Tag: iab-health insurance

Justice Department sues pharmaceutical company for allegedly failing to report suspicious opioid sales | CNN Politics

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The Justice Department on Thursday alleged that the AmerisourceBergen Corporation, one of the country’s largest pharmaceutical distributors, and two of its subsidiaries failed to report hundreds of thousands of suspicious prescription opioid orders to pharmacies across the country.

The lawsuit, which spans several states, alleges that AmerisourceBergen disregarded its legal obligation to report orders of controlled substances to the Drug Enforcement Agency for nearly a decade. The company ignored “red flags” that pharmacies in West Virginia, New Jersey, Colorado and Florida were diverting opioids into illegal drug markets, the suit says.

“The Department of Justice is committed to holding accountable those who fueled the opioid crisis by flouting the law,” Associate Attorney General Vanita Gupta said in a statement Thursday.

“Companies distributing opioids are required to report suspicious orders to federal law enforcement. Our complaint alleges that AmerisourceBergen – which sold billions of units of prescription opioids over the past decade – repeatedly failed to comply with that requirement,” she added.

If AmerisourceBergen is found liable at trial, the company faces billions of dollars in financial penalties, the Justice Department said.

Lauren Esposito, a spokesperson for AmerisourceBergen, countered on Thursday in a statement that said the Justice Department’s complaint rested on “five pharmacies that were cherry picked out of the tens of thousands of pharmacies that use AmerisourceBergen as their wholesale distributor, while ignoring the absence of action from former administrators at the Drug Enforcement Administration – the DOJ’s own agency.”

She added: “With the vast quantity of information that AmerisourceBergen shared directly with the DEA with regards to these five pharmacies, the DEA still did not feel the need to take swift action itself – in fact, AmerisourceBergen terminated relationships with four of them before DEA ever took any enforcement action while two of the five pharmacies maintain their DEA controlled substance registration to this day.”

Yet AmerisourceBergen was allegedly aware that in two of the pharmacies, drugs it distributed were likely being sold in parking lots for cash, the Justice Department said. In another pharmacy, the company was allegedly warned that patients likely suffering from addiction were receiving opioids, including some people who later died of a drug overdose.

The Justice Department also noted in its lawsuit that AmerisourceBergen’s reporting systems for suspicious opioid orders were deeply inadequate, and that the company intentionally changed its reporting systems to reduce the number of orders flagged as suspicious amid the opioid epidemic.

Even when orders were flagged as suspicious, AmerisourceBergen often didn’t report those orders to the DEA, according to the complaint.

Opioids are involved in the vast majority of drug overdose deaths, though synthetic opioids – particularly fentanyl – have played an outsized role. Synthetic opioids – excluding methadone – were involved in more than 72,000 overdose deaths in 2021, about two-thirds of all overdose deaths that year and more than triple the number from five years earlier.

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December 30, 2022
House investigation says FDA approval process of Alzheimer’s drug was ‘rife with irregularities’ | CNN

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A congressional investigation found that the US Food and Drug Administration’s “atypical collaboration” to approve a high-priced Alzheimer’s drug was “rife with irregularities.”

The report, released Thursday, was the result of an 18-month investigation by two House committees. It is sharply critical of Biogen, maker of the medication Aduhelm.

The report says Biogen set an “unjustifiably high price” for Aduhelm to “make history” for the company, and thought of the drug as an “unprecedented financial opportunity.” Biogen priced Aduhelm at $56,000 per year, even though its actual effects on a broad patient population were unknown.

More than 6.5 million people in the US live with Alzheimer’s, and that number is expected to grow to 13.8 million by 2060, according to the Alzheimer’s Association. The disease is the sixth leading cause of death in the United States. There is no cure, and effective treatments are extremely limited. Before Aduhelm’s approval in June 2021, the FDA had not approved a novel therapy for the condition since 2003.

The investigation found that Biogen planned an aggressive marketing campaign to launch the drug, intending to spend more than $3.3 billion on sales and marketing between 2020 and 2024 – more than 2½ times what it spent to develop Aduhelm.

