[House Hearing, 116 Congress] [From the U.S. Government Publishing Office] UTILIZATION MANAGEMENT: BARRIERS TO CARE AND BURDENS ON SMALL MEDICAL PRACTICES ======================================================================= HEARING BEFORE THE COMMITTEE ON SMALL BUSINESS UNITED STATES HOUSE OF REPRESENTATIVES ONE HUNDRED SIXTEENTH CONGRESS FIRST SESSION __________ HEARING HELD SEPTEMBER 11, 2019 __________ [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Small Business Committee Document Number 116-043 Available via the GPO Website: www.govinfo.gov __________ U.S. GOVERNMENT PUBLISHING OFFICE 37-560 WASHINGTON : 2019 -------------------------------------------------------------------------------------- HOUSE COMMITTEE ON SMALL BUSINESS NYDIA VELAZQUEZ, New York, Chairwoman ABBY FINKENAUER, Iowa JARED GOLDEN, Maine ANDY KIM, New Jersey JASON CROW, Colorado SHARICE DAVIDS, Kansas JUDY CHU, California MARC VEASEY, Texas DWIGHT EVANS, Pennsylvania BRAD SCHNEIDER, Illinois ADRIANO ESPAILLAT, New York ANTONIO DELGADO, New York CHRISSY HOULAHAN, Pennsylvania ANGIE CRAIG, Minnesota STEVE CHABOT, Ohio, Ranking Member AUMUA AMATA COLEMAN RADEWAGEN, American Samoa, Vice Ranking Member TRENT KELLY, Mississippi TROY BALDERSON, Ohio KEVIN HERN, Oklahoma JIM HAGEDORN, Minnesota PETE STAUBER, Minnesota TIM BURCHETT, Tennessee ROSS SPANO, Florida JOHN JOYCE, Pennsylvania Adam Minehardt, Majority Staff Director Melissa Jung, Majority Deputy Staff Director and Chief Counsel Kevin Fitzpatrick, Staff Director C O N T E N T S OPENING STATEMENTS Page Hon. Nydia Velazquez............................................. 1 Hon. Steve Chabot................................................ 2 WITNESSES Dr. Paul M. Harari, Professor, Chairman, Department of Human Oncology, University of Wisconsin School of Medicine and Public Health, Madison, WI, testifying on behalf of the American Society for Radiation Oncology (ASTRO)......................... 4 Dr. David R. Walega, MSCI, Associate Professor of Anesthesiology, Chief, Division of Pain Management, Vice Chair of Research, Department of Anesthesiology, Northwestern University Feinberg School of Medicine, Chicago, IL, testifying on behalf of the American Society of Anesthesiologists.......................... 6 Dr. John S. Cullen, FAAFP, Family Physician & Partner, Valdez Medical Clinic, LLC, Valdez, AK, testifying on behalf of the American Academy of Family Physicians.......................... 7 Dr. Howard Rogers, PhD., FAAD, Owner, Advanced Dermatology, LLC, Norwich, CT, testifying on behalf of the American Academy of Dermatology Association........................................ 9 APPENDIX Prepared Statements: Dr. Paul M. Harari, Professor, Chairman, Department of Human Oncology, University of Wisconsin School of Medicine and Public Health, Madison, WI, testifying on behalf of the American Society for Radiation Oncology (ASTRO)............ 27 Dr. David R. Walega, MSCI, Associate Professor of Anesthesiology, Chief, Division of Pain Management, Vice Chair of Research, Department of Anesthesiology, Northwestern University Feinberg School of Medicine, Chicago, IL, testifying on behalf of the American Society of Anesthesiologists....................................... 37 Dr. John S. Cullen, FAAFP, Family Physician & Partner, Valdez Medical Clinic, LLC, Valdez, AK, testifying on behalf of the American Academy of Family Physicians.................. 42 Dr. Howard Rogers, PhD, FAAD, Owner, Advanced Dermatology, LLC, Norwich, CT, testifying on behalf of the American Academy of Dermatology Association......................... 52 Questions for the Record: None. Answers for the Record: None. Additional Material for the Record: America's Health Insurance Plans (AHIP) and the Blue Cross Blue Shield Association (BCBSA)............................ 60 American Academy of Ophthalmology............................ 67 American Physical Therapy Association (APTA)................. 72 Consenus Statement on Improving the Prior Authorization Process.................................................... 81 Dr. Josh Bailey, PT, DPT, CEO, Rehabilitation Associates on behalf of the Virginia Physical Therapy Association........ 85 Final Stakeholder of the American Association of Neurological Surgeons/Congress of Neurological Surgeons................. 89 UTILIZATION MANAGEMENT: BARRIERS TO CARE AND BURDENS ON SMALL MEDICAL PRACTICES ---------- WEDNESDAY, SEPTEMBER 11, 2019 House of Representatives, Committee on Small Business, Washington, DC. The committee met, pursuant to call, at 11:32 a.m., in Room 2360, Rayburn House Office Building. Hon. Nydia Velazquez [chairwoman of the Committee] presiding. Present: Representatives Velazquez, Finkenauer, Kim, Davids, Chu, Evans, Schneider, Delgado, Houlahan, Craig, Chabot, Balderson, Hern, Hagedorn, Stauber, Burchett, and Joyce. Chairwoman VELAZQUEZ. Good morning. The committee will come to order. I thank everyone for joining us this morning, and I want to especially thank the witnesses who have traveled from across the country to be here with us today. On this committee, we are focused on breaking down barriers that many small businesses face. Whether it is ensuring small firms have access to affordable capital or reducing regulatory burdens, our focus on this committee is to create a thriving Main Street that makes towns and communities across the country better places to live, work, and raise a family. An essential part of any community are the doctors who are relied upon in every corner of our country to keep us healthy. But what many people forget is that many doctors, especially in rural and underserved communities, are themselves small businesses. They face the same challenges that any small employer encounters--making payroll, paying rent, managing overhead expenses, while also dealing with the same regulations that larger hospitals can manage through bigger budgets and more resources. However, when doctors spend hours dealing with paperwork or cannot treat a patient because a health insurance company will not approve a treatment, the result is patients suffering. And that is why we are here today--to discuss a barrier preventing family physicians and specialists from providing critical care to their patients. Prior authorization is a cost- savings tool used to reduce healthcare spending through improper payments and unnecessary care. Before doctors can provide even routine care procedures, diagnostic tests, or prescriptions, they must first obtain approval from a patient's insurer. While in some cases this process leads to appropriate treatments, reduces costs by eliminating expensive tests or unnecessary prescriptions, it also is putting an undue burden on physicians, their staff, and patients. It is not uncommon that patients now face delays of 2 weeks and sometimes over a month before getting treatment. In fact, more than 25 percent of doctors report that prior authorization has led to a serious adverse event for a patient in their care. And, 82 percent report the burdens associated with prior authorization lead to delayed care. Meanwhile, doctors are sitting on hold with insurance companies to explain why their patient needs a certain treatment. Sadly, this is an issue impacting doctors practicing in nearly every area of medicine in every part of the country. It affects each doctor paid by insurance, but is especially problematic for small group and solo practitioners that simply do not have the resources to hire additional administrative staff. Between the massive student loan debt many doctors face and these administrative burdens, it is no wonder that many doctors are deterred from pursuing the great American dream--to own and operate their own business. By 2030, the Association of American Medical Colleges expects the workforce shortage to expand to over 100,000 doctors nationwide. One way to combat this growing problem is to empower small private practices to fill the gaps. They can do this with common sense policies that streamline the prior authorization process--making it easier for them to do what they were trained to do--keep our communities healthy. I support reducing costs because our country spends nearly double the amount per person in health care than any other industrialized nation, yet our population ranks near the bottom in health outcomes compared to other high-income countries. There are reasonable ways to reduce costs such as increasing transparency in pricing so that consumers know what they are paying, allowing the government to negotiate the prices of prescription drugs so that our seniors can access affordable prescriptions, and increasing the use of technology. I am excited to hear about the potential solutions to this problem so that patients can get the care they need. I look forward to hearing about how we can modernize and streamline this process so that doctors can stop wasting time haggling with health insurance companies and continue to make the lives of patients and their families better. Again, I want to thank the witnesses for being here today, and I now yield to the Ranking Member, Mr. Chabot, for his opening statement. Mr. CHABOT. Thank you, Madam Chair. We are here today to hear from medical professionals about the burdens experienced by small medical practices, especially utilization management. The medical field is an integral part of our everyday lives. All participants from world renowned surgeons to clerical and administrative staff in this field deserve recognition for their diligent efforts to save lives. As we in Ohio know all too well, medical professionals are on the frontlines fighting the opioid epidemic. In 2016, there were over 42,000 deaths due to opioid overdose. This statistic is one of the reasons prior authorization has been implemented to help those in my home state and across the nation. Methods such as STEP therapy and prior authorization were introduced to reduce unnecessary procedures, prevent oversubscription of dangerously addictive drugs, and reduce human error. However, despite the reasoning for these processes, more must be done to streamline communication between practices and insurance providers. Many small medical practices struggle to afford necessary staff to complete the almost 60 extra hours spent per week on administrative tasks. Doctors spend extra time on the complex processes and paperwork required for prior authorization instead of tending to their patients. Patients become frustrated and 40 percent will abandon prescriptions requiring prior authorization at the pharmacy. While this may sound grim, there is still