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RX- Renalytix surges 28% on Medicaid news

MM Curator summary

The article below has been highlighted and summarized by our research team. It is provided here for member convenience as part of our Curator service.

 
 

[MM Curator Summary]: CMS prices a lab test and the market moves.

 
 

 
 

Clipped from: https://www.proactiveinvestors.com.au/companies/news/1028482/renalytix-surges-28-medicaid-news-1028482.html

TechHardware & electrical equipment

Written by:

Ian Lyall


Published: 19:05 03 Oct 2023

 
 

Shares of Renalytix PLC (AIM:RENX) surged 28% in early trading after the Centers for Medicare & Medicaid Services (CMS) announced a price of $950 for the company’s FDA-approved kidneyintelX.dkd test.

The test, which uses artificial intelligence (AI) to predict risks for people with type 2 diabetes and chronic kidney disease, will be listed on the nationwide Clinical Laboratory Fee Schedule starting 1 January, and the price will be locked in for at least three years.

Earlier this year, an American Medical Association (AMA) panel recommended that this advanced test get its own unique code to set it apart from the original KidneyIntelX test. This led to a national pricing review by CMS, confirming the $950 price tag.

Renalytix believes this pricing decision, backed by expert and public reviews, not only validates the value of their KidneyIntelX platform but also makes it easier to expand health insurance coverage for the test in the US. The company also sees this as a strong basis for pricing in international markets.

At 9.05 am, the shares were changing hands for 79.98p, up 17.48p on Monday’s close.

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RX (OR)- Audit finds lack of transparency in Medicaid prescription system

MM Curator summary

The article below has been highlighted and summarized by our research team. It is provided here for member convenience as part of our Curator service.

 
 

[MM Curator Summary]: Oregon wants to get all up in the PBM’s bitness.

 
 

 
 

Clipped from: https://theworldlink.com/news/local/audit-finds-lack-of-transparency-in-medicaid-prescription-system/article_e2809128-6530-5223-8def-321767a90f55.html

 
 

Oregon needs to provide better oversight of pharmacy benefit managers so people on Medicaid can have equal access to medication, state auditors found.

Getty Image

State regulators can do more to help Medicaid patients access medication by providing better oversight of an obscure but influential step of the prescription drug supply chain that starts with the manufacturer and ends with the pharmacist, auditors found.

An audit released Monday by the Secretary of State’s Office found the state’s regulation of pharmacy benefit managers is lax and limited, even though the organizations play a central role in the prescription medications of nearly 1.5 million low-income Oregonians enrolled in the Oregon Health Plan, the state’s Medicaid plan. That’s about one in three Oregonians.

Pharmacy benefit managers are middlemen in the prescription drug industry. They manage prescription drug plans for insurers, negotiating prices with manufacturers and pharmacies. They play a major role in the cost of drugs – Oregon Medicaid insurers spend hundreds of millions on medications a year – and patient access to crucial medications.

“Pharmacy benefit managers play an important role in delivering pharmacy benefits to millions of Oregonians, but as the audit shows, they operate in a complex structure that lacks transparency,” Oregon Secretary of State LaVonne Griffin-Valade said in a statement.

Their business practices can determine the financial health and viability of an independent pharmacy in rural Oregon – regardless of its distance from other pharmacies. Pharmacy benefit managers also influence whether a patient needs to travel to a specialty pharmacy to pick up a certain type of medication or what drugs an insurer will cover.

They can own pharmacies, too. That means that the pharmacies they own can get better reimbursements – and more money – than independent pharmacies, many in small rural towns with limited health care access.

“Pharmacists can help patients better manage their medications and their chronic diseases, which in turn can help them lead healthier lives, reduce hospital admissions and save money for the state, so that is a critical component,” Ian Green, the audits manager for the Oregon Secretary of State’s office, said in an interview with the Capital Chronicle. “We found that generally speaking, independent and community pharmacies have lower reimbursements than national pharmacy chains or specialty and mail order pharmacies.”

Auditors: Vague financial information

In Oregon, Medicaid insurers reported spending $767 million on prescription drug benefits in 2021. The state’s Medicaid insurers, also called coordinated care organizations, contract with the Oregon Health Authority to provide health benefits. They also subcontract with pharmacy benefit managers.

But auditors found that because pharmacy benefit managers are complex organizations with trade secrets it makes it close to impossible to gauge their profits and how much of the money comes from Oregon and U.S. taxpayers who pay for the Oregon Health Plan.

“This opaque system makes it impossible to understand the actual costs of prescription drugs and has garnered attention at multiple levels of government,” auditors wrote, noting that the Federal Trade Commission announced in 2022 it would launch an inquiry into pharmacy benefit managers.

Other findings of

the audit are:

An Oregonian on Medicaid who qualifies and uses a prescription drug can lose access if they move from one part of the state to another. This means they may need to try an ineffective medication first and jump through red tape to get qualified for coverage again. This is because Medicaid insurers assigned to various parts of Oregon have different agreements with pharmacy benefit managers.

“They should have the same access to medications, no matter where they live in Oregon,” Green said.

• Low or unfair reimbursement rates have led to a decline in local independent pharmacies, reducing access in rural regions.

Other states require pharmacy benefit managers to disclose more, including information about their payments and fees.

• The Oregon Health Authority, which oversees Medicaid, performs “minimal monitoring” of prescription benefit managers.

Audit recommendations

Auditors recommended the Oregon Health Authority require its Medicaid insurers to conduct annual independent audits of prescription benefit managers. Those audits are now optional, the report said.

