CUA Synopsis: AUA Advocacy Summit Summary 2019

By CUA Secretary, Dr. John Lam

By Dr. John Lam, CUA Secretary

The following is a comprehensive summary of the Annual Advocacy Summit hosted by the AUA from March 4-6, 2019.

Dear Members:

I attended this 3-day conference along with fellow California urologists, Drs. Peter Bretan, Hyung Kim, Eugene Rhee, Ira Sharlip, Jeremy Shelton, Aaron Spitz, Matthew Pollard, Alan Kaplan, William Bonney, Benjamin Chung, Kristen Greene, William Brubaker, and Kai Dallas.

The General Session started with Bob Woodward, a two-time Pulitzer Prize-winning journalist, author, and associate editor of The Washington Post, who gave the opening Keynote Speech. He spoke about his new book, “Fear: Trump in the White House,” that portrays a White House with infighting and a toxic and volatile work culture that many of President Trump’s top advisers and cabinet members became accustomed to working around their boss, whom they described as unstable and uninformed. Bob Woodward says the Trump administration is like nothing he has seen in his career spanning nine presidencies – which began with Richard Nixon.

Dr. David Penson, Chair of the AUA Science & Quality Council, moderated a session on “Prostate Cancer Screening: Access and Patient Advocacy.” Dr. Penson stated that the “battle” may have been won getting USPSTF to change from D to C, but the “war” of protecting access to PSA screening is still critical as the American Academy of Family Physicians (AAFP) and many primary care providers remain opposed to prostate cancer screening. Insurers may not always pay for PSA testing and the additional testing that may come as a result of the PSA test. In addition, many questions remain around the best way to screen – particularly in men at high-risk for the disease (African-Americans and men with a strong family history). Dr. Ballentine Carter from the Mid-Atlantic Section discussed 3 key points that should be considered in prostate cancer detection: detection and treatment of lethal prostate cancer reduces morbidity and deaths from prostate cancer; PSA is not specific for the lethal form of prostate cancer; and detection and treatment of lethal prostate cancer involves tradeoffs (gamble) between benefit and harm. A temporal relationship exists between changes in PSA testing/diagnosis rates and the USPSTF recommendation against PSA screening in 2012. PSA testing for diagnosis of prostate cancer declined in the U.S., which led to a decline in the incidence of prostate cancer and a subsequent increase in distant metastases among men >age 75 years. Following this, the USPSTF (May 2018) changed their position of on PSA-based prostate cancer detection and recommended individualized decision making for men ages 55 to 69 years because of data showing that in some men screening offered a small potential benefit of reducing the chance of death from prostate cancer. Mr. John Fortin, a patient survivor, from Prostate Cancer International gave a patient perspective on prostate cancer screening. The key takeaways were that there is an immediate need to improve access (ie. reducing financial barriers to screening, promoting screening of higher risk classes, and expanding access to new full body imaging); an immediate need to improve decision making through standardized communication materials including appropriate disclosure of outcomes/side effects that target audience(s) in optimal formats and simple language; and need for improvement opportunities such as ongoing study of screening/diagnosis, active surveillance, genomics, telemedicine, novel treatments, and outcomes (both oncologic and side effects). Dr. Mark Fallick, who serves as a member of the AUA State Advocacy and Legislative Affairs Committees, talked about the grassroots efforts in the development of New York State legislation that requires all health insurance plans in the state to provide prostate cancer screenings to men free of cost that took effect on January 1, 2019.

