Renal & Urology News - Jan-Feb 2021 Issue

JA N UA R Y/F E B R UA R Y 2 0 21

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Researchers Zero in on Diet-PCa Link

BY JODY A. CHARNOW RECENTLY PUBLISHED studies highlight a link between diet and prostate cancer (PCa) risk.

In one study, a team led by Benjamin C. Fu, PhD, of Harvard T.H. Chan School of Public Health in Boston, demonstrated an association between hyperinsulinemic and inflammatory diets and aggressive PCa. Another study, conducted by Justin Gregg, MD, of the University of Texas MD Anderson Cancer Center in Houston, and colleagues, found that adherence to a Mediterranean diet lowered the

likelihood that men on active surveillance (AS) for localized PCa would experience disease progression.

Dr Fu’s team prospectively followed 41,209 men in the Health Professionals Follow-up Study (1986 to 2014). They calculated scores for 2 validated dietary patterns from food frequency questionnaires that participants completed at baseline and updated every 4 years.

They calculated hyperinsulinemic and inflammatory diet scores based on the propensity of various foods to cause hyperinsulinemia and inflammation.

High Mg in CKD Ups Death Risk HIGH SERUM levels of magnesium increase the risks for cardiovascular (CV) events and death in patients with chronic kidney disease (CKD), suggesting clinicians need to be cautious about prescribing magnesium supplementation to these patients, according to investigators.

In a retrospective observational study, a team led by Isabel Galán, MD, of

Elevated vs normal magnesium levels also increased the risk of CV events.

Hospital General Universitario Reina Sofia, Murcia, Spain, found that serum magnesium levels increased as kidney function decreased, according to study findings published in the Journal of Renal Nutrition. In adjusted analyses, patients with hypermagnesemia, defi ned as serum magnesium levels higher than 2.2 mg/dL, had significant 34% and 54% increased risks for CV events and all-cause mortality, respectively, compared with those who had serum magnesium levels in the normal range (1.7 to 2.18 mg/dL).

Hypermagnesemia remained significantly associated with increased allcause mortality in a propensity score analysis that compared 287 patients continued on page 8

© XSANDRA / GETTY IMAGES

Hyperinsulinemic, inflammatory diets implicated

HEALTHY DIETS may slow progression of localized prostate cancer, new findings suggest.

A total of 5929 incident cases of PCa developed during 28 years of followup, including 1019 advanced and 667 fatal cases. On multivariable analysis, each 1 standard deviation (SD) increase in a hyperinsulinemic diet was significantly associated with a 7%

Advanced RCC Diagnoses Drop After ACA

BY NATASHA PERSAUD IMPLEMENTATION of the Patient Protection and Affordable Care Act (ACA) in 2010 coincided with reductions in advanced renal cell carcinoma (RCC) at diagnosis, especially among low-income patients, according to new data presented at SUO 2020, the virtual annual meeting of the Society of Urologic Oncology.

Using the National Cancer Database, investigators identified 83,310 patients (aged 40 to 64 years) eligible for Medicaid and who had newly diagnosed with RCC in the United States from 2010 to 2016. Following ACA implementation, the percentage of insured patients in both Medicaidexpansion and non-expansion states increased by 4.0% and 2.1%, respectively, Juan Javier-DesLoges, MD, an SUO fellow at UC San Diego Health in La Jolla, California, reported. The largest significant increases in insurance coverage occurred in expansion states, continued on page 8

and 9% higher risk for advanced and fatal PCa, respectively, Dr Fu’s team reported online in European Urology.

When the investigators stratified participants by age, they found that a hyperinsulinemic diet was significantly continued on page 8

IN THIS ISSUE 4

Tacrolimus plus low-dose steroids may have a role in MCNS

4

Testosterone therapy found to lower type 2 diabetes risk

5

Recruitment of young urologists into private practice challenging

6

Is the DRE for prostate cancer screening obsolete?

7

Apixaban may be a better choice than warfarin in advanced CKD

12

Use of innovative PCa treatment modalities varies by region

14

Q&A with LUGPA’s new president, Jonathan Henderson, MD

Proposed HIPAA changes would improve information sharing for coordinating health care.