Dementia, including Alzheimer’s, is one of the “costliest conditions to society,” according to the Alzheimer’s Association. In 2022 alone, Alzheimer’s and other dementias cost the US $321 billion, including $206 billion in Medicaid and Medicare payments, the association says.

Aduhelm’s cost to patients and to Medicare would be significant, the new report says. It was one of the key factors behind a big increase in Medicare premiums in 2022, according to the Centers for Medicare and Medicaid Services.

In anticipation of “pushback” from providers and payers, the report says, Biogen also prepared a narrative to sell the value of the drug.

The Committee on Oversight and Reform and the Committee on Energy and Commerce found that the collaboration between the FDA and Biogen in the approval process of the drug “exceeded the norm in some respects.”

Biogen had initially discontinued Aduhelm’s clinical trials in March 2019 after an independent committee found that it probably would not slow the cognitive and functional impairment – the decline in memory, language and judgment – that comes with Alzheimer’s. But in June 2019, the FDA and Biogen started a “working group” to see whether the effort could be saved.

The investigation found that the FDA and Biogen engaged in at least 115 meetings, calls and substantive email discussions from July 2019 to July 2020, including 40 meetings to guide Aduhelm’s potential approval. There may have been even more meetings, but the committees say the FDA failed to follow its own documentation protocol.

The agency then collaborated with Biogen to draft a document used to brief an independent advisory committee that met in November 2020. The trial results were mixed, with only one showing a small benefit to patients.

At that meeting, none of the committee’s members voted to say that the studies presented strong evidence that the drug was effective at treating Alzheimer’s.

The meeting was unusual, according to one former FDA adviser who had sat on the committee for several years. Dr. Aaron Kesselheim told CNN in 2021 that the relationship between the FDA and the company was out of the ordinary.

“There was a strange dynamic compared to the other advisory committee meetings I’ve attended,” the professor at Harvard Medical School said. “Usually, there’s some distance between the FDA and the company, but on this one, the company and the FDA were fully in line with each other in support of the drug.”

When the FDA approved the drug, Kesselheim and two other members of the advisory committee resigned in protest. He later labeled it “probably the worst drug approval decision in recent US history.”

The FDA often follows the independent committee’s recommendations, but in this case, it changed course and used its accelerated approval pathway, which sets a different standard of proof that a treatment could work.

The committee members said senior FDA leadership told them that the shift in how the drug would be approved came after an FDA expert council meeting in April 2021 provided “unfavorable feedback” for the traditional approval process, according to the new report.

The FDA also approved the drug for “people with Alzheimer’s disease,” a far broader population than was studied in Biogen’s clinical trials.

Internal documents from the company said that Biogen accepted this broader indication “despite internal reservations about the lack of evidence of clinical benefit for patients at disease stages outside of the clinical trials and an unknown safety profile,” the report says. Leaders expressed concern that the company could lose credibility, and it developed a communications strategy to deal with the “anticipated fallout,” the report says.

The committees recommended that the FDA document all of its meetings with drug sponsors, establish a protocol for briefing documents and advisory committees, and update its guidance for how Alzheimer’s drugs are developed and reviewed.

The committees also recommended that companies clearly communicate safety and efficacy concerns to the FDA and consider the value assessments made by outside experts when setting drug prices.

“The American people rely on FDA for assurance on the safety and efficacy of the medications they take. The number of patients and families impacted by Alzheimer’s disease will continue to increase, and it is crucial that FDA and drug companies adhere to established procedures and conduct themselves with the transparency necessary to earn public trust,” the report says.

The FDA said in a statement that its “decision to approve Aduhelm was based on our scientific evaluation of the data contained in the application, which is described in the approval materials.”

The agency says it is reviewing the committees’ findings and recommendations and says its own review found that the interactions with Biogen were appropriate.

“It is the agency’s job to frequently interact with companies in order to ensure that we have adequate information to inform our regulatory decision-making. We will continue to do so, as it is in the best interest of patients. That said, the agency has already started implementing changes consistent with the Committee’s recommendations.”

Biogen said in a statement Thursday that it has been working “cooperatively” with the investigation.

“Biogen has been committed to researching and developing treatments for Alzheimer’s disease for more than a decade. We have been focused relentlessly on innovation to address this global health challenge, and have adapted to both successes and setbacks,” it said. “Biogen stands by the integrity of the actions we have taken.”

