Moody’s: Proposed changes to 340B program will hurt the finances of nonprofit hospitals

http://www.fiercehealthcare.com/finance/moody-s-proposed-changes-to-340b-program-will-hurt-finances-nonprofit-hospitals?utm_medium=nl&utm_source=internal&mrkid=959610&mkt_tok=eyJpIjoiTURSbU5qazJZbU5sWlRKayIsInQiOiJJTnUxcUsyUm42Y3FjKzBZZXkzQytVR09NYzB0TzNZXC9rXC9YNnBFNXowa0duZGM1SU4yRGJYM2EraXk2TitOa3lwODlWVFNEXC9rc001WUJvcXNjc1U5ZDlYb3FWclNEUjBwbnNlNHc4RVwvc3dGWDVQclJtMDYyZXU4ZmJBNU1lcVkifQ%3D%3D

drugs

Inpatient drug costs will continue to rise for nonprofit and public U.S. hospitals, but the pace of drug price increases will likely slow down amid growing scrutiny of drug manufacturers’ pricing practices.

But even with the slowing rate of price increases, the rising drug costs and potential changes to Medicare 340B payments for outpatient drugs would further reduce hospital margins, according to a new report from Moody’s Investors Service.

Pharmaceutical costs have outpaced hospital revenue growth in recent years, contributing to weaker operating margins, Moody’s finds. “Price increases in recent years were extraordinarily high for certain branded hospital inpatient drugs, but drug manufacturers are pulling back on these increases,” said Diana Lee, a Moody’s vice president. “On the generic drug side, we expect that some of the pressure will ease as the U.S. Food and Drug Administration approves more generic drugs for the first time.”

However, the government’s proposed reduction of Medicare Part B outpatient drug reimbursement to 340B hospitals by roughly 30% would hurt hospital margins.

“Hospitals and health systems of varying size and across the rating spectrum have noted anecdotally that they have benefited from cost savings from this discount drug program,” Lee says. “In some instances, the savings and income gained from this program can be meaningful relative to total operating cash flow. While about half of hospitals in the nation are 340B providers, those that have limited financial flexibility would be most exposed to possible changes to the 340B program.”

Hospitals and industry trade groups have urged the Centers for Medicare & Medicaid Services to withdraw its proposal to cut the drug payments to hospitals in the federal drug discount program. Hospitals use the savings to waive copays and provide drugs and other services for free or reduced costs to low-income patients.

Last week a bipartisan group of more than 220 members of the House of Representatives also told CMS in a letter (PDF) they oppose the proposal.

“This program is a lifeline for the hospitals that serve our most vulnerable patients. These arbitrary cuts will do nothing to improve patient care, or address rising costs in the Medicare program. Instead they simply jeopardize access to the treatments and services that 340B hospitals provide,” said Rep. Mike Thompson (D-Calif.) in an announcement. “There is robust bipartisan agreement that CMS should go back to the drawing board to prevent harm to patients across the country.”

Rep. David P. McKinley (R-W.Va.) said CMS’ proposal was “misguided.” “Our letter shows strong bipartisan opposition to this proposed rule, and hopefully will convince CMS to change course. We must address the high costs of drugs, but this is not the way to do it,” he said.

Meanwhile, the Health Resources and Services Administration has once again delayed (PDF) the effective date of a different 340B final rule that would set drug price ceilings and penalties for drug manufacturers that knowingly overcharge hospitals for drugs purchased under the program. The Department of Health and Human Services said it has delayed the effective date to July 1, 2018, to give more time to make changes to facilitate compliance. “After reviewing the comments received from stakeholders regarding objections on the timing of the effective date and challenges associated with the complying with the final rule, HHS has determined that delaying the effective date to July 1, 2018, is necessary to consider some of the issues raised.”

Right After Trump Blamed High Drug Prices On Campaign Cash, Drugmakers Gave More

Right After Trump Blamed High Drug Prices On Campaign Cash, Drugmakers Gave More

“The cost of medicine in this country is outrageous,” President Donald Trump said at a rally in Louisville, Ky., two months after his inauguration. He went on about how identical pills have vastly lower price tags in Europe.

