Tagged Pharmaceuticals

Must-Reads Of The Week From Brianna Labuskes

Happy Friday! Before we dive in to the harder news, please join me in enjoying this story about scientists dosing a shy breed of octopus with ecstasy to see if the animal became cuddly and friendly while high. (I swear, it relates to health care: More studies are evaluating psychedelic drugs as outside-the-box treatments, especially for post-traumatic stress disorder in veterans.)

Now, here’s what else you may have missed:

Senators were busy bees this week on the Hill. In a rare bipartisan feat, the upper chamber passed a sweeping opioids package … but there’s some fine print. Lawmakers still have to iron out the (harder, more controversial) differences between the Senate and House versions of the legislation, and they probably won’t do that work until November — conveniently, after midterms. Until then, they have a talking point!

And you know that “doughnut hole” change (which forces drugmakers to pay more for medication used by Medicare beneficiaries) that pharma hates and has been pestering lawmakers about for ages? Congress might tuck a measure rolling that back into the opioid package.

The Associated Press: GOP, Dems Unite Behind Senate Bill Fighting Addictive Drugs

Stat: GOP Lawmakers Seeking to Use Opioids Bill to Deliver Drug Industry Major Victory

It’s not all roses for drugmakers, though: A Senate-passed bill would ban “gag clauses,” which currently keep pharmacists from talking to consumers about lower-cost options.

Stat: Senate Passes Bill That Would Ban ‘Gag Clauses’ Limiting Disclosures on Drug Prices

In a sharp divergence from the budget spectacles of years past, the Senate quietly OK’d a measure to avert a government shutdown. The measure included a big, 5 percent boost to the National Institutes of Health, which was the fourth-straight significant increase for the agency.

The Associated Press: Senate Backs Bill to Avert Shutdown, Boost Military Spending

There’s a real fear out there that we’re all one bad accident away from financial ruin. A bipartisan group of senators wants to protect patients from that worry with its proposed measure on surprise bills, otherwise known as “balance billing.” (Bonus: Check out the KHN story that Republican Sen. Bill Cassidy cited in his announcement.)

The Hill: Bipartisan Senators Unveil Proposal to Crack Down on Surprise Medical Bills

As the news continues to evolve over the sexual assault allegations against Supreme Court nominee Brett Kavanaugh, here’s a health tidbit you might have missed if you didn’t scan all the way to the bottom of today’s stories. Gov. Bill Walker of Alaska, an independent, and his lieutenant governor, Byron Mallott, both came out against Kavanaugh’s nomination — not because of the accusations, but because they’re worried he’s going to jeopardize Medicaid coverage. It will be interesting to see if that’s enough to sway Alaska Sen. Lisa Murkowski, a Republican, who is being watched closely as a possible swing vote.

The New York Times: Christine Blasey Ford Opens Negotiations on Testimony Next Week

Attorney general races are rarely the belles of the ball when it comes to elections. But as more of them use their position to try to check President Donald Trump’s policies (especially ones chipping away at the health law), the campaigns are drawing more eyes.

Politico: Obamacare Lawsuit Boosts Democrats in State AG Races

Preexisting conditions have been a bomb Republicans have been trying to defuse for weeks on the campaign trail, but even GOP strategists call it a losing battle. “What you have to do at this point is duck and cover,” said one in Politico’s coverage.

Politico: Republicans ‘Duck and Cover’ on Pre-Existing Conditions

A new, more detailed report has emerged of the slow-moving medical catastrophe that was Hurricane Maria. It’s also a grim insight into why counting a death toll becomes so complicated.

The Associated Press: Maria’s Death Toll Climbed Long After Rain Stopped

Meanwhile, an investigation has been launched into why two mentally ill women who were seeking care were taken from a safe hospital and driven into Florence’s floodwaters, where they both drowned.

The New York Times: They Were Seeking Mental Health Care. Instead They Drowned in a Sheriff’s Van.

In the miscellaneous, must-read file for the week:

  • The U.S. is the most dangerous place to have a baby in the developed world, yet states are doing little to address the issue. And the ones that are, often blame the moms.

USA Today: Maternal Deaths: What States Aren’t Doing to Save New Mothers’ Lives

  • We’re on the precipice of some amazing breakthroughs for cancer treatments, yet Native Americans and black patients are missing out because they’re underrepresented in clinical trials.

ProPublica/Stat: Black Patients Are Being Left Out of Clinical Trials for New Cancer Therapies

  • Personal health aides can be a lifeline for elderly patients. Inviting a stranger into your home, though, is inherently risky and there’s few regulations that exist to weed out predators.