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December 29, 2022
Social Security will not be able to pay full benefits in 2034 if Congress doesn’t act | CNN Politics

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Americans’ Social Security checks will get a lot smaller in 2034 if lawmakers don’t act to address the pending shortfall, according to an annual report released Friday by the Social Security trustees.

That’s because the combined Social Security trust funds – which help support payouts for the elderly, survivors and disabled – are projected to run dry that year. At that time, the funds’ reserves will be depleted, and the program’s continuing income will only cover 80% of benefits owed.

The estimate is one year earlier than the trustees projected last year. About 66 million Americans received Social Security benefits in 2022.

Medicare, meanwhile, is in a more critical financial condition. Its hospital insurance trust fund, known as Medicare Part A, will only be able to pay scheduled benefits in full until 2031, according to its trustees’ annual report, which was also released Friday.

At that time, Medicare, which covered 65 million senior citizens and people with disabilities in 2022, will only be able to cover 89% of total scheduled benefits. Last year, Medicare’s trustees projected that the hospital trust fund’s reserves would be depleted in 2028.

Immensely popular but long troubled, Social Security and Medicare are on shaky financial ground in large part because of the aging of the American population. Fewer workers are paying into the program and supporting the ballooning number of beneficiaries, who are also living longer. Also, health care is becoming increasingly expensive.

Social Security has two trust funds – one for retirees and survivors and another for Americans with disabilities.

Looking at them separately, the Old-Age and Survivors Insurance Trust Fund is projected to run dry in 2033, at which time Social Security could pay only 77% of benefits, primarily using income from payroll taxes. The date is one year earlier than estimated last year.

The Disability Insurance Trust Fund is expected to be able to pay full benefits through at least 2097, the last year of the trustees’ projection period.

Merging the two trust funds would require Congress to act, but the combined projection is often used to show the overall status of the entitlement.

Social Security’s projected long-term health worsened over the past year because the trustees revised downward their expectations for the economy and labor productivity, taking into account updated data on inflation and economic output.

However, the long-term projection for Medicare’s hospital trust fund’s finances improved, mainly due to lowered estimates for health care spending after the height of the Covid-19 pandemic. Also, the program is projected to take in more income because the trustees estimate the number of covered workers and average wages will be higher.

Regardless, the bottom line remains that Medicare is not bringing in enough money to pay the costs it is expected to incur, said Cori Uccello, senior health fellow at the American Academy of Actuaries.

“It’s still not a time to become complacent,” she said. Insolvency “is still less than a decade away.”

The trustees’ reports are the latest warnings to Congress that they will have to deal with the massive entitlement programs’ fiscal problems at some point soon. But addressing their issues is politically challenging. Elected officials are hesitant to suggest any changes that could lead to benefit cuts, even though that could reduce their options in the future.

“With each year that lawmakers do not act, the public has less time to prepare for the changes,” the trustees warned in a fact sheet.

The programs’ shortfalls are back in the spotlight this year as President Joe Biden and House Republicans battle over how to address the nation’s debt ceiling drama and mounting budget deficits. GOP lawmakers want to cut spending in exchange for resolving the borrowing limit, while the White House has said it will not negotiate.

In a memorable moment in his State of the Union address in February, Biden garnered public acknowledgment from congressional Republicans about keeping Social Security and Medicare out of the debt discussions.

But “not touching” Social Security means a hefty cut in benefits within a decade or so.

“Change is inevitable because without changes to current law, both Social Security and Medicare Hospital Insurance would go insolvent, subjecting program participants to sudden and severe payment cuts,” said Charles Blahous, senior research strategist at the Mercatus Center at George Mason University and former Social Security and Medicare trustee. “The outstanding question is whether change will be tolerably gradual, or instead highly damaging because it is too long delayed.”

Though Biden has repeatedly vowed to protect Social Security, his latest budget proposal did not include a plan to stabilize its finances.

However, his proposal did call for extending Medicare’s solvency by 25 years or more by raising taxes on those earning more than $400,000 a year and by allowing the program to negotiate prices for even more drugs.

