Sometimes well-intentioned laws have harmful consequences. On Wednesday the Trump administration moved to ease rules designed three decades ago to prevent fraud and bribery by doctors, but which now can hinder their efforts to improve patient care.
In a move long sought by doctors and hospitals, Health and Human Services Secretary Alex Azar proposed updates to two longstanding statutes banning physicians from referring patients for other medical services if it would financially benefit them. Officials say the laws are still important but were designed with the 1990s medical system in mind – not today’s system, where health providers are increasingly being paid for the quality of their care and how well they coordinate a patient’s care with other providers.
Azar and other top health officials said the proposed rules will loosen a heavy web of regulations on doctors and hospitals resulting from the federal “Stark” law and the Anti-Kickback Statute. These regulations are getting in the way of health providers trying to work more closely together to provide better, more coordinated care for Medicare patients. Health providers currently get paid for each test they order or service they perform.
“Our goal here is for patients to have a sense of ease in health care, where they know providers have the right incentive to move them through the system,” Azar said.
These proposed rules are highly technical – but they underscore a broader effort by the Trump administration to improve how health providers in the United States are paid for medical care. This was a top priority under the Obama administration, and Azar has stressed he is also keeping payment reform at the top of his to-do list.
It’s also an effort with strong bipartisan support at a time when the administration is seen as overtly political when it comes to health-care policy. Any day now, a federal appeals court is expected to rule on a lawsuit trying to dismantle all of Obamacare. Democrat-led states have stepped up to defend the law, because the administration won’t.
Administration officials are instead trying to draw attention to other steps they’re taking to improve health care in the United States, including reforming Medicare payments for dialysis patients and boosting popular private plans that provide Medicare benefits.
“The president and his administration are committed to fixing broken systems that don’t work for the American people,” said Joe Grogan, director of the White House Domestic Policy Council. “The president’s health vision for America is comprehensive and goes far beyond reforms for the individual market.
But even as Grogan and other officials detailed the proposed wonky Stark and anti-kickback changes, they threw in several jabs at Medicare-for-all ideas pushed by Democratic presidential candidates.
“While many Democrats are focused on Medicare-for-all – which will ultimately end up becoming Medicare for none, the president is focused on protecting care for our nation’s seniors,” Grogan said.
The new proposals apply only to the Medicare program. But, like all of Medicare policy, they would likely have ripple effects throughout the entire health-care system.
It’s been 30 years since Congress passed the Stark law. Its aim was to halt self-serving behavior by physicians by banning them from referring patients for tests, specialty care or other procedures that could financially benefit the doctors or their families.
This practice of self-referral can result in unnecessary testing and procedures for patients, raise overall health-care spending and compromise the trust patients place in their doctors to provide them with unbiased advice.
But things have changed since then. Many doctors and hospitals are entering into special financial arrangements where they get rewarded for working together and cutting down on unnecessary procedures. In this environment, extremely strict Stark and anti-trust regulations are viewed as unnecessary, since the providers in these arrangements don't get extra compensation anymore for providing extra services.
“It’s definitely time for an update,” Mark McClellan, who led the Centers for Medicare and Medicaid Services under former President George W. Bush, told me.
Azar and Grogan gave some examples of services that could currently be considered violations of Stark and anti-kickback regulations:
--A diabetes patient is admitted to the hospital for an emergency related to their disease. When they’re discharged, the hospital wants to provide them with remote monitoring of their blood sugar – provided by a diabetes care company – to help prevent another hospitalization.
--A doctor wants to give a patient with many different medical conditions a “smart pillbox” – provided by a medical device manufacturer -- that notifies them of when to take various medications.
In both examples, the providers would be viewed as benefiting financially from the provision of medical devices or services for the patients
Azar said the regulations – which won’t be finalized until after a public comment period – will create new exemptions from these laws for doctors and hospitals who are being paid based on quality not quantity. He said the regulations will also update existing exemptions and clarify the rules “so providers can spend less time and money on compliance.”
CMS Administrator Seema Verma said the changes will encourage more doctors and hospitals to participate in Medicare’s experiments to improve payments (she previewed this effort in a speech last spring).
“Unfortunately, the looming threat of liability under the Stark law has discouraged many providers from entering into value-based arrangements in the first place,” she said. “Times have changed and so must our approach.”
AHH: Sen. Bernie Sanders (I-Vt.) said he was “dumb” to ignore his symptoms before the heart attack he suffered a week ago. He acknowledged he will have to pull back on what has been a breakneck campaign pace because of his health, our Post colleague Chelsea Janes reports.
“During this campaign, I’ve been doing in some cases three or four rallies a day, running all over the state — Iowa, New Hampshire, wherever,” Sanders said, speaking outside his home in Burglinton, Vt. “And yet I, in the last month or two, just was more fatigued than I usually have been. And I should have listened to those symptoms.”
“We’re gonna change the nature of the campaign a bit,” he told reporters after returning from a visit to a cardiologist.
It was the first time the Vermont senator has been candid about the experience. He has spent the last few days at his Burlington home, recovering from his heart attack. Last Tuesday, he was taken to a hospital after feeling chest pains, and doctors inserted two stents into a blocked artery.
