Shefali Luthra

The Trump administration proposed on Oct. 15 that drugmakers reveal the list prices of their medicines in television ads, effectively setting the stage for months or possibly years of battle with the powerful industry.

PhotoDisk

The proposal, released late in the day, would require pharmaceutical companies to include in its television advertising the price of any drug that cost more than $35 a month. The price should be listed at the end of the advertisement in “a legible manner,” the rule states. It goes on to explain that the price should be presented against a contrasting background in a way that is easy to read.

Health and Human Services Secretary Alex M. Azar II, nodding to an industry proposal announced earlier in the day, said voluntary moves are not enough.

“We will not wait for an industry with so many conflicting and perverse incentives to reform itself,” Azar told the audience gathered at the National Academy of Sciences in Washington.

If approved, the proposed rule has no government enforcement mechanism that would force the companies to comply. Rather, it depends on shaming, noting that federal regulators would post a list of companies violating the rule. It would depend on the private sector to police itself with litigation.

“It is noteworthy that the government is unwilling to take enforcement action,” said Rachel Sachs, an associate professor of law at Washington University, St. Louis, and expert in drug-pricing regulation. The rule might never be finalized, she added.

“It will take many months if not years for this regulation to be implemented and free from the cloud of litigation that will follow it. And the administration knows that,” Ms. Sachs said.

Earlier on Oct. 15, the pharmaceutical industry trade group went on the offensive in anticipation of Mr. Azar’s speech by announcing its own plans.

“Putting list prices in isolation in the advertisements themselves would be misleading or confusing,” argued Stephen J. Ubl, CEO of the Pharmaceutical Researchers and Manufacturers of America, or PhRMA, the major trade group for branded drugs.

Instead, Mr. Ubl, whose trade group represents the largest pharmaceutical manufacturers on the globe, promised that pharma companies would direct consumers to websites that include a drug’s list price and estimates of what people can expect to pay, which can vary widely depending on coverage.

Drug manufacturers would voluntarily opt in to this disclosure starting next spring, he said. Mr. Ubl remained strongly critical of the White House proposal.

The Trump administration’s proposal comes weeks before midterm elections in which health care is a top voter concern. Polling from the Kaiser Family Foundation suggests most voters support forcing price transparency in drug advertisements. (Kaiser Health News is an editorially independent program of the foundation.)

The White House’s plan, which was teased in President Trump’s blueprint this summer, has won praise from insurance groups and the American Medical Association.

Sen. Chuck Grassley (R-Iowa) and Sen. Dick Durbin (D-Ill.) also proposed the plan in the Senate last month, but it failed to garner enough support.

Experts pointed out a host of complications, suggesting that neither PhRMA’s approach nor the White House’s would fully explain to consumers what they’ll actually pay for drugs.

On Oct. 15, Sen. Grassley applauded Mr. Azar’s announcement, saying it was a “common-sense way to lower prices.”

But Dale Cooke, a consultant who works with drug companies trying to meet Food and Drug Administration requirements for advertising, warned there is no reason to believe posting prices would help drive down prices.

“No one has ever explained to me why this would work,” Mr. Cooke said. “What’s the mechanism by which this results in lower drug prices?”

Even more, it could be confusing for patients, Mr. Cooke said. The proposed rule seemed to acknowledge this danger, he said, noting, “On the other hand, consumers, intimidated and confused by high list prices, may be deterred from contacting their physicians about drugs or medical conditions.”

A drug’s list price – the metric HHS wants to emphasize – often bears little relationship to what a patient pays at the drugstore. Insurance plans and pharmacy benefit managers often negotiate cheaper prices than the list price. Some patients qualify for other discounts. And often patients pay only what their copay or deductible requires at any given time.

Other consumers could be stuck paying the full cost, depending on how their insurance plan is designed, or if they don’t have coverage.

“The system is very opaque, very complicated, and importantly, there isn’t a huge relationship between list prices for drugs and what patients will expect to pay out-of-pocket,” said Adrienne Faerber, PhD, a lecturer at the Dartmouth Institute for Health Policy and Clinical Practice who researches drug marketing.

But the industry’s strategy, she said, also appeared lacking.

Under PhRMA’s plan, drugmakers would not standardize how they display their information. Where consumers go could vary on Pfizer’s website versus Merck’s to learn about the list price and the range of out-of-pocket costs. That, Ms. Faerber argued, would make it difficult for people to unearth relevant information.

PhRMA also announced it is partnering with patient advocacy groups to create a “patient affordability platform,” which could help patients search for costs and insurance coverage options.

Mr. Ubl cast PhRMA’s proposal as a way to address more effectively the government and public concern about drug price transparency.

Pharmaceutical manufacturers rely heavily on national advertising and together represent the third-highest spender in national television advertising, according to Michael Leszega, a manager of market intelligence at consulting firm Magna.

At certain times of day, pharmaceutical ads make up more than 40 percent of TV advertisements. And those commercials stand out because they are generally longer, with a long list of side effects and warnings the pharmaceutical industry must tag on at the end.

Those disclaimers highlight another challenge for the administration: legal action.

The rule notes its legal justification was based on the responsibility of the Centers for Medicare & Medicaid Services to ensure the health coverage programs that it administers – Medicare and Medicaid – must be operated in a manner that “minimizes reasonable expenditures.”

Sachs noted that the argument may be weak because most drugs are marketed to a wider audience than Medicare and Medicaid beneficiaries.

A body of Supreme Court decisions dictate how disclaimers and disclosures can be required, said constitutional law expert Robert Corn-Revere. He filed a “friend of the court” brief in a 2011 U.S. Supreme Court case related to commercial speech and the pharmaceutical industry.

Generally, the administration’s requirement must meet the standards of being purely factual, noncontroversial, and not burdensome, Mr. Corn-Revere said.
 

On the question of whether requiring drug prices be listed in advertising violates the First Amendment’s free-speech guarantee, Corn-Revere said it “all comes down to the specifics.”

Mr. Ubl, when asked earlier about legal action, didn’t rule out the possibility. “We believe there are substantial statutory and constitutional principles that arise” from requiring list-price disclosure, Mr. Ubl said, adding: “We do have concerns about that approach.”
 

KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation. Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

The Trump administration proposed on Oct. 15 that drugmakers reveal the list prices of their medicines in television ads, effectively setting the stage for months or possibly years of battle with the powerful industry.

PhotoDisk

The proposal, released late in the day, would require pharmaceutical companies to include in its television advertising the price of any drug that cost more than $35 a month. The price should be listed at the end of the advertisement in “a legible manner,” the rule states. It goes on to explain that the price should be presented against a contrasting background in a way that is easy to read.

Health and Human Services Secretary Alex M. Azar II, nodding to an industry proposal announced earlier in the day, said voluntary moves are not enough.

“We will not wait for an industry with so many conflicting and perverse incentives to reform itself,” Azar told the audience gathered at the National Academy of Sciences in Washington.

If approved, the proposed rule has no government enforcement mechanism that would force the companies to comply. Rather, it depends on shaming, noting that federal regulators would post a list of companies violating the rule. It would depend on the private sector to police itself with litigation.

“It is noteworthy that the government is unwilling to take enforcement action,” said Rachel Sachs, an associate professor of law at Washington University, St. Louis, and expert in drug-pricing regulation. The rule might never be finalized, she added.

“It will take many months if not years for this regulation to be implemented and free from the cloud of litigation that will follow it. And the administration knows that,” Ms. Sachs said.

Earlier on Oct. 15, the pharmaceutical industry trade group went on the offensive in anticipation of Mr. Azar’s speech by announcing its own plans.

“Putting list prices in isolation in the advertisements themselves would be misleading or confusing,” argued Stephen J. Ubl, CEO of the Pharmaceutical Researchers and Manufacturers of America, or PhRMA, the major trade group for branded drugs.

Instead, Mr. Ubl, whose trade group represents the largest pharmaceutical manufacturers on the globe, promised that pharma companies would direct consumers to websites that include a drug’s list price and estimates of what people can expect to pay, which can vary widely depending on coverage.

Drug manufacturers would voluntarily opt in to this disclosure starting next spring, he said. Mr. Ubl remained strongly critical of the White House proposal.

The Trump administration’s proposal comes weeks before midterm elections in which health care is a top voter concern. Polling from the Kaiser Family Foundation suggests most voters support forcing price transparency in drug advertisements. (Kaiser Health News is an editorially independent program of the foundation.)

The White House’s plan, which was teased in President Trump’s blueprint this summer, has won praise from insurance groups and the American Medical Association.

Sen. Chuck Grassley (R-Iowa) and Sen. Dick Durbin (D-Ill.) also proposed the plan in the Senate last month, but it failed to garner enough support.

Experts pointed out a host of complications, suggesting that neither PhRMA’s approach nor the White House’s would fully explain to consumers what they’ll actually pay for drugs.

On Oct. 15, Sen. Grassley applauded Mr. Azar’s announcement, saying it was a “common-sense way to lower prices.”

But Dale Cooke, a consultant who works with drug companies trying to meet Food and Drug Administration requirements for advertising, warned there is no reason to believe posting prices would help drive down prices.

“No one has ever explained to me why this would work,” Mr. Cooke said. “What’s the mechanism by which this results in lower drug prices?”

Even more, it could be confusing for patients, Mr. Cooke said. The proposed rule seemed to acknowledge this danger, he said, noting, “On the other hand, consumers, intimidated and confused by high list prices, may be deterred from contacting their physicians about drugs or medical conditions.”

A drug’s list price – the metric HHS wants to emphasize – often bears little relationship to what a patient pays at the drugstore. Insurance plans and pharmacy benefit managers often negotiate cheaper prices than the list price. Some patients qualify for other discounts. And often patients pay only what their copay or deductible requires at any given time.

Other consumers could be stuck paying the full cost, depending on how their insurance plan is designed, or if they don’t have coverage.

“The system is very opaque, very complicated, and importantly, there isn’t a huge relationship between list prices for drugs and what patients will expect to pay out-of-pocket,” said Adrienne Faerber, PhD, a lecturer at the Dartmouth Institute for Health Policy and Clinical Practice who researches drug marketing.

But the industry’s strategy, she said, also appeared lacking.

Under PhRMA’s plan, drugmakers would not standardize how they display their information. Where consumers go could vary on Pfizer’s website versus Merck’s to learn about the list price and the range of out-of-pocket costs. That, Ms. Faerber argued, would make it difficult for people to unearth relevant information.

PhRMA also announced it is partnering with patient advocacy groups to create a “patient affordability platform,” which could help patients search for costs and insurance coverage options.

Mr. Ubl cast PhRMA’s proposal as a way to address more effectively the government and public concern about drug price transparency.

Pharmaceutical manufacturers rely heavily on national advertising and together represent the third-highest spender in national television advertising, according to Michael Leszega, a manager of market intelligence at consulting firm Magna.

At certain times of day, pharmaceutical ads make up more than 40 percent of TV advertisements. And those commercials stand out because they are generally longer, with a long list of side effects and warnings the pharmaceutical industry must tag on at the end.

Those disclaimers highlight another challenge for the administration: legal action.

The rule notes its legal justification was based on the responsibility of the Centers for Medicare & Medicaid Services to ensure the health coverage programs that it administers – Medicare and Medicaid – must be operated in a manner that “minimizes reasonable expenditures.”

Sachs noted that the argument may be weak because most drugs are marketed to a wider audience than Medicare and Medicaid beneficiaries.

A body of Supreme Court decisions dictate how disclaimers and disclosures can be required, said constitutional law expert Robert Corn-Revere. He filed a “friend of the court” brief in a 2011 U.S. Supreme Court case related to commercial speech and the pharmaceutical industry.

Generally, the administration’s requirement must meet the standards of being purely factual, noncontroversial, and not burdensome, Mr. Corn-Revere said.
 

On the question of whether requiring drug prices be listed in advertising violates the First Amendment’s free-speech guarantee, Corn-Revere said it “all comes down to the specifics.”

Mr. Ubl, when asked earlier about legal action, didn’t rule out the possibility. “We believe there are substantial statutory and constitutional principles that arise” from requiring list-price disclosure, Mr. Ubl said, adding: “We do have concerns about that approach.”
 

KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation. Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

The Trump administration proposed on Oct. 15 that drugmakers reveal the list prices of their medicines in television ads, effectively setting the stage for months or possibly years of battle with the powerful industry.

PhotoDisk

The proposal, released late in the day, would require pharmaceutical companies to include in its television advertising the price of any drug that cost more than $35 a month. The price should be listed at the end of the advertisement in “a legible manner,” the rule states. It goes on to explain that the price should be presented against a contrasting background in a way that is easy to read.

Health and Human Services Secretary Alex M. Azar II, nodding to an industry proposal announced earlier in the day, said voluntary moves are not enough.

“We will not wait for an industry with so many conflicting and perverse incentives to reform itself,” Azar told the audience gathered at the National Academy of Sciences in Washington.

