Facing Pressure, Insurance Plans Loosen Rules For Covering Addiction Treatment

Facing Pressure, Insurance Plans Loosen Rules For Covering Addiction Treatment

KFF Health News, February 21, 2017

Aetna will stop requiring doctors seek approval before prescribing particular medications―such as Suboxone―that are used to mitigate withdrawal symptoms.

This article first appeared February 21, 2017 on Kaiser Health News.

By Shefali Luthra

Aetna, one of the nation's largest insurance companies, will remove a key barrier for patients seeking medication to treat opioid addiction. The change will take effect in March and apply to commercial plans, a company spokeswoman confirmed, and will make it the third major insurer to make the switch.

Specifically, Aetna will stop requiring doctors seek approval before prescribing particular medications ― such as Suboxone ― that are used to mitigate withdrawal symptoms, and typically given along with steady counseling. The insurance practice, called "prior authorization," can result in delays of hours to days in getting a prescription filled.

The change comes as addiction to opioids, which include heavy-duty painkillers and heroin, still sweeps the country. More than 33,000 people died from overdosing on these drugs in 2015, the most recent year for which statistics are available. And it puts Aetna in the company of Anthem and Cigna, which both recently dropped the prior authorization requirement for privately insured patients across the country. Anthem made the switch in January and Cigna this past fall.

Both companies took the step after facing investigation with New York's attorney general, whose office was probing whether their coverage practices unfairly barred patients from needed treatment. They made this adjustment as part of larger settlements.

It sounds like just a technicality ― a brief delay before treatment. But addiction specialists say this red tape puts people's ability to get well at risk. It gives them a window of time to change their minds or go into withdrawal symptoms, causing them to relapse.

"If someone shows up in your office and says, 'I'm ready,' and you can make it happen right then and there ― that's great. If you say, 'Come back tomorrow, or Thursday, or next week,' there's a good chance they're not coming back," said Josiah Rich, a professor of medicine and epidemiology at Brown University and doctor at Providence-based Miriam Hospital, who frequently treats patients with opioid addictions. "Those windows of opportunity present themselves. But they open and close."

As these major carriers drop the requirement, treatment specialists hope a trend could be emerging in which these addiction meds become more easily available. In New York, for instance, the attorney general's office will be following up with other carriers who still have prior authorization requirements, an office spokesperson said. The office would not specify which carriers it will next examine.

Meanwhile, though little research pinpoints precisely how widespread this coverage practice is for drugs that treat opioid addiction, experts say it's a fairly common practice.

"Just think of any big health insurance company that hasn't recently announced they're doing away with this, and it's a pretty safe bet they've got prior authorization in place," said Andrew Kolodny, a Brandeis University senior scientist and the executive director of Physicians for Responsible Opioid Prescribing, an advocacy group.

How does the problem manifest? Take Boston Medical Center, located in a region that's been particularly hard hit by opioid addiction. Doctors there wanted to launch an urgent care center focused on this patient population. Less than a year old, the program's treated thousands of people.

But prior authorization requirements have been intense, said Traci Green, an associate professor at Boston University's School of Medicine and deputy director of the hospital's injury prevention center. To help people get needed care ― before it was too late ― the center hired a staffer devoted specifically to filling out all the related insurance paperwork.

"It was like, 'This is insanity,'" Green said, adding that "navigating the insurance was a huge problem" for almost every patient.

But defenders of the requirement maintain that such controls have value. Insurance plans using prior authorization may view it as a safeguard when prescribing a potentially dangerous drug. "[It's] not a tool to limit access. It's a tool to ensure patients get the right care," said Susan Cantrell, CEO of the Academy of Managed Care Pharmacy, a trade group.

Other large insurance carriers ― such as United Healthcare and Humana ― list on their drug formularies a prior authorization requirement for at least some if not all versions of anti-addiction medication. A spokesperson from Humana said the practice is used "to ensure appropriate use."

Also, though, it is generally agreed that the practice is used to control the prescribing of expensive medications. Per dose, the cost of these drugs varies based on brand and precise formulation, but it can go as high as almost $500 for a 60-pack dose, which can last a month.

Regardless of intent, critics say, those extra forms and hoops do make it more difficult for patients in need to get these medications ― ultimately, they say, doing more harm than good.

"If you would like a physician to not do a particular treatment, put a prior authorization in front of it," Rich said. "That's what they're used for."

Meanwhile, addiction treatment advocates and health professionals are hoping to build on what they see as new momentum.

Earlier this month, the American Medical Association sent a letter to the National Association of Attorneys General, calling for increased attention to insurance plans that require prior authorization for Suboxone or other similar drugs.

Minnesota's attorney general has written to health plans in the state, asking they end prior authorization for addiction treatment. New York has also heard from other states interested in tackling the issue, the attorney general spokesperson said. And another project, called Parity Track, is soliciting complaints from consumers.

They're arguing based on a requirement that insurance plans, thanks to so-called "parity laws," must cover addiction treatment, and cover it at the same level as they do other kinds of health care.

The prior authorization requirement "doesn't meet the sniff test for parity," said Corey Waller, an emergency physician who chairs the American Society of Addiction Medicine's legislative advocacy committee. "It's a first-line, Food and Drug Administration-approved therapy for a disease with a known mortality. Every other disease with a known mortality ― the first-line drugs are available right away."