hope, and we are looking for solutions. Increased collaboration between private insurers and organizations like the AMA can ensure prior authorization requests are based on sound medical science. I want to thank the witnesses for sharing their experiences with us here, if we ever stop talking. I look forward to discussing solutions to reduce the burdens on small providers and ensure a more efficient healthcare system. And Madam Chairwoman, I appreciate you holding this hearing. I think this is one of the more important hearings that we have had this year. So, thank you for doing that. And thank the witnesses for coming today. Chairwoman VELAZQUEZ. Thank you, Mr. Chabot. The gentleman yields back. And if committee members have an opening statement prepared, we will ask that they be submitted for the record. I would like to take a minute to explain the timing rules. Each witness gets 5 minutes to testify and members get 5 minutes for questioning. There is a lighting system to assist you. The green light will be on when you begin, and the yellow light comes on when you have 1 minute remaining. The red light comes on when you are out of time, and we ask that you stay within the timeframe to the best of your ability. I would now like to introduce our witnesses. Our first witness is Dr. Paul Harari. Dr. Harari is the Jack Fowler Professor and Chairman of the Department of Human Oncology at the University of Wisconsin School of Medicine and Public Health. He joined the faculty at the University of Wisconsin in 1990 and became an endowed professor in 2003 and the Department Chairman in 2007. His clinical and laboratory research focuses primarily on treatment advances for head and neck cancer patients. Thank you, Dr. Harari, for being here today. Our second witness is Dr. David Walega. Dr. Walega is currently the Chief of the Division of Pain Medicine at Northwestern Medicine and the Vice Chair of the Department of Anesthesiology at Northwestern University Feinberg School of Medicine in Chicago, where he has been a faculty member since 2003. He earned his medical doctorate from Wayne State University in Detroit in 1993 and completed an internship in internal medicine and a residency at Northwestern University. He is a dedicated medical educator and holds the rank of associate professor at Northwestern University, where he has published numerous manuscripts and book chapters on pain- related topics and has lectured nationally and internationally. Thank you, Dr. Walega, for being here this morning. Our third witness is Dr. John Cullen, a family physician in Valdez, Alaska, and the president of the American Academy of Family Physicians, which represents 134,600 physicians and medical students nationwide. Dr. Cullen earned his Bachelor of Science in molecular and cell biology from the University of California-San Diego. He earned his medical degree from the University of Arizona College of Medicine-Tucson. Thank you, Dr. Cullen, for being here this morning. And now I yield to our Ranking Member, Mr. Chabot, to introduce our final witness. Mr. CHABOT. Madam Chairwoman, our final witness is Dr. Howard Rogers, testifying on behalf of the American Academy of Dermatology. Dr. Rogers is a graduate of Harvard University and holds both an MD and PhD from Washington University School of Medicine. Dr. Rogers completed a fellowship in my congressional district at the University of Cincinnati Hospital. He now owns a private dermatological practice in Connecticut, where he has treated approximately 35,000 cases of skin cancer in the last 19 years. We welcome you here, Dr. Rogers, and thank you for testifying today. Chairwoman VELAZQUEZ. Thank you, Mr. Chabot. Dr. Harari, you are now recognized for 5 minutes. STATEMENTS OF DR. PAUL M. HARARI, PROFESSOR, CHAIRMAN, DEPARTMENT OF HUMAN ONCOLOGY, UNIVERSITY OF WISCONSIN SCHOOL OF MEDICINE AND PUBLIC HEALTH; DR. DAVID R. WALEGA, MSCI; ASSOCIATE PROFESSOR OF ANESTHESIOLOGY, CHIEF, DIVISION OF PAIN MANAGEMENT, VICE CHAIR OF RESEARCH, DEPARTMENT OF ANESTHESIOLOGY, NORTHWESTERN UNIVERSITY FEINBERG SCHOOL OF MEDICINE; DR. JOHN S. CULLEN, FAAFP,FAMILY PHYSICIAN & PARTNER, VALDEZ MEDICAL CLINIC, LLC; DR. HOWARD ROGERS, PHD, FAAD, OWNER, ADVANCED DERMATOLOGY, LLC STATEMENT OF DR. PAUL M. HARARI Dr. HARARI. Chairwoman Velazquez, Ranking Member Chabot, and esteemed members of the Small Business Committee, thank you very much for the opportunity to testify before you today on barriers to health care and burdens on the physicians. I am testifying on behalf of the American Society for Radiation Oncology (ASTRO). I serve as the Chairman of ASTRO's Board of Directors and Professor and Chairman of Radiation Oncology at the University of Wisconsin. ASTRO represents more than 10,000 members who strive to give cancer patients the best possible care to advance the science of oncology. ASTRO's membership includes radiation oncologists, nurses, biologists, medical physicists, and other healthcare professionals who specialize in treating patients with radiation therapy. Our members work in hospitals, academic research institutions, private practices, and this year, more than 1.7 million people will be diagnosed with cancer in the U.S., and roughly 1 million of these will receive radiation therapy. Today, I wish to share with you a major problem that you have identified today. This one also facing the field of radiation oncology, prior authorization. While the system may have been designed as a path to streamline healthcare, in fact, it is frequently harmful to cancer patients in receiving treatment. There are three issues I would like to highlight today. First, prior authorization wastes precious time that physicians could be devoting to patient care. Second, delays in cancer care can have negative impacts on patient outcomes. And third, this disproportionately impacts providers in small community practice settings. Prior authorization has become an overly bureaucratic process that requires physicians to obtain approval from health insurance companies to prescribe a specific treatment, procedure, or medication. Radiation oncologists are increasingly restricted from exercising their clinical judgment in the best interest of their patients. Instead, insurance companies and third-party payers are making clinical decisions for these cancer patients. Who would you want to make cancer care decisions for you--your insurance company or your cancer physician? In a recent ASTRO survey, 9 of 10 radiation oncologists reported patient treatment delays due to the prior authorization process. In cancer care, timely treatment matters. Yet, prior authorization practices are delaying patients from receiving life-saving therapies, literally putting the lives of millions of people at risk. In my own practice at the University of Wisconsin Comprehensive Cancer Center we have 16 busy radiation oncologists who routinely face treatment delays for their patients related to prior authorization. Let me provide a personal example. When a prior authorization is denied despite the best efforts of my administrative staff and resident physicians, I may be called upon to conduct a peer-to-peer review by phone. This occurred for a patient of mine with a complex base of skull tumor. The peer reviewer was a thoughtful general practitioner who was unfamiliar with base of skull chordoma and unfamiliar with radiation and asked me for several minutes about the tumor, the natural history, the anatomy, the normal structures nearby, and before concluding said, Dr. Harari, you are obviously highly expert in this area. I will authorize the radiation treatment just as you prescribe. Meanwhile, my patient had been anxiously awaiting for 8 days while that tumor was growing to learn confirmation that they could receive the prescribed cancer treatment that was recommended. The problems associated with prior authorization are so pervasive that 2/3 of radiation oncologists surveyed have had to hire new staff to handle these requests. In an era of value- based care, where is the value when we are increasing costs to deliver care without any added clinical benefit? The issue of prior authorization is concerning for patients who receive treatment in private practices who often have less staff to handle these requests. In 2018, a report from the Office of the Inspector General stated that Medicare Advantage organizations may have an incentive to deny preauthorization of services in order to increase profits. In the same report, it was revealed that CMS had acknowledged widespread and persistent performance problems related to inappropriate denials of care and payment. In conclusion, legislation is needed to relieve radiation oncology patients and physicians of the burden from restrictive prior authorization. Members of this body can put themselves in the shoes of a newly diagnosed cancer patient to appreciate the significantly negative impact that treatment delays can have on their lives. ASTRO looks forward to working with policymakers and stakeholders to develop policy-based solutions to fix this broken system. Thank you very much. Chairwoman VELAZQUEZ. Thank you very much, Dr. Harari. Dr. Walega, you are now recognized for 5 minutes. STATEMENT OF DR. DAVID R. WALEGA Dr. WALEGA. Chairwoman Velazquez, Ranking Member Chabot, and members of the Committee, thank you for the opportunity to testify before the House Committee on Small Business today. I offer this testimony on behalf of the American Society of Anesthesiologists (ASA) and my colleagues who practice pain medicine. Physicians like me are all too familiar with the burdens of prior authorization and the toll it takes on our patients and our medical practices. Because of our current broken insurance system, physician time and practice resources are increasingly allocated to fighting insurers instead of caring for patients. It is a system built to fail. Presently in medicine we are facing dual crises. First, we have the opioid epidemic. Second is the crisis of chronic pain. The most recent statistics on the prevalence of chronic pain conditions in the United States is staggering. I would like to tell you about a patient of mine who I will call Betsy, to illustrate the complicated interaction of these dual crises and the predicament many pain specialists like me encounter daily. Betsy is 38. She came to me with a 10-year history of back pain and nerve pain in her legs following a failed spine fusion surgery. When I saw her she was dependent on high doses of opioids to manage her pain, and despite these high doses, her pain was not under control. She