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Renal & Urology News 1

FROM THE EDITOR EDITORIAL ADVISORY BOARD Medical Director, Urology

Medical Director, Nephrology

Robert G. Uzzo, MD, MBA, FACS G. Willing “Wing” Pepper Chair in Cancer Research Professor and Chairman Department of Surgery Fox Chase Cancer Center Temple University School of Medicine Philadelphia

Kamyar Kalantar-Zadeh, MD, PhD, MPH Professor & Chief, Division of Nephrology, Hypertension & Kidney Transplantation UC Irvine School of Medicine Orange, CA

Nephrologists Anthony J. Bleyer, MD, MS Professor of Internal Medicine/Nephrology Wake Forest University School of Medicine Winston-Salem, NC

Urologists Christopher S. Cooper, MD Director, Pediatric Urology Children’s Hospital of Iowa Iowa City

David S. Goldfarb, MD Professor, Department of Medicine Clinical Chief New York University Langone Medical Center Chief of Nephrology NY Harbor VA Medical Center

R. John Honey, MD Head, Division of Urology, Endourology/Kidney Stone Diseases St. Michael’s Hospital University of Toronto

Csaba P. Kovesdy, MD Chief of Nephrology Memphis VA Medical Center Fred Hatch Professor of Medicine University of Tennessee Health Science Center Memphis

Stanton Honig, MD Department of Urology Yale University School of Medicine New Haven, CT J. Stephen Jones, MD Chief Executive Officer Inova Health System Falls Church, VA Professor and Horvitz/Miller Distinguished Chair in Urologic Oncology (ret.)

Cleveland Clinic Lerner College of Medicine Cleveland Jaime Landman, MD Professor of Urology and Radiology Chairman, Department of Urology UC Irvine School of Medicine Orange, CA James M. McKiernan, MD John K. Lattimer Professor of Urology Chair, Department of Urology Director, Urologic Oncology Columbia University College of Physicians and Surgeons New York Kenneth Pace, MD, MSc Assistant Professor, Division of Urology St. Michael’s Hospital University of Toronto Vancouver, Canada

Edgar V. Lerma, MD Clinical Associate Professor of Medicine Section of Nephrology Department of Medicine University of Illinois at Chicago College of Medicine Chicago Allen Nissenson, MD Emeritus Professor of Medicine The David Geffen School of Medicine at UCLA Chief Medical Officer, DaVita Inc. Denver Rulan Parekh, MD, MS Associate Professor of Pediatrics and Medicine University of Toronto Robert Provenzano, MD Associate Professor of Medicine Wayne State University School of Medicine Detroit Vice President of Medical Affairs, DaVita Healthcare Denver Robert S. Rigolosi, MD Director, Regional Hemodialysis Center Holy Name Hospital Teaneck, NJ

Renal & Urology News Staff

Editor Jody A. Charnow

Web editor Natasha Persaud

Production editor Kim Daigneau Group creative director Jennifer Dvoretz Production manager Brian Wask

Vice president, sales operations and production Louise Morrin Boyle

Director of audience insights Paul Silver National accounts manager William Canning Editorial director, Haymarket Oncology Lauren Burke

Vice president, content, medical communications Kathleen Walsh Tulley

General manager, medical communications James Burke, RPh President, medical communications Michael Graziani

Urgency Again Propels Medical Advancement

I

n 1928, Dr Alexander Fleming, a Scottish physician and scientist, accidentally discovered a substance with antibacterial properties produced by a mold called Penicillium notatum. He called it penicillin. For more than a decade after Dr Fleming published his findings in the British Journal of Experimental Pathology in 1929, the discovery that would become one of the greatest medical advances of the 20th century met with little scientific interest.

Then World War II came along. Working with researchers from Oxford University in England who purified penicillin in 1939 and used it clinically for the first time in 1941, the United States — motivated to find a more effective treatment for wounds and illnesses in soldiers serving in the war — led a coordinated effort involving many scientists and multiple pharmaceutical companies to mass-produce penicillin.1,2 The effort brought penicillin out of the laboratory and into widespread clinical use, ushering in a new era in treating infectious diseases.

Nearly three-quarters of a century later, urgency once again provided an impetus to turn research into clinical reality. This time, rather than a war, the motivation is a pandemic. A desperate need for a vaccine to prevent infection with SARS-CoV-2, the novel coronavirus that causes COVID-19, catapulted messenger RNA (mRNA) vaccine technology from the laboratory into primetime. In less than a year, pharmaceutical companies Pfizer/BioNtech and Moderna, under contract with the US government as part of its “Operation Warp Speed,” translated investigational technology into COVID-19 mRNA vaccines and completed clinical trials that led to emergency use authorization from the Food and Drug Administration. A stunning achievement.

If mRNA vaccines bring an end to the pandemic and demonstrate long-term safety and efficacy, they may bring about a new era in infectious disease prevention. Researchers and pharmaceutical companies may be encouraged to develop mRNA vaccines to prevent many other illnesses, including those for which development of traditional vaccines has been elusive, such as HIV. With mRNA technology, vaccines can be produced more rapidly compared with conventional vaccines, which typically use weakened or killed pathogens to induce an immune response.