“Sanders, who has committed to releasing his medical records before the first primary votes but has not yet done so, said Tuesday he would provide the information at ‘the appropriate time,’” Chelsea writes. “Former vice president Joe Biden and Sen. Elizabeth Warren (D-Mass.) — fellow septuagenarians who join Sanders at the top of most polls — have also committed to releasing their medical records.”
OOF: Rates of three sexually transmitted diseases increased last year for the fifth year in a row, reaching a record high for 2018, according to a report from the Centers for Disease Control and Prevention.
The data from the Sexually Transmitted Disease Surveillance Report found combined cases of gonorrhea, chlamydia and syphilis increased last year, with a combined total of 2.4 million infections diagnosed and reported, CNN’s Jacqueline Howard reports.
"Yet not that long ago, gonorrhea rates were at historic lows, syphilis was close to elimination, and we were able to point to advances in STD prevention," Gail Bolan, director of the CDC's Division of STD Prevention, wrote in the report. “That progress has since unraveled. The number of reported syphilis cases is climbing after being largely on the decline since 1941, and gonorrhea rates are now increasing.”
OUCH: New data from the CDC found a large percentage of pregnant women are not getting two vaccines that public health officials encourage: the flu vaccine and pertussis-containing vaccine, called Tdap, which is packaged with tetanus and diptheria vaccines, Stat’s Helen Branswell reports.
An online survey taken over a two-week period last spring found 55 percent of pregnant women received a Tdap vaccine during pregnancy and 54 percent got a flu shot. It also found just 35 percent received both.
“Getting these vaccines protects pregnant women. But the antibodies that are passed to the developing fetus protect their babies after birth as well, when they are too young to be vaccinated,” Helen writes. “Babies get their first shot of pertussis-containing vaccine at 2 months and can’t be vaccinated against flu until they are 6 months old.”
According to the CDC report, between the 2010 and 2018 flu seasons, pregnant women were between a quarter and third of flu-related hospitalizations for women of childbearing ages.
Anne Schuchat, the CDC’s principal deputy director, said health care providers can encourage vaccinations. “I do think it’s pretty common in pregnancy for women to wonder ‘Well, should I do that? Is that OK? I thought I wasn’t supposed to do anything,’” she told Helen. “So the voice of the clinician can be very powerful: ‘Yes, I do think it’s important to do, it’s safe to do, it’s effective.’”
— Four school systems have sued e-cigarette company Juul for allegedly targeting teenagers and contributing to a vaping crisis that is now leaching resources from schools and educators, our Post colleague Moriah Balingit reports.
“We’re tired of companies that just want to make money at children’s expense,” said Whitney Meissner, superintendent of the tiny La Conner School District north of Seattle. The district filed a lawsuit on Monday. Three other districts that have sued Juul are Olathe Public Schools in Kansas, Three Village Central School District in New York and Francis Howell School District in Missouri.
“The lawsuits come as officials struggle to contain an outbreak of mysterious illnesses and deaths linked to vaping — although most cases involved patients who vaped THC, the active ingredient in marijuana,” Moriah writes. The school districts argue the company purposefully marketed to teenagers by making products that would be popular among youth.
She adds: “Juul did not respond to a request for comment on the lawsuits, but in the past it has defended its products by saying they were designed to help adult smokers quit. The company also has shut down social media accounts and stopped sales of flavored products to retail outlets in an effort to curb teen use.”
— Dicks Sporting Goods chief executive said the company destroyed $5 million worth of guns after it decided to remove military-style weapons from its stores last year.
The company turned the weapons into scrap metal rather than return them to manufacturers, our Post colleague Rachel Siegel reports.
CEO Ed Stack “has brought changing gun policies to the center of his role as chief executive. In the past year and a half, Dick’s has overhauled its gun sales policies, most recently pulling all guns out of 125 stores,” she writes. He also said the company’s firearms category is under “strategic review.”
Currently, 200 of its 730 stores don’t sell any firearms at all.
In an interview with Rachel, Stack also criticized Senate Majority Leader Mitch McConnell (R-Ky.) for inaction on House-passed legislation to require background checks on gun purchases. “I don’t know why he seems afraid to take it up," he said.
— Arizona is now raising objections after initially supporting a nationwide opioid settlement with OxyContin manufacturer Purdue Pharma. It's alleging the company looked to “undermine material terms of the deal,” our Post colleague Christopher Rowland reports.
Last month, Purdue reached a tentative agreement proposal that 24 states accepted — but 24 states and the District of Columbia had opposed the deal.
“Arizona did not declare its opposition to the deal. But in objecting to a stay of opioid litigation against Purdue Pharma and the billionaire Sackler family, which owns the company, the state’s attorney general is throwing a monkey wrench into a key element of the proposal,” Christopher writes. “ … If Arizona were to withdraw its support, that would mean a majority of states oppose the tentative pact. Oklahoma and Kentucky have settled with Purdue.”
“At nearly every turn during the course of subsequent negotiations, debtors have sought to undermine material terms of the deal,’’ Arizona wrote in a motion filed this week.
— And here are a few more good reads:
- The American Enterprise Institute holds a discussion on the "winners and losers of Medicare for All, Obamacare, and other health care proposals."
- The Senate Special Committee on Aging holds hearings to examine fall prevention, and national, state and local solutions to better support seniors on Oct. 16.
- The House Veterans Affairs Subcommittee on Oversight and Investigations holds a hearing on VA systems for protecting veterans from clinical harm on Oct. 16.