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Payer-Provider Divide Delays Care for IBD Patients

Health care providers have long been at odds with coverage policies and practices of health insurers in the U.S., but these rifts are becoming more adversarial with the growing momentum toward value-based care models. According to The New England Journal of Medicine Catalyst Insights Council, more than three-quarters of surveyed executives, clinical leaders and clinicians feel payers are not aligned with providers in their efforts to improve value in health care delivery, and many accused payers of being overly focused on cutting costs.

This discord is especially frustrating for physicians who treat patients with chronic diseases like inflammatory bowel disease. IBD care providers told Healio Gastroenterology and Liver Disease they must spend an unreasonable amount of time and resources advocating on behalf of their patients due to short-sighted coverage policies and cumbersome appeals processes that can result in dangerous delays in effective therapy.

“The short-term focus is really the problem,” Peter D.R. Higgins, MD, PhD, of University of Michigan Internal Medicine, said in an interview. “Insurance plans in the U.S. are essentially a 1-year contract, and most Americans switch insurance on average about every 3 years. Insurers therefore prioritize short-term outcomes, because in 5 years the patient may not be their customer anymore, thus any long-term cost-savings might end up benefiting some other insurance company. This way of thinking really disadvantages people with chronic diseases.”

Peter D.R. Higgins

Disproportionate focus on cost reductions runs deep among insurers, as evidenced by recent high-profile reports that Aetna made coverage decisions without reviewing patient medical records, according to David T. Rubin, MD, professor of medicine and chief of gastroenterology, hepatology, and nutrition at University of Chicago Medicine.

“As these revelations suggest, Aetna may not even be reviewing records and making decisions in the best interest of the patient,” Rubin said. “I’m relieved to see the state of California is pursuing the allegations seriously, and this is probably the tip of the iceberg, because all of us in the trenches who are dealing with this on a regular basis are not surprised. We’ve long suspected that policies are adhered to without regard for special circumstances or any physician input, and the bottom line has been to focus on the bottom line: save money at all costs, restrict access to expensive care and continue to preserve a profit margin for shareholders.”

Aetna publicly denied these allegations, which have prompted investigations in four states, but declined to comment for this story. Several other major health insurers did not return our requests for comment.

The call for change appears to be intensifying among gastroenterologists and other specialty physicians. Seeking solutions, some are experimenting with alternative payment models to better align stakeholders. Others are calling for greater transparency and governance of payer coverage policies, while some, like Rubin, say improving payer communications and timeliness of decisions on appeals is a more urgent and winnable battle.

Experts agreed that much of the difficulty in providing adequate therapy to patients with IBD stems from two specific payer policies: step therapy and prior authorization requirements. The American Gastroenterological Association, the American College of Gastroenterology and the Crohn’s & Colitis Foundation are all advocating for legislation that would reform step therapy protocols, and the AGA recently called on payers to streamline their prior authorization requirements.

Prior Authorization Reform

Services subject to prior authorization vary by payer and plan type, burdening providers with an increasingly unmanageable number of prior authorization requirements, most of which are neither transparent nor easily accessible, according to the AGA. The association therefore called on payers to standardize prior authorization requirements, provide greater transparency and accessibility to these criteria, and require reauthorization no more than once per year. Additionally, the AGA urged payers, including CMS, to foster true “peer-to-peer” dialogues, as prior authorization requests are sometimes reviewed by non-physician medical staff who lack expertise in the specialty.

“What AGA is trying to do is advocate for a much more reasonable, streamlined approach by requiring a response within a defined amount of time, and if the insurance company does not respond within this time frame, the patient and providers will have the right to assume it’s going to be covered,” Peter S. Margolis, MD, AGAF, chair of the AGA Government Affairs Committee, said in an interview. “We’re not asking for open formulary, but if insurance companies want to be involved with a limited formulary, there must be some reasonable approach; you can’t leave patients hanging and make doctors delay care with all this paperwork and rejection.”

Many providers who treat patients with IBD have joined Rubin in airing their frustrations with prior authorization requirements, coverage denials and the ensuing appeals process on Twitter using the hashtags #Fightwus and #Fightwme. In his online advocacy, Rubin has emphasized that insurers do need to control spending amid the soaring costs of health care in the U.S., and while there is certainly room for debate regarding their coverage policies, the more immediate issue is their poor communication quality and “horrible appeal processes.”

“The challenges we’ve been facing in terms of pre-auths and re-auths — which used to be annual but are now more commonly required every 6 or even 3 months — have to do with the way communications occur,” Rubin said. “A private insurer, by virtue of the relationship they have with their members, does have the right to refuse certain treatments. But what I don’t find acceptable, ever, is a lack of transparency and communication, and the harm that it’s causing without any accountability. There’s a disconnect, and the responsible thing for us to do is to seek regulation related to appropriate communication and appeals and timeliness of decision-making.”

Payer Communication Quality

Rubin and others told us they routinely experience payers claiming that faxes are lost or not received, phone calls require long hold times and multiple transfers, and appeals require long waiting periods, often weeks or months. Some insurers even prohibit appeals, they said.

Thus, communicating with payers requires “enormous” amounts of time and resources from physicians and their staff, Rubin said. Results from a U.S. provider survey he and colleagues shared at Digestive Disease Week 2016 showed that 67% of physicians who treat IBD patients said the process for obtaining reimbursement had increased, and that the most time-consuming processes were obtaining pre-authorization (47%), gathering data for appeals (16%) and explaining the process to the patient (13%). Other survey data he shared at Advances in IBD 2017 showed some gastroenterology practices communicated with payers more than 30 times a day to obtain authorizations, and 63% said a full-time employee spent 25% of their time dealing with these issues.

“This is something we face on a daily basis, and the amount of effort that goes into getting patients the medications they need is really astronomical,” Gary R. Lichtenstein, MD, professor of medicine and director of the Inflammatory Bowel Disease center at University of Pennsylvania in Philadelphia, said in an interview. “It requires an army of people to truly function in this capacity and to go through the necessary appeal process.”