In addition, because of the way mRNA vaccines work, there is no danger of recipients contracting the disease the vaccines are designed to prevent.

The COVID-19 virus likely will not be the last pathogen to cause a pandemic. If the COVID-19 mRNA vaccines fulfill their promise, governments and pharmaceutical companies will at least have a proven technology to address future emerging outbreaks.

Jody A. Charnow Editor

Chairman & CEO, Haymarket Media Inc. Lee Maniscalco

Renal & Urology News (ISSN 1550-9478) Volume 20, Number 1. Published bimonthly by Haymarket Media, Inc., 275 7th Avenue, 10th Floor, New York, NY 10001. For Advertising Sales & Editorial, call (646) 638-6000 (M–F, 9am–5pm, ET). For reprint/licensing requests, contact Customer Service at custserv@haymarketmedia.com. Postmaster: Send address changes to Renal & Urology News, c/o Direct Medical Data, 10255 W. Higgins Rd., Suite 280, Rosemont, IL 60018. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means (electronic, mechanical, photocopying, recording, or otherwise) without the prior written permission of Haymarket Media, Inc. Copyright © 2021.

1. Gaynes R. The discovery of penicillin—New insights after more than 75 years of clinical use. Emerg Infect Dis. 2017;23(5):849-853. doi:10.3201/eid2305.161556 2. Quinn R. Rethinking antibiotic research and development: World War II and the penicillin collaborative.

Am J Public Health. 2013;103:426–434. doi:10.2105/AJPH.2012.300693

2 Renal & Urology News

JANUARY/ FEBRUARY 2021

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Contents

JANUARY/FEBRUARY 2021

Nephrology 3

ONLINE

4

this month at renalandurologynews.com Clinical Quiz Test your knowledge by taking our latest quiz at renalandurologynews.com/ run-quiz

Drug Information Search a comprehensive drug database for prescribing and other information on more than 4000 drugs.

Apixaban May Offer an Edge Over Warfarin Apixaban lowered the risk for CKD progression compared with warfarin in a study of CKD patients with nonvalvular atrial fibrillation.

7

Data Support Upfront RAS Inhibitors for Advanced CKD The likelihood of requiring kidney replacement therapy was lower compared with starting with a calcium channel blocker.

4

Testosterone May Reduce Diabetes Risk Testosterone therapy was associated with a 41% decreased risk for type 2 diabetes in a study of overweight and obese men.

5

RCC Surgery Postponement May Be Safe Delaying nephrectomy for clinically localized disease does not increase the risk of tumor progression, researchers reported.

6

Time to Say Goodbye to the DRE for Prostate Cancer Screening Justin Dubin, MD, and Sanoj Punnen, MD, MAS, of the University of Miami Miller School of Medicine, say the digital rectal examination adds little to decision making.

News Coverage Visit our website for daily reports on the latest developments in clinical research.

VOLUME 20, ISSUE NUMBER 1

CALENDAR Annual Dialysis Conference Kansas City, Missouri March 5–7 National Kidney Foundation Virtual Spring Clinical Meetings April 6–10 ERA-EDTA Annual Congress Berlin, Germany June 5–8 Canadian Urological Association Annual Meeting Niagara Falls, Ontario, Canada June 26–29 European Association of Urology Annual Congress Milan, Italy July 9–13 American Urological Association Annual Meeting Las Vegas, Nevada September 10–13 International Continence Society Annual Meeting Melbourne, Australia October 12–15

Urology

Job Board Be sure to check our latest listings for professional openings across the United States.

Tacrolimus Shows Potential As Alternative MCNS Option Tacrolimus plus low-dose steroids vs highdose steroids alone achieve similar rates of complete remission, according to researchers.

7

HIPAA Compliance Read timely articles on various issues related to keeping protected health information secure.

IgA Nephropathy in Patients with IBD Characterized Among patients with both diseases, the diagnosis of IBD occurs prior to IgAN onset, a study found.

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12

Uptake of Novel PCa Treatment Modalities Varies by Region Cost and differences in marketplace competition are among the reasons cited for geographic disparities in the use of innovative approaches.

15

Departments 1

From the Editor Urgency again propels medical advances.

3

News in Brief The FDA has approved the first oral hormone therapy for advanced PCa.

15

Ethical Issues in Medicine How should healthcare providers decide who gets treated first?

16

Practice Management Proposed HIPAA rule changes may facilitate patient access to their health information.

For PCa screening ... we think [the digital

rectal examination] provides limited helpful information and potentially some risks.