Dr. Toby Chai, Chair of the AUA Research Advocacy Committee, moderated a session on “The Value of Research: How Funding for Urologic Research Improves Health Outcomes”. Dr. Travis Jerde, who serves as Secretary for the Society for Basic Urologic Research, talked about basic urological research and some of the highest priority needs of researchers, with funding as the common theme. NIH funding associated with every one of the 210 new drugs approved by the Food and Drug Administration from 2010-2016. This research involved >200,000 years of grant funding totaling more than $100 billion. >90% of funding for basic research related to the biological targets for drug action rather than the drugs themselves. NIH funding complements industry research and development, which is good for patients and good for the economy. Dr. Robert Waterhouse, from the R. Frank Jones Urological Society and AUA Public Policy Council member, introduced Dr. Arthur Burnett, who serves as a member on the AUA Research Advocacy Committee. Dr. Burnett discussed the importance of appropriate prostate cancer screening in African American Men with >60% increased incidence, ~ 2.5% increased prostate cancer specific mortality. He also talked about health-related burdens of health care disparities, which are associated with preventable physical and mental health adversity and exact a profound impact on social determinates of health, such as poverty, lower educational attainment, food insecurity and unsafe built environments. By eliminating disparities in health and heath care delivery this could save the U.S. over $230 billion annually in direct medical costs. Furthermore, figures of cost are likely underestimates when one considers financial losses associated with reduced quality of life, uncompensated care, lost productivity, and premature death. Dr. Gail S. Prins, member of the AUA Research Advocacy Committee, talked about two research examples that provided value and hope to improved health outcomes. The first example was “The ENACT (Engaging Newly Diagnosed Men About Cancer Treatment Options) Trial” to look at the impact of gene expression profile on treatment choice and outcome among minority men newly diagnosed with prostate cancer to address critical barriers in biomarker development. State-of-art studies of molecular research investigations of prostate cancer combined with racial disparities to try to avoid over- and under- treatment of men with a prostate cancer diagnosis. Biomarkers can improve shared decision making for prostate cancer. The second example was “Unraveling Prostate Cancer Disparity in African American Men: Challenge to the Free Hormone Hypothesis” that looks at how Vitamin D deficiency leads to increased intraprostatic hormones in African American men.

Dr. C.J. Stimson, AUA Regulatory Workgroup Co-Chair and AUA Legislative Affairs Committee member moderated the session on “Regulatory Burdens to Care”. Dr. William C. Reha from the American Association of Clinical Urologists talked about the “Unreasonable Regulatory Requirements/USP 800”. The United States Pharmacopeia (USP) is a not for profit scientific organization that develops quality standards regarding drugs, excipients, and supplements. USP 800 describes hazardous drug handling related to the receipt, storage, compounding, dispensing, administration, and disposal of both sterile and nonsterile products and preparations. USP standards are enforced by local, state, and federal regulatory agencies such as the Joint Commission, FDA, state pharmacy boards, the Centers for Medicare and Medicaid Services (CMS) and state medical boards. USP 800 implementation date is December 1, 2019. The National Institute for Occupational Safety and Health (NIOSH) has 3 groups of antineoplastic and other hazardous drugs (HD) in healthcare settings. Group 1: Antineoplastic drugs that may also pose a reproductive risk for susceptible populations. Group 2: Non-antineoplastic drugs that meet one or more NIOSH criteria for a HD. Group 3: Drugs that primarily pose a reproductive risk to men and women who are actively trying to conceive and women who are pregnant or breast-feeding. These groups are updated biennially (every 2 years). The reconstitution/administration of HD USP 800 Group 1 requires this to done in a hood with external ventilation situated walled-off rooms that function as containment secondary engineering controls, have negative pressure that ranges from 0.01 to 0.03 inches of water column relative to all adjacent areas, with at least 12 air changes per hour vented directly to the outside, HD stored and prepared in areas separate from non-HD, gowns, head, hair, and double shoe covers; two pairs of chemotherapy gloves, and a Closed System Drug-Transfer Device (CSTD) for individuals who administer HD. Urologic agents on Group 1/2016 NIOSH list: abiraterone, BCG, bicalutamide, degarelix, enzalutamide, flutamide, goserelin, leuprolide, mitomicin, thiotepa. The 2018 proposed HD list includes: botulinum toxins, all forms. Proactive steps include building a coordinated multi-specialty coalition including AUA USP 800 Task Force, AACU, LUGPA, state medical societies, AMA, and other stakeholders; move urologic pharmaceuticals down NIOSH list, such as BCG and Lupron Acetate, Group 1; literature review of prior documentation risks and adverse effects to administering agents such as BCG, Leuprolide Acetate, etc.; encourage development of CSTDs by manufacturers; develop white papers/best practices; administration versus compounding; access to care issues; and exception for small healthcare facilities, such as physician’s practices. Dr. Pete Stetson from New York Section who serves as the Chief Health Informatics Officer at Memorial Sloan Kettering Cancer Center gave a talk on ”Improving Efficiencies in Electronic Health Records”. He stated the quadruple aim of improved population health, reduced care cost, and satisfied providers leading to satisfied patients. Some of the strategies for reducing EHR burnout is governance, tools, measurement, research, and patient engagement. Dr. Jonathan Heinlen from the South Central Section gave a talk on the “Standardization of Prior Authorization.” There is significant time burden of authorization that represents 1 physician hour per week, 13.1 hours of nursing time per week, 6.3 hours of clerical time per week, and 37 prior authorizations per week. Furthermore, there are significant delays with 90% of physicians reporting delays in treatment due to prior authorization and 26% of physicians report 3+ days average delay. This is burdensome because 79% of prior authorization requests are eventually approved (72% initial request and 7% on appeal) and 80% of physicians report they are required to repeat prior authorization for medications even though a patient is stable on the medication. Most common method is fax or telephone, which is not efficient. From the payors point of view, an estimated 20% of costs are related to prior authorization. The barriers to development of prior authorization system are: no private company has a dominant market share, no one wants to invest in development when a standard doesn’t exist, and an external solution would likely be welcome. The barriers to standardization are: not clear who owns the process, provider infostructure with EMR, and CMS/Medicare doesn’t require prior authorization, except Medicare Advantage. Ms. Merel Nissenberg and Mr. Tom Kirk from the National Association of State Prostate Cancer Coalitions gave a talk on “Step-Therapy.” Step therapy is a protocol used by insurers as a form of utilization management that requires patients to fail another (less expensive) therapy first before they will be allowed to have the more expensive, but medically indicated treatment with the goal of cost-containment. It is most often used for oral medications. In the past, step therapy was most frequently seen with private insurance, but now Medicare Advantage uses it. CMS issued guidance giving Medicare Advantage plans the option of applying prior authorization and step therapy for physician-administered and other Medicare Part B drugs – effective January 1, 2019. Some states have passed legislation in opposition to step therapy and others still need to pass legislation or to enforce legislation already in the books. It is important to become knowledgeable on what’s going on in your state, read the “know your rights” brochure, visit websites for SAIM (state access to innovative medicines), Aimed Alliance, and Part B Access for Seniors and Physicians Coalition. On the federal level, it is important to pay attention to legislation that is introduced to protect patients from step therapy, advocate for safeguards so that patients are not harmed by step therapy practices (eg. learn how to override step therapy when medically appropriate).

