Tagged Cost and Quality

State Highlights: Ga. Senate Panel Amends But OKs Surprise Medical Bill Measure; Conn. Non-Profit Hospitals Fight Bid To Make Them Pay Local Property Taxas

Outlets report on news from Georgia, Connecticut, Minnesota, Kansas, Texas, Massachusetts, Florida, Washington, Arizona, Wisconsin, Ohio and Louisiana.

Georgia Health News: After Tweak In Payment Formula, Senate Committee OKs Remedy For ‘Surprise’ Billing
A Georgia Senate panel Thursday passed legislation to halt ‘’surprise’’ medical billing – but not without a last-minute amendment that changed the contentious payment formula. The Health and Human Services Committee approved Senate Bill 8, which will address those situations in which patients get unexpected bills from providers who are not in their network, even though the hospital is a network facility. (Miller, 2/16)

The CT Mirror: CT Hospitals Launch TV Ad To Protest New Tax Proposal
Connecticut’s hospital industry launched a new television ad Thursday to protest Gov. Dannel P. Malloy’s proposal to end nonprofit hospitals’ exemption from local property taxation. The Connecticut Hospital Association announced the commercial will air starting today on network and cable television stations, and also can be seen at http://nomorehospitaltax.org. The commercial opens by listing a variety of occupations and one common thread among the people in all of them: they all pay a price when taxes rise on Connecticut hospitals. (Phaneuf, 2/16)

The CT Mirror: Budget Cuts Cost CT Medical Examiner’s Office Full Accreditation 
The Connecticut Office of the Chief Medical Examiner (OCME) has lost its full accreditation and was downgraded to provisional status because of staffing and facility shortcomings driven largely by budget cuts. The National Association of Medical Examiners (NAME), which ordered the downgrade, will reassess Connecticut’s status in September, the state office announced this week. (Phaneuf, 2/16)

The Star Tribune: Report On Minnesota Hospital Errors Sees Problems With Lost Tissue Samples 
The misplacing of irreplaceable biological specimens has proved to be a vexing problem for Minnesota hospitals, which reported 31 instances in the 12 months that ended last Oct. 6. The state’s 13th annual report on hospital “adverse events,” released Thursday, included 336 reportable mistakes, including operations on the wrong body parts and disabling medication errors. But few were as common as lost tissue samples, which also can have serious consequences. (Olson, 2/17)

KCUR: House Committee OKs Involuntary Hold Plan For Kansans In Mental Health Crisis 
A bill that would allow treatment centers to detain Kansans in mental health crisis for up to three days moved forward Thursday after months of work to develop a compromise. A similar bill proposed last year raised concerns that it would deprive Kansans with mental illnesses of their due process rights. A committee of law enforcement officers, treatment providers, mental health advocates and others met six times between legislative sessions to come up with a compromise bill that still fulfilled the original goal of providing short-term mental health care. (Wingerter, 2/17)

Stat: Texas Board Recommends Sanctions Against Stanislaw Burzynski
Along-running battle between the Texas Medical Board and controversial Houston doctor Stanislaw Burzynski could be coming to a head. The board said this week that it had proposed $380,000 in fines and a stiff set of sanctions for Burzynski’s failure to adhere to proper medical procedures in treating cancer patients. The decision is preliminary, and will be submitted and formally reviewed on March 3. (Tedeshci, 2/16)

Boston Globe: For This Hospital Chaplain, Work Is A Matter Of Life And Death 
As [Alyssa] Adreani, 41, likes to point out, [she] isn’t hanging out in the Newton hospital’s chapel and doesn’t wear a collar or a cross. She makes the rounds of the neonatal intensive care unit, oncology, ICU, orthopedics, and medical/surgical units, following her personal Golden Rule of chaplaincy: “Wear comfortable shoes.” The Globe spoke with Adreani about how hospital chaplains are considered part of the treatment team, sometimes even improving health outcomes. (Atoji Keene, 2/16)

Seattle Times: State Regulators Investigating Swedish’s Cherry Hill Hospital, Top Surgeon 
State health regulators have launched an investigation into the practices of Swedish Health Services’ Cherry Hill hospital, days after a Seattle Times report uncovered wide-ranging concerns about patient care at the facility. David Johnson, a spokesman with the state Department of Health, said Thursday a case-management team authorized the new investigation after reviewing The Seattle Times’ findings. Johnson added that the state Medical Commission, which handles issues involving specific doctors, was in the process of investigating complaints filed against Dr. Johnny Delashaw. (Baker, 2/16)

Arizona Republic: New Flu-Tracking App Uses Maricopa County As Beta Site
A California-based health diagnostics company has chosen Maricopa County as the pilot testing site for Communidy, a free web app that allows users to see the age and county of people who currently have the flu. The app, which displays real-time data from doctors’ offices, hospitals, clinics and labs, may encourage people to get vaccinated early, said Machrina Leach, nurse program manager at the Maricopa County Department of Public Health. (Bosch and Jha, 2/16)

Milwaukee Journal Sentinel: United Community Center Opens Third Residential Treatment Facility
This month, the United Community Center, commonly known as UCC, opened its third residential treatment facility for people working to overcome alcoholism and drug addictions. The $1.1 million residence, named Latinas Unidas II, will enable 16 more women to participate in UCC’s residential treatment program at any given time. The new residence, UCC’s second for women, also will treat women who are pregnant or who have infant children, and the program will include prenatal and post-partum care, child care coordination and parenting classes. (Boulton, 2/16)

Cleveland Plain Dealer: Summa Health Gift Establishes Traumatic Stress Chair 
Longtime philanthropists Jim and Vanita Oelschlager have donated more than $4 million to Summa Heath over the last three decades. This week, couple’s foundation provided another donation to Summa Health to establish a Chair in Traumatic Stress. Dr. Patrick Palmieri, director of the Traumatic Stress Center, will serve as the first Oelschlager Chair. As director of the Summa Health Traumatic Stress Center, Palmieri is responsible for the center’s clinical, training and research activities for patients experiencing post-traumatic stress disorder, anxiety and depression. (Becka, 2/16)

Health News Florida: Students Discover Lead In Tap Water May Be Common In Older Homes 
Last semester, the students in Laura Manke’s community cares class embarked on a project, collecting samples of tap water from their homes.  And testing provided by University of South Florida researchers revealed that all of the 46 samples contained lead.Fortunately, the amount of lead in the water in their homes fell below levels that would trigger action under Environmental Protection Agency standards. But experts, including the EPA, say any amount of lead is not good for the body, especially in children under six. Damage can be permanent. (Ochoa, 2/16)

Pioneer Press: Forest Lake Nurse Avoids Jail Time For Stealing Patient’s Medication
A Forest Lake nurse who pretended to check on a patient so he could steal the man’s medication evaded jail time for the offense. Gregory Thomas Welcher, 30, was sentenced in Ramsey County District Court Thursday to five years probation on one count of felony-level theft. He also was ordered to spend one day in jail, but was given credit for the day he already logged at the Ramsey County Correctional Facility. Welcher pleaded guilty to the charge this past December. (Horner, 2/16)

Shreveport Times: Workshop Lets Caregivers Take Care Of Themselves
Social workers seeking a moment of rest from careers steeped in others’ suffering participated in a free “Compassion Fatigue” workshop on Thursday. The workshop, presented by the Noel Memorial United Methodist Church’s arts program, aimed at offering those who take care of others a chance to center and to take care of themselves. (Talamo, 2/16)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

5 Reasons Why An $89K Drug Has Congress Fuming

The latest flashpoint in the ongoing debate over high drug prices is Emflaza, an $89,000-a-year drug that treats Duchenne muscular dystrophy.

People who have been watching the drug price issue closely, however, can reasonably ask why there is so much heat at that price tag? Late last year, two drugs went on the market for six-figure prices. Exondys 51 sells for $300,000 a year and Spinraza for a whopping $750,000.

While they did draw headlines, neither of those drugs sparked the bipartisan congressional firestorm and patient outcry that Emflaza ignited this week. Here are five reasons why:

1. It’s not a new drug.

Emflaza, the brand name for deflazacort, has never been approved for sale in the United States, but the steroid has been sold for decades in other countries — at much lower prices.

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Some Duchenne patients in the U.S. have imported deflazacort from Europe and Canada for years for just $1,000 to $1,600 annually. Mohammed Haider, 27, of Mount Laurel, N.J., said he’s been buying it from European pharmacies since he was seven years old.

In medical circles, deflazacort is often compared with the widely used steroid, prednisone, which has been around since 1955.

2. It’s not a scientific breakthrough.

Exondys 51 and Spinraza are medical breakthroughs that target genes to treat underlying diseases.

Emflaza, on the other hand, addresses symptoms of muscle weakness and deterioration by decreasing inflammation and suppressing the immune system in Duchenne patients.

Dr. Aaron Kesselheim, an associate professor of medicine at Harvard Medical School, questions why Marathon won approval using the Orphan Drug Act, which was created by Congress to motivate companies to develop drugs to treat rare diseases.

Instead, Kesselheim said, this is a steroid that could be used more broadly.

“There’s no indication to me that this is a steroid specific to muscular dystrophy,” he said.

Marathon had considered researching whether Emflaza could treat patients with juvenile arthritis, but the company said last week it has no plans to pursue that use.

3. Emflaza doesn’t work alone.

The drug needs to be part of a cocktail of drugs Duchenne patients take, said Pat Furlong, the founder of the advocacy group Parent Project Muscular Dystrophy. She questions how many high-priced drugs insurers will pay for.

“Where is the breaking point where any given insurer says [that’s] too much,” and stops covering the drugs, Furlong said.

Marathon said the price was set based on a number of factors, including recouping its research costs. The FDA required the drug to be submitted as a new drug — regardless of its approval in other countries. A company spokeswoman said Marathon funded 17 studies for Emflaza’s approval.

4. Marathon has cultivated relationships in the Duchenne patient community.

At a heated meeting with patient advocates on Monday, Marathon CEO Jeff Aronin announced a delay in the rollout of the drug and later released an open letter saying the company would “not move forward with commercialization” until discussing options with Duchenne community leaders.

The company, which is a corporate sponsor for Parent Project Muscular Dystrophy, announced it will continue offering an expanded access program to patients. He also said patients currently receiving the drug from other countries can continue importing.

Joel Wood, whose Duchenne foundation has received money from Marathon, said he believed the company will uphold financial promises to patients.

“I will be the first one to pick up a pitch fork” if the company fails to do so, said Wood, who has a son with Duchenne.

5. Timing is everything.

There was muted criticism when Spinraza’s $750,000 price was announced over the Christmas holiday.

Perhaps emboldened by President Donald Trump who recently said drug makers are “getting away with murder,” lawmakers from both sides of the aisle are expressing anger about Emflaza’s price and demanding answers from the drugmaker.

Rep. Robert Aderholt, a Republican from Alabama who chairs the subcommittee that oversees FDA’s appropriations, said Monday that Emflaza is a “tipping point” on the issue.

Last week, Republican Sen. Chuck Grassley, chairman of the Senate Judiciary Committee, announced he has opened an inquiry into potential abuses of the Orphan Drug Act that may have contributed to high prices on commonly used drugs.

Sen. Bernie Sanders (I-Vt.) and Rep. Elijah Cummings (D-Md.) sent a letter to Marathon Monday calling Emflaza’s price “unconscionable.” They asked the company to explain itself and lower the price.

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

Categories: Cost and Quality, Health Industry, Syndicate

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Perspectives: Drugmakers Hike Prices Because They Can. The How Gets A Little More Complicated.

Read recent commentaries about drug-cost issues.

Bloomberg: Games Drugmakers Play
One of my goals when I joined Bloomberg View a month ago was to dive into the contentious subject of drug pricing. I’d like to explain to readers why the pharmaceutical companies have been raising prices so relentlessly these past half-dozen years, even as the practice has become a huge issue on Capitol Hill and in the country. My friend Barry Werth, who has written two fine books about the biotech company Vertex, says the answer is simple: “Because they can.” But the details of how they do it can be murky, complicated — and sometimes underhanded. (Joe Nocera, 2/13)

The Washington Post: Why People Should Be Able To Buy Drugs Approved In Other Countries
For years, muscular dystrophy patients in the United States have been purchasing the drug deflazacort — used to stabilize muscle strength and keep patients mobile for a period of time — from companies in the United Kingdom at a manageable price of $1,600 a year. But because an American company just got approval from the Food and Drug Administration to sell the drug in the United States, the price of the drug will soar to a staggering $89,000 annually, the Wall Street Journal reported last week. (Robert Gebelhoff, 2/14)

The Wall Street Journal: Don’t Ignore Politicians’ Ire Over Orphan Drugs
The latest drug-pricing drama has pushed the debate in a new direction. It would be a mistake for biotech shareholders to dismiss the uproar as the same old story. Marathon Pharmaceuticals’ decision to list the old steroid deflazacort at an $89,000 annual price to treat Duchenne muscular dystrophy, and the resulting outcry, has had an immediate impact on the company. Marathon said Monday that it plans to delay the drug’s U.S. launch, scheduled for next month, after politicians in Washington expressed anger over the company’s plans. (Charley Grant, 2/14)

Los Angeles Times: Trump Needs To Be Careful In Deregulating The Drug Industry
In a recent meeting with pharmaceutical-industry bigwigs, President Trump declared that “we’re going to be cutting regulations at a level that nobody’s ever seen before.” He also said that “we’re going to have tremendous protection for the people.”It’s hard to see how he can do both. (David Lazarus, 2/10)

Fayette Tribune: President Trump Misunderstands What Government Drug Price Negotiations Entail
President Donald Trump recently pledged to let federal officials negotiate the prices of drugs covered under Medicare. He claims this will save taxpayers billions of dollars. Nobody doubts that Trump and his team are shrewd negotiators. But the sorts of “negotiations” that Trump refers to have nothing in common with haggling over a real estate deal. Instead, the action that Trump has proposed — repealing the non-interference clause, originally drafted by Democratic Senators Ted Kennedy and Tom Daschle — would result in Medicare drug prices going up and patient choice going down. (Peter J. Pitts, 2/10)

North Jersey: Overdose Rescue Drug Overpriced
There’s no dispute opioid addiction is an epidemic.More than 183,000 people have died from opioid overdoses since 1999, according to the federal Centers for Disease Control and Prevention. In New Jersey, Gov. Chris Christie and legislators have responded with proposals to expand treatment for addicts and to limit the amount of drugs physicians can prescribe. Other states are following suit. Unfortunately, not all responses are as constructive. (2/13)

Scranton Times-Tribune: End Gouging For Antidote
The national opioid epidemic now claims more lives each day than guns or car crashes — about 91 a day nationwide, according to the Centers for Disease Control and Prevention. As appalling as that is, the toll would be far worse but for naloxone, a drug approved in 1971 that stops the respiratory arrest produced by opioid overdoses. Public health agencies have credited the drug with saving many thousands of people who might otherwise have died due to heroin or prescription opioid overdoses. (2/14)

Stat: The Creative Science Of Coining Drug Names
Cialis, Eliquis, Jevtana, Xgeva. These drug names may sound silly, but the process of creating and testing them is anything but. With more than 30,000 proprietary drugs in the United States alone, coming up with a unique brand name is no easy task. And while these names may seem like they were created by over-caffeinated Scrabble players, they are usually the result of intense focus by creative name development professionals coupled with clear-eyed research designed to enhance the prospects of Food and Drug Administration approval. (Mike Pile, 2/8)

Bloomberg: Teva Tries Out ‘Alternative Guidance’
Teva Pharmaceutical Industries Ltd. gave investors a nice surprise on its fourth-quarter earnings call Monday by maintaining its 2017 revenue and earnings guidance. Teva shares jumped about 4 percent on the news. Many investors had assumed Teva’s guidance, already cut in January, would have to come down again after a U.S. court knocked out patents on its best-selling drug Copaxone, making generic competition much more likely. The company’s CEO stepped down shortly afterwards. (Max Nisen, 2/13)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

Next Up On The Pharma Rebranding Bandwagon: Generics

News outlets report on stories related to pharmaceutical drug pricing.