But the justification for legal cases like New York's could get weaker. The 2010 health law, which lawmakers are working to repeal, included requirements that mental health and addiction treatment be considered an "essential health benefit." If that disappears, robust coverage for addiction could be less widely available, several noted.

Meanwhile, the stakes are substantial, Rich said. He recalled a patient who was taking a version of buprenorphine ― the active ingredient in Suboxone ― who had a brief relapse with heroin. That led to complications in the paperwork for renewing his prescription for treatment.

"Now he's out of the office, in the street, using more," Rich said of that case. "Incumbent upon [effective treatment] is the ability to get people started right away. If there's prior authorization? It's infuriating."

ER Visits Linked To Falls Spike Among California Seniors

ER Visits Linked To Falls Spike Among California Seniors

KFF Health News, February 21, 2017

Some of the rise appears to be explained by the estimated 21 percent growth in the state's senior population.

This article first appeared February 21, 2017 on Kaiser Health News.

By Anna Gorman

The number of California seniors who land in emergency rooms after falling has risen sharply in recent years, as their population grows and they live longer with more chronic illnesses often requiring an array of medications.

The number of visits to California emergency rooms by people over 65 who fell surged 38 percent from 167,785 in 2010 to 232,146 in 2015, according to data from the state's Office of Statewide Health Planning and Development.

Some of the rise appears to be explained by the estimated 21 percent growth in the state's senior population, from about 4.28 million in 2010 to 5.19 million in 2015, according to the California Department of Finance.

The ranks of people 85 and older, who account for one-third of all fall-related ER visits, are also swelling: That population grew by 19 percent in the same five-year period, according to the department's data.

In addition to their growing numbers, older adults nationwide have multiple chronic diseases and are taking numerous medications, both of which can contribute to falling, according to the CDC. And elderly adults may have cognitive decline, poor balance, physical weakness, and deteriorated vision.

"These kinds of things really affect the oldest of the old," said Jon Pynoos, professor of gerontology, policy and planning at the USC Leonard Davis School of Gerontology. "They are more prone to have complicated medical conditions."

Nationwide, about 2.8 million older adults are treated in emergency departments each year for injuries caused by falling, and more than 800,000 are hospitalized because of them, according to the U.S. Centers for Disease Control and Prevention.

Medical costs associated with falls are more than $31 billion each year, with hospital care accounting for about two-thirds of those expenses, according to the CDC. About one-fifth of falls cause serious injuries.

Fall-related injuries are particularly worrisome because they can lead to other problems, including immobility and even premature death, said Ted Chan, chairman of the Department of Emergency Medicine at UC San Diego and a professor at the medical school there. Hip fractures, in particular, can lead to severe health problems, including blood clots in the legs and lungs, pneumonia and loss of muscle mass, which can increase the risk of falling again.

"It is often when the real decline really starts to happen," Chan said. "They may never quite fully recover."

He said elderly patients who have serious falls need to be seen in the emergency room because they may have significant injuries requiring immediate medical attention. Doctors also need to determine why they fell.

"It may not be that they just tripped over something," Chan said. "It could be related to their heart or blood pressure."

Certain groups are more likely to end up in the emergency room after a fall, including homeless people, nursing home residents, people who live alone, and those of very advanced age, said Pynoos, the USC gerontology professor.

Joanne Lynch, 86, fell about two years ago while she was outside at night watering the garden at her Sacramento home. She was living alone at the time.

"I went face first into the flower bed," said Lynch, a retired hospital clerk.

A neighbor heard her yell and called 911. At the emergency room, doctors told her she had broken her wrist. Going to the emergency room assured her she didn't have an even more serious injury, she said.

"You can have a lot of things wrong with you internally that you don't even know," she said. "Peace of mind to an older person is worth more than anything else."

Some counties saw sharper increases than others in the number of fall-related emergency room visits by seniors. From 2010 to 2015, the number rose 54 percent in San Bernardino County, 47 percent in San Diego County and 31 percent in Los Angeles County.

The problem could worsen, as 10,000 baby boomers turn 65 every day in the United States.

The CDC urges older adults to talk to their doctors about whether their medications could make them dizzy or sleepy. The agency also recommends seniors build up their strength through exercise or physical therapy, get their eyes checked regularly and ensure their homes are free of hazards that could trip them. The agency also encourages medical providers to screen patients for the risk of falling.

There are several programs that have been proven to reduce fall rates or the fear of falling, according to the National Falls Prevention Resource Center, part of the National Council on Aging. Among them are Stepping On, which helps build seniors' self-confidence by teaching them about such topics as medication and home safety, and the Otago Exercise Program, in which physical therapists work on strength and balance with frail older adults over several months.

"The one good thing is there is more awareness," Pynoos said. "But people have to practice what they learn."

KHN's coverage in California is funded in part by Blue Shield of California Foundation.

Treatment Gaps Persist Between Low- And High-Income Workers, Even With Insurance

Treatment Gaps Persist Between Low- And High-Income Workers, Even With Insurance

KFF Health News, February 20, 2017

Low-wage workers were less likely to get preventive care even though many of those services are available without cost-sharing under the 2010 health law.

This article first appeared February 17, 2017 on Kaiser Health News.

By Michelle Andrews

Low-wage workers with job-based health insurance were significantly more likely than their higher-income colleagues to wind up in the emergency department or be admitted to the hospital, in particular for conditions that with good primary care shouldn't result in hospitalization, a new study found.

