Spurred on by midterm election results that showed healthcare to be a deciding issue, lawmakers are pushing a bevy of new proposals and approaches.

This article first appeared January 25, 2019 on Kaiser Health News.

By Shefali Luthra

The next presidential primary contests are more than a year away. But presumed candidates are already trying to stake a claim to one of health care's hot-button concerns: surging prescription drug prices.

"This is a 2020 thing," said Dr. Peter Bach, who directs the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center in New York and tracks drug-pricing policy.

Spurred on by midterm election results that showed healthcare to be a deciding issue, lawmakers — some of whom have already launched presidential run exploratory committees — are pushing a bevy of new proposals and approaches.

Few if any of those ideas will likely make it to the president's desk. Nevertheless, Senate Democrats eyeing higher office and seeking street cred in the debate are devising more innovative and aggressive strategies to take on Big Pharma.

"Democrats feel as if they’re really able to experiment," said Rachel Sachs, an associate law professor at Washington University in St. Louis who tracks drug-pricing laws.

Some Republicans are also proposing drug-pricing reform, although experts say their approaches are generally less dramatic.

Here are some of the ideas either introduced in legislation or that senators’ offices confirmed they are considering.

• Make a public option for generic drugs. The government could manufacture generics (directly or through a private contractor) if there is a shortage or aren’t enough competitors to keep prices down. This comes from a bill put forth by Sen. Elizabeth Warren (D-Mass.) and Rep. Jan Schakowsky (D-Ill.).
   
• Let Medicare negotiate drug prices. This idea has many backers — what differs is the method of enforcement. Sen. Sherrod Brown (D-Ohio) has suggested that if the company and the government can’t reach an agreement, the government could take away the company’s patent rights. A proposal from Sen. Bernie Sanders (I-Vt.) and Rep. Elijah Cummings (D-Md.) would address stalled negotiations by letting Medicare pay the lowest amount among: Medicaid's best price, the highest price a single federal purchaser pays or the median price paid for a specific drug in France, the United Kingdom, Germany, Japan and Canada.
   
• Pay what they do abroad. Legislation from Sanders and Rep. Ro Khanna (D-Calif.) would require companies to price their drugs no higher than the median of what’s charged in Germany, Japan, France, the United Kingdom and Canada. If manufacturers fail to comply, other companies could get the rights to make those drugs, too.
   
• Penalize price-gouging. This would target manufacturers who raise drug prices more than 30% in five years. Punishments could include requiring the company to reimburse those who paid the elevated price, forcing the drugmaker to lower its price, or charging a penalty up to three times what a company received from boosting the price. Backers include Sens. Richard Blumenthal (D-Conn.), Kamala Harris (D-Calif.), Jeff Merkley (D-Ore.) and Amy Klobuchar (D-Minn.).
   
• Import drugs. A Sanders-Cummings bill would let patients, wholesalers and pharmacies import drugs from abroad — starting with Canada, and leaving the door open for some other countries. Sen. Chuck Grassley (R-Iowa) and Klobuchar have a separate bill that is specific to patients getting medicine from Canada alone.
   
• Abolish "pay-for-delay." From Grassley and Klobuchar, this legislation would tackle deals in which a branded drugmaker pays off a generic one to keep a competing product from coming to market.
   

This flurry of proposed lawmaking could add momentum to one of the few policy areas in which conventional Washington wisdom suggests House Democrats, Senate Republicans and the White House may be able to find common ground.

"Everything is up in the air and anything is possible," said Dr. Walid Gellad, co-director of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh. "There are things that can happen that maybe weren’t going to happen before."

And there's political pressure. Polls consistently suggest voters have a strong appetite for action. As a candidate, President Donald Trump vowed to make drug prices a top priority. In recent months, the administration has taken steps in this direction, like testing changes to Medicare that might reduce out-of-pocket drug costs. But Congress has been relatively quiet, especially when it comes to challenging the pharmaceutical industry, which remains one of Capitol Hill's most potent lobbying forces.