Dr. James F. Smith from the Society for the Study of Male Reproduction talked about “Transgenderd Care”. Gender affirming treatments can have an impact on gametes, which may impact future fertility. There is a complex feedback system between the hypothalamic pituitary axis and production of sex steroid hormones and post-pubertal levels of sex hormones lead to irreversible physical changes. Cross-sex hormones impact the gonads at the ultrastructural level. Limited data exists on the impact of cross-sex hormones on reproductive potential. Fertility preservation and family building should be discussed prior to pursuing gender affirmation. Transgender men and women are actively building families and many without children have a desire to have children in the future. Adolescents may have a different perspective on future family building. Trans identified people have options to build families and there are multiple ways that trans identified individuals can build a family. Ultimately, what’s needed to conceive is a sperm, egg and a uterus. There are multiple ways to retrieve gametes. Fertility preservation and assisted conception can be costly, but it’s possible and people have been successful. Lastly, areas of clinical care understudied in this population: PSA testing, BPH (trans women).

Susanne Quallich from the Society for Urologic Nurses and Associates, Dr. Suzanne Groah from United Spinal Association, and Dr. John Weiner from Spina Bifida Association led a session on “Access to Rural Care”. They discussed their insights into the challenges of access to rural urologic care, especially for spina bifida/neurogenic bladder patients and how NP’s may be utilized.

