Tagged Prescription Drugs

Podcast: ‘What The Health?’ Meanwhile, In Other Health News…

Most followers of health policy have been consumed lately by the potential repeal or alteration of the Affordable Care Act, as well as the ongoing open enrollment for individual insurance for 2018.

But that’s far from the only health news out there. In this episode of “What the Health?” Julie Rovner of Kaiser Health News, Joanne Kenen of Politico, Alice Ollstein of Talking Points Memo, and Sarah Jane Tribble of Kaiser Health News discuss some of the important but under-covered stories you might have missed this fall, including prescription drug price fights and women’s reproductive health.

Among the takeaways from this week’s podcast:

  • Lobbyists are coming out of the woodwork – spending more than $42 million over the last quarter — on a battle over whether Medicare should reduce what it pays for drugs at hospitals that primarily serve low-income patients.
  • Massachusetts has passed its own guarantee of no-cost contraceptives for women, after the Trump administration rolled back the federal health law provision.
  • The health law’s individual mandate is front and center in the tax debate, but it’s not clear how the Senate will come down on it. Some GOP moderates are suggesting that they might support the repeal if another bill to help stabilize the individual insurance market is approved. Yet at the same time, the White House is signaling that it might be fine dropping the mandate.
  • Of course, if Congress opts not to tackle the mandate, the White House could take some actions later to neutralize the provision. That could add another log on the fire as critics seek help through the courts to stop administration actions.

Plus, for “extra credit,” the panelists recommend their favorite health stories of the week they think you should read, too.

Julie Rovner: The Washington Post and Kaiser Health News’ “Ambulance trips can leave you with surprising – and very expensive – bills,” by Melissa Bailey.

Joanne Kenen: The New York Times’ “Skin Cancers Rise, Along With Questionable Treatments,” by  Katie Hafner and Griffin Palmer.

Alice Ollstein: The Washington Post’s “What the parasites in a defector’s stomach tell us about North Korea,” by Cleve R. Wootson Jr.

Sarah Jane Tribble: The Washington Post’s “How we got the story about monkeypox,” by Lena H. Sun.

To hear all our podcasts, click here.

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Doctor’s Rx For A Stiff Knee: A Prescription For 90 Percocet Pills

I recently hobbled to the drugstore to pick up painkillers after minor outpatient knee surgery, only to discover that the pharmacist hadn’t yet filled the prescription. My doctor’s order of 90 generic Percocet exceeded the number my insurer would approve, he said. I left a short time later with a bottle containing a smaller number.

When I got home and opened the package to take a pill, I discovered that there were 42 inside.

Talk about using a shotgun to kill a mosquito. I was stiff and sore after the orthopedist fished out a couple of loose pieces of bone and cartilage from my left knee. But on a pain scale of 0 to 10, I was a 4, tops. I probably could have gotten by with a much less potent drug than a painkiller like Percocet, which contains a combination of the opioid oxycodone and the pain reliever acetaminophen, the active ingredient found in over-the-counter Tylenol.

When I went in for my follow-up appointment a week after surgery, I asked my orthopedist about those 90 pills.

“If you had real surgery like a knee replacement you wouldn’t think it was so many,” he said, adding that the electronic prescribing system set the default at 90. So when he types in a prescription for Percocet, that’s the quantity the system orders.

Such standard orders can be overridden, but that’s an extra step for a busy physician and takes time.

As public health officials grapple with how to slow the growing opioid epidemic — which claims 91 lives each day, according to federal statistics — the over-prescription of narcotics after even minor surgery is coming under new scrutiny.

While patients are today often given opioids to manage post-operative pain, a large supply of pills may open the door to opioid misuse, either by the patients themselves or others in the family or community who get access to the leftovers.

Post-surgical prescriptions for 45, 60 or 90 pills are “incredibly common,” said Dr. Chad Brummett, an anesthesiologist and pain physician at the University of Michigan Medical School.

Last year, the Centers for Disease Control and Prevention released a general guideline saying that clinicians who prescribe opioids to treat acute pain should use the lowest effective dose and limit the duration to no longer than seven days.

But more detailed guidance is necessary, clinicians say.

“There really aren’t clear guidelines, especially for surgery and dentistry,” Dr. Brummett said. “It’s often based on what their chief resident taught them along the way, or an event in their career that made them prescribe a certain amount.” Or, as in my case, an automated program that makes prescribing more pills simpler than prescribing fewer.

