price of a Humalog vial in 1999.
Cut the list price of Humalog (insulin lispro injection) 100 units/mL1, Lilly's most commonly prescribed insulin, and Humulin (insulin human) injection 100 units/mL2 by 70%, effective in Q4 2023.
Launch Rezvoglar, a basal insulin biosimilar of injected Lantus for $92 per five pack of KwikPens, a 78% discount to Lantus, effective April 1, 2023.
Automatically cap out-of-pocket costs at $35 at participating retail pharmacies for people with commercial insurance using Lilly insulin, effective immediately.
Provide access to $35 insulin for uninsured diabetics using its online website InsulinAffordability.com, effective immediately.
A Department of Health and Human Services report issued last month found that 1.5 million Medicare enrollees will benefit from a $35 cap on a month’s supply of insulin, which was mandated under the Inflation Reduction Act.
The report also found that nationally, the average out-of-pocket cost was $58 per insulin fill in 2019, typically for a 30-day supply. On the commercial side, the report found that patients with private insurance or Medicare paid about $63 per fill on average, and 1 in 5 Americans taking insulin paid more than $70 per prescription.
Pressure on Rivals
Lilly's announcement puts pressure to follow suit on competitors Novo Nordisk and Sanofi, who with Lilly manufacture more than 90% of the global insulin supply. Neither company would commit to copying Lilly's price cuts, but both also say they already have extensive policies in place for purchasing insulin at rates similar to what Lilly is charging.
In a Tweet Wednesday, President Joe Biden calls Lilly's announcement "a big deal" and added "it's time for other manufacturers to follow."
"For far too long, American families have been crushed by drug costs many times higher than what people in other countries are charged for the same prescriptions. Insulin costs less than $10 to make, but Americans are sometimes forced to pay over $300 for it. It's flat wrong," Biden says. "Last year, I signed a law to cap insulin at $35 for seniors and I called on pharma companies to bring prices down for everyone on their own. Today, Eli Lilly did that."
"Now it’s time for other drug manufacturers to join in. And it's time for Congress to build on, not repeal, our new prescription drug law, the Inflation Reduction Act," Becerra says.
While not mentioning his competitors, Ricks implied that Novo Norisk and Sanofi should follow Lilly's lead, noting that “7 out of 10 Americans don't use Lilly insulin."
"We are calling on policymakers, employers and others to join us in making insulin more affordable," Ricks says.
Denmark-based Novo Nordisk issued a statement affirming its "ongoing commitment to patient affordability and access over the past several years."
"For more than 10 years, we have had an offering through Walmart which includes a human insulin program for about $25 per vial," the drugmaker says. "In addition, through NovoCare, our My$99Insulin program provides eligible people living with diabetes a 30-day supply of a combination of our insulin products (up to three vials or two packs of pens) for $99, equating to $33/vial or $49.50/pack of pens. Our Immediate Supply program provides those who may be at risk of rationing their insulin a one-time free 30-day supply of our insulin."
Sanofi issued a statement saying it "believes that no one should struggle to pay for their insulin, regardless of their insurance status or income level, which is why we have a suite of innovative and patient-centric savings programs to help people reduce their prescription medicine costs."
The Paris-based company says that 100% of commercially insured people are eligible for Sanofi's copay assistance programs, regardless of income or insurance plan design, which caps out-of-pocket expenses for most patients to $15 or less for one month.
In addition, Sanofi says all uninsured people are eligible for a $35-a-month price through its Insulins Valyou Savings Program, and also allows uninsured people to pay as little as $99 for a 30-day supply of pens.
"We also provide free medications to qualified low- and middle-income patients through the patient assistance component of the Sanofi Patient Connection, and last year, Sanofi also launched Insulin Glargine U-100 at a price that is 60% less than the current Lantus list price, while continuing to offer Lantus to payers who choose to cover the existing product," the drugmaker says.
Hot Button Issue
The high cost of healthcare, and specifically the skyrocketing costs of prescription drugs, have been a hot topic in state and federal government circles, and in Congress, where Republicans and Democrats have says it's time to address the issue.