Spending on the entitlement programs is also projected to soar and exert increased pressure on the federal budget in coming years.

Mandatory spending – driven by Social Security and Medicare – and interest costs are expected to outpace the growth of revenue and the economy, according to a Congressional Budget Office outlook released in mid-February.

This story has been updated with additional information.

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April 12, 2021
These 5 states will be the first to kick residents off Medicaid starting in April | CNN Politics

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Millions of Americans are at risk of losing their Medicaid coverage in coming months, but residents in Arizona, Arkansas, Idaho, New Hampshire and South Dakota will be the first to bear the brunt of the terminations.

States have been barred by Congress from winnowing their Medicaid rolls since the Covid-19 pandemic began. That prohibition ends on Saturday, and some states are moving much more swiftly than others to kick off those deemed ineligible for the public health insurance program for low-income Americans.

That worries advocates, who say speed will result in eligible residents being incorrectly terminated. Also, it could hamper shifting those who no longer qualify to other types of coverage.

“This is the fable of the tortoise and the hare,” said Joan Alker, executive director of the Georgetown University Center for Children and Families. “Taking time is absolutely going to result in a better outcome for eligible children and families to remain covered. So speed is a big concern.”

The five states will start cutting off coverage in April, followed by 14 more states in May and 20 additional states plus the District of Columbia in June. All states must complete their redeterminations over the next 14 months.

Around 15 million people could be dropped from Medicaid, according to various estimates, though several million folks could find coverage elsewhere. Others may still be eligible but could be terminated for procedural reasons, such as not completing renewal forms. Those at risk include at least 6.7 million children, according to a Georgetown analysis.

Medicaid enrollment has ballooned since March 2020, when lawmakers passed the Families First Coronavirus Response Act, which prevented states from involuntarily removing anyone from coverage. In exchange, Congress boosted states’ federal Medicaid match rates by 6.2 percentage points.

The provision was initially tied to the national public health emergency, but lawmakers changed that as part of the federal spending bill that passed in December. In addition to being able to start conducting terminations in April, states will receive an enhanced federal match through the rest of this year, though it will phase down over time.

More than 92 million Americans were enrolled in Medicaid and the Children’s Health Insurance Program in December, up 31% since February 2020, according to the most recent data available from the Centers for Medicare and Medicaid Services.

Reviewing the eligibility of all those enrollees will be a monumental task for state Medicaid agencies, many of which are also contending with slim staffing. To gear up, they are hiring new employees, temporary workers or contractors or bringing back retirees, according to a recent survey conducted by Georgetown and the Kaiser Family Foundation.

Most states can automatically renew coverage for at least some of their enrollees using other data, such as state wage information. But agencies must get in touch with others in their Medicaid programs, which proved challenging even prior to the pandemic. Most states are using multiple methods to update enrollees’ contact information, including working with insurers that provide Medicaid coverage to residents.

If notices sent by mail are returned, states must make good faith attempts to contact enrollees through at least two other methods before cutting them off. And states have to adhere to additional requirements to continue to qualify for the enhanced match. If they don’t, CMS also could suspend their terminations, require they take corrective action or impose monetary penalties.

Of the roughly 15 million people who could lose Medicaid coverage, about 8.2 million will no longer qualify, according to a Department of Health and Human Services analysis released in August. Some 2.7 million of these folks would qualify for enhanced federal subsidies for Affordable Care Act policies that could bring their monthly premiums to as low as $0.

Some 6.8 million people, however, will be disenrolled even though they remain eligible.

Though the federal government has given states more than a year to conduct the eligibility reviews and terminations, some plan to move much more quickly.

Idaho, which has been monitoring enrollees’ eligibility throughout the pandemic, plans to complete its reevaluations by September, which it touts as one of the fastest timelines in the country.

Of the nearly 450,000 Idahoans in the program, about 150,000 of them either don’t qualify or haven’t been in touch with the state in the past three years. The state began sending notices in February to those who face termination. People have 60 days to respond before they are removed.

Those that are not eligible have 60 days from their termination date to enroll in Idaho’s state-based Obamacare exchange, Your Health Idaho. The exchange receives information nightly from the state Medicaid agency about residents who no longer qualify for public coverage but may be eligible for federal subsidies for Affordable Care Act policies.