If approved, the proposed rule has no government enforcement mechanism that would force the companies to comply. Rather, it depends on shaming, noting that federal regulators would post a list of companies violating the rule. It would depend on the private sector to police itself with litigation.

“It is noteworthy that the government is unwilling to take enforcement action,” said Rachel Sachs, an associate professor of law at Washington University, St. Louis, and expert in drug-pricing regulation. The rule might never be finalized, she added.

“It will take many months if not years for this regulation to be implemented and free from the cloud of litigation that will follow it. And the administration knows that,” Ms. Sachs said.

Earlier on Oct. 15, the pharmaceutical industry trade group went on the offensive in anticipation of Mr. Azar’s speech by announcing its own plans.

“Putting list prices in isolation in the advertisements themselves would be misleading or confusing,” argued Stephen J. Ubl, CEO of the Pharmaceutical Researchers and Manufacturers of America, or PhRMA, the major trade group for branded drugs.

Instead, Mr. Ubl, whose trade group represents the largest pharmaceutical manufacturers on the globe, promised that pharma companies would direct consumers to websites that include a drug’s list price and estimates of what people can expect to pay, which can vary widely depending on coverage.

Drug manufacturers would voluntarily opt in to this disclosure starting next spring, he said. Mr. Ubl remained strongly critical of the White House proposal.

The Trump administration’s proposal comes weeks before midterm elections in which health care is a top voter concern. Polling from the Kaiser Family Foundation suggests most voters support forcing price transparency in drug advertisements. (Kaiser Health News is an editorially independent program of the foundation.)

The White House’s plan, which was teased in President Trump’s blueprint this summer, has won praise from insurance groups and the American Medical Association.

Sen. Chuck Grassley (R-Iowa) and Sen. Dick Durbin (D-Ill.) also proposed the plan in the Senate last month, but it failed to garner enough support.

Experts pointed out a host of complications, suggesting that neither PhRMA’s approach nor the White House’s would fully explain to consumers what they’ll actually pay for drugs.

On Oct. 15, Sen. Grassley applauded Mr. Azar’s announcement, saying it was a “common-sense way to lower prices.”

But Dale Cooke, a consultant who works with drug companies trying to meet Food and Drug Administration requirements for advertising, warned there is no reason to believe posting prices would help drive down prices.

“No one has ever explained to me why this would work,” Mr. Cooke said. “What’s the mechanism by which this results in lower drug prices?”

Even more, it could be confusing for patients, Mr. Cooke said. The proposed rule seemed to acknowledge this danger, he said, noting, “On the other hand, consumers, intimidated and confused by high list prices, may be deterred from contacting their physicians about drugs or medical conditions.”

A drug’s list price – the metric HHS wants to emphasize – often bears little relationship to what a patient pays at the drugstore. Insurance plans and pharmacy benefit managers often negotiate cheaper prices than the list price. Some patients qualify for other discounts. And often patients pay only what their copay or deductible requires at any given time.

Other consumers could be stuck paying the full cost, depending on how their insurance plan is designed, or if they don’t have coverage.

“The system is very opaque, very complicated, and importantly, there isn’t a huge relationship between list prices for drugs and what patients will expect to pay out-of-pocket,” said Adrienne Faerber, PhD, a lecturer at the Dartmouth Institute for Health Policy and Clinical Practice who researches drug marketing.

But the industry’s strategy, she said, also appeared lacking.

Under PhRMA’s plan, drugmakers would not standardize how they display their information. Where consumers go could vary on Pfizer’s website versus Merck’s to learn about the list price and the range of out-of-pocket costs. That, Ms. Faerber argued, would make it difficult for people to unearth relevant information.

PhRMA also announced it is partnering with patient advocacy groups to create a “patient affordability platform,” which could help patients search for costs and insurance coverage options.

Mr. Ubl cast PhRMA’s proposal as a way to address more effectively the government and public concern about drug price transparency.

Pharmaceutical manufacturers rely heavily on national advertising and together represent the third-highest spender in national television advertising, according to Michael Leszega, a manager of market intelligence at consulting firm Magna.

At certain times of day, pharmaceutical ads make up more than 40 percent of TV advertisements. And those commercials stand out because they are generally longer, with a long list of side effects and warnings the pharmaceutical industry must tag on at the end.

Those disclaimers highlight another challenge for the administration: legal action.

The rule notes its legal justification was based on the responsibility of the Centers for Medicare & Medicaid Services to ensure the health coverage programs that it administers – Medicare and Medicaid – must be operated in a manner that “minimizes reasonable expenditures.”

Sachs noted that the argument may be weak because most drugs are marketed to a wider audience than Medicare and Medicaid beneficiaries.

A body of Supreme Court decisions dictate how disclaimers and disclosures can be required, said constitutional law expert Robert Corn-Revere. He filed a “friend of the court” brief in a 2011 U.S. Supreme Court case related to commercial speech and the pharmaceutical industry.

Generally, the administration’s requirement must meet the standards of being purely factual, noncontroversial, and not burdensome, Mr. Corn-Revere said.
 

On the question of whether requiring drug prices be listed in advertising violates the First Amendment’s free-speech guarantee, Corn-Revere said it “all comes down to the specifics.”

Mr. Ubl, when asked earlier about legal action, didn’t rule out the possibility. “We believe there are substantial statutory and constitutional principles that arise” from requiring list-price disclosure, Mr. Ubl said, adding: “We do have concerns about that approach.”
 

KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation. Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

In the drug-pricing battle, progressive lawmakers such as Sen. Bernie Sanders (I-Vt.) and patients’ rights activists rarely find themselves in step with the health industry’s big players.

But in a twist, these usually at-odds actors are championing similar tactics to tame prescription drug prices.

The strategies involve repurposing two obscure and rarely deployed workarounds in patent law that, in different ways, empower the federal government to take back patents and license them to other companies. The first is known as “march-in rights.” The second is generally referred to as Section 1498 because of its location in the U.S. Code.

Sanders has in recent years pointed to these steps as useful tools in the drug-pricing debate.

As an indicator of how high the stakes have become, these ideas also are finding traction among some major health industry players – most notably, two large trade groups that represent health plans and the “middlemen” companies that negotiate drug coverage.

“It used to be the case that everyone played nicely with one another, and now as prices have gone up, the knives have come out,” said Jacob S. Sherkow, a law professor at New York University who focuses on intellectual property and the pharmaceutical industry.

The push for march-in rights gained momentum this past summer, when activists launched a campaign challenging the patent for Truvada (emtricitabine/tenofovir), the HIV treatment by Gilead Sciences that has been shown to reduce the risks of contracting HIV when taken daily as a preventive.

Initially, patient advocates focused mainly on shaming insurance companies into providing better coverage of that pill, also known as pre-exposure prophylaxis, or PrEP, because it is taken before someone is exposed to the virus. But they soon found themselves targeting a frustration that insurance companies happened to share: the drug’s list price.

James Krellenstein, cofounder of the PrEP4All Collaboration, an advocacy group, was part of that campaign. Health plans had put barriers in place to limit access to the drug, he said. But they, too, were worried about Truvada’s escalating price.

“You can’t scale up to a level you need to unless we deal with the pricing problem,” he said.

Now, as insurers signal they might adopt an approach similar to that of the campaign, he voiced skepticism. On the one hand, the support could benefit their cause. At the same time, “they have their interests, and that’s not the interests of public health,” Mr. Krellenstein said.

Still, in Washington, the influence of groups like America’s Health Insurance Plans (AHIP), which is the largest trade association for health insurers, and the Pharmaceutical Care Management Association (PCMA), which represents those middlemen companies known as pharmacy benefit managers (PBMs), could add political credibility to these long-shot ideas.

President Trump has said curbing prescription drug costs is a high priority. But, as congressional action seems increasingly unlikely, these two approaches offer another possible path forward.

They are “already part of a law that is intact. ... An option the administration can take now,” said Walid Gellad, MD, MPH, director of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh.

AHIP says the Department of Health & Human Services should lean on a federal statute that lets the government take over drug patents and grant them to other manufacturers, as long as it adequately compensates the original patent holder.

Meanwhile, PCMA is pressing the administration to use the march-in rights championed by HIV activists. Provided under the 1980 Bayh-Dole Act, they empower the government to rescind a drug’s patent and let other companies develop versions of it. This applies only if government funding helped develop the drug, and it can be invoked only in specific circumstances, including a threat to public health or safety.

“Everybody is feeling the heat, and I think that is the reason you’re seeing this interest in using the tools that exist,” said Amy Kapczynski, a professor at Yale Law School who has written extensively about drug patents.

But opposition is strong among drugmakers.

“Policies should spur competition and new innovations to meet patient needs not disincentivize them such as the use of 1498 and march-in could do,” said Priscilla VanderVeer, a spokeswoman for the Pharmaceutical Researchers and Manufacturers of America, or PhRMA, a trade and lobbying group.

Gilead, which manufactures Truvada, has a similar stance.

“We believe that there is no rationale or precedent for the government to exercise march-in or other [intellectual property] rights related to Truvada for PrEP,” said Ryan McKeel, a spokesman for Gilead. The company’s other efforts to make the drug “available for health and safety needs,” he added, “clearly satisfy” the company’s legal requirements.

And the potential for march-in authority is still theoretical. It has never been used, despite at least five petitions to the National Institutes of Health, three of which cited high drug prices.

Section 1498 was used to negotiate lower drug prices in the 1960s and 1970s, but has since faded. In 2001, during the nation’s anthrax scare, HHS threatened to invoke it to procure more of the antibiotic used to treat the deadly bacterial disease, according to contemporaneous reports. Last year, Louisiana’s health secretary unsuccessfully tried to use it to ease the toll pricey hepatitis C medications exerted on the state’s Medicaid program.

NIH Director Francis Collins, MD, PhD, remains skeptical, repeatedly saying that a drug’s price doesn’t constitute a health or safety concern within the agency’s jurisdiction.

HHS Secretary Alex M. Azar II, speaking at a June Senate hearing, described march-in, also known as “compulsory licensing,” as a “socialist” approach.

But health plans and other payers, increasingly squeezed by fast-climbing prices, are undeterred – touting this kind of intervention as a “market-based solution.”

“The trends of drug prices in this country suggest that we all collectively need to find new approaches – including new approaches that are available under existing law – to try to change this trend,” said Mark Hamelburg, AHIP’s senior vice president of federal programs.

Kaiser Permanente, the health system and insurance provider, called for leveraging Section 1498 in a public comment submitted to HHS about its strategy to bring down drug prices. In a similar filing, Humana, a major insurer, pointed to “existing law [that] allows for actions around patents,” singling out march-in rights.

Humana did not respond to requests for comment. Both PCMA and Kaiser Permanente declined to comment beyond their statements. (Kaiser Health News is not affiliated with Kaiser Permanente.)

Nonetheless, experts say there are serious sticking points.

Neither of these legal provisions would be a sweeping solution. And both require administration buy-in.

“They’re only as effective as the government’s willingness to pursue them,” said Robin Feldman, a law professor at the University of California-Hastings.

Simply taking a patent doesn’t bring down prices, either. There are other ways manufacturers gain favorable market positioning for specific drugs, said Rachel Sachs, an associate law professor at Washington University in St. Louis who tracks drug-pricing laws.

And creating an opening for generics is only one step. Another drugmaker would still need to create a competing product, gain approval, and make it available. Then, theoretically, market competition can kick in.

Finally, there’s no guarantee such savings would benefit consumers, argued Nicholson Price, an assistant professor at the University of Michigan Law School. Insurance plans or PBMs could simply bargain greater discounts on drugs and pocket the money. (AHIP says any savings should be passed on.)

That’s the fundamental question, Mr. Krellenstein said.

“Is this going to be more armor in the fighting [between payers and drug companies]?” he said. “Or is it actually going to be a dramatic reform that actually results in real changes, that actually makes it easier for Americans to access the medications they need?”
 

KHN’s coverage of prescription drug development, costs, and pricing is supported in part by the Laura and John Arnold Foundation. Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

In the drug-pricing battle, progressive lawmakers such as Sen. Bernie Sanders (I-Vt.) and patients’ rights activists rarely find themselves in step with the health industry’s big players.

But in a twist, these usually at-odds actors are championing similar tactics to tame prescription drug prices.

The strategies involve repurposing two obscure and rarely deployed workarounds in patent law that, in different ways, empower the federal government to take back patents and license them to other companies. The first is known as “march-in rights.” The second is generally referred to as Section 1498 because of its location in the U.S. Code.

Sanders has in recent years pointed to these steps as useful tools in the drug-pricing debate.

As an indicator of how high the stakes have become, these ideas also are finding traction among some major health industry players – most notably, two large trade groups that represent health plans and the “middlemen” companies that negotiate drug coverage.

“It used to be the case that everyone played nicely with one another, and now as prices have gone up, the knives have come out,” said Jacob S. Sherkow, a law professor at New York University who focuses on intellectual property and the pharmaceutical industry.

