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5 Things to Know About the New Drug Pricing Negotiations

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by Arthur Allen and Rachana Pradhan and David Hilzenrath
Wed, 30 Aug 2023 09:00:00 +0000

The Biden administration has picked the first 10 high-priced prescription drugs subject to federal price negotiations, taking a swipe at the powerful pharmaceutical industry. It marks a major turning point in a long-fought battle to control ever-rising drug prices for seniors and, eventually, other Americans.

Under the 2022 Reduction Act, gave the federal government the power to negotiate prices for certain high-cost drugs under Medicare. The list of drugs selected by the Centers for Medicare & Services will grow over time.

The first eligible drugs treat diabetes, blood clots, blood cancers, arthritis, and heart disease — and accounted for about $50 in spending from June 2022 to May 2023.

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The United States is clearly an outlier on drug costs, with drugmakers charging Americans many times more than of other countries “simply because they could,” Biden said Tuesday at the White House. “I think it's outrageous. That's why these negotiations matter.”

He added, “We're going to keep standing up to Big Pharma and we're not going to back down.”

Democratic lawmakers cheered the announcement, and the pharmaceutical industry, which has filed a raft of lawsuits against the law, condemned it.

The companies have until Oct. 2 to present data on their drugs to CMS, which will make initial price offers in February, setting off negotiations set to end next August. The prices would go into effect in January 2026.

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Here are five things to know about the impact:

1. How important is this step?

Medicare has long been in control of the prices for its services, setting physician payments and hospital payments for about 65 million Medicare beneficiaries. But it was previously prohibited from involvement in pricing prescription drugs, which it started covering in 2006.

Until now the drug industry has successfully fought off price negotiations with Washington, although in most of the rest of the world governments set prices for medicines. While the first 10 drugs selected for negotiations are used by a minority of — 9 million — CMS plans by 2029 to have negotiated prices for 50 drugs on the market.

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“There's a symbolic impact, but also Medicare spent $50 billion on these 10 drugs in a 12-month period. That's a lot of money,” said Juliette Cubanski, deputy director of KFF's analysis of Medicare policy.

The long-term consequences of the new policy are unknown, said Alice Chen, vice dean for research at University of Southern California's Sol Price School of Public Policy. The drug industry says the negotiations are essentially price controls that will stifle drug development, but the Congressional Budget Office estimated only a few drugs would not be developed each year as a result of the policy.

Biden administration officials say reining in drug prices is key to slowing the skyrocketing costs of U.S. .

2. How will the negotiations affect Medicare patients?

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In some cases, patients may save a lot of money, but the main thrust of Medicare price negotiation policy is to provide savings to the Medicare program — and taxpayers — by lowering its overall costs.

The drugs selected by CMS range from specialized, hyper-expensive drugs like the cancer pill Imbruvica (used by about 26,000 patients in 2021 at an annual price of $121,000 per patient) to extremely common medications such as Eliquis (a blood thinner for which Medicare paid about $4,000 each for 3.1 million patients).

While the negotiations could patients whose Medicare drug plans require them to make large copayments for drugs, the relief for patients will come from another segment of the Inflation Reduction Act that caps drug spending by Medicare recipients at $2,000 per year starting in 2025.

3. What do the Medicare price negotiations mean for those not on Medicare?

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One theory is that reducing the prices drug companies can charge in Medicare will them to increase prices for the privately insured.

But that would be true only if companies aren't already pricing their drugs as high as the private market will bear, said Tricia Neuman, executive director of KFF's program on Medicare policy.

Another theory is that Medicare price negotiations will equip private plans to drive a harder bargain. David Mitchell, president of the advocacy group Patients for Affordable Drugs, predicted that disclosure of negotiated Medicare prices “will embolden and arm private sector negotiators to seek that lower price for those they cover.”

Stacie B. Dusetzina, a professor of health policy at Vanderbilt University, said the effect on pricing outside Medicare isn't clear.

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“I'd hedge my bet that it doesn't change,” she said.

Nonetheless, Dusetzina described one way it could: Because the government will be selecting drugs for Medicare negotiations based partly on the listed gross prices for the drugs — distinct from the net cost after rebates are taken into account — the process could give drug companies an incentive to lower the list prices and narrow the gap between gross and net. That could benefit people outside Medicare whose out-of-pocket payments are pegged to the list prices, she said.