Dr. Mara Holton, CEO of Anne Arundel Urology and Vice Chair of Large Urology Group Practice Association (LUGPA), John McManus from The McManus Group, Tracy Spicer from Avenue Solutions spoke on “Stark Law Under MACRA”. Value is now defined as the ratio between quality and cost, with quality composed not only of outcomes, but safety, service, and the total patient experience. The Stark Self-Referral regulations are an anachronism as it was developed 30 years ago in response to the perceived risk of overutilization of health care services in fee-for-service payment models. It was designed to prohibit physician and health care entities from distributing resources to shape clinical behavior. Currently, it is a barrier to clinical and financial integration, and promotion of ‘outcome-based’ medicine, contemplated by the ACA and MACRA. Hospital and primary care groups are given waivers through Accountable Care Organizations (ACOs). At the present, the only avenue to value-based care for independent physicians is through an ACO, the majority of which are hospital based. Center for Medicare and Medicaid Innovation (CMMI) has not approved a single Physician-Focused Payment Model Technical Advisory Committee (PTAC)-recommended APM and practices cannot test submitted APMs. Severely curtailed opportunities to innovate/participate, which are depriving patient populations of specialty expertise. Due to the absent opportunity to participate in APMs, specialists are forced to participate in MIPS. Urologists are disproportionately affected as there are almost no APM participation by employed or independent GU providers. Stark reform would benefit all practice types, and the development of APMs and episodes of care will be promoted. One cannot create payment models promoting value over volume when Stark Law specifically prohibits compensation based on volume or value of services. Reform of Stark will facilitate service arrangements between institutional and private providers. Arbitrage of site of service differential will allow pricing flexibility for collaborating groups while improving access for patients. There are two roads to Stark Law Reform: Regulatory and Legislative. Federal agencies may draft a regulation after reviewing or finding ambiguity in a law and realizing a clarifying regulation is necessary. A regulation becomes a rule when it is published into the Federal Register after final consideration of comments and adjustments. A regulation has the binding force of law. Legislation can be introduced by any senator or congressperson, and it can be finalized when the signed by the President or Congress overrides Veto. Finalized legislation has the binding force of law. Legislative activity included hearings in the House Ways & Means and Energy & Commerce Committees on the need for Stark reform. The shift to value-based care was that the Stark Law needs to be modernized to provide flexibilities for providers to adopt APMs and other value-based payment systems. The suggestions ranged from (i) repealing Stark Law entirely to (ii) expanding CMS authority to create exceptions to self-referral prohibition to (iii) expanding waivers relative to APMs. With regards to regulatory efforts, there is renewed interest in this last year with the appointment of Secretary Azar. CMS issued a RFI (request for information) on Stark Law and sought comments on: burdens associated with the financial relationships between parties in APMs, relationships on APMs and Stark Law, and need for revisions or additions to Stark Law exceptions.

Dr. Lane Palmer, President of the Society of Pediatric Urology and AUA Public Policy Council Member gave an “Intersex Advocacy Update 2019” to start off the second day of the summit. Last month, Senate Bill 201 was submitted in the California Legislature that proposes the prohibition of doctors from performing certain surgeries on children born with intersex conditions. Disguised as legislation that protects patient choice, this bill does the literal opposite and would have severely deleterious effects on the intersex community. SB 201, denies a parent’s right to make informed decisions for their children, potentially subjects children to adverse health consequences, limits access to medical options, and undermines the relationship between doctors and patients. Lastly, this bill would legislate and dictate the practice of medicine. The California Medical Association is officially opposing this bill.

Dr. Dolores J. Lamb representing The Society of Women in Urology gave a talk on “Collaborative Approaches to Overcome Workplace Challenges in Urology” and reports the trend of increasing number of women in urology with 23% of current residents being female. However, urology continues to have the lowest percentage of women surgeons compared to 26 other specialties. The majority of the 1,032 women urologists are less than 45 years old, Caucasian. Women urologists are more likely to work in academic medical centers, but few female urologists hold senior positions with the highest representation of women at 19% in the rank of assistant professor. Three women are Urology chairs: Dr. Cheryl Lee at Ohio State University, Dr. Eila Skinner at Stanford, and Dr. Martha Terris at Medical College of Georgia. Research funding rate and amount appears equal across gender within urology, and first and last female authorship has shown a remarkable increase. Women urologists earn less than men by approximately 20%. Women report high rates of satisfaction in life and with the decision to enter urology and equal rates of burnout.