At the same time, low-wage workers were much less likely to get preventive care such as mammograms and colonoscopies, even though many of those services are available without cost-sharing under the 2010 health law.

There's no single reason for the differences in health care use by workers at different wage levels, said Dr. Bruce Sherman, an assistant clinical professor at Case Western Reserve University in Cleveland and the study's lead author, which was published in the February issue of Health Affairs.

Finances often play a role. Half of workers with employer-sponsored insurance are enrolled in plans with a deductible of at least $1,000 for single coverage. As deductibles and other out-of-pocket costs continue to rise, low-wage workers may opt to pay the rent and put food on the table rather than keep up-to-date with regular doctor visits and lab work to manage their diabetes, for example.

Likewise, convenient access to care can be problematic for workers at the lower end of the pay scale.

"Individuals are penalized if they leave work to seek care," Sherman said. "So they go after hours and their access to care is limited to urgent care centers or emergency departments."

The study examined the 2014 health care claims, wage and other data of nearly 43,000 workers at four self-funded companies that offered coverage through a private health insurance exchange. Workers were stratified into four categories based on annual maximum wages of $30,000, $44,000, $70,000 and more than $70,000.

Workers in the lowest wage category were three times more likely to visit the emergency department than top earners, and more than four times more likely to have avoidable hospital admissions for conditions such as bacterial pneumonia or urinary tract infections. But they used preventive services only half as often, the study found.

There are no easy solutions. Varying premiums or deductibles based on workers' wages could take some of the bite out of low-wage workers' out-of-pocket costs, but very few employers have adopted that strategy, Sherman said. Offering plans that pay for certain services, such as care related to chronic conditions, before the deductible is met could boost the use of care. But preventive services are available without cost-sharing in most plans and many low-wage workers aren't getting recommended services.

"Health literacy concerns are important," said Sherman, but it may not be the only barrier. "Some focus groups I've participated in, employees have said, 'I understand the services are free, but if an abnormality is found that requires further services, I'll have to [pay for it]. So because I feel fine, I'm not going to go.'"

Tom Price, MD

New Rules Try To Shore Up Individual Health Insurance Market In 2018

KFF Health News, February 16, 2017

The Trump administration's new regulation makes it harder for patients to sign up outside of annual open enrollment periods and would allow insurers to collect past-due premiums before starting coverage for a new year.

This article first appeared February 16, 2017 on Kaiser Health News.

By Julie Rovner

While Congress continues to struggle with how to "repeal and replace" the Affordable Care Act, the Trump administration today unveiled its first regulation aimed at keeping insurers participating in the individual market in 2018.

"These are initial steps in advance of a broader effort to reverse the harmful effects of Obamacare, promote positive solutions to improve access to quality, affordable care and ensure we have a health system that best serves the needs of all Americans," Tom Price, secretary of the Department of Health and Human Services said in a Twitter message.

But the new rule, which had been widely expected, was actually begun by the outgoing Obama administration. In part, it is an effort to address complaints by insurers that consumers were "gaming" the system to purchase coverage only when they were sick and then dropping it when they were healthy.

To combat that, the regulation makes it harder for patients to sign up outside of annual open enrollment periods and would allow insurers to collect past-due premiums before starting coverage for a new year. It would also shorten the annual enrollment period by half, from three months to 45 days, ending right between Thanksgiving and Christmas. And it would give insurers more flexibility in the types of plans they offer and return regulation of the size and adequacy of health care provider networks to the states. 

But it remains unclear whether the action will be too little, too late to ensure insurance is available next year. That would be necessary to keep congressional Republicans' promises that people "do not get the rug pulled out from under them" during the transition to a new program, as House Speaker Paul Ryan (R-Wis.) says frequently.

On Tuesday, Humana announced it would stop selling policies in the health exchanges at the end of this year, and on Wednesday Mark Bertolini, the CEO of Aetna, suggested his firm might follow suit, repeating GOP charges that the individual market exchanges are in a "death spiral" where only sick people buy coverage.

While Humana was not a major player in the state exchange market—it only sold policies in 11 states for 2017—its exit could leave at least 16 counties in Tennessee, including Knoxville, with no insurance company offering policies on the health exchange, according to data from the Kaiser Family Foundation. (KHN is an editorially independent program of the foundation.)

That alarmed Sen. Lamar Alexander (R-Tenn.), chairman of the Senate Health, Education, Labor and Pensions Committee, who has been one of the leading voices in Congress advocating a slower repeal and replace strategy.

"Yesterday's news from Humana should light a fire under every member of Congress to work together to rescue Americans trapped in the failing Obamacare exchanges before they have no insurance options next year," Alexander said in a statement.

Last year Aetna's Bertolini also cited losses in the market as the reason for the company's scaling back participation in the exchanges, although in an unrelated case, a judge's ruling later said the decision had at least as much to do with pushing federal officials to allow Aetna to merge with Humana. On Monday that merger was officially called off after being blocked by a judge.

The new rules were greeted with cautious optimism by insurance industry trade groups.

"While we are reviewing the details, we support solutions that address key challenges in the individual market, promote affordability for consumers, and give states and the private sector additional flexibility to meet the needs of consumers," Marilyn Tavenner, president and CEO of America's Health Insurance Plans, said in a statement.