4. What are drug companies doing to stop this?

Even though negotiated prices won't take effect until 2026, drug companies haven't wasted time turning to the courts to try to stop the new program in its tracks.

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At least six drug companies have filed lawsuits to halt the Medicare drug negotiation program, as have the U.S. Chamber of Commerce and the Pharmaceutical Research and Manufacturers of America, known as PhRMA.

The lawsuits include a variety of legal arguments. Merck & Co., Johnson & Johnson, and Bristol Myers Squibb are among the companies arguing their First Amendment rights are being violated because the program would force them to make statements on negotiated prices they believe are untrue. Lawsuits also say the program unconstitutionally coerces drugmakers into selling their products at inadequate prices.

“It is akin to the Government taking your car on terms that you would never voluntarily accept and threatening to also take your house if you do not ‘agree' that the taking was ‘fair,'” Janssen, part of Johnson & Johnson, wrote in its lawsuit.

Nicholas Bagley, a law professor at the University of Michigan, predicted the lawsuits would fail because Medicare is a voluntary program for drug companies, and those wishing to participate must abide by its rules.

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5. What if a drug suddenly gets cheaper by 2026?

In theory, it could happen. Under guidelines CMS issued this year, the agency will cancel or adjourn negotiations on any drug on its list if a cheaper copycat version enters the market and finds substantial buyers.

According to company statements this year, two biosimilar versions of Stelara, a Johnson & Johnson drug on the list, are prepared to launch in early 2025. If they succeed, it would presumably scotch CMS' plan to demand a lower price for Stelara.

Other drugs on the list have managed to maintain exclusive rights for decades. For example, Enbrel, which the FDA first approved in 1998 and cost Medicare $1.5 billion in 2021, will not face competition until 2029 at the earliest.

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By: Arthur Allen and Rachana Pradhan and David Hilzenrath
Title: 5 Things to Know About the New Drug Pricing Negotiations
Sourced From: kffhealthnews.org/news/article/white-house-drug-pricing-announcement/
Published Date: Wed, 30 Aug 2023 09:00:00 +0000

Kaiser Health News

The Lure of Specialty Medicine Pulls Nurse Practitioners From Primary Care

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Michelle Andrews
Fri, 17 May 2024 09:00:00 +0000

For many patients, seeing a nurse practitioner has become a routine part of primary care, in which these “NPs” often perform the same tasks that patients have relied on for.

But NPs in specialty care? That's not routine, at least not yet. Increasingly, though, nurse practitioners and physician assistants are joining cardiology, dermatology, and other specialty practices, broadening their skills and increasing their income.

This worries some people who track the workforce, because current trends suggest primary care, which has counted on nurse practitioners to backstop physician shortages, soon might not be able to rely on them to the same extent.

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“They're succumbing to the same challenges that we have with physicians,” said Atul Grover, executive director of the Research and Action Institute at the Association of American Medical Colleges. The rates NPs can command in a specialty practice “are quite a bit higher” than practice salaries in primary care, he said.

When nurse practitioner programs began to proliferate in the 1970s, “at first it looked great, producing all these nurse practitioners that go to work with primary care physicians,” said Yalda Jabbarpour, director of the American Academy of Family Physicians' Robert Graham Center for Policy Studies. “But now only 30% are going into primary care.”

Jabbarpour was referring to the 2024 primary care scorecard by the Milbank Memorial Fund, which found that from 2016 to 2021 the proportion of nurse practitioners who worked in primary care practices hovered between 32% and 34%, even though their numbers grew rapidly. The proportion of physician assistants, also known as physician associates, in primary care ranged from 27% to 30%, the study found.

Both nurse practitioners and physician assistants are advanced practice clinicians who, in addition to graduate degrees, must complete distinct education, , and certification steps. NPs can practice without a doctor's supervision in more than two dozen states, while PAs have similar independence in only a handful of states.

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About 88% of nurse practitioners are certified in an area of primary care, according to the American Association of Nurse Practitioners. But it is difficult to track exactly how many work in primary care or in specialty practices. Unlike physicians, they're generally not required to be endorsed by a national standard-setting body to practice in specialties like oncology or cardiology, for example. The AANP declined to answer questions about its annual workforce survey or the extent to which primary care NPs are moving toward specialties.