Gary R. Lichtenstein

Adam Cheifetz, MD, director of the Center for Inflammatory Bowel Disease at Beth Israel Deaconess Medical Center, and associate professor of medicine at Harvard Medical School, echoed this sentiment.

“All gastroenterologists who treat IBD, and certainly those who prescribe biologic therapies, have encountered insurance denials and a frustrating appeals process,” he said.

Higgins agreed that biologics, given their expense, are the primary targets of insurance denials.

“The recent news about Aetna certainly sounds like what’s really going on,” he said. “For the vast majority of initial denials for biologics, I would guess no one looks at the medical records. It seems like it’s just automatic. If a medication is a biologic, it will get denied.”

However, Lichtenstein noted that the problem extends even beyond biologics.

“Several companies have deemed diagnostic tests as ‘experimental,’ but they’re a legitimate part of our standard medical practice to measure drug levels and antibody levels, and obtain biomarkers like CRP and calprotectin,” he said. “It’s often up to us to educate insurers about updates to clinical practice.”

While the problem is widespread, the difficulty of these communications often depends on the regional payer mix, according to Marla C. Dubinsky, MD, chief of gastroenterology, hepatology and nutrition and co-director of the Susan and Leonard Feinstein IBD Clinical Center at the Icahn School of Medicine, Mount Sinai, in New York City.

“We have multiple staff members getting authorizations for IV, subcutaneous and oral therapies all day,” she said. “But there are regional differences based on the contracting and the percentage of HMOs in a given state, which often requires a lot more effort than a private payer and this makes it nearly impossible to get newer therapies.”

Marla C. Dubinsky

While communicating with payers may frustrate providers, the more important issue is obviously the danger that delays pose to patients, according to Rubin.

“There’s a complete lack of understanding and respect for sick patients waiting for decisions that will affect their care,” he said. “In one egregious case, we were told an urgent appeals process for a very sick patent who needed therapy would take 2 to 4 weeks before being reviewed.”

Dangerous Delays

IBD patient and advocate Dan Sharp experienced the dangers of delayed treatment first-hand, and said it is a common experience among patients.

“My treatment was delayed when my gastroenterologist at the time recommended an off-label biologic that my insurance company subsequently denied,” he told us. “Although my physician’s office made some attempt to appeal the decision, he recommended I start a different therapy simply because I wouldn’t have to wait as long for it.”

Unfortunately, this therapy turned out to be ineffective.

“I ultimately moved my care to another center, whose physicians worked very hard to get my disease under control,” he said. “This required several hospitalizations, steroids, multiple antibiotics, a biologic, and total parenteral nutrition with home care services for 6 months, and nearly forced me into surgery.”

Despite these obstacles, Sharp considers himself fortunate to have had good coverage throughout most of his life and has since found an IBD center that advocates for their patients’ recommended treatments. Others in the IBD community, whom he regularly communicates with through his patient education and empowerment work, have not been so lucky.

“Within the IBD community at large, it is a regular occurrence to see and hear of people struggling with insurance denials,” he said. “Sadly, insurance denials can quickly deter many patients from their recommended treatment plan. I see many patients accept a denial without any attempt made at appealing the decision. They may have a physician who claims it’s not worth the trouble, as I have experienced in the past. Alternately, they may not be aware an appeal is possible, or how to begin the process.” (For more from Dan Sharp, see the Patient Perspective.)

Additional survey data Rubin shared at DDW showed 37% of providers said reimbursement policies and procedures are “normally” a barrier to patient management, while 35% said they are “sometimes” a barrier. Further, 45% said patient care was frequently compromised by delayed authorization, and 49% had to stop maintenance therapy in a stable patient at some point due to lack of reimbursement.

Breaks in therapy resulting from these delays are especially risky for patients on biologics due to the development of immunogenicity, Cheifetz said.

“When a biologic is working, you want it to continue working so the patient can avoid having a relapse of symptoms,” he said. “On a deeper level, breaks in care can lead to the development of antibodies against the drug, which can lead to secondary loss of response. If the antibodies are high enough, the patient can’t overcome them and will need to move on to another biologic. With infliximab, these antibodies have also been shown to increase the risk of infusion reactions.”

Treatment interruptions are a threat whenever patients change health insurance; Rubin cited a recent case of a patient who was on maintenance therapy for 3 years and then found a new job, and it took 79 days for her new insurance company to approve her staying on the same biologic.

Even without a change in insurance, annual reauthorizations can put patients at risk for breaks in treatment, according to Higgins.

“This is what I call the January problem,” he said. “Most prior authorizations for biologics expire on December 31, so you have to regenerate all the documentation, and engage in all the back-and-forth of prior authorization appeals every January, for every patient on biologics, even though the patient is doing well. So, you frequently get patients going off an effective biologic for a month or two, missing doses, having flares, developing bowel damage, and potentially forming antibodies to that biologic, which may cause it to stop working eventually.”

Bucking this trend, Blue Cross Blue Shield of Michigan has agreed to a pilot program this year in which all patients with IBD on infliximab can continue therapy without a new prior authorization in January, Higgins noted. However, it remains a common practice among payers.

Integrated Specialty Pharmacies

To help alleviate the burden of communicating with payers, specialty pharmacies are increasingly taking ownership of the process at centers across the country.

“There are cottage industries popping up all over the country that will offer to handle your therapies and your reusables to take the burden off your practice, and they can make plenty of money on the side,” Rubin said.

The specialty pharmacy integrated with University of Chicago’s IBD clinic has been very effective, achieving more than a 99% approval rate for its patients, according to clinical pharmacist Shivani Patel, PharmD.

“The unique thing about our set-up is that I as the pharmacist essentially own the appeals process,” she said. “My job is to make sure we’re getting these patients approved on the therapies they need in a timely manner, so I make the peer-to-peer calls, write medical necessity letters, gather the required clinical literature, and submit and follow up on appeals, with support from our nurses and physicians when needed. If patients are not approved through their insurance, then we attempt to get their therapies using patient assistance programs and grant foundations.”

While the collaboration has resulted in great success, the difficult process still results in frustrating delays, Patel said.