Boston Globe: Stranger in the House

  • And a fascinating Alzheimer’s treatment called “reminiscence therapy” has seen success overseas and is gaining traction here. Check out this one facility that recreated a 1950s town square, complete with Buddy Holly on the jukebox and an old-fashioned diner.

The Wall Street Journal: To Help Alzheimer’s Patients, A Care Center Re-Creates The 1950s

As a newsroom that has a dedicated chocolate drawer and sweet treats brought in by colleagues a few times a week, this article on employers cutting down on sugary snacks sparked a bit of a debate here. To ban or not to ban, that is the question of the week.

Have a great weekend!

‘A Lot Of Opportunities’ Exist For Cutting Drug Costs, Trump Health Official Tells Congress

Joe Grogan, OMB’s associate director for health programs, didn’t specify what lawmakers can do before year’s end to stem rising costs, but one bill with bipartisan support helps generic companies obtain samples of brand drugs as part of the development process. News on the industry also spotlights a new lobbying heavyweight for PBM and Medicaid pharmaceutical spending.

Massive Opioid Package Gives Congress Opportunity To Roll Back ‘Doughnut Hole’ Change That Pharma Hates

In February, Congress passed a provision forcing drug manufacturers to pay more for drugs used by Medicare beneficiaries. The industry has been railing about the change ever since, and the bipartisan opioid package might be lawmakers’ chance to hand pharma a big win.

As States Try To Rein In Drug Spending, Feds Slap Down One Bold Medicaid Move

States serve as “laboratories of democracy,” as U.S. Supreme Court Justice Louis Brandeis famously said. And states are also labs for health policy, launching all kinds of experiments lately to temper spending on pharmaceuticals.

No wonder. Drugs are among the fastest-rising health care costs for many consumers and are a key reason health care spending dominates many state budgets — crowding out roads, schools and other priorities.

Consider Vermont, California and Oregon, states that are beginning to implement drug price transparency laws. In Nevada, the push for transparency includes the markup charged by pharmacy benefit managers (PBMs). In May, Louisiana joined a growing list of states banning “gag rules” that prevent pharmacists from discussing drug prices with patients.

State-based experiments may carry even greater weight for Medicaid, the federal-state partnership that covers roughly 75 million low-income or disabled Americans.

Ohio is targeting the fees charged to its Medicaid program by PBMs. New York has established a Medicaid spending drug cap. In late June, Oklahoma’s Medicaid program was approved by the federal Centers for Medicare & Medicaid Services to begin “value-based purchasing” for some newer, more expensive drugs: When drugs don’t work, the state would pay less for them.

But around the same time, CMS denied a proposal from Massachusetts that was seen as the boldest attempt yet to control Medicaid drug spending.

Massachusetts planned to exclude expensive drugs that weren’t proven to work better than existing alternatives. The state said Medicaid drug spending had doubled in five years. Massachusetts wanted to negotiate prices for about 1 percent of the highest-priced drugs and stop covering some of them. CMS rejected the proposal without much explanation, beyond saying Massachusetts couldn’t do what it wanted and continue to receive the deep discounts drugmakers are required by law to give state Medicaid programs.

The Medicaid discounts were established in 1990 law based on a grand bargain that drugmakers say guaranteed coverage of all medicines approved by the Food and Drug Administration in exchange for favorable prices.

The New England Journal of Medicine dives into the CMS decision regarding Massachusetts and its implications for other state Medicaid programs in a commentary by Rachel Sachs, an associate professor of law at Washington University in St. Louis, and co-author Nicholas Bagley. They dispute the Trump administration’s claim that Massachusetts’ plan would violate the grand bargain.

We talked with Sachs about Massachusetts’ proposal and the implications for the rest of the country. Her answers have been edited for length and clarity.

Q: Why do you think states, such as Massachusetts, should be allowed to exclude some drugs, a move the pharmaceutical industry has said would break the deal reached back in 1990?

In our view, there’s a way to frame it where the bargain has been broken and Massachusetts is simply trying to restore the balance. The problem is that the meaning of FDA approval has changed significantly over the last almost 30 years. Now we have a lot more drugs that are being approved more quickly, on the basis of less evidence — smaller trials, using surrogate endpoints — where the state has real questions about whether these drugs work at all, not only whether they are good value for the money.

Q: You suggest that Massachusetts could make a reasonable case if it chose to challenge the CMS denial. How?