The Alliance of Community Health Plans, which represents nonprofit insurers, called the regulation "a promising first step." But in a statement, president and CEO Ceci Connolly warned that the rule "does not resolve all of the uncertainty for plans and patients alike. Without adequate funding it will be extremely difficult to provide high-quality, affordable coverage and care to millions of Americans."

Groups representing patients, however, were less happy with the changes. They argue that the rules could result in higher out-of-pocket costs.

Ron Pollack, executive director of the consumer group Families USA, said the new administration "is deliberately trying to sabotage the Affordable Care Act, especially by making it much more difficult for people to enroll in coverage."

Sick people are likely to jump through any hoops required to get coverage, but healthy people are less inclined to sign up when it is more difficult. So by making it harder for healthy people to enroll, said Pollack, "they are creating their own death spiral that would deter young adults from gaining coverage, thereby driving up costs for everyone."

And the American Cancer Society said that the new rules could hurt cancer patients in particular—for example, when they need to purchase new coverage after becoming too sick to work or moving to be closer to health providers. The proposed changes "would require documentation that is often challenging to quickly obtain," and could "delay a patient's treatment and jeopardize a person's chance of survival," said a statement from Chris Hansen, president of the society's Cancer Action Network.

Unless the new administration changes the date, insurers must decide by May 3 if and where they will sell insurance for next year on the state exchanges.

Meanwhile, the Republican-led Congress remains in a deadlock between conservatives in the House, who want to repeal the health law as soon as possible, and moderates in the Senate like Alexander, who want to wait until there is agreement on what will replace it.

"We should just do what we said we would do," Rep. Raul Labrador (R-Idaho) told reporters on Tuesday.

Conservatives say, at a minimum, Congress should pass the partial repeal bill it passed in 2015 that President Barack Obama vetoed. That measure would eliminate the expansion of the Medicaid program, financial help for people to purchase insurance, the penalties for not having coverage, and all the taxes that pay for the program, among other things.

"Why would it be difficult to get [the Senate] to vote for something they already voted for?" asked Rep. Mark Meadows (R-N.C.).

But congressional budget scorekeepers in January said that bill, which has no replacement provisions, could result in a doubling of premiums and 32 million more people without insurance.

And Republicans in the Senate, as well as President Donald Trump, continue to say that repeal and replace should take place simultaneously.

"I thought we were embarked on an effort to replace it," said Sen. John McCain (R-Ariz.).

Docs Bill Medicare for End-of-Life Advice As 'Death Panel' Fears Reemerge

Docs Bill Medicare for End-of-Life Advice As 'Death Panel' Fears Reemerge

KFF Health News, February 15, 2017

Nearly 14,000 providers billed almost $35 million—including nearly $16 million paid by Medicare—for advance care planning conversations from January through June.

This article first appeared February 15, 2017 on Kaiser Health News.

By JoNel Aleccia

End-of-life counseling sessions, once decried by some conservative Republicans as "death panels," gained steam among Medicare patients in 2016, the first year doctors could charge the federal program for the service.

Nearly 14,000 providers billed almost $35 million — including nearly $16 million paid by Medicare — for advance care planning conversations for about 223,000 patients from January through June, according to data released this week by the Centers for Medicare & Medicaid Services. Full year figures won't be available until July, but use appears to be higher than anticipated.

Controversy is threatening to reemerge in Congress over the funding, which pays doctors to counsel some 57 million Medicare patients on end-of-life treatment preferences. Rep. Steve King, R-Iowa, introduced a bill last month, the Protecting Life Until Natural Death Act, which would revoke Medicare reimbursement for the sessions, which he called a "yet another life-devaluing policy."

"Allowing the federal government to marry its need to save dollars with the promotion of end-of-life counseling is not in the interest of millions of Americans who were promised life-sustaining care in their older years," King said on Jan. 11.

While the fate of King's bill is highly uncertain — the recently proposed measure hasn't seen congressional action — it underscores deep feelings among conservatives who have long opposed such counseling and may seek to remove it from Medicare should Republicans attempt to make other changes to the entitlement program.

Proponents of advance care planning, however, cheered evidence of program's early use as a sign of growing interest in late stage life planning.

"It's great to hear that almost a quarter million people had an advance care planning conversation in the first six months of 2016," said Paul Malley, president of Aging with Dignity, a Florida nonprofit. "I do think the billing makes a difference. I think it puts it on the radar of more physicians."

Use of the counseling sessions is on track to outpace an estimate by the American Medical Association, which projected that about 300,000 patients would receive the service in the first year, according to the group, which backed the rule.

Providers in California, New York and Florida led use of the policy that pays about $86 a session for the first 30-minute office-based visit and about $75 per visit for any additional sessions.

The rule requires no specific diagnosis and sets no guidelines for the end-of-life discussions. Conversations center on medical directives and treatment preferences, including hospice enrollment and the desire for care if patients lose the ability to make their own decisions.

The new reimbursement led Dr. Peter Sutherland, a family medicine physician in Morristown, Tenn., to schedule more end-of-life conversations with patients last year.

"They were very few and far between before," he said. "They were usually hospice-specific."

Now, he said, he has time to have thorough discussions with patients, including a 60-year-old woman whose recent complaints of back and shoulder pain turned out to be cancer that had metastasized to her lungs. In early January, he talked with an 84-year-old woman with Stage IV breast cancer.