Auditors also recommended the health authority assign employees to monitor compliance who don’t have a conflict of interest. Currently, the authority has limited staff for compliance because employees with the necessary expertise work with the authority’s Oregon Prescription Drug Program, which purchases prescription drugs for programs including Oregon Health and Science University and the Oregon State Hospital.

The Oregon Health Authority agreed with the recommendations. In a response letter, the authority said it should have more staff assigned by mid-2024 and enact requirements for independent outside audits of pharmacy benefit managers by January 2025.

Auditors also recommended lawmakers pass bills that would change the system, including a universal list of covered prescription drugs for all Medicaid insurers to ensure fairness and equal access, and requirements for pharmacy benefit managers to provide data annually, including information about its fees and profits.

Oregon Capital Chronicle is part of States Newsroom, a network of news bureaus supported by grants and a coalition of donors as a 501c(3) public charity. Oregon Capital Chronicle maintains editorial independence. Contact Editor Lynne Terry for questions: info@oregoncapitalchronicle.com.

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RX- Oregon audit finds lack of transparency in Medicaid prescription system

MM Curator summary

The article below has been highlighted and summarized by our research team. It is provided here for member convenience as part of our Curator service.

 
 

[MM Curator Summary]: OR Medicaid will do audits of PBMs. There is also a recommendation to publish a universal list of OR Medicaid-covered drugs bundled in all this.

 
 

 
 

Clipped from: https://www.ijpr.org/health-and-medicine/2023-08-21/oregon-audit-finds-lack-of-transparency-in-medicaid-prescription-system

 
 

Secretary of State auditors recommend changes to provide equal prescription access to all Oregon Health Plan members.

State regulators can do more to help Medicaid patients access medication by providing better oversight of an obscure but influential step of the prescription drug supply chain that starts with the manufacturer and ends with the pharmacist, auditors found.

An audit released Monday by the Secretary of State’s Office found the state’s regulation of pharmacy benefit managers is lax and limited, even though the organizations play a central role in the prescription medications of nearly 1.5 million low-income Oregonians enrolled in the Oregon Health Plan, the state’s Medicaid plan. That’s about one in three Oregonians.

Pharmacy benefit managers are middlemen in the prescription drug industry. They manage prescription drug plans for insurers, negotiating prices with manufacturers and pharmacies. They play a major role in the cost of drugs – Oregon Medicaid insurers spend hundreds of millions on medications a year – and patient access to crucial medications.

“Pharmacy benefit managers play an important role in delivering pharmacy benefits to millions of Oregonians, but as the audit shows, they operate in a complex structure that lacks transparency,” Oregon Secretary of State LaVonne Griffin-Valade said in a statement.

Their business practices can determine the financial health and viability of an independent pharmacy in rural Oregon – regardless of its distance from other pharmacies. Pharmacy benefit managers also influence whether a patient needs to travel to a specialty pharmacy to pick up a certain type of medication or what drugs an insurer will cover.

They can own pharmacies, too. That means that the pharmacies they own can get better reimbursements – and more money – than independent pharmacies, many in small rural towns with limited health care access.

“Pharmacists can help patients better manage their medications and their chronic diseases, which in turn can help them lead healthier lives, reduce hospital admissions and save money for the state, so that is a critical component,” Ian Green, the audits manager for the Oregon Secretary of State’s office, said in an interview with the Capital Chronicle. “We found that generally speaking, independent and community pharmacies have lower reimbursements than national pharmacy chains or specialty and mail order pharmacies.”

Auditors: Vague financial information

In Oregon, Medicaid insurers reported spending $767 million on prescription drug benefits in 2021. The state’s Medicaid insurers, also called coordinated care organizations, contract with the Oregon Health Authority to provide health benefits. They also subcontract with pharmacy benefit managers.

But auditors found that because pharmacy benefit managers are complex organizations with trade secrets it makes it close to impossible to gauge their profits and how much of the money comes from Oregon and U.S. taxpayers who pay for the Oregon Health Plan.

“This opaque system makes it impossible to understand the actual costs of prescription drugs and has garnered attention at multiple levels of government,” auditors wrote, noting that the Federal Trade Commission announced in 2022 it would launch an inquiry into pharmacy benefit managers.

Other findings of the audit are:

  • An Oregonian on Medicaid who qualifies and uses a prescription drug can lose access if they move from one part of the state to another. This means they may need to try an ineffective medication first and jump through red tape to get qualified for coverage again. This is because Medicaid insurers assigned to various parts of Oregon have different agreements with pharmacy benefit managers.

“They should have the same access to medications, no matter where they live in Oregon,” Green said.

  • Low or unfair reimbursement rates have led to a decline in local independent pharmacies, reducing access in rural regions.
  • Other states require pharmacy benefit managers to disclose more, including information about their payments and fees. 
  • The Oregon Health Authority, which oversees Medicaid, performs “minimal monitoring” of prescription benefit managers.

Audit recommendations

Auditors recommended the Oregon Health Authority require its Medicaid insurers to conduct annual independent audits of prescription benefit managers. Those audits are now optional, the report said.

Auditors also recommended the health authority assign employees to monitor compliance who don’t have a conflict of interest. Currently, the authority has limited staff for compliance because employees with the necessary expertise work with the authority’s Oregon Prescription Drug Program, which purchases prescription drugs for programs including Oregon Health and Science University and the Oregon State Hospital.

