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Monthly Archives: April 2018

AUA Advocacy Summit Summary – March 12-14, 2018
By John S. Lam, MD

The American Urological Association (AUA) hosted its first independent advocacy summit from March 12-14, 2018 aimed to expand, strengthen and unify the voice of urology on policy matters that impact practices and patients by bringing together a broad array of stakeholders, including patient advocates and researchers.

I attended this 3-day conference along with fellow California urologists, Drs. Peter Bretan, Hyung Kim, Robert Lurvey, Eugene Rhee, Jay Shah, Ira Sharlip, Jeremy Shelton, Aaron Spitz, as well as fellows, residents, and medical students. The summit opened with a grassroots lobbying training session for those new to the process, as well as a session for those who are seasoned advocates.

What’s been happening on Capital Hill? In February, Congress repealed the Independent Payment Advisory Board or IPAB, committed to increase NIH funding by $2 B/2 years, passed improvements to MACRA/MIPS, Reauthorized CHIP for 10 years (longest in program’s history), increased debt limit into 2019, raised budget caps for FY18 and FY19, passed Medicare extenders legislations, and confirmed Alex Azar as HHS Secretary.

Tucker Carlson, host of Tucker Carlson Tonight and founder of The Daily Caller delivered the luncheon keynote address. Mr. Carlson gave a witty, engaging and non-partisan talk about the volatility of the current political landscape, including the 2016 general election, and he pointed out a need for accountability in politics.

The first general session was about prostate cancer advocacy and Dr. David Penson moderated the session with panel members who represented the R. Frank Jones Urological Society, the Society of Urology Oncology and Prostate Cancer International. Dr. Penson gave an introductory talk on the United States Preventive Services Task Force (USPSTF) Transparency and Accountability Act and PSA-based screening for prostate cancer. He reviewed the 3 large PSA-based screening trials. Conflicting results of the U.S. and European trials have led to considerable controversy and ambiguous recommendations about PSA screening. Now, in a third major trial (Martin et al. Effect of a Low-Intensity PSA-Based Screening Intervention on Prostate Cancer Mortality The CAP Randomized Clinical Trial. JAMA. 2018), which is the parent study of the Prostate Testing for Cancer and Treatment (ProtecT) trial, showed that among practices randomized to a single PSA screening intervention vs. standard practice without screening, there was no significant difference in prostate cancer mortality after a median follow-up of 10 years. This was a large trial in which U.K. investigators randomized 573 primary care practices to offer eligible men (age range, 50–69) either a single PSA screening or usual care. Each group included approximately 200,000 men, and about a third of the intervention group underwent PSA testing. Dr. Penson’s analysis was that this was a flawed study because it was not a study of screening versus no screening, but rather a study of a whole lot of screening versus some screening. Furthermore, a median follow-up of 10 years is “insufficient” to evaluate prostate cancer–specific mortality.

Dr. Penson cited several studies that showed that the number needed to screen and number needed treat to prevent one prostate cancer death decreased with longer term follow up supporting the need for PSA-based screening under the auspices of shared decision making. Under the Affordable Care Act, any preventative service that receives a “A” or “B” grade from the USPSTF must be covered by Medicare with no co-payment from the beneficiary, whereas “cost-sharing” is explicitly allowed for services that receive a “C”, “D” or “I” grade. The language, as written, opens the door for private payers and Medicare to deny coverage for services with a “C”, “D” or “I” grade on a case-by-case basis.  Dr. Robert Waterhouse discussed the background of the USPSTF and it’s 2017 draft recommendations on PSA-based screening, and the response by the AUA. Dr. Isaac Powell delivered a talk on health care disparities related to prostate cancer and presented data showing genetic differences in prostate cancer between white and black men, and that genetic signatures can be developed to predict aggressiveness of disease in these at-risk populations. Dr. Peter Carroll gave a talk on active surveillance and the role that PSA density, genomics and multi-parametric MRI may play in identifying men who need treatment.  Dr. Matthew Resnick gave a talk on determining cost-effectiveness (value) and that more judicious use of prostate cancer diagnosis and treatment improves value.  Mr. E. Michael Scott from Prostate Cancer International gave a presentation on the importance of working together for advocacy and the most successful advocacy avoids legislation.

The subsequent session on workforce was led by Dr. Patrick McKenna of the Society of Academic Urologists, and featured speakers from the Society of Women in Urology, the Society of Urologic Nurses and Associates and the Urological Association of Physician Assistants, along with special guest speaker Dr. Janis Orlowski, chief health officer for the Association of American Medical Colleges (AAMC). Dr. Dolores Lamb gave a talk on women in the urology workforce. She presented data that showed urology has lowest percentage of women physicians of any medical specialty, but the number of female entrants continues to grow. Female urologists are also compensated less and often “pigeon-holed” into a certain type of practice. The role of advanced practice providers (APPs) and physician assistants in the urologic/surgical setting were discussed by Susanne Quallich, PhD, NP-C and Jessica Nelson, MPAS, PA-C, respectively. Dr. Orlowski gave a talk on latest statistics on the health care workforce from the AAMC.