"She didn't understand what a living will was," Sutherland said. "We went through all that. I had her daughter with her and we went through it all."

The conversations may occur during annual wellness exams, in separate office visits or in hospitals. Nurse practitioners and physicians' assistants may also seek payment for end-of-life talks.

The idea of letting Medicare reimburse such conversations was first introduced in 2009 during debate on the Affordable Care Act. The issue quickly fueled allegations by some conservative politicians, such as former Republican vice presidential candidate Sarah Palin and presidential candidate John McCain, that they would lead to "death panels" that could disrupt care for elderly and disabled patients.

The idea was dropped "as a direct result of public outcry," King said in a statement.

"The worldview behind the policy has not changed since then and government control over this intimate choice is still intolerable to those who respect the dignity of human life," he said.

But in 2015, CMS officials quietly issued the new rule allowing Medicare reimbursement as a way to improve patients' ability to make decisions about their care.

End-of-life conversations have occurred in the past, but not as often as they should, Malley said. Many doctors aren't trained to have such discussions and find them difficult to initiate.

"For a lot of health providers, we hear the concern that this is not why patients come to us," Malley said. "They come to us looking to be cured, for hope. And it's sensitive to talk about what happens if we can't cure you."

A 2014 report by the Institute of Medicine, a panel of medical experts, concluded that Americans need more help navigating end-of-life decisions. A 2015 Kaiser Family Foundation poll found that 89 percent of people surveyed said health care providers should discuss such issues with patients, but only 17 percent had had those talks themselves. (KHN is an editorially independent program of the foundation.)

Use of the new rule was limited in the first six months of 2016. In California, which recorded the highest Medicare payments, about 1,300 providers provided nearly 29,000 services to about 24,000 patients at an overall cost of about $4.4 million — including about $1.9 million paid by Medicare.

The data likely reflect early adopters who were already having the talks and quickly integrated the new billing codes into their practices, said Dr. Ravi Parikh, an internal medicine resident at Brigham and Women's Hospital in Boston, who has written about advance care planning. Many others still aren't aware, he said.

Data from Athenahealth, a medical billing management service, found that only about 17 percent of 34,000 primary care providers at 2,000 practices billed for advance care planning in all of 2016.

The numbers will likely grow, said Malley, who noted that requests from doctors for advance care planning information tripled during the past year.

To counter objections, providers need to ensure that informed choice is at the heart of the newly reimbursed discussions.

"If advance care planning is only about saying no to care, then it should be revoked," Malley said. "If it truly is about finding out patient preferences on their own turf, it's a good thing."

Table at page bottom: Medicare Spending And Utilization Data For Advanced Care Planning Services By State, Jan. 1 — June 30, 2016

Influence of GOP Doctors Caucus Grows as Congress Looks to Replace Health Law

KFF Health News, February 15, 2017

The caucus is expected to play a major role determining the Trump administration's plans for replacement.

This article first appeared February 15, 2017 on Kaiser Health News.

By Phil Galewitz

The confirmation of Tom Price, the orthopedic surgeon-turned-Georgia congressman, as secretary of Health and Human Services represents the latest victory in the ascendancy of a little-known but powerful group of conservative physicians in Congress he belongs to — the GOP Doctors Caucus.

During the Obama administration, the caucus regularly sought to overturn the Affordable Care Act, and it's now expected to play a major role determining the Trump administration's plans for replacement.

Robert Doherty, a lobbyist for the American College of Physicians, said the GOP Doctors Caucus has gained importance with Republicans' rise to power. "As political circumstances have changed, they have grown more essential," he said.

"They will have considerable influence over the considerable discussion on repeal and replace legislation," Doherty said.

Price's supporters have touted his medical degree as an important credential for his new position, but Price and the caucus members are hardly representative of America's physician in 2017. The "trust us, we're doctors" refrain of the caucus obscures its heavily conservative agenda, critics say.

"Their views are driven more by political affiliation," said Mona Mangat, an allergist-immunologist and chair of Doctors for America, a 16,000-member organization that favors the current health law. "It doesn't make me feel great. Doctors outside of Congress do not support their views."

For example, while the American College of Obstetrics and Gynecology has worked to increase access to abortion, the three obstetrician-gynecologists in the 16-member House caucus are anti-abortion and oppose the ACA provision that provides free prescription contraception.

While a third of the U.S. medical profession is now female, 15 of the 16 members of the GOP caucus are male, and only eight of them are doctors. The other eight members are from other health professions, including a registered nurse, a pharmacist and a dentist. The nurse, Diane Black of Tennessee, is the only woman.

On the Senate side, there are three physicians; all of them Republican.

While 52 percent of American physicians today identify as Democrats, just two out of the 14 doctors in Congress are Democrats.

About 55 percent of physicians say they voted for Hillary Clinton and only 26 percent voted for Donald Trump, according to a survey by Medscape in December.

Meanwhile, national surveys show doctors are almost evenly split on support for the health law, mirroring the general public. And a survey published in the New England Journal of Medicine in January found almost half of primary care doctors liked the law, while only 15 percent wanted it repealed.

Rep. Michael Burgess, R-Texas, a caucus member first elected in 2003, is one of the longest serving doctors in Congress. He said the anti-Obamacare Republican physicians do represent the views of the profession.