On Jan. 12, California Attorney General Rob Bonta filed suit against Lilly, Sanofi and Novo Nordisk, and pharmacy benefits mangers CVS Caremark, Express Scripts, and OptumRx “for driving up the cost of the lifesaving drug through unlawful, unfair, and deceptive business practices in violation of California's Unfair Competition Law.”
"Insulin is a necessary drug that millions of Americans rely upon for their health, not a luxury good," Bonta says. "With (this) lawsuit, we're fighting back against drug companies and PBMs that unacceptably and artificially inflate the cost of life-saving medication at the expense of vulnerable patients."
Biden used his State of the Union address last month to scold "Big Pharma" for reaping "record profits" from insulin sales, and urged Congress to support a universal $35-a-month cap on the price of the life-sustaining diabetes drug.
Biden told Congress that the $35-a-month insulin price cap for Medicare enrollees under the IRA should be available to everyone regardless of their coverage status.
"Insulin has been around for 100 years,” Biden told a joint session of Congress. "The guy who invented it didn't even patent it because he wanted everyone to have it. It costs drug companies just $10 a vial to make. But, Big Pharma has been unfairly charging people hundreds of dollars – and making record profits."
Sen. Bernie Sanders (I-VT), chair of the Senate Health, Education, Labor and Pensions (HELP) Committee and an outspoken and ardent critic of pharma, credited the cost cuts to public pressure more than corporate benevolence on Lilly's part.
"This is what fighting back accomplishes: At a time when Eli Lilly made over $7 billion in profits last year, public pressure forced them to reduce the price of insulin by 70%," Sanders Tweeted. "Sanofi and Novo Nordisk must do the same."
CMS agrees that enhanced oversight is needed, but says OIG audit 'does not constitute credible information of overpayments.'
Federal watchdogs are recommending that the Centers for Medicare & Medicaid Services claw back as much as $216 million for noncompliant definitive drug testing paid to at-risk Medicare providers.
The Department of Health and Human Services’ Office of the Inspector General audited $3 billion in Medicare Part B payments between 2016 and 2020 and found that CMS had paid $704 million over that period for definitive drug testing services made to more than 5,200 providers.
The audit found that 1,026 at-risk providers in the five-year period routinely billed for a definitive drug testing service with the highest reimbursement amount (procedure code G0483) more than 75% of the time, compared with 4,227 "other providers" who "did not routinely bill this service."
"We determined that presumptive drug testing preceded most definitive drug testing services billed by both the at-risk and other providers," OIG says. "However, the at-risk providers may not have always used presumptive testing to determine the number of drug classes that needed to be tested using definitive drug testing, because they routinely billed for testing 22 or more drug classes using G0483 and the other providers did not."
The up-coded billings from at-risk providers occurred even though their patient mix and testing frequency were not significantly different from that of other providers, OIG says.
"This suggests that the at-risk providers may have been able to bill for definitive drug testing services using primarily procedure codes with lower reimbursement amounts, as the other providers did," OIG says. "If CMS's program safeguards had focused on at-risk payments to at-risk providers for procedure code G0483, Medicare could have saved up to $215.8 million for our audit period."
CMS Responds
While CMS has agreed with OIG’s recommendations for enhanced oversight, the agency disagreed with suggestions that it seek refunds from providers.
"This audit does not constitute credible information of overpayments because no overpayments were identified," CMS Administrator Chiquita Brooks-LaSure writes in a response to the audit. "Therefore, this audit is not sufficient basis upon which CMS can support a 60-day rule notice to identified providers."
Brooks-LaSure notes that OIG "classified providers as ‘at risk’ for improper payment only due to the frequency at which they billed this code and the amount of Medicare reimbursement they received during the audit period. This analysis alone does not provide findings of improper payment, which would have required medical review."
Instead of using agency resources to track down overpayments from providers with no assurances of collections, Brooks-LaSure says CMS will instead "send a comparative billing report to those providers that IOG identified, alerting them to the fact that their billing is an outlier compared to their peers."
The settlement is the latest development in an ongoing, bitter feud between former colleagues who've traded accusations of drug abuse and improper romantic relationships.