Concurrent breakout sessions addressed health care payment reform, the business of medicine and research advocacy. AUA Research Council Chair Dr. Aria Olumi moderated the four-person panel on research advocacy, while Dr. C.J. Stimson led the panel on health care payment reform and AUA Practice Management Committee Chair Dr. Jay Motola served as moderator for the Business of Medicine session.

Following a full first day of programming, the second day started with a networking breakfast that focused on key advocacy priorities that were led by Drs. Tom Rechtschaffen, Kevin Koo, Chris Gonzalez, Amanda North, Jason Jameson, Josh Langston, Aria Olumi, Toby Chai, C.J. Stimson and Deepak Kapoor.

Morning sessions focused on Men’s Health and advocacy for men’s access to the full continuum of care, as Sexual Medicine Society of North America (SMSNA) moderators Drs. Run Wang and Ira Sharlip led a panel featuring representatives not only from the SMSNA, but also the Men’s Health Network and Mr. Carlos Basurto, a prostate cancer survivor. Together with his wife Olivia, Mr. Basurto shared his poignant story of survivorship and his experience with sexual dysfunction after prostate cancer treatment.

Surgical quality improvement was the subject of the second panel for the day, moderated by Dr. Eugene Rhee. Following presentations about surgical quality improvement and the role of assessment tools, such as video, we then heard from world champion quarterback, broadcaster and entrepreneur Joe Theismann, who gave an inspiring presentation about self-improvement as an athlete and how these skills can be translated to surgeons.

Following special panel breakout sessions on physician burnout, shared decision-making in prostate cancer, and bladder health conditions that were moderated by Drs. Deborah Lightner, John Lynch, and Toby Chai, respectively, we headed to Capitol Hill for a full afternoon of meetings with lawmakers that included the offices of Senators Dianne Feinstein and Kamala Harris as well as Representatives Jared Huffman, Brad Sherman, Doris Matsui, Anna Eshoo, Zoe Lofgren, Ted Lieu, Mimi Walters, Scott Peters, and Juan Vargas. This year there were five issues/requests that we discussed with lawmakers and their staffs.

The first request was for Representatives to cosponsor H.R. 539, the “USPSTF Transparency and Accountability Act,” introduced by Reps. Marsha Blackburn (R-TN) and Bobby Rush (D-IL), includes critical reforms that would require the USPSTF to:

  • Publish research plans and make available reports on such evidence and recommendations for public comment;
  • Ensure medical specialty physicians are consulted;
  • Establish a stakeholders board to ensure input on developing, updating, publishing and disseminating evidence-based recommendations;
  • Codify the current grading system so it can’t be changed without review; and
  • Ensure that Medicare or other payers cannot deny payment for a preventive service solely based on the task force grade.

Urology is specifically concerned about the USPSTF’s 2012 recommendation related to prostate-specific antigen (PSA) based screening for prostate cancer for all men, regardless of risk.  The AUA supports a man’s right to be tested for prostate cancer – and to have his insurance pay for it, if medically necessary, and if he decides to do so following a detailed conversation with his physician about the benefits and harms of screening. The AUA is concerned that the 2012 recommendation does not recognize the appropriate screening needs for high-risk individuals and may perpetuate the current disparities, especially for African American men.

The second request was to address the workforce shortages in urology and other specialties that will jeopardize access to care by cosponsoring the bipartisan “Resident Physician Shortage Reduction Act” (H.R. 2267 / S. 1301) introduced by Representatives Joseph Crowley (D-NY) and Ryan Costello (R-PA); and Senators Bill Nelson (D-FL), Dean Heller (R-NV), and Charles Schumer (D-NY) that will improve the nation’s GME system and help to preserve access to specialty care by:

  • Increasing the number of Medicare GME residency slots by 15,000 over the next five years;
  • Directing half of the newly available positions to training in shortage specialties;
  • Prioritizing distribution of new slots (e.g., states with new medical schools); and
  • Studying strategies to increase the diversity of the health professional workforce.

Urology has been identified by several national surveys as a specialty that is facing a future physician deficit. Furthermore, an aging population that will require more urologic care and a desire to provide greater access to health care through the Affordable Care Act compounds this deficit.

The third request was to be an original co-sponsor to the bill to be introduced by Rep. Donald Payne Jr. to create an Office of Men’s Health within the U.S. Department of Health and Human Services, which would:

  • Coordinate public awareness, programs, and activities related to male health, including prostate cancer, diabetes, colorectal cancer, cholesterol, and mental health screening programs, for men identified as being at increased risk for these diseases;
  • Support comparative effectiveness review related to these diseases; and
  • Establish a clinical registries database to assess and measure quality improvement of programs and activities relating to male health.

Over the past decade, men have shown poorer health outcomes than women across all racial and ethnic groups as well as socioeconomic status. Common urological conditions impacting men that would benefit from improved coordination of public awareness and screening programs include prostate cancer, bladder cancer, and erectile dysfunction.