One aspect of prescription drug pricing that could see bipartisan action is insulin prices, which have skyrocketed, stoking widespread outcry and could be a target for bipartisan work. Warren's legislation singles out the drug as one the government could produce, and Cummings has already called in major insulin manufacturers for a drug-pricing hearing later this month. In addition, Rep. Diana DeGette (D-Colo.), the new chair of the House Energy and Commerce Oversight and Investigations Subcommittee, has listed prescription drug pricing as a high priority for her panel. As co-chair of the Congressional Diabetes Caucus, DeGette worked with Tom Reed (R-N.Y.) to produce a report on the high cost of insulin.

To be sure, some of the concepts, such as drug importation and bolstering development of generic drugs, have been around a long time. But some of the legislation at hand suggests a new kind of thinking.

House Speaker Nancy Pelosi (D-Calif.) has labeled drug pricing a top priority, and the pharmaceutical industry has been bracing for a fight with the new Democratic majority.

Meanwhile, in the GOP-controlled Senate, two powerful lawmakers — Sen. Lamar Alexander (R-Tenn.) and Grassley — have indicated they want to use their influence to tackle the issue. Alexander, who chairs the Health, Education, Labor and Pensions Committee, has said cutting health care costs, including drug prices, will be high on his panel's to-do list this Congress. Grassley runs the Finance Committee, which oversees pricing issues for Medicare and Medicaid.

"The solution to high drug prices is not just having the government spending more money. … You need to look at prices," Gellad said. "These proposals deal with price. They all directly affect price."

Given the drug industry’s full-throated opposition to virtually any pricing legislation, Sachs said, "it is not at all surprising to me to see the Democrats start exploring some of these more radical proposals."

Still, though, Senate staffers almost uniformly argued that the drug-pricing issue requires more than one single piece of legislation.

For instance, the price-gouging penalty spearheaded by Blumenthal doesn't stop drugs from having high initial list prices. Letting Medicare negotiate doesn't mean people covered by other plans will necessarily see the same savings. Empowering the government to produce competing drugs doesn't promise to keep prices down long term and doesn't guarantee that patients will see those savings.

"We need to use every tool available to bring down drug prices and improve competition," said an aide in Warren’s office.

KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

Shefali Luthra: ShefaliL@kff.org, @Shefalil

State regulators have formally accused at least 23 doctors of negligent prescribing. More accusations are expected.

This article first appeared January 23, 2019 on Kaiser Health News.

By Cheryl Clark

The Medical Board of California has launched investigations into doctors who prescribed opioids to patients who, perhaps months or years later, fatally overdosed.

The effort, dubbed “the Death Certificate Project,” has sparked a conflict with physicians in California and beyond, in part because the doctors being investigated did not necessarily write the prescriptions leading to a death. The project is one of a kind nationally, although a much more limited program is operated by North Carolina’s board.

So far, the board has launched investigations into the practices of about 450 physicians and referred the names of 72 nurse practitioners, physician assistants and osteopathic physicians to their respective licensing boards.

To date, the regulators have formally accused at least 23 doctors of negligent prescribing, and more accusations are expected. Some of the accusations, like one 63-page document filed against Dr. Frank Gilman, a San Diego internist, detail hundreds of prescriptions for one patient over four years, most of them by him. Gilman did not respond to a request for comment.

Using terms such as "witch hunt" and "inquisition," many doctors said the project is leading them or their peers to refuse patients’ requests for painkiller prescriptions — no matter how well documented the need — out of fear their practices will come under disciplinary review.

The project, first reported by MedPage Today, has struck a nerve among medical associations. Dr. Barbara McAneny, the American Medical Association president and an Albuquerque, N.M., oncologist whose cancer patients sometimes need treatment for acute pain, called the project "terrifying." She said "it will only discourage doctors from taking care of patients with pain."

The influential California Health Care Foundation also has pushed back against the project, saying it could harm patients. (California Healthline is an editorially independent publication of the California Health Care Foundation.)

Unusually aggressive for the board, the program is a reaction to the by now well-known phenomenon of physicians overprescribing opioids. Nationally, a host of policy changes and educational efforts have driven down the rate of opioid prescriptions in recent years.