See our story on page 6

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Renal & Urology News 3

News in Brief

Please visit us at www.renalandurologynews.com for the latest news updates from the fields of urology and nephrology

Short Takes FDA Approves Belimumab for Active LN in Adults

using the National Cancer Database by

The FDA has approved the use of be-

San Antonio in San Antonio, Texas,

limumab (Benlysta, GlaxoSmithKline)

and colleagues. Among patients with

for treating adults with active lupus

documented reasons for no surgery,

nephritis who are receiving standard

5.4% refused RC despite a physician’s

therapy. The approval was based on

recommendation to have the surgery.

Ahmed Elshabrawy, MD, of UT Health

results from a 104-week phase 3 ranproportion of patients achieved the

Low Bicarbonate in ADPKD Worsens Kidney Outcomes

primary efficacy renal response

Patients with autosomal dominant

(PERR) at 104 weeks when treated

polycystic kidney disease (ADPKD)

with belimumab plus standard therapy

who have low serum bicarbonate lev-

compared with placebo plus standard

els may be more likely to experience

therapy (43% vs 32%). Belimumab

worsening kidney outcomes, accord-

recipients had significant 1.5-fold

ing to study findings published online

increased odds of achieving the PERR

in Nephrology Dialysis Transplantation.

domized trial showing that a greater

compared with placebo.

In a study that included 296 patients with ADPKD, those in the lowest tertile

Study Reveals Why Some MIBC Patients Refuse RC

of baseline serum bicarbonate had a

Female and Black patients as well as

ing kidney function, defined as a 30%

those of advanced age or who receive

decrease in estimated glomerular filtra-

treatment at a nonacademic center

tion rate or kidney failure, compared

are more likely than other patients

with those in the highest tertile. “­Serum

to refuse radical cystectomy (RC)

bicarbonate may add to prognostic

for muscle-invasive bladder cancer

models and should be explored as a

(MIBC), according to a recent study

treatment target in ADPKD,” Charles

published online in Urologic Oncology.

J. Blijdorp, MD, of Erasmus Medical

nearly 3-fold increased risk for worsen-

The findings are based on a study of 74,159 patients with MIBC identified

Center in Rotterdam, The Netherlands, and colleagues concluded.

Sex Differences in CKD A population-based Swedish study of patients with moderate to severe chronic kidney disease (CKD) found that women had lower rates of disease progression and all-cause mortality (per 100 person-years) compared with men: ■ Overall ■ Men ■ Women

PER 100 PERSON-YEARS

25 20

19.6

20.8 17.6

15

10.1

10

10.6

9.2

5 0

CKD Progression*

All-cause mortality

*Advance by 1 CKD stage or start kidney replacement therapy.

Source: Swartling O et al. CKD progression and mortality among men and women: A nationwide study in Sweden. Published online January 9, 2021.

Am J Kidney Dis.

Tumor Size Affects Survival in T3a Renal Cell Carcinoma P

hysicians should consider tumor size when managing T3a renal cell carcinoma (RCC) and not just anatomic features alone when deciding on the optimal surgical approach, according to investigators.

In a paper published in Cancer Medicine, Luping Li, MD, of Zhengzhou University in Zhengzhou, China, noted that the 8th TNM staging system identifies T3a RCC as an anatomic extrarenal invasion and does not take tumor size into account. Findings from their study of 49,586 patients with T1-3aN0M0 RCC in the Surveillance, Epidemiology, and End Results database (2004-2015) showed that 4 cm or smaller T3a tumors and T1b tumors did not differ in their associated all-cause and RCC-specific mortality risks. For the entire T3a RCC cohort, each 1-cm increase in T3a tumor size was significantly associated with an 8% and 14% increased risk for all-cause and RCC-specific mortality, respectively.

First Oral Hormone Therapy for Advanced PCa Cleared R

elugolix, the first oral hormone therapy for advanced prostate cancer (PCa), has received Food and Drug Administration (FDA) approval.

The agency based its approval on a randomized, open-label trial that included men with advanced PCa randomly assigned to receive relugolix (Orgovyx; Myovant Sciences) once daily or injections of leuprolide every 3 months for 48 weeks. In the patients who received relugolix, the castration rate was 96.7%, according to an FDA press release.

“Today’s approval marks the first oral drug in this class and it may eliminate some patients’ need to visit the clinic for treatments that require administration by a health care provider,” said Richard Pazdur, MD, director of FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research.

IgA Nephropathy in Patients With IBD Characterized M

ost patients with IgA nephropathy (IgAN) associated with inflammatory bowel disease (IBD) receive their IBD diagnosis before IgAN, and in about a quarter of cases, IBD is active at IgAN onset, investigators concluded in a paper published in Nephrology Dialysis Transplantation.

