Safety net stakeholders urge a Senate committee to increase funding for community health centers and the National Health Service Corp., saying the programs are critical for providing healthcare in underserved areas.
This article first appeared January 29, 2019 on MedPage Today
WASHINGTON -- The federal government needs to provide more reliable funding for community health centers and the National Health Service Corps, and more money wouldn't hurt either, several witnesses said Tuesday at a Senate Health, Education, Labor, & Pensions (HELP) Committee hearing on healthcare providers in underserved communities.
"We were very grateful that in 2018 Congress generously brought the per-resident allocation back up to a more sustainable level," said John B. Waits, MD, CEO of Cahaba Medical Care, a community health center with 10 sites, based in Centreville, Alabama.
"But the last two reauthorizations were each for 2 years and didn't always provide sufficient certainty for teaching health centers to make binding 3-year commitments for the recruits we were authorized to hire and train ... What a difference it will make if Congress gives us stable funding for 5 years. We can budget more efficiently and keep our doors open."
"I'm here to ask your help in funding this incredibly important program," said Andrea Anderson, MD, director of family medicine at Unity Health Care, a CHC here, and part of the center's graduate medical education faculty. "Without action before October, the NHSC will once again face a funding cliff. ... I ask you to continue expanding funding for the NHSC to ensure that all the current applicants are funded. It's imperative to the health of our nation that we do not miss this opportunity." She noted that under current funding, the NHSC can only fund 10% of its scholarship applicants and less than half of its loan applicants.
Anderson's enthusiasm for the NHSC, which recruits physicians to serve in medically underserved areas, came from her own involvement with it. "I signed my NHSC contract in 1997 and came to Unity in 2004 to fulfill my obligation," she explained. "That's a total of nearly 22 years of NHSC ... By making it possible for physicians like me to serve these populations, NHSC helps [with] workforce shortages and social determinants of health."
The corps includes other providers such as physician assistants, nurse practitioners, and dentists, and serves populations in places such as critical access hospitals, mental health centers, prisons, and rural health clinics -- "places where primary care is needed most," she said, adding that because underrepresented minority students are more likely to serve populations similar to their own cultural background, the corp's presence "is impactful and inspirational to the next generation."
Committee members from both sides of the aisle seemed predisposed to hearing the witnesses' message. "Community health clinics are one way [people] can have affordable healthcare close to home," said committee chairman Sen. Lamar Alexander (R-Tenn.), who recently announced he would not seek re-election in 2020. "We must act by the end of September to make sure clinics receive this funding to keep their doors open."
Alexander said he and Sen. Patty Murray (D-Wash.), the committee's ranking member, are planning to introduce legislation to fund community health centers for 5 years at $4 billion a year; it would also fund the NHSC for 5 years.
Murray said several of the most vulnerable clinics in her state are at risk of closing. "We need to do more to provide stability ... I'm glad Sen. Alexander and I are able to do just that ... Funding these programs for the next 5 years will give health centers greater confidence they can hire the people they need."
Sen. Bill Cassidy, MD (R-La.), asked why, if the average resident at a health center earns $57,000 per year, it costs CHCs $150,000 to employ a resident. "How can I defend that [difference]?" he asked.
Much of the added cost can be attributed to fringe benefits and malpractice insurance, said Waits. "And interns see about three patients a day whereas faculty members see 15 to 20," so that is another cost to the facility.
Sen. Lisa Murkowski (R-Alaska) expressed envy for states with lots of community health centers. "We struggle in Alaska to be able to attract those good folks," she said. "We would like to have them up north and we don't have a medical school [to attract people], and that's not going to happen anytime soon." She asked what she could do to solve the problem.
Waits suggested that one way to recruit would be to set up "teaching health centers" where residents could get primary care training, but said stable funding would be needed. "If we were going to set up a teaching health center in Alaska, we would need to know that if we take 2 to 3 years to get set up as a teaching institution and then start recruiting first, second, or third-year students, we've used up 5 years," he said. "It could be done if there was the stability there."
Guaranteed funding for the NHSC loan repayment program also would help, said Dennis Freeman, PhD, CEO of Cherokee Health Systems, a group of community health centers based in Knoxville, Tennessee. "If [centers] could use NHSC as a recruitment tool, I think it would really help."
The portion of physicians who commit sexual assault is small, but since many of these doctors are repeat-offenders, they can likely abuse many patients, sometimes over the course of several years or decades.
This article first appeared January 24, 2019 on MedPage Today.
By Elizabeth Hlavinka, Staff Writer, MedPage Today
Although the so-called #MeToo movement got its start from allegations against Hollywood mogul Harvey Weinstein in late 2017, victims of sexual abuse -- in the church, in the locker room, in the workplace, and, yes, in the exam room -- had already begun to speak up and demand accountability.
And while media coverage has tended to focus on the individual perpetrators, it's clear that there is more to the problem than just a few "bad apples." In this new MedPage Today series, we explore the background to sexual assault committed by physicians, and look at some of the systems that enable abuse and others that try to prevent it.
Last month, 17 women sued Columbia University and its affiliated hospitals claiming they failed to intervene when Robert Hadden, MD, a former ob/gyn at New York-Presbyterian, sexually assaulted them during office visits.
Dozens of men filed similar suits against Ohio State University last summer, alleging that former wrestling team doctor Richard Strauss, MD, sexually abused them while the administration ignored his misconduct.
Meanwhile, a grand jury is investigating George Tyndall, MD, the longtime campus gynecologist at the University of Southern California, after more than 200 women came forward alleging he assaulted them during their appointments.
All follow the infamous case of Larry Nassar, DO, at Michigan State University, in which over 150 victims testified to being sexually abused by the former U.S.A. Gymnastics team doctor, many of whom had been minors at the time.
The Federation of State Medical Boards categorizes sexual misconduct into two categories. "Sexual impropriety" can include watching a patient undress, examining their genital areas without gloves, or making inappropriate comments.
"Sexual violations" occur when a physician engages in physical sexual contact with the patient (such as kissing, sexual intercourse, or touching any sexualized body part for purposes outside an exam), offers drugs in exchange for sexual acts, masturbates in their presence, or encourages a patient to masturbate.