UPMC will pay the federal government $8.5 million to settle whistleblower false claims allegations, ending one chapter in a bitter, years-long feud between former physician-colleagues at the prestigious health system that reads like a script taken from "General Hospital."
UPMC, University of Pittsburgh Physicians, and James L Luketich, MD, the renowned chair of the Department of Cardiothoracic surgeon at the sprawling, Pittsburgh-based health system, agreed to the fine to settle allegations that Luketich "regularly performed as many as three, complex surgical procedures at the same time, failed to participate in all of the ‘key and critical' portions of his surgeries, and forced his patients to endure hours of medically unnecessary anesthesia time, as he moved between operating rooms and attended to other patients or matters," the U.S. Justice Department says in a media release.
The DOJ complaint stated that "those practices amounted to violations of the statutes and regulations which prohibit ‘teaching physicians' (like Dr. Luketich) from billing the United States for ‘concurrent surgeries,' were well known to UPMC leadership, and increased the risk of surgical complications to patients."
"The Settlement Agreement provides that it is neither an admission of liability by the Defendants nor a concession by the United States that its claims are not well founded," DOJ says. "Instead, in order to avoid delay and the expense of protracted litigation, and in consideration of the promises and obligations of the Settlement Agreement, the parties agreed to resolve the case."
Luketich's attorney, Efrem M. Grail, says his client is "pleased this settlement puts an end to the Government's case."
"Medical schools and their hospitals have sought clarity about the billing regulation for teaching physicians at issue here for years, and the United States has never provided it," Grail says. "This settlement provides a mechanism we hope will lead to authoritative guidance so that universally respected surgeons like Dr. Luketich can return their focus to training young doctors to save lives without having to put up with baseless claims of fraud."
UPMC issued a statement acknowledging the "false claims action challenging UPMC's billing for some of Dr. Luketich's most complicated, team-based surgical procedures."
"At issue was compliance with the CMS's ‘Teaching Physician Regulation' and related billing guidance as well as with UPMC's internal surgical policies," the statement read. "Among other terms, the parties agreed that UPMC could seek clarity from CMS regarding how it should bill for such surgeries. While UPMC continues to believe Dr. Luketich's surgical practice complies with CMS's requirements, it has agreed to pay $8.5 million to the government to avoid the distraction and expense of further litigation. UPMC has also reserved the right to challenge the relator's share of the settlement."
'Sordid Vendetta'
This is where things turn nasty.
While the case with the government has been settled, Luketich is the plaintiff in a separate but related and ongoing defamation suit alleging that the whistleblowers -- two former colleagues – illegally recorded a February 2018 private medical consultation that Luketich had with his personal physician in a UPMC Presybterian Shadyside surgical observation room, during which they discussed Luketich's Suboxone prescription.
The whistleblowers – identified as Jonathan D'Cunha, MD, now chair of cardiothoracic surgery at Mayo Clinic, Arizona, and Lara Schaheen, MD, a UPMC resident at the time – allegedly recorded the conversation and circulated a transcript of it to peers, rival health systems, government officials and hospital administrators, the suit claims.
Documents filed by Luketich in an Allegheny County court allege that his two former colleagues "were acting on a deep-seated and visceral animus" against Luketich that began in 2017 after he confronted them about their alleged romantic relationship and the alleged favorably treatment that D'Cunda showed to Schaheen.
"Their personal interactions, as described by many with whom they worked, were far outside the norms of what would be expected of professional colleagues," Luketich's filing states. "For example, Dr. Schaheen drew circles on Dr. D’Cunha's wrist in the operating room, and Dr. Schaheen received text messages from Dr. D'Cunha while she was in the operating room asking her to 'come to the office and cuddle with [him].'"
The defamation suit alleges that D'Cunha and Schaheen, as part of a "sordid vendetta, sought to use the illegal recordings to portray Luketich "as a drug abuser and as an impaired physician."
Luketich wants an Allegheny County Court judge to throw out recordings, which he says were illegally obtained and which are being used as evidence in a separate suit filed against him by a former patient.