CMS did not explain why it didn’t grant Massachusetts’ waiver. It needs to give reasons for denying something that Massachusetts, in our view, has the legal ability to do. CMS’ failure to give reasons in this case resembles their failure to give reasons in a number of other cases that have recently led courts to strike down actions by the Trump administration for failure to explain the actions that they were taking.

(Note: A spokeswoman for Health and Human Services in Massachusetts says the state is not going to challenge the CMS decision.)

Q: While CMS blocked the Massachusetts experiment, it has approved the value-based purchasing plan in Oklahoma, and New York has capped its Medicaid drug spending. Aren’t those signs of flexibility for states?

In some ways, yes, and in other ways, no. New York passed a cap on state Medicaid pharmaceutical spending. But once the state hits that cap, it doesn’t mean the state will stop paying for prescription drugs. It just means the state is empowered to negotiate with some of these companies and seek additional discounts. They didn’t need CMS approval for this. New York doesn’t have the ability to say “If you don’t take this deal, we’re not going to cover this product.”

Oklahoma is pursuing outcomes-based pricing, which is of interest. It’s the first state to express interest in doing so. However, there are a lot of observers who are skeptical that outcomes agreements of this kind will materially lower prices or if they just provide companies cover to charge higher prices in the first instance.

Q: So what options do you see ahead for states given what happened in Massachusetts with the Medicaid waiver?

Unfortunately, states are quite limited in what they’re able to do on their own, in terms of controlling prescription drug costs — both costs that are borne by the state in its capacity as a public employer and its capacity as an insurer for the Medicaid population. and then more generally for the many citizens who are on private insurance plans throughout the state.

This is a real problem, this concern of federal pre-emption where states’ ability to go beyond federal law is often limited. So what we’re seeing now is more states like Massachusetts and Vermont taking action that forces the federal government to do something or say something. States are increasingly putting pressure on the federal government because they know that their ability to act on this problem of drug pricing is limited.

This story is part of a partnership that includes WBUR, NPR and Kaiser Health News.

Drug Companies Back New California Bill To Protect Integrity Of Research Data From Consumers

The legislation comes in reaction to a law that was geared toward protecting consumer privacy. Drug companies say, though, that it could inadvertently invalidate research, make it difficult to obtain funding and ultimately drive scientists from the state. In other industry news, companies in Massachusetts are being wooed by Maryland, and Europe signs off on another Humira copy.

Drug Companies Back New California Bill To Protect Integrity Of Research Data From Consumers

The legislation comes in reaction to a law that was geared toward protecting consumer privacy. Drug companies say, though, that it could inadvertently invalidate research, make it difficult to obtain funding and ultimately drive scientists from the state. In other industry news, companies in Massachusetts are being wooed by Maryland, and Europe signs off on another Humira copy.

New Medicare Advantage Tool To Lower Drug Prices Puts Crimp In Patients’ Choices

Starting next year, Medicare Advantage plans will be able to add restrictions on expensive, injectable drugs administered by doctors to treat cancer, rheumatoid arthritis, macular degeneration and other serious diseases.

Under the new rules, these private Medicare insurance plans could require patients to try cheaper drugs first. If those are not effective, then the patients could receive the more expensive medication prescribed by their doctors.

Insurers use such “step therapy” to control drug costs in the employer-based insurance market as well as in Medicare’s stand-alone Part D prescription drug benefit, which generally covers medicine purchased at retail pharmacies or through the mail. The new option allows Advantage plans — an alternative to traditional, government-run Medicare — to extend that cost-control strategy to these physician-administered drugs.

In traditional Medicare, which covers 40 million older or disabled adults, those medications given by doctors are covered under Medicare Part B, which includes outpatient services, and step therapy is not allowed.

About 20 million people have private Medicare Advantage policies, which include coverage for Part D and Part B medications.

Some physicians and patient advocates are concerned that the pursuit of lower Part B drug prices could endanger very sick Medicare Advantage patients if they can’t be treated promptly with the medicine that was their doctor’s first choice.

Critics of the new policy, part of the administration’s efforts to fulfill President Donald Trump’s promise to cut drug prices, say it lacks some crucial details, including how to determine when a less expensive drug isn’t effective.

“Do you have to lose vision before you are allowed to use” medication approved by the Food and Drug Administration, asked Richard O’Neal, vice president for market access for Regeneron, which makes Eylea, a medicine that is injected into the eye to treat macular degeneration. In 2016, Medicare paid $2.2 billion for Eylea prescriptions for patients in traditional Medicare, more than any other Part B drug, according to government data.

Medicare Advantage insurers spend about $12 billion on Part B drugs, compared to the $25.7 billion traditional Medicare spent in 2016 on such drugs. Insurers that adopt the step therapy policy can apply it only to new prescriptions — medicine a patient hasn’t received in the past 108 days.