Tracing a Pattern
A 2017 analysis that examined instances where physicians in the U.S. had sexually abused patients found that all 101 cases involved physicians who were men, nearly all of whom were over the age of 39 (92%), working in private practice (94.1%), and had been born in the U.S. (84.2%), reported James DuBois, PhD, ScD, of Washington University in St. Louis, and colleagues in Sexual Abuse.
Typically, most physicians in these cases (70%) were not board certified -- although three-quarters of those who were remained so while under investigation.
"One of the frustrating things about this is that there are a few things that are correlated with it, but in a sense, none of these are red flags," DuBois told MedPage Today, noting that the majority of physicians might have these same characteristics while never committing any sort of offense.
Abuse typically happened when physicians were alone with the patient (85.1%), and repeated abuse occurred in 96.0% of the cases.
"In terms of environment, this is also very challenging," DuBois said, recalling that in Nassar's case, many victims had their parents present in the room while the abuse occurred.
Using the LexisNexis law database, the researchers examined all cases recorded from 2008 to 2015. The database archives statutes and case judgments, and also provides access to medical board and regulatory documents. Women made up the vast majority of victims in this series (89.1%), in line with the proportion of women in the general population involved in rape cases (90%).
In any situation in which a patient is required to undress or reveal a part of themselves to a physician, it may not be abundantly clear to the patient what is medically relevant for the procedure or exam, and what violates the standard of care, such as during an obstetrician appointment, said Paul Appelbaum, MD, of Columbia University in New York City, who is also a member of the Standing Committee on Ethics of the World Psychiatric Association and a former American Psychiatric Association president.
In cases where physicians are invested in satisfying their sexual impulses, this physical advantage puts them in a position in which they can blur the lines between what is appropriate behavior and what is not, he said.
Fundamentally, it is simple: a patient comes to an exam room because she is worried about her health and she turns to her doctor to provide her with a solution.
"That puts them in a dependent posture to the doctor, which on the patient side may contribute to their difficulty in saying no to a doctor's inappropriate physical advantage," Appelbaum told MedPage Today. "On the doctor side -- for that small minority of the profession that is so inclined -- expecting that dependency and vulnerability may actually encourage them."
Like in most sexual assault cases, it's possible that patients who have been violated will feel guilty that they either encouraged this behavior or allowed it to occur, said Appelbaum, which may inhibit reporting. Additionally, the abuse can lead to a post-traumatic stress disorder (PTSD)-like reaction, in which patients fear, distrust, or avoid the medical profession altogether.
"You may hear accounts of patients who have been through this and then don't go to a doctor again for years and years, or aren't willing to go to a gynecologist for an annual appointment because of the last time they went," Appelbaum said. "Or perhaps they aren't willing to see any physician again because they're concerned that abuse may occur."
"That's a very serious consequence, because potentially we have patient health and lives at stake as a result of the misbehavior," he added.
Under the Radar
In DuBois' study, the abuse more often than not lasted at least 2 years (58%), and nearly all cases involved multiple kinds of professional breaches (88%), suggesting that many incidences of sexual and medical violations went undetected before a physician was disciplined for his or her actions. Rarely was the person who reported the abuse a colleague of the physician or staff member at his practice (7.0%) -- typically the whistleblower in these cases was the patient (69.3%).
Marissa Hoechstetter, the only plaintiff to reveal her name in the Columbia case, began seeing the accused gynecologist in 2009 after a friend, who was Hadden's niece, recommended him.
Hoechstetter said Hadden often made inappropriate remarks -- like asking if she was having trouble with orgasms, or telling her husband that she looked "like a porn star" -- and performed prolonged breast exams without a cover. During their visits, they often talked about Hadden's niece, a detail that later became clear was a "grooming" tactic Hadden used in an attempt to build a false sense of comfort and trust, she said.
Grooming behaviors are common in physician offenders, who may "test the waters" to create an environment of forced intimacy and determine "if his target will protest," according to a landmark 2016 national investigation by Atlanta Journal-Constitution.
This may be one reason victims refrain from coming forward. Patients may also want to avoid bringing serious accusations against their physicians that will get them into trouble, Appelbaum said. But because of the doctor-patient dynamic, some patients might not even know they are being abused, he said.
Hoechstetter was pregnant with twins during most of her visits, and Hadden delivered her girls. It was a few months after they were born, during a post-op visit in stirrups, that Hoechstetter felt Hadden lick her vagina. During this exam, as well as the majority of her experiences with Hadden, there was no chaperone in the room.
Knowing the complications that can arise with twins, Hoechstetter said that during her appointments, she was primarily occupied with finding out how her girls -- who are now 7 years old -- had developed since their last visit. Pregnant and in stirrups for most of the exams, it's possible she physically could not see Hadden perform deviant acts under the premise that they were medically relevant procedures -- a possibility that still haunts her.
"I feel like he took advantage of me in a really vulnerable situation where I was looking for someone who I took to be an expert in a facility I took to be world-class care," she said. "I think he used that to his advantage to get away with this behavior."
The portion of physicians who commit sexual assault is small (the Atlanta Journal-Constitution investigation found 3,100 doctors accused of sexual misconduct since 1999), but since many of these doctors are repeat-offenders, they can likely abuse many patients, sometimes over the course of several years or decades.
As few women report their sexual assaults in general (only 1 in 4 will go to the police), the number of assaults in medicine is likely underestimated.
Even if patients do report their assault, the process can be confusing or inaccessible, and their reports could be filed in a vague or incomplete manner.
According to the study from DuBois' group, due to "rules shrouding disciplinary databases in secrecy," much of the data regarding physicians who commit sexual assault are lacking. This, paired with the longevity of most cases, also suggests that if disciplinary actions were taken toward physicians who abused patients, they did not always prevent them from continuing to practice.
In Hadden's, Tyndall's, Strauss's, and Nassar's cases, reports of abuse were traced back to the 1990s.
Part 2 of this series will explore the role of large institutions and how their reactions to physician sexual assault may contribute to a culture of silence.
At a time when physician burnout is reaching critical proportions, clinicians are attempting to rebuild connections with patients and each other and strike a work-life balance.
This article first appeared January 23, 2019 on MedPage Today.