Stat: Generic Drug Lobby Rebrands Itself As Pricing Politics Intensify
The Generic Pharmaceutical Association is no more. Meet the Association for Accessible Medicines. Every industry group invested in the drug-pricing debate is gearing up and burnishing its brand. PhRMA, the brand-name pharmaceuticals lobby, has its “Go Boldly” campaign. Now the generics lobby is launching its own “education campaign” under a whole new name. (Scott, 2/14)

Stat: Will Pharma Use A Tax Break To Create Jobs? It Didn’t Last Time
Drug makers are promising to create tens of thousands of American jobs if President Donald Trump follows through on his promise to give them a big tax break if they “repatriate” cash they’ve stashed overseas. But that’s not what happened last time pharma got a tax holiday. Instead, drug makers used the tens of billions they brought back to the US to enrich their CEOs and drive up their stock prices. Rather than adding jobs, they laid off thousands of workers. (Garde, 2/10)

Stat: What Might Pharma Buy With Its Repatriated Cash?
If President Donald Trump keeps his promise, the world’s biggest drug makers will soon get access to billions of dollars siloed overseas. And if investors and analysts are right, much of that money will go toward acquisitions. So what might pharma buy with its freed-up capital? According to a recent investor survey by EvercoreISI, these are 2017’s most likely takeout targets. (Garde, 2/10)

Reuters: Pharma Industry Shuns Trump Push For Radical Shift At FDA
U.S. President Donald Trump’s vow to roll back government regulations at least 75 percent is causing anxiety for some pharmaceutical executives that a less robust Food and Drug Administration would make it harder to secure insurance coverage for pricey new medicines. The prospect of big change at the regulatory agency comes as drugmakers are under fire for high prices, including Marathon Pharmaceuticals LLC, which said Monday it was “pausing” the launch of its Duchenne muscular dystrophy drug after U.S. lawmakers questioned its $89,000 a year price. (2/15)

Bloomberg: CEO Under Fire For $89,000 Drug Has A History Of Steep Price Hikes 
The CEO of the latest drugmaker to face criticism over a product’s high price has a history of steep hikes on other drugs and at past companies. Marathon Pharmaceuticals LLC Chief Executive Officer Jeffrey Aronin, under fire for setting an $89,000 price on the company’s drug for a rare, deadly muscle disease, was questioned in a letter more than two years ago by Washington lawmakers about mark-ups on two heart drugs. Years earlier, as the leader of another company, Aronin took high price increases on a drug used to treat babies with a congenital defect. (Greifeld and Langreth, 2/14)

Bloomberg: Big Pharma Is Pointing Fingers, And Hoping Trump Will Listen 
In the fast-moving Washington game of who’s to blame for high U.S. drug prices, an often-overlooked industry is readying its defenses against pharmaceutical companies that fault other parts of the health sector for the costs faced by patients. Known as pharmacy benefits managers, or PBMs, the industry includes giants such as Express Scripts Holding Co. and CVS Health Corp., which negotiate prices with drugmakers, work with pharmacies and help set the co-pays patients pay out of pocket. Now these middlemen are now taking it from all sides. (Tracer, Langreth and Edney, 2/8)

Stat: SEC Plans To Review Some Pharma Industry Accounting Practices
Concerned about the way that some drug makers report earnings in their financial statements, the US Securities and Exchange Commission recently indicated plans to evaluate pharmaceutical industry accounting practices.The plans were disclosed in a Jan. 11 letter that the agency sent to Allergan over GAAP, or generally accepted accounting principles. (Silverman, 2/13)

The Baltimore Sun: Cost Of Overdose Drug Could Hamper Access In Maryland And Elsewhere 
The price of a drug that has saved the lives of more than 800 people overdosing on heroin or other opioids in Baltimore is rising rapidly.The antidote known as naloxone revives addicts after they’ve stopped breathing, with either a simple spray in their nose or an injection. The use of naloxone is a centerpiece of Baltimore public health officials’ wide-ranging efforts to battle the growing heroin epidemic, but the rising price of the antidote could constrain the campaign to stop or at least slow the rate of overdose deaths. (Cohn, 2/13)

Stat: Former PBM CEO Pleads Guilty To Paying Kickbacks
Aformer head of a pharmacy benefits manager pleaded guilty in federal court in Texas on Monday to paying kickbacks in order to win business from government health plans. Between 2001 and 2013, Douglas Pick, who was once chief executive at Pharmaceutical Technologies, orchestrated nearly $3.6 million in combined payments to the head of a health plan, as well as several individuals who were hired to boost business for the PBM, according to court documents. Pick faces up to three years in federal prison, according to the US Department of Justice. (Siverman, 2/14)

Stat: Gilead Faces New Patent Challenges To Hepatitis C Drugs In India
After losing one challenge to Gilead Sciences patents on hepatitis C drugs in India, patient advocacy groups are now challenging still other patents the company holds for its drugs in the country. At the same time, the groups are also challenging Gilead patents in Argentina, moves that reflect an ongoing strategy to widen patient access to the medicines. (Silverman, 2/14)

Nashville Tennessean: Tennessee Bill Would Nix Drug Swaps By Insurers, Benefit Drug Industry
A coalition of Tennessee patient and health care provider groups backed by major U.S. drug companies is behind a bill that would stop insurance companies from switching the medications they cover to cheaper substitutes midway through a coverage year. The Reliable Coverage Act would require insurance companies to keep providing the same medication coverage they promise when enrollees sign up each year. Currently insurers can change the medications they cover midway through an enrollment year by ending coverage of a particular drug entirely, which increases out-of-pocket costs for a drug or requires additional approval by the insurance company before a drug is covered. (Wadhwani and Boucher, 2/13)

Kaiser Health News: Former FDA Chief Cites 5 Things To Watch On Drug Approvals, And Keeping Drugs Safe
The just-departed commissioner of the Food and Drug Administration has concerns about plans to speed up drug approvals and dramatically reduce regulations at the agency, as advocated recently by President Donald Trump. Dr. Robert Califf, who stepped down last month, shared his thoughts about keeping Americans safe — and making sure drugs actually work — after about a year overseeing the federal agency. (Lupkin and Tribble, 2/14)

The Associated Press: Ex-Drug Company CEO Shkreli To Speak At Harvard
Controversial former pharmaceutical executive Martin Shkreli is set to speak at Harvard while out on bail awaiting his federal securities fraud trial. The former CEO of Turing Pharmaceuticals is expected to talk about investing and healthcare at an event organized by the Harvard Financial Analysts Club. The talk on Wednesday is open to the Harvard community only. (2/12)

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Viewpoints: Connecting Executive Pay With Patients; Is Technology Driving Up Health Costs

A selection of opinions on health care from around the country.

Fortune: Tying Health Care Executive Pay To Patient Health
Paying for performance is a growing trend across the health care industry. Insurers have been striking deals with pharma companies that will land them discounts on pricey drugs if those treatments don’t demonstrably improve patients’ health outcomes; hospitals are penalized if they have high rates of patient readmissions. But this model is also making its way to the C-suite, Modern Healthcare reports. To cite just one example: Executives at Trinity Health, which operates 93 hospitals, have their pay tied to the system’s overall effectiveness in keeping patients out of the hospital, lowering smoking and obesity rates, and other population health metrics. (Sy Mukherjee, 2/13)

Bloomberg: Trump Can Act Against Planned Parenthood
Controversial executive orders have been a hallmark of Donald Trump’s young presidency, but it’s worth noting that there is one that he has so far refrained from issuing. During the presidential campaign, Trump said he would “defund” — that is, stop providing federal funding to — Planned Parenthood. He can advance that goal by executive order if he wants. (Ramesh Ponnuru, 2/13)

The Des Moines Register: Vocal Minority Counts Most To GOP Over Planned Parenthood
The battle cry to defund Planned Parenthood was a guaranteed crowd-pleaser at GOP rallies and fundraisers throughout the 2016 campaign in Iowa. This wasn’t just a reliable applause line, it was a prompt for roars of approval. Few other issues generated as much enthusiastic reaction on the campaign trail. So what’s the deal with the new Des Moines Register/Mediacom Iowa Poll? It shows that three out of four Iowans support continuing state funding for non-abortion services at Planned Parenthood. (Kathie Obradovich, 2/13)

Courier-Post: Proposed NJ Opioid Solution Is Only A Band-Aid
Gov. Chris Christie’s recent State of the State speech included the concept of placing supply limits on opioid prescriptions, a blueprint some patient-advocates would call a quick-fix, and others not a solution at all. As lawmakers such as Christie attempt to combat negative outcomes associated with prescription treatment options, elected officials must not forget about the unintended consequences that can result from proposed legislation that limits a patient’s access to medically necessary treatments. (Shaina Smith, 2/13)

Los Angeles Times: Dr. Oz Takes On Those Bogus For-Profit Stem Cell Clinics–And Cuts Them To Shreds
The undercover investigation you’re about to see today is going to make you really angry, because we’re exposing the worst kind of scam — one that takes advantage of those most vulnerable, stealing not just their money, but their hope, their dignity.” That’s how Dr. Mehmet Oz introduces a series of segments scheduled to run on his daytime television program Tuesday. His quarry: those for-profit clinics offering supposed stem cell treatments for an implausible host of diseases — unproven, unlikely and very expensive cures. (Michael Hiltzik, 2/13)

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Know Your Policy Like The Back Of Your Hand, And Other Ways To Avoid High Medical Bills

Experts suggest five tips on avoiding scary costs after getting treatment.

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Drugmaker Hits Pause After Receiving Blistering Criticism Over $89,000 Medication

Hours after receiving a letter from Sen. Bernie Sanders and Rep. Elijah Cummings calling the pricing strategy on the muscular dystrophy drug unconscionable, Marathon Pharmaceuticals announced it was reevaluating the product launch.

The Associated Press: Company Announces Pause For Drug After Price Criticism
Marathon Pharmaceuticals announced Monday that it will temporarily halt the rollout of a drug to treat genetic muscle deterioration just hours after two members of Congress expressed outrage that the company planned to charge $89,000 a year for a drug that’s widely available abroad for about $1,000 a year. Sen. Bernie Sanders, I-Vt., and Rep. Elijah Cummings, D-Md., urged the company earlier in the day to lower the drug’s price. (Freking, 2/13)

The Wall Street Journal: Firm Delays Muscular Dystrophy Drug U.S. Launch Amid Criticism Of $89,000 Price
In a statement posted on the website of a nonprofit group involved with muscular dystrophy, Marathon CEO Jeffrey Aronin said the company was “pausing our launch,” which had been scheduled for March. The company will meet with “caregivers and explain our commercialization plans, review their concerns, discuss all options, and move forward with commercialization based on an agreed plan of action,” he said in the statement. (Walker and Pulliam, 2/13)

Stat: Sanders Blasts Marathon Over The High Price For Old Medicine
The [delay] comes just hours after two lawmakers, including Senator Bernie Sanders (I-Vt.), sent a harshly worded letter, blasting Marathon for “unconscionable” pricing for the drug, which would be used to treat a rare form of muscular dystrophy. And beyond urging the drug maker to lower its $89,000 price, they demanded the company fork over a raft of information, including development expenses and profit projections. (Silverman, 2/13)

The Hill: Sanders, Cummings Hit Pharma Company For Drug’s $89K Price Tag
Sen. Bernie Sanders (I-Vt.) and Rep. Elijah Cummings (D-Md.), two vocal critics of high drug prices, demanded answers from Marathon Pharmaceuticals Monday, calling the price of Deflazacort “unconscionable.” “Marathon’s apparent abuse of government-granted exclusivity periods and incentives to sell what should be a widely available drug for $89,000 a year is unconscionable,” Sanders and Cummings wrote in the letter to the CEO of Marathon. (Hellmann, 2/13)

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A Deep Dive Into 4 GOP Talking Points On Health Care

Republicans leaders have a lengthy list of talking points about the shortcomings of the health law. Shortly before his inauguration last month, President Donald Trump said that it “is a complete and total disaster. It’s imploding as we sit.” And they can point to a host of issues, including premium increases averaging more than 20 percent this year, a drop in the number of insurers competing on the Affordable Care Act marketplaces and rising consumer discontent with high deductibles and limited doctor networks.

Yet a careful analysis of some of the GOP’s talking points show a much more nuanced situation and suggest that the political fights over the law may have contributed to some of its problems. Here is an annotated guide to four of the most common talking points Republicans have been using. 

1. The individual health insurance market is collapsing. 

— House Speaker Paul Ryan, R-Wis., on Meet the Press, Feb. 5, “the law is literally in the middle of a collapse.”