The change in policy gives insurers a new bargaining tool: Pharmaceutical makers may want to compete by cutting prices to get their product on the plans’ list of preferred lists, allowing patients to receive the medicines without step therapy pre-conditions. That “strengthens their negotiating position with the manufacturers,” Medicare chief Seema Verma said when she unveiled the policy last month.

It could also save patients money since they usually pay a portion of the Part B prescription cost. In addition, Medicare is requiring plans to share the savings with enrollees.

“Competition is a big factor in price concessions,” said Daniel Nam, executive director of federal programs at America’s Health Insurance Plans, an industry trade group. But insurers haven’t had much leverage to negotiate lower prices for these drugs without strategies like step therapy, he said.

Federal health officials told insurers in a memo last month that they could substitute a less expensive Part B drug to treat a medical condition the FDA has not approved it for, if insurers can document that it is safe and effective. Yet coverage for a Part D drug is usually denied for a condition that doesn’t have FDA approval, according to the Center for Medicare Advocacy, which helps beneficiaries with appeals.

Several representatives of medical specialty groups recently met with Alex Azar, the secretary of the Department of Health and Human Services, to express their concerns.

Dr. Stephen Grubbs, vice president of clinical affairs at the American Society of Clinical Oncology, was among them. He said Azar told then the new step therapy policy would not have a big impact on cancer treatment.

Patients and their physicians who encounter problems getting specific Part B drugs can appeal using the “process that we have throughout the Medicare Advantage program and Part D plans,” advised Verma.

Under this system, if patients don’t want to follow their insurance plans’ requirements to try a less expensive medication first, they can request an exception to step therapy.

“They need their doctor’s support,” said Francine Chuchanis, director of entitlement rights at Direction Home, an Area Agencies on Aging organization that serves older adults and people with disabilities in northeastern Ohio. The physician must tell the plan why its restrictions should be lifted and provide extensive documentation.

The plans have 24 hours to respond to an expedited exception request and 72 hours for a regular one. During this time, “people are going without their drugs,” said Sarah Jane Blake, a Medicare counselor for New York’s StateWide Senior Action Council.

However, Dr. David Daikh, president of the American College of Rheumatology, said plans frequently do not meet the 72-hour deadline.

“We raised this point with the secretary and his staff,” he said. “They replied that they felt that there would not be a backlog for this program.”

If a plan denies the exemption, patients can file a “reconsideration” appeal. During this process, patients still can’t get their medicine unless they pay for it out-of-pocket.

Only a tiny fraction of Medicare Advantage beneficiaries filed a reconsideration appeal last year. Of the 3,498 cases that were decided, just 1 in 10 beneficiaries won decisions fully or partially in their favor, according to Medicare statistics.

“That’s disheartening to say the least,” said Blake, but she wasn’t surprised. “Beneficiaries are intimidated by the hoops they have to go through and often give up trying to purchase the drugs prescribed for them.”

KHN’s coverage of these topics is supported by
Laura and John Arnold Foundation
John A. Hartford Foundation

Must-Reads Of The Week From Brianna Labuskes

If you’ve been glued to your preferred weather service (as I have) over the past few days watching Hurricane Florence lumber toward the East Coast, you may have missed that it was a fairly huge news week for health. So, let’s get right to it!

President Donald Trump shocked and angered both allies and critics with accusations that the latest death toll from Hurricane Maria was inflated by the Democrats to make him look bad.

Bloomberg: Trump Defies Science With Rejection of Puerto Rico Death Toll

4 Takeaways On Puerto Rico’s Death Toll, In The Wake Of Trump’s Tweet Storm

For the first time since 2010, the decline in the uninsured rate stalled. Some blame the Trump administration’s whacks at the health law, but others say it’s just the marketplace leveling off.

The Washington Post: For First Time Since 2010, America’s Progress on Health Insurance Stalls

The fact that Sen. Joe Manchin (D-W.Va.) is using health care while campaigning in a deep-red state that loves Trump shows just how far politics has evolved on the issue. (Even though he’s certainly not mentioning “Obamacare” by name.)

The New York Times: Manchin Counts on Health Care to Stave Off Republican Tide in West Virginia

But a look at tweets on the topic shows it doesn’t matter to Russian trolls which way that popularity pendulum swings — they recognize the health law as a plank sure to sow discord and pit sides against each other.