The exchange is reaching out to those folks weekly while they still have Medicaid and then every 15 days during the two-month special enrollment period via various methods, including mail, email and text messages, said Pat Kelly, Your Health Idaho’s executive director.

The exchange works with 900 agents, brokers and enrollment counselors who can help folks sign up for policies. And it plans to start an advertising campaign this month highlighting the hefty subsidies.

“We have to really help Idahoans know and understand that low-cost options are available, and most importantly, that it’s comprehensive health insurance that they can get for $0 a month,” Kelly said.

Still, advocates in Idaho are concerned that the state’s push to unwind quickly will result in eligible residents losing coverage.

Many people are not aware that they once again need to prove that they qualify, and the state agency is understaffed and underfunded, said Hillarie Hagen, health policy associate at Idaho Voices for Children. Renewal letters may not make it to enrollees, and those who need help may not be able to get through to customer service.

“We are very concerned about families, and particularly children, losing health coverage without their knowledge – that they will find out when they show up to the doctor,” Hagen said.

Aware that many people don’t know they’ll have to renew their eligibility, Arizona’s Medicaid agency last summer sent text messages and letters and made robocalls to enrollees, asking them to update their contact information. It is also working with community partners, health care providers, pharmacies and insurers. And it’s ramping up another text campaign since the prior one was so successful, said Heidi Capriotti, public information officer for the Arizona Health Care Cost Containment System.

While the state can automatically redetermine the eligibility of about 75% of its Medicaid participants, it still has to connect with about 670,000 residents who could lose coverage because they are no longer eligible or they haven’t responded to the agency’s requests. The state plans to take 12 months to assess whether its enrollees still qualify.

South Dakota will start terminating Medicaid enrollees in April, though some low-income adults may become eligible again in July, when the state’s Medicaid expansion program begins.

Voters approved the broadening of Medicaid to low-income adults at the ballot box in November, over the objections of the Republican governor and legislature.

Nearly 152,000 residents were enrolled in Medicaid in January, an increase of more than 30% from March 2020, according to the state’s Department of Social Services. But more than 22,000 people appear to be ineligible currently.

The agency said in an FAQ that it will prioritize reviewing folks who are most likely to be ineligible because they no longer meet a coverage group or their income has increased, among other reasons.

Those who are not eligible will be disenrolled with 10-days’ notice. If they appear eligible for expansion in July, they’ll receive a notice about it when they are terminated and sent a reminder in June. The agency is encouraging any enrollees who are determined to be ineligible to reapply after Medicaid expansion takes effect.

But that three-month gap can wreak havoc on low-income residents’ health, said Jen Dreiske, deputy director of South Dakota Voices for Peace, which is working with the state’s immigrants and refugees to inform them of the unwinding. These folks may have to go without their heart medication or their cancer treatment. They may also be afraid to go to the doctor because of the cost.

“Why can’t we just wait until July 1?” Dreiske said. “Our concern is that people are going to get sick or die because they’re not going to be able to access the health care that they so desperately need.”

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April 12, 2021
Here’s what you can do if you lose Medicaid coverage | CNN Politics

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Though millions of Americans are expected to be kicked off of Medicaid in coming months, they don’t all have to be left uninsured.

But it could take some work to regain health coverage.

“For a lot of people, this can be a very disruptive period of time,” said Sabrina Corlette, co-director of the Center on Health Insurance Reforms at Georgetown University. “There is a significant time and paperwork burden being placed on families – a lot of them very low income, a lot of them medically vulnerable.”

States are now free to terminate the Medicaid coverage of residents they deem ineligible. States had been barred from involuntarily removing anyone for the past three years as part of an early congressional Covid-19 pandemic relief package, causing enrollment in Medicaid and the Children’s Health Insurance Program to balloon to more than 92 million people.

Of the roughly 15 million people who could lose Medicaid coverage over the next 14 months, about 8.2 million would no longer qualify, according to a Department of Health and Human Services analysis released in August.

Some 2.7 million of these folks would qualify for enhanced federal subsidies for Affordable Care Act policies that could bring their monthly premiums to as low as $0.