By Nicole Lou
The need to boost productivity numbers and take care of administrative matters leaves physicians no strangers to a lonesome, ever-digitizing work environment. Yet several clinicians are taking action to reclaim their connections with patients, and each other, in a time of increasing burnout and dissatisfaction with their work-life balance.
"Thanks to expanding digitization, we no longer need to engage our colleagues in the laboratory or radiology suite while on rounds or to discuss recommendations with a consultant: we can see the information we need right on our own computer screen. In the clinic, we can choose to type while taking a patient's history, rather than making eye contact," according to Richard Wenzel, MD, an infectious disease expert at Virginia Commonwealth University Health in Richmond.
"We're saving time. Yet when a patient becomes an RVU [relative value unit] statistic, when professional dissatisfaction is evident, empathy suffers and patients too are left dissatisfied," he wrote in a perspective in the New England Journal of Medicine.
Those are not the only problems with the RVU model -- it "drives competitiveness between physicians, not a sense of camaraderie. There is even competition among partners when deciding who will do cases," cardiologist Cindy Grines, MD, of Northwell Health in Hempstead, New York, told MedPage Today. "Hospitals say they want to help with physician satisfaction and burnout, but at the same time the message is to produce more. You just can't win!"
Social media and other virtual support tools can help recreate some of the early-career camaraderie felt in the residents' lounge, according to Ameya Kulkarni, MD, an interventional cardiologist at the Mid-Atlantic Permanente Medical Group in McLean, Virginia, in a separate NEJM article.
Yet it appears there is no substitution for face-to-face encounters, as Wenzel recalled how he lobbied his institution for a faculty dining room and retreat center, which subsequently had success hosting pre-rounding sessions by consulting teams in an open area.
"The resulting informal cross-talk among team members was facilitated by greater familiarity. Sustained engagement in such a retreat center between senior administrators and physicians might unexpectedly boost institutional creativity and simultaneously invigorate professional life," he suggested.
"We started by creating opportunities for doctors to spend time together outside work engaging in non-work-related activities," he wrote. "By spanning a range from sporting events to happy hours to activity-based events (musical jam sessions, golf outings, art classes, cooking sessions with local celebrity chefs, and subsidized playgroups for young families), we've tried to find a way to reach everyone."
Another program at Kulkarni's institution is the Pebbles Project, a structured discussion group for physicians interested in fixing the small operational problems they face every day.
Similarly, C. Michael Valentine, MD, president of the American College of Cardiology (ACC), noted a recent activity in which physicians in his group rotated around six stations giving ideas to improve practice and their lives.
"There are many studies that show that clinician wellness is directly linked to engagement in the process of process improvement. So we want our physicians to be better engaged and to be well-versed in the problems of burn-out and loneliness and dissatisfaction in practice," said Valentine, of Centra Medical Group's Stroobants Cardiovascular Center of in Lynchburg, Virginia, in a phone interview.
He said that physician loneliness is a topic that his center takes very seriously, as does the ACC. Centra is looking to hire a director of clinician wellness, while the ACC has made clinician wellness "a big part of our next strategic plan."
For their part, clinicians at Centra are generally ready and willing to have a hand in their own wellness, Valentine stated. In fall 2018, 150 signed up for a wellness retreat organized by a wellness committee. Global engagement programming, in which doctors travel as a group to areas like Vietnam and Tanzania, is also helping with their loneliness, according to him.
Some of these social programs may work better for certain fields and not others, however.
"Although our hospital has a physician lounge, it is very spartan and not conducive to meeting and developing relationships," Grines said. An afternoon tea may be more successful at getting doctors together, she suggested, adding that subsidized child care and play groups could be "wonderful."
"But will the hospitals pay for this? I find that physician benefits, administrative support, conference funds, department parties, etc. are being cut year after year," according to Grines.
Perhaps cardiology has a unique competitive and male-dominated atmosphere that isn't conducive to friendships in the first place.
"I have organized a few events (dinners, yoga) for our female cardiologists, and some female physicians attend, and others don't even respond to the invitation. Perhaps they are too busy with their job and life, or perhaps in this man's world, they are fearful to identify with a group of professional women," Grines said.
At the end of the day, she added, a friendly person who hangs out around the cath lab may be seen as lazy -- or worse yet, a spy, or a competitor "trying to steal cases."
The commission found that spending on ACO beneficiaries was about 1.2% below the benchmarks set in 2017, but they questioned the way patients are assigned to an ACO, and costs associated with membership changes.
This article first appeared January 21, 2019 on MedPage Today.
Medicare's accountable care organizations are helping the program save money, but they need some tweaking, members of the Medicare Payment Assessment Commission said.
"I was actually pleased with the results, given the short time period ACOs have been in existence," commission member Warner Thomas, of Ochsner Health System in New Orleans, said at a commission meeting here Friday. "I hope people feel like we're heading in the right direction."
The commissioners heard a report from MedPAC staff about a specific type of ACO within Medicare, known as the Medicare Shared Savings Program. Under that program, ACOs that achieve a cost of care below a defined benchmark are able to reap a share of the savings.
The commission staff found that spending on ACO beneficiaries was about 1.2% below the benchmarks set in 2017; shared savings payments amounted to about 0.8% of benchmarks. The staff also compared the growth in spending for beneficiaries assigned to ACOs to spending growth for other Medicare beneficiaries, and found gross savings of 1.1% to 1.2% of Medicare spending from 2013 to 2015, after adjustments in spending for changes in risk scores.
However, the staff also uncovered some differences among ACO patients. For one thing, beneficiaries who either switched into or switched out of an ACO ended up costing Medicare more money. Beneficiaries who switched ACOs in 2013, 2014, or 2015 had 1.2% higher spending growth compared with the average in the Medicare marketplace, while those first assigned to a newly formed ACO in 2016 had spending growth that was 2.1% higher. And those who were assigned to an existing ACO in 2016 had 16% higher spending growth.
In addition, while beneficiaries assigned to the same ACO from 2013 to 2016 had spending growth rates 10% below the average in the market, those who stayed in the same ACO from 2013 to 2015 but left in 2016 had spending growth rates 13.8% higher than average, noted Jeff Stensland, PhD, a principal policy analyst at MedPAC.