The Wall Street Journal: Nearly 600 Russia-Linked Accounts Tweeted About the Health Law

Baltimore health commissioner Dr. Leana Wen, an emergency room physician with a reputation for fiercely taking on the Trump administration, has been tapped as Planned Parenthood’s next president. Wen brings firsthand experience with the organization as a child of a low-income family.

The New York Times: Planned Parenthood Names Leana Wen, a Doctor, Its New President

More than 4,300 beneficiaries in Arkansas were kicked off the state’s Medicaid rolls after failing to report their required work hours. Republican Gov. Asa Hutchinson focused on the 1,000 or so residents who have found employment under the new regulations, but critics were quick to point to the number as confirmation of their worst fears that the new fervor for work requirements will lead to a lot of Americans losing insurance.

The Associated Press: Arkansas Drops 4,300 From Medicaid Plan Over New Work Rules

A letter alleging a sexual misconduct incident in Supreme Court nominee Brett Kavanaugh’s past, which Sen. Dianne Feinstein (D-Calif.) has turned over to the FBI, is adding fuel to an already fiery battle on the Hill.

A Sexual-Misconduct Allegation Against the Supreme Court Nominee Brett Kavanaugh Stirs Tension Among Democrats in Congress

Meanwhile, accusations of bribery are coming out of Maine, where advocates have guaranteed $1 million in fundraising pledges to Republican Sen. Susan Collins’ 2020 opponent if she votes to confirm Kavanaugh.

The Associated Press: $1 Million Pledged Against Collins If She Backs Kavanaugh

A pharma exec’s defense that raising drug prices 400 percent was a “moral requirement” raised more than a few eyebrows. It was a bold claim in an era where most companies are trying to at least appear concerned about the topic.

Financial Times: Pharma Chief Defends 400% Drug Price Rise As a ‘Moral Requirement’

Want to know how those pharmacy benefit managers (yup, the ones now getting lots of fingers pointed at them for the high cost of drugs) can pocket almost $200 for a bottle of pills that’s valued at $6? Check out Bloomberg’s explainer.

In the interest of making this “breezy,” here are some other big news stories from the week: Apple kills two birds with one stone with its new watch: convincing people they need to buy a low-selling product and edging into the health care industry; the number of immigrant teens being held by the government has ballooned; and lawmakers may perform what might be called, in this partisan landscape, a miracle and actually fund the government on time. (See, I was not exaggerating about the amount of news this week!)

Stat: The New Apple Watch, With FDA’s Blessing, Comes With an EKG App

The New York Times: Detention of Migrant Children Has Skyrocketed to Highest Levels Ever

Stat: Trump Wants Drug Prices in TV Ads. The Latest Roadblock? Republicans

Politico: Congress Dares Trump To Shut Down The Government In New Spending Deal

In a story that you can’t make up: A member of the family that owns Purdue Pharma (the maker of OxyContin and subject of more than 1,000 lawsuits regarding its role in the opioid epidemic) has been awarded a patent for a treatment for opioid use disorder.

Stat: Richard Sackler, Member of Clan Behind OxyContin, Has Patent for Opioid Treatment

If all of that wasn’t enough for you, here are a few must-read miscellaneous stories from the week: Nearly two decades after Kendra Webdale was pushed to her death in the subway, the law named in her honor designed to shore up mental health systems is acting more like a band-aid than a cure; advocates are shifting gears on gun safety by going after bullets, which are largely unregulated; recent transparency controversies have some asking: Why do medical journals still take authors at their word?; and a look at the people behind suicide hotlines.

The New York Times: A Horrific Crime on the Subway Led to Kendra’s Law. Years Later, Has It Helped?

The New York Times: California Tries New Tack on Gun Violence: Ammunition Control

Stat: Why Do Medical Journals Keep Taking Authors at Their Word?

CNN: When Someone Is Thinking of Suicide, These Are the People Who Talk Them Out of It

If you had a gloomy 2017, at least take heart in the fact that it wasn’t just you.

Please have a safe weekend if you’re in Florence’s path!

There’s A Crisis In Confidence For Americans In What Anyone In Washington Is Doing To Curb Drug Prices

Just 23 percent approve of steps President Donald Trump has taken to lower high drug costs, but only 20 percent approve of what Democrats in Congress are doing and 16 percent approve of how Republicans are handling the problem. Meanwhile, HHS Secretary Alex Azar promises the administration has “disruptive” changes coming.

There’s A Crisis In Confidence For Americans In What Anyone In Washington Is Doing To Curb Drug Prices

Just 23 percent approve of steps President Donald Trump has taken to lower high drug costs, but only 20 percent approve of what Democrats in Congress are doing and 16 percent approve of how Republicans are handling the problem. Meanwhile, HHS Secretary Alex Azar promises the administration has “disruptive” changes coming.