felt hopeless. She had seen multiple doctors and the cycle of this pain had been going on for years. That day in my office she tearfully pleaded, is there anything you can do for me? After examining her, I knew Betsy would be an ideal candidate for a non-opioid treatment for chronic pain called spinal cord stimulation (SCS). This is a treatment in which we surgically place small stimulating electrodes adjacent to the spinal cord to deliver imperceptible electrical impulses to the spinal cord to block pain signals from being transmitted to the brain. To make sure this treatment would be effective for Betsy, I recommended that she taper her opioids by at least 50 percent before we would proceed with treatment as high doses of opioids can cloud the effects of stimulation. Surprisingly, that day she tapered completely off of all of her medications. Per standard practice, I first implanted a temporary spinal cord stimulating system for a 10-day trial. Her health insurance provider did approve this. During the trial, we want to see at least a 50 percent reduction in a patient's pain with a commensurate improvement in their physical function. In Betsy's case, the gains with her temporary trial were nothing less than astounding. She became a completely different person. Her face had brightened, she moved around my office with ease. I heard her laugh for the first time. She told me that during the trial she went for walks around the neighborhood with her husband, something she had not been doing for years. She was able to play with her two children who have special needs. For those 10 days she had her life back and she was ecstatic. So I submitted the required forms and letters of medical necessity to her insured to obtain authorization to implant a permanent spinal cord stimulation system. That implant was denied by her insurer. I appealed the denial which was denied again. I appealed again and requested a peer-to-peer review. The concept behind the peer-to-peer review is that another physician chosen by the insurer objectively reviews the medical necessity of a proposed treatment and speaks directly to me, the provider. Unfortunately, peer-to-peer is a misnomer as the physician reviewer, as previously stated, is usually not a similarly trained or experienced specialist in the field. In fact, I have had a general pediatrician review prior cases like this one. In Betsy's case, the appeals process took 8-1/2 months. Feeling hopeless and experiencing intolerable levels of pain again after the temporary system was removed, Betsy went back on opioids to control her pain. She lost hope all over again even though we had a proven treatment that was effective for her. It was my appeal to the medical director to her insurance company that got the treatment finally approved. Today, Betsy has her spinal cord stimulator. She is not taking opioids. She is taking care of her kids. She is independent and she is returning to the workforce. She has her life back. Betsy's ultimate clinical outcome is the reason I became a physician, to help patients live their best lives despite an underlying medical condition. Physicians do not have the resources to fight this type of fight for every single patient, not in our current practice environment. These appeals take precious time away from providing care that other patients need, and for these reasons I am appreciative that the Committee is looking critically at this issue. In my submitted written testimony, I have included specific recommendations to remove barriers to comprehensive multidisciplinary pain care, as well as substance use disorder treatment. And I thank you for your consideration this morning. Chairwoman VELAZQUEZ. Thank you, Dr. Walega. Dr. Cullen, you are now recognized for 5 minutes. STATEMENT OF DR. JOHN S. CULLEN Dr. CULLEN. Chairman Velazquez, Ranking Member Chabot, and members of the Committee, I am honored to be here today representing the 134,600 members of the American Academy of Family Physicians. I am a practicing family physician in Valdez, Alaska, a community of about 4,000 people. I am also a small business owner and a partner of the Valdez Medical Clinic, LLC, and along with five family physician colleagues, we are the sole providers for a geographically isolated community 300 miles from the nearest tertiary care hospital, and the area we serve is about the size of Ohio. The AFP welcomes this hearing on utilization management as an important and necessary step towards reducing both barriers to care for patients and the administrative burdens for family physicians. As I detail in the written testimony, family physicians and their patients face a daunting array of administrative barriers to appropriate and necessary medical care. The result has been chaos in caring for our patients, burnout for family physicians, and worse outcomes for patients. Ask any practicing family physician about preauthorization and you are going to get an earful. Prior authorization is a major reason that small practices like mine are closing. In my own practice, a patient of mine had a combination of Crohn's Disease and severe psoriasis and we eventually controlled both disorders with a monoclonal antibody therapy after years of trying multiple other regimens and with consultation with multiple specialists. After 2 years, we had to reauthorize this medication which had been working so well, and that resulted in a delay of months, during which her condition worsened. And when we finally were able to get her back on the medication, she had a serum sickness reaction and suffered anaphylactic shock and we almost lost her. And she can now never use this medication that was working so well. Most family physicians in private practice have contractual relationships with seven or more insurance companies, including Medicare and Medicaid, and now our practice, and again, I am in a town of 4,000 people, has 35 different insurance plans we deal with, each of which has its own system of prior authorization and drug formularies, and which change on a regular basis. I often do not know in advance which medications in which class will be covered, and this often means that when I wrote a prescription, my patient has to take it to the pharmacy to find out if it is covered. And if it is not, then I need to find an alternative often by writing a new prescription and the process gets repeated. We use electronic preauthorization but we do not often get a timely answer and this leads to a phone call by me or one of my staff to a reviewer who often has a very hazy idea about the difference between generic and tradenames or even what the medication does. My patients rarely blame their insurance company for this administrivia. They blame me for not getting them the medications they need, yell at my staff, or just stop taking the medications they need to prevent hospitalization. And this is the hidden cost of prior authorization. My staff burn out and quit because of the frustration inherent in this crazy system, compounded by being yelled at by patients for not having their medications. So I was just told before I came here that my nursing supervisor is quitting next month. And she and one of my MAs is spending their entire time just doing prior authorizations. And that is not what she trained for. In the recent 2019 AFP survey, administrative burden was by far the top issue facing family physicians, of which EMRs and prior authorizations for medications, durable medical equipment, and procedures such as imaging were the most impactful. Prior authorization for durable medical equipment typically requires a physician to fill out a paper form or submit specific data for approval, and each DME company has different data requirements for submission. We are being pelted with DME forms. Family physicians simply want to be able to prescribe efficiently and effectively what their patients need to help them manage their condition in a way that maintains their health. And we know how to fix it. America's frontline physicians have developed joint principles on reducing administrative burden in health care. The AFP strongly urges the adoption of the prior authorization and STEP therapy recommendations that we shared in our written testimony. We call for prior authorizations to be minimized, standardized, and universally electronic to promote efficiency and reduce administrative burdens that direct valuable resources away from patient care and can inadvertently lead to negative patient outcomes. We support the Improving Seniors Timely Access to care Act, H.R. 3107. It is a bipartisan effort. It is a step in the right direction and will protect Medicare Advantage patients by streamlining prior authorization practices. The prior authorization practice is out of control. It is increasing, and rather than a tool for preventing unnecessary or expensive care, prior authorizations negatively impact patients' health, and is a significant cause for family physician burnout and the closure of small private practices. So thank you very much for your interest in reducing both barriers to care for patients and administrative burdens on family physicians. Chairwoman VELAZQUEZ. Thank you, Dr. Cullen. Dr. Rogers, you are now recognized for 5 minutes. STATEMENT OF DR. HOWARD ROGERS Mr. ROGERS. Thank you, Chairwoman Velazquez, Ranking Member Chabot, and members of the Small Business Committee, for the opportunity to speak before you today on behalf of the American Academy of Dermatology Association. I am Dr. Howard Rogers, board-certified dermatologist, and I own a small private practice, Advanced Dermatology, in Connecticut. As a small business owner, I appreciate the Committee's efforts to prioritize reducing administrative burden such as utilization management processes. My testimony will focus on how increasing administrative burdens are impacting small medical practices such as my business, and more importantly, I will highlight how prior authorizations delay necessary care for patients. Physicians' practices are on the frontlines of the healthcare system. Right now, while our country is grappling with how to increase patient access to high quality care while reducing costs, my colleagues and I are forced to comply with utilization management systems that seem designed to force doctors out of practice. I and other physicians in my practice dedicate at least 15 hours a week on prior authorizations alone. Prior auths drive up the cost of running a medical practice. They routinely delay critical patient care and contribute to physician burnout while providing no increase