Brummett is co-director of a Michigan program that has released recommendations for post-surgical opioid prescribing for a growing list of procedures.

To determine the extent to which surgery may lead to longer-term opioid use, Brummett and his colleagues examined the insurance claims of 36,177 adults who had surgery in 2013 or 2014 for which they received an opioid prescription. None of the patients had prescriptions for opioids during the prior year.

The study, published online in JAMA Surgery in June, found that three to six months after surgery, roughly 6 percent of patients were still using opioids, having filled at least one new prescription for the drug. The figures were similar whether they had major or minor surgery. By comparison, the rate of opioid use for a control group that did not have surgery was just 0.4 percent.

Some insurers and state regulators have increasingly stepped in to limit opioid prescriptions. Insurers routinely monitor doctors’ prescribing patterns and limit the quantity of pills or the dosage of opioid prescriptions, said Dania Palanker, an assistant research professor at Georgetown University’s Center on Health Insurance Reforms who co-authored a study on insurers’ response to the opioid crisis.

At least two dozen states have passed laws or rules in just the past few years aimed at regulating the use of opioids.

In my state of New York, Gov. Andrew Cuomo last year signed legislation that reduced the initial opioid prescription limit for acute pain from 30 days to no more than a seven-day supply.

As my experience demonstrated, however, a seven-day limit (those 42 pills in my case) can still result in patients receiving many more pills than they need. (For those who find themselves in a similar situation with excess pills, here is the safe and proper way to dispose of them.)

Still, some caregivers and patients worry that all this focus on overprescribing may scare physicians away from prescribing opioids at all, even when they’re appropriate.

“That’s my concern, that people are so afraid of things and taking it to such an extreme that patient care suffers,” said Dr. Edward Michna, an anesthesiologist and pain management physician at Brigham and Women’s Hospital in Boston who is on the board of the American Pain Society, a research and education group for pain management professionals. Michna has been a paid consultant to numerous pharmaceutical companies, some of which manufacture narcotics.

But other doctors say that one of the reasons doctors call in orders for lots of pills is their convenience.

“When you land on the front lines, you hear, ‘I like to write for 30 or 60 pills because that way they won’t call in the middle of the night’ ” for a refill, said Dr. Martin Makary, a professor of surgery and health policy at Johns Hopkins School of Medicine.

Makary is spearheading a consortium of Hopkins clinicians and patients that provides specific guidelines for post-surgical opioid use. The program, part of a larger effort to identify areas of overtreatment in health care, also identifies outlier prescribers nationwide to encourage them to change their prescribing habits.

The Hopkins group doesn’t have an opioid recommendation for my surgery. The closest procedure on their website is arthroscopic surgery to partially remove a torn piece of cartilage in the knee called the meniscus.  The post-surgical opioid recommendation following that surgery: 12 tablets.

Please visit khn.org/columnists to send comments or ideas for future topics for the Insuring Your Health column.

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Massachusetts Grabs Spotlight By Proposing New Twist On Medicaid Drug Coverage

In the absence of new federal policies to tame break-the-bank drug prices, Massachusetts’ state Medicaid program hopes to road-test an idea both radical and market-driven. It wants the power to negotiate discounts for the drugs it purchases and to exclude drugs with limited treatment value.

“This is a serious demonstration proposal,” said Sara Rosenbaum, a health policy expert and professor at George Washington University. “They’re not simply using [this idea] as an excuse to cut Medicaid. They’re trying to take a step toward efficiency.”

If the Department of Health and Human Services approves the Bay State’s plan, others will likely take similar action. According to the most recent federal data, Medicaid spending on prescription drugs increased about 25 percent in 2014 and nearly 14 percent in 2015.

Currently, state Medicaid programs are required to cover almost all drugs that have received Food and Drug Administration approval, including multiple drugs from different manufacturers used for the same purpose and in the same category. In exchange, manufacturers must discount those drugs — typically based on a set percentage of the list price, specified by federal law. The idea is Medicaid’s vulnerable beneficiaries get medications they need and the state doesn’t go broke paying for them.

As drug prices soar, states say, those fractional rebates no longer suffice to defray the burden of rising costs.

Take, for instance, the hepatitis C cures released in recent years. The price tags come in tens or even hundreds of thousands of dollars and — even after rebates — have cost Medicaid billions. In turn, some states tried to restrict access, so only the sickest patients could get the drugs. Advocates filed suit in response and won based on the argument that such limits violated Medicaid’s statutory drug benefit.