Insurer To Purdue Pharma: We Won’t Pay For OxyContin Anymore

The largest insurer in Tennessee has announced it will no longer cover prescriptions for what was once a blockbuster pain reliever. It’s the latest insurance company to turn against OxyContin, whose maker, Purdue Pharma, faces dozens of lawsuits related to its high-pressure sales tactics around the country and contribution to the opioid crisis. Last fall, Cigna and Florida Blue both dropped coverage of the drug.

Top officials at BlueCross BlueShield of Tennessee say newer abuse-deterrent opioids work better, and starting in January, the insurer covering 3.4 million Tennesseans will pay for those opioids made by other pharmaceutical companies instead.

“We felt it was time to move to those products and remove Oxycontin from the formulary, which does still continue to have a higher street value,” said Natalie Tate, the insurer’s vice president of pharmacy.

OxyContin was reformulated in 2010 to make the drug harder to misuse — but it’s still possible to crush or liquefy in order to snort or inject it.

The latest long-acting opioids that BlueCross BlueShield of Tennessee is going to start covering — Xtampza and Morphabond — are still more difficult to misuse, according to the company and some pharmaceutical experts.

Motives Questioned

In a page-long response a reporter’s query, a Purdue Pharma spokesman pointed out that no opioid drug is “abuse proof” or less addictive, accusing BCBST of financial motives that remove choices for many patients.

“We believe that patients should have access to FDA-approved products with abuse-deterrent properties,” Purdue’s Robert Josephson wrote in an email. “The recent decision by BlueCross BlueShield of Tennessee limits prescribers’ options to help address the opioid crisis.”

In response, BCBST’s Tate argued that ditching one of the most recognized names in opioids is not designed to save money, though it could in a roundabout way.

This move could reduce fraudulent prescriptions to street dealers or drug-seeking people with active addictions and cut down on costly hospital stays for overdoses, said pain consultant and pharmacist Jeff Fudin, an adjunct professor at Albany College in New York.

“It’s a smart idea to use dosage forms that have proven to have been better abuse-deterrent formulations,” he said. “In the long run, it actually will cost them a whole lot less money.”

Fudin said he’s often at odds with insurers over their decisions about which drugs to cover, but he applauds this decision, which he expects more insurers to follow.

Alternative Therapies

Practicing pain physicians in Tennessee — who regularly battle with insurance companies — also approve of the change, though they said OxyContin was already falling out of favor. And they argue trading one opioid for slightly safer ones doesn’t address a larger gripe that physicians have with insurers over paying for other, non-addictive types of treatment.

“We will have denials and prior authorizations on a muscle relaxer, and we will have no issue getting an opioid through the insurance company,” said Dr. Stephanie Vanterpool, an anesthesiologist at the University of Tennessee and the president-elect of the Tennessee Pain Society.

“The physicians or the doctor’s offices jump through hoops to get the better medication for the patients,” said Vanterpool. “And when I say better medication, I mean the medication that’s treating the cause of the pain, not just the medication that’s covering up the pain.”

BlueCross BlueShield of Tennessee is adding some alternative pain therapies in the coming year, according to its announcement last week. But Vanterpool would like to see a philosophical about-face.

Not to say OxyContin won’t be sorely missed by some patients.

“There are plenty of people who benefit from that drug,” said Terri Lewis, a patient advocate and rehabilitation specialist from Cookeville, Tenn.

She’s suspicious of BCBST’s motives since the insurer may be blamed for its role in the opioid crisis. Embattled Purdue Pharma could be a convenient scapegoat.

“Maybe this is a good decision,” Lewis said. “But it smells like a political decision.”

And this would be just the latest decision inserting politics into a nuanced medical problem.

A Blessing In Disguise?

The Tennessee legislature instituted some of the tightest opioid prescribing regulations in the country this year — a three-day limit for most people who aren’t already on opioids. And even long-term pain patients are having trouble getting refills.

John Venable of Kingsport, Tenn., was shown the door by his pain clinic in July after more than a decade on oxycodone — a generic, short-acting version of OxyContin.

“I just felt like I was in a hopeless state, like, ‘there is no help for John,’” he recalled.

At their worst, he said his headaches get so debilitating “that death would be a relief.” Despite his dread, he’s noticed something surprising over the last few months without opioids — his crippling headaches haven’t gotten that much worse, if at all.

“It very well might be a blessing in disguise,” Venable said.