— Senate Majority Leader Mitch McConnell, R-Ky., on the Senate floor Jan. 9: “Obamacare continues to unravel at every level, leaving Americans to pick up the pieces.”

Republicans are right that the individual market that the Affordable Care Act sought to overhaul is having challenges right now. Many insurance companies left the market at the end of 2016 after losing money, which reduced choices for individuals, and five states have only a single insurer providing coverage in 2017.

But even with these challenges, the health law’s marketplaces, also called exchanges, are providing coverage to more than 10 million Americans. Some analysts say they are far from collapse.

“I have never believed the individual market was in a true death spiral,” said Joe Antos of the conservative American Enterprise Institute. A death spiral is when so many healthy people leave a market that only sick people are left and insurers cannot spread costs.

Insurance markets also vary a lot by state, said John Ayanian, head of the University of Michigan’s Institute for Healthcare Policy and Innovation. “There are a fair number of states where the exchanges are working fairly well, costs are not rising too quickly, and people have a number of choices of health plans,” he said. “There are other states where they have just one choice and prices are going up.”

At the same time, legislation written by Republicans has led to some of the trouble in exchanges. Most directly, Congress limited federal payouts to insurers who encountered higher-than-expected costs in the exchanges. Republicans called the payments “insurance company bailouts,” even though similar federal measures have been used in other markets, such as the Medicare drug plans implemented more than a decade ago.

Still, the result was that the Department of Health and Human Services was able to provide insurers with only 13 percent of the money they were promised under the law in 2015. That shortfall led directly to the implosion of most of the nonprofit co-op health plans, and some private insurers referenced the shortfalls when they pulled out of the marketplaces this year. Yet when House Energy and Commerce Committee Chairman Greg Walden, R-Ore., noted at a Feb. 2 hearing that “only five out of the original 23 insurance co-ops remain. … They tried it, it didn’t work,” he did not mention the loss of the federal payments to cover early losses. 

2. Out-of-pocket spending is too high.

— Speaker Ryan, at CNN Town Hall Jan 12: “Deductibles are so high it doesn’t even feel like you’ve got insurance anymore.”

— Senate Majority Leader McConnell (in a CNN op-ed): “It’s raising health care costs by previously unimaginable levels, and it’s hurting the very people it was intended to help.”

Out-of-pocket spending is one of voters’ top concerns when it comes to health care. The January 2017 monthly tracking poll from the Kaiser Family Foundation found 67 percent of those polled said their top health priority is “lowering the amount individuals pay for health care,” followed closely by “lowering the cost of prescription drugs” at 61 percent. (Kaiser Health News is an editorially independent project of the foundation.)

High deductibles — often in the thousands of dollars — have become part of that problem.

People who are most angry about the Affordable Care Act, said Chris Jennings, a health official in the Clinton and Obama administrations, “want deductibles lower and more benefits.”

But Republicans’ most popular proposals for replacing current individual insurance plans — cutting back on required benefits and giving more people access to tax-preferred health savings accounts — would likely increase out-of-pocket spending for those who use health services (although it would be less expensive for people who are healthy all year long).

Letting people buy more bare-bones policies “means insurance doesn’t kick in until people have very significant medical bills,” said Ayanian.

Former Obama administration health official Sherry Glied, on a panel at the National Health Policy Conference in January, asked if having a $10,000 or $20,000 deductible (as some proposals would allow) with perhaps $1,000 in a health savings account “is better than having no coverage at all? Lots of people would go bankrupt at $20,000,” particularly if they don’t have the resources to fund the HSA with their own savings. 

3. Medicaid patients can’t find doctors to treat them.

— Sen. Bill Cassidy, R-La., on the Senate floor Jan. 9: “It is the illusion of coverage without the power of access.”

— Speaker Ryan, from CNN Town Hall Jan. 12: “… so our concern is, that people on Medicaid can’t get a doctor and if you can’t get a doctor, what good is your coverage?”

Studies do suggest that low pay (each state sets its own rates) does decrease physician participation in Medicaid, and finding specialty care can be difficult in some parts of the country. But overall the academic literature shows that Medicaid patients have a far easier time, and are far more likely to obtain health care services than people with no insurance.

Benjamin Sommers of the Harvard School of Public Health, who has studied the issue, said the idea that patients with Medicaid can’t get care comes from looking overall at how many doctors and other providers accept the program’s generally lower payments and higher administrative burdens. “But that’s not the best way to study this. The best question … is when you talk to the people with coverage and ask them if they can get the care they need.”

And he said “study after study” shows that “when people get Medicaid, their access to care improves dramatically,” including greater use of primary care, preventive screening, and care of chronic conditions. “Even with some potential limitations of provider participation, patients are much better off once they get that [Medicaid] coverage,” he said. 

4. The ACA has reduced jobs.

— Tom Price, the secretary of Health and Human Services, during a confirmation hearing before the Senate Health, Education, Labor and Pensions (HELP) Committee Jan. 18: “The ACA has decreased the workforce by the equivalent of 2 million FTE’s (full time employees).”

— Senate HELP Committee Chairman Lamar Alexander, R-Tenn., on the Senate floor Jan. 9: “Across the country … employers have cut jobs to afford Obamacare costs.”

Much of this talking point stems from a report by the Congressional Budget Office in 2014 that projected the nation’s workforce would drop by about 2 million jobs due to the health law, as well as anecdotal reports about employers cutting workers hours to avoid triggering the law’s requirement that they offer health insurance.

But a careful reading of the CBO report notes that the decline they estimate would be due less to employers cutting back, and more to older workers voluntarily opting to work fewer hours — perhaps because of fears of losing their premium subsidies or their Medicaid eligibility — or retiring because they no longer had to work in order to get health insurance.

It is true that some employers cut worker hours below the 30-hour threshold to avoid the employer coverage requirement.

However, the strengthening economy, including in the health care sector, has shrunk the part-time workforce and expanded full-time employment well beyond the numbers reduced by the Affordable Care Act, according to most analysts. In fact, so many jobs have been created in the industry since the ACA became law that it is becoming a problem itself, because having such a vast chunk of the economy devoted to health care makes it harder to reduce health spending.

Categories: Cost and Quality, Insurance, Medicaid, The Health Law

Hospital Roundup: Preventing Avoidable Patient Errors; Executive Incentives To Improve Quality

Other industry news relates to a Chinese eye hospital chain planning to enter the U.S. market, Ohio facilities joining to create a new trauma care network and a Florida hospital partnering with a Brazilian company to help patients with disabilities.

Stat: A Millionaire’s Mission: Get Hospitals To Stop Killing Their Patients
Joe Kiani likes to point out that the most worn spot on most medical monitoring devices is the mute button. … His tech fix — if widely implemented — could bring order to the cacophony of beeps, buzzes, and blaring alarms that can so overwhelm nurses and doctors that they push “mute” and miss true emergencies. It could make it easier for staff to monitor patients with complex needs. And it could flag, in advance, potentially fatal errors like incorrect dosing and drug allergies. (McFarling, 2/13)

Modern Healthcare: Paying For Population Health
Trinity Health system executives take home heftier paychecks when they keep patients healthy and out of the hospital. The annual incentive pay for each executive, including the 93-hospital system’s CEO, is docked if Trinity’s total patient population doesn’t show reduced rates of obesity, smoking, readmissions and hospital-acquired conditions. Hitting financial targets, on the other hand, receives little weight in the incentive plan. Trinity’s strategy is a sharp departure from the status quo of CEO pay packages where financial incentives have long dominated. But it is a surefire way to focus top leaders’ attention on the health system’s mission to deliver better outcomes and lower costs to patients in the 22 states where it operates. (Livingston, 2/11)

Nashville Tennessean: Dr. Ming Wang To Lead Chinese Eye Hospital Chain’s U.S. Expansion
Fast-growing Chinese eye hospital chain Aier Eye Hospital plans to enter the U.S. market this year, with headquarters in Nashville and a long-term goal to open eye clinics across the country. Leading eye surgeon Dr. Ming Wang of Wang Vision Institute has been tapped as CEO of Aier-USA. The company established a holding company in the U.S., with a starting fund of $50 million. Wang’s association with Aier dates back 15 years, when the company was a small private eye hospital trying to gain a foothold in China’s health care market, where the vast majority of hospitals are controlled by the government. (Alfs, 2/10)

Cleveland Plain Dealer: Major Hospitals Join Together For A Trauma Care Network: Strong Points 
Cleveland Clinic, MetroHealth and University Hospitals have joined together to create a new Northern Ohio Trauma System (NOTS), which will provide coordinated trauma care to patients throughout Cuyahoga County and the seven-county Northeast Ohio region. As part of this enhanced trauma network, University Hospitals is adding its trauma expertise to NOTS. The NOTS network was originally formed in 2010 between MetroHealth and Cleveland Clinic, and NOTS assisted the City of Cleveland public safety forces to get the right patient to the right place at the right time for their care. (MacFarland, 2/10)

Orlando Sentinel: Florida Hospital Partners With Brazilian Company Livox 
In the speech and language impairment world, Livox falls under the umbrella of augmentative and alternative communication, or AAC. The systems help people with disabilities and impaired communication express themselves despite conditions such as autism, stroke, cerebral palsy or even cancer. The devices can be sophisticated and expensive, such as the one Stephen Hawking uses. Or they can be much simpler apps with images, which produce sentences and phrases when pressed by the user. Livox is more user-friendly and easier to customize than other apps available on the market, according to families and speech therapists who use it. (Miller, 2/13)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

Medicaid: todo lo que necesita saber sobre el financiamiento “en bloque”

La administración del presidente Donald Trump ha dejado bien claro su compromiso de rescatar la vieja estrategia republicana para gerenciar el Medicaid, el programa que ofrece cobertura de salud a personas de bajos ingresos. Es la siguiente: devolver el control a los estados y limitar el gasto anual del gobierno federal.

La forma de financiamiento se llama “subvención en bloque”. Ahora, el Medicaid, que se expandió bajo la ley de salud de 2010 para asegurar a más personas, cubre a casi 75 millones de adultos y niños. Debido a que es un derecho, todo el que califica tiene la cobertura garantizada, y los estados y el gobierno federal combinan fondos para cubrir los costos.

Los conservadores han sostenido durante mucho tiempo que el programa sería más eficiente si los estados obtuvieran una suma fija del gobierno federal y luego lo administraran como mejor les parezca. Pero otros dicen que eso significaría menos financiamiento para el programa, lo que eventualmente se traduciría en mayores desafíos para obtener atención médica para personas de bajos ingresos.

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La “subvención en bloque” del Medicaid es una pieza central de las propuestas de salud apoyadas por el presidente de la Cámara de Representantes, Paul Ryan, y el representante Tom Price, quien fue confirmado como secretario del Departamento de Salud y Servicios Sociales (HHS) el 10 de febrero. La asesora de Trump Kellyanne Conway enfatizó que la estrategia es clave para la política de salud de la administración.

Pero, ¿cómo sería este proceso, y por qué es tan controversial? Vamos a desglosar cómo funcionaría esta política, y sus implicaciones para el gasto del gobierno y para el acceso de los consumidores al cuidado de salud.

¿Cómo funcionaría un financiamiento en bloque?

Hasta ahora, Trump no reveló detalles de su plan. Pero la idea básica es que los estados recibirían subvenciones federales fijas que estarían basadas en el gasto estatal y federal del Medicaid en ese estado. La subvención crecería ligeramente cada año para contabilizar la inflación, pero es posible que el costo de la salud aumente más.

Actualmente, los estados comparten el costo del Medicaid con el gobierno federal. Los más pobres pagan menos: por ejemplo, en Mississippi, el gobierno federal paga alrededor de tres cuartas partes del costo del programa, en comparación con el 50% en Massachusetts.

La financiación federal es abierta, pero a cambio, los estados deben cubrir ciertos servicios y a ciertos grupos de personas, por ejemplo, niños, mujeres embarazadas que cumplen con los criterios de ingresos y padres con hijos dependientes. Bajo una subvención en bloque, los estados tendrían más libertad para decidir quién califica, y para qué servicios.

“Va a depender de los detalles de cada propuesta de subvención, si habría ciertos beneficios que los estados tendrían que proveer”, dijo Edwin Park, vicepresidente de políticas de salud en el Center for Budget and Policy Priorities, en Washington, D.C. “Usualmente los estados tienen una flexibilidad sin casi ninguna restricción”.

¿Esto es lo mismo que el “límite per cápita”?

La subvención en bloque es ligeramente diferente de este otro modelo favorito de los conservadores. Los límites per cápita también han sido apoyados por Ryan.

Bajo estos límites, los estados también reciben una cantidad fija de dinero cada año, pero esa suma se calcula sobre la base de cuántas personas están en el programa. Ya que las subvenciones en bloque no se basan en la inscripción individual anual, el estado no necesariamente obtendría más dinero para compensar si, por ejemplo, más personas califican para el Medicaid a causa de una recesión económica. En teoría, un sistema de capitalización per cápita aumentaría la financiación. Pero si ocurre que un nuevo medicamento caro entró en el mercado, o apareció una nueva y costosa enfermedad, los presupuestos del Medicaid no cambiarían para absorber estos nuevos costos, señaló Park.

Parece que tanto demócratas como republicanos están muy acalorados con este tema. ¿Por qué es tan importante?

El sistema de subsidios en bloque es un cambio radical con respecto a cómo el Medicaid ha trabajado anteriormente. Los republicanos dicen que podría ahorrar al gobierno miles de millones de dólares. Pero otros analistas señalan que esos ahorros podrían limitar el acceso a la atención médica si la financiación se reduce. La ley de salud de 2010 instó a los estados a ampliar la elegibilidad para el Medicaid, por eso más personas enfrentarían el peso de esos recortes.

El impacto fiscal: la no partidista Oficina de Presupuesto del Congreso (CBO) estima que las recientes propuestas republicanas de subvención en bloque podrían reducir el gasto del Medicaid en un tercio en la próxima década. Los recortes empezarían siendo pequeños, creciendo a lo largo de los años.

Muchos republicanos dicen que, porque los estados tendrán una mayor flexibilidad, pueden innovar con sus programas del Medicaid.

