When tiny Australian biotech firm Innate Immunotherapeutics needed to raise money last summer, it didn't issue stock on the open market. Instead, it offered a sweetheart deal to "sophisticated U.S. investors," company documents show.
When tiny Australian biotech firm Innate Immunotherapeutics needed to raise money last summer, it didn't issue stock on the open market. Instead, it offered a sweetheart deal to "sophisticated U.S. investors," company documents show.
It sold nearly $1 million in discounted shares to two American congressmen sitting on House committees with the potential power to advance the company's interests, according to company records and congressional filings. They paid 18 cents a share for a stake in a company that was rapidly escalating in value, rising to more than 90 cents as the company promoted an aggressive plan to sell to a major pharmaceutical company. Analysts said the stock price could go to $2.
One of the beneficiaries was Rep. Tom Price, a Georgia Republican poised to become secretary of the Department of Health and Human Services, which regulates pharmaceuticals. Price told HHS ethics officials Thursday that if appointed, he will divest himself of the Australian stock as well as stock in about 40 other companies that could pose conflicts. He said he would sell within 90 days of appointment and abstain from any decision-making about companies in which he or his family has had an interest.
He has already seen about a 400 percent paper gain in his investment in Innate Immuno, stock trading records show.
The other and more substantial August investor was Rep. Chris Collins, a Republican from upstate New York, who along with family members owns about 20 percent of the foreign company. A key supporter of the president-elect, Collins sits on a key health subcommittee.
The outlines of the stock deal, first reported by the Wall Street Journal, resurrected concerns about powerful public officials gaining investment opportunities unavailable to the public, including from companies whose profits might be influenced by political decisions.
A review of corporate documents raises a more unusual aspect of the deal. Innate Immuno is a foreign company which, in documents and presentations, is explicit about a business strategy targeting the U.S. market, where the amount that can be charged for a new drug is generally far higher than in other countries.
Innate Immuno has hinged its strategy on winning a preliminary green light for a new multiple sclerosis drug, known as MIS416, from the HHS's Food and Drug Administration. It says in its private placement offering documents that money raised in the U.S. will help it finance the FDA approval process, which can take years. Innate Immuno CEO Simon Wilkinson could not be reached for comment.
Price's financial disclosures show that he acquired his first small stake in Innate Immuno in January 2015, investing about $5,000. He made two more small purchases in the company that year, declaring a small loss on the stock in his 2015 financial disclosure.
His largest purchase was on Aug. 31, 2016, valued at between $50,000 and $100,000, his disclosures show.
Government ethics experts said this week that Price's stake in Innate Immuno as it tries to develop a blockbuster drug would clash with his public duties, making divestiture mandatory.
While ethics rules for Congress are relatively relaxed, "the minute you go to the executive branch, it's a lot stricter," said Richard Painter, a University of Minnesota law professor who was President George W. Bush's chief ethics lawyer.
"Dr. Price takes his obligation to uphold the public trust very seriously," said Phil Blando, a spokesman for the Trump transition. He has "complied fully with all applicable laws and ethics rules governing his personal finances."
Innate Immuno told investors it would seek "investigational new drug" status from the FDA, which could shorten the approval process. The FDA would not confirm this week whether the company has filed an application.
The drug is in a small clinical trial in New Zealand due to end in April. MS drugs are especially expensive for patients, costing $5,000 a month or more.
Positive trial results could set the stage for Innate Immuno's stock to reach $2, said Australian stock analysts. In that scenario, Price's investment of between $50,000 and $100,000 would be worth between $555,000 and $1.1 million. House financial disclosures require reporting of ranges of value but not specific amounts.
"You could easily picture a drug that is in the billions of dollars in revenues, but that's assuming the [trial] data is there," said David Blake, an analyst at Bioshares, a newsletter covering Australian life sciences stocks. "It's really got to deliver."
A physician who chairs the House Budget Committee, Price also sits on the House Ways and Means Committee and the Congressional Health Care Caucus. He has a history of contacting the FDA on behalf of industry campaign donors.
His ownership of Innate Immuno while serving in the House creates its own appearance of a conflict of interest, ethics authorities said.
"There is an appearance problem … to have members of Congress buying and selling stocks that are affected by the work of the committees they sit on," Painter said. "It could be perfectly legal, but it looks terrible and shows lack of judgment."
Price's Innate Immuno stake is one of more than 40 companies he identifies as potential conflicts with the HHS job, including stock in Pfizer, Eli Lilly and Bristol Myers Squibb.
Collins, who sits on Innate Immuno's board, has been a major shareholder in the company since 2011 and has gradually increased his family's holdings to about 20 percent, corporate documents show. His investment in the private placement last summer was worth $720,000, according to regulatory documents.
"Congressman Collins has followed all ethical guidelines related to his personal finances during his time in the House and will continue to do so," said spokesman Michael McAdams.
All told, including Price, Collins and other U.S. investors, the sale raised $1.8 million. In addition to funding the FDA approval process, the company said it would use the money to finance the clinical trial and develop potential manufacturing for the drug.
All U.S. investors in the August deal received a 12 percent discount to the stock's market price at the time, which is not unusual in private placements, said Stuart Glazebrook, a biotech analyst for Gordon Capital Research, a securities research company in Melbourne, Australia.
For small companies, private issues can be more efficient than selling new public shares, he said. Selling at less than the market price raises odds of attracting investors, he said.
"It's an incentive," he said. "It's like Amazon offering 20 percent off today only if you commit today."
Ethics rules for FDA officials are especially strict, said Joshua Sharfstein, a former agency deputy commissioner.
"For the agency's leaders, even holding onto a single share of stock in a regulated company is prohibited," he said.
A decade ago FDA Commissioner Lester Crawford resigned and pleaded guilty to two criminal misdemeanors after being charged with concealing stock ownership in food and drug companies the agency regulated.
Innate Immuno executives have talked openly about selling the company to one of a number of pharmaceutical company suitors if its clinical trial is successful. Many small pharmaceutical companies with hot drugs go that route, reaping shareholders millions in quick profits.
The larger company would have the deep pockets to invest in more clinical trials that might be needed to obtain regulatory approval, analysts said.
The incoming Trump administration hasn't released its health plan to replace Obamacare. But, experts say, it is likely to give the states less federal money for treating the poor.
CONNELLSVILLE, Penn. – Judy Keller, 69, has always relied on Highlands Hospital for medical care, just as her parents did before her. When she walks through the halls, she recognizes faces from the community and even from her days working as a school teacher. The 64-bed facility, she says, is a mainstay of this rural Southwest Pennsylvania town.
"This hospital all my life has been here," said Keller, now retired. "[It] helps a lot of people who don't have adequate health care coverage — and I don't know what they would do without it." Aside from providing health care to a largely poor population, it provides hundreds of jobs in a town that locals say never recovered after industries such as coal mining and glass manufacturing disappeared.