The goal of California’s program, quietly launched four years ago, is not necessarily to link a doctor's specific prescription to a specific patient’s death — although many of the cases do — but to find doctors whose patterns of prescribing are so dangerous they may lead to patients' ultimately fatal addictions.

Sometimes a doctor was earmarked for investigation even though the cause of death included multiple drugs prescribed by many physicians, or suicide by overdose, board documents indicate.

Kimberly Kirchmeyer, executive director of the Medical Board of California, defended the project. She said the effort has found patterns of "gross negligence," incompetence and excessive prescribing.

"I understand their frustrations," she said of the complaining doctors, "but we do have to continue our role with consumer protection."

She noted that part of the point of the project is to educate doctors and, through probation requirements, change the behavior of those who prescribe excessively.

"That's education that could potentially save patients in the future," said Kirchmeyer, whose agency licenses some 141,000 doctors.

Some consumer groups consider the board’s bold effort to find overprescribing doctors not aggressive enough.

"It's long overdue," said Carmen Balber, executive director of the nonprofit Consumer Watchdog. The board should investigate opioid-related deaths that occurred more recently, she said: "They need to get their act together and speed things up."

The agency thus far has looked at deaths only in 2012 and 2013 in which opioids were confirmed as a cause or contributing cause. It matched the names of the dead with the prescription drugs they filled, which are listed in the state’s prescription database. The database also shows the names of the doctors who prescribed to them. Physician experts reviewed those doctors’ prescribing history and selected those who appeared to prescribe drugs heavily.

Some doctors said they were especially angered that the letters they received concerned prescriptions they wrote as long as nine years ago.

McAneny, of the AMA, noted that prescribing practices now deemed unacceptable came out of public policies years ago that "compelled doctors to treat pain more aggressively for the comfort of our patients." Also, payers have measured quality of care by whether their patients answered surveys about whether their pain was well-controlled.

"We’re [already] doing a lot of education to undo the damage" from those policies, she said.

Similarly, Dr. David Aizuss, a Los Angeles ophthalmologist who is president of the California Medical Association, said state and federal guidelines that took effect in 2014 and 2016 impose much more stringent prescribing precautions than “what was going on six or seven years ago.”

Many insurance plans and pharmacies in recent years have restricted dosages and durations of certain painkillers a physician may prescribe at one time.

The crackdown on doctors has created fear, said Dr. Robert Wailes, a pain medicine specialist in Encinitas and chair of the California Medical Association’s Board of Trustees.

"What we're finding is that more and more primary care doctors are afraid to prescribe and more of those patients are showing up on our doorsteps," he said.

Officially, the CMA stops short of saying the medical board should stop the project, perhaps to avoid any perception that the association condones overprescribing. But it has asked the board to hire an independent reviewer to assess the criteria the board is using to decide which physicians to investigate, and whether physicians in certain specialties or regions of the state are being targeted more than others.

Dr. Ako Jacintho, a San Francisco addiction medicine specialist, was notified by the board that he was in trouble over a year ago. A patient for whom he had prescribed methadone fatally overdosed in 2012. The letter said "a complaint" had been filed against him, and asked him to respond to the allegations or, if he delayed, face a citation or fine of $1,000 per day. (The medical board can file its own complaints against a doctor.)

The letter said the patient had died of "acute combined methadone and diphenhydramine intoxication." Jacintho had refilled the patient's prescription for methadone the day before but said a 10-milligram pill was not a toxic dose. And he said he never prescribed diphenhydramine, the antihistamine sold as Benadryl.

"The only way he would have died was if he had not taken it as directed, or had mixed it with a medication that was not prescribed," Jacintho said.

As of Dec. 21, Jacintho was still waiting to hear if he would face a formal accusation.

Last year, the board rewrote those letters in a less accusatory tone — describing the "review" as routine — although it still threatens doctors with $1,000 fines. In a much smaller subset of cases, it finds problems that result in formal accusations that can result in discipline, such as public reprimands or restrictions on a physician's ability to practice.