The push for march-in rights gained momentum this past summer, when activists launched a campaign challenging the patent for Truvada (emtricitabine/tenofovir), the HIV treatment by Gilead Sciences that has been shown to reduce the risks of contracting HIV when taken daily as a preventive.

Initially, patient advocates focused mainly on shaming insurance companies into providing better coverage of that pill, also known as pre-exposure prophylaxis, or PrEP, because it is taken before someone is exposed to the virus. But they soon found themselves targeting a frustration that insurance companies happened to share: the drug’s list price.

James Krellenstein, cofounder of the PrEP4All Collaboration, an advocacy group, was part of that campaign. Health plans had put barriers in place to limit access to the drug, he said. But they, too, were worried about Truvada’s escalating price.

“You can’t scale up to a level you need to unless we deal with the pricing problem,” he said.

Now, as insurers signal they might adopt an approach similar to that of the campaign, he voiced skepticism. On the one hand, the support could benefit their cause. At the same time, “they have their interests, and that’s not the interests of public health,” Mr. Krellenstein said.

Still, in Washington, the influence of groups like America’s Health Insurance Plans (AHIP), which is the largest trade association for health insurers, and the Pharmaceutical Care Management Association (PCMA), which represents those middlemen companies known as pharmacy benefit managers (PBMs), could add political credibility to these long-shot ideas.

President Trump has said curbing prescription drug costs is a high priority. But, as congressional action seems increasingly unlikely, these two approaches offer another possible path forward.

They are “already part of a law that is intact. ... An option the administration can take now,” said Walid Gellad, MD, MPH, director of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh.

AHIP says the Department of Health & Human Services should lean on a federal statute that lets the government take over drug patents and grant them to other manufacturers, as long as it adequately compensates the original patent holder.

Meanwhile, PCMA is pressing the administration to use the march-in rights championed by HIV activists. Provided under the 1980 Bayh-Dole Act, they empower the government to rescind a drug’s patent and let other companies develop versions of it. This applies only if government funding helped develop the drug, and it can be invoked only in specific circumstances, including a threat to public health or safety.

“Everybody is feeling the heat, and I think that is the reason you’re seeing this interest in using the tools that exist,” said Amy Kapczynski, a professor at Yale Law School who has written extensively about drug patents.

But opposition is strong among drugmakers.

“Policies should spur competition and new innovations to meet patient needs not disincentivize them such as the use of 1498 and march-in could do,” said Priscilla VanderVeer, a spokeswoman for the Pharmaceutical Researchers and Manufacturers of America, or PhRMA, a trade and lobbying group.

Gilead, which manufactures Truvada, has a similar stance.

“We believe that there is no rationale or precedent for the government to exercise march-in or other [intellectual property] rights related to Truvada for PrEP,” said Ryan McKeel, a spokesman for Gilead. The company’s other efforts to make the drug “available for health and safety needs,” he added, “clearly satisfy” the company’s legal requirements.

And the potential for march-in authority is still theoretical. It has never been used, despite at least five petitions to the National Institutes of Health, three of which cited high drug prices.

Section 1498 was used to negotiate lower drug prices in the 1960s and 1970s, but has since faded. In 2001, during the nation’s anthrax scare, HHS threatened to invoke it to procure more of the antibiotic used to treat the deadly bacterial disease, according to contemporaneous reports. Last year, Louisiana’s health secretary unsuccessfully tried to use it to ease the toll pricey hepatitis C medications exerted on the state’s Medicaid program.

NIH Director Francis Collins, MD, PhD, remains skeptical, repeatedly saying that a drug’s price doesn’t constitute a health or safety concern within the agency’s jurisdiction.

HHS Secretary Alex M. Azar II, speaking at a June Senate hearing, described march-in, also known as “compulsory licensing,” as a “socialist” approach.

But health plans and other payers, increasingly squeezed by fast-climbing prices, are undeterred – touting this kind of intervention as a “market-based solution.”

“The trends of drug prices in this country suggest that we all collectively need to find new approaches – including new approaches that are available under existing law – to try to change this trend,” said Mark Hamelburg, AHIP’s senior vice president of federal programs.

Kaiser Permanente, the health system and insurance provider, called for leveraging Section 1498 in a public comment submitted to HHS about its strategy to bring down drug prices. In a similar filing, Humana, a major insurer, pointed to “existing law [that] allows for actions around patents,” singling out march-in rights.

Humana did not respond to requests for comment. Both PCMA and Kaiser Permanente declined to comment beyond their statements. (Kaiser Health News is not affiliated with Kaiser Permanente.)

Nonetheless, experts say there are serious sticking points.

Neither of these legal provisions would be a sweeping solution. And both require administration buy-in.

“They’re only as effective as the government’s willingness to pursue them,” said Robin Feldman, a law professor at the University of California-Hastings.

Simply taking a patent doesn’t bring down prices, either. There are other ways manufacturers gain favorable market positioning for specific drugs, said Rachel Sachs, an associate law professor at Washington University in St. Louis who tracks drug-pricing laws.

And creating an opening for generics is only one step. Another drugmaker would still need to create a competing product, gain approval, and make it available. Then, theoretically, market competition can kick in.

Finally, there’s no guarantee such savings would benefit consumers, argued Nicholson Price, an assistant professor at the University of Michigan Law School. Insurance plans or PBMs could simply bargain greater discounts on drugs and pocket the money. (AHIP says any savings should be passed on.)

That’s the fundamental question, Mr. Krellenstein said.

“Is this going to be more armor in the fighting [between payers and drug companies]?” he said. “Or is it actually going to be a dramatic reform that actually results in real changes, that actually makes it easier for Americans to access the medications they need?”
 

KHN’s coverage of prescription drug development, costs, and pricing is supported in part by the Laura and John Arnold Foundation. Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

In the drug-pricing battle, progressive lawmakers such as Sen. Bernie Sanders (I-Vt.) and patients’ rights activists rarely find themselves in step with the health industry’s big players.

But in a twist, these usually at-odds actors are championing similar tactics to tame prescription drug prices.

The strategies involve repurposing two obscure and rarely deployed workarounds in patent law that, in different ways, empower the federal government to take back patents and license them to other companies. The first is known as “march-in rights.” The second is generally referred to as Section 1498 because of its location in the U.S. Code.

Sanders has in recent years pointed to these steps as useful tools in the drug-pricing debate.

As an indicator of how high the stakes have become, these ideas also are finding traction among some major health industry players – most notably, two large trade groups that represent health plans and the “middlemen” companies that negotiate drug coverage.

“It used to be the case that everyone played nicely with one another, and now as prices have gone up, the knives have come out,” said Jacob S. Sherkow, a law professor at New York University who focuses on intellectual property and the pharmaceutical industry.

The push for march-in rights gained momentum this past summer, when activists launched a campaign challenging the patent for Truvada (emtricitabine/tenofovir), the HIV treatment by Gilead Sciences that has been shown to reduce the risks of contracting HIV when taken daily as a preventive.

Initially, patient advocates focused mainly on shaming insurance companies into providing better coverage of that pill, also known as pre-exposure prophylaxis, or PrEP, because it is taken before someone is exposed to the virus. But they soon found themselves targeting a frustration that insurance companies happened to share: the drug’s list price.

James Krellenstein, cofounder of the PrEP4All Collaboration, an advocacy group, was part of that campaign. Health plans had put barriers in place to limit access to the drug, he said. But they, too, were worried about Truvada’s escalating price.

“You can’t scale up to a level you need to unless we deal with the pricing problem,” he said.

Now, as insurers signal they might adopt an approach similar to that of the campaign, he voiced skepticism. On the one hand, the support could benefit their cause. At the same time, “they have their interests, and that’s not the interests of public health,” Mr. Krellenstein said.

Still, in Washington, the influence of groups like America’s Health Insurance Plans (AHIP), which is the largest trade association for health insurers, and the Pharmaceutical Care Management Association (PCMA), which represents those middlemen companies known as pharmacy benefit managers (PBMs), could add political credibility to these long-shot ideas.

President Trump has said curbing prescription drug costs is a high priority. But, as congressional action seems increasingly unlikely, these two approaches offer another possible path forward.

They are “already part of a law that is intact. ... An option the administration can take now,” said Walid Gellad, MD, MPH, director of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh.

AHIP says the Department of Health & Human Services should lean on a federal statute that lets the government take over drug patents and grant them to other manufacturers, as long as it adequately compensates the original patent holder.

Meanwhile, PCMA is pressing the administration to use the march-in rights championed by HIV activists. Provided under the 1980 Bayh-Dole Act, they empower the government to rescind a drug’s patent and let other companies develop versions of it. This applies only if government funding helped develop the drug, and it can be invoked only in specific circumstances, including a threat to public health or safety.

“Everybody is feeling the heat, and I think that is the reason you’re seeing this interest in using the tools that exist,” said Amy Kapczynski, a professor at Yale Law School who has written extensively about drug patents.

But opposition is strong among drugmakers.

“Policies should spur competition and new innovations to meet patient needs not disincentivize them such as the use of 1498 and march-in could do,” said Priscilla VanderVeer, a spokeswoman for the Pharmaceutical Researchers and Manufacturers of America, or PhRMA, a trade and lobbying group.

Gilead, which manufactures Truvada, has a similar stance.

“We believe that there is no rationale or precedent for the government to exercise march-in or other [intellectual property] rights related to Truvada for PrEP,” said Ryan McKeel, a spokesman for Gilead. The company’s other efforts to make the drug “available for health and safety needs,” he added, “clearly satisfy” the company’s legal requirements.

And the potential for march-in authority is still theoretical. It has never been used, despite at least five petitions to the National Institutes of Health, three of which cited high drug prices.

Section 1498 was used to negotiate lower drug prices in the 1960s and 1970s, but has since faded. In 2001, during the nation’s anthrax scare, HHS threatened to invoke it to procure more of the antibiotic used to treat the deadly bacterial disease, according to contemporaneous reports. Last year, Louisiana’s health secretary unsuccessfully tried to use it to ease the toll pricey hepatitis C medications exerted on the state’s Medicaid program.

NIH Director Francis Collins, MD, PhD, remains skeptical, repeatedly saying that a drug’s price doesn’t constitute a health or safety concern within the agency’s jurisdiction.

HHS Secretary Alex M. Azar II, speaking at a June Senate hearing, described march-in, also known as “compulsory licensing,” as a “socialist” approach.

But health plans and other payers, increasingly squeezed by fast-climbing prices, are undeterred – touting this kind of intervention as a “market-based solution.”

“The trends of drug prices in this country suggest that we all collectively need to find new approaches – including new approaches that are available under existing law – to try to change this trend,” said Mark Hamelburg, AHIP’s senior vice president of federal programs.

Kaiser Permanente, the health system and insurance provider, called for leveraging Section 1498 in a public comment submitted to HHS about its strategy to bring down drug prices. In a similar filing, Humana, a major insurer, pointed to “existing law [that] allows for actions around patents,” singling out march-in rights.

Humana did not respond to requests for comment. Both PCMA and Kaiser Permanente declined to comment beyond their statements. (Kaiser Health News is not affiliated with Kaiser Permanente.)

Nonetheless, experts say there are serious sticking points.

Neither of these legal provisions would be a sweeping solution. And both require administration buy-in.

“They’re only as effective as the government’s willingness to pursue them,” said Robin Feldman, a law professor at the University of California-Hastings.

Simply taking a patent doesn’t bring down prices, either. There are other ways manufacturers gain favorable market positioning for specific drugs, said Rachel Sachs, an associate law professor at Washington University in St. Louis who tracks drug-pricing laws.

And creating an opening for generics is only one step. Another drugmaker would still need to create a competing product, gain approval, and make it available. Then, theoretically, market competition can kick in.

Finally, there’s no guarantee such savings would benefit consumers, argued Nicholson Price, an assistant professor at the University of Michigan Law School. Insurance plans or PBMs could simply bargain greater discounts on drugs and pocket the money. (AHIP says any savings should be passed on.)

That’s the fundamental question, Mr. Krellenstein said.

“Is this going to be more armor in the fighting [between payers and drug companies]?” he said. “Or is it actually going to be a dramatic reform that actually results in real changes, that actually makes it easier for Americans to access the medications they need?”
 

KHN’s coverage of prescription drug development, costs, and pricing is supported in part by the Laura and John Arnold Foundation. Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

The nation’s opioid epidemic has been called today’s version of the 1980s AIDS crisis.

In a New Hampshire speech on March 19, President Donald Trump pushed for a tougher federal response, emphasizing a tough-on-crime approach for drug dealers and more funding for treatment. And Congress is upping the ante, via a series of hearings – including one scheduled to last March 21-22 – to study legislation that might tackle the unyielding scourge, which has cost an estimated $1 trillion in premature deaths, health care costs, and lost wages since 2001.

Dr. Leana Wen, an emergency physician by training and the health commissioner for hard-hit Baltimore, said Capitol Hill has to help communities at risk of becoming overwhelmed.

“We haven’t seen the peak of the epidemic. We are seeing the numbers climb year after year,” she said.