"Doctors tend to be fairly conservative and are fairly tight with their dollars, and that the vast proportion of doctors in Congress [are] Republican is not an accident," Burgess said.

Price's ascendancy is in some ways also a triumph for the American Medical Association, which has long sought to beef up its influence over national health policy. Less than 25 percent of AMA members are practicing physicians, down from 75 percent in the 1950s.

Price is an alumnus of a boot camp the AMA runs in Washington each winter for physicians contemplating a run for office. Price is one of four members of the caucus who went through the candidate school. In December, the AMA immediately endorsed the Price nomination, a move that led thousands of doctors who feared Price would overturn the health law to sign protest petitions.

Even without Price, Congress will have several GOP physicians in leadership spots in both the House and Senate.

View tables here.

Those include Rep. Phil Roe of Tennessee, the caucus co-chair, who also chairs the House Veterans Affairs Committee, and Burgess, who chairs the House Energy and Commerce subcommittee on health. Sen. Bill Cassidy of Louisiana sits on both the Finance and the Health, Education, Labor and Pension Committees. Sen. John Barrasso of Wyoming chairs the Senate Republican Policy Committee.

Roe acknowledges that his caucus will have newfound influence. Among his goals in molding an ACA replacement are to kill the requirement that most people buy health insurance (known as the individual mandate) as well as to end the obligation that 10 essential benefits, such as maternity and mental health care, must be in each health plan.

He said the caucus will probably not introduce its own bill, but rather evaluate and support other bills. The caucus could be a kingmaker in that role. "If we came out publicly and said we cannot support this bill, it fails," Roe said.

The GOP Doctors Caucus has played a prominent role in health matters before Congress. For example, in 2015, when former House Speaker John Boehner needed help to permanently repeal a Medicare payment formula that threatened physicians with double-digit annual fee cuts, he turned to the GOP Doctors Caucus. It got behind a system to pay doctors based on performance — the so-called doc fix.

"When the speaker had a unified doctors' agreement in his coat pocket, he could go to Minority Leader Nancy Pelosi and show that, and that had a lot to do with how we got this passed," Roe said.

But not all doctors are unified behind the caucus. Rep. Raul Ruiz, one of the two physicians in the House who are Democrats, said he worries because few doctors in Congress are minorities or primary care doctors.

Ruiz, an emergency room physician from California who was elected in 2012, said he is wary about Price leading HHS because he is concerned Price's policies would increase the number of Americans without insurance.

Indeed, many doctors feel the caucus' proposals will not reflect their views — or medical wisdom. "My general feeling whenever I see any of their names, is that of contempt," said Don McCanne of California, a senior fellow and past president of the Physicians for a National Health Program. "The fact that they all signed on to repeal of ACA while supporting policies that would leave so many worse off demonstrated to me that they did not represent the traditional Hippocratic traditions which place the patient first."

Christina Jewett contributed reporting.

Judge Upends Effort To Limit Charity Funding For Kidney Patients’ Insurance

Former FDA Chief Cites 5 Things To Watch On Drug Approvals

KFF Health News, February 14, 2017

Robert Califf, MD, who stepped down last month, shared his thoughts about keeping Americans safe — and making sure drugs actually work — after about a year overseeing the federal agency.

This article first appeared February 14, 2017 on Kaiser Health News.

By Sydney Lupkin and Sarah Jane Tribble

The just-departed commissioner of the Food and Drug Administration has concerns about plans to speed up drug approvals and dramatically reduce regulations at the agency, as advocated recently by President Donald Trump.

Dr. Robert Califf, who stepped down last month, shared his thoughts about keeping Americans safe — and making sure drugs actually work — after about a year overseeing the federal agency. His takeaways:

1. Faster drug approvals, being advocated by Trump and others, don't necessarily mean less expensive drugs.

"What I'm concerned about is that when people hear 'faster approval,' you get an image of the FDA sitting on this application and, you know, twiddling thumbs," Califf said. "That's not what happens."

Califf explained that the slow part of getting a drug into patients' hands happens well before the drugmaker submits an application to the FDA. It can take decades to discover, tweak and test a new drug molecule, and that development process is what needs a boost.

"The real action [happens] before the application gets submitted and that can be a time frame from years to decades as people try to figure out what will work and what will not," Califf said.

Although faster drug development could bring development costs down, Califf said, "There's not a direct relationship between the cost of development and the price of drugs or devices."

2. A law passed in December should streamline drug approvals — in a positive way.

The 21st Century Cures Act, a bipartisan bill signed by President Barack Obama late last year, is a "very well-rounded piece of legislation that will speed up product development."

To begin with, it encourages the FDA to consider pieces of information in its approval process in addition to traditional clinical trials, including "real world evidence" and biomarkers. Biomarkers are used in studies in place of outcomes that are more difficult to measure. For example, tumor shrinkage is sometimes a biomarker for surviving cancer.

"Using real world evidence in clinical trials is one that I'm particularly excited about as a way to get better answers at a lower cost and faster at the same time," Califf said.

3. But Califf has concerns about maintaining drug safety standards and ensuring thorough clinical trials.

"The concept of safety is much more complex than most people think about until they look into it deeply," Califf said. "All drugs have risk. None of them are absolutely safe. And the actual safety risks are only revealed through clinical trials with the same quality and number of patients involved as it takes to look at efficacy."