Another 5 million are expected to secure other coverage, mainly through employers.

Some 6.8 million people, however, will be disenrolled even though they remain eligible for Medicaid.

Check out Obamacare policies: Folks who lose their Medicaid coverage can shop for health insurance plans on the Affordable Care Act exchanges.

Those whose annual incomes remain below 150% of the federal poverty level – $20,385 for a single person and $41,625 for a family of four in 2023 – can obtain enhanced federal assistance to lower their premiums to as little as $0 a month. That beefed-up subsidy is in place through 2025.

Many people with higher incomes can find subsidized policies for $10 or less.

State Medicaid agencies are tasked with easing residents’ transfer from Medicaid to the Obamacare marketplaces, but the smoothness of the process will vary greatly by state. Once someone is determined to no longer qualify for Medicaid, the agency must assess his or her eligibility for Affordable Care Act coverage and transfer the resident’s information to the exchange.

Some states that run their own Obamacare exchanges are taking extra steps to ensure their residents remain covered. Rhode Island, for instance, is automatically enrolling certain people in marketplace coverage. It’s also paying the first two months of premiums for some residents who actively select policies.

Those who lose Medicaid coverage and live in the 33 states covered by the federal marketplace, healthcare.gov, can apply for Affordable Care Act policies through a special enrollment period that runs through July 2024. State-based exchanges have their own deadlines, with some mirroring the federal exchange and others providing much shorter windows.

Navigators and insurance brokers can help consumers select plans.

Historically, very few people who lose Medicaid coverage wind up in Obamacare plans. About 4% of adults who were terminated from Medicaid enrolled in exchange policies in 2018, according to the Medicaid and CHIP Payment and Access Commission.

The coverage differs too. Those that switch to the marketplace may have to find other doctors that are in their insurers’ networks and may face out-of-pocket costs.

Consider job-based coverage: A number of people who are terminated from Medicaid may already be covered by their employers, particularly those who started new jobs during the pandemic. Others have the option of obtaining coverage through work, though it will almost certainly be more expensive than Medicaid since it will likely entail premiums, deductibles and copays.

Workers may find they can afford coverage for themselves but not for their families. If the premiums for family policies cost more than 9.12% of household income, spouses and children may be able to get subsidized coverage on the Affordable Care Act exchanges.

Employees should contact their human resources departments to sign up. Typically, they’ll have to enroll within 60 days of losing Medicaid, but those who are terminated from the program between now and July 10 will have until early September to sign up.

See if you or your children remain eligible for Medicaid: Millions of Americans who still qualify for Medicaid may lose coverage for procedural reasons. For example, they may have moved so they don’t receive the redetermination notices. Or they may not return the necessary paperwork to prove their eligibility.

So it’s crucial that folks update their contact information with their state agencies and reply to the letters they receive about renewing their Medicaid eligibility.

“When you get that packet in the mail, respond to it promptly,” Corlette said.

Those who are dropped have 90 days to submit their renewal paperwork to their state agency, which is required to reinstate them if they are found eligible. Beyond that time period, people may reapply. In most states, your coverage can be made retroactive for up to three months if you were eligible and received Medicaid-covered services.

Parents who no longer qualify and are terminated should check if their children remain eligible. As many as 6.7 million kids are at risk of losing Medicaid coverage, according to Georgetown’s Center for Children and Families.

Nearly three-quarters of the children projected to be dropped will remain eligible for Medicaid or CHIP but will lose coverage mainly because of administrative issues. Black and Latino children and families are more likely to be erroneously terminated, according to the center.

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April 12, 2021
Biden administration moves ahead with Medicare drug price negotiations amid industry lawsuits | CNN Politics

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Undeterred by a growing number of lawsuits, the Biden administration on Friday released revised guidance for Medicare’s new drug price negotiation program.

The latest guidance outlines how the Centers for Medicare and Medicaid Services will negotiate with drugmakers to reach agreement on a maximum fair price for a selected medicine, the agency said. It was informed by public input on the initial guidance the agency released in March, which explained how it will select the drugs and how the negotiations will be conducted.