'Dr. D'Cunha's Brave Decision'
D'Cunha's attorneys offer a different picture.
They claim D'Cunha blew the whistle because Luketich's longstanding practice of conducting and overseeing multiple surgeries at once was a violation of Medicare rules, and endangered patients. D'Cunha alleged that UPMC knew about it since 2015 but took no action against the renowned surgeon.
"The Department of Justice's complaint strongly refuted any suggestion that this lawsuit was merely a billing dispute involving confusing government regulations," D'Cunha's attorneys at Phillips & Cohen LLP say in a media release. "It alleged that the conduct did not involve merely technical violations of billing requirements or internal policies. Instead, the government alleged that Luketich's surgical practices defied the standard of care, abused patients' trust, inflated anesthesia time, increased the risk of complications to patients, and – on at least several occasions – resulted in serious harm to patients."
Claire Sylvia, D'Cunha's attorney and Phillips & Cohen says "Dr. D'Cunha's brave decision to step forward despite the personal costs he has endured in order to ensure that this conduct was addressed is exactly the kind of conduct the False Claims Act was intended to encourage and reward."
Her colleague, Jeffrey Dickstein, says the settlement "finally brings meaningful oversight of Dr. Luketich and UPMC."
"Patients deserve more of their surgeon's attention; the government demands it. Now they'll get it," Dickstein says.
The defamation suit and related countersuits are being heard in the Court of Common Please of Allegheny County Pennsylvania.
The Commission voted 4-0 to approve the creation of the Office of Technology.
The Federal Trade Commission on Friday launched an Office of Technology that the commission says will allow it to keep pace with technological challenges in the digital marketplace.
The Commission voted 4-0 to approve the creation of the Office of Technology.
“For more than a century, the FTC has worked to keep pace with new markets and ever-changing technologies by building internal expertise," FTC Chair Lina M. Khan said in a media release.
"Our office of technology is a natural next step in ensuring we have the in-house skills needed to fully grasp evolving technologies and market trends as we continue to tackle unlawful business practices and protect Americans," she said.
The Office of Technology will have dedicated staff and budget and will be led by Chief Technology Officer Stephanie T. Nguyen.
The new office will:
Strengthen and support law enforcement investigations into business practices and the technologies underlying them.
Advise and engage with staff and the Commission on policy and research, including 6(b) studies, reports, requests for information, policy statements, congressional briefings, and other initiatives.
Highlight market trends and emerging technologies that affect FTC work, meeting with the public and stakeholdersthrough workshops, conferences, and consultations and highlight key trends and best practices.
Khan said the Office of Technology builds on the FTC’s long-term efforts to expand in-house technological expertise, and brings the agency in line with other antitrust and consumer protection enforcers around the world.
The Senate Commerce Committee voiced bipartisan support for a bill to regulate PBMs.
U.S. Senate Commerce Committee members on Thursday vented bipartisan confusion and frustration about the opaque, unregulated, and possibly anticompetitive practices of pharmacy benefits managers and their reputed role in driving up drug costs for consumers.
"I gotta be honest with you, the way I see the situation on PBMs I don't know why the hell they even exist," Sen. John Tester (D-MT) told the committee, which met to discuss Pharmacy Benefit Manager Transparency Act of 2023, a bill that would enhance state and federal oversight of PBMs.
"They were set up for all the right reasons, going to negotiate drug prices, going to pass along benefits to the consumer. But what I see them doing in my state, I don't think the consumer gets much benefit. They're shutting down small businesses on Main Street right and left and those are called our local neighborhood pharmacies."
"As far as holding the big pharmaceutical companies accountable, I don't see it. And the reason I don't see it is because there is no transparency in PBMs. None, zero, nada, kaput, nothing," Tester said. "And quite frankly, when you combine that with anticompetitive tactics, this is a recipe were the only people that win with healthcare costs are the PBMs."
Tester's frustration was shared by Sen. Shelley Moore Capito (R-WV) who said she created a flow chart to understand the complex relationships between stakeholders.