Though data tracking the change is sparse, specialty practices are adding these advanced practice clinicians at almost the same rate as primary care practices, according to frequently cited research published in 2018.

The clearest evidence of the shift: From 2008 to 2016, there was a 22% increase in the number of specialty practices that employed nurse practitioners and physician assistants, according to that study. The increase in the number of primary care practices that employed these professionals was 24%.

Once more, the most recent projections by the Association of American Medical Colleges predict a dearth of at least 20,200 primary care physicians by 2036. There will also be a shortfall of non-primary care specialists, a deficiency of at least 10,100 surgical physicians and up to 25,000 physicians in other specialties.

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When it to the actual work performed, the lines between primary and specialty care are often blurred, said Candice Chen, associate professor of health policy and management at George Washington University.

“You might be a nurse practitioner working in a gastroenterology clinic or cardiology clinic, but the scope of what you do is starting to overlap with primary care,” she said.

Nurse practitioners' salaries vary widely by location, type of facility, and experience. Still, according to data from recruiter AMN Healthcare Physician Solutions, formerly known as Merritt Hawkins, the total annual average starting compensation, including signing bonus, for nurse practitioners and physician assistants in specialty practice was $172,544 in the year that ended March 31, slightly higher than the $166,544 for those in primary care.

According to forecasts from the federal Bureau of Labor Statistics, nurse practitioner will increase faster than jobs in almost any other occupation in the decade leading up to 2032, growing by 123,600 jobs or 45%. (Wind turbine service technician is the only other occupation projected to grow as fast.) The growth rate for physician assistants is also much faster than average, at 27%. There are more than twice as many nurse practitioners as physician assistants, however: 323,900 versus 148,000, in 2022.

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To Grover, of the AAMC, numbers like this signal that there will probably be enough NPs, PAs, and physicians to meet primary care needs. At the same time, “expect more NPs and PAs to also flow out into other specialties,” he said.

When Pamela Ograbisz started working as a registered nurse 27 years ago, she worked in a cardiothoracic intensive care unit. After she became a family nurse practitioner a few years later, she found a job with a similar specialty practice, which trained her to take on a bigger role, first running their outpatient clinic, then working on the floor, and later in the intensive care unit.

If nurse practitioners want to specialize, often “the doctors mentor them just like they would with a physician residency,” said Ograbisz, now vice president of clinical operations at temporary placement recruiter LocumTenens.com.

If physician assistants want to specialize, they also can do so through mentoring, or they can receive “certificates of added qualifications” in 10 specialties to demonstrate their expertise. Most employers don't “encourage or require” these certificates, however, said Jennifer Orozco, chief medical officer at the American Academy of Physician Associates.

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There are a number of training programs for family nurse practitioners who want to develop skills in other .

Raina Hoebelheinrich, 40, a family nurse practitioner at a regional medical center in Yankton, South Dakota, recently enrolled in a three-semester post-master's endocrinology training program at Mount Marty University. She lives on a farm in nearby northeastern Nebraska with her husband and five sons.

Hoebelheinrich's new skills could be helpful in her current hospital job, in which she sees a lot of patients with acute diabetes, or in a clinic setting like the one in Sioux Falls, South Dakota, where she is doing her clinical endocrinology training.

Lack of access to endocrinology care in rural areas is a real problem, and many people may travel hundreds of miles to see a specialist.

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“There aren't a lot of options,” she said.

——————————
By: Michelle Andrews
Title: The Lure of Specialty Medicine Pulls Nurse Practitioners From Primary Care
Sourced From: kffhealthnews.org//article/nurse-practitioners-trend-primary-care-specialties/
Published Date: Fri, 17 May 2024 09:00:00 +0000

Did you miss our previous article…
https://www.biloxinewsevents.com/clean-needles-save-lives-in-some-states-they-might-not-be-legal/

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Kaiser Health News

Clean Needles Save Lives. In Some States, They Might Not Be Legal.

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Ed Mahon, Spotlight PA and Sarah Boden, WESA
Fri, 17 May 2024 09:00:00 +0000

Kim Botteicher hardly thinks of herself as a criminal.

On the main floor of a former Catholic church in Bolivar, Pennsylvania, Botteicher runs a flower shop and cafe.