Senator John Barrasso, MD (R-WY), Chairman, Senate Republican Conference, address the AUA Advocacy Summit and talked about the importance of Graduate Medical Education. He also spoke about the Physician Assistant Direct Payment Act, which is bipartisan legislation that will allow Medicare to reimburse physician assistants (PAs) directly for the care they provide.

Rep. Jason Altmire (D-PA-4), 2007-2013, Author, Dead Center: How Political Polarization Divided America, discusses the epidemic of polarization that has gripped the country. He discusses the commonly cited causes of political polarization, such as gerrymandering, partisan media, and campaign finance, and offers politically realistic solutions to help bridge America’s partisan divide. Mr. Altmire gives an exciting insider’s perspective of the lobbying and pressure tactics that were used to woo congressional centrists during the debate on the Affordable Care Act. Lastly, he stated that it was important to share the stories of our patients in Urology as we advocate on Capitol Hill.

Following the morning General Session, we headed to Capitol Hill for a full afternoon of meetings with lawmakers that included the offices of Senators Kamala Harris and Dianne Feinstein as well as Representatives Karen Bass, Brad Sherman, Adam Schiff, Mike Levin, Anna Eshoo, Jared Huffman, and Jackie Speier. This year, there were three legislative asks that we discussed with lawmakers and their staffs.

The first request was for Members of Congress to submit the following Fiscal Year (FY) 2020 appropriations report language to the House and Senate Labor, Health and Human Services, and Education Appropriations Subcommittees encouraging the National Cancer Institute (NCI) to direct additional research efforts towards better understanding of prostate cancer among African American men and other populations at high-risk for the disease. In 2018, the U.S. Preventive Services Task Force (USPSTF) released upgraded recommendations for prostate cancer screening, but was unable to make specific recommendations on screening in African American men, citing a lack of available research evidence of the benefits to this population. The USPSTF has called for more studies to “confirm that African American men who undergo screening receive similar or greater reductions in prostate cancer mortality compared with men in the general population.” The USPSTF believes “studies are needed to explore the optimal screening frequency and whether beginning screening before age 55 years provides additional benefits in African American men.”

The second request was to ask Congress to support federal funding for urological research through three federal programs: support for increased funding in Fiscal Year (FY) 2020 for the Department of Defense (DoD) Congressionally Directed Medical Research Programs (CDMRP), support for pending legislation to reauthorize the Patient-Centered Outcomes Research Institute (PCORI) and avoid a lapse in their important research efforts, and request that Congress provide $41.6 billion for the National Institutes of Health (NIH) in FY 2020, a 6.4 percent increase over the current funding level.

The third request was to support the introduction of bipartisan legislation to address the issues associated with prior authorization. The AUA, along with more than 100 other health care organizations, has endorsed the “AMA Prior Authorization and Utilization Management Principles.” This is a set of 21 principles intended to “ensure that patients receive timely and medically necessary care and medications and reduce the administrative burdens.”

Following all the meetings, we heard from Congressional representatives and physicians at the Congressional Reception. Congresswoman Robin Kelly addressed the attendees and talked about how she strongly supports biomedical research funding.