The retired builder and one-time pastor said he prays that those losing OxyContin also will get to use the moment as an opportunity, though he knows many can’t cut ties with opioids. And he worries some will turn to more dangerous drugs off the street or even contemplate ending their own lives.

Experts point out that the number of opioid prescriptions has already been falling around the country. And in Tennessee, BCBS has experienced a 26 percent drop in opioid prescription claims over three years.

But restricting legal access to opioids hasn’t turned back the rise in overdose deaths, which hit a record in Tennessee and nationwide last year.

This story is part of a partnership that includes Nashville Public Radio, NPR and Kaiser Health News.

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

Unwitting Patients, Copycat Comments Play Hidden Role In Federal Rule-Making

A proposal to sharply cut a drug discount program that many hospitals rely on drew some 1,400 comments when the Trump administration announced its plan last year. Hundreds appeared to come from patients across the country — pleas from average Americans whose treatments for diseases such as cancer depend on costly medicines.

But a review of the responses found that some individuals were not aware they apparently had become part of an organized campaign to oppose what’s known as the “340B” program. Some had no memory of signing anything, much less sending their opinions about it.

Of the 1,406 comments that specifically mentioned 340B — part of several thousand comments submitted on a broad proposal to revise medical payment systems — about half included the same or similar wording and were submitted anonymously, an analysis by Kaiser Health News found. Those comments lamented “abuse” of the drug discounts, faulted hospitals for being “greedy” and used phrasing such as “quality, affordable, and accessible.”

Two that were duplicated hundreds of times made the very same grammatical mistake.

They “are clearly related,” said Robert Leonard, a forensic linguistic expert at Hofstra University whose team analyzed the submissions for KHN.

In fact, the wording in the duplicate comments tracks language in a formal letter submitted to regulators by a nonprofit trade group, the Community Oncology Alliance, which receives funding from pharmaceutical companies.

Cancer survivor Janice Choiniere’s name is on a public comment saying reform of the 340B program will help “those suffering from this insidious disease.” But when reached by phone, the 69-year-old Florida resident said she had “no idea” what the program is and didn’t recall signing a petition.

“My first thought is, I don’t fill out and send in responses casually,” Choiniere said. “I’m hoping nobody lifted my information.”

The quarter-century-old federal program requires pharmaceutical companies to sell certain drugs at steep discounts to eligible hospitals and clinics, which don’t have to share their savings with patients. Critics, including Republican lawmakers, have questioned what the facilities do with the money. Doctors in private practice, who are not eligible for the reduced rates, have warned that the program’s continued growth makes it susceptible to exploitation.

The administration’s plan, finalized in November, reduced by $1.6 billion annually what the Centers for Medicare & Medicaid Services pays for the targeted drugs. In late July, the agency proposed expanding those payment cuts.

As with any proposed rule, the purpose of requesting public comments is to help lawmakers and regulators consider the potential effects of their actions. But the pattern identified in the 340B comments, which were posted online by CMS, suggests the system can easily be manipulated. Patients may be especially vulnerable to being used.

“It feels like inappropriate influence,” said Peter Ubel, a physician and behavioral scientist at Duke University’s Fuqua School of Business. “When you have a life-threatening illness, you need to know you can trust your physician to care about your interests ahead of their own.”

KHN reached 10 individuals whose names appeared in the comments — either as a signature on a personal note or on a petition also signed by others. All were patients, former patients or caregivers seen at private practices connected to the Community Oncology Alliance.

Two patients confirmed they had written notes, although they couldn’t say when. Several said they must have signed or written something amid the paperwork handed to them at a doctor’s office during appointments or in follow-up correspondence. A few drew mental blanks.

The name of an 84-year-old melanoma patient shows as an online signature in an individual public comment that described the program’s reform as a matter of “life or death.” But the Florida man, who asked not to be identified, had little recollection of writing it. His wife remembered that he signed something at his doctor’s office “out front on a clipboard” before getting his biweekly cancer treatment.

“If my doctor wanted me to sign something, I would sign it for him,” the man said. He “saved my life.”

Julie Yarbrough, whose husband received treatment at New England Cancer Specialists in Maine, remembered signing a petition “at the [doctor’s] check-in area” about hospitals abusing 340B discounts. She was the only individual contacted who had a basic understanding of the program.

The patients reached by KHN sought care at either New England Cancer Specialists, which has three locations in Maine, or Florida Cancer Specialists, which runs nearly 100 treatment centers in that state. Data posted on the federal website regulations.gov show that more than 60 percent of the 340B-specific comments originated in Florida.