The Oregon Health Authority agreed with the recommendations. In a response letter, the authority said it should have more staff assigned by mid-2024 and enact requirements for independent outside audits of pharmacy benefit managers by January 2025.

Auditors also recommended lawmakers pass bills that would change the system, including a universal list of covered prescription drugs for all Medicaid insurers to ensure fairness and equal access, and requirements for pharmacy benefit managers to provide data annually, including information about its fees and profits.

The Oregon Capital Chronicle is a professional, nonprofit news organization. We are an affiliate of States Newsroom, a national 501(c)(3) nonprofit supported by grants and a coalition of donors and readers. The Capital Chronicle retains full editorial independence, meaning decisions about news and coverage are made by Oregonians for Oregonians.
 

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RX- Walgreens must face Medicaid fraud lawsuit over hepatitis C drugs, says appeals court

MM Curator summary

The article below has been highlighted and summarized by our research team. It is provided here for member convenience as part of our Curator service.

 
 

[MM Curator Summary]: Looks like Walgreens will have to answer for its part in a VA case in which Medicaid incorrectly had to pay for very expensive Hep-C drugs.

 
 

 
 

Clipped from: https://www.benefitspro.com/2023/08/21/walgreens-must-face-medicaid-fraud-lawsuit-over-hepatitis-c-drugs-says-appeals-court/

A federal appeals court has reinstated a lawsuit against Walgreens for violating the federal False Claims Act by improperly receiving hundreds of thousands of dollars from Virginia’s Medicaid program.

 
 

A federal appeals court has reinstated a lawsuit against Walgreens for allegedly defrauding Virginia’s Medicaid program by falsely representing that some patients were eligible for expensive hepatitis C drugs. The decision overturned a previous ruling by a lower court.

In a 3-0 decision, the 4th U.S. Circuit Court of Appeals in Richmond, Va., cleared the way for the nation’s largest pharmacy chain to face allegations that it violated the federal False Claims Act and Virginia state law. The case arose from alleged misconduct by Amber Reilly, a clinical pharmacy manager at a Walgreens in Kingsport, Tenn.

She was accused of falsifying patient records, including lab results, between January 2015 and June 2016 to obtain prior authorization from Virginia Medicaid for reimbursement for the drugs Sovaldi, Harvoni and Daklinza. Revenue from the Kingsport store grew by 321% during that time, court records showed. O’Reilly pleaded guilty to one count of health care fraud contained in October 2016 and was sentenced to 16 months in prison in June 2017.

Walgreens began an investigation but did not repay money it received for 12 Virginia Medicaid patients, even after the manager pleaded guilty to a similar scheme in Tennessee.

In December 2021, a trial judge dismissed the lawsuit, saying Walgreens’ misrepresentations were immaterial because Virginia’s prior authorization requirements violated federal law.

Related: Walgreens to pay $269 million over insulin fraud allegations

However, Circuit Judge Albert Diaz said Walgreens’ alleged misrepresentations were material under the False Claims Act because they “did, in fact, influence the decisionmakers” at Virginia Medicaid. He also said Walgreens could not escape liability by attacking Virginia’s eligibility requirements as illegal. “Allowing Walgreens to avoid liability by challenging Virginia’s eligibility criteria only after getting caught would hinder the act’s purpose of holding fraudsters accountable,” Diaz wrote.

Walgreens, the U.S. Justice Department and the Virginia attorney general’s office declined media request for comment.

Posted on

RX- 340 B Medicaid MCO Duplicate Discount Confusion and HHS

MM Curator summary

The article below has been highlighted and summarized by our research team. It is provided here for member convenience as part of our Curator service.

 
 

[MM Curator Summary]: MCOs will have to add a field to the drug claims they manage under proposed CMS rules. The new field will make it easier for manufacturers to not get dinged having to offer discounts on drugs twice.

 
 

 
 

Clipped from: https://www.natlawreview.com/article/hhs-takes-steps-to-resolve-340-b-medicaid-mco-duplicate-discount-confusion

On May 26, 2023, the Centers for Medicare and Medicaid Services (CMS) proposed an update to the Medicaid Drug Rebate Program (MDRP) rules, which includes provisions aimed at preventing 340B duplicate discounts on claims billed to Medicaid managed care organizations (MCOs). Duplicate discounts arise when both 340B discounts and Medicaid rebates are provided by a manufacturer for the same drug. Although drug manufacturers that participate in Medicaid are required to provide discounts on 340B drugs under the 340B Drug Pricing Program and are also required to provide state Medicaid programs with rebates under the MDRP on drugs dispensed to Medicaid beneficiaries, including Medicaid MCO enrollees, manufacturers are not required to provide both a 340B discount and a Medicaid rebate under the MDRP for the same drug.

IN DEPTH

Because the relevant statutory provisions do not clearly articulate whether the state Medicaid program, the Medicaid MCO or the 340B-participating provider (covered entity) is responsible for ensuring that duplicate discounts do not occur for Medicaid MCO claims, there currently is no uniform system for identifying Medicaid MCO claims for 340B drugs. In the years since Medicaid MCO drugs became eligible for rebates under the MDRP, the US Department of Health and Human Services (HHS) has generally encouraged the relevant stakeholders and affected parties to work together to develop a solution. To date, that has not occurred. It appears that HHS may finally be stepping in to develop, or at least work towards, a solution.