Pero los opositores señalan que la experimentación por sí sola no compensará los presupuestos más pequeños. Las subvenciones fijas podrían significar que los estados reduzcan los beneficios u obliguen a los beneficiarios a asumir más costos compartidos.

Algunos requisitos federales son necesarios, dijo Tom Miller, experto en el conservador American Enterprise Institute. La subvención en bloque podría ser “grandiosa o un desastre”, dijo, dependiendo de cómo se implemente.

El impacto potencial es significativo. Más de 10 millones de personas que recibieron seguro a través del Obamacare están en el Medicaid y podrían verse afectadas. Esa es también la razón por la cual algunos gobernadores republicanos -en particular en estados que abrazaron la expansión del Medicaid promovida por la ley de salud- se han unido a sus compañeros demócratas para expresar sus dudas.

Si no tengo mi seguro a través del Medicaid, ¿por qué debería preocuparme?

Medicaid es un programa gubernamental importante. En 2015, representó el 17% de los gastos de salud de la nación, dinero que proviene de dólares de los contribuyentes.

Además, las 75 millones de personas cubiertas representan casi una cuarta parte de la población de los Estados Unidos. Y casi dos tercios de las personas en hogares de ancianos pagan por su cuidado usando el Medicaid, de hecho, la mayor parte del gasto del programa va a los adultos mayores y los discapacitados. Si los legisladores están tratando de ahorrar $1,000 millones en una década, es difícil ver cómo esto podría ocurrir sin afectar los beneficios de los seniors, señaló Matt Salo, director ejecutivo de la Asociación Nacional de Directores del Medicaid.

Incluso si usted no está cubierto por el Medicaid, probablemente conoce a alguien que se vería afectado por la subvención en bloque.

Rehacer la financiación del Medicaid también podría afectar los servicios que ofrecen los hospitales y su fortaleza económica. Específicamente, los hospitales y clínicas que atienden a un gran número de beneficiarios del Medicaid podrían tener que repensar sus presupuestos, qué servicios pueden proporcionar y a cuántas personas pueden emplear. Eso es importante desde el punto de vista de la atención de salud, pero también es una gran fuente de trabajo: los hospitales suelen ser grandes empleadores comunitarios.

Por último, el debate también podría establecer el tono con el que el Congreso tratará a otros programas también llamados “de derecho”, como el Medicare y el Seguro Social. El CBO estima que, salvo cualquier cambio significativo, el gasto en el Seguro Social y otros programas de salud representará alrededor del 16% de todos los bienes y servicios anuales del país -el producto interno bruto- para 2046. Un cambio exitoso en el Medicaid podría allanar el camino para cambios similares en otros programas.

¿Cuáles son las probabilidades de que esto suceda realmente?

Ahora que el partido tiene control sobre el Congreso y la Casa Blanca, los republicanos han hecho del cuidado de la salud una prioridad absoluta, incluyendo disposiciones en el nuevo presupuesto para revocar el Obamacare.

Gran parte de una propuesta de subvención en bloque podría lograrse mediante la reconciliación presupuestaria, dijeron Park y Miller. Eso significa que podría votarse sin apoyo demócrata, incluso en el Senado, ya que sólo requeriría 51 votos.

Pero sin más detalles, cualquier evaluación de las consecuencias es, en el mejor de los casos, una especulación informada.

“¿Qué significa una subvención en bloque en términos de reglas? … Nadie ha llegado lo suficientemente lejos como para decir: ‘Esto es lo que realmente significa’ ‘, dijo Salo. “Este es un territorio desconocido para muchos de nosotros”.

Mary Agnes Carey, corresponsal senior de KHN, contribuyó con este artículo.

Categories: Cost and Quality, Medicaid, Noticias En Español, Repeal And Replace Watch, States, The Health Law


Grassley Launches Inquiry Into Orphan Drugs After KHN Investigation

Republican Sen. Chuck Grassley, chairman of the Senate Judiciary Committee, has opened an inquiry into potential abuses of the Orphan Drug Act that may have contributed to high prices on commonly used drugs.

In a statement, Grassley said the inquiry is “based on reporting from Kaiser Health News” and strong consumer concern about high drug prices.

“My staff is meeting with interested groups and other Senate staff to get their views on the extent of the problem and how we might fix it,” Grassley wrote on Feb. 3, adding that he will continue to work on bringing prices down in other ways as well.

A six-month Kaiser Health News investigation published in January found that the orphan drug program intended to help desperate patients is being manipulated by drugmakers. While the companies are not breaking the law, they are using the 1983 Orphan Drug Act to secure lucrative incentives and gain monopoly control of rare disease markets where drugs often command astronomical price tags.

KHN’s investigation, which was published and aired by NPR, found that many drugs that now have orphan status aren’t entirely new. More than 70 were drugs first approved by the Food and Drug Administration for mass market use. Those include cholesterol blockbuster Crestor, Abilify for psychiatric disorders, and rheumatoid arthritis drug Humira, the best-selling drug in the world.

Others are drugs that have received multiple exclusivity periods for two or more rare conditions. About 80 drugs fall into this latter category, including cancer drug Gleevec and wrinkle-fighting drug Botox.

Before the Orphan Drug Act passed, drugs for rare diseases were often abandoned during development — hence the name orphan. The patient populations were simply too small to be financially viable.

Senate Judiciary Committee Chairman Chuck Grassley (Chip Somodevilla/Getty Images)

Grassley, the senior senator from Iowa, is well positioned to call for changes in the law’s incentives. His Judiciary Committee oversees anticompetitive and patent-related issues. Grassley made headlines late last year calling for hearings to demand that drugmaker Mylan justify its price hikes for the lifesaving EpiPen.

Grassley’s office has reached out to staff members of the Senate Health, Education, Labor and Pensions Committee, which has jurisdiction over the FDA. When asked this week about a possible update to the law, the committee lauded the Orphan Drug Act for helping millions of families and said it “will continue oversight of the law to ensure it is working as intended.”

But there are questions over whether the law is working as intended. Dr. Robert Califf, who left his post last month as commissioner of the FDA, said he believes it’s time to review the orphan drug program and the incentives offered to corporations.

The decades-old law, Califf said, has been very successful in bringing effective treatments to rare disease patients. But like any program, he said, “once it reaches a mature phase, it’s important to reassess it.”

In talking about what could be changed, Califf said reexamining the FDA’s orphan drug policy “does need to occur at this point in time.”

Califf noted that before he arrived at the FDA in 2015 he was involved in consultant meetings where there “clearly is an effort for gaming” the orphan drug approval process.

“It’s understandable that whenever you put a financial incentive in place in the United States, people will try to figure out how to take advantage of it — almost all of them within the law,” Califf said. “So, I’m not talking about illegal activity but … there is a game of cat and mouse that goes on.”

In an interview late last year, PhRMA’s Anne Pritchett, vice president of policy and research at the drug industry’s lobbying group, said government incentives for orphan drug development are needed because the research involved is costly, risky and uncertain, and it can take years to develop a successful drug. This week, a PhRMA spokeswoman said they had not heard of any movement on changing or updating the Orphan Drug Act.

Dr. Martin Makary, a professor at Johns Hopkins University School of Medicine and a vocal critic of the high prices of orphan drugs, has offered up possible solutions. He suggested that drugmakers should pay back some of the federal incentive money once a drug reaches a blockbuster sales level for treating a rare disease.

“That money, at a certain point, could go back to the FDA through a back tax that starts after $1 billion in annual sales,” Makary said.

Former U.S. Rep. Henry Waxman (D-Calif.), who pioneered the Orphan Drug Act in the 1980s, thinks Congress should tackle prescription drug pricing on a variety of fronts, and that an update to the Orphan Drug Act is part of the solution.

Waxman noted that President Donald Trump has expressed concern about prescription drug prices and that could bring energy to the effort.

“Hopefully, he’ll come in with some good proposals and do something about the problem,” Waxman said. “I hope that when Congress does something, it will be something that has an impact.”

But Peter Saltonstall, president of the National Organization for Rare Disorders, said his group has heard “no energy” for changing the law now. He said his organization, which is the largest group representing rare disease patients, is constantly evaluating how well the Orphan Drug Act works.

“I think the Orphan Drug Act at least from our perspective has been successful,” Saltonstall said, adding that there are other prescription drug pricing concerns that could be addressed by Congress such as the high prices of a variety of drugs — orphans, he said, are a small portion of the nation’s total drug costs.

Today, more than 450 orphan drugs have been approved and gaining orphan designation is a popular business strategy for manufacturers. Drugs approved to treat rare diseases made up 40 percent of new drugs approved by the FDA in 2016 and nearly 50 percent of new drugs approved in 2015. The drugs are also very expensive with $111,820 as the average annual price of an orphan drug in 2014 versus $23,331 for a mass market drug.

As part of the 1983 law, Congress approved a basket of financial incentives to spur development. It includes seven years of market exclusivity to a drug for use on a specific rare disease. It also provided companies with tax credits on research and development and waived regulatory fees. And, notably, the drugs are often approved with smaller and fewer clinical trials because of the smaller patient populations.

In the 1990s, lawmakers introduced a number of amendments to the Orphan Drug Act in Congress, including proposals to impose taxes on profits and revoking exclusivity if the patient population exceeded the 200,000 bright line used to define a rare disease. The proposals all failed.

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

Categories: Cost and Quality, Health Industry, Pharmaceuticals, Syndicate

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Research Roundup: Wages And Health Spending; Workplace Injuries; Mexico City Policy

Each week, KHN compiles a selection of recently released health policy studies and briefs.

Health Affairs: Health Care Use And Spending Patterns Vary By Wage Level In Employer-Sponsored Plans
[W]e examined patterns of health care use and spending by wage category during 2014 among 42,936 employees of four self-insured employers enrolled in a private health insurance exchange. When demographics and other characteristics were controlled for, employees in the lowest-wage group had half the usage of preventive care (19 percent versus 38 percent), nearly twice the hospital admission rate (31 individuals per 1,000 versus 17 per 1,000), more than four times the rate of avoidable admissions (4.3 individuals per 1,000 versus 0.9 per 1,000), and more than three times the rate of emergency department visits (370 individuals per 1,000 versus 120 per 1,000) relative to top-wage-group earners. (Sherman et al., 2/6)

Health Affairs: Racial And Ethnic Differences In The Frequency Of Workplace Injuries And Prevalence Of Work-Related Disability
This study used national survey data to test for differences between members of minority groups and non-Hispanic white workers in the risk of workplace injuries and the prevalence of work-related disabilities. Non-Hispanic black workers and foreign-born Hispanic workers worked in jobs with the highest injury risk, on average, even after adjustment for education and sex. These elevated levels of workplace injury risk led to a significant increase in the prevalence of work-related disabilities for non-Hispanic black and foreign-born Hispanic workers. These findings suggest that disparities in economic opportunities expose members of minority groups to increased risk of workplace injury and disability. (Seabury, Terp and Boden, 2/6)

Health Affairs: Work, Health, And Insurance: A Shifting Landscape For Employers And Workers Alike
We examined the complex relationship among work, health, and health insurance …. Stagnation or deterioration in employment conditions and wages … has been accompanied by the erosion of health outcomes and employer-sponsored insurance coverage. … we present data and discuss the research that has established these links, and we assess the potential impact of policy responses to the evolving landscape of work and health. The expansion of insurance availability under the Affordable Care Act may have helped reduce the burden on employers to provide health insurance. However, the act’s encouragement of wellness programs has uncertain potential to help contain the rising costs of employer-sponsored health benefits. (Buchmueller and Valletta, 2/6)

Kaiser Family Foundation: Community Health Centers: Recent Growth And The Role Of The ACA
This brief draws on 2015 federal data on health centers and our 2016 Survey of Health Centers’ Experiences and Activities under the Affordable Care Act to provide a snapshot of health centers and their patients, analyze recent changes, and compare the experience of health centers in Medicaid expansion and non-expansion states. … Key findings include: Health centers are a core source of primary care in the U.S., particularly for Medicaid beneficiaries and uninsured people. … The Medicaid expansion strengthened health center finances and capacity. … Health centers report increased numbers of insured patients who are unable to pay their deductibles and cost-sharing. (Paradise et al., 1/18)

The Urban Institute: Access To Contraception In 2016 And What It Means To Women
This brief provides estimates of self-reported access to contraception among women at risk of unintended pregnancy and perceptions of the role of birth control in women’s lives. Most women are using contraception, the full cost of which is usually covered by health insurance or another program. Yet, some women report barriers to contraception access, many of which are related to cost. The majority of women agree that birth control has a positive effect on women’s lives. (Johnston, Courtot and Kenney, 1/23)

The Kaiser Family Foundation: The Mexico City Policy: An Explainer
On January 23, President Donald Trump reinstated the Mexico City Policy via presidential memorandum. This explainer provides an overview of the policy’s history and how it has been applied in the past. … The policy requires foreign non-governmental organizations (NGOs) to certify that they will not “perform or actively promote abortion as a method of family planning,” using funds from any source (including non-U.S. funds), as a condition for receiving U.S. government global family planning assistance and, as of Jan. 23, 2017, any other U.S. global health assistance. (1/23)

Here is a selection of news coverage of other recent research:

NBC/San Diego: Study Finds Medicare May Overpay Medicare Advantage Plans By $200B
A study at UCSD’s School of Medicine found that an incentive to increase patient risk scores could lead Medicare to overpay Medicare Advantage (MA) plans by roughly $200 billion over the next ten years. … The problem is they provide more benefits when they enroll a patient expected to use a large volume of medical services and less when plans enroll low risk patients. For example, spending is expected to be greater for an 85-year-old than for a 65-year-old, and greater for a patient with heart disease or diabetes, said university officials. (Pollack, 2/6)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

Five Quick Ways New HHS Secretary Tom Price Could Change The Course Of Health Policy

After a bruising confirmation process, the Senate confirmed Rep. Tom Price, R-Ga., to head up the Department of Health and Human Services, by a 52-to-47 vote.

As secretary, Price will have significant authority to rewrite the rules for the Affordable Care Act, some of which are reportedly nearly ready to be issued.

But there is much more now within Price’s purview, as head of an agency with a budget of more than $1 trillion for the current fiscal year. He can interpret laws in different ways than his predecessors and rewrite regulations and guidance, which is how many important policies are actually carried out.