“You know why?” the president asked, before spreading his hands wide. “Campaign contributions, who knows. But somebody is getting very rich.”

It was March 20, 2017.

The next day, drugmakers donated more money to political campaigns than they had on any other day in 2017 so far, according to a Kaiser Health News analysis of campaign spending in the first half of the year reported in Federal Election Commission filings.

Eight pharmaceutical political action committees made 134 contributions, spread over 77 politicians, on March 21. They spent $279,400 in all, showering Republicans and Democrats in both legislative bodies with campaign cash, according to FEC filings. The second-highest one-day contribution tally was $203,500, on June 20.

Brendan Fischer, who directs election reform programs at the Campaign Legal Center, said he found the timing of the contributions interesting: “I think it’s entirely possible that the drug companies sought to curry favor with members of Congress in order to head off any sort of potential attack on their industry by the press or by the federal government.”

During the Louisville rally, Trump also promised to lower drug prices, and pharmaceutical stocks tumbled afterward.

Although drug industry PACs have different structures and protocols, they are equipped to mobilize quickly to disperse funds to legislators.

“Writing a check doesn’t require much beyond putting pen to paper,” Fischer said.

FEC records show Merck’s PAC led the way that day, donating $148,000 to 60 candidates on March 21. House Speaker Paul Ryan (R-Wis.) received three maximum contributions to his various PACs from the drugmaker, totaling $15,000. Behind him with $7,500 was Sen. Tom Carper (D-Del.), who sits on the Senate Finance Committee.

Merck spokeswoman Claire Gillepsie said the contributions were “not tied to specific events.”

“Decisions on contributions are made at the beginning of a cycle and are approved by a contributions committee,” she said. A White House official referred requests for comment to the presidential campaign, which did not respond.

Companies may donate funds or lobby ahead of impending legislative issues and executive orders, or they may react to something a politician says.

“Presidents get a lot of attention to what they say,” said former congressman Lee Hamilton, who founded the Indiana University Center on Representative Government after three decades in the House of Representatives. “[Companies] have to react to that and defend the drug prices.”

Overall, FEC records show Merck spent $242,500 on campaign contributions and $3.7 million on lobbying in the first half of 2017.

The drugmaker, which makes diabetes pill Januvia, cancer drug Keytruda and shingles vaccine Zostavax, responded to outrage over drug prices earlier this year by revealing on its website that the average list prices of its drugs increased from 7.4 percent to 10.5 percent each year since 2010. Merck said discounts and rebates also increased, meaning it took home less money. But Thomson Reuters pointed out that the price increases outpaced inflation.

FEC records don’t indicate why a company donated to a politician or what that contribution led to, but when House Democrats accused Rep. Jason Chaffetz (R-Utah) of failing to schedule a hearing on prescription drug price hikes in 2015, The Intercept pointed out that the pharmaceutical industry had been among Chaffetz’s top campaign contributors.

Pharmaceutical lobbying dollars have also swelled in 2017, Kaiser Health News previously reported. In their disclosures, drug companies listed tax reform and drug pricing among issues on which they lobbied Congress.

March 21 was also the date of the National Republican Congressional Committee’s annual fundraising dinner, featuring Trump as keynote speaker. The event, which raises money for House Republicans, drew a record-breaking $30 million from a variety of industries, the NRCC reported.

But on that day, drugmakers also gave generously to Democrats and senators, according to FEC filings.

Pfizer and Novo Nordisk PACs donated $76,900 and $38,500 on March 21, respectively, to several dozen candidates on March 21, according to their filings. Five additional pharmaceutical PACs spent between $1,000 and $5,000 on contributions that day.

The companies say the timing was coincidental. A Novo Nordisk spokesman said the March 21 contributions from its PAC had been scheduled in advance “and in no way were tied to any specific statement.”

Pfizer spokeswoman Sharon Castillo said it takes three to four weeks to orchestrate and approve a PAC contribution.

“Pfizer’s political contributions to candidates and elected officials from both parties are led by two guiding principles — preserve and further the incentives for innovation, and protect and expand access to medicines and vaccines for the patients we serve,” Castillo said.