The last day of the summit started with a session on “Veterans Healthcare in Urology” moderated by Dr. Jeremy Shelton who serves as the AUA VA Health Workgroup Chair and AUA Legislative Affairs Committee member. Dr. Shelton stated that The VA Mission Act of 2018 is the biggest agenda for the VA this upcoming year and how to implement it fully. It is designed to greatly improve veteran access to VA healthcare, and addresses in-network and non-VA healthcare issues, veteran’s homes, access to walk-in VA care, prescription drug procedures, etc. Dr. Shelton also discussed access to health care in the VA system. The VA has attempted to measure patient-level wait times by calculating the interval between a patient’s request for an appointment and when the appointment occurs. Dr. Jones cited a recent study that VA wait times were, in general, comparable to those in the private sector, and may have improved in the past 3 years. He also discussed other issues impacting Veterans, which include coverage for infertility, homelessness, unemployment, suicide, and women’s health. In addition, a VA-Prostate Cancer Foundation Partnership, which is a $50 million 5 year initiative that has been formed to implement precision oncology prostate cancer care. Rep. Neal Dunn, MD (R-FL-2), Ranking Member, House Veteran’s Affairs Subcommittee on Health addressed the group. He discussed how the VA Mission Act builds upon the success of the Choice Program by streamlining community care programs so a veteran can access care from a provider outside of the VA when they need to. He also talked about the VICTOR Act, which helps veterans seek life-saving transplant care closer to their home. Lastly, he addressed significance of prostate cancer and its impact on Veterans, and the continuing need to raise awareness and promote research in this disease. Dr. Jeffrey Jones from the Urological Society for American Veterans (USVA) and AUA VA Health Workgroup Member presented several priority projects for USAV/AUA to work with 116^th Congress. These include: expand access to care by enhancing OR efficiency and reduced overhead, PSA screening within the VA, expand and enable Wounded Warrior, expand research partnerships, recruit and retain the best, fertility coverage, VA image/perception change to reflect reality, allow physicians who are veterans to review and arbitrate compensation and pension exam determined service connection rating (e.g. Agent Orange, Blue/chemical exposure, GU cancers), actualize the process of an interoperable EMR between active duty and VA, and improve accountability amongst support organizations within hospital to provide for the clinical enterprise. Mike Crosby, Founder of Veterans Prostate Cancer Awareness (VPCA) relayed the objectives of VPCA with goal of equating prostate cancer awareness to breast cancer awareness (blue = pink). The agenda of VPCA includes: educational outreach for veterans on prostate cancer, include veterans as high risk population in guidelines and screening policy, advocate for research into why veterans are at greater risk for developing prostate cancer, support VHA policy change efforts – screen all veterans annually, and encourage urology provider enrollment in Choice Program/Community Care Network.

Drs. Hossein Sadeghi-Nejad and Ira D. Sharlip from the Sexual Medicine Society of North America moderated a session on “America’s Wounded Warriors: How Urologists Can Support Sexual and Reproductive Health, Rehabilitation, and Access to Care”. Dr. Jim Dupree from the North Central Section and AUA Public Policy Council Member started the session with a talk on the “Impact of Health Policy on Access to Infertility Care in Military Personnel and Civilians”. Dr. Dupree felt it was important to support infertility as a disease state with an emphasis on how this would promote insurance coverage and payment. In addition, he stated that fertility preservation, which maintains ability to have genetically-related children, is disease prevention. There are few employer-sponsored insurance plans that cover infertility. Dr. Dupree discussed the need to expand and improve coverage for infertility and fertility preservation services both for veterans and for individuals living in in states that do not have insurance coverage for these conditions.

Col. Robert Dean, MD, U.S. Army Medical Corps gave an enlightening presentation on the “Urological Management of a Wounded Warrior” and had SFC U.S. Army (Ret.) Aaron Causey and Mrs. Kathleen Causey shared their journey of sex, intimacy, and infertility after a bomb injury left Mr. Causey as a double amputee as well as a ½ testicle that require him to take testosterone daily. Their story was profiled in a documentary, “The Next Part”, which took home a special jury mention award at the Tribeca Film Festival. Mrs. Causey pressed for improved patient counseling, better communication on available services, increased access to medication and research for the severely injured and a public discussion in pre-deployment briefs about the risk of injury and family planning. Dr. Dean summarizes that sperm salvage techniques are known for the wounded warrior, and that case by case decisions are the cornerstone for fertility care. In addition, legal and ethical issues exist, such as pre-deployment living will and pre-deployment gamete preservation. Funding for IVR and Gamete preservation is evolving as solid policies are still needed. Lastly, the urologist is a key resource for these patients. Dr. Bud Burnett finished up the session by giving a talk on “Genital Allotransplantation in a Wounded Warrior – Advances in Regenerative Medicine for Urotrauma” showcasing human penile allotransplantation and tissue engineering (corpora, urethra). Dr. Burnett described the process of penile transplantation and functional outcomes at Stellenbosch University as well as the experience at Johns Hopkins Hospital. He then discussed work from Wake Forest University on tissue engineered corpora constructs for treatment of complex penile deformities.