in quality of care. Dermatologists diagnose and treat more than 3,000 diseases. For many skin diseases and conditions, the medications are specialized and their use is highly nuanced, and it is dependent on numerous factors specific to the patient and his or her disease. Prior authorization policies place a third party in the decision-making position with little or no understanding of the complexity or full history of a patient's condition. So just imagine seeing a patient in your office with a severely painful condition or a rapidly spreading infection. You prescribe a highly effective medication, you walk the patient through how they are going to use that medication, and you assure the patient that they are going to soon feel better. Then the following scenario occurs. The prescription is denied because prior authorization is required and you try for days or weeks to get that medication approved while the patient continues to suffer. The patient goes to the pharmacy repeatedly and is told that the medication is denied, is no longer covered, requires a prior authorization, and there is nothing they can do about it. You can imagine the frustration and desperation of patients when they are at their most vulnerable. So in my office, my staff spent 70 hours a week, 70 hours a week on prior auths alone. I have had to hire two full-time staff at the cost of $120,000 a year with salary and benefits to handle the volume of prior auths. These funds could definitely be better spent on staff education, improved benefit packages for staff, new medical equipment, technology, all those things that bring us forward as physicians. We appreciate Congress working to help alleviate the prior authorization burdens by including language to create a standardized electronic prior authorization form for Medicare or prescription drugs in the support for Patients and Communities Act which passed in October 2018. Prior authorizations are also delaying patient access to necessary dermatologic procedures. Mohs micrographic surgery is a technique that dermatologists use to surgically excise skin cancers, ensuring in real time that the malignancy is fully treated while sparing as much healthy tissue as possible. Typically, Mohs surgery does not require a prior auth. However, the reconstruction of the defect left after the surgical excision does. And since the physician does not know the extent of the repair procedure that will be needed prior to the surgery, obtaining the prior authorization is not possible. And so this leaves the physician, me, with a patient with a hole in their skin and no authorization to repair it. By prohibiting plans from requiring prior authorization during skin cancer surgery, patients will be ensured the best chance of positive outcome. To address this burden, we ask the members of the Committee to support the Improving Seniors Timely Access Care Act (H.R. 3107). This legislation aims to relieve prior authorization burdens for procedures under Medicare Advantage Plans, as well as to provide transparency to patients and providers. So it is impossible for me to capture in these remarks how the prior authorization process hinders the practice of medicine. Even with the extra support staff, the providers in my practice are regularly disrupted from patient care to deal with prior auths. In fact, 1/4 of all communications in my office, be it phone calls, faxes, emails, EMR notifications, payer portals, they are all associated with prior authorizations. And the kicker is that most of my patients' prescriptions and repairs eventually get approved but only after exhaustive efforts of calling insurers and appealing denials. However, the process truly wears down my colleagues and staff to the point where I worry about burnout for them. We became physicians to help patients, not complete paperwork. And the constant struggle has become too much for many of my colleagues, including my practice partner who is retiring despite being in good health and loving seeing his patients. Prior authorization ultimately ends up costing the healthcare system more than it saves. So on behalf of the American Academy of Dermatology Association, I thank you for holding this hearing and your interest in safeguarding physicians and patients from unnecessary utilization management practices. And I am happy to answer any questions. Chairwoman VELAZQUEZ. Thank you, Dr. Rogers. Let me take this opportunity to thank all of you for your insightful testimonies, and specifically for putting a human face into the issue of prior authorization. I would like to ask each one of you, how often do you have to delay the start of treatment because of the prior authorization process? Dr. HARARI. Chairwoman, the survey that ASTRO conducted of all radiation oncologists recently identified that 9 in 10 radiation oncologists have patients with treatment delays. As many as 2/3 of patients will experience a delay in the start of their cancer treatment related to prior authorization. Chairwoman VELAZQUEZ. Yes? Dr. CULLEN. And I guess I am speaking just from a personal perspective but we have at least three or four a day if not more, just in my own, the patients that I am seeing. Chairwoman VELAZQUEZ. So in your view, are these health insurance companies that you have to deal with equipped to determine the course of action or the course of treatment that is best for your patients? Dr. WALEGA. I would like to answer that. Chairwoman VELAZQUEZ. Has there been any study conducted to that effect? Dr. WALEGA. As far as studies, I do not know but as I think we all commented, the individuals who are ultimately making the decision about our patients' fate and how their health care will be directed is made by someone who does not do what we do. They do not see the patient. They probably have not looked at the medical records that we have sent to them repeatedly, and they often do not know the latest technology that we are applying in these cases of treatment. Chairwoman VELAZQUEZ. So are you telling me that you do not know what type of data or scientific evidence the health insurance companies are using when making a decision? Dr. HARARI. I can tell you that there is very strong, robust scientific data that delaying cancer treatment can decrease survival. There are dozens of papers identifying each week of delay for fast growing tumors can knock off 1 or 2 or 3 percent of the cure aid. I am aware of no scientific data that the insurance companies provide as to why those delays are acceptable. Chairwoman VELAZQUEZ. In a 2018 report, and I believe that some of you mentioned it, the OIG stated that, and I quote, ``Medicare Advantage organizations may have an incentive to deny preauthorization of services in order to increase profits.'' To the entire panel, based on your experience, do you find this to be true? In other words, is this cost-saving measure used by insurers really a disguise that allows them to increase their profits at the expense of patients? And at the expense of the bottom line of your practices? Dr. HARARI. I am sorry to say that I think that this is true. This is certainly the experience of the radiation oncologists across the U.S. that were surveyed, identifying that 2/3 of the prior authorization denials were subsequently overturned on appeal, suggesting that the incentives that are derived by healthcare benefit managers may be prioritizing their actions over what is best for the individual cancer patient. Chairwoman VELAZQUEZ. Yes, Dr. Cullen? Dr. CULLEN. So I think for us one of the best examples is albuterol. Albuterol is an inhaler used for asthma. But I have to decide whether the insurance company will accept albuterol or whether they will accept ProAir or whether they will accept Ventolin. They are all the same thing. But it really depends on which one that insurance company will accept at that moment in time. And a lot of that is based on agreements that they have with pharmacy benefit managers. Another good example is we start joking about the PPI de jour. That is the proton pump inhibitor of the day because those change on a regular basis. We are never informed about what those changes are but these are common medications. I was talking earlier that I had to preauthorize hydrochlorothiazide which is a blood pressure medication that has been used forever and has a great safety track record. It is very inexpensive, but I had to prior authorize even that medication as a generic. So unfortunately, I think that that is the case. Chairwoman VELAZQUEZ. Dr. Rogers? Mr. ROGERS. Unfortunately, there is little or no transparency in how the prior authorizations are judged, nor the guidelines by which the reviewers look at the clinical information provided. It seems haphazard, and it is designed to wear the physician down to the point where care is not rendered, which would definitely increase profitability for the insurers. Chairwoman VELAZQUEZ. I do not have much time left but I would like to ask the following question and see which one of you would like to answer. Do the third-party benefit management companies, Medicare Advantage plans, hired to conduct prior authorization also have this perverse incentive? Dr. HARARI. I believe so because it is reflected in the overwhelming number of prior authorization denials that are then subsequently overturned after 2 to 3 weeks of fussing back and forth. Chairwoman VELAZQUEZ. I ran out of time. Thank you so very much. And now I recognize the Ranking Member, Mr. Chabot. Mr. CHABOT. Thank you, Madam Chair. Dr. Rogers, I will go with you first. In your opening statement you mentioned not being able to complete surgery for the patient because of prior authorization. Could you explain how on an everyday basis this actually works in the office and what specifically about prior authorization hinders the process? Just how does it make it that much more complicated than everything else? Mr. ROGERS. Sure. I would love to give you an example. So just a few days ago I was operating on a patient, and unexpectedly, the skin cancer that was on her nose extended all the way through from the outside to the inside resulting in a full thickness defect. In that sort of scenario, the reconstructive codes that are going to need to be used are, you know, extensive. And so I immediately asked my nurse, get on the phone to her Medicare Advantage plan and get prior authorization. So after an hour of being on the phone, the nurse said they are going to get back to us in a few days. But the woman, who if I do not properly reconstruct this nose, it is going to collapse. She is