Provisional data from the Centers for Disease Control and Prevention suggest that almost 45,000 Americans died from opioid overdoses in the 12-month period ending July 2017, up from about 38,000 in the previous cycle. (Those data are likely to change, since many death certificates have not yet been reported to the CDC.)

“It’s not going to get any better unless we take dramatic action,” Dr. Wen said.

And the time for most meaningful change could be dwindling. Advocates say what they need most is money, which would most likely come through the government spending bill that’s due March 23. But they aren’t holding their breath.

Show me the money

The federal budget deal, which was signed into law in early February, promised $6 billion over 2 years for initiatives to fight opioid abuse. Congress is still figuring out how to divvy up those funds. The blueprint is expected to be included in the spending bill this week.

In February, a bipartisan group of senators introduced a bill that would add another $1 billion in funding to support expanded treatment and also limit clinicians to prescribing no more than 3 days’ worth of opioids at a time.

That legislation is likely to have wide support in the Senate, but its path through the House is less certain.

This cash infusion is still not going to be enough, predicted Daniel Raymond, policy director for the Harm Reduction Coalition, a national organization that works on overdose prevention.

“It’s not clear whether there’s a real appetite to go as far as we need to see Congress go,” he said. “To have a fighting chance, we need a long-term commitment of at least $10 billion per year.” Academic experts said that assessment sounded on target.

The figure is more than 3 times what’s allocated in the budget and 10 times what even the new Senate bill would provide, and far beyond the spending levels put forth by any previous packages to fight the opioid epidemic.

The difficulty in getting funding – and a key reason why the bipartisan Senate bill might stall in the House – in part goes to the heart of Republicans’ philosophy about budgeting.

The GOP, which controls both chambers of Congress, has “always been very focused on pay-fors,” said a Republican aide to the House Energy and Commerce Committee, explaining that new funding is generally expected to be accompanied by cuts in current expenditures so that overall government spending doesn’t rise. And that could limit how much money lawmakers are ultimately willing to commit to fight opioid abuse.

Some observers worry this notion is pound-foolish.

“We have an enormous set of costs ahead of us if we don’t invest now,” said Dr. Traci Green, an associate professor of emergency medicine and community health science at Boston University, who has extensively researched the epidemic.

Ahead in Congress

Meanwhile, the House could take up its version of a separate Senate-passed proposal designed to, in certain cases, make more prominent any opioid history in a patient’s medical record. The idea is to prevent doctors from prescribing opioids to at-risk patients.

In addition, the House’s Energy and Commerce Committee in late February held a hearing focused on “enforcement” – discussing, for instance, giving the federal Drug Enforcement Administration more power in drug trafficking, and whether to treat fentanyl, a particularly potent synthetic opioid, as a controlled substance. The hearings March 21-22 will tackle a slew of public health–oriented bills, such as making sure overdose patients in the emergency room get appropriate medication and treatment upon discharge, or expanding access to buprenorphine, which is used to treat addiction.

And the House Ways and Means Committee, which has jurisdiction over Medicare – the federal insurance plan for seniors and disabled people – is working to develop strategies that limit access to opioids and make treatment more available.

These are some promising ideas, Mr. Raymond said, but it’s still “playing catch-up. … The big gap is the money, and the broader vision.”

This flurry of activity comes after Congress in 2016 passed two laws directly dealing with addiction and substance abuse disorders, the Comprehensive Addiction and Recovery Act and the 21st Century Cures Act. CARA promised $181 million – although it didn’t appropriate those dollars – while the Cures Act provided $1 billion over 2 years.

It’s playing out against the backdrop of steady policy tensions.

The Trump administration, which in October declared the opioid epidemic a public health crisis, has repeatedly pushed a more punitive approach, such as harsher sentences for drug trafficking, including the death penalty, and establishing mandatory minimum sentences. That emphasis, experts said, detracts from other parts of the plan that might highlight, say, addiction treatment.

Instead, those experts emphasized treatment and prevention as well as “harm reduction” ideas such as providing more overdose-antidote medication and funding programs like syringe exchanges.

They say focusing on punishment has been ineffective in the past and neglects the heart of the issue.

Certainly, curbing the flow of illegal drugs is important, Dr. Wen said. But it’s insufficient by itself. And the size of the problem means lawmakers need to provide quicker, more direct aid – not just proposals that tinker “around the edges.”

“We would never refuse any funding, because we need it desperately,” she said. “But ask us what we need.”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

The nation’s opioid epidemic has been called today’s version of the 1980s AIDS crisis.

In a New Hampshire speech on March 19, President Donald Trump pushed for a tougher federal response, emphasizing a tough-on-crime approach for drug dealers and more funding for treatment. And Congress is upping the ante, via a series of hearings – including one scheduled to last March 21-22 – to study legislation that might tackle the unyielding scourge, which has cost an estimated $1 trillion in premature deaths, health care costs, and lost wages since 2001.

Dr. Leana Wen, an emergency physician by training and the health commissioner for hard-hit Baltimore, said Capitol Hill has to help communities at risk of becoming overwhelmed.

“We haven’t seen the peak of the epidemic. We are seeing the numbers climb year after year,” she said.

Provisional data from the Centers for Disease Control and Prevention suggest that almost 45,000 Americans died from opioid overdoses in the 12-month period ending July 2017, up from about 38,000 in the previous cycle. (Those data are likely to change, since many death certificates have not yet been reported to the CDC.)

“It’s not going to get any better unless we take dramatic action,” Dr. Wen said.

And the time for most meaningful change could be dwindling. Advocates say what they need most is money, which would most likely come through the government spending bill that’s due March 23. But they aren’t holding their breath.

Show me the money

The federal budget deal, which was signed into law in early February, promised $6 billion over 2 years for initiatives to fight opioid abuse. Congress is still figuring out how to divvy up those funds. The blueprint is expected to be included in the spending bill this week.

In February, a bipartisan group of senators introduced a bill that would add another $1 billion in funding to support expanded treatment and also limit clinicians to prescribing no more than 3 days’ worth of opioids at a time.

That legislation is likely to have wide support in the Senate, but its path through the House is less certain.

This cash infusion is still not going to be enough, predicted Daniel Raymond, policy director for the Harm Reduction Coalition, a national organization that works on overdose prevention.

“It’s not clear whether there’s a real appetite to go as far as we need to see Congress go,” he said. “To have a fighting chance, we need a long-term commitment of at least $10 billion per year.” Academic experts said that assessment sounded on target.

The figure is more than 3 times what’s allocated in the budget and 10 times what even the new Senate bill would provide, and far beyond the spending levels put forth by any previous packages to fight the opioid epidemic.

The difficulty in getting funding – and a key reason why the bipartisan Senate bill might stall in the House – in part goes to the heart of Republicans’ philosophy about budgeting.

The GOP, which controls both chambers of Congress, has “always been very focused on pay-fors,” said a Republican aide to the House Energy and Commerce Committee, explaining that new funding is generally expected to be accompanied by cuts in current expenditures so that overall government spending doesn’t rise. And that could limit how much money lawmakers are ultimately willing to commit to fight opioid abuse.

Some observers worry this notion is pound-foolish.

“We have an enormous set of costs ahead of us if we don’t invest now,” said Dr. Traci Green, an associate professor of emergency medicine and community health science at Boston University, who has extensively researched the epidemic.

Ahead in Congress

Meanwhile, the House could take up its version of a separate Senate-passed proposal designed to, in certain cases, make more prominent any opioid history in a patient’s medical record. The idea is to prevent doctors from prescribing opioids to at-risk patients.

In addition, the House’s Energy and Commerce Committee in late February held a hearing focused on “enforcement” – discussing, for instance, giving the federal Drug Enforcement Administration more power in drug trafficking, and whether to treat fentanyl, a particularly potent synthetic opioid, as a controlled substance. The hearings March 21-22 will tackle a slew of public health–oriented bills, such as making sure overdose patients in the emergency room get appropriate medication and treatment upon discharge, or expanding access to buprenorphine, which is used to treat addiction.

And the House Ways and Means Committee, which has jurisdiction over Medicare – the federal insurance plan for seniors and disabled people – is working to develop strategies that limit access to opioids and make treatment more available.

These are some promising ideas, Mr. Raymond said, but it’s still “playing catch-up. … The big gap is the money, and the broader vision.”

This flurry of activity comes after Congress in 2016 passed two laws directly dealing with addiction and substance abuse disorders, the Comprehensive Addiction and Recovery Act and the 21st Century Cures Act. CARA promised $181 million – although it didn’t appropriate those dollars – while the Cures Act provided $1 billion over 2 years.

It’s playing out against the backdrop of steady policy tensions.

The Trump administration, which in October declared the opioid epidemic a public health crisis, has repeatedly pushed a more punitive approach, such as harsher sentences for drug trafficking, including the death penalty, and establishing mandatory minimum sentences. That emphasis, experts said, detracts from other parts of the plan that might highlight, say, addiction treatment.

Instead, those experts emphasized treatment and prevention as well as “harm reduction” ideas such as providing more overdose-antidote medication and funding programs like syringe exchanges.

They say focusing on punishment has been ineffective in the past and neglects the heart of the issue.

Certainly, curbing the flow of illegal drugs is important, Dr. Wen said. But it’s insufficient by itself. And the size of the problem means lawmakers need to provide quicker, more direct aid – not just proposals that tinker “around the edges.”

“We would never refuse any funding, because we need it desperately,” she said. “But ask us what we need.”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

The nation’s opioid epidemic has been called today’s version of the 1980s AIDS crisis.

In a New Hampshire speech on March 19, President Donald Trump pushed for a tougher federal response, emphasizing a tough-on-crime approach for drug dealers and more funding for treatment. And Congress is upping the ante, via a series of hearings – including one scheduled to last March 21-22 – to study legislation that might tackle the unyielding scourge, which has cost an estimated $1 trillion in premature deaths, health care costs, and lost wages since 2001.

Dr. Leana Wen, an emergency physician by training and the health commissioner for hard-hit Baltimore, said Capitol Hill has to help communities at risk of becoming overwhelmed.

“We haven’t seen the peak of the epidemic. We are seeing the numbers climb year after year,” she said.

Provisional data from the Centers for Disease Control and Prevention suggest that almost 45,000 Americans died from opioid overdoses in the 12-month period ending July 2017, up from about 38,000 in the previous cycle. (Those data are likely to change, since many death certificates have not yet been reported to the CDC.)

“It’s not going to get any better unless we take dramatic action,” Dr. Wen said.

And the time for most meaningful change could be dwindling. Advocates say what they need most is money, which would most likely come through the government spending bill that’s due March 23. But they aren’t holding their breath.

Show me the money

The federal budget deal, which was signed into law in early February, promised $6 billion over 2 years for initiatives to fight opioid abuse. Congress is still figuring out how to divvy up those funds. The blueprint is expected to be included in the spending bill this week.

In February, a bipartisan group of senators introduced a bill that would add another $1 billion in funding to support expanded treatment and also limit clinicians to prescribing no more than 3 days’ worth of opioids at a time.

That legislation is likely to have wide support in the Senate, but its path through the House is less certain.

This cash infusion is still not going to be enough, predicted Daniel Raymond, policy director for the Harm Reduction Coalition, a national organization that works on overdose prevention.

“It’s not clear whether there’s a real appetite to go as far as we need to see Congress go,” he said. “To have a fighting chance, we need a long-term commitment of at least $10 billion per year.” Academic experts said that assessment sounded on target.

The figure is more than 3 times what’s allocated in the budget and 10 times what even the new Senate bill would provide, and far beyond the spending levels put forth by any previous packages to fight the opioid epidemic.

The difficulty in getting funding – and a key reason why the bipartisan Senate bill might stall in the House – in part goes to the heart of Republicans’ philosophy about budgeting.

The GOP, which controls both chambers of Congress, has “always been very focused on pay-fors,” said a Republican aide to the House Energy and Commerce Committee, explaining that new funding is generally expected to be accompanied by cuts in current expenditures so that overall government spending doesn’t rise. And that could limit how much money lawmakers are ultimately willing to commit to fight opioid abuse.

Some observers worry this notion is pound-foolish.

“We have an enormous set of costs ahead of us if we don’t invest now,” said Dr. Traci Green, an associate professor of emergency medicine and community health science at Boston University, who has extensively researched the epidemic.

Ahead in Congress

Meanwhile, the House could take up its version of a separate Senate-passed proposal designed to, in certain cases, make more prominent any opioid history in a patient’s medical record. The idea is to prevent doctors from prescribing opioids to at-risk patients.

In addition, the House’s Energy and Commerce Committee in late February held a hearing focused on “enforcement” – discussing, for instance, giving the federal Drug Enforcement Administration more power in drug trafficking, and whether to treat fentanyl, a particularly potent synthetic opioid, as a controlled substance. The hearings March 21-22 will tackle a slew of public health–oriented bills, such as making sure overdose patients in the emergency room get appropriate medication and treatment upon discharge, or expanding access to buprenorphine, which is used to treat addiction.