The “Current Urologic Workforce Issues” session included talks by Drs. Matthew Gettman, Lindsey Kerr, Chad Ritenour, and Steven Chang. Dr. Gettman from the Endourological Society and a Member of AUA Legislative Affairs Committee spoke on “Telemedicine”. Telemedicine continues to expand and there are two broad categories, asynchronous and synchronous. Asynchronous or “store and forward” distance applications are delayed communications, such as those that transfer diagnostic images or video from one site to another for viewing in preparation for a consult. Synchronous programs are those occurring in “real-time” as demonstrable in two-way consult between a patient in concert with the their medical provider and a specialist at a distant site. Telemedicine services can be implemented through a multitude of modalities, including videoconferencing software, mobile applications, and wearable devices and monitors. Telemedicine improves access to health care while maintaining physician and patient satisfaction. In addition, there is currently use of a variety of telemedicine applications, including telerounding, teleproctoring, telesurgery, teleconsultation, and telementoring. Telemedicine can impact the workforce shortage facing urology with increased quality care with high patient satisfaction at decreased cost. CMS is also starting to promote telemedicine, and all major payers have at least some coverage. However, licensure and billing remain a challenge to widely implementing telemedicine as well as ethical and legal concerns. Dr. Kerr from the New England Section and a Member of AUA Public Policy Council gave a talk on the “Unionization of Health Care Workers” and makes a case for physician unionization. In 1972, Dr. Sanford Marcus, a surgeon in private practice formed the Union of American Physicians and Dentists (UAPD). It has been the most successful physician union and is affiliated with the AFL-CIO. Unions can assist with contract articles, health and safety, peer review, reverse discrimination, retirement benefits, contracting out, arbitration, etc. Dr. Ritenour from the Society of Academic Urologists and AUA Practice Management Committee Member gave a talk on “Graduate Medical Education”. The Medicare Act (1965) created process to support training doctors in order to take care of older population. The Balanced Budget Act of 1997 capped hospital at the 1996 levels of resident FTEs with rate exception. There are 21 new accredited urology programs and 327 new accrediting urology positions since in 2009 so it is about a 30% growth in 10 years. In addition, fewer medical students are applying to urology with an average of 71 applications submitted to programs and a match rate up to 85% in 2019. GME places a greater emphasis on patient safety and quality improvement, physician well-being, expectations for team-based care, flexibility of schedule within established clinical and education. An ACGME Milestones Focus Group show that future graduates will be data driven, more specialized, more female, more “employed”, more engaged with administrative leadership roles, more value-focused, more culturally competent, working less hours to have time for outside interests, and more using genetics/genomics. Support, predictability, trust, and making a living/decrease debt are what today’s residents want in a practice. There are some important strategies for residents transitioning to practice that include: on-boarding, finding ways to connect them, and giving them some responsibility. Dr. Chang from the Society of Urologic Oncology gave a talk on “Factors of Gaps in Care”. There have been significant advances in prostate and kidney cancer that have improved survival in patients with advanced disease. Gaps of care exist when there is a discrepancy between need and service, and it is prevalent and disparities exist among different populations (genetic and biological factors, health care access, socioeconomic factors, chemical and physical exposures, diet, and physical inactivity). Many counties in the U.S. do not have any urologist available and lack of urologists translates to worst outcomes and cancer survivorship. There are different interventions that attempt to close gaps of care, which include research, legislation, from individual to government, and must address disparities among populations. Lastly, gaps of care are impacting the care of patients and these include, but are not limited to financial toxicities, coordination of care with EHR interoperability.

Dr. Nitya Abraham from the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction delivered a talk on “Negotiating Affordable Drug Prices” providing insight into the challenges of drug pricing. Current self-pay costs on common urologic medications can vary greatly. The rate of increase in drug prices has outpaced the rate of inflation such that some patients may have to choose between food and medicine. The rise in drug price/cost is multifactorial and includes the manufacturer, wholesaler, retail pharmacy, insurer, pharmacy benefit manager (PBM), direct to consumer advertising, copay coupon, and physician choice of brand drugs. If the government is permitted to negotiate drug prices, potential benefits include: decreased cost, improved compliance with medications leading to better health, and improved quality of life. However, this may not necessarily be the best or only solution.