“I submitted an appeal on January 15 for a patient who is already on therapy,” she said. “She still had some medication from a patient assistance foundation, so we were trying to be proactive by getting her approved on her insurance before that medication runs out. A month later, we were told that the appeal is now under review. It’s an off-label medication so we knew we were going to hit a denial, and we’re basically racing against the clock before her medication runs out.”

Unfortunately, many practices lack the resources to designate staff to lead the charge on appeals in this fashion. For such practices, Lichtenstein noted that the Crohn’s & Colitis Foundation has pre-written appeal letters available on their website to help physicians challenge coverage decisions. In general, Patel said streamlining the appeals process as best as possible is key for all practices.

“The other key is to be proactive, because a lot of times we submit appeals and then follow up 2 weeks later and find out it was never received, or the number it was sent to is wrong, even though it’s the number written on the denial letter,” she said. “If the letter says it will be reviewed in 15 business days, chances are it might take longer, so if you follow up make sure someone received it, get a reference number for that appeal so you know you’re following up on something directly, set a reminder, get a calendar or some kind of system that keeps track of dates so that you can be prompted to follow up so things don’t get missed.”

The specialty pharmacy at University of Michigan’s IBD clinic has also done a good job of taking on the appeals process, “but to be honest it feels like an arms race,” Higgins said. “Insurance companies keep coming up with new ways to slow down drug approvals, and it’s hard to say how much of this is simple incompetence and how much is deliberate delaying tactics, but a lot of times it feels deliberate.”

For example, insurers often demand to speak with a physician before they will approve an appeal, “because they know that’s the weak link,” Higgins said. “A physician is busy trying to take care of patients, so it seems like they’re trying to force you to step away from patients and spend 45 minutes on hold, all so they can make it as hard as possible to get this drug approved. In effect, patients are being incentivized by lower premiums to pick the most recalcitrant health insurance as long as their doctor is willing to wait on hold for 2 hours every year to get their drug renewed, which basically shifts the cost of their insurance to their doctor.”

While inefficiency and lack of resources are the simplest explanations for the poor quality of communication with payers, Rubin and others also suspect that these delaying tactics could be intentional.

“At least on the surface, the communication processes look like they have been designed to obfuscate decision making and medical management,” Rubin said. “The cynical among us may think these systems are intentionally onerous so that we’ll give up on the more expensive therapies we’re requesting so the insurance company will save money. I would like to think that it’s less sinister than that.”

However, not all delays in effective IBD therapy are caused by slow decision-making on the part of payers. Step therapy or “fail first” policies — requiring patients to fail a series of cheaper therapies before the insurer will cover a recommended treatment — are an even more fundamental barrier, and many advocates are currently lobbying for legislative reform in Washington.

Policy Reform

The AGA has called on insurers to consolidate their step therapy and prior authorization requirements, and many GI organizations have voiced their support for The Restoring the Patient’s Voice Act (H.R. 2077), which has bipartisan support and would enforce “a clear and timely appeals process when a patient has been subjected to step therapy.”

According to Higgins, step therapy could save costs in theory, but in practice it doesn’t, largely due to the delayed appeals process after patients fail the required initial therapies.

Even worse, step therapy is simply outdated, not supported by current evidence, and can be particularly harmful for both adults and children with IBD, according to Dubinsky.

“The typical step-up approach where kids have to fail steroids and immunomodulators is very 1990s, and we have plenty of data to support that now,” she said. “The only drugs that change the natural history of IBD are biologics. Steroids are not healing the mucosa, and thiopurines have been shown to be ineffective in Crohn’s disease. So, the fact that we’re using ineffective and potentially dangerous therapies as a passthrough to get a biologic to a child, who probably needs it the most given the impact of inflammation on growth, for example, is simply harmful to children.”

Recently, Dubinsky and colleagues published a study showing that children exposed to thiopurines before or while receiving a biologic have a threefold increased risk for malignancy. This association has also been previously demonstrated in adult studies. It is therefore difficult to justify the required use of these potentially harmful therapies for the sake of cost reductions, she said.

The real problem underlying policy that prevents access to effective therapies is that they are often shaped by back end contracting between payers, pharmacies and industry, a process that is entirely opaque to physicians and patients, Dubinsky noted.

“Decisions on tiers and step processes begin on the contracting end, and there needs to be more transparency,” she said.

Rubin agreed that more accountability in contracting practices is needed, including for the pharmaceutical industry.

“There are certainly issues with the cost of therapies, and the behind-the-scenes rebates and arrangements being made with payers so that their therapies can be referred or not,” he said. “You never know if on January 1, all the therapies you’ve been using with your patients are suddenly not going to be available any longer because there was an agreement made 3 months earlier by the managed care group in a pharmaceutical company, which none of us know about, that changes the tier of one drug vs. another. So, the lack of information about all this and how often it changes is also a huge problem.”

In addition to greater transparency in contracting, Dubinsky said increased communication with other stakeholders would result in more sensible payer coverage policies.

“Payers aren’t asking physicians where they think a new drug best fits in their policy based on our real-world experience outside the realm of clinical trials, and that needs to change,” Dubinsky said.

Illustrating this problem, new research published in Value in Health showed that, although payers recognize the value of real-world evidence, it is unlikely to inform their pharmacy and therapeutic decisions. Only 10% of polled physicians and pharmacists employed by payers said observational studies were routinely considered when shaping medication use policies, largely due to timeliness of study results, as real-world studies are typically conducted after coverage and reimbursement decisions have already been made.

“Ideally, all stakeholders should be engaged when deciding where new and even existing drugs should fit in the policy, and there needs to be better governance on how drugs get onto preferred tiers or are designated as passthroughs,” Dubinsky said. “Everyone who is involved in managing patients should be involved in the decision when a drug gets approved, where it best fits in the real world.”

With cost control central to payer decisions, alternative payment models are emerging solutions to delivering value-based care that work for all stakeholders. These new approaches require physicians to take on the risks of expense and provide compensation based on quality of care, allowing them to make treatment decisions rather than the payer, in hopes of reducing overall costs in the long-term.