Under the proposed rule, CMS would modify the standard Medicaid MCO contract requirements to require Medicaid MCOs that provide coverage of covered outpatient drugs to use unique, Medicaid-specific codes and group numbers on beneficiary insurance cards. The use of these identifiers would assist state Medicaid programs, MCOs and 340B covered entities to identify Medicaid MCO claims that might not otherwise be readily apparent as Medicaid MCO claims. Currently it is not uncommon for Medicaid MCOs to use the same group identifiers as claims for patients with private insurance. If implemented as proposed, the various stakeholders could more efficiently develop additional tools to identify such claims as being for 340B drugs or to exclude such claims for being filled using 340B drugs. CMS indicated that this change would allow the MDRP to run more efficiently, and would be helpful to all parties by ensuring that Medicaid rebates and 340B discounts are being provided appropriately. CMS proposed that this new requirement be implemented into Medicaid MCO contracts no later than the next rating period, following the effective date of the final rule adopting this provision.

While the proposed rule would provide an important tool to assist in the development of additional policies to prevent duplicate discounts on Medicaid MCO claims, it would not itself effectuate a full solution. The proposed rule also does not address the ongoing concern among 340B covered entities that state Medicaid programs or Medicaid MCOs could expand 340B “carve out” requirements or reduce reimbursement rates on 340B drugs dispensed to Medicaid MCO enrollees, thereby removing the opportunity for 340B covered entities to obtain the benefit that Congress intended for them to receive through the 340B Program—i.e., generating revenue from 340B drug sales to enable 340B covered entities to provide and expand services in their communities.

CMS solicited comments on the proposed change by July 25, 2023, and specifically requested comments regarding the implementation timeframe and operational issues that may arise from requiring the inclusion of unique Medicaid identifiers on Medicaid MCO beneficiary identification cards.

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RX- Biden-Harris Administration Announces Proposal to Advance Prescription Drug Transparency in Medicaid

MM Curator summary

The article below has been highlighted and summarized by our research team. It is provided here for member convenience as part of our Curator service.

 
 

[MM Curator Summary]: In which CMS will dive deeper on exactly how RX manus set prices. Or will try to, anyway.

 
 

Clipped from: https://www.hhs.gov/about/news/2023/05/23/biden-harris-administration-announces-proposal-advance-prescription-drug-transparency-medicaid.html

New HHS proposal would shed light on cost of prescription drugs and save states and federal government money in Medicaid

The Biden-Harris Administration has made lowering prescription drug costs in America a key priority — and President Biden is continuing to deliver results. Today, the U.S. Department of Health and Human Services, through the Centers for Medicare & Medicaid Services (CMS), is proposing steps to further drive down prescription drug costs in Medicaid and build on President Biden’s executive order to lower prescription drug costs for Americans. CMS’ latest notice of proposed rulemaking (NPRM) would shed light on the actual cost of drugs covered by Medicaid. Under this proposal, Medicaid would have increased ability to hold drug manufacturers accountable for what Medicaid programs pay for drugs.

“President Biden is not only committed to protecting Medicaid, but continues to take bold actions to strengthen the program,” said HHS Secretary Xavier Becerra. “With today’s proposed rule, we are advancing unprecedented efforts to increase transparency in prescription drug costs, being good stewards of the Medicaid program, and protecting its financial integrity. This proposed rule will save both states and the federal government money.”

“This proposed rule prioritizes CMS’ role as a good steward of Medicaid dollars while also strengthening program integrity and the management of pharmacy benefits for people with Medicaid coverage,” said CMS Administrator Chiquita Brooks-LaSure. “We’re committed to preserving access to life-saving treatments and securing fiscal sustainability for the Medicaid program, which remains a lifeline for millions of people.”

Today’s proposed rule to improve the Medicaid Drug Rebate Program follows the Biden-Harris Administration’s historic creation of the Medicare Prescription Drug Inflation Rebate Program. As part of President Biden’s new prescription drug law, for the first time ever, drug companies must now pay rebates to Medicare when their prescription drug prices increase faster than the rate of inflation for certain drugs dispensed to people with Medicare.

Increase Transparency of Prescription Drug Costs

This rule would allow CMS to have more insight into what the most expensive drugs on the market today actually cost to manufacture and distribute. The proposed regulation would give CMS and states additional tools, like a drug price verification survey, which would result in greater transparency into manufacturers’ drug prices. This survey would verify drug prices to increase transparency about why certain drug prices are expensive for Medicaid and help states better negotiate what the Medicaid program pays for high-cost drugs. With this information, state Medicaid agencies would be able to operate their pharmacy programs more effectively while helping more people get vital drug treatments. This increased transparency under Medicaid would advance the Biden-Harris Administration’s efforts to complement the Inflation Reduction Act and further drive down prescription drug costs without impacting coverage of drugs for Medicaid beneficiaries. For additional information on the drug price verification survey, visit Medicaid.gov.

Increase Transparency of Managed Care Plans

Another proposed provision aims to enhance transparency into the costs of administering drug benefits in Medicaid-managed care plans. Managed care plans cover more than 75% of Medicaid beneficiaries. Managed care plan pharmacy benefit managers (PBMs) often negotiate and administer the pharmacy benefit, though there has been a lack of transparency into the amount plans have paid to PBMs for administering the drug benefit and the amount pharmacies have been paid for the drugs. This lack of transparency has raised concerns about PBMs using spread pricing arrangements to increase their profit margins by charging an MCO more for a drug than the amount a PBM pays a pharmacy. To address this issue, CMS is proposing that contracts between states, Medicaid-managed care plans, and third-party contractors, such as PBMs, reflect transparent reporting of drug payment information among third-party contractors. This proposal will help ensure that taxpayer dollars are actually going to pay for drugs and not increased profits.