The fourth request was to ask for increased funding in Fiscal Year (FY) 2019 for the Department of Defense (DoD) Congressionally Directed Medical Research Programs (CDMRP) as numerous urologic conditions benefit each year from CDMRP funding.

The last request was to take the following actions to reduce burden related to the use of certified electronic health record (EHR) techology (CEHRT):

  • Encourage the Office of the National Coordinator for Health Information Technology (ONC) to examine the high cost of operating and upgrading CEHRT, specifically focusing on: 1) the financial and administrative burden on physician practices, hospitals, and health systems for routine upgrades to certified electronic health record technology (CEHRT), as well as for ongoing maintenance and operations; 2) the cost drivers that contribute to vendors’ escalating fees; and 3) potential solutions to mitigate the amount and frequency of ongoing fees from CEHRT vendors.
  • Cosponsor S. 2059, the “EHR Regulatory Relief Act,” introduced by Sens. John Thune (R-SD), Lamar Alexander (R-TN), Richard Burr (R-NC), Mike Enzi (R-WY), Pat Roberts (R-KS), and Bill Cassidy, MD (R-LA). The EHR Regulatory Relief Act would make permanent a 90-day reporting period for the Advancing Care Information performance category of the Merit-based Incentive Payment System (MIPS) and provide flexibility for scoring under that category, to include removing the “all-or-nothing” approach.

The passage the American Recovery and Reinvestment Act of 2009 created policy requirements and financial incentives for clinicians to adopt and meaningfully use CEHRT. Costs associated with upgrades to HER systems as well as with maintenance and routine operations are substantial and create a significant burden on physician practices. S. 2059 seeks to lessen the burden on healthcare providers by shortening the reporting period for eligible physicians and hospitals from 365 days to 90 days and dropping the threshold from 100 percent to 70 percent of the required metrics.

Following all the meetings, we heard from Congressional representatives and physicians, Raul Ruiz (D-CA-36) and Neal Dunn (R-FL-2) during an evening reception on Capitol Hill.

The third and final day wrapped with a presentation on the USPSTF and testicular self-exam by Dr. Ajay Nangia representing the Society for the Study of Male Reproduction. The USPSTF has given testicular cancer screening a ‘D’ rating. Dr. Nangia discussed the methodological flaws and a lack of evidence for this rating, and that the D rating contrasts with the widely held support of testicular screening among practitioners. North Carolina Representative and urologist, Dr. Greg Murphy, gave a talk on the value of state advocacy and Dr. Gary Kirsh gave a talk on the advocacy efforts of the Large Urology Group Practice Association (LUGPA).

We also heard a session moderated by Dr. Jeremy Shelton on veteran’s affairs issues from Dr. Jeffery Jones representing the Urological Society for American Veterans and House VA Committee Chair Rep. Phil Roe, MD (R-TN-1), and health policy efforts from the House Energy & Commerce Committee Ranking Member Frank Pallone (D-NJ-6) and House Ways & Means Committee member David Schweikert (R-AZ-6).

The last general session was on advocacy for intersex and disorders of sexual development that was moderated by Dr. Lane Palmer from the Societies for Pediatric Urology. There is a Senate Concurrent Resolution in the California legislature that should be of special interest to California urologists. SCR 110 (Wiener) Sex characteristics, is a measure that would, among other things, call upon stakeholders in the health professions to protect children born with variations of sex characteristics from nonconsensual, medically unnecessary surgeries. The CUA has lobbied for and received support from the California Medical Association to prevent a moratorium on early surgery for intersex conditions.

Lastly, we heard brief discussion on a hot-button policy issue presented by Drs. Eugene Rhee and Aaron Spitz involving the National Institute for Occupational Safety and Health (NIOSH) on drugs proposed for placement on the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2018 (List), as well as the NIOSH Policy and Procedures for Developing the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings. The situation with compounding drugs and subsequently more stringent requirements for handling make these lists of drugs untenable in 5 primary issues:

  • Costs of delivery of this care
    1. Cost to install this new mixing/ventilation systems are prohibitive
    2. Many physicians lease their offices and will not be allowed to install new ventilation systems and may have to find alternative office sites
  • Access to the care needed particularly rural areas
    1. The provision of standard cancer care for prostate and bladder cancer will not be possible in many of the locations it is currently done
  • Quality of care as patients will decline further care in light of lack of availability
  • Unnecessary regulatory burden to US practices irrespective of type of practice in light of the paucity of evidence
    1. Some of the medications on the list considered theoretically “harmful” but there is little chance of exposure. For instance, many of the prostate cancer injections come in self-contained packaging and there is little to no possibility of exposure to the health care provider in preparing and administering these meds
  • The USP 800 Hazardous Drug List includes drugs prescribed by all specialties in the care of patient and their treatment. Urology is not the only specialty affected
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Jason  Archambault, MD

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Jennifer  Botelho, PA-C

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