"You've got the researchers, the manufacturing, the distributor, the PBM, the insurer, the doctor or hospital, the pharmacy, and then it gets to the patient," Capito said, "and I guarantee you if we actually had that in front of us, it would be more difficult to read than a flowchart from the Corps of Engineers. It would be ‘if this, that', ‘if this, that' and before you know it total confusion, which is what we have in terms of the lack of transparency with PBMs."
Committee Chair Maria Cantwell (D-WA), the sponsor of SB127, likened the complex, secretive inner workings of PBMs to the arcane practices of the housing and banking sectors before the 2008 crash.
"I'm reminded of a time when we had a similar issue of derivatives and one of our colleagues on the Senate floor said ‘we can't regulate derivatives, we don't understand them.' And then shortly thereafter, our whole U.S. economy blew up," Cantwell said. "So I guarantee you, we can look at this market, and we can understand what's going on. And we certainly can benefit from more transparency."
The committee took no action on the bill Thursday.
Mystery and Margin
Expert witness Erin Trish, PhD, co-director of pharmaceutical and health Economics at USC's Schaeffer Center, told the committee that the opaque dealings of PBMs are intentional and to their benefit.
"Prescription drug markets are complicated, and it takes a lot of boxes and arrows to show you even a simplified version of how the dollars and goods flow," Trish said. "While this complexity keeps health economists like me in business, it still remains a mystery to most Americans. And where there is mystery, there is margin."
Trish said that PBMs initially were independent of health plans and effectively reduced prices, encouraged generics, and expanded mail-order services. However, in recent years PBMs have consolidated to the point where three companies -- CVS Health (33%), Cigna (26%) and UnitedHealthcare (21%) -- control 80% of the market.
"The wave of consolidation in the last few years—including health insurers buying up PBMs and PBMs expanding their footprint in pharmacy markets—and other activities have distorted behavior," she said. "Unfortunately, evidence indicates that PBMs are now leveraging their position to extract profits in ways that are detrimental to patients, payers, and the drug innovation system more broadly."
Prof. Casey B. Mulligan, director of The Initiative on Enabling Choice and Competition in Healthcare at the University of Chicago, warned against unintended consequences in the PBM Transparency Act of 2023 and other PBM regulations, which he said "put some of these economic gains (made by PBMs) at risk by constraining the use of benefit-management tools; discouraging investment in the capital assets that help manage utilization, claims, and other activities of drug plans; and creating barriers to further innovation and entry in the PBM business."
"In the likely case that large incumbent PBMs are better able to adapt to the regulations than smaller new PBMs are, the regulations would have the unintended consequence of reducing competition – growing large PBMs at the expense of smaller ones – while they increase the resource costs of managing pharmacy benefits," Mulligan said. "Even if a new regulation eliminated only 10% of the value of benefit management – something like $14 billion annually – it would not pass a cost-benefit test unless it also resulted in a commensurate regulatory benefit."
Sen. Chuck Grassley (R-IA), speaking as a witness before the committee, raised concerns that PBMs push consumers to buy more expensive drugs so the PBMs can collect higher rebates.
"PBMs are blocking a cheaper product," Grassley said. "PBMs will claim they pass on savings to consumers or through lowering premiums, but their spread pricing and clawback tactics prove otherwise."
"When a PBM goes with a higher-price product, consumers may pay more out of pocket before their deductible kicks in or through co-insurance," he said. "The consumer ought to be the point of everything we are trying to accomplish."
The models were authorized under an executive order by President Joe Biden to 'complement' drug cost-savings provisions in the Inflation Reduction Act.
The Biden administration on Tuesday unveiled three drug cost-savings models for Medicare enrollees, including a plan to offer Medicare Part D enrollees about 150 generic drugs for $2 a month.
The models, authorized under an executive order by President Joe Biden, "complement" drug cost-savings provisions in the Inflation Reduction Act, Health and Human Services Secretary Xavier Becerra says.
"HHS is using every tool available to us to lower healthcare costs and increase access to high-quality, affordable health care," Becerra said.
"We are full steam ahead in delivering the cost savings from the President's Inflation Reduction Act of 2022, and people on Medicare are already feeling the benefits. But as President Biden has made clear, we must build on the new prescription drug law with further action, which is why HHS is implementing these new projects to bring down prescription drug costs."