Nizar Joher, MD, of Hôpital Henri Mondor in Paris, and colleagues examined the presentation, therapeutic management, and outcomes of 24 patients with IBDassociated IgAN relative to a cohort of 134 patients with primary IgAN and no IBD. Of the 24 patients, 75% had Crohn’s disease and 25% had ulcerative colitis. In 23 cases, IBD was diagnosed before IgAN and was considered active at IgAN onset in 23.6% of patients. After a mean follow-up of 7.2 years, 4 patients (16.7%) had a poor kidney outcome: end-stage kidney disease in 3 patients and a greater than 50% decrease in estimated glomerular filtration rate from initial values in 1 patient. A similar disease course was observed in patients with primary IgAN, according to the investigators.

4 Renal & Urology News

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Tacrolimus Shows Potential As Alternative MCNS Option

Testosterone May Reduce Diabetes Risk

Study explored using the drug in combination with low-dose steroids

TESTOSTERONE treatment may help prevent type 2 diabetes in overweight and obese men beyond the effects of diet and exercise, new data suggest.

In the Testosterone for Diabetes Mellitus (T4DM) trial, investigators randomly assigned 1007 men aged 50 to 74 years with a waist circumference of 95 cm or higher, a serum testosterone concentration of 14.0 nmol/L or less (but without pathological hypogonadism), and impaired glucose tolerance or newly diagnosed type 2 diabetes to receive intramuscular testosterone undecanoate (1000 mg) or placebo.

All men also participated in a WW (formerly Weight Watchers) lifestyle program involving group meetings and online access to diet and activity guidelines and self-monitoring tools.

Testosterone treatment was associated with a significant 41% decline in type 2 diabetes risk, Gary Wittert, MD, of South Australian Health and Medical Research Institute in Adelaide,

Noninferiority Demonstrated Results showed that 79.1% of patients in the tacrolimus plus low-dose steroid group achieved complete remission within 8 weeks compared with 76.8% receiving high-dose steroid therapy, a finding that the investigators said demonstrated that tacrolimus was noninferior to high-dose steroids for MCNS. “Combined tacrolimus and low-dose steroid represent an important therapeutic option to limit exposure to steroids, especially for patients with contraindications or intolerance to standard highdose steroid treatment,” Dr Lee said.

Fewer Relapses Significantly fewer patients relapsed on maintenance tacrolimus (3-8 ng/mL) plus tapered steroid (5.7%) compared with tapered steroids alone (22.6%).

In terms of safety, the investigators observed no significant differences between the study arms. Most adverse events (AEs) were classified as mild or moderate. Two cases of severe AEs occurred in each of the groups.

The investigators said that, to their knowledge, their study is the first randomized controlled trial to directly compare these 2 protocols in adult patients with MCNS. “Future comparative studies should further taper or discontinue tacrolimus, and extend the follow-up period beyond 24 weeks, to determine if there is a true reduction in relapse or if the combined tacrolimus and low-dose steroid treatment only delays the time to relapse versus standard treatment.”

© BIOPHOTO ASSOCIATES / SCIENCE SOURCE

BY JOHN SCHIESZER TACROLIMUS MAY be an effective alternative to high-dose steroids as firstline treatment for adults with minimal change nephrotic syndrome (MCNS), according to investigators.

A 24-week open-label study of 144 adults found that tacrolimus plus lowdose steroids was noninferior to highdose steroid therapy for achieving complete remission at 8 weeks, Sang Koo Lee, MD, of Asan Medical Center at the University of Ulsan in Seoul, South Korea, and colleagues reported in the Journal of the American Society of Nephrology. Treatment with a maintenance dose of tacrolimus during steroid tapering reduced the relapse rate and appeared to result in no clinically relevant safety differences.

“The efficacy and safety of combined tacrolimus and low-dose steroid has not been known well,” Dr Lee said.

The investigators randomly assigned 144 patients with primary biopsy-confirmed MCNS (initial or relapsed) to receive tacrolimus, a calcineurin inhibitor (CNI) 0.05 mg/kg twice daily plus prednisolone 0.5 mg/kg once daily or once-daily 1 mg/kg prednisolone alone for up to 8 weeks or until complete remission is achieved. Once patients achieved complete remission, the steroid was tapered to a maintenance dose of 5.0 to 7.5 mg/d in both groups until 24 weeks after study drug initiation.

The patients ranged in age from 16 to 79 years. A total of 113 patients completed the study.

Tacrolimus plus low-dose steroids show promise for minimal change nephrotic syndrome.