But in the wake of this fall's presidential election, Highlands — like many other rural hospitals — will likely face new financial challenges that will intensify longstanding struggles, experts say. The Affordable Care Act, which President-elect Donald Trump has vowed to repeal, threw a number of life-savers to these vital but financially troubled centers. And its full repeal, without a comparable and viable replacement, could signal their death knell.
Highlands provides one window into how some of these shifts could reverberate in small towns across the country. And ironically, 64 percent of people here in Fayette County — one of the state's poorest — voted for Trump. Pennsylvania, which has the third largest rural population in the nation, played a pivotal role in his upset victory this fall.
"All these rural hospitals are operating on thin margins. The removal of any income source or coverage, or expansion of bad debt, is going to create significant financial hardship," said Alan Morgan, CEO of the National Rural Health Association.
Rural hospitals have long operated on the edge. In the past six years, more than 70 such facilities have closed, citing financial duress. Almost 700 more have been deemed at risk of following the same path. Meanwhile, the need for reliable health care remains pressing. Conditions such as heart and lung disease are widespread in rural areas. Addiction to the prescription painkillers known as opioids is acute. Nationally, the Medicaid expansion offered a bit of stability for some rural hospitals at risk of closure. Researchers say it disproportionately benefited such facilities — particularly here and other states with large rural populations, such as Illinois, Kentucky and Michigan.
In Pennsylvania, 625,000 people enrolled in the expanded Medicaid program. Close to 300,000 came from rural areas, said Andy Carter, president of the Hospital and Health System Association of Pennsylvania. As of October, about 42,700 of Fayette's residents had Medicaid, according to state data, an increase of about 8 percent from 39,460 in June 2015. (Pennsylvania's Medicaid expansion took effect in January of that year.) That's close to one-third of the county's population.
Despite that, Highlands CFO Andursky said he barely noticed the increase — the threat of closure is a "daily concern," he said. "It seems like you're taking two steps forward, three steps back," Andursky said. "It's not like I can look to five years out — because I have to worry about tomorrow. I can't worry about next year."
That pessimism can be heard throughout this town of about 7,600 residents. While the law was described as historic, many here do not perceive that it helped them. Like many other states, Pennsylvania re-branded their expanded offering of federal insurance program for the poor, fearing that "Medicaid" which is also often referred to as "Medical Assistance" would be off-putting; now it is called "Healthy PA."
Bryan McMullin, a 47-year-old who works in Connellsville's river-rafting business, got coverage last year but said good health care remains hard to come by. "In this area, nothing's changed in 40 years, no matter who is president," he explained from a barstool at a pub near the now-vacant glass factory.
Daniel Martin, a 28-year-old Highlands patient who also works in the rafting trade, said he uses his new coverage for his monthly blood medication. A Trump voter, he hadn't realized that coverage now could be in jeopardy.
And small towns like this tend to be far sicker than the norm. In Fayette, more than 1 in 10 people is estimated to have diabetes. Out of 67 counties in the state, Fayette ranks 66th for health outcomes and more than a third of its residents are obese. It's tied with northern Potter County for the second-highest teen birth rate in the state. Between 2014 and 2015, the county saw about 31 people overdose for every 100,000, according to an analysis by the federal Drug Enforcement Agency.
Plus, the hospital is Connellsville's second-largest single employer, after the school district. It contributes an estimated $15 million to the local economy, Andursky said. That's in a town where unemployment's already at 7.6 percent — up from last year and higher than the state and national averages.
"When I was a kid, everybody had a job, everybody had health care. Now, look at the statistics," said McMullin, one of the rafters.
There are other hospitals in the region.
Uniontown, about 15 miles away, is also in Fayette County. It has 175 beds — more than double Highlands — but no behavioral health services to treat problems like addiction. Frick, another small rural hospital about 12 miles away, technically serves neighboring Westmoreland County. For more serious conditions, and trauma care, university hospitals are about an hour away — in Pittsburgh on one end, and Morgantown, West Virginia, on the other. Patients in extremis often get stabilized at the local hospitals before transfer.
But rain and snow, combined with mountainous terrain and limited public transit, mean traveling even short distances poses hardship. "It is still challenging to have to travel even 20 miles to get your care," said Lisa Davis, director of Pennsylvania's Office of Rural Health and outreach associate professor of health policy and administration at Pennsylvania State University. "It could take you all day to get to a one-hour appointment."
In a medical emergency, getting care quickly can mean the difference between life and death
So far, the incoming Trump administration hasn't released its health plan to replace Obamacare. But, experts say, it is likely to give the states less federal money for treating the poor. It is unclear how rural hospitals will compensate for the financial benefits they are likely to lose — or how many more rural hospitals will fall.
"What they need to do is be sure to protect the government programs: Medicare and Medical Assistance," Andursky said. "We can't put them at risk."
The nonprofit California Integrated Data Exchange, launched by insurers Blue Shield of California and Anthem Inc. in 2014, intends to merge with the Inland Empire Health Information Exchange. Together, they would have insurance claims and medical records of 16.7 million people.
After a sluggish start, the Cal INDEX medical database has agreed to a merger that would create one of the largest repositories of patient records in the country.
The nonprofit California Integrated Data Exchange, launched by insurers Blue Shield of California and Anthem Inc. with much fanfare in 2014, announced Tuesday that it intends to merge with the Inland Empire Health Information Exchange. Together, they would have insurance claims and medical records of 16.7 million people.
Obama administration veteran Claudia Williams, 53, will take the helm as chief executive on Feb. 1.
San Francisco-based Cal INDEX is an ambitious initiative to give hospitals and doctors a single place to get patient information culled from medical records and insurance claims. State leaders and other supporters say giving an emergency room or a doctor the ability to instantly access a patient's medical history can improve the quality of care, reduce medical errors and cut wasteful spending.
Across the country, efforts at creating these digital databases or health information exchanges often have hit technical snags and industry turf battles. One of the most successful examples has been the Indiana Health Information Exchange, which holds records on more than 12 million people and participation by more than 100 hospitals and 12,000 medical practices.
The California database merger, which is subject to approvals from the state attorney general, is expected to close in the first quarter of 2017. The newly formed organization will be renamed later.
Williams served as senior adviser for health innovation and technology at the White House from 2012 until last week. Previously, from 2010 to 2012, she was director of health information exchange in the information technology office at the U.S. Department of Health and Human Services.
She helped oversee federal stimulus money for expanding electronic medical records and creating regional health information exchanges.
In an interview, Williams said she's eager to put her government experience into practice in California.
"I was looking at the best opportunity for me to make good on the promise of actually getting information moving to improve patient care," Williams said.
Access to real-time patient information has become critical as the U.S. health care system moves away from fee-for-service medicine and overhauls how care is delivered. A wide variety of payment reforms, such as creation of accountable care organizations and scrutiny of hospital readmissions, rely on hospitals and physicians knowing about all of the various care patients receive, whether it's in or outside their normal provider network.