not going to be able to breathe properly and the cosmetics of it will be severely affected. So in that sort of scenario I go ahead and perform the reconstruction including cartilage grafting and flap reconstructions with the distinct possibility that there will be no payment on the end. Mr. CHABOT. Thank you very much, Doctor. Dr. Cullen, many states have recently passed laws on STEP therapy protocols that would benefit doctors, patients, and insurers. Do you think these legislative efforts can improve some of the burdens that you have described with prior authorizations? Dr. CULLEN. I think specifically reducing the amount of time to get a response, those kind of legislations have been shown to be invaluable. I, unfortunately, have not been able to experience any of these personally because Alaska has not done either one of those as far as STEP therapy or timeliness in response. We would like to see the STEP therapy though drastically reduced as an academy because we do not see that as being a valuable way to pursue this. Mr. CHABOT. Okay. Thank you very much, Doctor. Dr. Walega, according to CDA data, most opioids are not prescribed by physicians such as yourself but rather primary care physicians or dentists. Are prior authorization requirements for opioids worth the extra time it takes if it helps keep addictive medications at bay? Dr. WALEGA. First of all, I would like to mention that the number of opioid prescriptions in the United States is going down and the number of deaths related to prescribed opioids has also precipitously dropped. The deaths that we are seeing is primarily from recreational use, basically street drugs, heroin and fentanyl. As far as the pathway of primary care physicians writing for opioids as well, I think we have made tremendous gains in educating providers, primary care providers, as well as ancillary providers with regard to not going to opioids first, and if opioids are going to be prescribed, having much more tight guidelines, practice guidelines around that. Urine drug screening on a regular basis if the prescribing will continue. Having the patient read and sign and agree to an opioid agreement which states the prescriber will be the only prescriber. The patient will take the medication as prescribed, not run out early, not double the dose, not treat themselves without the provider's input. So that problem, I think, is decreasing. We still do see the CDC guidelines on opioid prescribing misappropriate or misapplied wherein here is a CDC rule that says do not prescribe more than X amount of drug per day to all patients, and that is misapplied. We have patients who have done very well on doses of opioids higher than that doing well, showing no use of substance use disorder. And that medication is being denied at times. Mr. CHABOT. Thank you, Doctor. I appreciate it. I want to get one to Dr. Harari real quickly. Doctor, Cincinnati Children's Hospital in my congressional district helps community practices with their billing and software needs. Do you know of any other hospital systems that do this? Dr. HARARI. There are. There certainly are. We have at the University of Wisconsin, and I am sure similar in your state, as a major academic center where we have satellite outreach clinics in community practice settings where we provide the radiation oncologists and physics technical care and we will assist them with the billing process in those community processes. Mr. CHABOT. Thank you very much. And I would note, Cincinnati Children's Hospital is usually in the top three best children's hospitals in the country. And when you consider the size of Cincinnati versus some other areas, we are very proud of Cincinnati Children's Hospital. So, thank you very much. Chairwoman VELAZQUEZ. The gentleman yields back. And now we recognize the gentlelady from Kansas, Ms. Davids for 5 minutes. Ms. DAVIDS. Thank you, Madam Chair. I appreciate the opportunity for us to discuss this very important topic today. I definitely am determined to do everything I can while during my time here in Congress to increase patients' access to health care. I am very, very concerned about the prior authorization and STEP therapy being used are barriers to that access. I have heard from a lot of providers in the Kansas Third District which I represent, providers and physicians, and they are frustrated. They are disheartened by the way that prior authorization and STEP therapy are used to delay care. And I know some similar sentiments have been shared here today. I was recently able to take a tour of a pediatric orthopedic practice in Prairie Village, Kansas, and learned about the burden of STEP therapy in their practice. For that small business, fighting for a single STEP therapy protocol exemption or appeal costs their nursing staff sometimes 1 or 2 full hours as different insurance providers use different and often complex processes. That kind of arduous paperwork just to provide the right care to patients imposes increased administrative costs which I am sure you are familiar with. And just the time to the medical practice. I guess the first question I would ask is prior authorization and STEP therapy are intended to be processes that encourage providers and insurers to seek the most cost- effective treatments and procedures. Do you think those processes generally reduce out-of-pocket costs for patients? And I will just open it up because I am sure everybody on the panel probably has thoughts on that. Dr. CULLEN. I do not think that it does. I mean, first off, I think that if we just had a transparency of what the direct costs were, the actual costs, that we would more to reduce costs for our patients than any other factor. Because as family physicians, that is what we try to do. We try to reduce the burden for our patients regardless. What I have seen though is that the costs really have risen as we have engaged in this whole process of prior authorization and STEP therapy. And so it really does not seem to be doing its intended purpose, if that ever was its intended purpose. But like I said, I think just having a transparency of what things actually cost is going to do more than anything else. Mr. ROGERS. From the dermatology perspective, I can tell you that in many circumstances the cost to the patient is grossly higher. And I will just use an example of what is called a topical calcineurin inhibitor, which is a type of cream that is nonsteroid and has no side effects associated with the skin. And a lot of insurers are requiring two failures of steroid medication which may be contraindicated to sensitive areas like groin, face, things like that, before you can get coverage of the medication that is going to work with the least side effects. And so the patient has multiple copays before they actually get what they need. Dr. WALEGA. I also think there are cases in which the steps of the STEP therapy really do not make sense for the patient and it wastes valuable time and money. I think in cases, particularly with specialists, I am probably biased, but by the time the patient gets to a medical specialist, many of the simple things have failed. And our judgment I think is quite important, and in some cases we should be deferred to and we are not. Ms. DAVIDS. Well, one, I appreciate that and Dr. Cullen, I would just say I think you hit the nail on the head when you said if it was the intended purpose. I will leave it at that. I appreciate your time, your testimony, and the work that you all are doing. And with that I yield back. Chairwoman VELAZQUEZ. The gentlelady yields back. And now we recognize the gentleman from Minnesota, Mr. Hagedorn, for 5 minutes. Mr. HAGEDORN. Thank you, Madam Chair. Thanks to the witnesses. I would agree. You go out and do all this education, training. Put years and years of work to prepare to treat patients and then you go to do the work and you have to ask permission every step of the way and people are looking over your back and questioning you. And then sometimes changing basic decisions that you make as to how best to treat patients. And so whatever we can do in order to make it possible for you to do your job, we will support you 100 percent. We will support that bill you are talking about with the Safe STEP Act. And also, but is this not also part of kind of a scam that is going on with these pharmaceutical benefit manager programs where you will prescribe a drug and there may be like two competing drugs do the same thing and when it comes time to fill it at the pharmacy there are these rebates and things that they get back the money. It does not go to the patient. It does not go to the consumer. It certainly does not go to you. And they are picking winners and losers as to which drugs to use based on basically kickbacks. They jack up the price of the drug in many instances in order to make that happen. Are you familiar with this? Do you see this in your practice? I will leave it to anybody. You do not have to use my language on it. I am pretty tough. You know what I am talking about though; right? Mr. CULLEN. I think that I am going to defer to your expertise on this. Mr. HAGEDORN. Well, we spent some time during the break with a local pharmacy and they walked us through it. And it is pretty rough what happens. And it is, again, it is not helping the consumer and it is not helping the patient, necessarily. But they are deciding based upon what works best for them financially which of the drugs to prescribe. And in the olden days, you know, doctors would talk with pharmaceutical company owners. Now you cannot have hardly any of those conversations. You cannot take a pen. They have wiped you out of that, which is fine, I guess. But there is this kind of middle man that is doing that job now and I would like to see some of the reforms. If you do not want to address it, maybe it is too sensitive. But we will move on from there. The other thing I would say is this is not just a problem that you have with private insurance companies; right? Do you not deal with the government a little bit and have some of the same issues? Like, there are some things that we can do to streamline that with Medicare, Medicaid? I will start over here. Dr. HARARI. Absolutely. This is pervasive, and I think your words that this is not benefitting the patient is very precious. There is no benefit to a cancer patient to have a delay in the start of their treatment. And even when there is the intent to be sure that an effective therapy is being delivered often by pushing the physician to generate a less expensive therapy that comes with