"These beneficiaries had the benefit of care coordination the ACO provided [those first 3 years], but something happened in 2016: most likely they changed physicians they saw, possibly due to a change in health status," said Stensland. "This tells us there's an association between changes in assignment and changes in spending. For example, a beneficiary may fall ill and start to use a new set of physicians."
Another thing complicating the study results is the way the patients were assigned to the ACO. Patients are generally assigned to an ACO if they have gotten primary care services from a physician in that ACO, although if they don't have a lot of primary care services initially, they can be assigned based on having had a service from a specialty physician in the organization. The question then becomes when the patients are considered members of the ACO.
Some patients are "retrospectively" assigned -- that is, the ACO is held responsible for the patient's health costs in the same year they join the ACO, but the ACO doesn't find out that the patient was assigned to them until the end of that year -- while others are "prospectively" assigned, in which case the ACO is responsible for spending on the patient in the year after they are assigned to the ACO. The prospective assignment method has several benefits, since the ACO physician will have seen the patient already and the ACO will know at the beginning of each year which patients they're responsible for.
Commission member Brian DeBusk, of DeRoyal Industries in Powell, Tennessee, said that retrospective attribution seemed to be "one of the serious flaws" with the ACO program. "It seems like prospective attribution solves a lot of those problems," he said.
Commissioner Dana Gelb Safran, of BlueCross BlueShield of Massachusetts, said her organization uses a "concurrent assignment" method for its own ACOs. "[The ACO] knows all through the year who [the plan] thinks is attributed to them, but at the end of the year we 'settle up' on who is manifest as their patient, because of all the switching that happens," she said.
Commissioner Bruce Pyenson, of Milliman in New York City, expressed some reservations about ACOs. "This work identifies one of the prevailing myths of population health that many hoped would be realized with the ACO movement -- that if somehow we engaged physicians and patients better and got them into the system consistently, we'd be able to bring magic of better care to them and they'd be healthier and less expensive," he said.
"We often attempt to blame the patient -- if patients were only more compliant, or only indentured servants and didn't move around, but the reality is that it is not the patient who decides on unnecessary surgery and admissions, and excessive stay in a [skilled nursing facility] and that sort of thing," he continued. "We're up against a failure to take the kind of steps [effective in the short term] at saving money."
But Pyenson explained that incentives are not aligned to make that happen. "Hence we're in this awkward situation of a program that seemed so promising but is disappointing," he said. "There is a potential for things to change here -- the ability to direct care more strongly, I think, would be a very important tool to get at underlying potential savings in the short term."
DeBusk suggested that Medicare may have to do more to engage beneficiaries in the ACO process, perhaps a surcharge for people who insist on "unmanaged care."
"At some point, we have to recognize that people who insist in not participating in any of the choices in front of them are costing the system money," he said.
Drugmakers aren't just going to walk away from Medicare, he says.
This article first appeared January 15, 2019 on Medpage Today.
By Joyce Frieden
WASHINGTON -- Health and Human Services (HHS) Secretary Alex Azar delivered a spirited defense Tuesday on the Trump administration's plan to change the way drugs are paid for under Medicare Part B.
"Pharma has gotten some stakeholders to claim that this plan will cause drug companies to not offer their drugs for sale in Medicare," Azar said at a briefing here sponsored by the Council for Affordable Health Coverage. "Are we seriously to believe that a drug company will walk away from earning a 26% premium from the world's largest payer to earn less from a European country?"
Under the administration's proposal, known as the International Pricing Index (IPI) model, "Medicare would receive a share of the discounts that drug companies currently give other countries," Azar explained. "The IPI model aims to cut the cost of the most expensive drugs in Medicare Part B by 30%."
"That means going from paying 80% more than what other wealthy countries pay for these drugs to 26% more," he continued. "Our target price, in other words, will still pay manufacturers more on average than they make in any other country on earth. As a wealthy country, we'll still be paying more than other wealthy countries -- just not offensively more."
Azar explained that the price reduction will be phased in over a 5-year period. "In the first year, 20% of the price will be determined by our international target, and 80% by the current Medicare pricing system. The following year, it will be 40% target price, 60% the current system, and so forth. This gives drug companies time to adjust. In other countries, manufacturers will have time to negotiate a price more in line with what Americans pay."
In situations where drugmakers can't negotiate a higher price abroad in order to raise the price they get from Medicare, "they may have to continue giving cheaper prices overseas and take a cut in Medicare reimbursement," he said. "The ultimate results here will be driven by forces in the drug market and decisions drug companies make in response to them. Their fate is in their hands."
Azar took issue with critics who claimed that pharmaceutical manufacturers don't have a choice in what they charge other countries. "This is belied by the fact that companies do sometimes decline to sell to countries because the price offered is too low," he said. "They don't launch their drug there, or they delay its launch."
He also pointed to a drop in the number of price increases that drugmakers implemented in the wake of the administration's announcement of its blueprint for lowering drug prices. "From the release of the President's drug pricing blueprint last May through the end of 2018, drug companies took 57% fewer price increases on brand drugs compared with the same period in 2017," said Azar. "Some companies, such as Amgen, Merck, and Gilead, have cut the list price on certain drugs, and early data suggests that the 2019 price increases have been smaller and fewer in number than we saw in 2018."
But they still have a long way to go, he added. "In fact, some manufacturers are still in denial about whether bringing down list prices is even an important goal. They claim that these skyrocketing prices don't matter. But these prices do matter to patients, and our programs, in a number of important ways," since patients' deductibles reset every year and they must pay the list price until they finish up their deductible. "This can mean thousands of dollars in drug costs for the 47% of Americans in high deductible health plans."
Azar said HHS was willing to work with anyone -- including both Democrats and Republicans -- who had ideas on how to lower prices. "We are open to any ideas that preserve drug safety and keep the patient at the center. Nothing that meets that standard is off the table until prices come down. That is an invitation to all of you: We know you have ideas, and many of you have brought them to us. A number of you have already been valuable allies in this fight. So continue to engage with us."
Out of nearly 400 comments spanning 3,700 pages, many commenters suggested adding an exception to the law for APMs while others wanted to add provisions that would allow for more use of coordinated care.
This article first appeared December 10, 2018 on Medpage Today.
By Joyce Frieden
WASHINGTON -- Getting an exception for value-based payment arrangements put into the Stark self-referral law is one of the most important issues to providers in implementing these new systems, experts said here.