The Medicare $2 Drug List for chronic conditions such as high blood pressure and high cholesterol. Under this model (the Medicare High-Value Drug List Model), CMS says Part D plans would be encouraged to offer a low, fixed co-payment across all cost-sharing phases of the Part D drug benefit for a standardized Medicare list of generic drugs that treat chronic conditions.
The Cell and Gene Therapy Access Model addresses an emerging – but often prohibitively expensive -- area of drug development that can cost upwards of $1 million. Under this model, state Medicaid agencies would ask CMS to administer multi-state, outcomes-based agreements with drugmakers for certain cell and gene therapies.
The Accelerating Clinical Evidence Model would develop payment methods for drugs approved under accelerated approval, in consultation with the Food and Drug Administration and would also reduce Medicare spending on drugs that have no clinical benefit.
Innovation Center Director Liz Fowler said the models "will test strategies to make it easier for Medicare patients to afford and access needed prescriptions at $2 or less, help expand access to cutting-edge cell and gene therapies for people with Medicaid, and help ensure drugs already on the market are safe and effective."
Fowler told reporters at a media availability Tuesday that the models likely would not take effect until at least 2025.
"Realistically, 2023 Open Enrollment, we've already started down that road," Fowler said. "We haven't even started working with the model yet. And for 20224, the Inflation Reduction Act provisions are still going into effect and so we'll need to make sure that the incentive model is operationally feasible in light of those changes."
Wisconsin Sen. Tammy Baldwin wants answers on Ascension's private equity investments, executive pay, charity care, staff shortages and 'conflicting priorities'.
U.S. Sen. Tammy Baldwin (D-WI) wants Ascension CEO Joseph Impicciche to detail "Ascension's questionable priorities that appear to go against its non-profit mission."
"As a nonprofit, tax-exempt, health system, Ascension is required to provide charitable benefits to the community and operate solely to serve a public, rather than a private interest," Baldwin writes in her letter this month.
"Despite these requirements, Ascension has significant for-profit investment activities that dwarf what the system provides in annual charity care."
Baldwin cited reports in the Milwaukee Journal Sentineland Milwaukee Magazinehighlighting "disruptions to patient care, long wait times in the emergency department, delayed surgeries and staff concerns about patient safety" at Ascension Columbia St. Mary's, and the closure of a labor and delivery unit on Milwaukee's south side at Ascension St. Francis.
Baldwin notes that Ascension CFO Elizabeth Foshage boasted at this year's J.P. Morgan Healthcare Conference that Ascension held $18 billion in cash and investments.
"According to Ascension, these investments are 'generating capital gains that can be re-invested to support Ascension's Mission to care for those who are poor and vulnerable,' yet there is no indication that the proceeds of Ascension's investment funds are being reinvested in Ascension's Wisconsin hospitals," Baldwin writes.
"In fact, I am concerned that the opposite is occurring—that by operating like a private equity fund, Ascension is squeezing staff, closing facilities, and extracting cash from its member hospitals for dubious 'management fees' all to advance its investment activities and provide compensation to its executives."
Baldwin also raises questions about Ascension Capital, which the health system calls a "strategic investment initiative, generating capital gains that can be re-invested to support Ascension's Mission to care for those who are poor and vulnerable."
Baldwin notes that recent financial statements show that Ascension's investment funds have lost the system nearly $750 million in the most recent financial quarter.
"These losses are roughly $200 million more than the amount that Ascension provided toward charity care over that same span," Baldwin writes. "Such an investment return—even if it is uncharacteristic of the fund's longer-term performance—raises serious questions about how Ascension Capital tangibly subsidizes the health system's charity care. It also suggests that a less volatile, more conservative investment approach might be more appropriately suited to the system's mission."
Ascension issued this statement: "Ascension and its physicians, nurses and caregivers are proud of our mission to provide care for those most vulnerable – especially during the past three years of the COVID pandemic – and we look forward to continuing to work with Senator Baldwin on ways to serve the community."
