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

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 21^st 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.

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 Trump's promise to undo the health law could compromise anti-addiction efforts, says President Obama's former "drug czar," Michael Botticelli.

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

By Shefali Luthra

The GOP is working to repeal and replace the 2010 health law, known for insuring more than 20 million people. And the change could affect another health concern: the nation's opioid abuse problem.

Just ask President Barack Obama's former "drug czar," Michael Botticelli.

Botticelli just finished running the White House's Office of National Drug Policy, a post he assumed in early 2014 as the opioid epidemic began making national headlines. The drugs, which claimed more than 33,000 lives in 2015, include heroin and painkillers like OxyContin.

Fighting addiction—and opioids in particular—defined his tenure. But Botticelli was known for bringing a patient's perspective. His background, after all, isn't medicine or law enforcement. He previously headed Massachusetts' Bureau of Substance Abuse. And he's in recovery himself, having spent almost 30 years sober after battling alcoholism.

Q: What do you think is needed to address the opioid epidemic?

We have not heard President Donald Trump talk about how he is going to deal with this. He heard [about] this issue on the campaign trail.

There is significant concern on the potential impact repealing the Affordable Care Act might have. We had a whole host of initiatives, but one of the main components was to ensure people had adequate access to treatment. Clearly, the Affordable Care Act had a major impact. When you look at data about why people are not able to get treatment, not having access to insurance is one of the major reasons people cite.

Q: What are the specific elements of repealing and replacing the law that you're concerned about?

People with opioid addiction do not just need general access to substance abuse services. They often have a variety of comorbid mental health and medical conditions. We've seen a dramatic increase in people with hepatitis C among people with opioid addiction who are injecting drugs. We've seen in certain parts of the country outbreaks of HIV. Medicaid expansion has played a huge role in people's ability to access treatment for both substance use disorder and other conditions.

One of the concerns is not just for people's ability to access care—but what happens to those millions who are already receiving it? If there is a significant disruption in people's ability to access treatment, it has a devastating impact.

Q: In addition to the repeal effort, the GOP has talked about revamping Medicaid so that it would be funded through block grants, which could give states more freedom to manage the program, but also could limit its budget. Could those affect the fight against opioid addiction?

In addition to requiring treatment for substance use disorders be considered an essential benefit, the Affordable Care Act imparted federal parity regulations to cover those. Without federal oversight, states might choose to not cover those services, and not cover them on par with other medical needs.

There are reasons we have federal parity laws. There's a long history of both private and public insurance plans not adequately covering—or covering at all—substance use disorder services.

And so there's a potential [to lose those protections by] moving to a block grant, where states have much more flexibility over who they cover and the kinds of services they pay for.

This goes back to the very long history of Medicaid, both private and public insurance, either not paying or not adequately covering these [services].

Q: Has the Trump administration been in touch with you—about opioid policy specifically, or drug policy generally?

No. And we had no contact with anyone on the Trump transition team before I left. It's giving me and other people pause about to what extent this administration considers this a priority.

Q: Do you have a sense that the new administration has a sense of policy that might be effective? And what are the challenges they'll face going forward?

Well, I think that we have seen not only in my time in the Obama administration, but in my time in Massachusetts—that this really requires a comprehensive response. And a dedicated response. And it needs to be well resourced, to be a priority across the federal government

I think if we were able to achieve anything, it was really understanding that this was an 'all hands on deck' approach, and we needed various elements of the administration focused on this issue if we're going to make progress on this. We need it. And I think part of what was successful was this was a clearly articulated priority by President Obama. You know, I think that we were able—and whether it was getting the billion dollars for treatment through the [21st Century] Cures Act, I think it was a demonstrated priority on the part of the president.

We still have over 140 people dying every single day as a result of drug overdoses. And the entirety of the response can't be, "We're just going to build a wall to stop the flow of drugs coming in from across the border."

This was an epidemic that was created by legally prescribed drugs, here in the United States, and so we need to make sure we're doing everything in our power to make progress. Fundamental to that is making sure people have appropriate and timely access to treatment.

Q: Addiction science is a fairly new field. There's a lot of unanswered questions. How does the administration's interest in federally funded research fit in here?

Any drug policy that's going to be effective has got to be based on science and research.

The research that the National Institute of Drug Abuse and National Institutes of Health funded to understand addiction as a brain disorder and not a moral failing made us pivot to a drug policy that was based on scientific principles. People have raised concerns to what extent those principles and that science are going to continue.

Q: Is this an area you plan to stay involved in?

This has been my life's work, and I have every intent to continue that. I'm trying to decide now in what capacity. But I'm pretty certain I'm going to stay involved.

Q: Do you think policy makers will continue to focus on addiction—not just the administration, but Congress as well?

My hope is that we are not going to lose momentum, and that we're not going to backslide on the focus on the opioid epidemic. We can't. We are losing too many people on a daily basis.