Despite its designation as a "Death Certificate Project," the California effort has not focused only on doctors whose patients died. In an unknown number of overdose cases, the board has sent letters to living patients asking them to authorize their doctors to relinquish their medical records to the board, adding that those documents would otherwise be subpoenaed.

Dr. Paul Speckart, a San Diego internist, said three of his patients last year received board letters that seemed to question his quality of care when all he did was try to relieve their well-documented pain. The board has not filed any accusations against him.

"You can't even begin to understand how disrupting and upsetting this is," Speckart said. "It's not just a threat on your license; it's a threat that you've not been a good physician."

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

Drug companies routinely make hidden pacts with middlemen that effectively block patients from getting cheaper generic medicines.

This article first appeared January 18, 2019 on Kaiser Health News.

By Jay Hancock and Sydney Lupkin

Lisa Crook was lucky. She saved $800 last year after her insurance company started covering a new, less expensive insulin called Basaglar that was virtually identical to the brand she had used for years.

The list price for Lantus, a long-acting insulin made by Sanofi that she injected once a day, had nearly quadrupled over a decade.

With Basaglar, "I've never had my insulin cost drop so significantly," said Crook, a legal assistant in Dallas who has Type 1 diabetes.

But many people with diabetes can't get the deal Crook got. In a practice that policy experts say smothers competition and keeps prices high, drug companies routinely make hidden pacts with middlemen that effectively block patients from getting cheaper generic medicines.

Such agreements "make it difficult for generics to compete or know what they're competing against," said Stacie Dusetzina, an associate professor of health policy at Vanderbilt University School of Medicine.

Here's how it works: Makers of established brands give volume-based rebates to insurers or intermediaries called pharmacy benefit managers. In return, those middlemen often leave competing generics off the menu of drugs they cover, called a formulary, or they jack up the price for patients. The result is that many can't get the cheaper drugs unless they shoulder a bigger copay or buy them with no help from insurance.

Brand-drug sellers "pay for position" on the formulary, said Michael Rea, CEO of Rx Savings Solutions, which helps health plans and employers manage pharma costs. "In this country, the most cost-effective drugs don't necessarily mean anyone will have access to them … [Companies with] the deepest pockets win."

This so-called rebate trap joins a long history of efforts by makers of brand-name drugs to stifle generics, including protecting drugs with multiple layers of dubious patents, "pay for delay" deals to keep generics off the market and withholding key ingredients needed for generic production, critics say.

Because rebate contracts are secret, nobody knows the full extent of the practice nor how much it costs the health system in unrealized savings.

"The deals between the drug companies and the PBM middle players are guarded as fiercely as Fort Knox," said Robin Feldman, a law professor at the University of California, Hastings College of the Law, who studies pharma policy. "No one gets to see them."

But new research is turning up plenty of evidence of rebates distorting the market, such as numerous instances of effective, less expensive generics missing from formularies or patients burdened with higher out-of-pocket costs for generic drugs.

In unpublished research, Dusetzina found that only 17 percent of Medicare plans for seniors covered Basaglar, the biosimilar launched by Eli Lilly two years ago. Nearly all of them covered brand-name Lantus, sold by Sanofi, as of early last year.

Her research suggests rebates from Sanofi might have induced insurers to leave lower-priced Basaglar off their formularies, Dusetzina said.

Sanofi works with insurers and pharmacy benefit managers "to negotiate access for patients to our portfolio of products including Lantus," said company spokesman Jon Florio, declining to disclose specifics.

What's a pharmacy benefit manager? Watch our explainer.

Medicare plans covering Lantus but not Basaglar include numerous offerings from Anthem, the biggest for-profit, Blue Cross and Blue Shield insurer.

"After evaluating the total cost impact on consumers, taxpayers and the government, we chose to cover the brand drug, Lantus, over the biosimilar, Basaglar," said Anthem spokeswoman Lori McLaughlin.

Replacement versions of complex drugs often made from living cells are called biosimilars, not generics. Basaglar is considered clinically equivalent to Lantus but, because of a legal wrinkle, won't technically be considered a biosimilar by regulators until 2020.