With respect to study limitations, the authors acknowledged that open-label trials can be limited by reporting bias due to lack of allocation concealment and blinding. Other limitations included a relatively short follow-up duration and a study population made up of patients of a single ethnicity (Korean).

“This study does prove that we can safely and efficiently treat minimal change disease with much lower doses of steroids when combining them with tacrolimus,” said Abdallah Geara, MD, an assistant professor of clinical medicine at Penn Medicine in Philadelphia, Pennsylvania, who was not involved in the study.

Study Provides a Blueprint Most patients with MCNS do not end up with significant kidney dysfunction long term, but the side effects of highdose steroids have a major long-term impact, Dr Geara said. “This study provides clinicians with a blueprint on how to combine low-dose steroids with CNI and tapering regimen, which is currently not established in the nephrology community,” Dr Geara said.

Renu Regunathan-Shenk, MD, assis­ tant professor of medicine at the George Washington University School of Medicine and Health Sciences in Washington, DC, praised the study for its clinical relevance. “While the current KDIGO [Kidney Disease: Improving Global Outcomes] guidelines recommend high-dose steroid as first-line treatment for minimal change disease, in practice many adults cannot tolerate this treatment as it may cause or exacerbate conditions such as diabetes, obesity, and psychiatric disease,” Dr RegunathanShenk said.

Many patients also discontinue steroids due to cosmetic side effects such as weight gain, acne, and facial puffiness, she said. The addition of a CNI to lowdose steroids may help minimize these side effects and reduce relapse rates, which are higher in the adult population.

“I am surprised that the time to remission did not differ between the 2 groups, as in my practice I often see patients respond to calcineurin inhibitors faster than they do to steroid treatment,” Dr. Regunathan-Shenk said. ■

Testosterone therapy was associated with a 41% decreased risk for type 2 diabetes.

Australia, and colleagues reported in Lancet Diabetes & Endocrinology. At 2 years, fewer patients treated with testosterone than placebo had a 2-hour oral glucose ­tolerance of 11.1 mmol/L or more: 12% vs 21%, respectively, according to the investigators.

With respect to safety, hematocrit greater than 54% (22% vs 1%) and a PSA increase of 0.75 μg/mL or more (23% vs 19%) occurred in greater proportions of the testosterone than placebo group. Prespecified serious adverse events occurred in 10.9% vs 7.4%, respectively, and 2 patients in each group died.

“Although these data might inform decisions about testosterone as a pharmacotherapy for diabetes prevention, the minimum dose exposure, duration of treatment, durability of effect, and long-term safety remain to be determined,” according to Dr Wittert’s team.

For now, they consider it premature to use testosterone in men without pathologic hypogonadism. ■

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Renal & Urology News 5

Private Practices Face Obstacles to Recruiting Young Urologists

RCC Surgery Postponement May Be Safe

Many urologists completing their training prefer academic settings, data show

DELAYING SURGERY for clinically localized renal cell carcinoma (RCC) of up to 6 months does not increase the risk of tumor progression, a finding that has implications for RCC treatment during the COVID-19 pandemic, a study found.

“During the current COVID-19 pandemic and subsequent recovery, urologists and their patients can expect delays in radical and partial nephrectomy for clinically localized RCC,” Eric A. Singer, MD, of Rutgers Cancer Institute of New Jersey in New Brunswick, and colleagues concluded in a paper published in Urologic Oncology.

“In most patients with clinically localized cT1b tumors, surgery may be safely delayed for up to 6 months without significant sacrifices in overall survival.”

For patients with cT2 tumors, they added, “we must carefully weigh tumor characteristics and patient comorbidities when discussing surgical delay.

However, our data suggests that most patients experiencing a delay of 3 months due to the COVID-19 pandemic will not experience worse oncological outcomes.”

BY JODY A. CHARNOW PRIVATE PRACTICES looking to recruit urologists fresh out of training have to take into account that these physicians may have different career expectations compared with previous generations of urologists, according to speakers at a session during the Large Urology Group Practice Association (LUGPA) 2020 virtual annual meeting.

Survey data from the 2019 Urologists in Training Census, which is conducted by the American Urological Association (AUA), suggest that residents and ­fellows in general favor work/life balance over compensation, and they lean toward employment in academic settings or hospitals.

Well-Balanced Lifestyle Sought “Residents and fellows really are just looking for opportunities to have a well-balanced lifestyle … and job satisfaction as opposed to rigorous hours and tough call schedules,” said Robert Jansen, MD, of Atlantic Urology Clinics in Myrtle Beach, South Carolina. This mindset, he said, may run counter to the expectations of older urologists, he said.