“Virtually everything people do every day is impacted by the way the Department of Health and Human Services is run,” said Matt Myers, president of the Campaign for Tobacco-Free Kids. HHS responsibilities include food and drug safety, biomedical research, disease prevention and control, as well as oversight over everything from medical laboratories to nursing homes.

Price, a Georgia physician who opposes the Affordable Care Act, abortion and funding for Planned Parenthood, among other things, could have a rapid impact without even a presidential order or an act of Congress

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Some advocates are excited by that possibility. “With Dr. Price taking the helm of American health policy, doctors and patients alike have sound reasons to hope for a welcome and long-overdue change,” Robert Moffit, a senior fellow at the conservative Heritage Foundation, said in a statement when Price’s nomination was announced.

Others are less enthusiastic. Asked about what policies Price might enact, Topher Spiro of the liberal Center for American Progress said at that time: “I don’t know if I want to brainstorm bad ideas for him to do.”

Here are five actions the new HHS secretary might take, according to advocates on both sides, that would disrupt health policies currently in force:

Birth control coverage: Under the ACA, most insurance plans must provide women with any form of contraception approved by the Food and Drug Administration at no additional cost. This has been particularly controversial in regards to religious employers who object to artificial contraception, leading to alterations in the rules, and resulting in a two separate Supreme Court rulings, one about private firms’ rights to make religious objections, and one about nonprofit religious hospitals and schools.

As secretary, Price would have two main options. He could expand the “accommodation” that already exempts some houses of worship from the requirement to any employer with a religious objection. Or, because the specific inclusion of birth control came via a regulation rather than the law itself, he could simply eliminate no-copay birth control coverage from the benefits insurance plans must offer. (This assumes continuing existence of the health law, at least for the short term.)

Medicare payment changes: The health law created an agency within Medicare, called the Center for Medicare and Medicaid Innovation, that was tasked with exploring new ways to pay doctors and hospitals that would reduce costs while maintaining quality. The HHS secretary has the authority to require doctors and hospitals to participate in the experiments and new payment models. Some have proved unpopular with physician and hospital groups, in particular the idea of paying providers so-called bundled payments for packages of care, rather than allowing them to bill item-by-item; one such package covers hip and knee replacements, from the time of surgery through post-surgical rehabilitation. Price, as a former orthopedic surgeon himself, would likely act to scale back, delay or cancel that project, since he “has been a critic in the past,” said Dan Mendelson, CEO of Avalere Health, a Washington-based consulting firm.

Planned Parenthood funding: Republicans have been agitating to separate Planned Parenthood from its federal funding literally for decades. Congress would have to change Medicaid law to permanently defund the women’s health group, which also performs abortions (with non-federal funds) at many of its sites. But an HHS secretary has many tools at his disposal to make life miserable for the organization.

For example, during the Reagan and George H.W. Bush administrations, rules were put in place, and eventually upheld by the Supreme Court, that would have banned staff in federally funded family planning clinics from counseling or referring for abortion women with unintended pregnancies. The subsequent Clinton administration repealed the rules, but they could make a comeback under the new secretary’s leadership.

Price could also throw the weight of the department into a probe into Planned Parenthood’s ties to firms allegedly selling fetal tissue for profit, which has also been investigated by a House committee.

Tobacco regulation: After years of discord, Congress finally agreed to give the Food and Drug Administration (limited) authority to regulate tobacco products in 2009. “The core authority is statutory,” said Matt Myers of the Campaign for Tobacco-Free Kids, who advocated for the law. That means Congress would have to act to eliminate many of its changes. But a secretary who opposes the law (Price voted against it at the time) could weaken enforcement, says Myers. Or he could rewrite and water down some rules, including recent ones affecting cigars and e-cigarettes.

“The secretary has very broad discretionary authority not to vigorously enforce or implement the statute in an aggressive manner,” Myers said.

Conscience protections: At the very end of the George W. Bush administration, HHS issued rules intended to clarify that health care professionals did not have to participate in performing abortions, sterilizations or other procedures that violated a “religious belief or moral conviction.”

Opponents of the rules complained, however, that they were so vague and sweeping that they could apply not just to opponents of abortion, but also to those who don’t want to provide birth control to unmarried women, or HIV treatment to homosexuals.

The Obama administration revised the rules dramatically, much to the continuing consternation of conservatives. They were among the few health-related items included in the health section of Trump’s website before he was inaugurated and the page was taken down. “The Administration will act to protect individual conscience in health care,” it said. Many expect the rules to be reinstated in their original form.

This is an updated version of a story that initially ran Dec. 9, 2016. It was updated Feb. 10, 2017 to reflect that Tom Price had been confirmed by the Senate.

Categories: Cost and Quality, Public Health, Repeal And Replace Watch, Syndicate, The Health Law

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Dozens Of New Cancer Drugs Do Little To Improve Survival, Frustrating Patients

Marlene McCarthy’s breast cancer has grown relentlessly over the past seven years, spreading painfully through her bones and making it impossible to walk without a cane.

Although the 73-year-old knows there’s no cure for her disease, she wants researchers to do better. It’s been years, she said, since she has found a drug that has actually helped. McCarthy said she’s frustrated that the Food and Drug Administration is approving cancer drugs without proof that they cure patients or help them live longer.

“That simply isn’t good enough,” said McCarthy, of Coventry, R.I. “I understand [why] that could be satisfactory for some people. It isn’t to me.”

Pushed by patient advocates who want earlier access to medications, the­ Food and Drug Administration has approved a flurry of oncology drugs in recent years, giving some people with cancer a renewed sense of hope and an array of expensive new options. A few of these drugs have been clear home runs, allowing patients with limited life expectancies to live for years.

Many more drugs, however, have offered patients only marginal benefits, with no evidence that they improve survival or quality of life, said Dr. Vinay Prasad, assistant professor of medicine at the Oregon Health and Sciences University, who has written extensively about the FDA’s approval process for cancer drugs.

Overall cancer survival has barely changed over the past decade. The 72 cancer therapies approved from 2002 to 2014 gave patients only 2.1 more months of life than older drugs, according to a study in JAMA Otolaryngology–Head & Neck Surgery.

And those are the successes.

Two-thirds of cancer drugs approved in the past two years have no evidence showing that they extend survival at all, Prasad said.

The result: For every cancer patient who wins the lottery, there are many others who get little to no benefit from the latest drugs.

“We are very concerned about the push to get more drugs approved, instead of effective drugs approved,” said Fran Visco, president of the National Breast Cancer Coalition, who said the last game-changing breast cancer drug, Herceptin, was approved nearly 20 years ago.

In a November study published in JAMA Internal Medicine, researcher Diana Zuckerman looked at 18 approved cancer drugs that didn’t help patients live longer. Only one had clear data showing that it improved patients’ lives, such as by relieving pain or fatigue.

Two drugs harmed quality of life. For example, thyroid cancer patients taking the most expensive drug, cabozantinib, scored worse on a scale measuring five symptoms: diarrhea, fatigue, sleep disturbance, distress, and difficult remembering, Zuckerman said.

“Our patients need drugs that provide the greatest possible benefit, particularly when you put that in the context of cost,” said Dr. Richard Schilsky, senior vice president and chief medical officer at the American Society of Clinical Oncology, which represents cancer specialists. “You begin to question what is the real value of a therapy when the benefit is small, the toxicity may be similar to a previous drug and the cost is much higher.”

Cancer drugs approved last year cost an average of $171,000 a year, according to the Center for Health Policy and Outcomes at New York’s Memorial Sloan Kettering Cancer Center. Although the high prices can lead patients to think they’re getting the Mercedes of cancer drugs, research shows that a medication’s price has no relationship to how well it works.

“We cannot have a system where drugs that may not even work are being sold for these amazingly crazy amounts of money,” said Zuckerman, president of the National Center for Health Research, a nonprofit in Washington that aims to explain research to consumers.

Recognizing the slow pace of progress, the American Society of Clinical Oncology has set goals for new cancer drugs of extending life or controlling tumors for at least 2.5 months. The bar was set relatively low because “it’s not very often that we come across a transformative treatment,” said Dr. Sham Mailankody, an assistant attending physician and myeloma specialist at Memorial Sloan Kettering.

Yet in a study published in September in JAMA Oncology, Mailankody found that only one in five cancer drugs approved from 2014 to 2016 met those standards.

Even those slim gains, achieved during carefully controlled clinical trials, can evaporate in the real world, where patients are often older and sicker than those who participate in research studies, said Hanna Sanoff, an associate professor and section chief of the University of North Carolina School of Medicine Gastrointestinal Medical Oncology Program.

Cancer is primarily a disease of aging; 59 percent of patients are over 65 and 30 percent are older than 75. Yet only 33 percent of participants in cancer trials are over age 65 and just 10 percent are over 75, according to a 2012 study in the Journal of Clinical Oncology.

In a study published in September in The Oncologist, Sanoff found that a drug that improved survival in liver cancer by three months offered no survival advantage among Medicare patients outside the clinical trial.

McCarthy, who reviews breast cancer research proposals for the Department of Defense, said she was twice turned down for clinical trials because of her age. When researching experimental therapies, “I’d get excited by something that seemed promising, only to be told I was too old to join the trial, because the cutoff age was 70,” she said.

Marlene McCarthy, 73, from Coventry, R.I., works on a computer as her husband Joe McCarthy, looks on. Marlene McCarthy, a mother of four, was first diagnosed with breast cancer at 44. Seven years ago, the disease returned in her bones, a condition that is not curable. (Katye Brier/for KHN)

McCarthy works on a computer as her husband, Joe, looks on. McCarthy, a mother of four, was first diagnosed with breast cancer at 44. Seven years ago, the disease returned in her bones, a condition that is not curable. (Katye Brier for KHN)

Lowering The Bar

FDA officials said there are good reasons why many promising cancer drugs lack evidence of improved survival.

Because some cancers grow slowly, it can take many years for a study to show whether a new drug helps people live longer, said Dr. Richard Pazdur, director of the FDA’s Oncology Center of Excellence. While individual drugs may only modestly improve survival, “when used sequentially or in combination, they can transform a disease,” Pazdur said.

The design of some cancer trials also can make it hard to tell if drugs help patients live longer. That’s because many trials now allow patients in the control group the opportunity to “cross over” to get the drug being studied, if preliminary data suggests it could help them, Pazdur said. While such crossover benefits people in the study, who are facing a life-threatening disease, it can lead to inconclusive findings.

Lastly, Pazdur said that overall survival rates also don’t reflect that fact that some drugs, such as targeted therapies for lung cancer, allow a subset of patients to do extremely well, surviving for years instead of months.

The number of patients with advanced melanoma who survive five years after diagnosis has increased from 5 percent before the advent of immune therapies to 30 percent to 40 percent today, said Dr. Steven O’Day, director of immuno-oncology and clinical research at the John Wayne Cancer Institute at Providence Saint John’s Health Center in Santa Monica, Calif. Immune therapies work by stimulating a patient’s natural immune system to combat cancer cells.

“There is a lot of excitement about these [immunotherapy] drugs, and for good reason,” Schilsky said. “There’s no diminishing the progress that’s been made.”

The FDA wants to give patients the chance to benefit as soon as possible, rather than waiting for definitive proof of improved survival, Pazdur said. In some cases, the FDA requires pharmaceutical companies to perform long-term studies after drugs are approved, to measure whether drugs live up to their early promise.

But many of these studies never provide an answer, Zuckerman said. Once a drug is approved and is available to anyone, patients have no incentive to participate in a clinical trial. So studies can end with no clear conclusion.

In a 2015 study, Prasad looked at 36 drugs approved without proven survival advantages. More than four years later, only five had evidence of improved survival.

Otis Brawley, chief medical officer at the American Cancer Society, said he’s concerned that the FDA is lowering its standards.

“We’re getting less rigorous scientifically because we want to get these drugs out to people faster,” Brawley said.

Unless the FDA requires companies to provide survival data before approving a drug, “we may never have answers,” Zuckerman said. “We will have all of these expensive drugs on the market and we will never have the information we need about how well they work or even how safe they are.”

President Donald Trump has vowed to cut regulations at the FDA and recently told pharmaceutical industry leaders that he wants to further speed up the drug approval process.

Helpful Or Harmful?

Cancer patients, who are making decisions at a time of intense stress, don’t always understand the full risks and benefits of therapy, Brawley said. Studies suggest that both patients and doctors tend to overestimate drugs’ benefits, but underestimate their risks and side effects.

A study of 2,944 people in JAMA Internal Medicine found that 39 percent mistakenly believed the FDA only approves “extremely effective” drugs, while 25 percent mistakenly believed the agency only approves treatments without serious side effects.

Even doctors think “we are better than I actually think we are,” Brawley said. “The thought that these drugs could be harmful is foreign to them.”

Patients “see the survival benefit, and of course these are scared, desperate people trying to get themselves any chance they can get,” said Dr. Ellyn Lee, who guides patients about cancer treatments as director of Seattle’s Swedish Palliative Care Services. “However, the survival benefit is not often realized, or it’s three months of misery due to side effects and bankruptcy at the end. Is that really fair?”

One of the biggest recent changes at the FDA is that more drugs are being approved based on “progression-free survival” — medical jargon for the amount of time that patients live while their tumors are under control.

Because small changes in tumor size aren’t always clearly visible on scans, doctors consider tumors to be under control as long as they don’t grow more than 20 percent, Brawley said.

Doctors always hope that a drug that delays tumor growth will help patients live longer. But in a study published in 2015, Prasad found that most statistical analyses have found the link between progression-free survival and overall survival to be very weak.

Measures such as progression-free survival “are just a guess as to whether or not the drug actually works,” Brawley said. “The problem with approving a drug based on a progression-free survival is that you don’t know if the drug is actually doing anything positive for the patient.”

Brawley said he’s concerned that patients could be harmed by oncology drugs whose long-term side effects are unknown.

The drug Avastin, which was approved for breast cancer in 2008, without evidence that it improved survival, lost its approval three years later, after studies showed it did not help people live longer. The FDA concluded that life-threatening side effects, which included heart attacks, bleeding and high blood pressure, outweighed the drug’s benefits.

“There are all these drugs that we used for a long, long time, but we ended up taking them off the market because we finally realized they were harmful,” Brawley said. “We are setting ourselves up for that again.”