The last session was “Alternative Payment Models/Value-Based Payments” moderated by Dr. Tom Rechtschaffen who is Chair of the AUA Legislative Affairs Committee. Dr. C.J. Stimson broke down “value-based payments”, which basically involves the quality of care delivered and the spending involved, but the “devil” of the details is thousands of pages related to these two factors. It is a way to pay doctors for the services provided and adjusting payments to doctors based on the quality of the care deliver and the spending incurred by patients. He reviewed the Quality Payment Program (QPP), in which there are two ways to take part in: MIPS (Merit-Based Incentive Payment System) or Advanced APMs (Alternative Payment Models). MIPS uses 4 performance categories that carry different weights that will shift as the program progresses: quality (45%), promoting interoperability (35%), cost (15%), and improvement activities (15%) to determine a final score for the payment adjustment. Payment adjustments are budget neutral and made on a sliding scale. Payment adjustments are based on performance from two years prior that allows for submission of data and performance feedback. Dr. Robert Dowling from the American Association of Clinical Urologists talked about what goes into the cost category in MIPS. As the MIPS program matures, the cost and quality categories is what is going to account for the majority of the composite score. The cost category weight is increasing. In the 3^rd of the QPP, there are eight Wave 1 episodes, and if you perform a service or if your patient has a diagnosis that falls into one of these episode groups, then it triggers an episode. The Urologic Disease Management Clinical Subcommittee recommended the Renal or Ureteral Stone Surgical Treatment episode-based cost measure for development because of its high impact in terms of patient population and Medicare spending. Episode-based measures – kidney and ureteral stone management could be live as soon as 2020 in MIPS (Medicare patients). This may be the harbinger of similar episode based measures in high volume procedures or diagnoses: nephrectomy, procedure for BPH, prostate biopsy. Field testing indicates significant variations in cost. Experience in other episode-based programs (Oncology Care Model) indicates opportunities for cost savings include reduction in ER visits and readmissions.

The AUA also had the opportunity to visit the Office of the National Coordinator for Health information Technology (ONC), U. S. Pharmacopeia (USP), the National Institute for Occupational Safety and Health (NIOSH), the National Institute on Aging (NIA), the National Institutes of Diabetes and Digestive and Kidney Diseases (NIDDK), and the National Institute of Child Health and Human Development (NICHD) during the Advocacy Summit.

USP Meeting: Drs. Aaron Spitz and William Reha met with key senior leadership to discuss the requirements of USP Chapter 800, including the National Institute for Occupational Safety and Health (NIOSH) list of hazardous drugs that goes into effect on December 1, 2019. They pointed out that if the guidance in Chapter 800 as it relates to compounding of hazardous drugs is inappropriately applied to practices and facilities that administer these drugs, it will negatively impact provision of cancer treatments to patients. In addition, guidance requiring installation of closed system drug-transfer devices such as hoods and ventilation systems in offices is cost-prohibitive. The USP will continue to discuss the guidance with the AUA and also plans to continue to provide outreach to address our concerns with the various state agencies, such as the Joint Commission, National Association Pharmacy Boards, and state pharmacy and medical boards.

NIOSH Meeting: Drs. Eugene Rhee and Jay Motola met with NIOSH representatives to discuss their List of Antineoplastic and Other Hazardous Drug in that Healthcare Setting that includes urology drugs used to treat bladder and prostate cancer such as BCG, goserelin, histrelin, leuprolide and triptorelin. NIOSH representatives agreed to consider the AUA’s request to have the NIOSH List drugs reclassified and keep the line of communications open. They also shared the administrative burdens and problems with access to care for urology patients with the current category classifications of drugs. Discussion of administrative versus compounding of drugs and how the drugs were categorized by NIOSH were exchanged. NIOSH representatives clarified that the list of drugs is being revised and each drug will be reviewed line by line to determine if they should be on the list.

ONC Meeting: Drs. Micheal Darson and Alan Kaplan shared their experiences that electronic health records (EHRs) negatively impact their practices on a day-to-day basis and ultimately can affect patient access and quality of care for their patients. Through the 21st Century Cures Act, ONC aims to reduce provider burden and improve interoperability. Its recent report on burden reduction outlines successes in health information technology (IT) as well as challenges that remain. In particular, the burden of Evaluation and Management documentation for visits and prior authorization are significant obstacles, and ONC leadership outlined their efforts to separate billing from documentation to alleviate physician burden.

Thank you.

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