collateral damage in the name of radiation, we are applying a simple plan to treat a brain tumor where the beam has to go through the eye and cause damage to normal tissue or go through the heart to treat a lung cancer because they want to see a simple, just front and back radiation rather than a conformal plan. Less expensive but more damage to the normal tissue for the patient. And so in terms of cost, ultimately this costs the healthcare house of medicine much more to deal with those side effects. So this happens on all sides. Dr. WALEGA. On a more practical level I know that my Medicaid patients and the Medicare Advantage patients are scheduled 15 business days after their evaluation with me when I have put forth a treatment plan because we know it is going to take at least that long to get that approved. So 15 business days is 3 weeks. That is a long time to wait for treatment when you have pain that is described as 10 out of 10. Dr. CULLEN. We actually have fewer problems with Medicaid and Medicare than with a lot of the private insurers. I mean, this is a process that is going across the board but I guess in answer to your previous comment, the big problem we are having is that the formularies are changing on a regular basis and that is because of things other than patient care. And so that is something that we are dealing with. It is creating just tremendous chaos in our ability to prescribe for our patients. And it is causing chaos for the patients because a lot of times they have been on medications for years and all of a sudden we have to come up with something else. And even if we change the dosage, we have to come up with another prior authorization plan. This has absolutely gotten out of control. So in light of that, actually, the Medicaid and Medicare are actually doing better than the others. Mr. ROGERS. Congressman, I agree with you entirely in that government plans are a problem in addition to private insurers. At least in my state, the kind of most egregious delays in care and not getting back to our office of whether a prescription is approved or denied is frequently seen with the state Medicaid. Mr. HAGEDORN. Thank you very much. Chair, thank you. Chairwoman VELAZQUEZ. The gentleman yields back. And now we recognize the gentleman from Pennsylvania, Vice Chair of the Committee, Mr. Evans. Mr. EVANS. Thank you, Madam Chair. I thank you, Madam Chair, and the Ranking Member for this hearing. This is very appropriate during this time. Dr. Cullen, according to your testimony, primary care physicians spend nearly 50 percent of their time on administrative activities, such as prior authorization and only 20 percent of their time on clinical activities. Do these burdensome tasks limit the number of patients primary care physicians can accept and treat? Dr. CULLEN. Indeed. So I have been in practice for 25 years. Before all this started I would see about 25 patients a day. I am now down to about 15 patients a day. So this has reduced the number of patients that I have been seeing. That is a problem because we are looking at a severe shortage of primary care physicians in this country, and what I am experiencing is being replicated across the country. Mr. EVANS. Can you explain the role in that particular case of primary care or family physicians in the patient's overall health care? Dr. CULLEN. So one of the reasons why our healthcare system is as expensive as it is, is that we do not prioritize primary care to the extent that we should. We are spending about 4 percent of our dollars on primary care. Other healthcare systems that are spending a lot less money on health care than we are have upwards of 15 to 20 percent of their dollars spent on primary care. The problem is, is that things that are not caught in a timely fashion or the chronic diseases that end up in hospitalizations, if we do not have family physicians and primary care physicians managing those, you end up spending a lot more money. So for every dollar spent on especially advanced primary care, you save about $13 overall to the healthcare system as a whole. One of the reasons why we are spending as much as we are, 18 percent of our GDP on health care is because we are not prioritizing primary care. Mr. EVANS. Can anyone else on the panel, that same question I asked, explain the role of primary care family physicians and patient, give some reaction to that? Any other comments on that? Yes? Mr. ROGERS. I agree with the incredible importance of having ready access to primary care with a huge variety of different treatments that they can do in disease processes. As a small specialist, I also see the value of specialty care in that there are more advances in medicine every year than has ever been in the past of medicine. And so in order to provide patients with the most up-to-date care, we need an integrated system that allows primary and specialty care to interact and collaborate efficiently. Dr. WALEGA. I would also add that we have discussed the shortage of primary care physicians. That trend is continuing. When medical students finish medical school and they go through their training, they often have $100,000, $200,000, $300,000 worth of debt. I cannot imagine that one would be able to pay off that debt in a timely way if you are seeing 12 to 15 patients a day in a family practice. It just does not make any economic sense at all. So that trend will continue. Dr. HARARI. There is a reason that many of the U.S. medical schools are emphasizing primary care to their medical students. At the University of Wisconsin, we are one of two schools of medicine and public health that is trying to serve the needs of the state in rural areas of Wisconsin. Many states have this issue where the cities are well served with primary care but the rural communities are not. And so as Dr. Cullen alluded to, we have to make a much more concerted effort to provide talented primary care providers to our citizens. Mr. EVANS. Madam Chair, I yield back the balance of my time. Chairwoman VELAZQUEZ. The gentleman yields back. And now we recognize the gentleman from Pennsylvania, Dr. Joyce, Ranking Member of the Subcommittee on Rural Development, Agriculture, Entrepreneurship, and Trade for 5 minutes. Mr. JOYCE. Thank you, Madam Chairwoman. Today, I have with me a letter signed by 371 national and state-based patient, provider, and other healthcare stakeholder groups in support of H.R. 3107, the Improving Seniors Timely Access to Care Act, which would bring the needed transparency and accountability to prior authorization in the Medicare Advantage Program. I respectfully ask that the letter be submitted for the record. Chairwoman VELAZQUEZ. Without objection, so ordered. Mr. JOYCE. Thank you, Madam Chair. First of all, I look out at this esteemed group, and with bias I say it is the most intelligent group that has presented to our Committee so far. Mr. CHABOT. We have got a lot of intelligent people here. Mr. JOYCE. Thank you, Ranking Member Mr. Chabot. I have worked closely with radiation oncologists, I have friends, I have utilized anesthesiologists with backgrounds in pain management. And daily, until just 8 months ago, I would interact with family practitioners who are the heart and soul of American medical care. And of course, when I look at Dr. Rogers, I see a compadre, a board-certified dermatologist, a fellow in the American Academy of Dermatology. We share so much. I hear your story and I thank each and every one of you for bringing it to the halls of Congress. It is so important for us to realize what you go through on a daily basis for as you said, Dr. Cullen, to make people's lives better. It seems like a simple goal. And yet there are obstacles that are being placed in front of you. And we need to hear and work hard to repair those obstacles that are in front of you. So please allow me, if I can address the first question to Dr. Rogers for being here today. Dr. Rogers has an interesting expertise that I would like to illuminate and tell everyone on the Committee what he does. He is a board-certified dermatologist, as he said, that takes care of over 3,000 diseases, skin diseases, and diseases that affect all organ systems in the body. In addition to that, he did additional training in Cincinnati with Dr. Brett Coldiron in Mohs micrographic surgery which is a long name for a type of surgical training that allows the dermatologist to remove the skin cancer and see that the margins are clear and then repair it. So it seems like a simple process. He talked about treating a patient with a skin cancer on their nose and arduously he removed that skin cancer until there was no sign of it left behind and then he went to repair that and he could not have the authorization to do that repair. This is a tragedy. This does not allow for good patient care. So what does that mean? That means that the patient is going to have to come back, risk adverse reactions, the collapse of the cartilage of their nose while he waits for the approval to do that, and go through anesthesia again. Go through the injections that he has already put the patient through and is prepared to repair that. Dr. Rogers, did I summarize this case clearly? Mr. ROGERS. You did. Thank you, Congressman. You did summarize that well. As a dermatologic surgeon, it is clear to us that as we are working on the patient, there are a lot of patient-specific factors. We cannot know exactly how best to repair somebody from a functional standpoint so that they are going to breathe, have normal lip function, have normal eyelid function, as well as a great cosmetic result beforehand, which is basically what the insurer is asking for. They are asking for a prior authorization exactly how this is going to go. And when you are in the operating room, you do not know until you are there and then you are scrambling to try to get prior authorization to do a medically necessary procedure to put this patient back together. Mr. JOYCE. In other areas, let's talk general dermatology if I may, please. Someone comes into your office. They have a cellulitis, a skin infection of the upper extremity. And let's say from our common knowledge base that you prescribe a form of penicillin, maybe a cephalosporin that has been in the generic form since I graduated from medical school, from a long time ago. And you want to prescribe Cephalexin. What obstacles are placed in front of you, Dr. Rogers? Mr. ROGERS. Yeah. So this has actually become a problem this year which is just kind of unimaginable. So the main standard of care treatment for a staph infection, superficial