Dr Jansen reviewed findings from the 415 residents and 97 fellows who responded to the AUA census. He pointed out that only 35% of residents and 10% of fellows indicated that they are considering entering private practice upon completion of their training.

In addition, 49.7% of residents and 73.2% of fellows anticipate taking an academic job following completion of training. Less than 40% of men and 2% of women residents plan to enter private practice. Among fellows, 13.6% of men and 0% of women are considering a private practice position.

“Many trainees in their programs do see themselves as part of a family,” Dr Jansen said. “There’s a lot of collegiality not just among each other, but also among their attendings. They would like to see this continue in their career.”

For both residents and fellows, the top 3 factors that influence their choice of future practice settings were family/ life balance/call schedule, geographic location, and compensation, he noted.

Academic Settings Favored Survey data from the 2019 Urologists in Training Census conducted by the American Urological Association suggest that residents and fellows lean toward employment at academic medical centers rather than entering private practice after completing their training.

80

■ Residents ■ Fellows

60 40 20 0

73.2% 49.7%

35% 9.8% Private practice

Academic medical center

Source: American Urological Association. 2019 Urologists in Training Census.

“Geography, interestingly, is equally as important as lifestyle, so this should be considered when you’re looking at your recruitment pool,” Dr Jansen said.

AUA census data show that 46% of all urologists report being employed in an institutional setting: 27% in academic hospitals, 16% in public or private hospitals, and 3% in Veterans Affairs hospitals. In addition, 78% of employed urologists say their job offers a good work/life balance compared with 41% of self-employed urologists.

“The consensus here is that the majority of all of urologists believe that a better work/life balance can be achieved through an employed model,” said Joshua Langston, MD, chief medical officer at Urology of Virginia.

“We have to ask ourselves, ‘What do the employed models have that attracts the next generation of urologists, and can we offer some of the similar benefits in independent practice?’”

Dr Jansen said a common question among interviewees is how much call they would have to take. “I think this generation is looking for a newer and a more efficient way of doing things, or at least asking the question, ‘Is there a better way?’”

Different Employment Tracks One of the most important considerations when trying to attract young urologists to join a practice is the creation of different employment tracks, said Timothy A. Richardson, MD, of Wichita Urology in Wichita, Kansas.

“It doesn’t have to be the standard partnership track. That’s the only

thing that really existed when most of us went into practice. But that’s simply not what some people are looking for today,” Dr Richardson told attendees.

“Employment with a straight salary and no partnership needs to be an option, or part-time employment, or maybe just flexible call arrangements.”

Potential recruits might prefer lower compensation in exchange for less call, he noted.

He advised listeners to start their candidate search 2 to 3 years ahead of anticipated need, and observed, “Most chief residents already have a job when they start their last year.”

He cautioned against being in a rush to hire somebody. “Don’t just get a warm body, be patient,” he said, adding that practices need to find urologists who fit the culture of their group in terms personality, work ethic, career goals, and other attributes.

Do Not Compete With Hospitals Compensation should be competitive with LUGPA practices, not hospitals, Dr Richardson said. “Starting salaries at hospitals are high, you can’t compete with that, so don’t try to,” he said.

Individuals who are interviewing candidates should point out to them that hospitals offer high salaries for the first year or two, but then income often decreases over time, whereas income typically rises when a physician buys into a practice and becomes a partner.

Practices also should consider offering to pay moving expenses, signing bonuses, and stipends during residency or fellowship, Dr Richardson said. ■

Nephrectomy can be delayed safely for up to 6 months in many patients, data show.

Among patients with cT1b lesions, a surgical delay of 1-3 months and more than 3 months was significantly associated with a 13% and 55% increased risk of death, respectively, compared with undergoing surgery within 1 month of diagnosis, after adjusting for multiple potential confounders, the investigators reported. They pointed out, however, that these patients still have favorable overall survival. Patients with surgical delays of 1-3 and more than 3 months have 5-year overall survival rates of 80.1% and 70.9%, respectively.

Using information from the National Cancer Database, Dr Singer’s team studied 29,746 patients who underwent partial or radical nephrectomy for cT1b, cT2a, or cT2b RCC tumors. The median follow-up duration for patients with cT1b, cT2a, and cT2b tumors was 47.7, 33.3, and 35.2 months, respectively. ■

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Data Support Upfront RAS Inhibitors for Advanced CKD

Apixaban May Offer an Edge Over Warfarin

Kidney replacement therapy risk lower vs starting with CCB treatment

PATIENTS WITH chronic kidney disease (CKD) who also have nonvalvular atrial fibrillation may have a lower risk for progression to a more advanced CKD stage when treated with apixaban instead of warfarin, a new study suggests.