State officials contend that the current Medicaid rebate system may encourage drug price inflation, since a set percentage of a higher price yields a greater profit. Also, the legal requirement to cover most prescriptions leaves little wiggle room to negotiate a better price.

So, Massachusetts wants to go a different route, requesting a federal exemption known as a Section 1115 waiver, which is meant to let states test ways of improving Medicaid. It wants to pick which drugs it covers based on most beneficiaries’ medical needs and which medicines demonstrate the highest rates of cost effectiveness.

It says it will be able to negotiate better prices as a result, saving public dollars while maintaining patients’ access to needed therapies.

The federal Centers for Medicare & Medicaid Services, which will ultimately approve or reject Massachusetts’ proposal, has no deadline for its decision. A Massachusetts spokeswoman said officials are pushing for an answer by year’s end.

Already, though, the pitch is turning heads.

“This is absolutely something a lot of other states are looking very closely at,” said Matt Salo, executive director of the National Association of Medicaid Directors.

If the request is approved, agreed Jane Horvath, a senior policy fellow at the National Academy for State Health Policy, other states would follow suit “in about five minutes.”

Critics worry this change could make it harder for low-income people to get needed medications, without necessarily providing them an alternative. In the past decade, though, it has become commonplace for people with commercial insurance to have limited drug choices — meaning only those medicines listed on a plan’s formulary are covered.

The Pharmaceutical Research and Manufacturers of America (PhRMA), the drug industry’s trade group, has already lodged its displeasure, saying this would limit consumer access and is unnecessary on top of the rebates Medicaid programs receive.

“The pharmaceutical industry has a reputation for being litigious. This would be a big deal for them,” said Andy Schneider, a Medicaid expert at Georgetown University, who worked at CMS under the Obama administration. If CMS approves the waiver, analysts said, the industry would likely sue, though PhRMA wouldn’t comment on potential legal action.

But federal approval is no sure thing.

On one hand, the Trump administration has encouraged states to test changes that would run Medicaid more like a private insurance plan. Through that frame, Massachusetts’ approach seems a logical fit. Though a formal strategy has not been released, President Donald Trump has said his administration intends to bring drug prices “way down.”

On the other hand, analysts said, CMS’ decision-making regarding waivers has proven unpredictable. The agency declined to comment beyond confirming it was reviewing Massachusetts’ request.

It’s clear why states are interested. On average, between 25 and 30 percent of state budgets go to Medicaid, and program directors across the country identify rising drug costs as a major contributor to spending increases, according to a recent survey by the Kaiser Family Foundation. (Kaiser Health News is an editorially independent program of the foundation.)

In Massachusetts, Medicaid accounts for about 40 percent of the state’s budget. Prescription-drug spending has in the past seven years more than doubled — from about $917 million in 2010 to about $1.94 billion last year, according to figures provided by the state health department.

If the waiver is approved, the state’s Medicaid program would cover at least one medication per therapeutic class — that is, per specific medical need.

It also would have an appeals process for people to get their off-formulary drugs covered, if they’re medically necessary.

Number crunchers say it’s hard to estimate what this would save. It depends on how the state negotiates, how industry responds and what the program covers. The potential result is significant, though.

“You’d have to be foolish not to consider this,” said Ameet Sarpatwari, an epidemiologist and lawyer at Harvard Medical School, who studies drug pricing and related legislation.

But consumer groups worry about Medicaid’s low-income beneficiaries, even as they acknowledge that rising drug costs are unsupportable for state budgets.

“The Medicaid population is different from the commercially insured — they’re more vulnerable and have a lot more going on in their lives, and are generally poorer. So they have fewer resources to try to get the services and prescription drugs they need,” said Suzanne Curry, associate director of policy and government relations at Health Care For All, a Massachusetts-based advocacy group.

Although Massachusetts, a state with a long history of innovation, has committed to making sure patients get needed medicine, “you have to ask what will real-world implementation looks like,” said Benjamin Sommers, an associate professor of health policy and economics at Harvard’s public health school. Appeals processes, he noted, can be onerous or restrictive.

And even if Massachusetts receives federal approval, it still couldn’t challenge the cost of certain expensive drugs that are the only offering in their therapeutic class. For instance, Spinraza, which treats the rare but debilitating disease of spinal muscular atrophy, has a price tag of $750,000 for an initial year of treatment. With no therapeutic equivalent, it would still have to be covered.