Merck scrapped its own biosimilar version of Lantus last fall, despite receiving tentative approval by the Food and Drug Administration, after "assessing … the market environment," the company said.

Coverage of Lilly's Basaglar has grown, and the drug is now included in formularies used by slightly more than half the patients who have health insurance, said Eli Lilly spokesman Greg Kueterman.

In another forthcoming study, this one examining 2018 Medicare coverage, researchers at Johns Hopkins Bloomberg School of Public Health found that "almost every plan has at least one branded drug on the formulary that's in a better place than the generic," said Gerard Anderson, the professor leading the research.

(A grant from the Laura and John Arnold Foundation, which helps support Kaiser Health News, financed the Hopkins research.)

In 2015, only 19 percent of generic drugs covered by Medicare were in the preferred formulary tiers with the lowest out-of-pocket costs, found a study last year by consultants Avalere. In 2011, on the other hand, 71 percent of generics had been in the best tier, which helps determine what patients are prescribed.

The Association for Accessible Medicines, the generic drug lobby, paid for that study. Rebate-influenced barriers to generics are "increasingly problematic," said AAM CEO Chip Davis.

Disputes over formulary choices have hit the courts. Pfizer sued Johnson & Johnson in 2017, alleging that rebates induced insurers to prefer Remicade, an anti-inflammatory biologic, at the expense of Pfizer's lower-priced product.

Critics of rebate traps include top Trump administration officials, under pressure from a president who has promised to lower drug prices.

Because quick rebates from brands are often more attractive to PBMs and insurers than long-term savings from generics, "this is a real challenge in terms of biosimilars coming to market and gaining market share" Scott Gottlieb, head of the FDA, said in an interview.

Such objections add to a crescendo of grievances against hidden rebates. Consumers and advocates have complained for years that rebates cut costs for PBMs and insurers but do little for patients, who are often left paying their out-of-pocket share based on soaring list prices.

Crook's out-of-pocket costs for Lantus rose steadily over the years to about $900 annually, she said. After switching to Basaglar last year, her cost was less than $100.

Mark Gooley, who has Type 1 diabetes and lives in Florida, said he started ordering Lantus by mail from Canada after the U.S. list price rose fourfold in a little more than a decade.

"I have a very low opinion of companies like Sanofi," he said. "They could afford to sell it to me when it came out" at a much lower price, he said. "Inflation has not been 400 percent."

Because of rebates paid to PBMs, Sanofi's net price for Lantus has actually decreased over the past five years despite the list-price increases, said company spokesman Florio. "Unfortunately, these savings are not consistently passed through to patients," he said.

PBMs say they respond to the terms drug companies offer and negotiate to save billions for government, insurers and employers. "Simply put, the easiest way to lower costs would be for drug companies to lower their prices," the Pharmaceutical Care Management Association, the PBM lobby, said in an emailed statement.

For its part, PhRMA, the branded-drug association, has said it wants to scrap the rebate system and have PBMs paid for services provided.

Congress has done little to fix the rebate problem despite widespread criticism, but senior legislators in both chambers have pledged to address high drug prices this year.

Last summer, the Department of Health and Human Services proposed changing "safe harbor" protections that shield pharma rebates from being viewed as illegal kickbacks. But the proposal, under review at the Office of Management and Budget since July, has never been publicly aired, leaving the industry to wonder how substantial it is and if it will ever take effect.

California Attorney General Xavier Becerra scores a win for California and other states in his effort to block Trump administration birth control rules.

This article first appeared January 15, 2019 on Kaiser Health News.

By Samantha Young

SACRAMENTO, Calif. — Xavier Becerra, the political savvy Democratic attorney general of California, has sued the Trump administration 45 times in the past two years, often with much fanfare.

In winning a legal challenge Sunday against new government rules limiting birth control, he once against cemented himself as a national figure leading a fight against the administration across a range of issues — especially health care.

The 12 other states and the District of Columbia that had joined Becerra's lawsuit also gained a last-minute reprieve from the federal regulations that would have taken effect Monday. They would have allowed most employers to refuse to provide insurance coverage for workers’ birth control by raising a religious or moral objection.