Williams said she wants the California database to electronically alert primary care doctors every time one of their patients arrives in the emergency room so they can follow up appropriately.
"I have a lot of knowledge of what works and doesn't work," she said.
Williams is taking over an organization that thus far has fallen short of its hype. The involvement of Blue Shield and Anthem was designed to give Cal INDEX an early boost by providing records on millions of Californians who have insurance coverage through the two companies. At launch in 2014, the two insurers said they were investing $80 million in the project.
But several challenges soon emerged. Its first CEO, David Watson, lasted less than two years and left to work in the private sector. There were two interim CEOs in the meantime.
Also, as in other states, persuading additional health plans and medical providers to supply patient data and pay fees to access the information proved difficult because they're used to being competitors.
Cal INDEX holds data on 11.7 million people, and the Inland Empire health exchange — serving providers in 18 counties, including the Central Valley — will bring an additional 5 million patient records and 150 participating health care partners.
Last month, Cal INDEX got a shot in the arm when a big health system in Southern California, St. Joseph Hoag Health, announced it was joining the exchange.
Dr. Bradley Gilbert, chairman of the Inland Empire exchange and CEO of the Inland Empire Health Plan, said "this is a case of two is better than one. Each have different strengths that complement each other well."
Inland Empire Health Plan, which serves Riverside and San Bernardino counties, has contributed about $4 million to the health information exchange there since it was founded in 2009.
Dr. Farzad Mostashari, the former national coordinator for health IT in the Obama administration, hired Williams in Washington and said she excelled at running the federal grant program for health information exchanges.
He said some regional exchanges have tried to gain the endorsement of the state Medicaid program to increase participation among hospitals and other providers.
For now, the California Department of Health Care Services, which runs Medi-Cal, doesn't have a direct business relationship with Cal INDEX.
"The first challenge for [Williams] is getting the lay of the land and developing those relationships with health plans, Medicaid, doctor groups, public health," said Mostashari, now CEO of the health technology firm Aledade Inc.
Mark Savage, vice chair of the Cal INDEX board, said Williams was the ideal candidate for CEO.
"I'm also mindful of setting reasonable expectations, and it will take her some time to come in and build a combined company," he said.
Cal INDEX only shares patients' clinical data, not their financial information, with participating providers, hospitals and insurers. Users cannot sell any of the data, release it publicly, or use it to set provider rates.
For now, consumers can't review their own records in the database. There's an opt-out provision for consumers on the Cal INDEX website, which if selected would mean their information would not show up.
Savage said it's important that patients eventually gain access to their full medical records through this statewide organization, but he isn't sure when that would occur.
For the patients and the employees of Mary's Center, a community health center that serves Washington, D.C., and its Maryland suburbs, the 2010 health law had a big impact on business. The facility has always promised care to anyone who walks through its doors. But since Obamacare's implementation, the patient population and the quality of care they receive has changed.
"The first set of patients we saw — it was like, 'Wow, I can see a doctor for the first time. I can afford to go to the doctor,'" recalled Maria Gomez, the center's president. "There were patients that knew they had tumors, or knew they hadn't had a pap smear in a long, long time."
But it wasn't just access to care, Gomez added. The law, which extended health insurance to more than 20 million people, also provided new streams of revenue. Since Mary's Center was handling fewer uninsured patients, that financial security let it hire more specialists and operate more health education programs.
Similar stories played out at many of the nation's more than 1,400 federally-backed community health centers, according to two studies published today in Health Affairs. The research offers evidence that in states that embraced the health law, community health centers — which play a key role in providing health care to low-income people, often in medically underserved areas — further extended their reach. It also quantified the types of clinic visits and health services provided that resulted from the expansion.
These findings, though, also highlight the uncertainties some of these clinics face as the incoming Trump administration and the GOP Congress advance plans to repeal and replace Obamacare.
"I'd love to think we can think of policies that will reduce harm, and make things better," said Leighton Ku, director of the Center for Health Policy Research at George Washington University and an author on one of the studies. "But my crystal ball isn't that clear."
The two studies, which appear in the journal Health Affairs, use data from the federal Health Resources and Service Administration to examine Medicaid, the federal-state insurance plan for low-income people. Under the law, states could opt into an expanded version of the program that covered more people. GOP plans to undo the 2010 law would likely include erasing that option. Many Republicans also want to change Medicaid from its current open-ended, entitlement status into a block grant, which would send a set, lump sum of funding to states and allow them more flexibility to tailor the program to address local health needs, potentially spurring innovation and more efficiency.
"There may be things that can done in the delivery of care for community health centers, which ultimately is more valuable and effective than the traditional Medicaid program," said Tom Miller, a resident fellow at the American Enterprise Institute, a conservative think tank.
It's too soon to say, Miller argued, how health care funding will play out, how money could be used and who will benefit. But other advocates of the law — including many leaders of community health centers — say that current discussions leave strong potential for funding cuts that would limit their ability to provide care. The Health Affairs findings play into that concern.
Ku's paper, which used data from 2012 to 2015 to track visits to community health centers, compared how many patients visited the centers, their insurance, and whether they sought medical, dental or mental health care. In states that opted into the expansion, health centers saw more patient visits, lower rates of uninsured patients — a financial boon for clinics that typically operate on thin margins — and an increase in patients specifically seeking mental health care.
The second study examined data from 2011 to 2014 and found that, in states that expanded Medicaid, patients were more likely to receive asthma treatment when it was needed, have their body mass index assessed, get pap smears and keep their blood pressure relatively stable.
"Achieving better quality in [these areas] requires medications — access to prescription drugs," noted Amal Trivedi, an associate professor of health services, policy and practice at Brown University and an author on the second study.
Some clinic officials noted that these statistics illustrate tangible gains.
Community health centers in Michigan, which pursued the expansion, saw a double-digit increase in the percentage of Medicaid patients — from 44 percent to 54 percent — even as the overall number of patients served grew, noted Jen Anderson, a spokeswoman for the Michigan Primary Care Association, the trade group for the state's centers. More of those patients were diabetic or asthmatic, she added, and now able to get previously unaffordable medications.
Without that coverage, Trivedi speculated, the improvements health centers made in treating these and other conditions could be reversed.
The studies found that the centers, too, benefited from the expansion, which has allowed them to staff up to do provide mental health and other types of care.
In Pennsylvania, for instance, which has been hard hit by the opioid epidemic, more clinics have been able to develop specialized addiction treatment programs, said Cheri Rinehart, president of that state's health center association. Other clinics report that health law dollars have allowed them to hire case workers to follow up with patients to make sure they have stable housing and access to healthy food as well as transportation to doctors' appointments.
Those kinds of efforts will be much harder if Congress acts on its proposed repeal without a meaningful replacement, Gomez said.
"We'll have to cut services for everyone," she said.
At Mary's Center, she said, that would mean tamping down on dental care, cardiology or endocrinology to treat diabetes. The center would also likely downsize how many doctors and nurses it employs, making it harder to see as many patients in a timely manner.
These centers are often the only real option for care. If they can't provide a service, people will likely go without until it's an emergency, Pennsylvania's Rinehart noted.
Without the coverage expansion, community health centers "will have to re-evaluate all the services they're providing," Rinehart said. "Just like a body in crisis, you focus on the core, and lose many of the ancillary services that are critical."
New study raises the possibility that some women who believe their lives were saved by mammograms were actually harmed by cancer screenings that led to treatment they didn't need, says Dr. Otis Brawley, chief medical officer of the American Cancer Society.
One in three women with breast cancer detected by a mammogram is treated unnecessarily, because screening tests found tumors that are so slow-growing that they're essentially harmless, according to a Danish study published Monday in Annals of Internal Medicine, which has renewed debate over the value of early detection.
The study raises the uncomfortable possibility that some women who believe their lives were saved by mammograms were actually harmed by cancer screenings that led to surgery, radiation and even chemotherapy that they didn't need, said Dr. Otis Brawley, chief medical officer of the American Cancer Society, who wrote an accompanying editorial but was not involved in the study.
Researchers increasingly recognize that not all breast cancers pose the same risk, even if they look the same under a microscope, Brawley said. While some early tumors turn into deadly monsters, others stop growing or even shrink. But assuming that all small breast lesions have the potential to turn deadly is akin to "racial profiling," Brawley wrote in his editorial.
"By treating all the cancers that we see, we are clearly saving some lives" Brawley said in an interview. "But we're also 'curing' some women who don't need to be cured."
Although experts such as Brawley have long discussed the risks posed by "overdiagnosis," relatively few women who undergo cancer screenings are even aware of the debate.
The American College of Radiology, which strongly supports breast cancer screenings, acknowledges that mammograms lead some women to be treated unnecessarily, but said the problem is much less common than the new study suggests. Another study from Denmark – whose national health program keeps detailed records – estimated the overdiagnosis rates at only 2.3 percent.
"The amount of overdiagnosis really is small," said Dr. Debra Monticciolo, chair of the American College of Radiology's Commission on Breast Imaging. "Articles like this aren't very helpful," she said, because they leave women confused about how to be screened for breast cancer.
Yet treating women for cancer unnecessarily can endanger their health, said Fran Visco, president of the National Breast Cancer Coalition, an advocacy group. Radiation can damage the heart or even cause new cancers. Visco notes that breast cancer activist Carolina Hinestrosa, a vice president at the coalition, died at age 50 from soft-tissue sarcoma, a tumor caused by radiation used to treat an early breast cancer.
Women should understand these risks, Visco said. Instead, women often hear only about mammograms' benefits.
"Women have been inundated with the early detection message for decades," Visco said.
The risks of overdiagnosis and false positives, which can lead women with benign growths to undergo biopsies and other follow-up tests, have caused some experts to reevaluate breast cancer screenings. Although mammograms don't find all tumors, they reduce the risk of dying from breast cancer by 25 percent to 31 percent for women ages 40 to 69, according to the Agency for Healthcare Research and Quality, part of the Department of Health and Human Services.
Medical groups now offer differing advice on mammograms:
The American College of Radiology takes the most aggressive stance, recommending annual mammograms beginning at age 40. Tumors should be found when they're "smaller and easier to treat," Monticciolo said.
The U.S. Preventive Services Task Force, an independent expert panel that advises the federal government on health, provoked a firestorm of criticism in 2009 when it bucked that advice, recommending that women get mammograms every other year beginning at age 50. The group noted that breast cancer risk rises with age, so mammograms are more likely to discover cancer – as opposed to benign growths – after age 50.
The American Cancer Society also scaled back its screening advice in 2015, recommending women get annual mammograms from 45 to 54, followed by screenings every other year after that.
In the new study, Danish researchers estimated the rate of overdiagnosis by comparing the number of early-stage and advanced breast tumors before and after the country started offering mammograms. If screenings work as intended, the number of small, curable breast tumors should increase, while reducing the number of large cancers by about the same amount.
Although mammograms in Denmark detected a lot more breast cancers, these were mostly small, early-stage tumors, said study coauthor Dr. Karsten Jorgensen, a researcher at the Nordic Cochrane Center in Copenhagen, Denmark. The number of advanced cancers did not fall.
The debate about overdiagnosis illustrates the limits of medical technology, Brawley said.
Although researchers can estimate the statistical rate of overdiagnosis, doctors treating actual patients can't definitively tell which breast tumors need treatment and which might be safely ignored, Brawley said. So doctors tend to err on the side of caution and treat all breast cancers with surgery and, in many cases, radiation and chemotherapy.
An estimated 253,000 new cases of breast cancer will be diagnosed in U.S. women this year, with nearly 41,000 deaths, according to the American Cancer Society.
An additional 63,000 women will be diagnosed with ductal carcinoma in situ, also known as DCIS, which has some, but not all, of the typical traits of cancer. Although DCIS cells have changed to appear malignant under the microscope, they haven't invaded surrounding tissue.
The American Cancer Society defines DCIS as the earliest stage of breast cancer, and women with the condition typically undergo the same treatment given to women with early invasive cancers. Although DCIS isn't life-threatening, doctors recommend treating it to prevent it from becoming invasive.
Other experts note that DCIS carries such low risk that it should be considered merely a risk factor for cancer. Researchers are conducting studies to measure whether it's safe to scale back treatment of DCIS.
Over the past decade, Tom Price has waded into issues related to specific drugs and medical devices, making 38 inquiries with the federal Food and Drug Administration, according to federal records.
Rep. Tom Price, the physician and Georgia Republican tapped for the nation's leading health care job, has long criticized federal spending as excessive. Yet during his years in Congress, he's worked hard to keep federal dollars flowing to his most generous campaign donors.
Price has been a go-to congressman, a review of his records show, for medical special interests hotly sparring with regulators or facing budget cuts. Over the past decade, he has waded into issues related to specific drugs and medical devices, making 38 inquiries with the federal Food and Drug Administration, according to federal records obtained through the Freedom of Information Act. He questioned the FDA on his constituents' behalf about matters as minute as a device for fertility treatment and an ingredient in pain creams.
In other cases, he has gone to bat for companies whose executives and employees have generously contributed to his campaigns and political action committees.
"It looks like he's somebody who could throw the store open to a lot of niche special interests," said Ross Baker, a political science professor at Rutgers University who specializes in Congress. "These are things that fly under the radar. If you take a meat ax to Medicare, for example, everybody would know about it. But this kind of stuff is done in the dark of night."
Just a few weeks before Trump tapped Price to lead the Department of Health & Human Services in November, the congressman took the stage at an Atlanta conference for vendors who sell canes, hospital beds and power wheelchairs. Price was the star of the show — a conference with 5,000 attendees. He spoke to the gathered crowd about the Medicare cuts plaguing the industry and pledged to fight them. The leaders of the Medtrade conference honored Price with an award for his stalwart advocacy and convened a $100-per-person fundraiser in his honor.
Price, 62, a tea party Republican and orthopedic surgeon from the northern Atlanta suburbs, was elected to Congress in 2004 after four terms in the Georgia state Legislature. A third-generation physician, he has said he entered politics on a quest to limit government meddling in health care. He has won significant campaign support over the years from drug firms and physician groups.
Records obtained through a public records request show that Price has taken an interest in his constituents' struggles with the FDA. He hand-signed a letter of concern over the availability of heart valves used in pediatric surgeries in 2005. Four years later, he urged review of a local company's sperm-analysis device. He dubbed the company a "pillar of the community" and said it should be exempted from a clinical trial that would be "impossible to pass." Earlier this year, his staffer pressed the FDA on behalf of a constituent trying to getcapsaicin palmitate, a hot-pepper ingredient similar to one available over the counter — on a list of approved products for specialized pain creams.
A staunch opponent to President Barack Obama's Affordable Care Act, or Obamacare, which he says destroys "the sacred doctor-patient relationship," Price has offered several plans, including the Empowering Patients First Act, to repeal and replace the president's health reforms. He favors instead offering patients health savings accounts which they may tap to pay for coverage and care, and tax credits to help people buy health insurance on their own.
Price's office did not respond to interview requests or to detailed written questions about his relationships with contributors or his legislative record. His confirmation hearing could come before President-elect Trump's inauguration on Jan. 20, and Senate Minority Leader Chuck Schumer has said Price is among the top targets for Democrats — and whose nomination they are trying to derail. The Office of Government Ethics will review Price's financial disclosure report, which contains information about his assets, income and other personal financial information and then advise the Senate Finance Committee on whether Price needs to take steps to avoid conflicts of interest.
In recent weeks, Price has come under criticism for his stock trading in drug companies, including an Australian firm that plans to seek U.S. approval for a promising drug.
Phil Blando, a Trump transition spokesman, said Price has complied with the law and ethics rules. Blando said that Price "takes his obligation to uphold the public trust very seriously" and, if confirmed by the Senate, will work with ethics officials to "ensure his continued compliance and transparency."
Champion of Medical Equipment
When thousands gathered at the Medtrade meeting to learn about the latest home medical equipment in the fall, Price pledged to help them.
The industry has battled widespread changes in government payment mandated by Congress in 2003 and implemented by the Obama administration. The reforms came after a decade of Justice Department prosecutions that targeted fraudsters who bought wheelchairs at wholesale prices, allegedly gave them to seniors who didn't need or want them and billed Medicare at a premium.
The most recent reforms have included budget cuts and a competitive bidding program meant to limit medical supply profitability, including the wheelchairs. Providers of home medical equipment have ranked as key Price backers, contributing $52,600 to his campaign since 2013, according to a Kaiser Health News analysis of federal contributions.
Despite his longtime stance as a budget hawk, Price has sided with industry leaders who say the cuts harm rural medical suppliers who face higher costs delivering equipment. Price said in a press release that the cuts jeopardize seniors' access to life-saving medical equipment, including scooters and oxygen tanks. "Georgia's seniors ought to have access to quality health care," Price said in a statement in May.
Price introduced a bill that month to delay cuts in Medicare spending for durable medical equipment, like hospital beds and motorized wheelchairs. The bill passed the House in July but died in the Senate.
Medical equipment industry leaders credit Price with helping reverse or delay some cuts through the recently signed 21st Century Cures Act, according to the blog of the Iowa-based VGM Group, which describes itself as "the nation's premier purchasing organization" and a "silent partner" to thousands of independent providers of home medical equipment. The company and its executives have contributed more than $17,000 to Price. One leader aired his gratitude to the congressman in another blog post calling the delay of the cuts a "red letter day" for durable medical equipment suppliers.
Price has also helped protect companies that provide home health aides and nursing care to homebound seniors — a lucrative industry that prosecutors have identified as prone to fraud. Alarmed by a Medicare plan to review such claims prior to payment, industry leaders turned to Price and another congressman for help, according to the Partnership for Quality Home Healthcare, which lauded both men for listening to their concerns.
Home health companies also contributed more than $24,000 to Price from 2013 to earlier this year.
Criticizing the cost-saving plan as overly broad and impeding patients' access to care, in September, Price introduced a billthat would delay the claim-review project a year. The bill, cosponsored by Rep. Jim McGovern (D-Mass.), stalled in a subcommittee in October.
Support for Traveling Doctors
In Congress, Price has been a vocal critic of America's medical malpractice system — a bugaboo for many surgeons but also for a company based in his district that has provided reliable campaign donations. That firm, Jackson Healthcare, staffs hospitals and practices with temporary doctors, called locum tenens.
One of Price's largest PAC contributors is Richard L. Jackson, the company's chairman and CEO. The two spoke together in 2009 at a forum aimed at limiting malpractice lawsuits. Both men have asserted doctors' attempts to avoid such lawsuits have led to costly and excessive medical care. In a 2010 interview, Jackson mentioned that he had discussed "defensive medicine" with Price, and other Congress members. Price, for his part, has referenced Jackson Healthcare's study on the high cost of such health care.
The malpractice issue has had particular relevance to the locum tenens industry and to Jackson's company in particular. It has faced multiple lawsuits over the alleged misdeeds of temporary doctors, including care of patients in Veterans Affairs and Indian Health Service hospitals.
Price has repeatedly introduced legislation to curtail malpractice cases and, on another front, to protect the tax status of traveling doctor companies. In September he introduced the House version of a bill that would help change the IRS code to classify travelling doctors as contractors, not employees, so that the company providing them wouldn't be legally vulnerable for taxes in distant states. A Senate version was introduced earlier by Georgia Republican Sen. Johnny Isakson. The bills died in committee last year.
Jackson and his son, Shane, the company's president, have supported Price with donations to his campaign and joint fundraising committee, which contributes to Republican campaigns. Since 2011, Jackson and his son, have contributed at least $43,000 to Price's campaign or a joint fundraising committee with $35,000 arriving last January.
A spokeswoman for Jackson said Price's bill would not have affected his company since, in practice, it already regarded its doctors as contractors, as did the government.
But Sean Ebner, president of another major traveling doctor company, said the measure would have eliminated the possibility of a surprise tax bill.
"The designation of who's an independent contractor can change state by state," Ebner, who heads Staff Care, said in an interview. "[The bill] removes ambiguity, which would be positive."
Influence with the FDA
If confirmed as HHS secretary, Price would oversee many of the rules and regulations and bottlenecks that regularly draw howls from the medical industry. He would also have authority over the FDA, which regulates pharmaceuticals. The agency may soon have purview over a company that Price has personally invested in.
The Australian firm Innate Immunotherapeutics reported in an annual report that it plans to bring its key Multiple Sclerosis drug to the FDA for approval. Several months ago, Price purchased between $50,000 and $100,000 worth of stock in the company, according to a routine financial disclosure required of Congress members.
The FDA is also currently mulling another regulatory issue that could make or break the company of a top contributor. Parker H. "Pete" Petit, along with his family has contributed $35,900 to Price's campaign and leadership PAC since 2010. Petit also was finance chair for Trump in Georgia and, with his family, contributed $125,000 to the president-elect's PAC.
Petit is the CEO of MiMedx, a Georgia biotech firm in Price's district, which has contested a decision from the FDA on some products to aid wound healing.
In August 2013, the FDA concluded in a letter that the products, which consist of discarded placentas and amniotic fluid, should be regulated since their manufacturing constituted manipulating human tissue. The FDA letter sent MiMedx stock tumbling and spurred a securities lawsuit filed in federal court in Georgia. The case accused MiMedx of misleading investors by downplaying the gravity of the FDA's scrutiny. A nearly $3 million settlement was reached in April.
Petit has acknowledged seeking congressional help on the issue, without being specific. The FDA said it couldn't comment on the matter. MiMedx did not return calls.
The Republican strategy of repealing the Affordable Health Care Act before devising a replacement plan has the support of only one in five Americans, according to a Kaiser Family Foundation survey.
The Republican strategy of repealing the Affordable Health Care Act before devising a replacement plan has the support of only one in five Americans, a poll released Friday finds.
The Kaiser Family Foundation survey also disclosed that shrinking the federal government's involvement and spending in health care — the long-sought goal of House Speaker Paul Ryan and other Republican lawmakers — is less important to most Americans than is ensuring medical care is affordable and available. (Kaiser Health News is an editorially independent project of the foundation.)
Views split not only on partisan lines but also within the Republican Party, where nearly four in 10 think that the government should guarantee health care is available to the elderly and to low-income people, even if it means more federal involvement.
Despite the rout of Democrats in the election, which gave the GOP control of both the White House and Congress, the public's view on the Affordable Care Act remains as divided as it has been since it was passed by President Barack Obama and congressional Democrats in 2010. Currently, 47 percent of the public wants to keep the law, which upended the way insurers do business and expanded coverage to 20 million Americans.
Opponents have not coalesced behind the GOP's two-stage plan of repealing the law immediately and then constructing a replacement. More people (28 percent) want a replacement plan announced before repealing the existing law than the share that says the law needs to be disassembled now (20 percent).
The survey found there are opportunities on both sides of the debate to influence public opinion. Twenty-two percent of those who said they want the law to remain switched their views when told that some consumers have seen large increases in cost. The same portion changed sides after being told the country cannot afford the expense of helping people buy health insurance.
Those opposed to the law are also willing to reconsider their views. More than a third of those said they would not want the law repealed after being told that some people with preexisting health problems would no longer be able to get insurance. A quarter reversed their opinion after being told some people who got insurance because of the law would lose it if the law were repealed. President-elect Donald Trump has said he wants people with preexisting conditions protected after the law is repealed.
Democratic fears that repeal of the Affordable Care Act will damage health care are not shared by most Americans. Six in 10 people believe the quality of their care will stay the same, and only two in 10 think their care will worsen. Families where someone has a serious medical condition are more worried, but even among them, only a third anticipate the cost of their health care will suffer if the law is repealed.
The poll found that the public's most widely shared health goal is reducing the cost of care, with 67 percent of respondents calling it a top priority. Lowering the cost of prescription drugs is a top priority for 61 percent of the public, followed by addressing prescription pain killer addictions, with 45 percent listing it. Abolishing the Affordable Care Act is a top priority for 37 percent of the public, primarily among Republicans.
The poll was conducted from Dec. 13 through 19 among 1,204 adults. The margin of error is +/- 3 percentage points for the full sample.
Medicare potentially overpaid five of health plans $128 million in 2007 alone, according to confidential government documents released recently in response to a public records request and lawsuit. But officials never recovered most of that money.
Six years ago, federal health officials were confident they could save taxpayers hundreds of millions of dollars annually by auditing private Medicare Advantage insurance plans that allegedly overcharged the government for medical services.
An initial round of audits found that Medicare had potentially overpaid five of the health plans $128 million in 2007 alone, according to confidential government documents released recently in response to a public records request and lawsuit.
But officials never recovered most of that money. Under intense pressure from the health insurance industry, the Centers for Medicare and Medicaid Services quietly backed off their repayment demands and settled the audits in 2012 for just under $3.4 million — shortchanging taxpayers by up to $125 million in possible overcharges just for 2007.
Medicare Advantage is a popular alternative to traditional Medicare. The privately run health plans have enrolled more than 17 million elderly and disabled people — about a third of those eligible for Medicare — at a cost to taxpayers of more than $150 billion a year. And while the plans generally enjoy strong support in Congress, there are critics.
"It's unclear why the Obama Administration allowed CMS to overpromise and under-deliver so badly on collecting these overpayments," Sen. Chuck Grassley, R-Iowa, told Kaiser Health News in an email response to the findings.
He said CMS "should account for why this process seems to be so broken and why it can't seem to fix it, despite recommendations to do so. The taxpayers depend on getting this process right."
The failure to collect also alarmed Steve Ellis, vice president of the budget watchdog group Taxpayers for Common Sense in Washington.
"They need to put up a bigger and stronger fight to make sure these programs are operated on the straight and narrow," Ellis said.
Yet outside of public view, federal officials have been losing a high-stakes battle to curb widespread billing errors by Medicare Advantage plans, according to the records obtained through a Freedom of Information Act lawsuit filed by the Center for Public Integrity.
The Center for Public Integrity first disclosed in 2014 that billions of tax dollars are wasted annually partly because some health plans appear to exaggerate how sick their patients are, a practice known in health care circles as "upcoding."
Last August, the investigative journalism group reported that 35 of 37 health plans CMS has audited overcharged Medicare, often by overstating the severity of medical conditions such as diabetes and depression.
The newly released CMS records identify the companies chosen for the initial 2007 audits as a Florida Humana plan, a Washington state subsidiary of United Healthcare called PacifiCare, an Aetna plan in New Jersey and an Independence Blue Cross plan in the Philadelphia area.
The fifth one focused on a Lovelace Medicare plan in New Mexico, which has since been acquired by Blue Cross.
Each of the five audits, which took more than two years to complete, unearthed significant — and costly — billing mistakes, though the plans disputed them.
For example, auditors couldn't confirm that one-third of the diseases the health plans had been paid to treat actually existed, mostly because patient records lacked "sufficient documentation of a diagnosis."
Overall, Medicare paid the wrong amount for nearly two-thirds of patients whose records were examined; all five plans were far more likely to charge too much than too little. For 1 in 5 patients, the overcharges were $5,000 or more for the year, according to the audits. None of the plans would discuss the findings.
As preliminary results of the audits started to roll in, CMS officials outlined steps to recover more than $128 million from the five plans at a confidential agency briefing in August 2010, according to a policy memo prepared for the meeting. The records don't indicate who attended.
That day, CMS set Humana's payment error at $33.5 million, PacifiCare at $20.2 million, Aetna at $27.6 million, Independence Blue Cross at nearly $34 million and Lovelace at just under $13 million. Those estimates were based on extrapolation of a sample of cases examined at each plan.
CMS "has developed a process for moving forward with payment recovery," according to a briefing paper from the 2010 meeting.
But that process fizzled after two years of haggling with the plans and insurance industry representatives, who argued the audits were flawed and the results unreliable. In August 2012, CMS gave in and notified the plans it would settle for a few cents on the dollar.
"Given this was a new process, the decision was made at the time to tie repayments to the actual claims reviewed as part of the 2007 pilot audit," said CMS spokesman Aaron Albright. "For subsequent audits, we said we intended to determine repayments by extrapolating the error rate of the sample of claims reviewed to all claims under the contract." Albright said more of the audits are underway. Allowing the insurers to dodge liability dealt a serious blow to the government's efforts to crack down on billing abuses — a setback one taxpayer advocate called alarming.
"That's a very bad way to operate the system." said Patrick Burns, acting executive director and president of Taxpayers Against Fraud in Washington, on hearing of the outcome. "Nobody is held accountable."
Indeed, CMS kept the settlement terms under wraps until 2015, after an inquiry by Grassley. The senator had requested details about Medicare Advantage fraud controls in response to articles published by the Center for cmcmsublic Integrity.
In a July 31, 2015 letter to Grassley, CMS Acting Administrator Andy Slavitt attached a table that showed the five plans repaid just under $3.4 million. The letter didn't mention the earlier estimate that the government was due $128 million. Grassley said it should not have taken the FOIA lawsuit to make that information available to the public.
Perhaps adding insult to injury, these numbers might never have seen the light of day without a lengthy lawsuit," Grassley said this week.
Paying based on risk scores
When Congress created the current Medicare Advantage program in 2003, it devised a new way to pay the health plans.
The method, phased in starting in 2004, seemed simple enough: pay higher rates for sicker patients and less for people in good health using a formula called a risk score.
But CMS officials soon realized that risk scores rose much faster at some plans than others, a possible sign of upcoding, or other billing irregularities, records show. These overcharges topped $4 billion in 2005, one CMS study found.
The special audits, called Risk Adjustment Data Validation, or RADV, were designed to identify, and hold accountable, health plans that couldn't justify their fees with supporting medical evidence.
Until these audits, CMS "pretty much went on the honor system with the plans," an unnamed agency official wrote in an undated presentation.
In the five 2007 pilot audits, two sets of auditors inspected medical records for a random sample of 201 patients at each plan. If the medical chart didn't properly document that a patient had the illnesses the plan had reported, Medicare wanted a refund. Auditors gave the plans the benefit of the doubt when auditors couldn't agree, according to the CMS briefing paper.
Finally, CMS applied a standard technique used in fraud investigations in which the payment error rate is extrapolated across the entire health plan, which greatly multiplies the amount due. CMS said it was conservative in assessing the penalties and allowed the plans to appeal.
Appeals or no, the health plans recoiled at the prospect they could be on the hook for millions of dollars they hadn't budgeted for and didn't believe they owed. The actual 2007 overage for the 201 Humana patients, for example, was $477,235. Once extrapolated, it soared to $33.5 million.
Michael S. Adelberg, a former CMS official who is now an industry consultant in Washington, said that in retrospect the audit process was "probably rushed."
Adelberg said the audits "raised strong industry concerns" on a variety of fronts, from whether CMS had the legal authority to conduct them to the soundness of their methods. CMS stands by its audit techniques and has defended RADV as the only way it can assure plans bill honestly.
Yet agency records released through the FOIA case suggest CMS lacked the will to press ahead with extrapolated audits for Medicare Advantage plans given the fierce industry backlash — even though they do so in overpayment cases targeting other types of medical providers.
One confidential CMS presentation dated March 30, 2011, notes that officials had received more than 500 comments expressing "significant resistance" to the RADV audits.
The presentation goes on to say the audit program's success depended on its "ability to address the challenges raised."
CMS didn't overcome those challenges. Instead, it agreed to settle the five initial audits for $3.4 million, just what it found in the patient files it reviewed — without the extrapolations. And the center did the same for 32 additional 2007 audits, which officials had predicted would refund up to $800 million to the federal treasury. In the end, CMS wound up with $10.3 million from the 32 plans.
The RADV program's shortcomings, though little known to the public, haven't gone totally unnoticed. The program was the target of a sharply critical May 2016 report by the Government Accountability Office, which noted that Medicare Advantage plans have overbilled the government by billions of dollars, but rarely been forced to repay the money or face other consequences.
The GAO, the watchdog arm of Congress, called for "fundamental improvements." The watchdogs also found that CMS has spent about $117 million on the audits, but recouped just under $14 million.
Government officials didn't dispute that the RADV process had taken far too long and yielded way too little. But while CMS has resumed extrapolated audits, there's little evidence it is speeding things up.
CMS expected to complete extrapolated audits for payments made in 2011 and finish the job in early 2014, agency records show.
But it has yet to do so. In late December, an agency spokesman said he had no new information about when the 2011 audits would be finished or how much the government would collect.
While the industry awaits the results, it has hardly warmed to the process.
America's Health Insurance Plans, an industry trade group, argued in a June 2016 position paper that RADV was "not yet stable and reliable," adding that the audits "could disrupt the care being provided by plans that are working hard to meet the needs of their enrollees."
John Gorman, a former government health care official and current industry consultant, said he expects RADV to forge ahead under the incoming administration. But he predicted efforts to collect overpayments will "slow down" because the Trump team will prove to be "more sympathetic" to business interests than the Obama administration. The Trump transition office did not respond to a request for comment.
Gorman said that while career civil servants at CMS decide which plans get audited, how much to assess the health plans as a result rests with "political appointees" who are susceptible to industry lobbying, which he termed "the old Potomac two-step."
But Grassley said he is determined to keep a close eye on the audit program. "I intend to press the incoming administration on holding CMS accountable for overpayments that harm taxpayers," he said.
Taxpayer advocate Ellis said with so much public money at stake, the government needs to step up its game.
"You can presume that the more people get away with overpayments the more they are going to take," he said. "As the program gets bigger the problem get bigger."
This story is a collaboration between Kaiser Health News and the Center for Public Integrity. Kaiser Health News, a nonprofit health newsroom whose stories appear in news outlets nationwide, is an editorially independent part of the Kaiser Family Foundation. The Center for Public Integrity is a nonpartisan, nonprofit investigative news organization. Schulte, formerly of the Center for Public Integrity, is now a senior correspondent at Kaiser Health News.