8 Questions
Baldwin wants Impicciche to provide:
1. A list of investments by all investment funds operating at Ascension, and additional information on Ascension's investment returns as a percentage of its revenue from fiscal years 2015 through 2022.
2. All re-investments made by Ascension Capital into charity care services from fiscal years 2015 through 2022 by location.
3. An explanation of Ascension's relationship with R1 RCM, including a description of R1 RCM's current contracted activities and associated revenue from fiscal years 2017 through 2022. How does R1 RCM assist in Ascension's debt collection practices and are any Wisconsin facilities currently using R1 RCM's services?
4. A description of all management fees, including direct costs retained by the health system, charged to Ascension Columbia St. Mary's and Ascension St. Francis, including the contract between the ministry and the hospitals.
5. A detailed description of how $66 million in Provider Relief Funds was used to address staffing concerns at Ascension Columbia St. Mary and Ascension St. Francis.
6. The community health needs assessments required by the Affordable Care Act completed by Ascension for all its care venues in Wisconsin.
7. A detailed description of approximately $256 million in reported community benefits funded by the health system in the past three months.
8. A description of the compensation packages, including all equity, stock options, restricted stock units, or performance-related metrics for Ascension executives, and provide detailed compensation descriptions for any board activity attributed to roles on Ascension affiliated organizations for Anthony Speranzo, CEO of Ascension Capital and Anthony Tersigni, Chairman of the Board, Ascension Capital.
Although the findings raise concerns, the figures for cannabis-related deaths in Florida pale when compared with opioid- and alcohol-related deaths.
Cannabis and synthetic cannabis have been linked to nearly 400 deaths in Florida between 2014 and 2020, a new study shows.
Researchers from Florida Atlantic UniversityChristine E. Lynn College of Nursing, using state law enforcement data, identified 386 people whose deaths were linked to cannabis use. Of these, 258 fatalities were linked to synthetic cannabis, and nearly 65% of these deaths involved synthetic cannabis as the only drug involved.
"Synthetic cannabinoids are part of the new psychoactive substances that are two to 100 times more potent than THC, the main psychoactive compound in marijuana," says study senior author Armiel Suriaga, PhD, an assistant professor at Lynn College. "Synthetic cannabinoids are manufactured chemicals sprayed onto dried, shredded leaves or plant materials that mimic the effect of cannabis, but their actual effects are unpredictable, harmful and deadly."
Although the findings are a cause of concern, the figures for cannabis-related deaths in Florida pale when compared with other drugs and alcohol. For example, the National Center for Drug Abuse Statistics reports that excessive drinking results in 10,655 deaths each year in Florida, and that the five-year average annual rate of excessive alcohol deaths per capita in the Sunshine State increased by 54% from 2015 to 2019. The NCDAS data shows that Florida averages about 3,200 opioids-related deaths each year.
Florida legalized medical cannabis in 2014 and has seen a 1,107% increase in the number of people carrying medical cannabis cards, from about 65,310 cardholders in 2018 to 788,297 as of Jan. 27, the study reports.
The results, published in the Journal of Nursing Scholarship, show that nearly 28% of the dead were ages 45–54 years, compared to 9% ages 8 to 24, demographic disparities that researchers attribute to health conditions in older people, such as cardiovascular diseases.
Among the study's findings:
Nearly 88% of the deaths were among men.
Approximately 65% were non-Hispanic whites.
100% of cannabis-related deaths occurred in urban counties.
In rural counties, 28% of deaths were related to synthetic cannabis, and 40% were African American.
Nearly all (99%) of the deaths were from drug overdoses (84%) and motor vehicular crashes (14%) that caused blunt traumas to the head and body. More crash-related deaths were traced to cannabis use rather than synthetic cannabis use. Four people died from drowning while on cannabis.
"The persistent deaths from cannabis and synthetic cannabis use are a legitimate public health concern," Suriaga says. "The public should remain vigilant of the adverse health outcomes associated with these substances and their unpredictable effects, especially for men who are disproportionately affected, and particularly for people with underlying cardiovascular and respiratory conditions."