And the House Ways and Means Committee, which has jurisdiction over Medicare – the federal insurance plan for seniors and disabled people – is working to develop strategies that limit access to opioids and make treatment more available.

These are some promising ideas, Mr. Raymond said, but it’s still “playing catch-up. … The big gap is the money, and the broader vision.”

This flurry of activity comes after Congress in 2016 passed two laws directly dealing with addiction and substance abuse disorders, the Comprehensive Addiction and Recovery Act and the 21st Century Cures Act. CARA promised $181 million – although it didn’t appropriate those dollars – while the Cures Act provided $1 billion over 2 years.

It’s playing out against the backdrop of steady policy tensions.

The Trump administration, which in October declared the opioid epidemic a public health crisis, has repeatedly pushed a more punitive approach, such as harsher sentences for drug trafficking, including the death penalty, and establishing mandatory minimum sentences. That emphasis, experts said, detracts from other parts of the plan that might highlight, say, addiction treatment.

Instead, those experts emphasized treatment and prevention as well as “harm reduction” ideas such as providing more overdose-antidote medication and funding programs like syringe exchanges.

They say focusing on punishment has been ineffective in the past and neglects the heart of the issue.

Certainly, curbing the flow of illegal drugs is important, Dr. Wen said. But it’s insufficient by itself. And the size of the problem means lawmakers need to provide quicker, more direct aid – not just proposals that tinker “around the edges.”

“We would never refuse any funding, because we need it desperately,” she said. “But ask us what we need.”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

In a rare show of bipartisanship for the mostly polarized 115th Congress, Republican and Democratic Senate leaders announced a 2-year budget deal that would increase federal spending for defense as well as key domestic priorities, including many health programs.

Not in the deal, for which the path to the president’s desk remains unclear, is any bipartisan legislation aimed at shoring up the Affordable Care Act’s individual health insurance marketplaces. Senate Majority Leader Mitch McConnell (R-Ky.) promised Sen. Susan Collins (R-Maine) a vote on health legislation in exchange for her vote for the GOP tax bill in December. So far, that vote has not materialized.

The deal does appear to include almost every other health priority Democrats have been pushing the past several months, including 2 years of renewed funding for community health centers and a series of other health programs Congress failed to provide for before they technically expired last year.

“I believe we have reached a budget deal that neither side loves but both sides can be proud of,” Senate Minority Leader Chuck Schumer (D-N.Y.) said on the Senate floor. “That’s compromise. That’s governing.”

Said McConnell, “This bill represents a significant bipartisan step forward.”

Senate leaders are still negotiating last details of the accord, including the size of a cut to the ACA’s Prevention and Public Health Fund, which would help offset the costs of this legislation.

According to documents circulating on Capitol Hill, the deal includes $6 billion in funding for treatment of mental health issues and opioid addiction, $2 billion in extra funding for the National Institutes of Health, and an additional 4-year extension of the Children’s Health Insurance Program (CHIP), which builds on the 6 years approved by Congress in January.

In the Medicare program, the deal would accelerate the closing of the “doughnut hole” in Medicare drug coverage that requires seniors to pay thousands of dollars out-of-pocket before catastrophic coverage kicks in. It would also repeal the controversial Medicare Independent Payment Advisory Board (IPAB), which is charged with holding down Medicare spending for the federal government if it exceeds a certain level. Members have never been appointed to the board, however, and its use has not so far been triggered by Medicare spending. Both the closure of the doughnut hole and creation of the IPAB were part of the ACA.

The agreement would also fund a host of more limited health programs – some of which are known as “extenders” because they often ride along with other, larger health or spending bills.

Those programs include more than $7 billion in funding for the nation’s federally funded community health centers. The clinics serve 27 million low-income people and saw their funding lapse last fall – a delay advocates said had already complicated budgeting and staffing decisions for many clinics.

And in a victory for the physical therapy industry and patient advocates, the accord would permanently repeal a limit on Medicare’s coverage of physical therapy, speech-language pathology and outpatient treatment. Previously, the program capped coverage after $2,010 worth of occupational therapy and another $2,010 for speech-language therapy and physical therapy combined. But Congress had long taken action to delay those caps or provide exemptions – meaning they had never actually taken effect.

According to an analysis by the nonpartisan Congressional Budget Office, permanently repealing the caps would cost about $6.47 billion over the next decade.

Lawmakers would also forestall cuts mandated by the ACA to reduce the payments made to so-called Disproportionate Share Hospitals, which serve high rates of low-income patients. Those cuts have been delayed continuously since the law’s 2010 passage.

Limited programs are also affected. The deal would fund for 5 years the Maternal, Infant and Early Childhood Home Visiting Program, a program that helps guide low-income, at-risk mothers in parenting. It served about 160,000 families in fiscal year 2016.

“We are relieved that there is a deal for a 5-year reauthorization of MIECHV,” Lori Freeman, CEO of the Association of Maternal & Child Health Programs – an advocacy group – said in an emailed statement. “States, home visitors, and families have been in limbo for the past several months, and this news will bring the stability they need to continue this successful program.”

And the budget deal funds programs that encourage doctors to practice in medically underserved areas, providing just under $500 million over the next 2 years for the National Health Service Corps and another $363 million over 2 years to the Teaching Health Center Graduate Medical Education program, which places medical residents in Community Health Centers.
 

Kaiser Health News correspondent Emmarie Huetteman contributed to this article. KHN’s coverage of these topics is supported by Heising-Simons Foundation and The David and Lucile Packard Foundation. Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

In a rare show of bipartisanship for the mostly polarized 115th Congress, Republican and Democratic Senate leaders announced a 2-year budget deal that would increase federal spending for defense as well as key domestic priorities, including many health programs.

Not in the deal, for which the path to the president’s desk remains unclear, is any bipartisan legislation aimed at shoring up the Affordable Care Act’s individual health insurance marketplaces. Senate Majority Leader Mitch McConnell (R-Ky.) promised Sen. Susan Collins (R-Maine) a vote on health legislation in exchange for her vote for the GOP tax bill in December. So far, that vote has not materialized.

The deal does appear to include almost every other health priority Democrats have been pushing the past several months, including 2 years of renewed funding for community health centers and a series of other health programs Congress failed to provide for before they technically expired last year.

“I believe we have reached a budget deal that neither side loves but both sides can be proud of,” Senate Minority Leader Chuck Schumer (D-N.Y.) said on the Senate floor. “That’s compromise. That’s governing.”

Said McConnell, “This bill represents a significant bipartisan step forward.”

Senate leaders are still negotiating last details of the accord, including the size of a cut to the ACA’s Prevention and Public Health Fund, which would help offset the costs of this legislation.

According to documents circulating on Capitol Hill, the deal includes $6 billion in funding for treatment of mental health issues and opioid addiction, $2 billion in extra funding for the National Institutes of Health, and an additional 4-year extension of the Children’s Health Insurance Program (CHIP), which builds on the 6 years approved by Congress in January.

In the Medicare program, the deal would accelerate the closing of the “doughnut hole” in Medicare drug coverage that requires seniors to pay thousands of dollars out-of-pocket before catastrophic coverage kicks in. It would also repeal the controversial Medicare Independent Payment Advisory Board (IPAB), which is charged with holding down Medicare spending for the federal government if it exceeds a certain level. Members have never been appointed to the board, however, and its use has not so far been triggered by Medicare spending. Both the closure of the doughnut hole and creation of the IPAB were part of the ACA.

The agreement would also fund a host of more limited health programs – some of which are known as “extenders” because they often ride along with other, larger health or spending bills.

Those programs include more than $7 billion in funding for the nation’s federally funded community health centers. The clinics serve 27 million low-income people and saw their funding lapse last fall – a delay advocates said had already complicated budgeting and staffing decisions for many clinics.

And in a victory for the physical therapy industry and patient advocates, the accord would permanently repeal a limit on Medicare’s coverage of physical therapy, speech-language pathology and outpatient treatment. Previously, the program capped coverage after $2,010 worth of occupational therapy and another $2,010 for speech-language therapy and physical therapy combined. But Congress had long taken action to delay those caps or provide exemptions – meaning they had never actually taken effect.

According to an analysis by the nonpartisan Congressional Budget Office, permanently repealing the caps would cost about $6.47 billion over the next decade.

Lawmakers would also forestall cuts mandated by the ACA to reduce the payments made to so-called Disproportionate Share Hospitals, which serve high rates of low-income patients. Those cuts have been delayed continuously since the law’s 2010 passage.

Limited programs are also affected. The deal would fund for 5 years the Maternal, Infant and Early Childhood Home Visiting Program, a program that helps guide low-income, at-risk mothers in parenting. It served about 160,000 families in fiscal year 2016.

“We are relieved that there is a deal for a 5-year reauthorization of MIECHV,” Lori Freeman, CEO of the Association of Maternal & Child Health Programs – an advocacy group – said in an emailed statement. “States, home visitors, and families have been in limbo for the past several months, and this news will bring the stability they need to continue this successful program.”

And the budget deal funds programs that encourage doctors to practice in medically underserved areas, providing just under $500 million over the next 2 years for the National Health Service Corps and another $363 million over 2 years to the Teaching Health Center Graduate Medical Education program, which places medical residents in Community Health Centers.
 

Kaiser Health News correspondent Emmarie Huetteman contributed to this article. KHN’s coverage of these topics is supported by Heising-Simons Foundation and The David and Lucile Packard Foundation. Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

In a rare show of bipartisanship for the mostly polarized 115th Congress, Republican and Democratic Senate leaders announced a 2-year budget deal that would increase federal spending for defense as well as key domestic priorities, including many health programs.

Not in the deal, for which the path to the president’s desk remains unclear, is any bipartisan legislation aimed at shoring up the Affordable Care Act’s individual health insurance marketplaces. Senate Majority Leader Mitch McConnell (R-Ky.) promised Sen. Susan Collins (R-Maine) a vote on health legislation in exchange for her vote for the GOP tax bill in December. So far, that vote has not materialized.

The deal does appear to include almost every other health priority Democrats have been pushing the past several months, including 2 years of renewed funding for community health centers and a series of other health programs Congress failed to provide for before they technically expired last year.

“I believe we have reached a budget deal that neither side loves but both sides can be proud of,” Senate Minority Leader Chuck Schumer (D-N.Y.) said on the Senate floor. “That’s compromise. That’s governing.”

Said McConnell, “This bill represents a significant bipartisan step forward.”

Senate leaders are still negotiating last details of the accord, including the size of a cut to the ACA’s Prevention and Public Health Fund, which would help offset the costs of this legislation.

According to documents circulating on Capitol Hill, the deal includes $6 billion in funding for treatment of mental health issues and opioid addiction, $2 billion in extra funding for the National Institutes of Health, and an additional 4-year extension of the Children’s Health Insurance Program (CHIP), which builds on the 6 years approved by Congress in January.

In the Medicare program, the deal would accelerate the closing of the “doughnut hole” in Medicare drug coverage that requires seniors to pay thousands of dollars out-of-pocket before catastrophic coverage kicks in. It would also repeal the controversial Medicare Independent Payment Advisory Board (IPAB), which is charged with holding down Medicare spending for the federal government if it exceeds a certain level. Members have never been appointed to the board, however, and its use has not so far been triggered by Medicare spending. Both the closure of the doughnut hole and creation of the IPAB were part of the ACA.

The agreement would also fund a host of more limited health programs – some of which are known as “extenders” because they often ride along with other, larger health or spending bills.

Those programs include more than $7 billion in funding for the nation’s federally funded community health centers. The clinics serve 27 million low-income people and saw their funding lapse last fall – a delay advocates said had already complicated budgeting and staffing decisions for many clinics.

And in a victory for the physical therapy industry and patient advocates, the accord would permanently repeal a limit on Medicare’s coverage of physical therapy, speech-language pathology and outpatient treatment. Previously, the program capped coverage after $2,010 worth of occupational therapy and another $2,010 for speech-language therapy and physical therapy combined. But Congress had long taken action to delay those caps or provide exemptions – meaning they had never actually taken effect.

According to an analysis by the nonpartisan Congressional Budget Office, permanently repealing the caps would cost about $6.47 billion over the next decade.

Lawmakers would also forestall cuts mandated by the ACA to reduce the payments made to so-called Disproportionate Share Hospitals, which serve high rates of low-income patients. Those cuts have been delayed continuously since the law’s 2010 passage.

Limited programs are also affected. The deal would fund for 5 years the Maternal, Infant and Early Childhood Home Visiting Program, a program that helps guide low-income, at-risk mothers in parenting. It served about 160,000 families in fiscal year 2016.

“We are relieved that there is a deal for a 5-year reauthorization of MIECHV,” Lori Freeman, CEO of the Association of Maternal & Child Health Programs – an advocacy group – said in an emailed statement. “States, home visitors, and families have been in limbo for the past several months, and this news will bring the stability they need to continue this successful program.”

And the budget deal funds programs that encourage doctors to practice in medically underserved areas, providing just under $500 million over the next 2 years for the National Health Service Corps and another $363 million over 2 years to the Teaching Health Center Graduate Medical Education program, which places medical residents in Community Health Centers.
 