GOP leaders are vowing to make tort reform a key part of their replacement plan for the Affordable Care Act. Critics say the political agenda isn't addressing the bigger goal of reducing overall patient harm.
As top Republicans see it, a medical malpractice crisis is threatening U.S. health care: Frivolous lawsuits are driving up malpractice insurance premiums and forcing physicians out of business. Doctors and hospitals live in fear of litigation, ordering excessive tests and treatments that make health care unaffordable for Americans.
That's why Republican House Speaker Paul Ryan and Rep. Tom Price, tapped to be the nation's top health official by President-elect Donald Trump, are vowing to make tort reform a key part of their replacement plan for the Affordable Care Act.
But, according to researchers and industry experts, the reality doesn't match the GOP rhetoric. They say the nation's medical malpractice insurance industry is running smoothly and the last crisis dates back more than a decade.
"It's a wonderful time for doctors looking for coverage and it's never been better for insurers," said Michael Matray, editor of Medical Liability Monitor, a trade publication.
Doctors are paying less for malpractice insurance than they did in 2001 — without any inflation adjustment, according to the Doctors Company, one of the nation's largest malpractice insurers. And the rate of claims has dropped by half since 2003.
"It's a time of relative calm and this hasn't been a front burner issue or crisis," said Nicholas Pace, a researcher who studies the civil justice system at the Rand Corp., a nonprofit think tank. "But now Republicans see an opportunity to make changes they have wanted for a long time as they replace Obamacare."
Their proposals would make it easier for doctors to defend themselves in malpractice cases and raise the burden of proof on patients claiming to have been injured. Many Republicans also back sharp limits on damage awards, often citing California's landmark law capping noneconomic damages at $250,000 as a national model.
Price, an orthopedic surgeon in the Atlanta area for more than 20 years, has long championed "lawsuit abuse reform" as a way to reduce the nation's runaway health spending.
"We waste hundreds of billions of dollars due to lawsuit abuse in this country and the practice of defensive medicine," Price said in June at a press conference to promote the House Republicans' replacement plan for the health law. "Instead of just putting a Band-Aid on it, we propose a bold and robust solution."
But any such savings are vastly overstated, experts say. They warn that Republicans risk going too far in reducing consumer access to the justice system and fair compensation for medical mistakes.
Some academics and consumer advocates say the GOP political agenda isn't addressing the bigger goal of reducing overall patient harm. This year, researchers estimated that medical errors claim more than 250,000 lives annually, which would make it the nation's third-leading cause of death behind heart disease and cancer.
"What strikes me about these current proposals is that they really represent the agenda of medical professionals, which is all about limiting liability," said Michelle Mello, a Stanford University law professor and health researcher. "To take any malpractice reform seriously, it has to offer something to improve the situation of patients and lead to safer outcomes."
Although the costs are tough to quantify, studies suggest that about 3 percent of the nation's $3.2 trillion in health care spending, nearly $100 billion, is related to malpractice cases and defensive medicine (ordering unnecessary tests and treatments to protect against litigation). That's a considerable sum, but researchers have found that stronger legal protections don't necessarily change physician behavior and produce less expensive care.
House Republicans contend the costs are far greater — more than $300 billion annually. In a 2010 interview, Price went even higher, suggesting that defensive medicine accounted for a quarter of all U.S. health care spending.
Now Price and a Republican-controlled Congress are in a position to put their ideas for tort reform into law. Limits on malpractice damages are a perennial favorite of conservatives who say the current system merely serves trial lawyers fishing for a big payday.
Price's proposed legislation for replacing the Affordable Care Act doesn't include a cap on damage awards. But he has supported Ryan's "Better Way" plan that specifically cites the pioneering financial limits imposed in California as an effective solution.
California and other states "have shown that such reforms result in an increase in doctors, increased access to specialists, and reduction in medical liability insurance premiums," Ryan's plan says.
More than 30 states already have some form of cap on damages in malpractice suits. To varying extents, both industry officials and researchers credit state efforts to rein in litigation and payouts with helping to contain costs. Insurers say they're doing well but would welcome tort reform at a national level.
Researchers caution that caps are hardly the only factor in keeping premiums down, saying economic cycles and insurers' investment returns are also important forces. And they note that courts have struck down caps in some states as ineffective or unconstitutional.
Meanwhile, plaintiffs' lawyers say damage caps make them reluctant to take on cases, given the money often required for expert witnesses and trial preparation.
The caps "have some modest effects on costs, but it comes at a price of people being able to access the civil justice system," Mello said.
Caps on noneconomic damages for "pain and suffering" can also disproportionately hurt women and the elderly, who more often can't get significant economic damages because they aren't big wage earners.
California imposed its cap of $250,000 on noneconomic damages in 1975 and it has never been increased to keep pace with inflation.
A Rand study examined the outcomes in 257 medical malpractice trials in California during the late 1990s. The cap was triggered in nearly half of the cases that plaintiffs won, and the overall amount of damages was cut by 30 percent, from $421 million to $295 million.
That state law wiped out most of a $7 million jury award for noneconomic "pain and suffering" damages to the family of Steven Olsen in 1994. At 2 years old, Steven suffered brain damage and went blind after his doctors failed to administer a scan that would have detected an abscess on his brain, his family said.
Scott Olsen, Steven's father, said he left his job recently as a technical writer in Chula Vista, Calif., to care for his 26-year-old son, who can't feed or dress himself.
The family received $4 million in economic damages as part of the litigation. But Scott Olsen said "it's immoral that a jury doesn't get to decide the severity of the injury." He said those damage awards hold medical providers accountable and help prevent the same mistakes from hurting more patients.
A 2014 ballot measure that would have raised the California cap to more than $1.1 million failed to pass, garnering support from only a third of voters.
Another key proposal from Price calls for establishing clinical practice guidelines for physicians to follow and use to defend malpractice claims — an idea that has attracted bipartisan support in the past.
"If your doctor does the right thing for a given diagnosis or a given set of symptoms, they ought to be able to use it as an affirmative defense in a court of law," Price said in June at an event sponsored by the conservative American Enterprise Institute.
Experts say that only about 15 percent of malpractice cases would be affected by the adoption of clinical guidelines.
Price also has a more controversial proposal — to fund the creation of state-run tribunals to rule on injury claims. It would require patients to prove gross negligence by doctors, a higher legal standard than in civil court, and would create panels of medical experts to screen cases for merit.
Given all the competing assertions and proposals out there, and differing views even among Republicans, health policy experts urge a cautious approach on tort reform.
"You need solid empirical evidence before you move forward on national malpractice reform, not anecdotes or horror stories from a particular county in western New Hampshire," said Rand's Pace. "That is not how you decide to overhaul the entire system."
The federal government has cut payments to hospitals with high rates of patient injuries this year. Those hospitals will lose 1 percent of Medicare payments over the federal fiscal year, which runs from October 2016 through next September. Maryland hospitals are exempted from penalties because that state has a separate payment arrangement with Medicare.