The program, which was authorized by the Inflation Reduction Act that congressional Democrats passed last year, has prompted a fierce backlash from the pharmaceutical industry. Two drug manufacturers and two industry groups have filed lawsuits, arguing the measure is unconstitutional.

But the administration is not backing down from implementing its historic new power. It intends to keep its timeline of announcing the first 10 drugs that will be selected for negotiation by September 1. CMS and the drugmakers will negotiate during 2023 and 2024. The prices will be effective starting in 2026.

“The Biden-Harris Administration isn’t letting anything get in our way of delivering lower drug costs for Americans,” Secretary of Health and Human Services Xavier Becerra said in a statement. “Pharmaceutical companies have made record profits for decades. Now they’re lining up to block this Administration’s work to negotiate for better drug prices for our families. We won’t be deterred.”

The initial set of drugs will be chosen from the top 50 Part D drugs that are eligible for negotiation that have the highest total expenditures in Medicare. CMS will consider multiple factors when developing its initial offer, including the drugs’ clinical benefits, the price of alternatives, research and development costs and patent protection, among others.

If drugmakers don’t comply with the process, they will have to pay an excise tax of up to 95% of the medications’ US sales or pull all their drugs from the Medicare and Medicaid markets. The pharmaceutical industry contends that the true penalty can be as high as 1,900% of sales.

CMS said it received more than 7,500 comments on its initial guidance from patient groups, drug companies, pharmacies and others.

The changes it is making are aimed at improving transparency while keeping confidentiality in mind, as well as fostering “an effective negotiation process,” the agency said.

They include revising the confidentiality process to state that CMS will release information about the negotiations when it publishes the explanations of the prices. Also, drug companies may publicly discuss the negotiations – the prior secrecy requirement had been a point of contention among manufacturers that was mentioned in the lawsuits. And they won’t be required to destroy data relating to the negotiations.

In addition, CMS will hold patient-focused listening sessions to provide drug companies and the public more opportunities to engage with the agency. The sessions – which will give patients, caregivers and others the chance to share input on how a medication addresses unmet needs, how it impacts specific populations and what therapeutic alternatives exist – will be held in the fall for the first round of drugs.

Merck, Bristol Myers Squibb, the Pharmaceutical Research and Manufacturers of America, known as PhRMA, and the US Chamber of Commerce have all recently filed lawsuits in federal courts across the US. They each argue the program is unconstitutional in various ways.

The challengers also say that the negotiation provision will harm innovation and patients’ access to new drugs.

Among the arguments are that the program violates the Fifth Amendment’s “takings” clause because it allows Medicare to obtain manufacturers’ patented drugs, which are private property, without paying fair market value under the threat of serious penalties.

Plus, the negotiations process violates the First Amendment, the challengers say, because it coerces manufacturers into saying that they agree to the price that the government has dictated and that it’s fair.

Another argument is that the process violates the Eighth Amendment by levying an excessive fine if drugmakers refuse to negotiate and continue selling their products to the Medicare market.

Merck expects its diabetes drug Januvia to be among the drugs named in September and its blockbuster cancer treatment Keytruda and diabetes drug Janumet to be subject to negotiation in the future. Bristol Myers Squibb believes its blood thinning medication, Eliquis, will be subject to negotiations this year, and its cancer medication, Opdivo, will be selected in a subsequent round.

The changes in the revised guidance did not allay the complaints of the pharmaceutical industry. PhRMA said that transparency remains “severely limited,” patients’ views are not being taken into account and Medicare beneficiaries could have less access to drugs.

“The very few substantive changes to the final guidance demonstrate CMS saw this as a box checking exercise, not an opportunity to mitigate the negative impacts this price setting policy will have on patients or the broader health care sector,” PhRMA said in a statement.

“The approach CMS took in this final guidance confirms what we claimed in our lawsuit – Congress’ unconstitutional shortcuts taken in the law have given the administration far too much flexibility to set prices at their whim without any oversight or accountability to anyone,” the group continued.

The Biden administration will “vigorously defend” the drug price negotiation program, said CMS Administrator Chiquita Brooks-LaSure.

“We feel the law is on our side,” she said in a call with reporters Friday.

This story has been updated with additional information.

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April 12, 2021