Kaiser Health News correspondent Emmarie Huetteman contributed to this article. KHN’s coverage of these topics is supported by Heising-Simons Foundation and The David and Lucile Packard Foundation. Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Every November, like clockwork, she gets the same letter, said Lindsay Irvin, MD, a pediatrician in San Antonio.

It’s from the drug company Pfizer, and it informs her that the price tag for the pneumococcal vaccine Prevnar 13 is going up. Again.

And it makes her angry.

“They’re the only ones who make it,” she said. “It’s like buying gas in a hurricane – or Coke in an airport. They charge what they want to.”

The Advisory Committee on Immunization Practices (ACIP) recommends Prevnar 13 for all children younger than 2 years – given at 2, 4, 6, and 15 months – as well as for adults aged 65 years and older.

The vaccine’s formulation has remained mostly unchanged since its 2010 federal approval, but its price continues creeping up, increasing by about 5%-6% most years. In just 8 years, its cost has climbed by more than 50%.

It is among the most expensive vaccines Dr. Irvin provides her young patients.

Doctors and clinics purchase the vaccine and then, once they inject patients, they typically recoup the cost through patients’ insurance coverage. In most cases there are no out-of-pocket costs.

But the steady rise in prices for branded drugs contributes indirectly to rises in premiums, deductibles, and government health spending, analysts say.

A full pediatric course of the vaccine typically involves four shots. In 2010, a single shot cost about $109, according to pricing archives kept by the CDC. It currently costs about $170, according to those archives. Next year, Pfizer says, a shot will cost almost $180.

“Pfizer and other drug companies are raising their prices because they can,” said Gerard Anderson, PhD, a health policy professor at Johns Hopkins University who studies drug pricing. “They have a patent, and they have a CDC recommendation, which is a double whammy – and a strong incentive for price increases.”

The company disagrees – arguing vaccine pricing supports research for new immunizations, along with ongoing efforts to keep products safe and to improve effectiveness. For instance, Prevnar 13’s shelf life was extended from 2 years to 3 years this year. Pricing also doesn’t affect access.

“Thanks to comprehensive health authority guidelines, Prevnar 13 is one of the most widely available public health interventions, supported by broad insurance coverage and innovative federal programs that guarantee access to vulnerable populations,” Pfizer spokeswoman Sally Beatty said in an interview.

But such arguments don’t justify the pattern of “consistent price increases,” suggested Ameet Sarpatwari, PhD, an epidemiologist and lawyer at Harvard Medical School, Boston, who studies drug policy.

“Does that explain what’s going on? Probably not,” he said. “The onus should be on them to show us why this is needed.”

Consumers are not likely to feel a pinch from these increases directly. The Affordable Care Act requires that ACIP-recommended vaccines are covered by insurance, with no cost sharing.

There are other implications, though.

Higher vaccine prices make it harder for physicians to stock up, noted Michael Munger, MD, a family physician in Overland Park, Kan., and president of the American Academy of Family Physicians.

They have to buy immunizations in advance to provide them for patients. Insurance will eventually reimburse them – typically at cost – but it can take months for that to come through, which is an especially tough proposition for small practices on tight budgets.

“You’ve got to keep track of your inventory, and make sure you don’t have any waste, and are going to get adequate reimbursement,” he said. “The cost of vaccines is definitely something in primary care we worry about, because we’re on thin margins. ... You don’t want to provide a service you lose money on, even if it’s as important as immunization.”

Gardasil, a human papillomavirus vaccine, has also seen its price climbing. And, in a similar response, ob.gyns. are providing it in smaller numbers.

A vaccine like Prevnar 13 is harder to make than older vaccines that are much cheaper, said William Moss, MD, a professor at Johns Hopkins Bloomberg School of Public Health, Baltimore, who specializes in vaccines and global children’s health. It provides immunization for 13 different variations of pneumococcal infection. That makes it a more effective vaccine, but also one that requires greater investment.

Critics, however, note that those investments were made by another company, Wyeth Pharmaceuticals. Pfizer bought Wyeth in 2009, along with the rights to the vaccine.
 

KHN’s coverage of prescription drug development, costs, and pricing is supported by the Laura and John Arnold Foundation. Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Every November, like clockwork, she gets the same letter, said Lindsay Irvin, MD, a pediatrician in San Antonio.

It’s from the drug company Pfizer, and it informs her that the price tag for the pneumococcal vaccine Prevnar 13 is going up. Again.

And it makes her angry.

“They’re the only ones who make it,” she said. “It’s like buying gas in a hurricane – or Coke in an airport. They charge what they want to.”

The Advisory Committee on Immunization Practices (ACIP) recommends Prevnar 13 for all children younger than 2 years – given at 2, 4, 6, and 15 months – as well as for adults aged 65 years and older.

The vaccine’s formulation has remained mostly unchanged since its 2010 federal approval, but its price continues creeping up, increasing by about 5%-6% most years. In just 8 years, its cost has climbed by more than 50%.

It is among the most expensive vaccines Dr. Irvin provides her young patients.

Doctors and clinics purchase the vaccine and then, once they inject patients, they typically recoup the cost through patients’ insurance coverage. In most cases there are no out-of-pocket costs.

But the steady rise in prices for branded drugs contributes indirectly to rises in premiums, deductibles, and government health spending, analysts say.

A full pediatric course of the vaccine typically involves four shots. In 2010, a single shot cost about $109, according to pricing archives kept by the CDC. It currently costs about $170, according to those archives. Next year, Pfizer says, a shot will cost almost $180.

“Pfizer and other drug companies are raising their prices because they can,” said Gerard Anderson, PhD, a health policy professor at Johns Hopkins University who studies drug pricing. “They have a patent, and they have a CDC recommendation, which is a double whammy – and a strong incentive for price increases.”

The company disagrees – arguing vaccine pricing supports research for new immunizations, along with ongoing efforts to keep products safe and to improve effectiveness. For instance, Prevnar 13’s shelf life was extended from 2 years to 3 years this year. Pricing also doesn’t affect access.

“Thanks to comprehensive health authority guidelines, Prevnar 13 is one of the most widely available public health interventions, supported by broad insurance coverage and innovative federal programs that guarantee access to vulnerable populations,” Pfizer spokeswoman Sally Beatty said in an interview.

But such arguments don’t justify the pattern of “consistent price increases,” suggested Ameet Sarpatwari, PhD, an epidemiologist and lawyer at Harvard Medical School, Boston, who studies drug policy.

“Does that explain what’s going on? Probably not,” he said. “The onus should be on them to show us why this is needed.”

Consumers are not likely to feel a pinch from these increases directly. The Affordable Care Act requires that ACIP-recommended vaccines are covered by insurance, with no cost sharing.

There are other implications, though.

Higher vaccine prices make it harder for physicians to stock up, noted Michael Munger, MD, a family physician in Overland Park, Kan., and president of the American Academy of Family Physicians.

They have to buy immunizations in advance to provide them for patients. Insurance will eventually reimburse them – typically at cost – but it can take months for that to come through, which is an especially tough proposition for small practices on tight budgets.

“You’ve got to keep track of your inventory, and make sure you don’t have any waste, and are going to get adequate reimbursement,” he said. “The cost of vaccines is definitely something in primary care we worry about, because we’re on thin margins. ... You don’t want to provide a service you lose money on, even if it’s as important as immunization.”

Gardasil, a human papillomavirus vaccine, has also seen its price climbing. And, in a similar response, ob.gyns. are providing it in smaller numbers.

A vaccine like Prevnar 13 is harder to make than older vaccines that are much cheaper, said William Moss, MD, a professor at Johns Hopkins Bloomberg School of Public Health, Baltimore, who specializes in vaccines and global children’s health. It provides immunization for 13 different variations of pneumococcal infection. That makes it a more effective vaccine, but also one that requires greater investment.

Critics, however, note that those investments were made by another company, Wyeth Pharmaceuticals. Pfizer bought Wyeth in 2009, along with the rights to the vaccine.
 

KHN’s coverage of prescription drug development, costs, and pricing is supported by the Laura and John Arnold Foundation. Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Every November, like clockwork, she gets the same letter, said Lindsay Irvin, MD, a pediatrician in San Antonio.

It’s from the drug company Pfizer, and it informs her that the price tag for the pneumococcal vaccine Prevnar 13 is going up. Again.

And it makes her angry.

“They’re the only ones who make it,” she said. “It’s like buying gas in a hurricane – or Coke in an airport. They charge what they want to.”

The Advisory Committee on Immunization Practices (ACIP) recommends Prevnar 13 for all children younger than 2 years – given at 2, 4, 6, and 15 months – as well as for adults aged 65 years and older.

The vaccine’s formulation has remained mostly unchanged since its 2010 federal approval, but its price continues creeping up, increasing by about 5%-6% most years. In just 8 years, its cost has climbed by more than 50%.

It is among the most expensive vaccines Dr. Irvin provides her young patients.

Doctors and clinics purchase the vaccine and then, once they inject patients, they typically recoup the cost through patients’ insurance coverage. In most cases there are no out-of-pocket costs.

But the steady rise in prices for branded drugs contributes indirectly to rises in premiums, deductibles, and government health spending, analysts say.

A full pediatric course of the vaccine typically involves four shots. In 2010, a single shot cost about $109, according to pricing archives kept by the CDC. It currently costs about $170, according to those archives. Next year, Pfizer says, a shot will cost almost $180.

“Pfizer and other drug companies are raising their prices because they can,” said Gerard Anderson, PhD, a health policy professor at Johns Hopkins University who studies drug pricing. “They have a patent, and they have a CDC recommendation, which is a double whammy – and a strong incentive for price increases.”

The company disagrees – arguing vaccine pricing supports research for new immunizations, along with ongoing efforts to keep products safe and to improve effectiveness. For instance, Prevnar 13’s shelf life was extended from 2 years to 3 years this year. Pricing also doesn’t affect access.

“Thanks to comprehensive health authority guidelines, Prevnar 13 is one of the most widely available public health interventions, supported by broad insurance coverage and innovative federal programs that guarantee access to vulnerable populations,” Pfizer spokeswoman Sally Beatty said in an interview.

But such arguments don’t justify the pattern of “consistent price increases,” suggested Ameet Sarpatwari, PhD, an epidemiologist and lawyer at Harvard Medical School, Boston, who studies drug policy.

“Does that explain what’s going on? Probably not,” he said. “The onus should be on them to show us why this is needed.”

Consumers are not likely to feel a pinch from these increases directly. The Affordable Care Act requires that ACIP-recommended vaccines are covered by insurance, with no cost sharing.

There are other implications, though.

Higher vaccine prices make it harder for physicians to stock up, noted Michael Munger, MD, a family physician in Overland Park, Kan., and president of the American Academy of Family Physicians.

They have to buy immunizations in advance to provide them for patients. Insurance will eventually reimburse them – typically at cost – but it can take months for that to come through, which is an especially tough proposition for small practices on tight budgets.

“You’ve got to keep track of your inventory, and make sure you don’t have any waste, and are going to get adequate reimbursement,” he said. “The cost of vaccines is definitely something in primary care we worry about, because we’re on thin margins. ... You don’t want to provide a service you lose money on, even if it’s as important as immunization.”

Gardasil, a human papillomavirus vaccine, has also seen its price climbing. And, in a similar response, ob.gyns. are providing it in smaller numbers.

A vaccine like Prevnar 13 is harder to make than older vaccines that are much cheaper, said William Moss, MD, a professor at Johns Hopkins Bloomberg School of Public Health, Baltimore, who specializes in vaccines and global children’s health. It provides immunization for 13 different variations of pneumococcal infection. That makes it a more effective vaccine, but also one that requires greater investment.

Critics, however, note that those investments were made by another company, Wyeth Pharmaceuticals. Pfizer bought Wyeth in 2009, along with the rights to the vaccine.
 

KHN’s coverage of prescription drug development, costs, and pricing is supported by the Laura and John Arnold Foundation. Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Four years ago, when meningitis B, an extremely rare but potentially lethal form of the infection, sickened a small number of college students at Princeton and the University of California–Santa Barbara, there was no vaccine against the disease sold in the U.S. Despite its availability abroad, it had never been licensed in the country due to its limited marketability.

Scientific evidence supporting an absolute need to immunize against meningitis B still falls short. The risk of contracting it is smaller than that of being involved in a car crash.

But the headlines prompted by those 13 campus cases – which resulted in one death and one double amputation – helped reshape the financial prospects for a vaccine.

Today, two brand-name vaccines, both with price tags of more than $300, are widely advertised on television and touted as a smart investment for parents who love their college-bound kids.

“As moms, we send our kids out into the world, full of hope,” says a mother in the ad for Bexsero, sold by pharmaceutical giant GlaxoSmithKline, as her son loads up the car to go off to college.

Says another voice, “And we don’t want something like meningitis B getting in their way.”