The 1989 law, named after former congressman Fortney H. "Pete" Stark (D-Calif.), "prohibits a physician from making referrals for certain designated health services payable by Medicare to an entity with which he or she (or an immediate family member) has a financial relationship (ownership, investment, or compensation), unless an exception applies," the Centers for Medicare & Medicaid (CMS) notes on its website.
Designated health services include clinical lab services, physical therapy, occupational therapy, radiology, durable medical equipment, home health services, outpatient prescription drugs, and inpatient and outpatient hospital services.
In July, CMS administrator Seema Verma said that her agency hoped to issue a proposed regulation by the end of the year to loosen the Stark rule. "One of the barriers around [promoting] value-based care is burdensome regulations, and that's where Stark comes into it," Verma said at a briefing sponsored by the Alliance for Health Policy and APCO Worldwide, a public relations firm here. "We are going to do something on Stark -- I'm very certain about that -- and we hope to have something out by the end of the year."
In September, witnesses at a House hearing testified that the law was getting in the way of forming accountable care organizations and other alternative payment models (APMs).
CMS issued a request for information, asking stakeholders to send suggestions for how the law should be changed. Out of nearly 400 comments spanning 3,700 pages, many commenters suggested adding an exception to the law for APMs while others wanted to add provisions to the current exceptions that would allow for more use of coordinated care, Chip Hutzler, JD, a partner at HealthCare Appraisals of Boca Raton, Florida, a firm that appraises the value of provider payment arrangements, said Monday at a meeting for the American Bar Association health law section.
"It's very hard to fit APMs into existing exceptions easily," Hutzler said. "In some cases, they're also asking to modify existing exceptions, but they recognize that's sometimes harder to get [to], when you've got existing exceptions [that are] statutory... They may be difficult to modify." Most of the suggestions "had the same tenor of [saying that] if it's a value-based arrangement involving risk-sharing of some kind, and involving payment for quality, efficiency, and cost savings... and involving physicians and maybe designated health service entities together, collaborating, they want to fit that into some sort of new exception."
One problem with trying to improve the Stark is that "you've got a conflicting set of regulatory priorities out there," he continued. "On the one hand, Stark tries very hard to isolate treatment decisions, medical decisions from financial considerations. But all the value-based initiatives we've been talking about over the last decade -- SSP [Shared Savings Plans], MACRA [the Medicare and CHIP Reauthorization Act physician payment provisions], CJR [the Comprehensive Care for Joint Replacement payment model] -- those all try to integrate financial considerations with treatment decisions, and those two concepts conflict. So you can't have it both ways with certain things you do... That's the problem you face with the Stark law; it's not set up to handle all these value-based initiatives very well."
Other comments focused on the issue of determining "fair market value" when making compensation arrangements for healthcare providers, including the volume and value of referrals. "Does the method of compensation impact the fair market value? I think it does in some cases," said Hutzler. "Some compensation situations are riskier than others and may warrant additional pay as a result of that... It's hard to de-couple entirely volume and value from fair market value, but we can certainly try."
There were also a lot of comments on the definition of group practice, which is part of another exception in the Stark law. "This is a major area where [practices] can get additional money... So people often want to change the group practice definition -- because it's very hard to meet -- so more groups could fit into it," said Hutzler. "So there were a lot of comments around the group practice definition."
After requesting these comments, "will CMS do anything?" Hutzler said. "I expect they will... but no guarantee on that... The timing on this is the most uncertain element of it." Matthew Edgar, a technical adviser to CMS on the issue who also spoke at the event, was circumspect on the issue. "Unfortunately there's nothing I can say about that, but we did request comments and those were not just for personal edification."
The commission also discussed a new path to turn mid-level providers into full-fledged physicians.
This article first appeared December 06, 2018 on Medpage Today.
By Shannon Firth
WASHINGTON -- What's known as "incident to" billing for nurse practitioners and physician assistants in Medicare could vanish if the government adopts a recommendation currently before the the Medicare Payment Advisory Commission (MedPAC).
At a meeting Thursday, the panel explored the pluses and minuses of scrapping this type of billing, under which mid-level providers bill services as "incident to" physician services using the physician's national provider identifier (NPI). If the recommendation is adopted, NPs and PAs would bill directly to Medicare for their services.
Currently, when NPs and PAs bill directly under their own NPIs, they're paid 85% of the fee schedule amount, whereas services billed "incident to" are paid at 100%. NPs and PAs may not bill "incident to" when working in a hospital with a new patient, or for a new problem with an existing patient, MedPAC technical staff explained.
Currently, Medicare claims don't require documentation of whether a service is billed "incident to" even though a "substantial share" of services are being billed that way, MedPAC's technical staff said.
In a draft recommendation for the Secretary of Health and Human Services, the commission would suggest that Congress require all advanced practice nurses and PAs to bill Medicare directly.
Staff told commission members that the "incident to" pathway has a number of flaws including clouding policymakers' understanding of who's providing care, preventing "an accurate valuation" of fee schedule services, and increasing Medicare and beneficiary spending.
They also noted a trend towards more PAs and NPs moving away from primary care towards specialties such as dermatology and orthopedics. Estimates suggest about half of NPs practice in primary care, as do about 27% of PAs. However, data in this area are limited, staff said.
The lack of solid information limits Medicare's ability to channel resources towards those areas that need it most, such as primary care.
Eliminating "incident to" billing would incur "modest savings" for the Medicare program, and beneficiaries costs would also be reduced, while staff did not expect any changes in access to care. Some NPs and PAs would see a slight decline in payment, staff added.
Allowed charges for NPs grew 17% annually from 2010 to 2017, from $1.2 billion to $3.8 billion, according to staff. Similarly PAs allowed charges grew an average 14% per year, from $0.9 billion to $2.2. billion. Numbers of NPs and PAs billing Medicare also grew, by 14% and 10%, respectively, per year from 2010 to 2017.
However, these figures may be underestimates because they don't include "incident to" billing charges, the staff explained.
Eliminating "incident to" billing is "long overdue" and "excellent policy," said commission member Brian DeBusk, PhD, of DeRoyal Industries in Powell, Tennessee, not only for clinical reasons but also to maintain data integrity.