Pfizer’s PAC donated more than any pharmaceutical PAC in the first half of 2017, contributing $418,400 in all — nearly 70 percent more than the first six months of the 2015 election cycle, according to FEC records. In February of this year, the company’s CEO was among several executives from drugmaking firms and other global companies to pen a letter to Congress in support of tax reform. In December 2016, Pfizer received a letter from the Senate Special Committee on Aging, asking it to explain its price increases for the opioid overdose reversal drug, naloxone.

“Pfizer is committed to addressing the prevention, treatment and effective response to the growing opioid abuse in the United States,” Castillo said, adding that the company is donating up to 1 million naloxone doses and $1 million in grants toward opioid addiction awareness efforts.

Novo Nordisk has spent $178,000 on campaign contributions so far this year, or nearly four times more than it spent the first six months of 2015, according to its filings with the FEC. The company is one of the top three insulin makers, and in July, Sen. Amy Klobuchar (D-Minn.) sent the companies letters asking them to justify their price increases. In November, Sen. Bernie Sanders (I-Vt.) and Rep. Elijah Cummings (D-Md.) asked the Justice Department and the Federal Trade Commission to investigate the insulin makers for possible price collusion. The companies have denied the allegations.

“We’re certainly aware of policymakers’ concerns about the price of insulin, and we’re committed to collaborate with all those involved in the healthcare supply chain to ensure patient access,” said Novo Nordisk spokesman Ken Inchausti.

“From the public record, you can’t tell for sure” what prompted the spike in political contributions from pharmaceutical companies, said Tony Raymond, a former analyst at the Federal Election Commission who founded Political Money Line to track campaign finance. The PACs could have been “killing two birds with one stone” by donating to legislators across the board on the night of the NRCC fundraiser, or they could have been responding to what Trump said.

“We’re talking about a couple phone calls and then they could courier a check over to someone,” he said.

Presidential candidates in fantasy land over health care

https://www.publicintegrity.org/2015/09/28/18071/presidential-candidates-fantasy-land-over-health-care

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Commentary: candidates say this and that about health care, but it’s the insurers and pharmaceutical companies that call the tune.

Presidential candidates from both parties are full of sound and fury about various aspects of the U.S. health care system, but unless we as a nation get serious about big money in politics, all the noise will ultimately amount to nothing.

Every one of the Republican candidates has pledged to repeal and replace the Affordable Care Act. But I’m not sure they realize that the interests of the insurance and pharmaceutical industries,  as well as hospitals and physicians,  were considered first and foremost as the law was being drafted.

Yes, Obamacare has brought some needed reforms to the insurance marketplace and has enabled millions of previously uninsured Americans to finally get coverage. But health insurers have not only thrived since the law was passed, they are more profitable than ever, and that has made their executives and investors happy—and richer. The stock prices of the five largest for-profit insurers have tripled and in some cases quadrupled since the law was passed.

And now that many more people can afford to see a doctor and pick up their prescriptions and hospitals are not having to provide as much charity care, most health care providers would be just as upset as the insurers if a repeal of the law became a real possibility.

On the Democratic side, Hillary Clinton and Bernie Sanders have both announced plans to fix some of the problems not addressed by the ACA.  Both of them said they favored allowing Medicare to negotiate with pharmaceutical companies for lower prices and they both want to make it legal for Americans to re-import drugs from Canada and elsewhere.  They also criticized the outsized profits of many drug makers and pledged to force the companies to provide more information about how much they actually spend on research and development.

Clinton also proposed capping out-of-pocket drug spending for some people with chronic conditions at $250 a month. Even though her campaign acknowledged that the cap would apply to only about a million people, the proposal drew sharp rebukes from both the insurance and pharmaceutical industries.

America’s Health Insurance Plans, the industry’s largest PR and lobbying group, said it opposed any plan “that would impose arbitrary caps on insurance coverage.”

AHIP even criticized Clinton’s and Sanders’ plans to enable Medicare to negotiate for lower drug prices, saying that imposing caps and “forc(ing) government negotiation on prescription drug prices will only add to the cost pressures facing individuals and families across the country.”