Increased Transparency in Drug Classifications

The NPRM also focuses on the potential misclassification of drugs as brand name or generic. The proposed rule includes provisions to ensure states would receive the appropriate rebates to which they are entitled, since states receive a higher percentage of rebate dollars for brand-name drugs compared to generics. With increased transparency, states would be able to determine if manufacturers appropriately classified their covered outpatient drugs, and if they did not, give CMS the ability to take action to correct the misclassification.

For additional information on these and other provisions in the NPRM, please visit Federal Register. CMS looks forward to accepting public comment on the NPRM through July 25, 2023.

Posted on

RX- Lilly ordered to pay millions more in False Claims Act case

 
 

MM Curator summary

The article below has been highlighted and summarized by our research team. It is provided here for member convenience as part of our Curator service.

 
 

[MM Curator Summary]: Lilly appealed and the bill keeps going up.

 
 

Clipped from: https://www.fiercepharma.com/pharma/lilly-damages-tripled-183m-long-running-false-claims-case

 
 

When a federal jury last year ordered Eli Lilly to pay $61 million for skimping out on Medicaid rebates, the company vowed to fight the verdict. But instead of the result Lilly wanted, the award has been tripled to more than $183 million.

On Tuesday, Illinois federal judge Harry Leinenweber ruled that Eli Lilly owes triple damages from last year’s award after whistleblower Ronald Streck convinced a jury that the company violated the False Claims Act and short-changed Medicaid on rebate payments.

Since the case falls under the False Claims Act, the award was eligible for “trebled” damages, according to court filings.

The case dates to 2014, when whistleblower Streck—a pharmacist and lawyer—sued Eli Lilly for allegedly launching retroactive price increases and failing to pay Medicaid rebates based on the higher prices.

Streck and his attorneys moved forward with litigation in 2018 after the U.S. government declined to intervene in the case, Streck’s law firm said last year.

In the order Tuesday, Leneinweber pointed out that Lilly “changed its practices years before the trial.” In court, Lilly argued its corrective actions weighed in favor of “minimal, if any, penalties,” according to the document.

Still, Leneinweber decided that the company indeed owes $183.69 million under the “trebled” damages rules in the False Claims Act. The judge ultimately noted that “while Lilly could have, of course, behaved better, it could have acted far worse.”

Lilly, for its part, said it’s “committed to upholding high standards of corporate conduct in our business dealings.” The company is “disappointed” with the outcome, but it plans to appeal and is “confident that the Seventh Circuit will reverse,” a spokesperson said over email.

Streck also filed a False Claims Act whistleblower suits against Bristol Myers Squibb and other companies in 2013 but later withdrew his claims against the other defendants. BMS ultimately settled for $75 million in 2021 while Astellas Pharma’s U.S. unit resolved its case for $18 million that same year.

Editor’s note: This story has been updated with comments from Eli Lilly. 

Posted on

REFORM- Prescription for housing? California wants Medicaid to cover 6 months of rent

 
 

MM Curator summary

The article below has been highlighted and summarized by our research team. It is provided here for member convenience as part of our Curator service.

 
 

[MM Curator Summary]: CA is looking to spend $20k a year per person on rent for homeless folk for six months, despite poor results in the Cal-AIM pilot. The ole’ “it didn’t work because we didn’t do enough of it” explanation. Even if you thought the pilots were a success, there’s still one problem: you gotta build more housing. Cue the real estate guys…

 
 

 
 

Clipped from: https://www.news-medical.net/news/20230322/Prescription-for-housing-California-wants-Medicaid-to-cover-6-months-of-rent.aspx

Gov. Gavin Newsom, whose administration is struggling to contain a worsening homelessness crisis despite record spending, is trying something bold: tapping federal health care funding to cover rent for homeless people and those at risk of losing their housing.

States are barred from using federal Medicaid dollars to pay directly for rent, but California’s governor is asking the administration of President Joe Biden, a fellow Democrat, to authorize a new program called “transitional rent,” which would provide up to six months of rent or temporary housing for low-income enrollees who rely on the state’s health care safety net — a new initiative in his arsenal of programs to fight and prevent homelessness.

“I’ve been talking to the president. We cannot do this alone,” Newsom told KHN.

The governor is pushing California’s version of Medicaid, called Medi-Cal, to fund experimental housing subsidies for homeless people, betting that it’s cheaper for taxpayers to cover rent than to allow people to fall into crisis or costly institutional care in hospitals, nursing homes, and jails. Early in his tenure, Newsom proclaimed that “doctors should be able to write prescriptions for housing the same way they do for insulin or antibiotics.”

But it’s a risky endeavor in a high-cost state where median rent is nearly $3,000 a month, and even higher in coastal regions, where most of California’s homeless people reside. Experts expect the Biden administration to scrutinize the plan to use health care money to pay rent; and also question its potential effectiveness in light of the state’s housing crisis.

“Part of the question is whether this is really Medicaid’s job,” said Vikki Wachino, who served as national Medicaid director in the Obama administration. “But there is a recognition that social factors like inadequate housing are driving health outcomes, and I think the federal government is open to developing approaches to try and address that.”