The IBD Medical Home at the University of Pittsburgh Medical Center (UPMC) is one such model called the patient-centered medical home (PCMH).

“We need a different cost structure, and I think UPMC’s medical home is the right model of care delivery,” Dubinsky said.

Alternative Care Models

Launched in 2015 by Miguel D. Regueiro, MD, and colleagues, the UPMC IBD Medical Home is a population-based care model for IBD patients in which the gastroenterologist acts as the principle care provider.

Also known as a specialty medical home (SMH), this model is “based on the premise that providers and payers working together can achieve more efficient, high-quality care for patients than either party working alone,” Regueiro and colleagues wrote in a Clinical Gastroenterology and Hepatology article outlining a blueprint for the model.

So far, it appears to be working. Regueiro and colleagues reported that care quality has improved, emergency department visits, hospitalization and costs have declined, and patient satisfaction is high.

The IBD Medical Home at UPMC is partnered with an in-house health plan, and while an in-house program is not required for this model to work, Regueiro said partnership with a payer is essential.

“Payers have essential resources for infrastructure support, preventive services delivery, marketing and engagement expertise, large databases for risk stratification and gap closure, and care management capacity to be a valuable partner,” he and colleagues wrote. “In the short term, philanthropy, grants, and crowd-sourcing options can be used to provide initial support for components of the SMH, however, these rarely are sustainable long-term options. Thus, the most critical collaboration necessary to considering a SMH is between payer(s) (insurance company or Health Plan) and the specialty provider.”

The trend toward value-based health care delivery and reduced utilization prompted Regueiro and colleagues to design this model, to get ahead of the curve and claim some agency in how these new cost structures will look, Regueiro said.

“Some gastroenterologists in IBD are realizing that if we don’t make this change, at some point we’ll be told by the payer or other entity that the way we practice medicine will change. I think those who are starting to get out in front of this are realizing that this may be coming down the line anyway, so why don’t we write the script and decide how care is provided?” he previously told Healio Gastroenterology and Liver Disease. “When we’re talking about potential reimbursement changes for specialty medicine, and for possible capitation and costs around specialty care, this is a way to basically figure out how you can get to the table with a payer.”

Another alternative IBD care model called Project Sonar has been successful in pilot studies and has even received a recommendation from the Physician-Focused Payment Model Technical Advisory Committee established under MACRA. Developed by the Illinois Gastroenterology Group, this “intensive medical home model” improves care and reduce costs by engaging patients in their own care and identifying those at risk for complications using remote monitoring software.

Value-Based Insurance Design (V-BID) is another promising solution, according to Higgins. Coined by Mark Fendrick, MD, of the University of Michigan Institute for Healthcare Policy & Innovation, V-BID models lower or remove financial barriers to essential, high-value clinical services, and are informed by a philosophy of “clinical nuance.” Fendrick worked with an insurer to explain their “medication silo” aimed at reducing drug costs was not communicating with their “hospitalization silo,” thus undermining the two groups, Higgins said.

After identifying that high co-pays were causing patients with diabetes to ration their ACE inhibitors, driving many to experience kidney failure and end up on dialysis, which cost the insurer more money, Fendrick convinced them to provide these medications for free.

“The theory was that the long-term benefits would save the insurer money, and that turned out to be the case,” Higgins said.

Over the past decade, Fendrick and colleagues have helped guide V-BID pilots in both public and private insurance programs including Medicare Advantage and TRICARE.

While integrated care models show promise for better aligning payers and providers in the future — two-thirds of the respondents polled by the NEJM Catalyst Insights survey reported they were optimistic about their progress — experts agreed that all major stakeholders need better alignment to improve health care.

“If we take the stand that we all want to work together to have appropriate evidence-based and cost-effective therapies, then it behooves everyone to participate in that process, including payers, pharma, physicians and even patient advocacy groups,” Rubin said.

In the meantime, Rubin said health care providers need to continue advocating for their patients and dealing with the most urgent problems resulting from payer-provider divisions. Sharp agreed.

“Health care providers must continue to fight for their ability to use the best available tools, on behalf of their patients,” Sharp said. “Insurance companies hold an enormous amount of power over patients, and this can be quite a disheartening realization for many. For a patient, knowing that you have a physician who will advocate for you and your best interest is enormously valuable. It builds trust, which is the foundation of any great patient-physician partnership.” – by Adam Leitenberger

Disclosures: Cheifetz reports he received consultancy fees from AbbVie, Janssen, Takeda, Miraca, Ferring, AMAG, and Pfizer. Dubinsky reports consulting and research support from Janssen and Prometheus labs, and consulting for AbbVie, Takeda, Pfizer, Genentech, Protagonist, and Salix. Higgins reports financial relationships with the Crohn’s & Colitis Foundation, AbbVie, Allergan, Amgen, Arena, Ascentage Pharma, Buhlmann, Eli Lilly, Genentech, GI Health Foundation, Janssen, Lycera, Medimmune, Nestle, Pfizer, Prime Medical Education, RedX Pharma, Seres, Shire, Takeda and UCB. Regueiro reports he serves as a consultant and on advisory boards for AbbVie, Janssen, UCB, Takeda, Miraca, Pfizer, Celgene, and Amgen, and he receives research support from AbbVie, Janssen, and Takeda. Rubin reports he has financial relationships with AbbVie, ACG, Celgene, Cornerstones Health, Forward Parma, Genentech, GoDuRn, Janssen, Lockwood Group, Miraca Life Sciences, Pfizer, Prometheus Laboratories, Roche, Samsung Bioepis, Sandoz Pharmaceuticals, Shire, Takeda and UCB Pharma. Lichtenstein reports financial relationships with AbbVie, Actavis, Alaven, CellCeutrix, Celgene, Ferring, Gilead, Hospira, Janssen, Orthobiotech, Ironwood, Luitpold/American Regent, Merck, Pfizer, Prometheus Laboratories, Romark, Salix Pharmaceuticals/Valeant, Santarus/Receptos/Celgene, Shire Pharmaceuticals, Takeda, UCB.