If you’re wondering why insurers don’t want Medicare to have the ability to negotiate with drug companies, here’s why: it would make their Medicare Advantage plans, which offered prescription drug benefits to seniors long before the traditional Medicare program could, much less attractive. The irony is that private insurers can negotiate with drug companies but the federal government cannot.

And if you’re wondering why that is, here’s why: lobbyists for drug companies and insurers have defeated every bill that has been proposed over the years to allow Medicare to negotiate for drug prices, just as they have been able to defeat every bill—even those with bipartisan support—that would allow Americans to order medications from Canadian pharmacies.

When Congress was considering legislation to add a prescription drug benefit to Medicare in 2003, industry lobbyists insisted that language that would have authorized the government to negotiate with drug companies be stripped out of the bill.  Six years later, they won again when they the Obama administration caved in to pressure from the drug companies and made certain that the ACA would not include drug negotiation authority for Medicare. This despite the fact that Obama had said when he was a senator from Illinois that, “Drug negotiation is the smart thing to do and the right thing to do.”

In fact, the drug companies always win, which is why Americans pay far more than citizens of any other country for prescription medications. We pay exactly 100 percent more per capita for pharmaceuticals than the average paid by citizens of the 33 other developed countries that comprise the Organization for Economic Cooperation and Development (OECD).

Obama also once supported drug re-importation, as did Sen. John McCain, the Arizona Republican who lost to Obama in the 2008 presidential election. In 2012, two years after the passage of the Affordable Care Act, McCain teamed up with Sen. Sherrod Brown, (D-Ohio) in another attempt to get Congress to pass a drug re-importation bill.

When it became clear that his bill would not pass, McCain took to the floor to denounce the ability of well-financed special interests to control the federal government.

“What you’re about to see is the reason for the cynicism that the American people have about the way we do business in Washington. (The pharmaceutical industry)… will exert its influence again at the expense of low-income Americans who will again have to choose between medication and eating.”

Don’t expect that to change anytime soon. As long as interest groups can spend unlimited amounts of money to influence elections and can hire hundreds of lobbyists to do their bidding, millions of Americans will have to decide between health care and eating, while executives and shareholders get richer and richer.

Everyone Says We Must Control Exorbitant Drug Prices. So, Why Don’t We?

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Of all the promises President Donald Trump made for the early part of his term, controlling stinging drug prices might have seemed the easiest to achieve.

An angry public overwhelmingly wants change in an easily vilified industry. Big pharma’s recent publicity nightmare included thousand-percent price increases and a smirking CEO who said, “I liken myself to the robber barons.” Even powerful members of Congress from both parties have said that drug prices are too high.

But any momentum to address prescription drug costs — a problem that a large number of Americans now believe government should solve — has been lost amid rancorous debates over replacing Obamacare and stalled by roadblocks erected via lobbying and industry cash.

“There is a very aggressive lobby that is finding any and all means to thwart any reform to a system that has produced very lucrative profits,” said Ameet Sarpatwari, an epidemiologist and lawyer at Harvard Medical School who follows drug legislation. “Everything that’s coming out is being hit and hit hard — even stuff that’s commonsensical.”

Those in Congress concerned with health policy have spent much of the year advancing proposals to overhaul the Affordable Care Act, none of which would affect pharmaceutical pricing. The latest Republican proposal, by Senators Lindsey Graham of South Carolina and Bill Cassidy of Louisiana, is no different.

Meanwhile, more than two dozen bills aimed at curbing drug costs have been introduced in this or the previous Congress, according to the Drug Pricing Lab, a Memorial Sloan Kettering Cancer Center program that has catalogued ideas for reducing prices. Many have bipartisan support.

Proposals include importation from other developed countries, where regulations keep prices down; allowing government to negotiate the price of Medicare-covered drugs; speeding approval of cheaper generics; requiring notification before raising drug prices; and restricting consumer drug ads.

 

California Drug Price Bill Sweeping In Scope, Lacking In Muscle

California Drug Price Bill Sweeping In Scope, Lacking In Muscle

A California bill headed to the governor’s desk may be the most sweeping effort in the nation to shine a light on drug pricing, but it lacks the muscle being applied in other states to directly hold those prices down.

The idea behind the law is that if everyone knows when and why prices are rising, political leaders eventually will be more empowered to challenge those increases.

“Transparency is a longer-term play. It’s about building political will, getting more information and helping build the case for the changes that we need” in order to have more sustainable drug prices, said Ted Lee, a senior fellow at Yale University’s Global Health Justice Partnership, which recently released a report on steps states can take to reduce drug prices.

Some experts have said transparency alone is not enough to bring down drug prices, and more extensive changes are needed.

“We need really far-reaching reforms that say ‘sorry, pharma, we’ve had enough. We’re not going to do it your way. We’re going to do it our way,’” said Peter Maybarduk, director of the Global Access to Medicines Program at Public Citizen, a consumer watchdog group. The group wants sweeping changes at the federal level that would reduce spending on drugs, such as allowing Medicare to negotiate prices with drug companies and limiting market exclusivity on certain pharmaceuticals.

The California measure would put a spotlight on drug prices from different angles, imposing reporting obligations on both insurers and drug manufacturers.

The campaign for the bill brought together some unlikely political allies in the California State Capitol this year: Consumer advocates, insurers, employer groups, labor unions and even a prominent billionaire environmentalist shared the same platforms at press conferences, urging legislators to force drug manufacturers to disclose and justify their high prices.

Gov. Jerry Brown has about a month to decide whether to sign the bill. Brown rarely comments publicly about legislation before he takes action, but a spokesman, Brian Ferguson, said the governor’s office had worked closely with legislative staff on the bill.

The pharmaceutical industry remains fiercely opposed to the legislation and has vowed to lobby the governor against it.

The measure “will not improve the accessibility or affordability of medicines for patients,” Priscilla VanderVeer, deputy vice president of public affairs for the Pharmaceutical Research and Manufacturers of America (PhRMA), said in an email.

Under the proposed law, pharmaceutical companies would be required to give state agencies and insurers 60 days’ notice if they planned a price increase of more than 16 percent over two years on drugs with a wholesale cost of $40 or higher. And they would have to explain the reasons for the increase.

Manufacturers would also have to report the introduction of certain high-priced drugs to market, explain their marketing plans for the product and say if it is an improvement on drugs that are already available.

Health plans would be obliged to report to state regulators on the drugs with the highest annual cost increases and document how much drug spending factored into their premiums.

Yale’s Lee said both price control and transparency laws play important roles in regulating prescription drug costs. Ellen Albritton, a senior policy analyst at Families USA, said transparency measures such as California’s bill are a “key part” of what is needed for the U.S. to get drug prices under control. She said various actions by states, taken together, build the case for federal action.

This year, at least two states have passed laws that tackle high drug prices head-on and may have a more immediate effect on consumer costs than the California measure, Lee said.

Maryland and New York, for example, passed laws this year that use a variety of legal levers to impose financial penalties or require discounts if prices are too high.

Maryland’s law empowers the state’s attorney general to take legal action if it determines drugmakers are “price gouging” on generic drugs. A violation by the company could trigger refunds to consumers and a fine for the manufacturer.

The New York law introduces a drug price cap in the state’s Medicaid program and would require rebates on drugs that exceed their limits, according to a Yale University analysis.

The California bill’s author, Sen. Ed Hernandez (D-Covina), said he didn’t believe price controls were the right approach. “I still believe in the basic tenet of free enterprise,” he said. The market should play itself out.”

But California’s bill is more comprehensive in some ways than other states’ laws. It requires new reporting in the private and public insurance markets and encompasses generic, brand-name and specialty pharmaceuticals. Other state laws affect only one payer, as in New York, or one subset of drugs, as in Maryland.

Vermont has a transparency measure, passed last year, that mandates reporting on a narrower subset of drugs than California’s proposal. Nevada’s recently passed drug price law requires disclosures from insulin makers.

Hernandez, who chairs the state Senate’s health committee, said the California bill could be a national model for drug price policy because transparency works to bring costs down. Consumers across state lines will benefit from California’s law, he said.

“I encourage the federal government, especially California’s representatives in the U.S. House and Senate, to consider similar legislation as we continue this discussion at a national level,” Hernandez said.

He said industry opposition to his bill has been fierce, with “legions” of lobbyists clogging Capitol hallways and full-page ads in local newspapers during the final days of the legislative session, which ended Friday.

Despite the industry’s resistance, Hernandez said, the effort to address high drug costs had bipartisan support and rallied players who are usually at odds on other matters.

“It has become a huge coalition because it’s impacting everybody,” he said.

Facebook Live: The Prescription Drug Pricing Pipeline

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Who contributes to what you pay at the pharmacy? Why are prescription drugs so expensive in the United States? In this Facebook Live, KHN’s Julie Appleby talks with Stephanie Stapleton and answers readers’ questions about the prescription drug pricing pipeline and the industry stakeholders who have a role in what you pay.

For more in-depth conversations with KHN reporters, check out our Facebook video archive.

Here are videos and a chart to help make sense of drug pricing. And remember you can republish KHN content for free:

Pharmacy benefit managers — companies that are often unnoticed and even less understood by most consumers — hold an important place in the prescription drug-pricing pipeline. In this video, Kaiser Health News details the emergence of these multimillion-dollar corporations and the impact they have on medication costs and patients’ access to these treatments.

Podcast: ‘What The Health?’ Why Is It So Difficult To Control Drug Prices?

http://khn.org/news/podcast-what-the-health-why-is-it-so-difficult-to-control-drug-prices/?utm_campaign=KFF%3A%20The%20Latest&utm_source=hs_email&utm_medium=email&utm_content=55441015&_hsenc=p2ANqtz-9e7_gZXAdvCjfT8GtdskXSSOirfF7966DDJa4zoZD9o34ccah4IJn9ru3eZt6HEtUGe2i4BhJZUdiiRH2KC7RVkVAPOQ&_hsmi=55441015

Mary Agnes Carey of Kaiser Health News, Sarah Karlin-Smith of Politico, Margot Sanger-Katz of The New York Times and Julie Appleby of Kaiser Health News discuss the recent extension of cost-sharing subsidies for millions of low-income beneficiaries on the Affordable Care Act’s marketplaces — as well as the state of play on Capitol Hill and in the states concerning efforts to lower prescription drug costs.

Climbing Cost Of Decades-Old Drugs Threatens To Break Medicaid Bank

http://khn.org/news/climbing-cost-of-decades-old-drugs-threatens-to-break-medicaid-bank/

Skyrocketing price tags for new drugs to treat rare diseases have stoked outrage nationwide. But hundreds of old, commonly used drugs cost the Medicaid program billions of extra dollars in 2016 vs. 2015, a Kaiser Health News data analysis shows. Eighty of the drugs — some generic and some still carrying brand names — proved more than two decades old.

Rising costs for 313 brand-name drugs lifted Medicaid’s spending by as much as $3.2 billion in 2016, the analysis shows. Nine of these brand-name drugs have been on the market since before 1970. In addition, the data reveal that Medicaid outlays for 67 generics and other non-branded drugs cost taxpayers an extra $258 million last year.

Even after a medicine has gone generic, the branded version often remains on the market. Medicaid recipients might choose to purchase it because they’re brand loyalists or because state laws prevent pharmacists from automatically substituting generics. Drugs driving Medicaid spending increases ranged from common asthma medicines like Ventolin to over-the-counter painkillers like the generic form of Aleve to generic antidepressants and heartburn medicines.

Among the stark examples:

  • Ventolin, originally approved in 1981, treats and prevents spasms that constrict patients’ airways and make it difficult to breathe. When a gram of it went from $2.58 to $2.90 on average, Medicaid paid out an extra $54.5 million for the drug.
  • Naproxen sodium, a painkiller originally approved in 1994 as brand-name Aleve, went from costing Medicaid an average of $0.72 to $1.70 a pill, an increase of 136 percent. Overall, the change cost the program an extra $10 million in 2016.
  • Generic metformin hydrochloride, an oral Type 2 diabetes drug that’s been around since the 1990s, went from an average 10 cents to 13 cents a pill from 2015 to 2016. Those extra three pennies per pill cost Medicaid a combined $8.3 million in 2016. And cost increases for the extended-release, authorized generic version cost the program another $6.5 million.

“People always thought, ‘They’re generics. They’re cheap,’” said Matt Salo, who runs the National Association of Medicaid Directors. But with drug prices going up “across the board,” generics are far from immune.

Historically, generics tend to drive costs lower over time, and Medicaid’s overall spending on generics dropped $1.6 billion last year because many generics did get cheaper. But the per-unit cost of dozens of generics doubled or even tripled from 2015 to 2016. Manufacturers of branded drugs tend to lower prices once several comparable generics enter a market.

Medicaid tracks drug sales by “units” and a unit can be a milliliter or a gram, or refer to a tablet, vial or kit.

Old drugs that became far more expensive included those used to treat ear infections, psychosis, cancer and other ailments:

  • Fluphenazine hydrochloride, an antipsychotic drug approved in 1988 to treat schizophrenia, cost Medicaid an extra $8.5 million in 2016. Medicaid spent an average $1.39 per unit in 2016, an increase of 347 percent vs. the year before.
  • Depo-Provera was first approved in 1960 as a cancer drug and is often used now as birth control. It cost Medicaid an extra $4.5 million after its cost more than doubled to $37 per unit in 2016.
  • Potassium phosphates — on the market since the 1980s and used for renal failure patients, preemies and patients undergoing chemotherapy — cost Medicaid an extra $1.8 million in 2016. Its average cost to Medicaid jumped 290 percent, to $6.70 per unit.

A shortage of potassium phosphates began in 2015 after manufacturer American Regent closed its facility to address quality concerns, according to Erin Fox, who directs the Drug Information Center at the University of Utah and tracks shortages for the American Society of Health-System Pharmacists.

When generics enter a market, competition can drive prices lower initially. But when prices sink, some companies inevitably stop making their drugs.

“One manufacturer is left standing … [so] guess who now has a monopoly?” Salo said. “Guess who can bring prices as far up as they want?”

According to a Food and Drug Administration analysis, drug prices decline to about half of their original price with two generic competitors on the market and to about a third of the original price with five generics available. But if there’s only one generic, a drug’s price drops just 6 percentage points.

The increases paid by Medicaid ultimately fall on taxpayers, who pay for the drugs taken by its 68.9 million beneficiaries. And those costs eat “into states’ ability to pay for other stuff that matters to [every] resident,” said economist Rena Conti, a professor at the University of Chicago who co-authored a National Bureau of Economics paper about generic price hikes in July. The manufacturers’ list prices for the drugs named here also rose in 2016, according to Truven Health Analytics, which means customers outside Medicaid also paid more.

Conti said that about 30 percent of generic drugs had price increases of 100 percent or more the past five years.

Medicaid spending per unit doesn’t include rebates, which drug manufacturers return to states after they pay for the drugs upfront. Such rebates are extremely complicated, but generally start at the federally required 23.1 percent for brand-name drugs, plus supplemental rebates that vary by state, Salo said. Final rebate amounts are considered proprietary, he noted. “All rebates are completely opaque … [it’s] “black-box stuff.”

Fox said drug prices could also jump when a pharmaceutical product changes ownership, gets new packaging or just hasn’t had a price increase in a long time.

Recently named FDA Commissioner Scott Gottlieb has made increasing generic competition a core mission. Plans include publishing lists of off-patent drugs made by one manufacturer and preventing brand-name drugmakers from using anti-competitive tactics to stave off competition.

Doctors, pharmacists and patients don’t always receive warning when a price hike is about to occur, Fox said.

“Sometimes, we will get notices. Other times, it’s like a bad surprise,” she said, adding that the amount of wiggle room for alternatives depends on the drug and the patient.

Following some price hikes, doctors can use fewer units of a drug or switch it out entirely, she said.

Ofloxacin otic, long used to treat swimmer’s ear, became so expensive when generic manufacturers exited the market that doctors started using eye drops in patients’ ears, Fox said.

When old drugs get more expensive, hospitals try to eliminate waste by making smaller infusion bags and keeping really expensive drugs in the pharmacy instead of stocked in readily available shelves and drawers. But that’s not always possible.