Bruce Alexander, a spokesperson for the Centers for Medicare & Medicaid Services, declined to say whether the federal government would approve California’s request. Yet, Biden’s Medicaid officials have approved similar experimental programs in Oregon and Arizona, and California is modeling its program after them.

California is home to an estimated 30% of the homeless people in the U.S., despite representing just 12% of the country’s overall population. And Newsom has acknowledged that the numbers are likely far greater than official homeless tallies show. Top health officials say that, to contain soaring safety-net spending and help homeless people get healthy, Medi-Cal has no choice but to combine social services with housing.

Statewide, 5% of Medi-Cal patients account for a staggering 44% of the program’s spending, according to state data. And many of the costliest patients lack stable housing: Nearly half of patients experiencing homelessness visited the emergency room four times or more in 2019 and were more likely than other low-income adults to be admitted to the hospital, and a large majority of visits were covered by Medi-Cal, according to the Public Policy Institute of California.

“What we have today doesn’t work,” said Dr. Mark Ghaly, secretary of the California Health and Human Services Agency, explaining his argument that housing is a critical component of health care. “Why do we have to wait so long for people to be so sick?”

The federal government has already approved a massive social experiment in California, known as CalAIM, which is transforming Medi-Cal. Over five years, the initiative is expected to pour $12 billion into new Medi-Cal services delivered outside of traditional health care. In communities across the state, it is already funding services for some low-income patients, including paying rental security deposits for homeless people and those facing eviction; delivering prepared healthy meals for people with diabetes; and helping formerly incarcerated people find jobs.

The transitional rent program would add another service to those already available, though only a sliver of the 15.4 million Medi-Cal enrollees actually receive those new and expensive social services.

Rent payments could begin as soon as 2025 and cost roughly $117 million per year once fully implemented. And while state officials say anyone who is homeless or at risk of becoming homeless would be eligible, not everyone who qualifies will receive new services due to capacity limits. Among those who stand to benefit are nearly 11,000 people already enrolled in Medi-Cal housing services.

The ongoing conversation is how do we convince the federal government that housing is a health care issue,” said Mari Cantwell, who served as Medi-Cal director from 2015 to 2020. “You have to convince them that you’re going to save money because you’re not going to have as many people showing up at the emergency room and in long-term hospitalizations.”

Health care experiments in California and around the country that funded housing supports have demonstrated early success in reducing costs and making people healthier. But while some programs paid for housing security deposits or participants’ first month of rent, none directly covered rent for an extended period.

“Without that foundational support, we are playing in the margins,” Newsom said.

State health officials argue that paying for six months of rent will be even more successful at reducing health care costs and improving enrollees’ health, but experts say that, to work, the initiative must have strict accountability and be bundled with an array of social services.

In a precursor to the state’s current initiative, California experimented with a mix of housing assistance programs and social services through its “Whole Person Care” pilot program. Nadereh Pourat, of the UCLA Center for Health Policy Research, evaluated the program for the state concluding that local trials reduced emergency visits and hospitalizations, saving an average of $383 per Medi-Cal beneficiary per year — a meager amount compared with the program’s cost.

Over five years, the state spent $3.6 billion serving about 250,000 patients enrolled in local experiments, Pourat said.

And a randomized control trial in Santa Clara County that provided supportive housing for homeless people showed reductions in psychiatric emergency room visits and improvements in care. “Lives stabilized and we saw a huge uptick in substance use care and mental health care, the things that everybody wants people to use to get healthier,” said Dr. Margot Kushel, director of the University of California-San Francisco’s Center for Vulnerable Populations at Zuckerberg San Francisco General Hospital and Trauma Center, who worked on the study.

But insurers implementing the broader Medi-Cal initiative say they are skeptical that spending health care money on housing will save the system money. And health care experts say that, while six months of rent can be a bridge while people wait for permanent housing, there’s a bigger obstacle: California’s affordable housing shortage.

“We can design incredible Medicaid policies to alleviate homelessness and pay for all the necessary supportive services, but without the adequate housing, frankly, it’s not going to work,” Kushel said.

Newsom acknowledges that criticism. “The crisis of homelessness will never be solved without first solving the crisis of housing,” he said last week, arguing California should plow more money into housing for homeless people with severe mental health conditions or addiction disorders.

He will ask the legislature to put before voters a 2024 ballot initiative that would infuse California’s mental health system with at least 6,000 new treatment beds and supportive housing units for people struggling with mental health and addiction disorders, many of whom are homeless. The proposed bond measure would generate from $3 billion to $5 billion for psychiatric housing and treatment villages aimed at serving more than 10,000 additional people a year. The initiative also would ask voters to set aside at least $1 billion a year for supportive housing from an existing tax on California millionaires that funds local mental health programs.

“People who are struggling with these issues, especially those who are on the streets or in other vulnerable conditions, will have more resources to get the help they need,” Newsom said.

For transitional rent, six months of payments would be available for select high-need residents enrolled in Medi-Cal, particularly those who are homeless or at risk of becoming homeless — and those transitioning from more costly institutions such as mental health crisis centers, jails and prisons, and foster care. Medi-Cal patients at risk of inpatient hospitalization or who frequent the emergency room would also be eligible.

“It’s a pretty big challenge; I’m not going to lie,” said Jacey Cooper, the Medi-Cal director. “But we know that people experiencing homelessness cycle in and out of emergency rooms, so we have a real role to play in both preventing and ending homelessness.”

Public health experts say the problem will continue to explode without creative thinking about how to fund housing in health care, but they warn the state must be wary of potential abuses of the program.