Commissioner Susan Thompson, RN, of Unity Point Health, in Des Moines, Iowa, also supported the move to direct billing as a way of making the "front-line primary care" NPs and PAs provide more transparent.
Jaewon Ryu, MD, JD, noted it would be important, particularly in hospital systems and multi-specialty groups, to explore where NPs and PAs might choose to migrate as a result of the recommendation, or in what settings advanced practitioners could be allocated.
The recommendation "may have unintended consequences on primary care areas of those systems," Ryu said.
In addition to support for moving to direct billing, the group also saw near-unanimous agreement on two other recommendations: to refine Medicare's specialty designation of APRNs and PAs; and to maintain the physician payment update in current law for 2020, which is for no increase.
The commission will vote on all three recommendations in January.
'Degree Completion' for NPs, PAs?
DeBusk also floated a novel suggestion that prompted extensive discussion: creation of a streamlined "degree completion" path, as he called it, for NPs and PAs to become licensed physicians.
Not everyone was on board with that.
"[T]here's a lot in medical care that people that are trained less extensively than physicians can productively do," countered fellow commission member Paul Ginsburg, PhD, of the Brookings Institution.
"To take this and say, 'Well, we just want it to be a path to becoming a physician, by a way other than going to medical school,' seems to defeat the entire purpose of these physician extender categories," Ginsburg continued.
Commissioner Dana Gelb Safran, ScD agreed, noting that not all care requires a physician.
Given the emerging understanding of the importance of social determinants of health and the literature that shows physician training is "poorly adapted" to making use of this new evidence, Gelb Safran said she questioned the need to funnel more clinicians onto the physician track.
"I just think we need to give thought to how we are actually going to produce more health in the population and what's the workforce we need for that, as opposed to how are we going to produce more healthcare services," she said.
DeBusk said he wouldn't recommend that all NPs or PAs complete such programs but expressed frustration that mid-level providers who've demonstrated their skill and want to become physicians must "start over from scratch."
While she supported the concept of "degree completion," Marjorie Ginsburg, BSN, said she was surprised that there isn't already such a pathway and also took issue with the terminology.
"To make this in any way appear that they are physicians that somehow haven't yet happened is really a mistake."
DeBusk later apologized for using the term "degree completion," calling it "tone deaf."
The 2008 decision to mandate large-scale clinical cardiovascular trials transformed the treatment of diabetes for millions of people in an incredibly positive way. But there's an unexpected twist.
This article first appeared December 05, 2018 on Medpage Today.
By Milton Packer MD
For the past 100 years, diabetes has been regarded primarily as a disorder of blood glucose. And for much of the past 40 years, physicians believed that antidiabetic drugs should be prioritized by their ability to lower blood glucose towards normal levels.
This conceptual model made sense for type 1 diabetes and even for certain patients with type 2 diabetes (many young and middle-age adults). In these individuals, hyperglycemia was believed to cause so-called microvascular injuries in the eyes, kidneys, and nerves. Meticulous control of blood glucose -- for 10 years or more -- could reduce the occurrence of these events.
But, microvascular disease was not the major concern for most patients with diabetes in the community. Most middle-age to elderly patients with type 2 diabetes were not at near-term risk of microvascular events. But, they were at exceptionally high risk for major life-threatening cardiovascular events -- specifically, cardiovascular death, myocardial infarction, stroke, and heart failure. These events were not only clinically devastating, but these patients were at risk of experiencing these events early after being given the diagnosis of diabetes, long before they were likely to develop microvascular disease.
The problem: Physicians had no evidence that these major cardiovascular events could be prevented by efforts to control blood glucose.
For decades, physicians prescribed drugs to treat diabetes without knowing that they were any good for preventing the types of problems that really mattered. The FDA approved new drugs for the treatment of diabetes based merely on their ability to lower blood glucose.
It was a mess. And, it was embarrassing.
Why didn't the pharmaceutical industry carry out the clinical trials to find out the true effect of their drugs on heart attacks, strokes, heart failures, and death? Such trials typically require thousands of patients (5,000-15,000) who are treated for 3-6 years. The cost of each trial: $200-$400 million. Drug companies claimed that such trials were burdensome and unnecessary. To make matters worse, experts in diabetes agreed with them.
But, the world changed in 2007-2008. An analysis in the New England Journal of Medicine reported that one glucose-lowering drug -- rosiglitazone (Avandia) -- appeared to be associated with an increased risk of cardiovascular death and myocardial infarction.
Given the possibility of cardiovascular harm, the FDA felt compelled to respond with a change in policy. In 2008, the agency started to require all pharmaceutical companies that wanted to market a new antidiabetic drug to perform large-scale trials to specifically assess the effect of each new drug on the risk of cardiovascular death, heart attacks, and stroke, over a period of 2-5 years. These trials would ensure that each new drug did not increase cardiovascular risk.
From 2008 to the present, more than 100,000 patients with diabetes were enrolled in nearly 20 large-scale, long-term trials that were specifically designed to evaluate the effects of new antidiabetic drugs on major cardiovascular events. And, because of their substantial costs, drug companies really resented the requirement to do them.
How many of these large-scale trials found that a new antidiabetic drug actually increased the risk of cardiovascular death, myocardial infarction, and stroke? Zero. No trial actually confirmed the original fears of cardiovascular harm that had generated the change in FDA policy in 2008.
But, the trials yielded dramatically informative results. Some drugs that lowered blood glucose actually prevented the occurrence of cardiovascular death, heart attacks, stroke, and heart failure. But just as importantly, the trials also showed that some glucose-lowering drugs had no benefits on cardiovascular events at all, and that some actually increased the risk of heart failure. Sadly, the glucose-lowering drugs with the fewest benefits of the heart and kidneys were the ones most often prescribed by physicians. (I wrote about this in the American Journal of Medicine in July.)
The main point: The difference between the drugs with and without cardiovascular benefits had absolutely nothing to do with their effects on blood glucose. Some drugs exerted additional effects to protect the kidneys in ways that were also unrelated to the magnitude of changes in blood glucose. But, it was not possible to predict the effects of a new drug class in advance -- without doing the large-scale cardiovascular trials.
These results were extraordinarily important. The combined evidence indicated that physicians treating patients with type 2 diabetes needed to make different choices. Drugs that had cardiovascular benefits needed to be considered first -- because heart attacks, strokes, and heart failures were life-threatening and because they occurred early. If these drugs were insufficient to control blood glucose, more conventional and popular antidiabetic drugs could be added later.
As a result, physicians have now adopted a completely different approach to treating diabetes. During this past month, this new approach has been embraced by diabetologists and cardiologists, both in the U.S. and in Europe.
The bottom line: the 2008 FDA decision to mandate large-scale clinical cardiovascular trials transformed the treatment of diabetes for millions of people in an incredibly positive way.
It is a great story -- but the story has an unexpected twist.
The concern about cardiovascular risk raised in the original 2007 NEJM report proved to be unfounded. The original paper suggested that rosiglitazone caused heart attacks, but rosiglitazone does not cause heart attacks. A re-evaluation of the evidence by the FDA at a public hearing in June 2013 concluded that there was no scientific basis for the original concern.
In short, the 2008 FDA policy was based on an error.
But what a wonderful mistake! An error in 2008 led to an FDA policy that forced drug companies to do trials that they had been previously unwilling to do. The trials were desperately needed. A policy based on an error made them happen.
Some who work at the FDA may feel badly about having made an error back in 2008. But I think that the FDA should be congratulated.
In truth, for 50 years, the FDA had actually made a series of enormous mistakes in allowing new drugs for diabetes to come to market without knowing their true cardiovascular effects. An inadvertent misinterpretation of data at the FDA in 2008 led to a much-needed new policy that corrected decades of ignorance.
Yet, last week, at the annual meeting of the Cardiovascular Clinical Trialists Forum in Washington, D.C., some pharmaceutical companies argued that the FDA should go back to the way things were 10 years ago. Claiming (correctly) that the 2008 policy was based on a mistake; they proposed that the policy should be reversed. They want new drugs for diabetes to be approved based solely on changes in blood glucose, without ever finding out what their true cardiovascular effects might be.
My response to them: No way. We're not going back.
It is horrific to even suggest that physicians should prescribe new drugs for diabetes without knowing about their long-term cardiovascular effects. The 2008 policy may have been based on a mistake. But the earlier policy of approving drugs based solely on blood glucose was also erroneous -- and it was dangerous.
Let's be clear about the facts. A successful drug for type 2 diabetes has the potential to earn more than $50 billion over its patent life. Drug companies have no justification for claiming that it is burdensome and unnecessary to spend 0.5% of that total to carry out a trial that shows what their drugs really do to patients.
If you care about patients with diabetes, let your voice be heard -- now. Tell the FDA that it should keep its current policy about cardiovascular trials for new antidiabetic drugs in force.
Drug shortages cause higher rates of medication errors, delayed treatment of life-saving medications and inferior outcomes, and even death.
This article first appeared November 28, 2018 on Medpage Today.
By Shannon Firth
WASHINGTON -- With drug shortages endangering patients, frustrating providers, and costing hospitals millions each year, stakeholders debated strategies to fix the problem during a day-long meeting hosted by the FDA and the Duke Margolis Center for Health Policy.
In late 2017, the FDA listed 39 new drug and biologic shortages and 41 continuing shortages, and noted briefing documents from Duke. While that was an improvement from the peak shortage years of 2011-2013, many of the drugs that remain in short supply are essential to care. Most are older generic drugs, and many are injectables rather than oral medications, said panelists.
Impact on Patient Care
"We've been in continuous drug shortage mode for over 10 years now," said Ritu Sahni MD, MPH, an advocate for the National Association of EMS Physicians and an audience participant.
Sanhi described shortages of injectable opioids, injectable anti-emetics, and cardiac arrest medications, and called for tracking, monitoring, and categorizing emergency medications uniquely.
"When those are unavailable to my crew in the back of an ambulance driving 30 miles an hour or 60 miles an hour, there's no other choice," he said. "This is life-threatening and immediate stuff."
Another audience participant said that even simple products that have been under shortage like "normal saline" can save lives. Other medications like magnesium sulfate, and drugs used for hypertensive crises have also been in short supply.
"It's becoming increasingly difficult to provide appropriate care and safe care," said Jessica Hardesty, MD, an obstetrician.
Drug shortages cause higher rates of medication errors, delayed treatment of life-saving medications and inferior outcomes, and even death, said Yoram Unguru, MD, a pediatric hematologist/oncologist at the Herman and Walter Samuelson Children's Hospital at Sinai in Baltimore.
In addition, substituting an alternative drug for standard of care can have consequences, said Unguru, a meeting panelist.
In 2009, during a shortage of mechlorethamine, which is used to treat patients with Hodgkins lymphoma, cyclophosphamide was used as a substitute in 40 teenagers. He said that their event-free survival rate was 12.5% lower than expected with the usual agent.
While there weren't any deaths in the group given the alternative treatment, those adolescents did experience "more rounds of toxic therapy" such as stem cell transplants, for which long-term effects are still uncertain, Unguru said. (A 2012 article in The New England Journal of Medicinereviewed the mechlorethamine shortage.)
Drug shortages can also lead to medication errors, noted panelists.
In a recent survey from the Institute for Safe Medication Practices (ISMP), 21% of the 300 respondents (which include pharmacy directors, pharmacy managers, pharmacy purchasing agents, pharmacy technicians, and medication safety officers) said that they knew of "at least one medication error related to a drug shortage" that happened in the 6 months preceding the survey. In written descriptions, the most common related to the wrong dose or wrong concentration of medicine.
Root Causes
In order to craft solutions to these problems, stakeholders first explored their causes.
Blair Childs, senior vice president of public affairs for healthcare consulting firm, Premier Inc., cited four common ones.
A drug shortage may be triggered when one manufacturer dramatically drops its market price -- often for "high-demand products" -- to secure market share, thereby driving other producers out. The manufacturer will then often leverage "barriers to entry" to the market to rebuild its profit margin. (In some instances, the manufacturers undercutting the market may be overseas, he noted.)
A second cause of shortages involves Drug Efficacy Study Implementation (DESI) drugs, the approximately 3,000 older drugs that lack the same safety and efficacy research as products introduced after 1962 legislation began requiring such evidence.
To encourage manufacturers to complete these studies, FDA policy forces all other companies to leave the market once one company has submitted an NDA. Prices for these products are often very low and can increase dramatically once a single manufacturer gains the monopoly, Childs said.
Another well-known reason for shortages include production issues that dry up supplies. Disruptions to the active pharmaceutical ingredient (API) suppliers, such as an impurity that leads to a recall of a product, can also lead to a product shortage. Changes in API requirements can have the same effect. For instance, a change to the monograph for potassium chloride led to a shortage.
One other situation that can create a drug shortage is the "grey market", wherein industry players buy large quantities of a product for resale to hospitals at jacked-up prices.
Prices on the grey market for some products have increased 300%-1600%, Childs said.
Finding Solutions
A consortium of hospitals along with the Department of Veterans Affairs set up CivicaRx earlier this year, with the specific mission to produce low-price generic drugs that are in high demand.
Martin VanTrieste, PharmD, the venture's president and CEO, said he believes that all drug shortages have economic causes at their core, and suggested that competition and sustainable, fair prices are key to resolving the problem.
Manufacturers also need to build redundancy into their supply chain instead of using a single source. One of the reasons for the medication shortages caused by Hurricane Maria was this lack of redundancy, he said.
Finally, VanTrieste said that greater transparency is needed. He's called on the FDA countless times to force drug sellers to make their suppliers' identities and locations public, without success. CivicaRx, however, is entirely transparent about its manufacturing processes, he said.
Rena Conti, PhD, associate research director for the Biopharma and Public Policy at the Institute for Health System Innovation and Policy at Boston University, seconded the need for more transparency.
"There must be reasons why there's so much asymmetric information," Conti said, noting that many of the answers related to drug shortages could be found in contracts which are now "shielded" from public view.
Price is also a driver, she said: "Maybe the pricing signal doesn't work here."
Policies that dampen the pricing signal, such as bundled payments or consumer price index penalties -- wherein generic manufacturers are forced to pay rebates when the average manufacturer price outpaces inflation -- may discourage participation. She wondered aloud whether loosening such constraints might draw more suppliers to the market.
Because the supply of both the base ingredient and the fill-and-finish products is so constrained, and the number of willing industry players are few, she suggested thinking "really outside the box" for potential suppliers, considering both importation as well as unconventional possibilities, such as universities or the Department of Defense. The latter may want to produce drugs for national security reasons, she said.
Erin Fox, PharmD, a University of Utah College of Pharmacy faculty member who has studied the issue, told MedPage Today that importation is only useful as a "last resort.
Imported drugs, in her experience, are often priced higher, and can end up sitting on the shelf unused, because they lack the proper bar codes and labels to be easily scanned into systems.
Speaking on the panel, Fox stressed the need to think of APIs as part of national security. "If we let other countries control our [APIs], we may be at risk."
As for price, Fox noted that because of how diagnosis-related group (DRG) payments work, hospitals already under cost pressures often aren't paid for products such as saline or anti-emetics.
Fox suggested that it's worth rethinking DRG payments and perhaps considering a different reimbursement model.
After burning for more than a week, the fire elevated air pollution levels in San Francisco and surrounding areas to the point where the region reportedly has the poorest air quality on the planet.
This article first appeared November 18, 2018 on Medpage Today.
By Salynn Boyles
SEATTLE -- The short- and long-term health impact of environmental events, such as the Camp Fire in California, on large populations are not well understood, according to experts at the American College of Allergy, Asthma, and Immunology (ACAAI) annual scientific meeting.
The Camp Fire, which was still burning across more than 200 miles of Northern California on Sunday, ranked among one of the worst natural disasters in the U.S. this century, with the death toll continuing the climb and close to 1,300 people still counted among the missing.
After burning for more than a week, the fire elevated air pollution levels in San Francisco and surrounding areas to the point where the region reportedly has the poorest air quality on the planet.
Most outdoor events in San Francisco (about 180 miles from the fire zone) on Saturday were cancelled or postponed, including the game between football rivals Stanford University and the University of California Berkeley. San Francisco officials also took the city's iconic open-air cable cars out of commission due to the poor air quality.
David Peden, MD, of the University of North Carolina Gillings School of Global Public Health in Chapel Hill, spoke about the Camp Fire at an ACAAI session on the impact of the environment on allergic disease.
"At these levels, any outdoor activity is dangerous for people with chronic diseases like COPD [chronic obstructive pulmonary disease] or heart disease," Peden said. "Everyone understands the allergy risk, and the risk for other airway diseases. But there is a clear signal of inflammation in cardiac disease and breathing pollution triggers inflammation."
Peden, who studies the roll of air pollution in airway and cardiovascular disease, noted that while California has seen wildfires of increasing frequency and intensity, other regions of the country are also increasingly vulnerable as drought conditions intensify. These areas include eastern Montana, western portions of the Dakotas, and large parts of the Mexican border.
Peden, along with ACAAI attendee Katherine Gundling, MD, of the University of California San Francisco, told MedPage Today that current air quality in San Francisco -- reported to be in the very unhealthy PM2.5 range of 201-300 on Saturday -- compared unfavorably to some of the most polluted areas of China and India, which have average air quality PM2.5 in the range of 100-150.
Peden stated that during the 2013 California Rim Fire, daily air pollution exposure levels among people in urban areas affected by the fire were up to 35 times greater than the 24-hour PM2.5 standard (35μg/m3) considered safe by the Environmental Protection Agency (EPA).
Gundling agreed that it will take time to understand the short- and long-term health impact of events like the Camp Fire.
"There is simply no precedent for this," she told MedPage Today. "We are used to wildfires, but not fires that kill large numbers of people who have no chance of escape. That is the new and horrible reality we are living."
She added that the increasing frequency and intensity of the California fires should serve as a wake-up call for the country.
"These fires are different," she said. "It's not just that there are more of them and that they are more severe. It's a number of factors. It's climate change. It's forest management. All of this has to be addressed."
Forecasts were for air quality to remain in the unhealthy 100-200 range through Tuesday in San Francisco, the East Bay, and other parts of the Bay area. Rain bringing wind is expected in the area on Tuesday.
Public health officials advised residents to stay indoors whenever possible and wear N95 masks when outdoors. Some city governments and independent organizations are distributing face masks.