But states are desperate to push back in new ways and however they can. “We have seen in the past year … drugs that have almost bankrupted state budgets,” Sarpatwari said. “There will be many other states that will be interested in following this lead.”

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

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Medicare Seeks Comment On Ways To Cut Costs Of Part D Drugs

Noting that the true price of a drug is often hidden from consumers, Medicare officials requested comments late Thursday on how to use discounts and rebates to help decrease what enrollees pay for prescriptions.

The proposal request, buried in hundreds of pages released late Thursday afternoon, asked for public comment on how to share the rebates and discounts that are negotiated by manufacturers, pharmacists and insurers. Insurers and pharmacy benefit managers, or PBMs, administer Medicare’s Part D drug program and negotiate behind-the-scenes fees and discounts that are often hidden from public view.

Officials at Medicare “are asking: ‘Tell us what you want,’” said Jack Hoadley, a commissioner with the Medicare Payment Advisory Commission and a health policy analyst at Georgetown University. “They are open to ideas both around manufacturer rebates and the pharmacy price concessions.”

Requests for comments are open until Jan. 16 and, Hoadley said, it may be a challenge to institute any changes before 2020. But other parts of the proposed rule are more likely to take effect sooner. Those include:

  • Allowing enrollees to buy drugs at the pharmacy they prefer, by revising participation rules to motivate more local pharmacies to participate in the program.
  • Lowering drug costs by allowing for midyear changes to prescription drug formularies when a generic becomes available.
  • Treating lower-cost drugs called biosimilars, such as cancer drug Zarxio, the same as generics when determining how much they cost out-of-pocket.

While the request for information on the fees and discounts is not yet a proposal, pressure has been building for the administration to take action.

Earlier this year, the Centers for Medicare & Medicaid Services (CMS) released a fact sheet that set the stage for change, describing how the fees kept Medicare Part D and monthly premiums lower but translated to higher out-of-pocket spending by enrollees and increased costs to the program overall.

Supporters of a rule change say they want the fees disclosed and for them to be applied to what enrollees pay for their drugs. However, there are questions about how the rule would work and whether it would drive up premium prices for Medicare Part D plans.

“There’s a potential to bring about the price reductions at the point of sale,” Hoadley said. “That might come at the expense of higher premiums. Money is going to move from one pot to another.”

In the proposal out Thursday, CMS writes that when manufacturer rebates and pharmacy price concessions are not reflected at the point of sale, Medicare enrollees might get a break with lower premiums but “end up paying a larger share of the actual cost of a drug.”

Congress has also raised concerns, sending letters to CMS officials asking about transparency, sharing the discounts with enrollees and introducing related legislation.

When Sen. Chuck Grassley (R-Iowa) and 10 other senators sent a letter in July to the agency asking for more transparency in the fees, CMS Administrator Seema Verma responded last month that they were analyzing the issue.

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

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Pressure Builds To Cut Medicare Patients In On Prescription Deals

Medicare enrollees, who have watched their out-of-pocket spending on prescription drugs climb in recent years, might be in for a break.

Federal officials are exploring how beneficiaries could get a share of certain behind-the-scenes fees and discounts negotiated by insurers and pharmacy benefit managers, or PBMs, who together administer Medicare’s Part D drug program. Supporters say this could help enrollees by reducing the price tag of their prescription drugs and slow their approach to the coverage gap in the Part D program.

The Centers for Medicare & Medicaid Services (CMS) could disclose the fees to the public and apply them to what enrollees pay for their drugs. However, there’s no guarantee that such an approach would be included in a proposed rule change that could land any day, according to several experts familiar with the discussions.

“It’s obvious something has to be done about this. This is causing higher drug prices for patients and taxpayers,” Rep. Earl “Buddy” Carter (R-Ga.), a pharmacist, said this week.

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While Medicare itself cannot negotiate drug prices, the health insurers and PBMs have long been able to negotiate with manufacturers who are willing to pay rebates and other discounts so their products win a good spot on a health plan’s list of approved drugs.

Federal officials described these fees in a January fact sheet as direct and indirect remuneration, or DIR fees.

In recent years, pharmacies and specialty pharmacies have also begun paying fees to PBMs. These fees, which are different than the rebates and discounts offered by manufacturers, can be controversial, in part, because they are retroactive or “clawed back” from the pharmacies.

The controversy is also part of the reason advocates, such as pharmacy organizations, have lobbied for this kind of policy change.

PBMs have long contended that they help contain costs and are improving drug availability rather than driving up prices.