Courtesy CDC

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Four years ago, when meningitis B, an extremely rare but potentially lethal form of the infection, sickened a small number of college students at Princeton and the University of California–Santa Barbara, there was no vaccine against the disease sold in the U.S. Despite its availability abroad, it had never been licensed in the country due to its limited marketability.

Scientific evidence supporting an absolute need to immunize against meningitis B still falls short. The risk of contracting it is smaller than that of being involved in a car crash.

But the headlines prompted by those 13 campus cases – which resulted in one death and one double amputation – helped reshape the financial prospects for a vaccine.

Today, two brand-name vaccines, both with price tags of more than $300, are widely advertised on television and touted as a smart investment for parents who love their college-bound kids.

“As moms, we send our kids out into the world, full of hope,” says a mother in the ad for Bexsero, sold by pharmaceutical giant GlaxoSmithKline, as her son loads up the car to go off to college.

Says another voice, “And we don’t want something like meningitis B getting in their way.”

Courtesy CDC

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Four years ago, when meningitis B, an extremely rare but potentially lethal form of the infection, sickened a small number of college students at Princeton and the University of California–Santa Barbara, there was no vaccine against the disease sold in the U.S. Despite its availability abroad, it had never been licensed in the country due to its limited marketability.

Scientific evidence supporting an absolute need to immunize against meningitis B still falls short. The risk of contracting it is smaller than that of being involved in a car crash.

But the headlines prompted by those 13 campus cases – which resulted in one death and one double amputation – helped reshape the financial prospects for a vaccine.

Today, two brand-name vaccines, both with price tags of more than $300, are widely advertised on television and touted as a smart investment for parents who love their college-bound kids.

“As moms, we send our kids out into the world, full of hope,” says a mother in the ad for Bexsero, sold by pharmaceutical giant GlaxoSmithKline, as her son loads up the car to go off to college.

Says another voice, “And we don’t want something like meningitis B getting in their way.”

Courtesy CDC

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Although the GOP-controlled Congress is pledging its continued interest – despite stalls and snags – in dismantling Obamacare, some “red state” legislatures are changing course and showing a newfound interest in embracing the health law’s Medicaid expansion.

And a study published April 12 in Health Affairs adds to these discussions, percolating in places such as Kansas, Georgia, Virginia, North Carolina, and Maine. Thirty-one states plus the District of Columbia already opted to pursue the expansion, which provided federal funding to broaden eligibility to include most low-income adults with incomes up to 138 percent of the federal poverty level (about $16,000 for an individual).

Researchers analyzed data from the National Association of State Budget Officers for fiscal years 2010-2015 to assess the fiscal effects of expansion’s first 2 years.

Their findings address arguments put forth by some GOP lawmakers, who say the expansion will add to the nation’s budget deficit and saddle states with additional coverage costs, forcing them to skimp on other budget priorities like education or transportation.

The researchers concluded that when states expanded eligibility for the low-income health insurance program they did see larger health care expenditures – but those costs were covered with federal funding. In addition, expansion states didn’t have to skimp on other policy priorities – such as environment, housing, and other public health initiatives – to make ends meet.

“This is a potential big benefit, not only to people who get coverage, but to state economies,” said Benjamin Sommers, MD, PhD, an associate professor of health policy and economics at Harvard University’s public health school, and the study’s first author.

This finding – that states expanding Medicaid didn’t encounter unforeseen budget problems – shouldn’t be surprising.

“Expansion is basically free” to the states, agreed Massachusetts Institute of Technology economist Jonathan Gruber, PhD, one of Obamacare’s architects who worked with Dr. Sommers to systematically compare the budgets of all 50 states to examine Medicaid expansion’s impact. “That’s the big insight,” he said. “There’s no sort of hidden downside.”

And that may be part of what’s fueling this renewed interest, said Edwin Park, vice president for health policy at the left-leaning Center for Budget and Policy Priorities. These states are seeing the federal windfall their neighbors received while trying to navigate public health concerns like opioid addiction, he said. They “are looking at how their neighbors or expansion states have done and see the benefits,” Mr. Park said. “The primary argument against the expansion on the state level has been it’s going to break the bank. The research demonstrates that’s not the case.”

But a caveat: The data used in this analysis reflected only years during which the federal government picked up 100% of the tab for expanding Medicaid eligibility and therefore could overestimate the benefit to state budgets. That’s because in 2017 that federal support begins to taper off, and by 2020 states have to pay 10 percent of the expansion costs themselves.

That means policymakers should exert caution in reading too much into this study, said Tom Miller, a resident fellow at the conservative American Enterprise Institute. Because states will eventually shoulder more of the cost, he said, studies that assess its budgetary impact are preliminary at best. Plus, Miller said, other factors such as relative economic growth could have padded state budgets in the years studied – masking any unintended costs with a bigger Medicaid program. It’s unclear whether in times of downturn Medicaid would take a bigger bite out of state budgets.

“It’s just the beginning of this – it’s an early snapshot,” he said.

Dr. Sommers argued the limited data set means researchers should continue to track how state budgets compare between expansion and nonexpansion states. But even when states do take on more of Medicaid’s cost, that may not pose such a burden, suggested Sara Rosenbaum, a professor of health law and policy at George Washington University. Expanding Medicaid brings in other potential economic benefits that this paper doesn’t account for – less uncompensated care in hospitals, for instance – that could offset the expenditures states ultimately take up.

A bigger concern, some experts say, is that – even without the Obamacare repeal – some GOP health proposals would change the federal government’s Medicaid funding mechanism from being an open-ended match to a block grant or per-capita cap in an effort to curb national spending. Those proposals would take away at least some of the federal dollars that have insulated state budgets.

“Ironically, all the arguments that have been made against expansion for years – like creating a hole in the state budget or breaking the bank – that’s exactly what a per-capita grant or block grant does,” Park said.

As more states take on the Medicaid debate, those consequences matter, both Dr. Sommers and Dr. Gruber said. And not just for state budgets – for consumers, too.

“The main lesson is there’s no sort of big hidden cost of expanding Medicaid. What you see is what you get,” Dr. Gruber said. “You get free health insurance for your citizens.”
 

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Although the GOP-controlled Congress is pledging its continued interest – despite stalls and snags – in dismantling Obamacare, some “red state” legislatures are changing course and showing a newfound interest in embracing the health law’s Medicaid expansion.

And a study published April 12 in Health Affairs adds to these discussions, percolating in places such as Kansas, Georgia, Virginia, North Carolina, and Maine. Thirty-one states plus the District of Columbia already opted to pursue the expansion, which provided federal funding to broaden eligibility to include most low-income adults with incomes up to 138 percent of the federal poverty level (about $16,000 for an individual).

Researchers analyzed data from the National Association of State Budget Officers for fiscal years 2010-2015 to assess the fiscal effects of expansion’s first 2 years.

Their findings address arguments put forth by some GOP lawmakers, who say the expansion will add to the nation’s budget deficit and saddle states with additional coverage costs, forcing them to skimp on other budget priorities like education or transportation.

The researchers concluded that when states expanded eligibility for the low-income health insurance program they did see larger health care expenditures – but those costs were covered with federal funding. In addition, expansion states didn’t have to skimp on other policy priorities – such as environment, housing, and other public health initiatives – to make ends meet.

“This is a potential big benefit, not only to people who get coverage, but to state economies,” said Benjamin Sommers, MD, PhD, an associate professor of health policy and economics at Harvard University’s public health school, and the study’s first author.

This finding – that states expanding Medicaid didn’t encounter unforeseen budget problems – shouldn’t be surprising.

“Expansion is basically free” to the states, agreed Massachusetts Institute of Technology economist Jonathan Gruber, PhD, one of Obamacare’s architects who worked with Dr. Sommers to systematically compare the budgets of all 50 states to examine Medicaid expansion’s impact. “That’s the big insight,” he said. “There’s no sort of hidden downside.”

And that may be part of what’s fueling this renewed interest, said Edwin Park, vice president for health policy at the left-leaning Center for Budget and Policy Priorities. These states are seeing the federal windfall their neighbors received while trying to navigate public health concerns like opioid addiction, he said. They “are looking at how their neighbors or expansion states have done and see the benefits,” Mr. Park said. “The primary argument against the expansion on the state level has been it’s going to break the bank. The research demonstrates that’s not the case.”

But a caveat: The data used in this analysis reflected only years during which the federal government picked up 100% of the tab for expanding Medicaid eligibility and therefore could overestimate the benefit to state budgets. That’s because in 2017 that federal support begins to taper off, and by 2020 states have to pay 10 percent of the expansion costs themselves.

That means policymakers should exert caution in reading too much into this study, said Tom Miller, a resident fellow at the conservative American Enterprise Institute. Because states will eventually shoulder more of the cost, he said, studies that assess its budgetary impact are preliminary at best. Plus, Miller said, other factors such as relative economic growth could have padded state budgets in the years studied – masking any unintended costs with a bigger Medicaid program. It’s unclear whether in times of downturn Medicaid would take a bigger bite out of state budgets.

“It’s just the beginning of this – it’s an early snapshot,” he said.

Dr. Sommers argued the limited data set means researchers should continue to track how state budgets compare between expansion and nonexpansion states. But even when states do take on more of Medicaid’s cost, that may not pose such a burden, suggested Sara Rosenbaum, a professor of health law and policy at George Washington University. Expanding Medicaid brings in other potential economic benefits that this paper doesn’t account for – less uncompensated care in hospitals, for instance – that could offset the expenditures states ultimately take up.

A bigger concern, some experts say, is that – even without the Obamacare repeal – some GOP health proposals would change the federal government’s Medicaid funding mechanism from being an open-ended match to a block grant or per-capita cap in an effort to curb national spending. Those proposals would take away at least some of the federal dollars that have insulated state budgets.

“Ironically, all the arguments that have been made against expansion for years – like creating a hole in the state budget or breaking the bank – that’s exactly what a per-capita grant or block grant does,” Park said.

As more states take on the Medicaid debate, those consequences matter, both Dr. Sommers and Dr. Gruber said. And not just for state budgets – for consumers, too.

“The main lesson is there’s no sort of big hidden cost of expanding Medicaid. What you see is what you get,” Dr. Gruber said. “You get free health insurance for your citizens.”
 

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Although the GOP-controlled Congress is pledging its continued interest – despite stalls and snags – in dismantling Obamacare, some “red state” legislatures are changing course and showing a newfound interest in embracing the health law’s Medicaid expansion.

And a study published April 12 in Health Affairs adds to these discussions, percolating in places such as Kansas, Georgia, Virginia, North Carolina, and Maine. Thirty-one states plus the District of Columbia already opted to pursue the expansion, which provided federal funding to broaden eligibility to include most low-income adults with incomes up to 138 percent of the federal poverty level (about $16,000 for an individual).

Researchers analyzed data from the National Association of State Budget Officers for fiscal years 2010-2015 to assess the fiscal effects of expansion’s first 2 years.

Their findings address arguments put forth by some GOP lawmakers, who say the expansion will add to the nation’s budget deficit and saddle states with additional coverage costs, forcing them to skimp on other budget priorities like education or transportation.

The researchers concluded that when states expanded eligibility for the low-income health insurance program they did see larger health care expenditures – but those costs were covered with federal funding. In addition, expansion states didn’t have to skimp on other policy priorities – such as environment, housing, and other public health initiatives – to make ends meet.

“This is a potential big benefit, not only to people who get coverage, but to state economies,” said Benjamin Sommers, MD, PhD, an associate professor of health policy and economics at Harvard University’s public health school, and the study’s first author.

This finding – that states expanding Medicaid didn’t encounter unforeseen budget problems – shouldn’t be surprising.

“Expansion is basically free” to the states, agreed Massachusetts Institute of Technology economist Jonathan Gruber, PhD, one of Obamacare’s architects who worked with Dr. Sommers to systematically compare the budgets of all 50 states to examine Medicaid expansion’s impact. “That’s the big insight,” he said. “There’s no sort of hidden downside.”

And that may be part of what’s fueling this renewed interest, said Edwin Park, vice president for health policy at the left-leaning Center for Budget and Policy Priorities. These states are seeing the federal windfall their neighbors received while trying to navigate public health concerns like opioid addiction, he said. They “are looking at how their neighbors or expansion states have done and see the benefits,” Mr. Park said. “The primary argument against the expansion on the state level has been it’s going to break the bank. The research demonstrates that’s not the case.”

But a caveat: The data used in this analysis reflected only years during which the federal government picked up 100% of the tab for expanding Medicaid eligibility and therefore could overestimate the benefit to state budgets. That’s because in 2017 that federal support begins to taper off, and by 2020 states have to pay 10 percent of the expansion costs themselves.

That means policymakers should exert caution in reading too much into this study, said Tom Miller, a resident fellow at the conservative American Enterprise Institute. Because states will eventually shoulder more of the cost, he said, studies that assess its budgetary impact are preliminary at best. Plus, Miller said, other factors such as relative economic growth could have padded state budgets in the years studied – masking any unintended costs with a bigger Medicaid program. It’s unclear whether in times of downturn Medicaid would take a bigger bite out of state budgets.