staph infection, is oral Cephalexin. We all know if you have a staph infection you have got to jump on it right away. And there is an insurer who has placed a prior authorization on Cephalexin, and I have seen two instances in my office where superficial infections have gotten out of control because of a prior authorization process that delayed treatment. The patient went to the pharmacy, did not get their medicine, and then progressed rapidly and had to be hospitalized resulting in hundreds of thousands of dollars of expense that could have been dealt with right at the pharmacy. Chairwoman VELAZQUEZ. The gentleman's time has expired. I now recognize the gentlelady from Minnesota, Ms. Craig, for 5 minutes. Ms. CRAIG. Thank you so much, Madam Chairwoman. I just want to start by saying I had an ear infection last week and I went to see my primary care physician and I got an earful pretty much in addition to treatment for that ear infection on exactly what each of you have testified this morning. So thank you so much for being here. Health care is absolutely the number one issue that I hear about in my congressional district. My colleague from Minnesota just a moment ago talked about the cost of prescription drugs. My own experience in health care has been that when we have these conversations it is a little bit like the circling firing squad. Brand name pharmaceuticals blame the PBMs. PBMs blame the pharmaceutical companies. And everybody blames the health insurance companies. I am curious as we sit here today on a couple of issues though. Where do you think each of you, as members of Congress, we can beyond just the administrative burden which is absolutely clear is an issue in our country, where else would you have those of us who just arrived in Congress focus in terms of the cost of health care? Not just the cost of health insurance but the cost of health care? And I was particularly curious, Dr. Cullen, your comments around prevention over care. And then I want to ask the specialists a couple of questions, too. Dr. CULLEN. So a lot of it I think has to do with access. And how much people are paying out of pocket, which is definitely getting worse. I had a patient recently who did not come in to be seen for an ear infection because of her copay. As a result she developed just a rip-roaring otitis externa that I ended up having to put her in the hospital for. So what would have been a $65 visit and a $25 prescription of an antibiotic turned into probably a $15,000 to $20,000 hospitalization. We are doing this repeatedly where we are saving money up front and we are paying so much more down the road. And that is not only true with just the cost. I mean, there is a human cost, too, because, for example, maternal mortality has increased and part of that has to do with the access for prenatal care which is diminishing and we are having obstetrical deserts develop in the country. Access is probably one of our biggest things. Because we do not have that access, and I would include the access to a primary care physician, that we are spending enormous amounts of money at the other end where we could be spending a little bit in the beginning and we could be recouping that investment enormously at the other end. I think that is probably the biggest issue outside of the amount of administrative work. Right now we are spending, yes, it is two for one, 2 hours of administrative time for every hour of patient care. If we cut that in half we could see twice as many patients. I mean, this is something we definitely need to address. Ms. CRAIG. I also just want to follow up with that with Dr. Harari. Tell me, is there any reason in your mind to justify prior authorization for CT scans when dealing with routine cancer care? It is interesting to me that that is even a barrier for you. Dr. HARARI. It is interesting to us as well. I recognize that in the broad scale of medicine, imaging can benefit from care and judicious allocation of resources. But when a patient has a cancer diagnosis and they need to have high quality imaging, be that a PET scan or a CT scan to best, most accurately define their tumor so that a surgery or radiation or chemotherapy can be most effectively delivered, it is unfortunate sometimes to have so much second guessing of the known cancer expertise on what that imaging should be. Ms. CRAIG. And where would you have us focus on driving down the cost of health care? Dr. HARARI. You mentioned, the others have mentioned the issue of prevention. Cancer prevention is an enormous area of potential benefit. The funding of the National Cancer Institute and the NIH in advancing prevention studies, the known role of tobacco and alcohol and nutritional elements that contribute to cancer, we could diminish the cancer burden in the U.S. dramatically with some steps in those areas as opposed to waiting until there is an advanced cancer present. Ms. CRAIG. Thank you. Madam Chair, I am just about out of time, so I will yield back. Chairwoman VELAZQUEZ. The gentlelady yields back. And now we recognize the gentleman from Oklahoma, Mr. Hern, Ranking Member of the Subcommittee on Economic Growth, Tax, and Capital Access for 5 minutes. Mr. HERN. Thank you, Madam Chairwoman, Ranking Member, and certainly to the docs that are here to testify on real problems in medicine today. Like my colleague said, no matter where you go, you do not have to be a doctor, you can be a patient. If they know you are in Congress, you are going to hear the issues. And so it is great to hear it firsthand. I have been a businessman for 34 years, and what we know is regulations cause problems. Certainly, when you have extraneous regulations like you all are experiencing, it is very difficult. In my world, it is Dodd-Frank and many other regulations that cause a real burden on the small business. We have heard these from many times over and people sitting in your same position. As the Ranking Member said, we have had a lot of really smart people talking about regulation, regulatory problems across many industries. You know, in the small business practices, your hurdles really are about utilization management programs that are all sizes that really create a real problem. It could be as much as pharmaceutical companies advertising on TV a better drug than you prescribe. And the patient saying I want that drug because I saw an advertisement. We have a whole plethora of issues that we need to get after in this realm. As my colleague once again said, this is one of the number one issues, if not the number one issue in America today to figure this out. Fortunately for me personally, I have a colleague that is a dear, dear friend of mine that you have already heard from that I want to yield the balance of my time. I am a person that says instead of some of us that just talk about and use talking points, let's let folks who are really experts in this field, and I want to yield the balance of my time to Dr. Joyce, please. Mr. JOYCE. Thank you, Representative Hern. And thank you, Madam Chair, for allowing me just to complete this. I think the message that you brought to us today is clear. That STEP therapies and authorizations delay care. So I am going to allow Dr. Rogers just to kind of shine the light on what you mentioned briefly. But I am going to lay some background. So he talked about treating some serious skin conditions and the ability to make a decision not to use topical steroids, which have severe side effects in some situations of where you apply them. So you might not want to put a topical steroid on your face because it thins the skin. And there are other areas of the body that you might choose to use a prescription Vitamin D analog. He mentioned it by its name. And yet, Dr. Rogers, I am going to turn it back to you with the remaining time. So I send to you a 12-year-old with a type of dermatitis, an inflation of the skin that you make a decision to use a nonsteroid, a topical therapy that has very few side effects to the skin that is a Vitamin D analog. What challenges do you face? Mr. ROGERS. So for dermatology, pediatric patients are, they are special. They have a very high amount of surface area of skin, and so you always have to worry about side effects and absorption in those patients. And so you do not necessarily go through the standard way of thinking about patients. You start with safety first because that is how I would deal with my own children. And so when I see a patient like this, first of all, I know that I am in for a long, lengthy battle. It is not the old days where you write a prescription, send them to the pharmacy, and they get what you prescribe and get better. So I come out of the exam room and I say, all right, we are going to start this Vitamin D analog. Could you start the process? And so the prescription gets entered and the pharmacy then gets a denial. And then they send back a number for us to call of the pharmacy benefit manager that is associated with this insurance. And then my staff spends an hour on the phone to figure out what clinical information it is that they want. Then we get some forms, fill those out, send it back. Then, they send it back saying denied. You need to go through STEP therapy. I write an appeal letter saying this is a 12-year-old boy. I do not want to be placing a high-potency topical steroids that are going to result in side effects in this patient. It is not standard of care. They delay for 2 weeks and then it results in a denial. I write another appeal letter and get a peer-to-peer which may or may not go through. The whole process took me an hour and it took my staff 4 hours for this denial. And the frustration level is quite extreme. Mr. JOYCE. And in the meantime, the patient care is delayed; is that true? Mr. ROGERS. Delayed and the patient continues to suffer needlessly. Mr. JOYCE. I think that you have all come to us to shine a light on this problem, and I thank my colleague for the additional time. Madam Chair, I yield back. Chairwoman VELAZQUEZ. Thank you. The gentleman yields back. Now we recognize the gentleman from Illinois, Mr. Schneider, for 5 minutes. Mr. SCHNEIDER. Thank you, Madam Chairman. And I want to thank the witnesses. I apologize. We are oftentimes pulled in different directions, so I am just getting here. But I had a chance to read through your testimonies, so I appreciate you sharing your experiences. Dr. Walega, I will start with you. Also from Chicago. Been a patient at Northwestern. A fan of Northwestern. Graduate of Northwestern. But in your testimony you described the testimony of a 