Pressure has been building for the administration to take action. Earlier this year, the federal agency’s fact sheet set the stage for change, describing how the fees kept Medicare Part D monthly premiums lower but translated to higher out-of-pocket spending by enrollees and increased costs to the program overall.

In early October, Carter led a group of more than 50 House members in a letter urging Medicare to dedicate a share of the fees to reducing the price paid by Part D beneficiaries when they buy a drug. Also in the House, Rep. Morgan Griffith (R-Va.) introduced a related bill.

On the Senate side, Chuck Grassley (R-Iowa) and 10 other senators sent a letter in July to CMS Administrator Seema Verma as well as officials at the Department of Health and Human Services asking for more transparency in the fees — which could lead to a drop in soaring drug prices if patients get a share of the action.

A response from Verma last month notes that the agency is analyzing how altering DIR requirements would affect Part D beneficiary premiums — a key point that muted previous political conversations.

But advocates say the tone of discussions with the agency and on Capitol Hill have changed this year. That’s partly because Medicare beneficiaries have become more vocal about their rising out-of-pocket costs, increasing scrutiny of these fees.

Ellen Miller, a 70-year-old Medicare enrollee in New York City’s borough of Queens, sent a letter to the Trump administration demanding lower drug prices. Miller’s prescription prices went up this year, sending her into the Medicare “doughnut hole” by April, compared with October in 2016. With coverage, Miller pays about $200 a month for several prescriptions that help her cope with COPD, or chronic obstructive pulmonary disease, as well as another chronic illness.

In the doughnut hole, where coverage drops until catastrophic coverage kicks in, her out-of-pocket costs climb to $600 a month.

It’s “ridiculous, and that doesn’t count my medical bills,” Miller said.

The number of Medicare Part D enrollees with high out-of-pocket costs, like Miller, is on the rise. And in 2015, 3.6 million Medicare Part D enrollees had drug spending above the program’s catastrophic threshold of $7,062, according to a report released this week by the Kaiser Family Foundation. (Kaiser Health News is an editorially independent program of the foundation.)

Supporters of the rule change say making the fees more transparent and applying them to what enrollees pay would provide relief for beneficiaries like Miller.

The Pharmaceutical Care Management Association (PCMA), which represents the PBMs who negotiate the rebates and discounts, says changing the fees would endanger the Part D program.

“In Medicare Part D, you have one of the most successful programs in health care,” said Mark Merritt, president and chief executive of PCMA. “Why anybody would choose to destabilize the program is beyond me.”

CMS declined to comment on a vague reference to a pending rule change, which was posted in September.

For now, though, according to the CMS fact sheet, the fees pose two compounding problems for seniors and the agency:

  • Enrollees pay more out-of-pocket for each drug, causing them to reach the program’s coverage gap quicker. In 2018, the so-called doughnut hole begins once an enrollee spends $3,750 out-of-pocket and ends at $5,000, and then catastrophic coverage begins.
  • Medicare, thus taxpayers, pays more for each beneficiary. Once enrollees reach the threshold for catastrophic coverage, Medicare pays the bulk cost of the drugs.

CVS Health, one of the nation’s top three PBMs, released a statement in February calling the fees part of a pay-for-performance program that helps improve patient care. The fees, CVS noted, are fully disclosed and help drive down how much Medicare pays plans that help run the program.

“CVS Health is not profiting from this program,” the company noted.

Express Scripts, also among the nation’s top three PBMs, agreed that the fees lower costs and give incentives for the pharmacies to deliver quality care. As for criticism from the pharmacies, Jennifer Luddy, director of corporate communications for the company, said, “We’re not administering fees in a way that penalizes a pharmacy over something they cannot control.”

Regardless, even if a rule is changed or a law is passed, there is some question as to how easily the fees can translate into lower costs for seniors, in part because the negotiations are so complicated.

When the Medicare Payment Advisory Commission, which provides guidance to Congress, discussed the negotiations in September, Commissioner Jack Hoadley thanked the presenters and said, “In my eyes, what you’ve revealed is a real maze of financial … entanglements.”

Tara O’Neill Hayes, deputy director of health care policy at the conservative American Action Forum, said passing on the discounts and fees to beneficiaries when they buy the drug could be difficult because costs crystallize only after a sale has occurred.

“They can’t be known,” said Hayes, who created an illustration of the negotiations.

“There’s money flowing many different ways between many different stakeholders,” Hayes said.

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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