In the former church's basement, she also operates a nonprofit organization focused on helping people caught up in the drug epidemic get back on their feet.

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The nonprofit, FAVOR ~ Western PA, sits in a rural pocket of the Allegheny Mountains east of Pittsburgh. Her organization's home county of Westmoreland has seen roughly 100 or more drug overdose deaths each year for the past several years, the majority involving fentanyl.

Thousands more residents in the region have been touched by the scourge of addiction, which is where Botteicher in.

She helps people find housing, , and , and works with families by running support groups and explaining that substance use disorder is a disease, not a moral failing.

But she has also talked publicly about how she has made sterile syringes available to people who use drugs.

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“When that person comes in the door,” she said, “if they are covered with abscesses because they have been using needles that are dirty, or they've been sharing needles — maybe they've got hep C — we see that as, ‘OK, this is our first step.'”

Studies have identified public health benefits associated with syringe exchange services. The Centers for Disease Control and Prevention says these programs reduce HIV and hepatitis C infections, and that new users of the programs are more likely to enter drug treatment and more likely to stop using drugs than nonparticipants.

This harm-reduction strategy is supported by leading health groups, such as the American Medical Association, the World Health Organization, and the International AIDS Society.

But providing clean syringes could put Botteicher in legal danger. Under Pennsylvania , it's a misdemeanor to distribute drug paraphernalia. The state's definition includes hypodermic syringes, needles, and other objects used for injecting banned drugs. Pennsylvania is one of 12 states that do not implicitly or explicitly authorize syringe services programs through statute or regulation, according to a 2023 analysis. A few of those states, but not Pennsylvania, either don't have a drug paraphernalia law or don't include syringes in it.

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Those working on the front lines of the opioid epidemic, like Botteicher, say a reexamination of Pennsylvania's law is long overdue.

There's an urgency to the issue as well: Billions of dollars have begun flowing into Pennsylvania and other states from legal settlements with companies over their role in the opioid epidemic, and syringe services are among the eligible interventions that could be supported by that money.

The opioid settlements reached between drug companies and distributors and a coalition of state attorneys general included a list of recommendations for spending the money. Expanding syringe services is listed as one of the core strategies.

But in Pennsylvania, where 5,158 people died from a drug overdose in 2022, the state's drug paraphernalia law stands in the way.

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Concerns over Botteicher's work with syringe services recently led Westmoreland County officials to cancel an allocation of $150,000 in opioid settlement funds they had previously approved for her organization. County Commissioner Douglas Chew defended the decision by saying the county “is very risk averse.”

Botteicher said her organization had planned to use the money to hire additional recovery specialists, not on syringes. Supporters of syringe services point to the cancellation of as evidence of the need to change state law, especially given the recommendations of settlement documents.

“It's just a huge inconsistency,” said Zoe Soslow, who leads overdose prevention work in Pennsylvania for the public health organization Vital Strategies. “It's causing a lot of confusion.”

Though sterile syringes can be purchased from pharmacies without a prescription, handing out free ones to make drug use safer is generally considered illegal — or at least in a legal gray area — in most of the state. In Pennsylvania's two largest , Philadelphia and Pittsburgh, officials have used local health powers to provide legal protection to people who operate syringe services programs.

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Even so, in Philadelphia, Mayor Cherelle Parker, who took office in January, has made it clear she opposes using opioid settlement money, or any city funds, to pay for the distribution of clean needles, The Philadelphia Inquirer has reported. Parker's position signals a major shift in that city's approach to the opioid epidemic.

On the other side of the state, opioid settlement funds have had a big effect for Prevention Point Pittsburgh, a harm reduction organization. Allegheny County reported spending or committing $325,000 in settlement money as of the end of last year to support the organization's work with sterile syringes and other supplies for safer drug use.

“It was absolutely incredible to not have to fundraise every single dollar for the supplies that go out,” said Prevention Point's executive director, Aaron Arnold. “It takes a lot of energy. It pulls away from actual delivery of services when you're constantly having to find out, ‘Do we have enough money to even purchase the supplies that we want to distribute?'”

In parts of Pennsylvania that lack these legal protections, people sometimes operate underground syringe programs.

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The Pennsylvania law banning drug paraphernalia was never intended to apply to syringe services, according to Scott Burris, director of the Center for Public Health Law Research at Temple . But there have not been court cases in Pennsylvania to clarify the issue, and the failure of the to act creates a chilling effect, he said.

Carla Sofronski, executive director of the Pennsylvania Harm Reduction Network, said she was not aware of anyone having faced criminal charges for operating syringe services in the state, but she noted the threat hangs over people who do and that they are taking a “great risk.”

In 2016, the CDC flagged three Pennsylvania counties — Cambria, Crawford, and Luzerne — among 220 counties nationwide in an assessment of communities potentially vulnerable to the rapid spread of HIV and to new or continuing high rates of hepatitis C infections among people who inject drugs.

Kate Favata, a resident of Luzerne County, said she started using heroin in her late teens and wouldn't be alive if it weren't for the support and community she found at a syringe services program in Philadelphia.

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“It kind of just made me feel like I was in a safe space. And I don't really know if there was like a come-to-God moment or come-to-Jesus moment,” she said. “I just wanted better.”

Favata is now in long-term recovery and works for a medication-assisted treatment program.

At clinics in Cambria and Somerset Counties, Highlands Health provides free or low-cost medical care. Despite the legal risk, the organization has operated a syringe program for several years, while also testing patients for infectious diseases, distributing overdose reversal medication, and offering recovery options.

Rosalie Danchanko, Highlands Health's executive director, said she hopes opioid settlement money can eventually support her organization.

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“Why shouldn't that wealth be spread around for all organizations that are working with people affected by the opioid problem?” she asked.

In February, legislation to legalize syringe services in Pennsylvania was approved by a committee and has moved forward. The administration of Gov. Josh Shapiro, a Democrat, supports the legislation. But it faces an uncertain future in the full legislature, in which Democrats have a narrow majority in the House and Republicans control the Senate.

One of the bill's lead sponsors, state Rep. Jim Struzzi, hasn't always supported syringe services. But the Republican from western Pennsylvania said that since his brother died from a drug overdose in 2014, he has come to better understand the nature of addiction.

In the committee vote, nearly all of Struzzi's Republican colleagues opposed the bill. State Rep. Paul Schemel said authorizing the “very instrumentality of abuse” crossed a line for him and “would be enabling an evil.”

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After the vote, Struzzi said he wanted to build more bipartisan support. He noted that some of his own skepticism about the programs eased only after he visited Prevention Point Pittsburgh and saw how workers do more than just hand out syringes. These types of programs connect people to resources — overdose reversal medication, wound care, substance use treatment — that can save lives and lead to recovery.

“A lot of these people are … desperate. They're alone. They're afraid. And these programs bring them into someone who cares,” Struzzi said. “And that, to me, is a step in the right direction.”

At her nonprofit in western Pennsylvania, Botteicher is hoping lawmakers take action.

“If it's something that's going to help someone, then why is it illegal?” she said. “It just doesn't make any sense to me.”

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This story was co-reported by WESA Public Radio and Spotlight PA, an independent, nonpartisan, and nonprofit newsroom producing investigative and public-service journalism that holds power to account and drives positive change in Pennsylvania.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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This story can be republished for free (details).

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By: Ed Mahon, Spotlight PA and Sarah Boden, WESA
Title: Clean Needles Save Lives. In Some States, They Might Not Be Legal.
Sourced From: kffhealthnews.org/news/article/clean-needles-syringe-services-programs-legal-gray-area-risk-pennsylvania/
Published Date: Fri, 17 May 2024 09:00:00 +0000

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Watch: John Oliver Dishes on KFF Health News’ Opioid Settlements Series

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Fri, 17 May 2024 09:00:00 +0000

Opioid manufacturers, distributors, and retailers are paying tens of billions of dollars in restitution to settle lawsuits related to their role in the nation's overdose epidemic. A recent of “Last Tonight With John Oliver” examined how that money is being spent by and local governments across the United States.

The segment from the KFF Health “Payback: Tracking the Opioid Settlement Cash.” You can learn more about the issue and read our collection of articles by Aneri Pattani here.

——————————
Title: Watch: John Oliver Dishes on KFF News' Opioid Settlements Series
Sourced From: kffhealthnews.org/news/article/watch-john-oliver-kff-health-news-payback-opioid-settlements-series/
Published Date: Fri, 17 May 2024 09:00:00 +0000

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