“Breast cancer doesn’t seem to have a road map to cure. It’s just a damn sneaky disease,” said Marlene McCarthy, 73, from Coventry, R.I. She lives with advanced breast cancer that has spread to her bones, a painful condition that makes it difficult to walk. She uses a cane to walk. (Katye Brier/for KHN)

“Breast cancer doesn’t seem to have a road map to cure,” said Marlene McCarthy. “It’s just a damn sneaky disease.” (Katye Brier for KHN)

McCarthy has been disappointed in the new cancer therapies she’s tried. The last drug that kept her tumors from growing was letrozole, which was approved in 1997. It kept McCarthy’s tumors under control for three years.

In 2015, after her tumors began growing again, McCarthy began a new breast cancer drug, called Ibrance. The FDA approved Ibrance because it improved progression-free survival by 10 months when combined with a standard hormonal therapy. Four months after McCarthy began the drug, however, scans found new bone tumors.

A spokeswoman for Pfizer, Sally Beatty, noted that Ibrance’s proven benefits have improved since then. In a study published in November, women taking the Ibrance combination lived 24.8 months with limited tumor growth, compared to 14.5 months for women who took the hormonal therapy alone.

McCarthy opted not to try another breast cancer drug, Afinitor, after doctors warned her that it posed too many risks. The FDA approved Afinitor in 2012 because it limited tumor growth for four months longer than placebo.

“That’s nothing to be excited about,” said McCarthy, who has four children and four grandchildren. “I want to live more than four months.”

But keeping tumors in check can be a huge help to patients, said Pazdur, who notes that there are many ways for drugs to help patients, even without extending life. Shrinking a bone tumor, for example, can relieve pain. Shrinking a lung tumor can make it easier for someone to breathe.

“Most patients are pleased if they go to the doctor and the doctor says, ‘Your scan says everything is stable. There are no new lesions,’” Schilsky said. “I’ve given that result to patients many times over the years and they are all happy about it. Are they as happy as they would be if the tumor were gone? Of course not. But being free from progression and otherwise feeling OK is not such a bad outcome.”

As someone with incurable cancer, McCarthy remains frustrated with the pace of progress. Scientists, she said, aren’t asking the right questions.

McCarthy said she wants researchers to focus on prevention of cancer, and to learn why breast cancers like her can remain dormant for years before suddenly reactivating. Her cancer, which was first diagnosed when she was 44, disappeared for two decades before reappearing in her bones.

“The status quo isn’t good enough,” said McCarthy. “I want us to have a breast cancer vaccine to prevent my granddaughter from getting cancer. I’ll be working for that with my dying breath.”

KHN’s coverage of end-of-life and serious illness issues is supported by The Gordon and Betty Moore Foundation and coverage related to aging & improving care of older adults is supported by The John A. Hartford Foundation.

Categories: Cost and Quality, Health Industry, Syndicate

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‘Massive Confusion’ Abounds For Insurers As GOP Wavers On Obamacare Redo

Premiums for Obamacare plans sold by New Mexico Health Connections could rise as little as 7 percent next year, says Martin Hickey, the insurance company’s CEO. Or they might soar as much as 40 percent, he said.

It all depends on what happens in Washington. Such is the vast uncertainty about how the Trump administration and Republican-controlled Congress are approaching their promises to repeal, repair and replace the Affordable Care Act.

There is “pretty massive confusion,” said Hickey, whose 45,000-member plan is one of the few nonprofit insurance “co-ops” created by the ACA to be still in business. “The more uncertainty they create, the higher the rates” will be for 2018.

Insurers have a hard enough time making the normal predictions of who will get sick and how much it will cost. Now the usual fog of rate setting is compounded by the possibility that basic rules of coverage could get overhauled or even disappear before anything takes their place.

Consumers and patients could ultimately pay the price.

The stakes include how much plans sold through the health law’s online marketplaces and similar coverage will cost next year — or even whether insurance will be available. Challenges during the recently completed enrollment period, in which some carriers canceled plans and rates rose 20 percent on average, increase the urgency, executives say.

“This is nothing less than a nightmare scenario for the carriers,” said Robert Laszewski, a former insurance executive and consultant who works with large plans. “The Republicans don’t seem to understand that they’ve got to stabilize the market.”

Coverage for 2017, which has already been finalized, will not be changed. Nor will people covered through job-based insurance or the Medicare plan for seniors be much affected by the uncertainty.

In some states, preliminary 2018 rates are due in less than two months. But prospects for policymaking clarity recede each day that Republicans deliver contradictory messages or fail to agree on a plan, industry officials say.

While some in the party want to go slow on an overhaul and ensure they’ve thought out a replacement before abolishing the health law, others favor immediate repeal.

If the administration and Congress scrap the ACA’s coverage requirement for most people or its subsidies helping people buy care, the market could deteriorate or collapse, say insurance consultants and executives.

A month ago President Donald Trump told the New York Times that Obamacare is “a catastrophic event,” adding, “we have to get to business” in repealing it. On Feb. 5 he seemed to advocate a more measured approach, telling Fox News that “at least the rudiments” of a replacement would be in place by 2018.

Even that could spook insurance executives contemplating plans for next year in the Obamacare marketplaces, also known as exchanges. They want to know the rudiments of a replacement plan now and details not much later.

“I don’t think there’s a real clear path to repeal or replace or repair or anything,” said Kevin G. Fitzgerald, an insurance lawyer with Foley & Lardner. “Some of our clients will probably move forward on the assumption that something will happen to maintain the exchanges more or less the way they are. Others may pull out early.”

Big, national insurers have said it would be hard to commit to the marketplaces next year unless they get a much better idea of what they’ll look like.

Several had already scaled back coverage for this year, leaving many parts of the country with only one company selling through the marketplaces. Continued uncertainty could prompt even those holdouts to bail, said Fitzgerald.

“If in those states those carriers decide, ‘We’ve lost enough and we’re going to sit this year out,’ there are no exchanges,” he said. “And that certainly is a possibility.”

The Trump administration has proposed regulations, initiated in the last days of the Obama regime, intended to steady the market. Tweaks may include crackdowns on sick consumers who join plans outside open-enrollment periods and allowing insurers to charge slightly more for older members, Huffington Post and Politico have reported.

That — plus assumptions that Republicans will eventually have a replacement plan helping Obamacare patients maintain coverage — could reassure insurance companies, said Dan Mendelson, CEO of Avalere Health, a health care consulting firm.

“I’m not saying it would be completely pain-free,” he said. “You probably would see some plans get out of the market. But if plans start to believe there’s a long-term solution, they’re going to want to stay in because getting in and out of the market costs money.”

What industry really wants is certainty government will continue helping consumers pay for coverage — one of the most contentious and uncertain aspects.

For two years the Republican-controlled House of Representatives has legally challenged one type of subsidy — federal payments to reduce out-of-pocket costs for lower-middle income consumers. The Obama administration defended the subsidies in court, but insurers worry that Trump officials could drop the defense or that a judge could declare the payments illegal.

Industry interest in the suit “is incredibly high,” said Todd Van Tol, a partner with Oliver Wyman, a consultancy with many insurer clients. The disappearance of those subsidies “would likely trigger a fairly significant insurer pullback in fairly rapid order,” he said.

Even the most publicly minded insurers might not continue offering individual Obamacare plans if an uncertain market threatened their financial stability, said Ceci Connolly, CEO of the Alliance of Community Health Plans, a trade group of nonprofit carriers.

“We want to be able to do this, but if there’s potential for significant losses it would be irresponsible to maybe do it,” she said. “There seems to be a growing recognition of the challenge ahead and also the need for stability, but boy — this clock is coming up fast.”

Categories: Cost and Quality, Insurance, Repeal And Replace Watch, Syndicate, The Health Law


Georgia Legislative Panel Hears Concerns About Surprise Medical Billing

Physician, hospital and insurer groups each expressed concerns Tuesday about Georgia Senate legislation that aims to prevent “surprise billing’’ of patients, but perhaps the most compelling testimony came from a legislator’s wife.

The Senate Health and Human Services Committee heard testimony on a proposal to halt these medical bills, which can come from ER doctors, anesthesiologists, radiologists, pathologists and others who are not in a patient’s insurance network — even though the hospital where they work is.

Vicki Willard, wife of Rep. Wendell Willard, a Sandy Springs Republican, testified that in August, she went to Emory Saint Joseph’s Hospital after experiencing numbness in her cheek and arm.

She knew St. Joseph’s was in her insurance network. “I’m an educated advocate for my health care,’’ she told the panel.

But four weeks after her treatment there, Willard said, she received an unexpected $700 bill from a cardiologist.

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She then called her insurer. The first cardiologist who had seen her, she found out, was a network doctor. But a second cardiologist — the one who sent her the bill — wasn’t in her network, even though that doctor was in the same medical group as the other doctor.

“I have absolutely no control over that,’’ Willard said. “That’s extremely frustrating.”

Sen. Renee Unterman (R-Buford), a nurse who chairs the panel and sponsor of Senate Bill 8, said health insurers and medical providers can’t agree on a solution to the “complicated issue.’’

“It’s like putting cats and dogs in a room,’’ she said. “The one that suffers the most is the consumer.”

Beth Stephens of Georgia Watch, a consumer watchdog organization, said issues with medical bills were the No. 1 reason why consumers called her organization in 2016.

The two current proposals on surprise billing — Unterman’s in the Senate and one in the House — call for greater transparency about which doctors are in an insurer’s network and an estimated cost of the procedure.

The Unterman proposal would also create a database of reasonable charges for a procedure. If a bill is disputed, the insurer and doctor would have to work out a resolution.

“I have tried my best to be fair,’’ said Unterman. “To listen to both sides.”

Representatives from the insurance industry said that one database of rates that Unterman’s bill would use, Fair Health, should not be used as a benchmark for reimbursements because it’s too high.

Physician organizations have said they support Fair Health, and blamed “narrow’’ insurance networks for many instances of high non-network charges.

Hospital groups, meanwhile, said the transparency required to educate patients about network providers should be shared among hospitals, physicians and insurers.

Other states, including Florida, recently passed legislation to address the problem.

Categories: Cost and Quality, Health Industry, Insurance, Syndicate

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Perspectives: Reality Of Global Drug Pricing Is Much More Complex Than Trump Realizes

Read recent commentaries about drug-cost issues.

Stat: Dear Mr. President: Your Big Idea On Drug Pricing Is Half-Baked
Let’s be blunt: Your idea is half-baked. Why? Because it is much more complicated than you think. Unlike the United States, most other countries provide some form of insurance coverage for their populations and take responsibility for negotiating drug prices. Government agencies around the world have been pushing back against drug makers over the rising cost of medicines, a development that has proven not only popular with voters, but increasingly necessary given strained budgets. Some Americans, however, grumble that they are, in effect, subsidizing other countries. That may be true, but the US has failed to take any significant steps to lower prices. (Ed Silverman, 2/6)

Bloomberg: Trump Had One Good Idea. Then He Ditched It.
It wasn’t all that long ago — though it seems that way, admittedly, with the never-ending flood of Trumpian news — that I was prepared to acknowledge that President Donald Trump actually has a few good ideas. Or at least one. It was Tuesday morning. The new president was about to go into a meeting with chief executives from Johnson & Johnson, Merck and a handful of other major pharma companies. During his campaign, he often said that if he were elected, the federal government would start negotiating with the drug companies over the prices Medicare and Medicaid had to pay for drugs — something it’s now prevented from doing by statute. This is an issue that resonated with most Americans, the majority of whom want the government to do something about high drug prices. (Joe Nocera, 2/2)

The Washington Post: Trump Loses Backbone On Drug Prices. Is There A Pill For That?
Amid all the kerfuffle in the last week over immigration, the Supreme Court, Iran and Arnold Schwarzenegger’s TV ratings, too little attention was paid to an extraordinary meeting at the White House at which President Trump reneged on a campaign promise and sold out millions of “forgotten” Americans to giant drug companies. (Steven Pearlstein, 2/4)

St. Louis Post Dispatch: Trump Must Follow Tough Talk On Drug Pricing With Action
Another runaway drug-pricing problem is putting an easy-to-use version of naloxone, a life-saving drug that can reverse an opioid overdose, out of reach for most drug addicts, their families and first responders. The cost of an auto-inject version of the drug, specifically approved for people without medical training to use in life-threatening situations, has increased more than 500 percent to $4,500 since 2014. The wholesale price of insulin, a life-saving drug for some 1.25 million Americans who suffer from Type 1 diabetes, increased from $45 for a highly concentrated monthly form in 2001, to $1,447 last year. This is life and death for patients whose pancreases can’t make insulin. (2/5)

The Hill: Hate High Drug Prices? Blame Greedy Companies And Our Politicians
One might first think that Acthar was an ancient civilization in Mesopotamia or a prison facility in upstate New York. In fact, it is the most expensive drug for the U.S. government. In 2015, Medicare paid $504 million for H.P. Acthar Gel, an average of $162,300 per patient. So then it must at least be the hottest new drug for cancer or dementia, right? Not so, unfortunately. (Dr. Hagop M. Kantarjian and Michael A. Carrier, 2/1)

Houston Chronicle: Complicated, Expensive Drug Market Needs Simplification 
Production costs are rarely the key factor in determining a price, because when your life depends on a drug, you will pay almost anything to get it.Just ask the 8,000 people in the U.S. and Europe who suffer from paroxysmal nocturnal hemoglobinuria, a disease that destroys red blood cells at night, causing life-threatening clots, anemia and organ failure. Alexion Pharmaceutical’s drug Soliris is the only treatment available, and it can cost $440,000 a year, making it the most expensive drug sold in. (Chris Tomlinson, 2/7)

Bloomberg: Repatha Will Test The New Drug Pricing Reality
The epic battle between drug makers and the insurers and pharmacy benefit managers that pay for their medicines just opened a fascinating new front. Amgen Inc.’s earnings report Thursday afternoon was largely overshadowed by its announcement that its cholesterol-lowering drug Repatha succeeded in a clinical trial designed to prove it helps prevent heart attacks and other cardiovascular events. (Max Nisen, 2/3)

Conservative Review: Killing TPP Saved Poor Countries From High Drug Prices. How About Saving Ourselves?
Donald Trump is well known to be no fan of the Trans Pacific Partnership. In fact, one of his first acts as president was to issue a notice that the U.S. is withdrawing from the agreement, citing concerns that the deal is unfair to American workers. While Trump was focused primarily on the trade aspects of the deal, there are other provisions of the agreement relating to pharmaceuticals and intellectual property that should be just as worrying. Now, as President Trump expresses a wish to make prescription medicine more affordable, he would do well to apply the same skepticism he had for trade to the sweetheart deals Big Pharma has traditionally received from government. (Logan Albright, 2/5)

Bloomberg: Teva’s Dividend Should Follow Its CEO Out
When a CEO abruptly steps down after three years in charge, it’s a safe bet the new guy isn’t inheriting a corporate bouquet of roses. That’s certainly the case at generics giant Teva Pharmaceutical Industries Ltd. Erez Vigodman’s surprise exit Monday afternoon leaves interim CEO and ex-Chairman Yitzhak Peterburg with a struggling generics business, the likely loss of billions in sales from its best-selling product Copaxone after a court invalidated several patents, and a debt load that exceeds the company’s market cap. (Max Nisen, 2/7)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

Drugmakers Eager To Shift Focus From Price To Value

News outlets report on stories related to pharmaceutical drug pricing.