About 92 percent of drugs that get into human clinical trials don't make it to market because they fail to show any benefit or, worse, they have unexpected toxicity, he said.

"Declaring a drug is safe after very little information is treacherous," Califf said.

Califf recently wrote for JAMA on the FDA's balancing act of protecting the public and encouraging innovation. And the FDA released a paper last month documenting examples of a promising drug, vaccine or device that each did well in a Phase 2 clinical trial but "bombed out" in Phase 3, Califf said. Drugs typically go through three "phases" of studies called clinical trials before gaining FDA approval. With each new phase, researchers test drugs or other products on more people and on more measures of safety and effectiveness.

"It's 22 examples of why it's a big mistake to think that you can judge the balance of risk and benefit from a small amount of data," Califf said.

4. Faster, better drugs can't be approved if the FDA is understaffed, he argued.

Califf called a potential FDA hiring freeze "unfortunate" and said new staff is needed to meet the faster approval timelines and to give advice to those developing drugs so "bad mistakes" aren't made.

The FDA has been steadily hiring staff to keep up with the growing industry it oversees. But hundreds of openings are still left to be filled.

Califf said the drug industry's most valued interaction with the FDA is "during the process of [drug] development," which begins before a drug application is submitted for approval. FDA staff can provide timely feedback and advice that can help a company choose the right studies needed for approval and, effectively, speed up drug development.

"A hiring freeze at this time when we are just revving up with 21st Century Cures is unfortunate. I hope that the dust will settle soon and the FDA can get back to its hiring," Califf said.

5. The FDA is using big data to track the safety of drugs already on the market — and it plans to do that a lot more.

The FDA has an established adverse event database but after pain reliever Vioxx was pulled from the market in 2004, the agency began working on a system called Sentinel.

The initiative uses claims data to look at drug safety. It has 180 million individual electronic records and tracks every dispensed prescription, hospitalization as well as serious outcomes, Califf said. In addition, Sentinel is now being opened up to industry and academia.

"It's used every day by the FDA," Califf said, adding that the system is "getting better and better."

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

Judge Upends Effort To Limit Charity Funding For Kidney Patients' Insurance

Judge Upends Effort To Limit Charity Funding For Kidney Patients' Insurance

KFF Health News, February 14, 2017

The federal government has expressed concern that providers of charity for financial assistance to cover health insurance costs might be inappropriately steering patients to marketplace plans instead of Medicare or Medicaid.

This article first appeared February 14, 2017 on Kaiser Health News.

By Michelle Andrews

Every night, Jason Early attaches a catheter in his chest to a machine by his bed that, over the course of nine hours while he sleeps, removes his blood from his body, cleanses it and returns it because his kidneys are no longer able to do the job.

It's been about 18 months since the 28-year-old Dallas resident started getting dialysis after his kidneys failed as a complication from the Type 1 diabetes with which he was diagnosed as a child.

Like many patients with end-stage renal disease, Early, who is completing a bachelor's degree in finance at the University of North Texas at Dallas, turned to a charity for financial assistance to cover his health insurance costs.

Such "third-party payments" by nonprofit groups, health care providers and others are controversial. The federal government has expressed concern that providers and organizations they're affiliated with might be inappropriately "steering" patients to marketplace plans instead of Medicare or Medicaid, for which they are often eligible. The public programs reimburse for the dialysis services at lower rates than most private plans. The efforts by charities have also long been a sore spot with health insurers, who say they encourage sick patients who have expensive health care needs to opt for private coverage.

Insurers suffered a setback recently when a federal judge temporarily blocked a new rule from the Department of Health and Human Services that was set to go into effect Jan. 13. It would require that dialysis centers inform insurers if the centers are making premium payments either directly or indirectly through a third party for people covered by marketplace plans. Insurers would then have the option of accepting or denying the payments.

In granting the preliminary injunction last month, U.S. District Court Judge Amos Mazzant in Sherman, Texas, criticized the government's administrative process for establishing the regulation and said it hadn't considered the benefits of private individual insurance or the fact that the rule would leave thousands of patients without coverage.

Insurers were not pleased. "Inappropriate steering and third-party payments increases costs for all consumers, and it risks harm to patients who are often eligible for public coverage options," said Kristine Grow, a spokesperson for America's Health Insurance Plans, an industry group. "We continue to urge [the Department of Health and Human Services] to prohibit these payments when there is alternative coverage for patients."

But patient advocates were delighted. "We thought this was an important win for dialysis patients because it not only spoke to the procedural elements of the rule but to the substance, the potential of dialysis patients to have their coverage taken away," said Hrant Jamgochian, the chief executive of Dialysis Patient Citizens, an advocacy group and the lead plaintiff in the lawsuit.

Premium assistance has been critical to improving Early's quality of life. "Without the [American Kidney Fund] assistance I would be living to pay my medical costs," he said. "They give me an opportunity to get a breather from medical costs so that I can live my life outside of my illness."

Although some patients, such as Early, are able to undergo dialysis at home, many must spend four hours at a dialysis center three times a week. The process is debilitating and time-consuming.

Many people lose their employer-sponsored health insurance because they are unable to work. Medicare is often an alternative because under the law, people with end-stage renal disease — even those younger than 65 — are generally eligible for coverage.

Others may sign up for private coverage on the exchanges. Some may qualify for Medicaid.