“We do a good job of educating patients and letting them know how to get involved,” said Michael Diaz, director of patient advocacy for Florida Cancer Specialists and vice president on the Community Oncology Alliance’s executive committee. “They need to be able to contribute and give their opinion.”

Steve D’Amato, executive director of New England Cancer Specialists and an Alliance board member, mentioned patients’ support in a letter accompanying a petition posted multiple times to the government portal Oct. 10. The petition included the trade group’s website; D’Amato noted that “patient signatures obtained in just 2 days” were attached.

When asked recently about patients who didn’t recall signing something, D’Amato said he did not have the petition in front of him and referred all questions to the Alliance’s executive director, Ted Okon. In an interview, Okon denied that the organization had any role in soliciting patient comments.

“We didn’t do anything with patient petitions,” said Okon, although talking points and material were sent to practices nationwide for them to use when submitting comments. “This is what we do in terms of advocating.”

Susannah Rose, scientific director of research in the Cleveland Clinic’s patient experience office, said there is “always a worry about coercion” when doctors make a request of patients, but more so when oncologists do the asking.

“Cancer patients often feel very much in the hands of their oncologists, and they are often suffering from significant distress,” said Rose, who serves on the ethics committee of the American Society of Clinical Oncology.

The Washington-based Alliance represents private oncology practices as well as about 50 corporate members, according to its website. Formed in 2003 when Congress approved Medicare’s prescription drug program, it was a leading critic of a controversial 2016 proposal to change how CMS paid for some drugs in Medicare. The group’s revenue nearly quadrupled that year, to $16.3 million from $4.4 million in 2015, according to federal tax filings. The proposal never became reality.

Pharmaceutical giants Sanofi, Pfizer, Eli Lilly, Bristol-Myers Squibb and Merck each confirmed paying annual dues of $75,000 to the Alliance. The five companies also paid it nearly $1 million between 2014 and 2017 for research papers, conferences, filming and patient education, according to corporate transparency reports.

Walgreens and PhRMA, the pharmaceutical industry trade group, also confirmed membership but did not disclose how much they pay in dues. Okon said corporate membership fees range from $25,000 to $75,000 annually while individual oncologists and their practices pay “usually on the order of a thousand dollars, two thousand dollars.”

Drug manufacturers do not influence the Alliance’s position on 340B, he said, noting in an email that “correlation is not causality.”

After the comment period ended, CMS slashed 340B payments to hospitals by $1.6 billion annually. Medicare had been paying hospitals 6 percent above a drug’s average sales price; it now pays them 22.5 percent less than the average sales price.

CMS Administrator Seema Verma and Eric Hargan, deputy secretary of the Health and Human Services Department, emphasized that public comments played into their decision. In the 1,133-page final rule, they said they shared the concern that current Medicare payments “are well in excess of the overhead and acquisition costs” for drugs bought under the program.

“We thank the commenters for their support,” they wrote.

Kaiser Health News data correspondent Sydney Lupkin contributed to this report.

How KHN Found The Duplicated Rhetoric On 340B

Kaiser Health News data correspondent Sydney Lupkin downloaded thousands of publicly filed comments from regulations.gov regarding a rule that revised Medicare payments to hospitals. Lupkin found that of the 1,406 comments on the docket that explicitly mentioned “340B,” three separate comments were duplicated hundreds of times. Those three widely repeated comments made up more than half (763) of all the comments posted about the 340B drug discount program. (Note: The analysis did not review PDF attachments that were submitted as comments.)

Hofstra University professor Robert Leonard, and analysts Juliane Ford and Dakota Wing who work for his consulting firm, compared those three comment types with a letter submitted to regulators in September by Community Oncology Alliance, a nonprofit advocacy group. COA’s comment letter included 2,928 words. The three duplicated comments used 242, 260 and 306 words.

The analysts used a technique that tallies the number of N-grams, which is a set of serial words found in a string, shared in each document. They found multiple examples. One near 10-gram sequence that appeared in all 763 comments is a variation of the sentence: “The mission of COA is to ensure that cancer patients receive quality, affordable, and accessible cancer care in their own communities.” It varied by the use of a few words, such as changing “communities” to “community” or using the word “local” instead.

Notably, the use of an Oxford comma in the same string of words — “quality, affordable, and accessible” — appeared in all four comments.

“It defies imagination that three or four individual people would pick the same words in the same strain,” said Leonard, who is director of the graduate program in forensic linguistics at Hofstra University.

The frequent use of the informal word “bad” also caught the attention of researchers. And two comments that were duplicated hundreds of times made the same grammatical mistake — using a non-standard plural “American’s” with a superfluous apostrophe.

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

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