“These drugs do have a place in daily therapy. Sometimes they’re life-sustaining and sometimes they’re lifesaving,” said Michael O’Neal, a pharmacist at Vanderbilt University Medical Center. “In this case, you just need to take it on the chin, and you hope one day for competition.”

47 Hospitals Slashed Their Use Of 2 Key Heart Drugs After Huge Price Hikes

http://www.npr.org/sections/health-shots/2017/08/09/542485307/47-hospitals-slashed-their-use-of-two-key-heart-drugs-after-huge-price-hikes?utm_source=Sailthru&utm_medium=email&utm_campaign=Newsletter%20Weekly%20Roundup:%20Healthcare%20Dive%2008-12-2017&utm_term=Healthcare%20Dive%20Weekender

Even before media reports and a congressional hearing vilified Valeant Pharmaceuticals International for raising prices on a pair of lifesaving heart drugs, Dr. Umesh Khot knew something was very wrong.

Khot is a cardiologist at the Cleveland Clinic, which prides itself on its outstanding heart care. The health system’s internal monitoring system had alerted doctors about the skyrocketing cost of the drugs, nitroprusside and isoproterenol. But these two older drugs, frequently used in emergency and intensive care situations, have no direct alternatives.

“If we are having concerns, what is happening nationally?” Khot wondered.

As it turned out, a lot was happening.

Following major price increases, use of the two cardiac medicines has dramatically decreased at 47 hospitals, according to a research letter Khot and two others published Wednesday in the New England Journal of Medicine.

The number of patients in these hospitals getting nitroprusside, which is given intravenously when a patient’s blood pressure is dangerously high, decreased 53 percent from 2012 to 2015, the researchers found. At the same time, the drug’s price per 50 milligrams jumped more than 30-fold — from $27.46 in 2012 to $880.88 in 2015.

The use of isoproterenol, key to monitoring and treating heart-rhythm problems during surgery, decreased 35 percent as the price per milligram rose from $26.20 to $1,790.11.

The two drugs, which are off patent, have long been go-to medicines for doctors.

“This isn’t like a cholesterol medicine; these are really, very specialized drugs,” says Khot, who is lead author on the peer-reviewed research letter. When patients get the drugs, he says, “they are either sick beyond sick in intensive care or they’re under anesthesia [during] a procedure.”

Valeant bought the drugs in early 2015 from Marathon Pharmaceuticals. Last year, Valeant announced a rebate program to lower the price hospitals paid for the drugs.

And Valeant’s Lainie Keller, a vice president of communications, says the company is committed to limiting price increases.

“The current management team is committed to ensuring that past decisions with respect to product pricing are not repeated,” Keller says.

Pharmacist Erin Fox, the director of drug information at University of Utah Health Care, said the findings by Khot and his colleagues reveal “exactly what a lot of pharmacists have been talking about. When prices are unsustainable, you have to stop using the drug whenever you can. You just can’t afford it.”

Fox says her Utah health system has removed isoproterenol from its bright-red crash carts, which are stocked for emergencies like heart attacks. But Nitroprusside is more difficult to replace.

“If you need it, you need it,” Fox says. “That’s exactly why the usage has not gone down to zero, even with the huge price increases.”

Cleveland Clinic leaders spent months investigating each drug’s use and potential alternatives, Khot says.

“We’re not going to ration or restrict this drug in any way that would negatively impact these patients,” Khot says, adding that he hopes to do more research on how the decreased use of both drugs has affected patients.

Dr. Richard Fogel is a cardiologist and electrophysiologist at St. Vincent, an Indiana hospital that’s part of Ascension, a large nonprofit chain with facilities in 22 states and the District of Columbia. He told a Senate committee last year that the cost of the two drugs alone drove a nearly $12 million increase in Ascension’s spending over one year.

“While we understand a steady, rational increase in prices, it is the sudden, unfounded price explosions in select older drugs that hinder us in caring for patients,” Fogel told the committee.

The NEJM letter also analyzed the use of two drugs that remained stable in price over that time period, as a control group — nitroglycerin and dobutamine. The number of patients treated with nitroglycerin, a drug used for chest pain and heart failure, increased by 89 percent. Khot warns that the drugs can’t always be used as substitutes.