“It’s just the beginning of this – it’s an early snapshot,” he said.

Dr. Sommers argued the limited data set means researchers should continue to track how state budgets compare between expansion and nonexpansion states. But even when states do take on more of Medicaid’s cost, that may not pose such a burden, suggested Sara Rosenbaum, a professor of health law and policy at George Washington University. Expanding Medicaid brings in other potential economic benefits that this paper doesn’t account for – less uncompensated care in hospitals, for instance – that could offset the expenditures states ultimately take up.

A bigger concern, some experts say, is that – even without the Obamacare repeal – some GOP health proposals would change the federal government’s Medicaid funding mechanism from being an open-ended match to a block grant or per-capita cap in an effort to curb national spending. Those proposals would take away at least some of the federal dollars that have insulated state budgets.

“Ironically, all the arguments that have been made against expansion for years – like creating a hole in the state budget or breaking the bank – that’s exactly what a per-capita grant or block grant does,” Park said.

As more states take on the Medicaid debate, those consequences matter, both Dr. Sommers and Dr. Gruber said. And not just for state budgets – for consumers, too.

“The main lesson is there’s no sort of big hidden cost of expanding Medicaid. What you see is what you get,” Dr. Gruber said. “You get free health insurance for your citizens.”
 

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

As lawmakers grapple with how best to combat the nation’s prescription painkiller abuse crisis, a recent survey is shedding light on how patients who get these medications  — drugs such as OxyContin, methadone or Vicodin — sometimes share or mishandle them.

According to findings detailed in a research letter published Monday in JAMA Internal Medicine, about one in five people who were prescribed the highly addictive drugs reported having shared their meds with a friend, often to help the other person manage pain. Most people with a prescription either had or expected to have extra pills left after finishing treatment. And almost 50 percent didn’t know how to safely get rid of the drugs left over after their treatment was complete, or how to store them while going through treatment.

The study’s authors suggested that the results point to changes doctors could make in prescribing practices and counseling to help alleviate the problems.

“We’ve all been saying leftover medications are an issue,” said Wilson Compton, deputy director of the federal National Institute on Drug Abuse, who wasn’t involved with the study. “Now I have a number that is concerning.”

The survey was sent to a random sample of almost 5,000 people in 2015. Of the recipients, about 1,000 had used prescription painkillers in the past year. Almost all of the people in this group responded to the survey.

Public concerns about painkiller abuse are growing louder. About 2 million people were addicted to prescription opioids in 2014, the most recent year for which data is available, according to the Centers for Disease Control and Prevention. Overdoses kill 44 people per day, the U.S. Department of Health and Human Services estimates. Researchers say deaths in 2014 were almost four times as common as they were in 2000.

“There’s a growing awareness among medical advisers, policymakers and even members of the general public that these are medications that can do serious harm,” said Colleen Barry, one of the study’s authors. She is a professor of health policy at Johns Hopkins University and co-director of the university’s Center for Mental Health and Addiction Policy Research.

And it is not news that most people who use prescription painkillers for nonmedical reasons often get them through social channels rather than a physician. In 2013 — the most recent year for which this data is available — the National Survey on Drug Use and Health estimated that number to be more than 80 percent.

But this paper’s findings illustrate some of the forces behind drug-sharing, Barry said, and in turn indicate how to stop it. For instance, the authors recommend that doctors prescribe smaller amounts of drugs, to minimize leftovers that could be shared or stolen. That tracks with new opioid prescribing guidelines issued by the Centers for Disease Control and Prevention.

“We probably prescribe a little bit more than we need to, and it’s not like people throw these away afterward. The leftovers are something we’re not thinking about,” said Jonathan Chen, an instructor at Stanford University School of Medicine, who has researched opioid abuse. Chen, who was not involved in the study, is also a practicing physician.

Meanwhile, it’s still tough for people to get rid of the drugs when they finish with them, and few say they know about safe storage practices. That’s another avenue for prevention.

Most respondents, for instance, didn’t lock up the pills when storing them. That makes it easier for someone else to take them.

And the prevalence of sharing medications suggests consumers need to be better educated about how addictive prescription opioids are, Barry said.

Doctors, added NIDA’s Compton, also need to understand the risk that, when they prescribe pills, they could end up used by someone else.

“One out of five people that I write a prescription to for opioids may share those with someone else. That’s a lot of people,” he said.

Physicians, meanwhile, haven’t historically been trained to counsel patients on safe drug disposal, meaning patients are often left unaware. Just under a quarter of respondents reported they remembered learning from the doctor or nurse about how to get rid of their meds safely. Chen said he couldn’t recall ever going over disposal practices with a patient. Even if he did, he said, it’s hard to know if patients would remember that information.

And when they are informed, it’s still difficult for consumers to easily get rid of pills they no longer need. The federal Drug Enforcement Administration sponsors “drug take-back days” twice a year. Some local law enforcement agencies hold similar events. But such events are often sporadic enough that it’s hard to make them a real habit, Barry noted.

Making those practices easier is essential, Barry said. And changing the culture around those drugs is key, so people understand the risk.

“Just the realization on the part of the public as well as physicians that these medications are not like Tylenol — these are highly addictive meds,” she said. “That message is starting to get out there.”

This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation.

As lawmakers grapple with how best to combat the nation’s prescription painkiller abuse crisis, a recent survey is shedding light on how patients who get these medications  — drugs such as OxyContin, methadone or Vicodin — sometimes share or mishandle them.

According to findings detailed in a research letter published Monday in JAMA Internal Medicine, about one in five people who were prescribed the highly addictive drugs reported having shared their meds with a friend, often to help the other person manage pain. Most people with a prescription either had or expected to have extra pills left after finishing treatment. And almost 50 percent didn’t know how to safely get rid of the drugs left over after their treatment was complete, or how to store them while going through treatment.

The study’s authors suggested that the results point to changes doctors could make in prescribing practices and counseling to help alleviate the problems.

“We’ve all been saying leftover medications are an issue,” said Wilson Compton, deputy director of the federal National Institute on Drug Abuse, who wasn’t involved with the study. “Now I have a number that is concerning.”

The survey was sent to a random sample of almost 5,000 people in 2015. Of the recipients, about 1,000 had used prescription painkillers in the past year. Almost all of the people in this group responded to the survey.

Public concerns about painkiller abuse are growing louder. About 2 million people were addicted to prescription opioids in 2014, the most recent year for which data is available, according to the Centers for Disease Control and Prevention. Overdoses kill 44 people per day, the U.S. Department of Health and Human Services estimates. Researchers say deaths in 2014 were almost four times as common as they were in 2000.

“There’s a growing awareness among medical advisers, policymakers and even members of the general public that these are medications that can do serious harm,” said Colleen Barry, one of the study’s authors. She is a professor of health policy at Johns Hopkins University and co-director of the university’s Center for Mental Health and Addiction Policy Research.

And it is not news that most people who use prescription painkillers for nonmedical reasons often get them through social channels rather than a physician. In 2013 — the most recent year for which this data is available — the National Survey on Drug Use and Health estimated that number to be more than 80 percent.

But this paper’s findings illustrate some of the forces behind drug-sharing, Barry said, and in turn indicate how to stop it. For instance, the authors recommend that doctors prescribe smaller amounts of drugs, to minimize leftovers that could be shared or stolen. That tracks with new opioid prescribing guidelines issued by the Centers for Disease Control and Prevention.

“We probably prescribe a little bit more than we need to, and it’s not like people throw these away afterward. The leftovers are something we’re not thinking about,” said Jonathan Chen, an instructor at Stanford University School of Medicine, who has researched opioid abuse. Chen, who was not involved in the study, is also a practicing physician.

Meanwhile, it’s still tough for people to get rid of the drugs when they finish with them, and few say they know about safe storage practices. That’s another avenue for prevention.

Most respondents, for instance, didn’t lock up the pills when storing them. That makes it easier for someone else to take them.

And the prevalence of sharing medications suggests consumers need to be better educated about how addictive prescription opioids are, Barry said.

Doctors, added NIDA’s Compton, also need to understand the risk that, when they prescribe pills, they could end up used by someone else.

“One out of five people that I write a prescription to for opioids may share those with someone else. That’s a lot of people,” he said.

Physicians, meanwhile, haven’t historically been trained to counsel patients on safe drug disposal, meaning patients are often left unaware. Just under a quarter of respondents reported they remembered learning from the doctor or nurse about how to get rid of their meds safely. Chen said he couldn’t recall ever going over disposal practices with a patient. Even if he did, he said, it’s hard to know if patients would remember that information.

And when they are informed, it’s still difficult for consumers to easily get rid of pills they no longer need. The federal Drug Enforcement Administration sponsors “drug take-back days” twice a year. Some local law enforcement agencies hold similar events. But such events are often sporadic enough that it’s hard to make them a real habit, Barry noted.

Making those practices easier is essential, Barry said. And changing the culture around those drugs is key, so people understand the risk.

“Just the realization on the part of the public as well as physicians that these medications are not like Tylenol — these are highly addictive meds,” she said. “That message is starting to get out there.”

This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation.

As lawmakers grapple with how best to combat the nation’s prescription painkiller abuse crisis, a recent survey is shedding light on how patients who get these medications  — drugs such as OxyContin, methadone or Vicodin — sometimes share or mishandle them.

According to findings detailed in a research letter published Monday in JAMA Internal Medicine, about one in five people who were prescribed the highly addictive drugs reported having shared their meds with a friend, often to help the other person manage pain. Most people with a prescription either had or expected to have extra pills left after finishing treatment. And almost 50 percent didn’t know how to safely get rid of the drugs left over after their treatment was complete, or how to store them while going through treatment.

The study’s authors suggested that the results point to changes doctors could make in prescribing practices and counseling to help alleviate the problems.

“We’ve all been saying leftover medications are an issue,” said Wilson Compton, deputy director of the federal National Institute on Drug Abuse, who wasn’t involved with the study. “Now I have a number that is concerning.”

The survey was sent to a random sample of almost 5,000 people in 2015. Of the recipients, about 1,000 had used prescription painkillers in the past year. Almost all of the people in this group responded to the survey.

Public concerns about painkiller abuse are growing louder. About 2 million people were addicted to prescription opioids in 2014, the most recent year for which data is available, according to the Centers for Disease Control and Prevention. Overdoses kill 44 people per day, the U.S. Department of Health and Human Services estimates. Researchers say deaths in 2014 were almost four times as common as they were in 2000.

“There’s a growing awareness among medical advisers, policymakers and even members of the general public that these are medications that can do serious harm,” said Colleen Barry, one of the study’s authors. She is a professor of health policy at Johns Hopkins University and co-director of the university’s Center for Mental Health and Addiction Policy Research.

And it is not news that most people who use prescription painkillers for nonmedical reasons often get them through social channels rather than a physician. In 2013 — the most recent year for which this data is available — the National Survey on Drug Use and Health estimated that number to be more than 80 percent.

But this paper’s findings illustrate some of the forces behind drug-sharing, Barry said, and in turn indicate how to stop it. For instance, the authors recommend that doctors prescribe smaller amounts of drugs, to minimize leftovers that could be shared or stolen. That tracks with new opioid prescribing guidelines issued by the Centers for Disease Control and Prevention.

“We probably prescribe a little bit more than we need to, and it’s not like people throw these away afterward. The leftovers are something we’re not thinking about,” said Jonathan Chen, an instructor at Stanford University School of Medicine, who has researched opioid abuse. Chen, who was not involved in the study, is also a practicing physician.

Meanwhile, it’s still tough for people to get rid of the drugs when they finish with them, and few say they know about safe storage practices. That’s another avenue for prevention.

Most respondents, for instance, didn’t lock up the pills when storing them. That makes it easier for someone else to take them.

And the prevalence of sharing medications suggests consumers need to be better educated about how addictive prescription opioids are, Barry said.

Doctors, added NIDA’s Compton, also need to understand the risk that, when they prescribe pills, they could end up used by someone else.

“One out of five people that I write a prescription to for opioids may share those with someone else. That’s a lot of people,” he said.

Physicians, meanwhile, haven’t historically been trained to counsel patients on safe drug disposal, meaning patients are often left unaware. Just under a quarter of respondents reported they remembered learning from the doctor or nurse about how to get rid of their meds safely. Chen said he couldn’t recall ever going over disposal practices with a patient. Even if he did, he said, it’s hard to know if patients would remember that information.

And when they are informed, it’s still difficult for consumers to easily get rid of pills they no longer need. The federal Drug Enforcement Administration sponsors “drug take-back days” twice a year. Some local law enforcement agencies hold similar events. But such events are often sporadic enough that it’s hard to make them a real habit, Barry noted.

Making those practices easier is essential, Barry said. And changing the culture around those drugs is key, so people understand the risk.

“Just the realization on the part of the public as well as physicians that these medications are not like Tylenol — these are highly addictive meds,” she said. “That message is starting to get out there.”

This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation.