Since Republicans can't get around a Democratic filibuster in the Senate, they are forced to use an arcane legislative tool called budget reconciliation to disassemble parts of the law.
After capturing the White House, Republicans put repealing the health law at the top of their to-do list. But since they can't get around a Democratic filibuster in the Senate, they are forced to use an arcane legislative tool called budget reconciliation to disassemble parts of the law. KHN's Julie Rovner and Francis Ying explain the process.
Rigorous cleaning practices don't ensure that medical scopes are free of contamination, and many of these reusable devices have scratches and dents that could harbor blood, tissue and bacteria, a new study found.
The seven-month study, published Tuesday in the American Journal of Infection Control, found that 12 of 20 gastroscopes and colonoscopes examined tested positive for bacterial growth, even after being disinfected using the current guidelines or additional measures.
In addition, 17 of the scopes were pulled from use at the end of the study and returned to the manufacturer for repair due to serious defects. Photos in the study show numerous scratches and dents on the ends of the scopes that could trap organic material as well as brown stains, debris and residual fluid stuck inside scope channels.
The scopes were relatively new at the beginning of the study and all were manufactured by Tokyo-based Olympus Corp., the leading maker of gastrointestinal scopes used in the United States and worldwide.
"Physicians, other caregivers, hospitals and regulators should be paying keen attention to this issue, as patients have a right to assume that clean instruments are being used on them," said Cori Ofstead, the study's lead author and an epidemiologist in St. Paul, Minn.
Since 2015, federal prosecutors, lawmakers and government regulators have been investigating a series of outbreaks of antibiotic-resistant "superbugs" across the country tied to scopes. Most of the scrutiny has been focused on a specific device known as a duodenoscope, which is used to inspect and treat problems in the gastrointestinal tract. It has been tied to at least 35 deaths in the past four years.
But this study and other outbreak reports suggest a broader problem affecting other types of scopes, which could put more patients at risk of dangerous infections nationwide. However, the bacteria this latest study found weren't the drug-resistant superbugs that can be deadly for patients.
The research was limited to a small number of scopes at one surgery center affiliated with the University of Minnesota Health System. But outside experts said the research was rigorous and raised serious concerns.
"It was quite shocking to see the pictures in this study," said Michelle Alfa, a professor in the department of medical microbiology at the University of Manitoba and an adviser to U.S. regulators on scope testing.
"Those scopes shouldn't be in use. I'm amazed the gastroenterologist could even see anything because the lens was covered in so much crud. The insides look pretty gruesome, too," Alfa said.
Alfa said the staining and discoloration inside the scopes indicated a buildup of biofilm, a slimy material that shields bacteria and other microbes from being removed during cleaning. "It's like your roast pan that gradually gets brown crud baked on it and you can't pick it off," she said.
The U.S. Food and Drug Administration, which regulates medical devices, said it's aware of the study's findings and urges hospitals to immediately remove from service any scopes that show signs of damage.
"The FDA continues to actively monitor challenges associated with reprocessing reusable medical devices and to look for ways to reduce the risk of infection with reprocessed endoscopes," said agency spokeswoman Deborah Kotz.
Since the recent outbreaks and subsequent government warnings, many hospitals have adopted a variety of new safety measures to combat scope-related infections.
But Ofstead said subjecting scopes to additional rounds of manual cleaning, automated washing and a different disinfectant didn't have much impact. "The findings suggest that cleaning wasn't working, perhaps because cleaning doesn't work when endoscopes are damaged," said Ofstead, chief executive of the medical research firm Ofstead & Associates.
This study focused on widely used colonoscopes and gastroscopes, which have somewhat simpler designs than duodenoscopes and are believed to be easier to disinfect. The study didn't track patients and there was no evidence of infection among people treated at the study site.
At the surgery center, researchers split the 20 scopes into two groups. One group got regular cleaning and high level disinfection with glutaraldehyde. The other group received additional cleaning and tests to verify that the scopes were clean before disinfection with peracetic acid.
The colonoscopes, which peer at the inner lining of the large intestine, presented fewer problems than gastroscopes, designed to examine the upper gastrointestinal tract. When the clinic's technicians performed tests to detect contamination, they found the first manual cleaning worked 99 percent of the time for colonoscopes. (Subsequent testing showed further contamination.)
For gastroscopes, only 48 percent were deemed clean after the first try. And 11 percent never reached the benchmark for clean even after two rounds of manual scrubbing and two rounds of automated cleaning and high-level disinfection.
The researchers said gastroscopes may be incurring more damage and becoming more resistant to cleaning due to exposure to stomach acid and bile in the upper gastrointestinal tract. They said more research is needed to determine the reasons and to identify more effective cleaning methods.
Olympus, the device manufacturer, issued repair reports on 14 of the scopes and it said 13 of them had at least one critical defect, according to researchers.
In a statement, the company said it "welcomes additional research and perspectives as helpful to the entire medical community and our own efforts to increase patient safety related to endoscopes."
In October 2015, the FDA ordered Olympus and two other scope manufacturers, Pentax and Fujifilm, to study the effectiveness of their cleaning protocols for duodenoscopes at clinical sites in the field.
Ofstead said medical providers are still waiting for that critical information while problems in the field persist. "They haven't yet published any real-world results showing their protocols work even though the FDA told them to do these studies," Ofstead said.
Those studies appear to be in the early stages, according to data on the FDA website. Olympus said it's planning for its duodenoscopes to be tested for bacterial growth after reprocessing at four different sites.
Linda Greene, a registered nurse and president of the Association for Professionals in Infection Control and Epidemiology, agreed manufacturers need to address the safety issues posed by scope defects.
"The concerns about damage in frequently used scopes begs questions about design issues," said Greene, the manager of the infection prevention program at the University of Rochester's Highland Hospital in New York.
The ACA has used financial incentives to encourage hospitals to experiment with ways to improve care, which has led sizable upfront investment by many hospitals in ACOs, EHRs, staff training and hiring and creating new services.
Much has been written about the 20 million people who gained health insurance under the Affordable Care Act, and what could happen to these patients if the ACA is repealed without a replacement. But some people don't realize that hospitals nationwide could take a big financial hit on several fronts, too.
First, it's likely that fewer patients would be able to pay their hospital bills, health policy analysts say, so the institutions would be stuck with that bad debt, as they were before Obamacare.
"If the Medicaid expansion goes away wholesale, and things go back to the way they were before this expansion was in place, a lot of those hospitals would see an increase in their uncompensated care costs," said Rachel Garfield, an analyst with the Kaiser Family Foundation. The American Hospital Association estimates that hospitals across the U.S. could lose more than $160 billion from the reduction in Medicaid revenue and the increase in unpaid medical bills. (KHN is an editorially independent program of the foundation.)
Then there's this: The ACA has used financial incentives to encourage hospitals to experiment with ways to improve their care of patients, while reducing health care's cost. That sort of experimentation has included a sizable upfront investment by many hospitals.
Massachusetts General Hospital in Boston, for example, signed agreements with physicians and insurers to create accountable care organizations, in hopes of saving money in the long run. With an ACO, insurers pay doctors for making sure the patient is getting the best and most appropriate care, instead of paying for every test and procedure a doctor does.
"We have now more than 20 different programs," said Dr. Timothy Ferris, an internist and medical director of the Mass General Physicians Organization. "Video visits, electronic consultation with specialists, home hospitalization, [and] programs for patients with diabetes and heart disease. I would be worried that a repeal of the ACA would undermine our ability to invest in services for our patients."
Ferris acknowledged that most of those experiments haven't yet saved money. But they need more time to work out the kinks safely, he said.
"One of the things that it's difficult for people outside of health care to appreciate — particularly politicians — is how long it takes to make significant improvements in the delivery of care," Ferris said. "You have to be very careful when you make changes."
Ferris said the threatened repeal of the ACA makes him worry "that the progress we've made over the past five years would be threatened."
Many other hospitals across the country have invested in accountable care organizations — often overhauling their medical records systems, hiring staff and creating new services. Dennis Keefe, head of a large hospital chain called Care New England in Rhode Island, said he, too, worries about the future of his ACO, Integra.
"I think, if there's a real change in direction away from these alternative payment models, we will be assuming risk to care for a population," Keefe said. "We have invested enormously to be successful in this area."
But these seismic changes in the way hospitals do business were predicated, he adds, on long-term support from the federal government — support that might disappear if the ACA is repealed.
"These short-term plans are not regulated like Obamacare plans, so carriers have a lot of flexibility in benefits and pricing," said the executive director of Agile Health Insurance. "It's almost like the old individual market before the ACA."
Short-term health plans have been around for decades, bridging coverage gaps for people who are between jobs or have recently graduated from school, among other things. After the health law passed, some people gravitated toward them because they were willing to trade comprehensive coverage for a cheaper sticker price — even if it meant paying a tax penalty for not having the comprehensive coverage required in the law. Sales increased.
Now, as Republicans look for ways to weaken the health law's coverage requirements and explore the possibility of not enforcing the requirement that people have health insurance, short-term plans may be poised to grow even more. If that happens, consumer advocates warn it could be bad for consumers.
As their name suggests, short-term plans provide coverage for a limited period of time, often six months or less. They generally don't cover such things as preexisting conditions, maternity services or prescription drugs. The policies typically have maximum coverage limits of about $1 million. Insurers can turn people down if they're sick and may decide not to renew someone's policy. All of these practices are prohibited in plans that qualify as individual insurance under the Affordable Care Act.
Precisely because of these limitations, however, the premiums are typically a lot cheaper than those for ACA-compliant coverage. In the fourth quarter of 2016, the average monthly premium a shopper would pay for a short-term plan sold through online insurance vendor ehealth.com was $124, compared with $393 for someone who bought a regular Obamacare plan and didn't qualify for premium subsidies.
When the health law passed, insurers increasingly began offering short-term plans that stretched the definition of "short," sometimes providing coverage for as long as 364 days.
"Carriers were exploiting a loophole in the law that defined a health insurance plan as one that was 365 days," said Sabrina Corlette, a research professor at Georgetown University's Center on Health Insurance Reforms. "If they were shorter they didn't have to comply with ACA protections."
Short-term plans serve a tiny but growing proportion of the roughly 22 million people who have coverage on the individual market. At the end of 2013, before the health law's major reforms took effect, there were approximately 108,800 people covered by these policies, which earned premiums of $97.5 million, according to figures from the National Association of Insurance Commissioners. Two years later, roughly 148,100 people had short-term plans and premium earnings have grown to $160.5 million.
Some insurers have taken notice. Online health insurance vendor Health Insurance Innovations launched Agile Health Insurance in the spring of 2015 to focus on sales of short-term plans. In the third quarter 2016, Agile sold 21,000 short-term policies.
"These short-term plans are not regulated like Obamacare plans, so carriers have a lot of flexibility in benefits and pricing," said Sam Gibbs, Agile's executive director. "It's almost like the old individual market before the ACA."
And that's just the problem, said some policy experts.
"To many consumers it looks like health insurance, except it's cheaper," said Karen Pollitz, a senior fellow at the Kaiser Family Foundation. But the plans don't protect people when unforeseen events occur such as a car accident or a cancer diagnosis. With a short-term plan, if you get sick or you're in the hospital when your plan comes up for renewal, "it won't be renewed," Pollitz said. (KHN is an editorially independent program of the foundation.)
Not all insurers embrace widespread sale of short-term plans. "The big health insurance companies are really mixed on this," said Timothy Jost, emeritus professor at Washington and Lee University School of Law and an expert on the health law. "They see this as a seriously destabilizing force in the market, this crap coverage."
Last October, the Obama administration issued a final rule that would make it more difficult for consumers to buy short-term plans to substitute for regular Obamacare plans. The regulation, which takes effect April 1, said short-term plans must be less than three months in duration. People can request a renewal of the policies, but insurers can turn them down. The policies and related materials also have to prominently display a warning that they don't satisfy the law's requirement that people have health insurance.
Some hope that the rule may be changed or rescinded by the Trump administration or overturned by the new Congress under the little-used Congressional Review Act. Neither option can happen at the stroke of a pen, however.
Health insurance brokers and agents are one group that would like to continue to sell longer term short-term plans.
"Our folks do a lot of business with short-term plans," said Marcy Buckner, vice president of government affairs at the National Association of Health Underwriters, an industry group. The regulation is one that the group will request that the Trump administration rescind.
"In most areas [a short-term plan] is cheaper, and it's some consumers' way of saying, 'I don't need all of those things,' " said Buckner.
"This is the first time the department has sanctioned a health plan in recent history. The amount is significant," said Sarah Brooks, deputy director of health care delivery systems at the Department of Health Care Services.
California officials have fined health care giant Kaiser Permanente $2.5 million for failing to turn over required data on patient care to the state's Medicaid program.
The California Department of Health Care Services said this was the first fine imposed against one of its Medicaid managed care plans since at least 2000. The state relies on the data to help set rates, ensure adequate care is available and monitor how taxpayer dollars are being spent in the program, known as Medi-Cal in California.
Jennifer Kent, the department's director, notified Kaiser of the sanctions in a Jan. 13 letter that was obtained by California Healthline. The department later posted it online.
"This is the first time the department has sanctioned a health plan in recent history. The amount is significant," said Sarah Brooks, deputy director of health care delivery systems at the Department of Health Care Services. "We do take it very seriously."
Kaiser isn't appealing the sanctions and the health plan said it's "working toward compliance." The company said the sanctions were in no way related to the quality of patient care or access to treatment. (Kaiser Health News, which produces California Healthline, is not affiliated with Kaiser Permanente.)
Brooks said her agency is in ongoing discussions with Kaiser and additional fines could be imposed depending on the company's actions and whether Kaiser's violations put the agency out of compliance with federal rules. That could force the state to repay money to the Centers for Medicare & Medicaid Services, which funds the Medi-Cal program jointly with the state.
Kaiser, the state's dominant HMO, is among 22 health plans that participate in the Medi-Cal managed care program, which covers about 80 percent of Medi-Cal enrollees in the state.
The Oakland-based company failed to submit data on out-of-network care that Medi-Cal patients received from November 2014 to September 2016, according to the state. Kaiser also didn't file data on "all physician-administered drugs" from March 2010 to March 2015, records show. That information is about infusions and other drugs given to patients in a doctor's office or clinic.
The insurer missed a June 30 deadline to comply and a subsequent one Jan. 1, which triggered the current penalties. The fine related to medical claims was $742,500 and the drug data fine was $1.79 million, for a total of $2.5 million.
The reporting lapses are unusual since Kaiser pioneered use of electronic medical records and health data collection. But the company indicated in a statement that being an integrated health system that operates a health plan, its own hospitals and medical groups complicated matters.
Nathaniel Oubre, Kaiser Permanente's vice president for Medi-Cal, said its systems and technology — including electronic health records — are focused on "quality, access and integration of care."
But he said the systems were not designed or updated to collect information in the format required by the state.
"We are taking steps to change this," he said. "We are making investments in technology that will facilitate compliance with the state's data reporting requirements."
Medi-Cal represents a small portion of Kaiser's overall business, and some industry experts said the company may have been hesitant to alter its information technology systems to meet the state's demands.
Kaiser said it serves about 700,000 Medi-Cal enrollees across the state. Rival Anthem Inc. serves more than 1 million Medi-Cal patients.
In Medi-Cal managed care, the state pays insurers a fixed amount per enrollee to provide comprehensive care. That's different from the conventional fee-for-service system in which the state pays medical providers directly for services rendered.
In addition to being an insurer, Kaiser runs 38 hospitals across the country and hundreds of clinics. More than 18,000 salaried doctors work at its affiliated medical groups. Kaiser operates in eight states and the District of Columbia, but nearly 80 percent of its 10.6 million members are in California. For 2015, the company reported revenue of $60.7 billion and net income of $1.9 billion.
Kaiser has faced other stiff fines from California regulators. In 2013, the California Department of Managed Health Care fined the insurer $4 million for problems related to mental health treatment.
Two years later, the managed care agency criticized Kaiser again for failing to address the long delays in treatment for mental health patients.
Brooks said the state is rolling out a new ratings system for all Medi-Cal managed care plans next year that will track the quality of patient care, appeals processes, contract compliance and other performance measures.
Governor Jerry Brown said his state would not "turn back" on advances it's made in health coverage. Under the new federal leadership, he said, the "future is uncertain and dangers abound."
In an unusually impassioned speech, Gov. Jerry Brown vowed Tuesday to protect California's health care gains under Obamacare against Republican attempts in Washington, D.C., to roll them back.
"More than any other state, California has embraced the Affordable Care Act," Brown told state legislators and appointees in his annual State of the State address at California's Capitol. "I intend to join with other Governors and Senators, and with you, to do everything we can to protect the health care of our people."
Brown said California would not "turn back" on advances it's made in health coverage under pressure from the new Republican administration in Washington. Under the new federal leadership, he said, the "future is uncertain and dangers abound."
Health coverage for Californians under the Affordable Care Act "has come with tens of billions of dollars from the federal government," said Brown. "Were any of that were to be taken away, our state budget would be directly affected, possibly even devastated."
Leveraging an estimated nearly $20 billion federal money, health coverage has been extended to five million Californians under Obamacare, which includes federally subsidized private health plans and an expansion of eligibility for Medicaid, the program for low-income people — known in this state as Medi-Cal.
Brown received cheers and several standing ovations from legislators during his speech, an address intended to set the state' policy-making tone for the year. The 78-year old governor was visibly energized during his 16-minute speech, often speaking in an emphatic, defiant tone. While also emphasizing renewable energy initiatives and an inclusive immigration policy, Brown veered off script to voice support for women's reproductive health care.
"We're going to fight for Planned Parenthood, which has been unfairly attacked in too many places in this country," he said.
Health care advocates quickly piped up on Twitter and in press releases to support the governor, saying he is rightly alarmed at the threat of losing billions of federal dollars not just from the repeal of the Affordable Care Act, but also under Congressional proposals to change Medicaid into a state block grant program.
"We look forward to working with [Governor Brown] to fight for our health in Congress," Anthony Wright, executive director of Health Access, said in a statement.
Kieryn Darkwater, a young transgender person of color, praised the speech on Twitter, saying it provided reassurance that California is a safe place for immigrants and others who are "marginalized."
"I deeply appreciated that he spent so much time talking about the issues of health care and protections for our communities," Darkwater, an Oakland-based activist, artist and programmer said via email to California Healthline.
Darkwater is enrolled in Medi-Cal, which covers much-needed mental health medications and gender transition hormone treatments.
"Medi-Cal is currently keeping me both alive and able to stay afloat financially," Darkwater said.
Assemblymember Rob Bonta, D-Oakland, the former chairman of the Assembly Health Committee, tweeted that he was proud Brown "came out swinging in strong defense of health, immigrants, [and] science."
Even some state Republicans responded favorably to Brown's call for bipartisanship.
Senate Republican Leader Jean Fuller, R-Bakersfield, said reaching across party lines is especially important to build bridges with national policymakers.
"Working with Washington should emulate the bipartisan successes we have had in our state," Fuller wrote in a statement.
Covered California, the state's Obamacare insurance exchange, reported strong enrollment numbers today despite uncertainty surrounding a possible repeal of the health reform law. Officials said 320,000 Californians have signed up in the subsidized marketplace since November, roughly on par with last year's enrollment over the same time period.
President Donald Trump's executive order on Inauguration Day did not provide administration officials with any new powers to unravel parts of the Affordable Care Act.
The Trump administration has significant power to undermine the workings of the Affordable Care Act. The bigger question is how much of that power it will use.
President Donald Trump's executive order on Inauguration Day urging federal officials to "take all actions consistent with law to minimize the unwarranted economic and regulatory burdens" of the federal health law did not provide administration officials with any new powers to unravel parts of the law.
"They had all this authority before," said Len Nichols, a health policy professor at George Mason University in Virginia who supports the health law. Trump, he said, "is signaling 'I care' " about this issue.
In the short term, efforts will be minimal, said Joe Antos of the conservative American Enterprise Institute, because the White House is still getting its personnel on board. There are no high-level political appointees yet installed at the Department of Health and Human Services, Labor and Treasury, which have primary authority over the law.
"They need their appointees," said Antos. Until more Trump personnel actually start work, he added, "I don't think they're going to be able to do much." The nominees for secretaries of HHS, Labor and Treasury are encountering various degrees of turbulence in their Senate confirmation process.
But even when the new personnel do take office, it remains unclear exactly how far the new administration will go. That's because while they can make the law stop working, it will take Congress to actually put in place something new.
"If they start down that road" of unraveling the law, said Nichols, "then the insurers will pull out as soon as possible. And 2018 will not be pretty." That's a reference to the fact that plans offering coverage in the individual market are concerned that changes would make it easier for healthy people to exit the market, leaving only sicker and more expensive people behind and no way to spread costs.
Yet both Trump and Republican leaders in Congress have vowed not to strip away anyone's insurance and to provide a "stable transition"to a new system. Trump told The Washington Post earlier in the month his goal was "insurance for everybody."
And Antos said that many of the administration's options might be more difficult than they first appear.
For example, he pointed to one item that has been widely speculated as a possible change the administration is considering: cutting back the specific requirements for benefits that have to be included in various health plans.
Although such alterations are theoretically subject to rewrite through regulations, "it's the state insurance commissioners that approve that," he said. "The states all changed their regulations in order to conform with the federal rules."
Indeed, according to the National Conference of State Legislatures, 46 states enacted more than 175 separate laws between 2011 and 2013 to bring their rules into accord with the federal health law.
Those states "might have to repeal or amend their laws if the ACA were repealed," said Timothy Jost, an emeritus law professor at Virginia's Washington and Lee University who has studied the health law extensively. "For example, states that adopted the insurance reforms into law might find their markets nonviable without the federal subsidies and mandates."
In addition, any changes made by the Trump administration would have to take care to stay within the confines of federal requirements, including allowing for public notice and comment, said Antos, which gets particularly complicated with health care because it crosses so many boundaries.
"There has to be coordination between HHS and Treasury and maybe Labor, and it has to be legal," he said. "So understanding what you can and cannot do is going to be very difficult."
To be clear, there are a couple of actions the administration could take fairly easily that would have a major impact. The largest would likely come from dropping the appeal of a lawsuit that would immediately end cost-sharing help for up to 6 million people with incomes under 250 percent of the poverty line.
That would almost certainly send the insurance market for individuals into chaos, both backers and opponents of the health law agree, and would interfere with GOP promises to try to ensure stability in the market until they can come up with a replacement.
A second, more strategic change would be to eliminate the special rule that ensures that members of Congress and their staffs can still get employer contributions for their insurance, even though the law requires them to purchase that coverage through the health law's insurance exchanges.
"If Trump undoes that, then members and staff take a pay cut of up to $12,000 immediately," because they would have to make up the premium costs on their own, said Michael Cannon of the libertarian Cato Institute, an opponent of the health law. "That will motivate members of both parties to behave differently" in the speed with which they might come up with a health law replacement.
But even Cannon, who would like to see the law eliminated as soon as possible, concedes that "the politics of those two things would be dicey."
This story has been updated to correct a reference to the Trump administration's decision on the appeal of a lawsuit over the health law. That suit deals with funding for cost-sharing help for low-income marketplace customers and does not affect premium subsidies.
Tom Price pressed Medicare officials on a funding change that led to a windfall for the small biotech company run by one of his top campaign contributors, according to a document released under an open records request.
Tom Price, the Georgia congressman tapped for the nation's top health job, pressed Medicare officials on a funding change that led to a windfall for the small biotech company run by one of his top campaign contributors, according to a document released under an open records request.
Price is facing a Senate hearing Tuesday on his nomination to be secretary of Health and Human Services, a role that would put him at the helm of an agency overseeing billions in spending. His initial hearing revealed the depth of Democratic lawmakers' concerns about Price's investments in health care stocks.
The document shows for the first time the nature of the assistance Price provided for MiMedx, a firm in his district that would become a top campaign contributor, seeding his political funds with more than $40,000 in the years since Price directed the letter to Medicare officials.
The Medicare letter that Price and seven other lawmakers sent on Oct. 9, 2013, was related to a product called EpiFix, a small graft made of pulverized placenta that's meant to aid wound healing. Price's signature is first on the letter, which was signed by five other physicians who are members of Congress.
"Senate Democrats may find it significant that MiMedx only began contributing to Rep. Price after he intervened with Medicare on their behalf," said Brett Kappel, a campaign finance lawyer in Washington. "He was the company's congressman for 10 years before that, and no one at the company had contributed to him before the Medicare decision in the company's favor."
Before President Donald Trump's swearing-in Friday, a spokesman for Trump's transition acknowledged that Price has helped the company "in navigating regulatory waters, just as he would for any constituent."
A request for comment Monday directed to the HHS press office was answered by a senior communications adviser at the agency who lauded Price as a physician who is "grateful for the opportunity to bring his expertise to enacting better policies."
"Any suggestion that his motivations for public service have been anything other than to seek to improve the lives of the American people is simply wrong," said Ryan Murphy, the HHS adviser, who was previously a spokesman for Price in his personal office and most recently communications director for the House Budget Committee, of which Price is chairman.
In an emailed response to questions, MiMedx chief executive Pete Petit said Monday that the company made a presentation to the Congressional Doctors Caucus in Washington in support of Medicare's proposed payment change, in line with the letter Price and others sent. Petit said they did so even though the proposed change was "worse for MiMedx," but "the best policy for the industry."
He acknowledged, though, that the policy Medicare ultimately approved was "a win for MiMedx and the industry because the final rule amount reimbursement increased over the proposed rule amount."
The company makes skin grafts and injections made of placentas and amniotic membranes, which are meant to help with wound healing.
Federal campaign finance records show MiMedx, through its political action committee, chief executive and his relatives, has contributed more than $40,000 to Price's campaign and joint fundraising committees since 2014, with contributions starting six months after Price sent the letter. With combined PAC and individual donations, the company was ranked as Price's top contributor for 2015-2016 by the nonpartisan Center for Responsive Politics.
The 2013 letter to then-Medicare administrator Marilyn Tavenner has strong echoes of the same concerns MiMedx executives were airing at the time. It touches on the issue of "waste" in the use of oversized grafts used to help heal wounds around the ankle and on the feet of people with diabetes. The letter says $75 million in wound grafts were wasted in 2011 because of an inefficient pricing model that paid for sections of graft that were being thrown away. It encourages Medicare to move to a new, tiered system of reimbursing for the wound grafts.
"As stewards of our taxpaying constituents' dollars, we are committed to ensuring public programs such as Medicare are administered in the most efficient manner," Price and seven other congressmen wrote in the letter to Tavenner released under a records request by CQ HealthBeat. "We believe this proposal will reduce waste."
In an earnings call that same month, Petit reported that the company had been "quite busy in Washington meeting with Senators and Congressmen and encouraged them to support the CMS reimbursement change on skin substitutes."
Also that October, executives briefed investors on concerns that resemble those detailed in the lawmakers' letter. The earnings call transcript said competitors' grafts result in "massive wastage" that they estimate at $100 million, given that 80 percent of competitors' grafts are discarded.
It wasn't long, though, before MiMedx had great news. During a Dec. 5, 2013, call with investors, the company reported that Medicare changed its wound payment policies in ways that exceeded its expectations. The changes include ending the waste and moving to a tiered payment system.
Executive Bill Taylor estimated that doctors can pay the company $318 for a sheet of EpiFix and then bill Medicare for $1,371.19 in reimbursement. The result: Doctors who use EpiFix on patients would be able to keep about $1,000, a strong incentive to use the graft.
"It's a real win for MiMedx," Petit told investors.
The company has seen significant revenue growth, reporting in a press release that its income for 2014 — the year the Medicare pay change took effect — was $118 million, double the amount it earned the year before. Company executives have told investorsthe advanced wound care market is expected to be worth $1.25 billion in 2018.
Earlier this month, Kaiser Health News reported that Petit urged employees in 2015 to contribute to its PAC as he was publicly pressing the Food and Drug Administration to change its stance on the regulation of the injection.
An email from Petit's address sent to managers demanded donations "IMMEDIATELY" to the company's PAC, according to documents reviewed by KHN.
"I'm going to ask one more time for our field management to send something to our PAC. And, IMMEDIATELY," said the email sent under Petit's name. "We have PAC business to transact, and we need at least 50 donors to do so."
The ongoing FDA scrutiny could potentially affect the company's bottom line or lead to a recall of their injectable wound-care products, the firm told investors in 2013. The FDA declined to say whether it heard from Price about the company or to answer questions about its review of MiMedx products. Petit, a prominent businessman in the Atlanta suburbs, served as a Trump campaign finance chair in Georgia. Petit said he and his wife saw Price and his wife at an inaugural event but did not discuss MiMedx.
Research published in the Annals of Internal Medicine found that the number of chronically ill Americans with insurance increased by about 5 percentage points in 2014, the first year the law required Americans to have coverage.
As President Donald Trump and Republicans in Congress devise a plan to replace the 2010 health law, new research suggests a key component of the law helped people with chronic disease get access to health care — though, the paper notes, it still fell short in meeting their medical needs.
Research published Monday in the Annals of Internal Medicine found that the number of chronically ill Americans with insurance increased by about 5 percentage points — around 4 million people — in 2014, the first year the law required Americans to have coverage, set up marketplaces for people to buy coverage and allowed for states to expand eligibility for Medicaid, the federal-state insurance plan for low-income people. If states opted into the Medicaid expansion, people with chronic illnesses such as heart disease, diabetes, depression and asthma were more likely to see those gains.
Still, the study suggests, the law fell short in terms of guaranteeing those people could get medical treatment, see a doctor and afford medications.
The study is the first to examine how the health law affected people with these long-term diseases, which require careful and continuous management, and whose treatment drives a vast majority of the nation's health care costs. If these people don't get regular treatment they are especially likely to wind up needing emergency care.
"This hones in on the patients that are most dependent on having coverage and access," said Danny McCormick, an associate professor at Harvard Medical School and senior author on the study. "Most chronic conditions require ongoing treatment. And if you don't get it, often it results in more expensive care downstream."
As the GOP crafts its replacement plan, those findings could indicate what elements of the law are worth keeping, and what needs to be addressed. The Medicaid expansion in particular has come under heightened scrutiny from the GOP. This past weekend, a senior aide to President Donald Trump also said the administration wants to turn control of the program over to states, which experts say could result in less funding.
The researchers say their findings suggest reversing the Medicaid expansion would pose significant problems for people with long-term illness.
They used data from the Behavioral Risk Factor Surveillance System — an annual survey jointly run by state health departments and the Centers for Disease Control and Prevention — to examine records for more than 600,000 adults with at least one chronic condition. Diseases included coronary artery disease, stroke, asthma, pulmonary disease, diabetes, depression and arthritis. They compared insurance rates in the three years and examined whether people used that insurance to see a doctor.
"There's a clear difference between what happened for [chronically ill] individuals in states, based on how states implemented Medicaid. The Medicaid expansion was one of the strongest parts of the law," McCormick said.
If policymakers are serious about using health dollars more efficiently, and getting better health outcomes, he added, the findings support including such an expansion in any new policy platform.
The paper builds on research suggesting people generally were more likely to get insurance if they lived in states that expanded Medicaid. States such as West Virginia, Illinois and Kentucky — which opted into the expansion — saw double-digit gains in coverage of chronically ill people.
"Medicaid expansion is one of the tools you would think of to help people with chronic conditions – and we are seeing more evidence this is the case," said Benjamin Sommers, an associate professor of health policy and economics at Harvard's public health school, who was not involved with this study. "The question of whether this informs [the policy] debate — it clearly should. It clearly should be relevant."
That said, Obamacare was hardly a panacea, the researchers argue. Even after the law's insurance changes, about 15 percent of people with chronic disease didn't have coverage. More than one in four didn't have a check-up in 2014. About 23 percent of people with chronic disease still had to go without doctors' visits because of factors like cost. And those gaps were more pronounced for blacks and Hispanics. They were more likely on average to remain uninsured even after the health law took effect and to face obstacles in using new health insurance if they had it.
The paper suggests some possible causes: People didn't understand how to use their insurance, or they had plans that required them to pay out of pocket large copays or deductibles — flat spending fees consumers have to front before coverage kicks in. Many marketplace plans were categorized as "high-deductible plans."
"You've got hypertension or diabetes, and you have a very low income. It's really hard to take your medications" without coverage and minimal cost-sharing, McCormick said. "Someone who's insulin dependent who doesn't get insulin? it's going to result in an emergency room visit, or a hospital visit. There's a large potential for downstream complications."
But those gaps in coverage and access to care probably got smaller in the years following 2014, Sommers suggested. Other research has shown that with time, more people got insurance and learned how to use it.
"This is likely the tip of the iceberg in terms of what the Affordable Care Act was doing," Sommers said. "It's useful and part of a larger body of evidence making it clear access to care has improved among a range of populations."
But, he noted, the findings do emphasize an important issue: The health law by itself did not expand health care to all Americans, or even all Americans with chronic conditions.
"The Affordable Care Act is not a universal coverage law. It's a huge expansion for coverage but still left 20 to 30 million uninsured," he said. "Even for those with coverage, some are still experiencing challenges."
Trump has not yet offered his plan but said universal coverage will be part of his health care plan — although aides have since walked back on that claim. Meanwhile, an analysis this month by the nonpartisan Congressional Budget Office suggested that the repeal plan offered last year by Republicans eventually would increase the uninsured population by as many as 32 million.
Letters provided by CMS after an open records request show that the Health and Human Services pick has repeatedly stepped up in favor of drug firms, device manufacturers and higher physician payments.
As Cabinet nominee Tom Price faces a Senate confirmation hearing Tuesday, a newly released trove of documents sheds further light on how he interacted as a congressman with the Centers for Medicare and Medicaid, the massive agency he may soon oversee.
Letters provided by CMS after an open records request show that the Health and Human Services pick has repeatedly stepped up in favor of drug firms, device manufacturers and higher physician payments, leading some experts to question whether he would be a reliable advocate for the public's health.
The documents reveal additional instances where Price, a doctor from Georgia, set aside his priority of budget discipline in favor of special medical interests, including by sending a letter endorsing a medical procedure that Medicare later decided not to pay for, pointing to weak evidence that it helped patients get better.
"He's clearly shown in this case and in other ways allegiance to the corporate interest, but not to the patient interest," said Diana Zuckerman, president of the National Center for Health Research, a nonpartisan think tank that has studied medical device safety.
Price aligned with pharmaceutical firms in one letter, criticizing a policy meant to steer doctors away from the costliest drugs. He also sided with physicians who balked at a move to cut their pay for epidural pain relief injections.
A spokesman for the Trump transition, Phillip Blando, said Price has "always brought a compassion and commitment" to caring for patients and his public service as a lawmaker.
"Any suggestion that his motivations for public service have been anything other than seeking to improve the lives of the American people is simply wrong," Blando said in a statement.
On Wednesday, Democratic lawmakers pressed the Republican congressman on his investments and elicited few details on the congressman's plans for replacing Obamacare during a four-hour Senate health committee hearing.
Pointed questions came from Sen. Patty Murray, D-Washington, who grilled Price about his investment in an Australian drug company, Innate Immunotherapeutics. Price bought stock cheaper than what was offered on the open market, according to a Kaiser Health News report cited in the hearing.
Newly released documents show that in August, Price signed a letter to Medicare criticizing the use of "step therapy" in the drug program for seniors. The policy encourages doctors to first prescribe low-cost, established drugs and determine if they're working before going to newer, more expensive options. In the letter, Price and eight other lawmakers said the program should remain flexible enough that it does not "take prescribing power out of the hands of physicians."
Julie Donohue, co-director of the University of Pittsburgh Center for Pharmaceutical Policy and Prescribing, said Medicare's use of step therapy is one of the few tools it has to contain soaring drug costs.
"Unfortunately, unfettered choice of medicines … leads to higher drug spending and higher cost for taxpayers, so you have to strike the right balance," Donohue said.
Another letter in 2013 would have helped major pharmaceutical firms by reducing the reports they must file on educational materials they hand out to doctors. Price and 22 other lawmakers wanted to relieve the companies from reporting what they spend giving doctors journal article reprints or textbook chapters. At the time, Medicare declined to make a change.
Dr. Adriane Fugh-Berman, a physician and Georgetown University professor who studies drug industry relations with doctors, said the disclosure is important since such materials handed out to doctors are often vetted and controlled by drug companies, and then are used as promotional materials by sales teams.
A proposal similar to the 2013 letter recently emerged as a flashpoint before the 21st Century Cures Act passed in December. Then, Sen. Charles Grassley threatened to hold up the bill over a provision exempting drug firms from reporting on the handouts, as well as another stream of funding, continuing education to doctors.
"With taxpayers and patients paying billions of dollars for prescription drugs and medical devices, and prices exploding, disclosure of company payments to doctors makes more sense than ever," Grassley said in a November statement, spurring the provision to be dropped.
Another letter shows Price endorsing a medical procedure before it was proven to help patients.
In a 2012 letter, Price urged Medicare officials to assign a payment code for a new procedure meant to relieve a condition associated with lower back pain. Price's letter notes that the procedure was pioneered by a California company called Vertos Medical that sells the device used to perform the spinal operation.
"We have spoken with providers unaffiliated with Vertos who … have confirmed that this is a significant therapy that we need to advance," according to the letter signed by Price and Dr. Bill Cassidy, a Republican Louisiana senator who is also a physician.
Lobbying records show that Vertos spent $70,000 on lobbying in 2012, the same year Price and Cassidy sent the letter. Lobbying records do not show whether Vertos reached Price. Vertos and its lobbyist, Jeffrey J. Kimbell & Associates, did not respond to requests for comment.
The doctors' request to Medicare, though, did not achieve the desired outcome. Medicare officials later examined research saying the procedure had helped patients, but issued a decision refusing to pay for it, citing "weak studies, questions about missing information, questions about adverse events and conflicts of interest."
The Medicare decision says "the evidence does not support a conclusion of improved health outcomes for our Medicare beneficiaries."
In 2014, Medicare said it would pay for the procedure only if it's done as part of more rigorous studies, which so far have had favorable results.
Price waded in with the Congressional Doctors Caucus in early 2014 over another controversial medical procedure. He and seven other lawmakers signed a letter complaining about a Medicare pay cut to doctors who perform epidural pain-relief injections on patients' spines.
The letter also came after researchers began to question whether the side-effects of the spinal injections — including nerve damage, paralysis and strokes — were worth the short-term pain relief benefit, according to a report in the journal Surgical Neurology International.
Medicare responded to lawmakers' concerns over the proposed pay cut, saying it was the result of an analysis comparing doctor pay rates to the amount of time the services take to perform. Medicare ultimately reduced the scope of the pay cut, though, after heavy lobbying by pain physicians and lawmakers.
Murray and other Senate Democrats have called for a House ethics inquiry into Price. Public Citizen, a nonprofit government accountability group, also filed a complaint with the Securities and Exchange Commission.
"After this week's hearing, I'm afraid we have more questions than answers about Congressman Price's stock trades and the kind of information he had when they were made," Murray told reporters Thursday. "I remain deeply disappointed that Republicans brushed aside these serious concerns and decided to hold his nomination hearing anyway."
Lawmakers have recently called for an investigation into Price's purchase of six pharmaceutical company stocks in March, weeks before he led a bipartisan effort to quash a policy change that would have hurt the companies' bottom line. In last week's hearing, Price said his stockbroker made the purchases without his knowledge.