Health care providers have long been at odds with coverage policies and practices of health insurers in the U.S., but these rifts are becoming more adversarial with the growing momentum toward value-based care models. According to The New England Journal of Medicine Catalyst Insights Council, more than three-quarters of surveyed executives, clinical leaders and clinicians feel payers are not aligned with providers in their efforts to improve value in health care delivery, and many accused payers of being overly focused on cutting costs.

This discord is especially frustrating for physicians who treat patients with chronic diseases like inflammatory bowel disease. IBD care providers told Healio Gastroenterology and Liver Disease they must spend an unreasonable amount of time and resources advocating on behalf of their patients due to short-sighted coverage policies and cumbersome appeals processes that can result in dangerous delays in effective therapy.

“The short-term focus is really the problem,” Peter D.R. Higgins, MD, PhD, of University of Michigan Internal Medicine, said in an interview. “Insurance plans in the U.S. are essentially a 1-year contract, and most Americans switch insurance on average about every 3 years. Insurers therefore prioritize short-term outcomes, because in 5 years the patient may not be their customer anymore, thus any long-term cost-savings might end up benefiting some other insurance company. This way of thinking really disadvantages people with chronic diseases.”

Peter D.R. Higgins

Disproportionate focus on cost reductions runs deep among insurers, as evidenced by recent high-profile reports that Aetna made coverage decisions without reviewing patient medical records, according to David T. Rubin, MD, professor of medicine and chief of gastroenterology, hepatology, and nutrition at University of Chicago Medicine.

“As these revelations suggest, Aetna may not even be reviewing records and making decisions in the best interest of the patient,” Rubin said. “I’m relieved to see the state of California is pursuing the allegations seriously, and this is probably the tip of the iceberg, because all of us in the trenches who are dealing with this on a regular basis are not surprised. We’ve long suspected that policies are adhered to without regard for special circumstances or any physician input, and the bottom line has been to focus on the bottom line: save money at all costs, restrict access to expensive care and continue to preserve a profit margin for shareholders.”

Aetna publicly denied these allegations, which have prompted investigations in four states, but declined to comment for this story. Several other major health insurers did not return our requests for comment.

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The call for change appears to be intensifying among gastroenterologists and other specialty physicians. Seeking solutions, some are experimenting with alternative payment models to better align stakeholders. Others are calling for greater transparency and governance of payer coverage policies, while some, like Rubin, say improving payer communications and timeliness of decisions on appeals is a more urgent and winnable battle.

Experts agreed that much of the difficulty in providing adequate therapy to patients with IBD stems from two specific payer policies: step therapy and prior authorization requirements. The American Gastroenterological Association, the American College of Gastroenterology and the Crohn’s & Colitis Foundation are all advocating for legislation that would reform step therapy protocols, and the AGA recently called on payers to streamline their prior authorization requirements.

Prior Authorization Reform

Services subject to prior authorization vary by payer and plan type, burdening providers with an increasingly unmanageable number of prior authorization requirements, most of which are neither transparent nor easily accessible, according to the AGA. The association therefore called on payers to standardize prior authorization requirements, provide greater transparency and accessibility to these criteria, and require reauthorization no more than once per year. Additionally, the AGA urged payers, including CMS, to foster true “peer-to-peer” dialogues, as prior authorization requests are sometimes reviewed by non-physician medical staff who lack expertise in the specialty.

“What AGA is trying to do is advocate for a much more reasonable, streamlined approach by requiring a response within a defined amount of time, and if the insurance company does not respond within this time frame, the patient and providers will have the right to assume it’s going to be covered,” Peter S. Margolis, MD, AGAF, chair of the AGA Government Affairs Committee, said in an interview. “We’re not asking for open formulary, but if insurance companies want to be involved with a limited formulary, there must be some reasonable approach; you can’t leave patients hanging and make doctors delay care with all this paperwork and rejection.”

Many providers who treat patients with IBD have joined Rubin in airing their frustrations with prior authorization requirements, coverage denials and the ensuing appeals process on Twitter using the hashtags #Fightwus and #Fightwme. In his online advocacy, Rubin has emphasized that insurers do need to control spending amid the soaring costs of health care in the U.S., and while there is certainly room for debate regarding their coverage policies, the more immediate issue is their poor communication quality and “horrible appeal processes.”

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“The challenges we’ve been facing in terms of pre-auths and re-auths — which used to be annual but are now more commonly required every 6 or even 3 months — have to do with the way communications occur,” Rubin said. “A private insurer, by virtue of the relationship they have with their members, does have the right to refuse certain treatments. But what I don’t find acceptable, ever, is a lack of transparency and communication, and the harm that it’s causing without any accountability. There’s a disconnect, and the responsible thing for us to do is to seek regulation related to appropriate communication and appeals and timeliness of decision-making.”

Payer Communication Quality

Rubin and others told us they routinely experience payers claiming that faxes are lost or not received, phone calls require long hold times and multiple transfers, and appeals require long waiting periods, often weeks or months. Some insurers even prohibit appeals, they said.

Thus, communicating with payers requires “enormous” amounts of time and resources from physicians and their staff, Rubin said. Results from a U.S. provider survey he and colleagues shared at Digestive Disease Week 2016 showed that 67% of physicians who treat IBD patients said the process for obtaining reimbursement had increased, and that the most time-consuming processes were obtaining pre-authorization (47%), gathering data for appeals (16%) and explaining the process to the patient (13%). Other survey data he shared at Advances in IBD 2017 showed some gastroenterology practices communicated with payers more than 30 times a day to obtain authorizations, and 63% said a full-time employee spent 25% of their time dealing with these issues.

“This is something we face on a daily basis, and the amount of effort that goes into getting patients the medications they need is really astronomical,” Gary R. Lichtenstein, MD, professor of medicine and director of the Inflammatory Bowel Disease center at University of Pennsylvania in Philadelphia, said in an interview. “It requires an army of people to truly function in this capacity and to go through the necessary appeal process.”