Stat: Trump’s Pharma Crusade Could Bring Changes Industry Wants
Congressman Greg Walden, a key House Republican for pharmaceutical policy, suggested this week that President Trump wants to encourage drug makers to enter value-based contracts with private health plans and the government insurance programs. Maybe that’s what the president has meant all along in his vague promises to change bidding and negotiations. (Scott, 2/3)

NPR: Trump Wants Medicare To Negotiate Drug Prices Directly With Drugmakers
Drug companies could be forgiven if they’re confused about whether President Donald Trump thinks the government should get involved in negotiating the price of prescription drugs for Medicare patients. … So on Tuesday, White House spokesman Sean Spicer cleared up the confusion, for now at least. When asked during his daily news briefing whether the president is in favor of having Medicare negotiate lower prices for prescription medicine, Spicer said, “He’s for it, yes. Absolutely.” (Kodjak, 2/7)

Bloomberg: Trump Sinks Pharma Stocks On Medicare Drug Price Negotiation
President Donald Trump supports Medicare drug price negotiations, his spokesman said Tuesday, remarks that sent pharmaceutical stocks swinging again as investors tried to assess whether drugmakers will be forced into bidding wars for government business. “He’s for it, yes,” White House spokesman Sean Spicer said at a press briefing in response to a question asking to clarify Trump’s position on the matter. Trump has given conflicting signals in the past weeks on whether he would let the government intervene directly in drug prices to reduce health-care costs. (Daurat and Olorunnipa, 2/7)

WBUR: Pfizer CEO On Trump, Drug Prices And The FDA 
President Trump made a campaign promise to lower the price of prescription drugs. After meeting with several big pharmaceutical companies last week, the president emerged with different plans to do that, from reducing taxes to cutting back regulations. Here & Now’s Jeremy Hobson speaks with Ian Read, the CEO of Pfizer, one of the biggest pharmaceutical companies in the world, about drug prices, the Food and Drug Administration and how Pfizer is adjusting to the new administration. (Hobson, 2/7)

The CT Mirror: Trump Attempt To Rein In Drug Prices May Have Limited Success 
President Donald Trump wants to stop the sharp hikes in prescription drug prices, but appears limited in what he can and will do. On the last day in January, Trump called the price hikes for medicine “astronomical” and met behind closed doors with chief executives from some of the nation’s biggest drug companies. (Radelat, 2/8)

Stat: In Germany, Pharma Groups Greet Trump’s Remarks With Scorn
American drug makers have been wary of criticizing President Trump for fear of provoking a nasty tweet. Here in Germany, however, the top trade groups for pharmaceutical industries have come out swinging — taking on the American president for both the tone and the substance of his remarks.Trump’s accusation that the drug industry is “getting away with murder” with sky-high prices has drawn particular scorn. (Feldwisch-Drentrup, 2/6)

CNBC: Drug Prices Rose 11 Percent Last Year, Providing Fuel For Both Sides Of Price Debate
Drug prices, on their face, rose by about 11 percent last year, according to Express Scripts, the largest U.S. pharmacy benefits manager. But costs for employers increased just 2.5 percent across all prescription drugs, Express Scripts said in its new Drug Trend Report, released Monday. The St. Louis-based PBM, which negotiates drug prices on behalf of insurers and employers, hailed the difference in figures as evidence that it saves the system money. (Tirrell, 2/6)

CBS News: Express Scripts CEO On PBMs And Rising Costs Of Drugs
Pharmacy benefit managers, or PBMs, negotiate drug prices directly with drug companies. They work on behalf of insurance and employer groups that pay for drugs. The companies act as middlemen and collect rebates and other fees. PBMs say they are the ones trying to lower drug prices. Tim Wentworth, CEO of Express Scripts — the largest PBM — joins “CBS This Morning” to discuss rising drug prices and what role they play in the debate. (2/7)

The Fiscal Times: Drug Prices Are Soaring: Here’s Why You May Not Get The Meds You Need 
The base price of the most commonly used brand-name drugs rose on average by nearly 11 percent in 2016, providing added grist to the debate over the need for government intervention to slow the rate of growth of pharmaceutical prices and eliminate blatant price gouging. A new study released on Monday by Express Scripts, a major pharmacy benefit management services based in St. Louis, found that the average price of brand name drugs has steadily risen by more than 200 percent since 2008, far outpacing the 11 percent overall cost-of-living increase during the same period. (Pianin, 2/6)

Stat: Another Channel For Pharma Lobbying: Political Groups With No Limits
Last year PhRMA announced plans to save its political spending for lobbying against federal efforts to fight rising drug prices. But the pharmaceutical industry group found giving to political groups known as 527s a good way to channel money to political party operations in the states. Federal election reports filed for the end of 2016 show that PhRMA gave more than $1.77 million to Republican groups, including GOPAC, which supports both federal and state candidates. PhRMA donated slightly over $1 million to Democratic groups. (Kaplan, 2/1)

Bloomberg: Big Pharma’s Offer To Trump: Discounts When Drugs Don’t Work
President Donald Trump says drug prices are astronomical and something needs to be done. Pharmaceutical giants have an answer that doesn’t involve lowering list prices: refunding some of the money to insurers if a drug doesn’t work as expected. The concept of pay-for-performance isn’t new in the industry. But the number of such agreements between drugmakers and insurers has grown in the past year as Big Pharma seeks to defuse criticism over the soaring prices of some brand drugs, which can cost $10,000 a month or more for cancer treatments. (Hopkins, Langreth and Paton, 2/6)

Bloomberg BNA: No Dearth Of Legislation On Tackling High Drug Costs
Lawmakers are pushing various ideas to combat high prescription drug prices. Some lawmakers have already introduced legislation or said they plan to introduce legislation on this issue. Solutions include allowing Medicare to negotiate with pharmaceutical manufacturers to lower prices, increasing access to generic drugs and importing less expensive drugs from other countries. (Mixter, 2/7)

Stat: Lilly Cuts 200 R&D Jobs, But Says An Alzheimer’s Failure Not Why
On the heels of a recent failure of an Alzheimer’s drug clinical trial, Eli Lilly is eliminating about 200 research and development jobs, a company spokeswoman confirmed, although she maintained the cuts are strictly an effort to fine-tune its workforce and are not related to the recent flop. (Silverman, 2/3)

Stat: Former Life-Sciences General Counsel Wins Whistleblower Case
In an intriguing case, a federal court jury awarded nearly $8 million to the former top lawyer at a small life sciences company, who claimed he was fired after reporting that bribes were paid in China. The verdict, which was handed down on Monday, capped an unusual episode that was being closely watched by lawyers and companies nationwide, not just the pharmaceutical industry, because of an unusual twist — the former general counsel was also the whistleblower. It also arrives as a growing number of drug makers have been fined for paying bribes in foreign countries. (Silverman, 2/7)

Boston Globe: Second Cambridge Biotech Worker Faces Insider Trading Charge 
Federal prosecutors have charged a former Merrimack Pharmaceuticals Inc. employee with conspiracy, part of a larger case alleging that another local biotech worker used confidential information about drug studies to buy stock. Songjiang Wang of Westford was arrested Tuesday on a charge of conspiracy, according to court records. His attorney did not respond to a message seeking comment Tuesday afternoon. (Woodward, 2/7)

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State Highlights: Ga. Lawmakers Wrestle With Surprise Medical Billing Solution; In N.H., Dartmouth-Hitchcock Cancer Center Gets OK In Dispute Over Fundraising Cash

Outlets report on news from Georgia, New Hampshire, New York, Florida, Virginia, Wisconsin, Ohio, New Jersey and California.

Atlanta Journal Constitution: Surprise Billing For Medical Care Gets Georgia State Senate Hearing
Surprise billing of medical patients – when people go to a hospital in their insurance network but get surprised by a bill from an out-of-network doctor anyway – is a big problem. Legislators are still wrestling with a solution. On Tuesday the state Senate’s Health and Human Services Committee met to discuss one proposal on surprise billing: Senate Bill 8, sponsored by the committee’s chairwoman, Renee Unterman, R-Buford. (Hart, 2/7)

Atlanta Journal-Constitution: What’s Happening Today At The Georgia Legislature?
The House and Senate will be back in session at 10 a.m. today. The House has several insurance bills on its calendar, including House Bill 74, which would help identify troubled insurance companies. The Senate has a couple of minor bills requested by the state Department of Agriculture, including SB 69, which would eliminate a requirement for organic companies to register annually with the state since federal law requires them to register annually with the USDA. (Galloway, 2/8)

Atlanta Journal Constitution: Medical Marijuana Bill Passes Georgia Senate Committee
Georgia’s limited medical marijuana law would be expanded to include autism, under legislation passed Tuesday in a state Senate committee. Senate Bill 16 is the first of several bills dealing with the law’s expansion to move this year, although medical marijuana advocates oppose the bill because it would also roll back the maximum THC level in the cannabis oil now allowed here. (Torres, 2/7)

New Hampshire Union Leader: Report: Cancer Center Can Use Fundraiser For Operating Costs
Dartmouth-Hitchcock’s Norris Cotton Cancer Center properly used $6.1 million raised for cancer research, a state regulator has ruled, in a dispute that led its former director to file a whistleblower lawsuit. Thomas Donovan, head of the state Justice Department’s Charitable Trusts Unit, said the fundraising dollars, including money from the center’s signature fundraiser, The Prouty, were directed to be used for the cancer center’s benefit. The review did not find language restricting the gift from being used for the center’s operations, according to Donovan. (Cousineaug, 2/7)

New Hampshire Union Leader: State Numbers Show A Slow Start To Winter Stomach Bug
The mild winter has meant less shoveling, fewer warm layers and something else — fewer outbreaks of the dreaded winter stomach bug. Beth Daly, chief of the state’s Bureau of Infectious Disease Control, said there’s been only 15 reported outbreaks of norovirus illness since December. The norovirus season usually runs from December until March and produces approximately 70 outbreaks, Daly said. While the numbers seem to be lower than usual, Daly said it’s too soon to predict if this season will be an easier one on Granite Staters’ bellies. (Grosky, 2/7)

The Associated Press: Company Accused Of Scamming 9/11, NFL Concussion Victims
A company that promised sick 9/11 responders and NFL players with concussion injuries that it could “cut through red tape” to get their payouts faster lured them into advances that meant hundreds of thousands of dollars in illegally high interest and fees, authorities said Tuesday. In a lawsuit filed Tuesday, New York’s attorney general and the Consumer Financial Protection Bureau allege that New Jersey-based RD Legal Funding and its founder Roni Dersovitz snared 9/11 responders who are struggling with cancer and respiratory illness as well as former NFL players with brain injuries into taking costly advances on their settlements. (Sweet, 2/7)

Miami Herald: Florida Marijuana Rules Too Restrictive, State Told In Fort Lauderdale 
New medical marijuana regulations proposed by state health officials would block patients from timely and affordable access to medication, restrict physicians in treating their patients, and potentially undercut the development and distribution of quality medicine, an overflow crowd told Florida Department of Health officials Tuesday morning in Fort Lauderdale. (Smiley, 2/7)

Richmond Times Dispatch: Culpeper Cardiologist Accused Of Striking Hospital Nursing Director 
A Culpeper cardiologist faces a misdemeanor assault and battery charge stemming from a reported confrontation with a female nursing director inside Novant Health UVa Health System Culpeper Medical Center last week. According to the official criminal complaint filed in Culpeper County General District Court, Dr. Zia Roshandel, 47, of Blue Ridge Cardiovascular Associates is accused of hitting Irene C. D’Gama in the shoulder following what she described as a heated argument inside her office Thursday. (Simmons, 2/7)

The Associated Press: Clinic Falsely Told Dozens They Had Alzheimer’s, Suits Say
Shawn Blazsek knew a string of concussions from high school football and boxing was catching up with him. He would go days without sleeping and was forgetting how to tie his shoes. Still, at age 33, he was stunned after being told he had Alzheimer’s disease. He started planning out who would take care of his four kids if something happened to his wife, and thought about how hard it would be for them when he could no longer recognize his family. So he stuffed fistfuls of sleeping pills into a bottle and wrote himself a note, vowing to swallow all of them when he wasn’t able to remember the names of his children. That day never came. (Seewer, 2/8)

The Associated Press: Dozens Plead Guilty, But Doctor Goes To Trial In $200M Fraud
Details of a long-running health care kickback scheme that allegedly featured prostitutes, cash-stuffed envelopes and private jet junkets began to unfold in federal court Tuesday as a 79-year-old physician went on trial. Dr. Bernard Greenspan isn’t alleged to have engaged in any of the seamier activities surrounding now-defunct Biodiagnostic Laboratory Services, but prosecutors painted him as eager to accept about $200,000 in bribes from the company over several years in exchange for sending his patients’ blood samples there. (Porter, 2/7)

San Jose Mercury News: Stanford Team Is Growing Healthy Skin For Diseased Patients
Small sheets of healthy skin are being grown from scratch at a Stanford University lab, proof that gene therapy can help heal a rare disease that causes great human suffering. The precious skin represents growing hope for patients who suffer from the incurable blistering disease epidermolysis bullosa — and acceleration of the once-beleaguered field of gene therapy, which strives to cure disease by inserting missing genes into sick cells. (Krieger, 2/7)

Miami Herald: Fugitive Who Fled To Cuba To Evade $130 Million Healthcare Fraud Case Arrested At MIA 
Soon after the feds broke up a family-run chain of clinics that tried to steal $130 million from Miami-Dade Public Schools and a string of major U.S. companies, a trio of Cuban immigrants fled to Mexico and eventually back home to the island. For almost two years, the chain’s boss, Reynaldo Castillo, and his right-hand man, Jose Gerardo Gonzalez, hid in Cuba. Castillo and Gonzalez were wanted for their leading roles in an indictment charging a total 16 defendants with healthcare fraud in March of 2015. (Weaver, 2/7)

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Americans Say Their Number 1 Concern Is Health Care Costs

A Monmouth University poll finds that health care costs outrank terrorism or crime as a worry for families. Also, a Harvard health care researcher finds that high deductibles can have a very personal effect, and lawmakers in Georgia weigh efforts to stop surprise medical bills for consumers.