Advocates for kidney patients say coverage on the individual market is better than Medicare for some people. In marketplace plans, the maximum amount that someone can be required to pay out-of-pocket for covered services in 2017 is $7,150. But there's no cap on beneficiaries' spending in Medicare, and patients are on the hook for 20 percent of the cost for doctor visits and other outpatient services such as dialysis. Supplemental "Medigap" plans can help cover out-of-pocket costs, but 23 states don't require insurers to sell those plans to people with end-stage renal disease who aren't yet 65.

Last year, Early bought an Aetna silver plan with a $1,500 deductible and a $6,000 out-of-pocket maximum on the Texas health insurance exchange. The American Kidney Fund paid the $359 monthly premium. The policy covered all of his diabetes drugs and equipment. By the end of the first month of dialysis copayments, Early reached his spending maximum and the plan paid everything after that.

But Aetna exited several marketplaces this year, including Texas, and Early signed up for Medicare in January. Now he's responsible for a $134 monthly Part B premium, $65 for his prescription drug plan and $300 a month in copays for drugs. Medicare doesn't cover the insulin pump he uses, so he'll have to pay $300 monthly out of pocket for that too. At the moment he's also paying $478 each month for the basic Medigap "A" supplemental plan available in Texas to patients younger than 65 with end-stage renal disease. The Medigap plan covers his 20 percent coinsurance payments for dialysis and other outpatient care.

He said he's been told that the American Kidney Fund, a charity that provides assistance to about 20 percent of the more than 450,000 people who are on dialysis and receives funding from dialysis providers, will start picking up his Medigap premiums soon. He hopes so.

"I miss my Aetna plan," he said.

Sixty percent of the people who receive premium assistance from the American Kidney Fund get help with their Medicare or Medigap plans rather than marketplace or other private coverage, said LaVarne Burton, the president and CEO. Even though the judge's order doesn't apply to people in public plans, she hopes it will discourage insurers that are increasingly erecting barriers to third-party payment.

"We want to protect the ability that these individuals have to make the choice that meets their needs," Burton said.

Price could have a rapid impact on policy without a presidential order or an act of Congress.

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

KFF Health News, February 10, 2017

Price could have a rapid impact on policy without a presidential order or an act of Congress.

This article first appeared February 10, 2017 on Kaiser Health News.

By Julie Rovner

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

President Donald Trump has acknowledged that the effort to remake the health law could last into next year. Conservatives, however, are pushing back.

Conservatives Urge Speed Up Of Health Law Repeal

KFF Health News, February 9, 2017

President Donald Trump has acknowledged that the effort to remake the health law could last into next year. Conservatives, however, are pushing back.

This article first appeared February 9, 2017 on Kaiser Health News.

By Julie Rovner

Leading conservative Republicans from the House and Senate say Congress is moving too slowly on efforts to "repeal and replace" the Affordable Care Act. But their potential resistance to compromise—even with other members of their own party—underscores just how hard a task Republicans have set for themselves.

"We think it's time to do something, and that's to get rid of this law," Rep. Jim Jordan, R-Ohio, told reporters at an event sponsored by the conservative Heritage Foundation. "The biggest problem with waiting is that's not what we told the voters."

Sen. Mike Lee, R-Utah, pictured above, one of the leading conservative voices in that chamber, said he will vigorously oppose efforts for Republicans to wait until they have a plan ready to replace the law before they repeal it. "There is a lot less agreement about what comes next," he said. "If we load down the repeal bill with what comes next, it's harder to get both of them passed."

After getting off to a quick start, GOP efforts to dismantle the health law appear to have slowed considerably. House and Senate committees have already missed a deadline of Jan. 27 to write and pass their proposed repeal and replace provisions, although Senate leaders acknowledged early this year that marker would likely not be met. At a party retreat last month, Republicans still seemed uncertain exactly how and when they would proceed.

In an interview that aired just before the Super Bowl, President Donald Trump for the first time acknowledged that the effort to remake the health law could last into next year.

Conservatives, however, are pushing back.

Rep. Mark Meadows, R-N.C., who heads the hard-right House Freedom Caucus, said he recognizes that people are "anxious" about changing the health law. "The quicker we can give them answers, the better off we are," he said.

"Health care gets better and costs less once you repeal Obamacare," said Jordan.

All three said they are sensitive to the needs of health insurers, who are threatening to stop offering coverage in the individual market after this year unless they get a better idea of what rules they will have to follow.

"Every month that goes by we create a heavier burden for insurance companies to figure out," said Meadows.

They insisted that adds imperative to the repeal push.

At a minimum, said Lee, Congress should immediately pass the bill it passed in 2015 that was vetoed by President Barack Obama. That partial repeal would have eliminated the expansion of the Medicaid program for the poor, as well as all the insurance subsidies that help people afford coverage and the taxes that pay for the program.

"If we can get something more aggressive, then great," he said. "But we cannot make progress until we first repeal Obamacare."

Insurers and others, including the Congressional Budget Office, have said that repealing parts of the law without a replacement could plunge the individual insurance market into chaos and increase the number of people without any insurance by 32 million over 10 years.

But the conservatives rejected that characterization. "The chaos the American people are facing right now is related to a set of circumstances put in place by Obamacare," said Lee. "I wish there were a non-chaotic path" to fix it.

Pages