“It has to be designed carefully because, unfortunately, there are always people looking to game the system,” said Dr. Tony Iton, a public health expert who is now a senior vice president at the California Endowment. “Decisions must be made by clinicians — not housing organizations just looking for another source of revenue.”

For Stephen Morton, who lives in the Orange County community of Laguna Woods, the journey from homelessness into permanent housing illustrates the amount of public spending it can take for the effort to pay off.

Morton, 60, bounced between shelters and his car for nearly two years and racked up extraordinary Medi-Cal costs due to prolonged hospitalizations and repeated emergency room trips to treat chronic heart disease, asthma, and diabetes.

Medi-Cal covered Morton’s open-heart surgery and hospital stays, which lasted weeks. He landed temporary housing through a state-sponsored program called Project Roomkey before getting permanent housing through a federal low-income housing voucher — an ongoing benefit that covers all but $50 of his rent.

Since getting his apartment, Morton said, he’s been able to stop taking one diabetes medication and lose weight. He attributes improvements in his blood sugar levels to his housing and the healthy, home-delivered meals he receives via Medi-Cal.

“It’s usually scrambled eggs for breakfast and the fish menu for dinner. I’m shocked it’s so good,” Morton said. “Now I have a microwave and I’m indoors. I’m so grateful and so much healthier.”

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.

  

 

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RX- Medicaid, with planned payment pilot, girds for influx of pricey gene therapies

MM Curator summary

The article below has been highlighted and summarized by our research team. It is provided here for member convenience as part of our Curator service.

 
 

[MM Curator Summary]: Pharma guys are totally on board with the CMS plan to “centralize” the way payment happes for these new drugs, so we should feel good about this not turning into another MDRP-style total spending game/cluster.

 
 

 
 

Clipped from: https://www.biopharmadive.com/news/gene-therapy-medicaid-payment-model-outcomes/643102/

An article from

 
 

The proposed model could help state Medicaid agencies explore outcomes-based payment schemes, but may come too late for a looming test.

 
 

The Centers for Medicare and Medicaid Services is planning a payment model around cell and gene therapies that would centralize use of outcomes-based agreements. Getty / Edited by BioPharma Dive

People with the blood disorder sickle cell are anticipating the arrival of two gene therapies that could dramatically reshape their disease, potentially offering something approaching a cure.

Insurers, too, are preparing for the treatments, which are expected to carry price tags in the seven figures. While five other expensive gene therapies are already available in the U.S., sickle cell is far more prevalent than the inherited diseases they treat, affecting an estimated 100,000 people in the country. Many are covered through Medicaid, the federal insurance plan for people with limited income.

An experimental model proposed by the Centers for Medicare and Medicaid Services last week could help state agencies better afford those medicines, as well as offer a testing ground for payment schemes that could apply to other pricey gene therapies. Yet the timeline for its implementation might mean it comes after the first sickle cell gene therapies reach market.

“Sickle cell is a call to action,” said Michael Sherman, chief medical officer of Point32 Health, the parent company of Harvard Pilgrim Health Care and Tufts Health Plan.

“Without these kinds of models, we’re going to see access issues,” he added. “The Medicaid state agencies, like other parts of the financing system, were never designed with this sort of upfront shock.”

The gene therapy model is one of three pilot programs CMS will test in the coming years in response to an executive order from President Joe Biden directing the agency to find further ways to lower prescription drug costs. Administration officials described these programs as building on last year’s Inflation Reduction Act, which gave Medicare the authority to negotiate prices for a limited number of drugs.

Under the gene therapy model, state Medicaid agencies could delegate authority to CMS to coordinate multistate frameworks to pay for gene therapies based on how much patients benefit from treatment. In sickle cell, for example, payment could be contingent on whether patients remain free of the pain crises they regularly experience.

These types of payment schemes, typically known as outcomes-based arrangements, are already used in some cases for the currently available gene therapies. But budget limitations and federal price reporting requirements have limited their use within Medicaid, indirectly shaping how they’re designed for private insurers, too.

edcines cleared by the FDA’s main review office since 2015 have been cancer drugs, a tally that reflects the advent of cancer immunotherapy as well as continued progress in matching treatment to genetics.

“There’s a lot of benefit, I think, to having both more of a centralized purchaser or negotiator across Medicaid programs … and having more centralized data collection,” said Stacie Dusetzina, a professor of health policy at Vanderbilt University Medical Center. “I think it also gives CMS a little bit of an upper hand at the negotiating table.”

Jeff Marrazzo, the former CEO of gene therapy developer Spark Therapeutics, agrees that a centralized approach in Medicaid could help.

“What I’ve observed is that state Medicaid agencies … generally have experienced more challenges with providing access to cell and gene therapies,” he wrote in an email. “This is due in part to the cost density of cell and gene therapies, but also because these organizations lack the infrastructure required to implement alternative pricing, reimbursement, and access models.”

Marrazzo cited data collection as one example, noting that some state agencies might lack the ability to appropriately track clinical outcomes for patients treated with a gene therapy.

CMS envisions testing several different types of outcomes-based arrangements, including an annuity model where continued payment is based on continued benefit. (To date, gene therapy developers have favored a rebate-based approach, where a certain percentage of their treatment’s cost is returned to the insurer if a specific outcome is not achieved.)

Five years ago, Spark proposed a similar annuity-based idea to help insurers pay for its then newly approved gene therapy Luxturna, for a type of childhood blindness. Spark priced the treatment at $425,000 per eye and sought to offer an installment payment plan, proposing the CMS run a demonstration project around Luxturna.