McClatchy: Americans More Worried About Health Care Cost Than Other Concerns 
American families aren’t as worried about terrorism or crime as they are about paying their health care bills, a new poll suggests. Health care costs have emerged as the No. 1 concern for American families, according to a new national Monmouth University poll. Health care costs outranked a variety of other concerns that registered in the single digits, including college tuition and taxes. (Clark, 2/7)

Asbury Park Press: Poll: Health Care Cost Tops Americans’ Biggest Concerns
National security and immigration have been taking up much of the spotlight lately with Donald Trump in the White House, but what has Americans worried the most is their health care, according to a new Monmouth University Poll. About 25 percent of respondents in a nationwide poll said the cost of health care was the biggest concern facing their family, a 10-point jump over a similar poll conducted in 2015. By contrast, national security and immigration — issues that jumped to the forefront during the chaotic first weeks of the Trump administration — ranked very low in the survey. (Davis, 2/7)

Kaiser Health News: With A High Deductible, Even A Doctor Can Short Change His Health
All the doctor’s tricks were failing him. He’d tried neck massage, pressure to the eyes, ice on the face. But an hour in, Ashish Jha still couldn’t slow his racing heart. His wife asked what he’d recommend if a patient called with the same problem. “I said, ‘Oh, that’s easy.’ Go to the emergency department.” As a physician, Jha knew this tachycardia could possibly lead to a heart attack. Yet he felt caught by a decision he’d made in enrolling his family in a so-called high-deductible insurance plan. (Gorenstein, 2/8)

Georgia Health News: Senate Panel Hears Surprising Testimony On Surprise Medical Bills 
The Senate Health and Human Services Committee heard testimony on a proposal to halt these medical bills, which can come from ER doctors, anesthesiologists, radiologists, pathologists and others who are not in a patient’s insurance network — even though the hospital where they work is. “It’s a very complicated issue,’’ said Sen. Renee Unterman (R-Buford), who chairs the panel and is a nurse by profession. She is the sponsor of Senate Bill 8. Health insurers and medical providers can’t agree on a solution, she said. (Miller, 2/7)

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With A High Deductible, Even A Doctor Can Short Change His Health

All the doctor’s tricks were failing him. He’d tried neck massage, pressure to the eyes, ice on the face. But an hour in, Ashish Jha still couldn’t slow his racing heart.

His wife asked what he’d recommend if a patient called with the same problem. “I said, ‘Oh, that’s easy.’ Go to the emergency department.”

As a physician, Jha knew this tachycardia could possibly lead to a heart attack. Yet he felt caught by a decision he’d made in enrolling his family in a so-called high-deductible insurance plan. Such plans are an increasingly common type of coverage for millions of Americans, offering lower premium costs in exchange for higher out-of-pocket expenses. The Harvard University health policy researcher had chosen his — with its $6,000 deductible — as a kind of personal experiment in better understanding how that tradeoff influences health.

And now, when faced with the prospect of paying thousands of dollars for an ER visit, Jha stayed home.

“I should have gone to the hospital,” he recounted recently. But “I knew there was a big bill waiting for me if I did, and I rolled the dice.”

At least 46 million Americans have health plans with deductibles of $1,000 a year or greater, according to Paul Fronstin, director of the health research and education program at the Employee Benefit Research Institute. That number represents 25 percent of employees compared with just 4 percent a decade ago. Some people are given no option by employers trying to shift rising health costs to workers. Others choose the coverage — which is popular on the Affordable Care Act insurance exchanges — for the lower premium payments.

Understanding high deductibles — including whom they help and whether they control short- and long-term spending — is part of Jha’s research on health costs and quality of care. That was the motivation behind his experiment, to “get out of the ivory tower and understand what it’s like to live with one of these,” as he put it.

In his case, the answer was clear: While his decision to avoid the ER saved the health system money, it was unwise from the perspective of patient care.

Studies dating to the 1970s have consistently shown that when consumers must spend a big chunk of their own money on their care, they can cut back by as much as 15 percent. That slowdown happens fast, dropping like a health care guillotine.

The question researchers still are weighing, though, is what consumers slice off. Do they stop filling name-brand prescriptions when equally effective generics are available?

Or do they avoid critical care, as Jha did in staying home instead of heading to the hospital?

“What I take away from [his] story,” said Amitabh Chandra, a friend and fellow Harvard health policy economist, “is that simply calling the patient a consumer doesn’t make buying health care anything like buying cars and computers.”

(Courtesy of Jha's Twitter profile)

(Courtesy of Jha’s Twitter profile)

Last year, Chandra and three colleagues looked at what happened after a Fortune 100 company switched 75,000 well-paid, tech-savvy employees into high-deductible plans. What they found closely mirrored Jha’s personal pattern.

Workers — both the healthy and the sick — skipped out on care indiscriminately. “Prevention, imaging or drugs, consumers were cutting back on all those,” Chandra said.

“That’s a sign they don’t really know what care is valuable and what care isn’t valuable.”

High-deductible supporters argue that consumers need time to adapt and more tools that will help them price-shop effectively.

The researchers considered that, too. The company put $3,750 into a health savings account for each employee and provided a state-of-the-art online tool to compare prices for tests, doctor’s appointments and other services. “We found no evidence that consumers were learning to price-shop after two years of high-deductible coverage,” Chandra said. “None.”

High deductibles can be particularly dangerous for poor or chronically ill consumers, he noted. “First they get hit with the illness. And then they get hit financially and cognitively with the demands of having to figure out where they should go for care.”

University of Minnesota economist Stephen Parente, who is working closely with congressional Republicans to build whatever replaces the Affordable Care Act, says high deductibles must be tweaked. He would like to see a standard insurance policy carry at least a $5,000 individual deductible but provide special exceptions for care for people with chronic conditions such as diabetes and asthma.

Some 117 million adults have such conditions, which become more expensive if left untreated. For them, self-rationing could compromise their health as well as further drive up spending.

Parente has teamed up with Mark Fendrick, a health policy professor at the University of Michigan, to develop a “version 2.0,” which would allow people dealing with chronic disease to access certain preventative services before they meet their deductible cap. Fendrick calls it a “high-value health plan.”

Jha and his wife agreed to extend his experiment into a second year. Since his heart scare, his cardiologist has increased his medication and discussed a procedure that would likely end the tachycardia entirely. He admits he would have already scheduled the appointment except for that same high deductible.

“I can step back and be completely clear what the right answer here is,” Jha said.

“I should go get the procedure. But it’s hard to be rational about this stuff.”

This story was done in partnership with Marketplace and Kaiser Health News.

Categories: Cost and Quality, Insurance, Syndicate

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Researchers, Business Interests Anxiously Await Patent Decision On CRISPR

The patent dispute over the gene editing technology has been with the court for two months, but some observers believe a decision could be coming soon.

Stat: Waiting For The CRISPR Patent Decision? Here’s What We Know
It’s been 61 days since the one and only oral argument in the CRISPR patent case. Where’s the decision? Investors, lawyers, patent agents, biotech executives, and scientists have been anxiously waiting for the Patent Trial and Appeal Board to decide whether foundational CRISPR-Cas9 patents awarded to the Broad Institute of Harvard and MIT beginning in 2014 “interfered” with a patent application filed in 2012 by the University of California. Based on the time it usually takes PTAB to hand down a decision, this one should arrive “any day now,” said Jacob Sherkow of New York Law School, an expert on intellectual property law. (Begley, 2/6)

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For Lessons On Dangers Of Relaxing FDA Regulations, Look No Further Than This $94K Cancer Drug

In an era where officials speak of deregulating and “streamlining” the FDA, a story of a blockbuster drug demonstrates the possible pitfalls of removing thorough vetting of experimental treatments. Meanwhile, the CEOs who met with the president reveal what happened behind closed doors, a California lawmaker takes aim at drug coupons, spiking insulin prices make diabetes one of the country’s most expensive diseases and more pharmaceutical news.

Los Angeles Times: Trump And Congress May Make It Easier To Get Drugs Approved — Even If They Don’T Work
In June, pharmaceutical giant Genentech sent doctors a letter saying they should no longer prescribe a blockbuster drug called Tarceva to most patients suffering from lung cancer. A study had found that only a small number of patients —  those with a certain gene mutation —  might be helped by the drug, the company said.The news upended a 2010 decision by the Food and Drug Administration to greatly expand use of the $94,000-a-year drug, despite warnings from a panel of experts that said there was little evidence it actually worked. (Petersen, 2/3)

The Washington Post: What CEOs Say Happened In Trump’s Closed-Door Meeting With Big Pharma
Since the early days of his campaign, President Trump vocally criticized rising drug prices. Occasionally, he faulted the government’s inability to negotiate directly on drugs purchased through Medicare, a practice prohibited by law. But in a meeting Tuesday with pharmaceutical executives, Trump’s words were less clear. The executives say, behind closed doors, Trump never brought up government intervention on drug pricing. Meanwhile, Trump’s public remarks were loaded with conflicting signals. (Johnson, 2/3)

Stat: Lilly Cuts 200 R&D Jobs, But Says An Alzheimer’s Failure Not Why
On the heels of a recent failure of an Alzheimer’s drug clinical trial, Eli Lilly is eliminating about 200 research and development jobs, a company spokeswoman confirmed, although she maintained the cuts are strictly an effort to fine-tune its workforce and are not related to the recent flop. The drug maker is calling its cutback a “voluntary reallocation program,” a move that will reduce its global R&D staff of roughly 7,000 people by nearly 3 percent. Lilly currently employs about 40,000 people worldwide. (Silverman, 2/3)

NPR: Heat, Humidity And Aging Make Medicine Less Potent
Most of us have reached for a painkiller, at one time or another, only to discover the date on the label shows it’s expired. But what does an “expiration” date on medicine really mean? Is it dangerous if you take it anyway? Less effective? It turns out that date stamped on the label actually means a lot. It’s based on scientific evidence gathered by the manufacturer showing how long the drug’s potency lasts. (Neighmond, 2/6)

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Hospitals Lost Billions In Funding When ACA Passed — Now They’re Fighting To Get It Back

The health law cut two types of hospital funding: charity care money and annual raises in Medicare reimbursement. But as Republicans take aim at dismantling the legislation, hospitals say they’re going to need those cuts repealed too. Meanwhile, insurers don’t want to go back to pre-health law days when they were seen as the bad guys.

The Wall Street Journal: Hospitals Fear Changes To Health Law, Press GOP On Revenue Concerns
Hospital executives are descending on Washington with a message: They are concerned about losing insured patients and revenue under any plan to dismantle or significantly alter the Affordable Care Act. In a flurry of recent meetings, the executives have told lawmakers they don’t want Americans to lose insurance under any alternative the Republicans devise for the Affordable Care Act. If that happens, however, hospitals say they want Congress to restore billions of dollars in federal funding they lost when the ACA took force. (Evans, 2/5)

Des Moines Register: Obamacare Has Eased Hospitals’ Burdens Of Caring For Uninsured
Iowa hospitals have seen a $127 million drop in annual charity-care costs since the Affordable Care Act took full effect in 2014, financial reports show. That was a decline of almost 38 percent. Over the same period, 2013 through 2015, Iowa hospitals saw a $168 million annual drop in “bad debt,” or medical bills that were sent but weren’t paid. Hospital leaders say the improved finances helped them stabilize and improve their organizations. They worry that if the law is completely rescinded, they would be worse off than they were before it passed. (Leys, 2/5)

NPR: Health Insurers Say They Don’t Want To Go Back To Being The Bad Guys
President Donald Trump and other Republican leaders have been working to repeal and replace the Affordable Care Act. And the millions of Americans who have health insurance through the Obamacare marketplaces aren’t the only ones wondering about their fate. Leaders of insurance companies are, too. (2/3)

In other health law-related news —

San Jose Mercury News: Repeal And Replace? All Americans Could Lose Obamacare Protections
Lost in the bipartisan battle in Congress, many health experts say, are all the little-known aspects of former President Barack Obama’s signature health care law: They say it’s not just the 22 million Americans who now buy individual health policies on insurance exchanges — or who qualify for an expanded Medicaid program — who benefited from the 2010 law. From coast to coast, tens of millions of other Americans — including many who often rail against “Obamacare’’ — are also covered by the law’s consumer protections. (Seipel, 2/4)

Denver Post: Colorado Health Exchange A Political Football In Debate About Obamacare Repeal
The leaders at Colorado’s health insurance exchange are working to keep alive the online marketplace, even if the Affordable Care Act is repealed, while Republican state lawmakers want to shut it down now. The contradictory approaches put Connect for Health Colorado, the state-based exchange where 175,000 residents purchased insurance in 2016, at the center of a debate that is only amplified by the efforts in Washington to repeal President Barack Obama’s signature health care law. (Frank, 2/3)

The Philadelphia Inquirer: ACA-Established N.J. Health Insurer To Be Liquidated
A Superior Court of New Jersey judge on Friday approved the liquidation of Health Republic Insurance of New Jersey, one of 23 nonprofit consumer-operated and -oriented health plans established under the Affordable Care Act. Last fall, the New Jersey Department of Banking and Insurance put the insurer in rehabilitation, taking it out of the market for this year, but holding out the possibility that it could return to selling health insurance plans next year if Health Republic found investors. The insurer was expected to have a deficit of $18 million last month. (Brubaker, 2/3)

And KHN explains how budget reconciliation works —

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