Those rules were also halted for the rest of the country on Monday when a Pennsylvania judge granted a nationwide injunction in a similar lawsuit.

The contraception case is one of several fronts where Becerra has led state coalitions to defend the Affordable Care Act in lawsuits in Texas, California and Washington, D.C.

"The Trump administration is trying to chip away at those protections," said Andrew Kelly, an assistant professor at the Department of Health Sciences at California State University-East Bay. "It's left to states like California and Attorney General Becerra in taking a lead in confronting these efforts."

Becerra is perhaps best known for leading the opposition to the Texas v. U.S. lawsuit. In that suit, the Texas attorney general argued that the Affordable Care Act should be rendered unconstitutional because Congress eliminated the tax penalty on the uninsured. A federal judge last month sided with Texas, ruling that the federal health care law is unconstitutional.

Becerra, who said he helped write the health care law, said he felt compelled to step in when the Trump administration decided not to defend the law. Sixteen states and the District of Columbia joined that lawsuit, which is now on appeal.

The multistate strategy is one that attorneys general have used often in the past few decades when they don't agree with policies coming out of Washington, legal and political experts say. And it's not unique to one political party.

Republican attorneys general, for example, sued the Obama administration to block the expansion of Medicaid in their states. When George W. Bush was president, the state of Massachusetts led Democratic states in an effort to force the Environmental Protection Agency to regulate greenhouse gas emissions from cars.

The legal tit for tat is what Nicholas Bagley, a professor at the University of Michigan Law School, described as a disconcerting "militarization" of the state attorneys general offices to press an agenda in the courts.

"At a time of polarized politics, there's every incentive to pull whatever levers are available to you to try to advance your goals," Bagley said. "Over time, the state attorneys general have come to the view that the courts are an important forum to have these fights over important questions."

The behavior of the attorneys general also comes in response to an administration that is using its executive authority to push initiatives that it can't get Congress to approve.

President Donald Trump is left "to try to use either the regulatory process or executive order to accomplish his goals," said Gerald Kominski, a professor of health policy at UCLA. "Anyone who opposes those goals has to proceed through the legal process to challenge them."

Becerra, the first Latino to serve as California attorney general, has sued the Trump administration on a wide range of issues: health care, immigration, the Muslim travel ban, citizenship questions on the census, the border wall, climate change and clean-water rules.

When the former congressman was sworn in to his second term last week, he declared that he had "been a little busy keeping the dysfunction and insanity in Washington, D.C., from affecting California," and defending the state from the "overreach of the federal government." And he doesn't have any plans to let up.

"Whether it's the criminals on our streets or the con man in the boardrooms or the highest office of the land," Becerra said, "we've got your back."

But Becerra's record has been mixed.

The victory in court Sunday was limited. Oakland-based U.S. District Judge Haywood Gilliam Jr. blocked the rules from taking effect in the District of Columbia and the 13 states that challenged them, but he refused to stop them from taking effect in the rest of the country. That national reprieve came a day later in a Pennsylvania court, with U.S. District Judge Wendy Beetlestone describing the harm to women as "actual and imminent."

If the administration appeals, as expected, Pennsylvania, along with California and its legal coalition would move ahead with their cases to permanently throw out the rules, arguing that the Affordable Care Act guaranteed women no-cost contraception as part of their preventive health care, a provision that they say has benefited more than 62 million women since 2012, when the regulations went into effect.

The Trump rules, California argued in legal filings, would "transform contraceptive coverage from a legal entitlement to an essentially gratuitous benefit wholly subject to an employer's discretion." In its proposed regulations, the U.S. Department of Health and Human Services described the exemption as narrow and one that would affect a fraction of women — no more than 127,000.

That's a number Becerra disputes.

In claiming victory on the birth control lawsuit, Becerra said Sunday that his coalition will continue to advocate for women's access to reproductive health care.

How much more will Becerra fight during the next four years? Addressing the crowd who gathered this month to see him sworn in to a second term, he conveyed a simple response:

"The sky is the limit."