Gary R. Lichtenstein

Adam Cheifetz, MD, director of the Center for Inflammatory Bowel Disease at Beth Israel Deaconess Medical Center, and associate professor of medicine at Harvard Medical School, echoed this sentiment.

“All gastroenterologists who treat IBD, and certainly those who prescribe biologic therapies, have encountered insurance denials and a frustrating appeals process,” he said.

Higgins agreed that biologics, given their expense, are the primary targets of insurance denials.

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“The recent news about Aetna certainly sounds like what’s really going on,” he said. “For the vast majority of initial denials for biologics, I would guess no one looks at the medical records. It seems like it’s just automatic. If a medication is a biologic, it will get denied.”

However, Lichtenstein noted that the problem extends even beyond biologics.

“Several companies have deemed diagnostic tests as ‘experimental,’ but they’re a legitimate part of our standard medical practice to measure drug levels and antibody levels, and obtain biomarkers like CRP and calprotectin,” he said. “It’s often up to us to educate insurers about updates to clinical practice.”

While the problem is widespread, the difficulty of these communications often depends on the regional payer mix, according to Marla C. Dubinsky, MD, chief of gastroenterology, hepatology and nutrition and co-director of the Susan and Leonard Feinstein IBD Clinical Center at the Icahn School of Medicine, Mount Sinai, in New York City.

“We have multiple staff members getting authorizations for IV, subcutaneous and oral therapies all day,” she said. “But there are regional differences based on the contracting and the percentage of HMOs in a given state, which often requires a lot more effort than a private payer and this makes it nearly impossible to get newer therapies.”

Marla C. Dubinsky

While communicating with payers may frustrate providers, the more important issue is obviously the danger that delays pose to patients, according to Rubin.

“There’s a complete lack of understanding and respect for sick patients waiting for decisions that will affect their care,” he said. “In one egregious case, we were told an urgent appeals process for a very sick patent who needed therapy would take 2 to 4 weeks before being reviewed.”

Dangerous Delays

IBD patient and advocate Dan Sharp experienced the dangers of delayed treatment first-hand, and said it is a common experience among patients.

“My treatment was delayed when my gastroenterologist at the time recommended an off-label biologic that my insurance company subsequently denied,” he told us. “Although my physician’s office made some attempt to appeal the decision, he recommended I start a different therapy simply because I wouldn’t have to wait as long for it.”

Unfortunately, this therapy turned out to be ineffective.

“I ultimately moved my care to another center, whose physicians worked very hard to get my disease under control,” he said. “This required several hospitalizations, steroids, multiple antibiotics, a biologic, and total parenteral nutrition with home care services for 6 months, and nearly forced me into surgery.”

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Despite these obstacles, Sharp considers himself fortunate to have had good coverage throughout most of his life and has since found an IBD center that advocates for their patients’ recommended treatments. Others in the IBD community, whom he regularly communicates with through his patient education and empowerment work, have not been so lucky.

“Within the IBD community at large, it is a regular occurrence to see and hear of people struggling with insurance denials,” he said. “Sadly, insurance denials can quickly deter many patients from their recommended treatment plan. I see many patients accept a denial without any attempt made at appealing the decision. They may have a physician who claims it’s not worth the trouble, as I have experienced in the past. Alternately, they may not be aware an appeal is possible, or how to begin the process.” (For more from Dan Sharp, see the Patient Perspective.)

Additional survey data Rubin shared at DDW showed 37% of providers said reimbursement policies and procedures are “normally” a barrier to patient management, while 35% said they are “sometimes” a barrier. Further, 45% said patient care was frequently compromised by delayed authorization, and 49% had to stop maintenance therapy in a stable patient at some point due to lack of reimbursement.

Breaks in therapy resulting from these delays are especially risky for patients on biologics due to the development of immunogenicity, Cheifetz said.

“When a biologic is working, you want it to continue working so the patient can avoid having a relapse of symptoms,” he said. “On a deeper level, breaks in care can lead to the development of antibodies against the drug, which can lead to secondary loss of response. If the antibodies are high enough, the patient can’t overcome them and will need to move on to another biologic. With infliximab, these antibodies have also been shown to increase the risk of infusion reactions.”

Treatment interruptions are a threat whenever patients change health insurance; Rubin cited a recent case of a patient who was on maintenance therapy for 3 years and then found a new job, and it took 79 days for her new insurance company to approve her staying on the same biologic.

Even without a change in insurance, annual reauthorizations can put patients at risk for breaks in treatment, according to Higgins.

“This is what I call the January problem,” he said. “Most prior authorizations for biologics expire on December 31, so you have to regenerate all the documentation, and engage in all the back-and-forth of prior authorization appeals every January, for every patient on biologics, even though the patient is doing well. So, you frequently get patients going off an effective biologic for a month or two, missing doses, having flares, developing bowel damage, and potentially forming antibodies to that biologic, which may cause it to stop working eventually.”

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Bucking this trend, Blue Cross Blue Shield of Michigan has agreed to a pilot program this year in which all patients with IBD on infliximab can continue therapy without a new prior authorization in January, Higgins noted. However, it remains a common practice among payers.

Integrated Specialty Pharmacies

To help alleviate the burden of communicating with payers, specialty pharmacies are increasingly taking ownership of the process at centers across the country.

“There are cottage industries popping up all over the country that will offer to handle your therapies and your reusables to take the burden off your practice, and they can make plenty of money on the side,” Rubin said.

The specialty pharmacy integrated with University of Chicago’s IBD clinic has been very effective, achieving more than a 99% approval rate for its patients, according to clinical pharmacist Shivani Patel, PharmD.

“The unique thing about our set-up is that I as the pharmacist essentially own the appeals process,” she said. “My job is to make sure we’re getting these patients approved on the therapies they need in a timely manner, so I make the peer-to-peer calls, write medical necessity letters, gather the required clinical literature, and submit and follow up on appeals, with support from our nurses and physicians when needed. If patients are not approved through their insurance, then we attempt to get their therapies using patient assistance programs and grant foundations.”

While the collaboration has resulted in great success, the difficult process still results in frustrating delays, Patel said.

“I submitted an appeal on January 15 for a patient who is already on therapy,” she said. “She still had some medication from a patient assistance foundation, so we were trying to be proactive by getting her approved on her insurance before that medication runs out. A month later, we were told that the appeal is now under review. It’s an off-label medication so we knew we were going to hit a denial, and we’re basically racing against the clock before her medication runs out.”

Unfortunately, many practices lack the resources to designate staff to lead the charge on appeals in this fashion. For such practices, Lichtenstein noted that the Crohn’s & Colitis Foundation has pre-written appeal letters available on their website to help physicians challenge coverage decisions. In general, Patel said streamlining the appeals process as best as possible is key for all practices.

“The other key is to be proactive, because a lot of times we submit appeals and then follow up 2 weeks later and find out it was never received, or the number it was sent to is wrong, even though it’s the number written on the denial letter,” she said. “If the letter says it will be reviewed in 15 business days, chances are it might take longer, so if you follow up make sure someone received it, get a reference number for that appeal so you know you’re following up on something directly, set a reminder, get a calendar or some kind of system that keeps track of dates so that you can be prompted to follow up so things don’t get missed.”

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The specialty pharmacy at University of Michigan’s IBD clinic has also done a good job of taking on the appeals process, “but to be honest it feels like an arms race,” Higgins said. “Insurance companies keep coming up with new ways to slow down drug approvals, and it’s hard to say how much of this is simple incompetence and how much is deliberate delaying tactics, but a lot of times it feels deliberate.”

For example, insurers often demand to speak with a physician before they will approve an appeal, “because they know that’s the weak link,” Higgins said. “A physician is busy trying to take care of patients, so it seems like they’re trying to force you to step away from patients and spend 45 minutes on hold, all so they can make it as hard as possible to get this drug approved. In effect, patients are being incentivized by lower premiums to pick the most recalcitrant health insurance as long as their doctor is willing to wait on hold for 2 hours every year to get their drug renewed, which basically shifts the cost of their insurance to their doctor.”

While inefficiency and lack of resources are the simplest explanations for the poor quality of communication with payers, Rubin and others also suspect that these delaying tactics could be intentional.

“At least on the surface, the communication processes look like they have been designed to obfuscate decision making and medical management,” Rubin said. “The cynical among us may think these systems are intentionally onerous so that we’ll give up on the more expensive therapies we’re requesting so the insurance company will save money. I would like to think that it’s less sinister than that.”

However, not all delays in effective IBD therapy are caused by slow decision-making on the part of payers. Step therapy or “fail first” policies — requiring patients to fail a series of cheaper therapies before the insurer will cover a recommended treatment — are an even more fundamental barrier, and many advocates are currently lobbying for legislative reform in Washington.

Policy Reform

The AGA has called on insurers to consolidate their step therapy and prior authorization requirements, and many GI organizations have voiced their support for The Restoring the Patient’s Voice Act (H.R. 2077), which has bipartisan support and would enforce “a clear and timely appeals process when a patient has been subjected to step therapy.”

According to Higgins, step therapy could save costs in theory, but in practice it doesn’t, largely due to the delayed appeals process after patients fail the required initial therapies.

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Even worse, step therapy is simply outdated, not supported by current evidence, and can be particularly harmful for both adults and children with IBD, according to Dubinsky.

“The typical step-up approach where kids have to fail steroids and immunomodulators is very 1990s, and we have plenty of data to support that now,” she said. “The only drugs that change the natural history of IBD are biologics. Steroids are not healing the mucosa, and thiopurines have been shown to be ineffective in Crohn’s disease. So, the fact that we’re using ineffective and potentially dangerous therapies as a passthrough to get a biologic to a child, who probably needs it the most given the impact of inflammation on growth, for example, is simply harmful to children.”

Recently, Dubinsky and colleagues published a study showing that children exposed to thiopurines before or while receiving a biologic have a threefold increased risk for malignancy. This association has also been previously demonstrated in adult studies. It is therefore difficult to justify the required use of these potentially harmful therapies for the sake of cost reductions, she said.

The real problem underlying policy that prevents access to effective therapies is that they are often shaped by back end contracting between payers, pharmacies and industry, a process that is entirely opaque to physicians and patients, Dubinsky noted.

“Decisions on tiers and step processes begin on the contracting end, and there needs to be more transparency,” she said.

Rubin agreed that more accountability in contracting practices is needed, including for the pharmaceutical industry.

“There are certainly issues with the cost of therapies, and the behind-the-scenes rebates and arrangements being made with payers so that their therapies can be referred or not,” he said. “You never know if on January 1, all the therapies you’ve been using with your patients are suddenly not going to be available any longer because there was an agreement made 3 months earlier by the managed care group in a pharmaceutical company, which none of us know about, that changes the tier of one drug vs. another. So, the lack of information about all this and how often it changes is also a huge problem.”

In addition to greater transparency in contracting, Dubinsky said increased communication with other stakeholders would result in more sensible payer coverage policies.

“Payers aren’t asking physicians where they think a new drug best fits in their policy based on our real-world experience outside the realm of clinical trials, and that needs to change,” Dubinsky said.

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Illustrating this problem, new research published in Value in Health showed that, although payers recognize the value of real-world evidence, it is unlikely to inform their pharmacy and therapeutic decisions. Only 10% of polled physicians and pharmacists employed by payers said observational studies were routinely considered when shaping medication use policies, largely due to timeliness of study results, as real-world studies are typically conducted after coverage and reimbursement decisions have already been made.

“Ideally, all stakeholders should be engaged when deciding where new and even existing drugs should fit in the policy, and there needs to be better governance on how drugs get onto preferred tiers or are designated as passthroughs,” Dubinsky said. “Everyone who is involved in managing patients should be involved in the decision when a drug gets approved, where it best fits in the real world.”

With cost control central to payer decisions, alternative payment models are emerging solutions to delivering value-based care that work for all stakeholders. These new approaches require physicians to take on the risks of expense and provide compensation based on quality of care, allowing them to make treatment decisions rather than the payer, in hopes of reducing overall costs in the long-term.

The IBD Medical Home at the University of Pittsburgh Medical Center (UPMC) is one such model called the patient-centered medical home (PCMH).

“We need a different cost structure, and I think UPMC’s medical home is the right model of care delivery,” Dubinsky said.

Alternative Care Models

Launched in 2015 by Miguel D. Regueiro, MD, and colleagues, the UPMC IBD Medical Home is a population-based care model for IBD patients in which the gastroenterologist acts as the principle care provider.

Also known as a specialty medical home (SMH), this model is “based on the premise that providers and payers working together can achieve more efficient, high-quality care for patients than either party working alone,” Regueiro and colleagues wrote in a Clinical Gastroenterology and Hepatology article outlining a blueprint for the model.

So far, it appears to be working. Regueiro and colleagues reported that care quality has improved, emergency department visits, hospitalization and costs have declined, and patient satisfaction is high.

The IBD Medical Home at UPMC is partnered with an in-house health plan, and while an in-house program is not required for this model to work, Regueiro said partnership with a payer is essential.

“Payers have essential resources for infrastructure support, preventive services delivery, marketing and engagement expertise, large databases for risk stratification and gap closure, and care management capacity to be a valuable partner,” he and colleagues wrote. “In the short term, philanthropy, grants, and crowd-sourcing options can be used to provide initial support for components of the SMH, however, these rarely are sustainable long-term options. Thus, the most critical collaboration necessary to considering a SMH is between payer(s) (insurance company or Health Plan) and the specialty provider.”

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The trend toward value-based health care delivery and reduced utilization prompted Regueiro and colleagues to design this model, to get ahead of the curve and claim some agency in how these new cost structures will look, Regueiro said.

“Some gastroenterologists in IBD are realizing that if we don’t make this change, at some point we’ll be told by the payer or other entity that the way we practice medicine will change. I think those who are starting to get out in front of this are realizing that this may be coming down the line anyway, so why don’t we write the script and decide how care is provided?” he previously told Healio Gastroenterology and Liver Disease. “When we’re talking about potential reimbursement changes for specialty medicine, and for possible capitation and costs around specialty care, this is a way to basically figure out how you can get to the table with a payer.”

Another alternative IBD care model called Project Sonar has been successful in pilot studies and has even received a recommendation from the Physician-Focused Payment Model Technical Advisory Committee established under MACRA. Developed by the Illinois Gastroenterology Group, this “intensive medical home model” improves care and reduce costs by engaging patients in their own care and identifying those at risk for complications using remote monitoring software.

Value-Based Insurance Design (V-BID) is another promising solution, according to Higgins. Coined by Mark Fendrick, MD, of the University of Michigan Institute for Healthcare Policy & Innovation, V-BID models lower or remove financial barriers to essential, high-value clinical services, and are informed by a philosophy of “clinical nuance.” Fendrick worked with an insurer to explain their “medication silo” aimed at reducing drug costs was not communicating with their “hospitalization silo,” thus undermining the two groups, Higgins said.

After identifying that high co-pays were causing patients with diabetes to ration their ACE inhibitors, driving many to experience kidney failure and end up on dialysis, which cost the insurer more money, Fendrick convinced them to provide these medications for free.

“The theory was that the long-term benefits would save the insurer money, and that turned out to be the case,” Higgins said.

Over the past decade, Fendrick and colleagues have helped guide V-BID pilots in both public and private insurance programs including Medicare Advantage and TRICARE.

While integrated care models show promise for better aligning payers and providers in the future — two-thirds of the respondents polled by the NEJM Catalyst Insights survey reported they were optimistic about their progress — experts agreed that all major stakeholders need better alignment to improve health care.

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“If we take the stand that we all want to work together to have appropriate evidence-based and cost-effective therapies, then it behooves everyone to participate in that process, including payers, pharma, physicians and even patient advocacy groups,” Rubin said.

In the meantime, Rubin said health care providers need to continue advocating for their patients and dealing with the most urgent problems resulting from payer-provider divisions. Sharp agreed.

“Health care providers must continue to fight for their ability to use the best available tools, on behalf of their patients,” Sharp said. “Insurance companies hold an enormous amount of power over patients, and this can be quite a disheartening realization for many. For a patient, knowing that you have a physician who will advocate for you and your best interest is enormously valuable. It builds trust, which is the foundation of any great patient-physician partnership.” – by Adam Leitenberger

Disclosures: Cheifetz reports he received consultancy fees from AbbVie, Janssen, Takeda, Miraca, Ferring, AMAG, and Pfizer. Dubinsky reports consulting and research support from Janssen and Prometheus labs, and consulting for AbbVie, Takeda, Pfizer, Genentech, Protagonist, and Salix. Higgins reports financial relationships with the Crohn’s & Colitis Foundation, AbbVie, Allergan, Amgen, Arena, Ascentage Pharma, Buhlmann, Eli Lilly, Genentech, GI Health Foundation, Janssen, Lycera, Medimmune, Nestle, Pfizer, Prime Medical Education, RedX Pharma, Seres, Shire, Takeda and UCB. Regueiro reports he serves as a consultant and on advisory boards for AbbVie, Janssen, UCB, Takeda, Miraca, Pfizer, Celgene, and Amgen, and he receives research support from AbbVie, Janssen, and Takeda. Rubin reports he has financial relationships with AbbVie, ACG, Celgene, Cornerstones Health, Forward Parma, Genentech, GoDuRn, Janssen, Lockwood Group, Miraca Life Sciences, Pfizer, Prometheus Laboratories, Roche, Samsung Bioepis, Sandoz Pharmaceuticals, Shire, Takeda and UCB Pharma. Lichtenstein reports financial relationships with AbbVie, Actavis, Alaven, CellCeutrix, Celgene, Ferring, Gilead, Hospira, Janssen, Orthobiotech, Ironwood, Luitpold/American Regent, Merck, Pfizer, Prometheus Laboratories, Romark, Salix Pharmaceuticals/Valeant, Santarus/Receptos/Celgene, Shire Pharmaceuticals, Takeda, UCB.

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