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Its ability to do so was limited by Medicaid rules requiring drugmakers give the program the “best price” they offer on their products. In the event a patient didn’t benefit from treatment, and an insurer therefore didn’t owe the remaining installment payments, Spark would have had to report that fractional cost as its best price.

CMS recently tweaked its policy, allowing drugmakers to report multiple “best prices” in the context of outcomes-based arrangements. “This was an important first step,” Marrazzo wrote. “Along with the [recent] policy change, I do believe CMS providing a more centralized approach could lead to more annuity models being taken up, particularly by Medicaid plans.”

The agency plans to focus the model on a specific disease, and indicated sickle cell as a likely candidate. Behind the advancing sickle cell treatments is a growing pipeline of other gene therapies in development.

“Our concern has been that, for some of these more rare diseases, we haven’t seen the access that we would like to see. Sickle cell is one of them,” said CMS Administrator Chiquita Brooks-LaSure on a call with reporters last week. “One of the reasons we’re so excited about this model is because we think states need some assistance from us to really be effective in the space.”

But CMS doesn’t envision launching the gene therapy model until 2026 at the earliest, years after the two gene therapies now nearing market are expected to be approved. Their developers — Bluebird bio and partners Vertex Pharmaceuticals and CRISPR Therapeutics — are currently preparing approval applications that they expect to finish filing with the FDA this quarter.

The latest developments in oncology research


More than one quarter of the medcines cleared by the FDA’s main review office since 2015 have been cancer drugs, a tally that reflects the advent of cancer immunotherapy as well as continued progress in matching treatment to genetics.

Under current timelines, CMS would begin developing the model this year and announce model specifications in 2024 and 2025, with implementation following the year after. The agency would then track metrics like gene therapy spending, use and change in access over time to evaluate its success.

To some, earlier would be better. “Being in a business, I don’t understand why it takes two years to announce model specifications,” Sherman said.

The planned model is also voluntary, so CMS would need to rely on participation from both state Medicaid agencies and from drugmakers. The latter group, CMS argued in its report, would be enticed by the prospect of simpler market access.

That access could come with some tradeoffs, however. “It may be a little bit less attractive because of the inability to command the highest possible price, especially if there is a large population that’s going to be treated and many Medicaid programs are interested in joining together into this kind of one model,” Dusetzina said.

Posted on

RX- U.S. proposes Medicare, Medicaid programs to cut drug costs, including $2 generics

MM Curator summary

The article below has been highlighted and summarized by our research team. It is provided here for member convenience as part of our Curator service.

 
 

[MM Curator Summary]: CMS has some bright ideas on managing Medicaid rx spending, including CMS taking over the way states pay for cell/gene therapies, and creating a mandatory model for how states pay for drugs fast-tracked by the FDA. No where on earth could those ideas have come from?

 
 

 
 

Clipped from: https://www.reuters.com/world/us/us-proposes-medicare-medicaid-programs-cut-drug-costs-including-2-generics-2023-02-14/

 
 

 

WASHINGTON, Feb 14 (Reuters) – The U.S. health department proposed on Tuesday three new pilot projects aimed at lowering prescription drug prices for people enrolled in government health insurance plans, including offering some essential generic drugs for $2 a month.

The Centers for Medicare and Medicaid (CMS) said it would test the models in the Medicare health program for people age 65 or over and the disabled and the Medicaid program for the poor.

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The proposed models would lower the out-of-pocket cost of commonly used generic drugs for chronic conditions, such as hypertension, to $2 a month for people on Medicare, improve access to expensive lifesaving cell and genetic treatments for those on Medicaid, and get CMS better deals for expensive new therapies that lack complete clinical trial data, CMS said.

 
 

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The first model sees CMS encouraging Medicare Part D plans, which cover most prescription drugs, to offer a monthly $2 fixed co-payment for a standard list of around 150 generic drugs targeting conditions common among Medicare beneficiaries, such as hyperlipidemia and hypertension. It is voluntary.

The second voluntary model allows state Medicaid agencies to pay for cell and gene therapies by delegating authority to CMS so it can facilitate contracts and payment models as well as structure and coordinate multi-state arrangements with manufacturers.

The agency also said it would work on developing a mandatory model for payment methods for drugs approved by the U.S. Food and Drug Administration (FDA) under its Accelerated Approval Program (APP).

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CMS has raised concerns about covering drugs under the pathway such as those for Alzheimer’s disease because it does not require the same degree of drug efficacy data as the FDA’s regular approval process.

The model would address the high cost and lack of confirmed effectiveness of drugs that receive accelerated approval through providing drugmakers with incentives to speed up the completion of confirmatory clinical trials, CMS said, and would be developed in consultation with the FDA.

CMS will announce the first model’s start date “as soon as operationally feasible”, it said. Development on the Medicaid gene and cell therapy model will start in 2023 and launch for testing in 2026. The agency will start working with the FDA on the accelerated approval model in 2023 but has no planned launched date yet.

 
 

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Reporting by Ahmed Aboulenein; Editing by Caroline Humer and Stephen Coates

Our Standards: The Thomson Reuters Trust Principles.

Ahmed Aboulenein

Thomson Reuters

Washington-based correspondent covering U.S. healthcare and pharmaceutical policy with a focus on the Department of Health and Human Services and the agencies it oversees such as the Food and Drug Administration, previously based in Iraq and Egypt.