38- year-old patient who goes through a process. You do the first step of the test to make sure the treatment works and then you have to go through the delays. And I read that story with empathy, frustrations. You can run through the list of emotions. What would the right process look like if you were just to describe it? What are the goals that we should we working to achieve in putting guardrails on the system but making sure that you are able to do what you want to do and that the patient is able to get, in this case, the woman is able to get the treatment that she deserves? Dr. WALEGA. So I know the case was fairly extreme but I actually experience these same similar stories every day. I think the main point of this case was a tremendous delay between when we found a proven therapy that improved profoundly this patient's quality of life, her family's quality of life beyond expectations, 8-1/2 months later requiring, you know, going back on opioids, I think everyone in this room has been concerned about the opioid crisis. The pendulum is swinging on opioid prescribing. We do not ever want to put a patient back on opioids if we found something better, more effective, that can be used for the patient's entire life. A shorter period between the time of the proposed therapy and the actual approval. We need to have a specialist who is similarly trained or experienced to help make the decision whether the treatment that we are proposing is medically necessary. Our role should not be to educate someone who knows absolutely nothing about the therapy or the disease process. That individual should not be in charge of deciding the patient's healthcare fate. Mr. SCHNEIDER. And to that point, Dr. Harari, and I may be repeating myself of things said earlier, but in your written testimony you talked about the times that you are talking to someone who is not a peer-to-peer review. And you know, if you can elaborate on that. Is it absolutely necessary to have someone who is a peer or just have someone who understand what you are talking about? Is that trainable? Dr. HARARI. Thank you, Congressman. Ultimately, we want to have someone who has the best interest of cancer patients in mind. And repeatedly, it is apparent that that is not necessarily the case when we are going through the prior authorization process. There does appear to be a repeated denial and delay strategy knowing that some practitioners, particularly small, private community practitioners who do not have the bandwidth to hire personnel to combat the paperwork with prior authorization. We have had ASTRO members recount stories where they say I will go ahead and deliver the slightly less optimal radiation treatment plan knowing that then I will not have to go through a 5-hour process or recreate multiple treatment plans that are going to be denied. So ultimately, that is hurting cancer patient outcome and ultimately adding cost to the system. Mr. SCHNEIDER. Okay. And my last question I will ask the whole panel and start with you, Dr. Rogers and go across. I understand the problems with process, and I come to this as an industrial engineer, process engineer, process matters. What about the goals of trying to make sure, not just that we are getting the right care but the right cost? Is there a problem with the goals at the very beginning or is this strictly the process? Mr. ROGERS. In a time of increasing healthcare expenditures, of course the goal has to be to deliver cost- effective, high-quality care. Having a prior authorization process that is efficient, transparent, and workable for a small business practice would meet that goal plus the goals of running a small business. Mr. SCHNEIDER. Dr. Cullen? Dr. CULLEN. And I would agree with the goal is we want high quality but a less costly system than we have currently. As far as the process, we have all gone through training for many, many years and I think that one of the frustrations about this is the not trusting us to use our best judgment based on our education and based on our experience. We could save enormous amounts of money by just not engaging in all this activity. So I think we need to minimize the prior authorization process as much as possible. So I have two people that are doing full time. They are doing prior authorization. They could be better served taking care of patients, doing prevention, doing education. Instead, all of our resources are really devoted to something that we have the training just to take care of. Mr. SCHNEIDER. And I am out of time. Chairwoman VELAZQUEZ. The gentleman's time has expired. Mr. SCHNEIDER. I yield back. Chairwoman VELAZQUEZ. Now we recognize the gentleman from Ohio, Mr. Balderson, for 5 minutes, who is the Ranking Member of the Subcommittee on Innovation and Workforce Development. Mr. BALDERSON. Thank you, Madam Chair. And thank you all, panel. I appreciate you all taking the time to be here today. I am going to be very brief. I know that everybody has been here for quite some time. But last year, physicians, pharmacists, medical groups, hospitals, and health insurance announced their commitment to working together to improve prior authorization process for patients' medical treatments. I have a consensus here, and I would like to put this in the record, please, that was done by many member organizations that most of you are associated with. And if you do not know what this is, I can most certainly give it to you. We can send you guys a copy so you can go over this. AMA authorized it. Blue Cross Blue Shield, American Hospital Association, amongst some of the few. But in it, the healthcare leaders stated their intent to work together to streamline requirements for therapies, as well as accelerate industry adoption of national electronic standards for prior authorization. What other actions could be taken to improve the challenges faced by healthcare professionals? And anybody on the panel can answer the question. Dr. Harari? Dr. HARARI. Thank you, Congressman, for bringing that forward. And the comment, there are a lot of elements of the prior authorization that could be streamlined and improved. There are centers of excellence in terms of quality and value that are having 90 percent of their denied prior authorizations overturned on appeal. Those centers could be identified to say there is no practice challenge here. We could spot check 1 in 10 cases for prior authorization rather than torture them through every case. There are a variety of examples like that. Increased transparency, publication, public dissemination of the utilization parameters that each insurance provider uses so that it is not a mystery to the patient and to the provider as to which regulations they are using. Often, they are not using national standards. In oncology, National Comprehensive Cancer Network, 30 of the top cancer centers in the Nation that create guidelines, many of these third-party benefit manager organizations do not even adhere to those national benchmarks. So there are a number of areas of transparency that could be improved. Mr. BALDERSON. Thank you. That was a great answer. Would anybody else like to comment? Doctor Rogers, I apologize. Mr. ROGERS. Thank you very much for that excellent question. One of the things that comes to me that could definitely improve the situation from a transparency standpoint and also from a consistency standpoint would be to have, instead of pharmacy benefit managers deciding on how best to administer prior authorizations, have the physicians who are at the point of the spear weigh in. You know, the American Academy of Dermatology would love to have a seat at the table in terms of defining what is reasonable in terms of different treatment algorithms and would have much greater buy-in from our physicians if we could have that sort of collaborative arrangement. Mr. BALDERSON. We are dealing with PPMs in the state of Ohio I am sure you have heard. Dr. CULLEN. So I think, I told the story earlier that I had to prior authorize hydrochlorothiazide which is a generic medication. I think that all generics should not have to go through the prior authorization process. I think that is just absolutely ridiculous. And so I think that as much as we can minimize that prior authorization I think is really important. As physicians, we really do try to do the right thing by our patients and we are spending a lot of money just because there are a few outliers. And I think that all of us are trying to do the very best we can for our patients for the least amount of cost. And I think there needs to be some recognition that that is what we are trying to do. Part of the problem with prior authorization is assuming that physicians are only in it for other reasons and that is just not the way it really is. And so I think that I would like to see all of that whole process minimized. For those practices that are involved in quality-based payment contracts, there is really no reason to have prior authorization at all. And that is with alternative payment methodologies. Not fee-for-service. We were actually getting paid by the quality we deliver. And so there should be no prior authorization for those practices. Mr. BALDERSON. Would you like to add or do you think that everybody has fulfilled the---- Thank you very much. And I appreciate it. I yield back, Madam Chair. Chairwoman VELAZQUEZ. The gentleman yields back. Let me take this opportunity again to thank all of the witnesses for taking time out of their schedule to be here with us today. As we have heard today, our country's healthcare providers want nothing more than to provide their patients with the highest quality and clinically appropriate care. However, time and time again, delays in treatment are leading to adverse outcomes by taking doctors away from patient care. We need to improve the prior authorization process by streamlining and standardizing some of the procedures, while also making sure there is a clear understanding by doctors and patients of the items and services subject to prior authorization. I look forward to working with my colleagues on both sides of the aisle on this important issue. And believe me, this is a committee that works in a bipartisan way. I ask unanimous consent that members have 5 legislative days to submit statements and supporting materials for the record. Without objection, so ordered. If there is no further business to come before the committee, we are adjourned. Thank you. [Whereupon, at 12:59 p.m., the Committee was adjourned.] A P P E N D I X [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] [all]