Using Medicare claims data from 2013-2017, investigators identified 12,816 patients (mean age 80 years; 51% female; 88% White) with stage 3 to 5 CKD and nonvalvular atrial fibrillation. Of these patients, 50.3% were newly prescribed apixaban, a direct oral anticoagulant, and 49.7% were newly prescribed warfarin, a vitamin K antagonist.

Apixaban was associated with a 10% lower risk for CKD stage progression compared with warfarin, James B. Wetmore, MD, MS, of Hennepin Healthcare Research Institute in Minneapolis, Minnesota, and colleagues reported in the American Journal of Kidney Diseases. At baseline, 84% of patients had stage 3, 15% stage 4, and 1% stage 5 CKD.

BY JOHN SCHIESZER INITIATION OF antihypertensive therapy with a renin-angiotensinsystem inhibitor (RASi) in patients with advanced chronic kidney disease (CKD) may confer additional renal benefits compared with starting patients on a calcium channel blocker (CCB), according to new evidence from administrative databases in Sweden.

Investigators examined the risks for kidney replacement therapy (KRT), mortality, and major adverse cardiovascular events (MACE) in patients with advanced CKD by using 2007 to 2017 data from the Swedish Renal Registry.

The study included 2458 and 2345 new users of RASi and CCB, respectively, who had an estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73m2.

Patients had a median age of 74 years, and 38% were women. “We chose this comparison because it mirrors a common clinical scenario, that of starting a first or subsequent antihypertensive medication and choosing between these 2 drug classes,” said study investigator Catherine Clase, MB, MSc, an associate professor at McMaster University in Ontario, Canada.

Decreased KRT Risk The RAS inhibitor group had a significant 21% decreased risk for KRT compared with the CCB group, the investigators reported in the American Journal of Kidney Diseases. The RAS inhibitor and CCB groups, however, had similar risks for mortality and MACE. The absolute 5-year mortality risk was 48.3% among RAS inhibitor users and 49.5% among CCB users. The absolute 5-year risk of MACE was 25.0% among RAS inhibitor users and 25.1% among CCB users. Overall results were consistent across subgroups and in as-treated analyses, according to the investigators.

“This evidence may potentially inform clinical decisions on the choice of antihypertensive therapy for this patient

group, minimally included in pivotal trials,” the investigators concluded.

The investigators defined new users as individuals receiving a RAS inhibitor or CCB without dispensation of either drug in the previous 6 months.

They excluded prevalent users of these agents, individuals with a history of kidney transplantation, individuals with an eGFR greater than 30 mL/min/1.73 m2, or those initiating both drugs simultaneously. The majority of patients initiating RASi therapy received enalapril (37.2%), candesartan (23.4%), losartan (21.4%) or ramipril (9.6%). Among these patients, 249 individuals (10.1%) experienced a cardiovascular hospitalization in the 6 months prior to

RAS inhibitors and CCBs are associated with similar risks for MACE, mortality. initiation. Of the patients initiating a CCB, 97.7% received a dihydropyridine, which was primarily amlodipine (55.4%) or felodipine (36.9%). Among these patients, 231 (9.9%) had a cardiovascular hospitalization in the 6 months prior to initiation.

Study Limitations The authors acknowledged a number of study limitations. They noted, for example, despite adjusting for a wide range of potential confounders, residual confounding-by-indication bias cannot be excluded in observational studies. In addition, the reasons why patients were started on these drugs are unknown.

“The strength of the current study is the number of patients analyzed and the relatively long median follow-up, but the study carries the limitations associated with the observational study design, as well as studying Swedish

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registry with probably uniformly Caucasian individuals, limiting generalization of results,” commented Emaad Abdel-Rahman, MBBS, PhD, professor of nephrology at the University of Virginia in Charlottesville.

Dr Abdel-Rahman cited a recent observational study of 678 patients with stage 4-5 CKD who participated in the Chronic Renal Insufficiency Cohort (CRIC) study that demonstrated no difference in the rate of progression to end-stage kidney disease or death between participants treated continuously with RASi or not treated at all for the duration of the study.

Clinically Useful Information Kausik Umanath, MD, MS, section head of clinical research in the division of nephrology and hypertension at Henry Ford Hospital in Detroit, Michigan, praised the new study as providing clinically useful information. “It is surprising to note that despite published guidelines for many years, a substantial portion of patients reach CKD stage 4/5 and are not already on a renin-angiotensin system inhibitor,” Dr Umanath said. “I am not surprised that initiating therapy later in the course of CKD still provides benefit in terms of forestalling kidney disease progression. Comparative effectiveness studies like this are particularly valuable when they come out of Europe due to the centralization of healthcare systems, which allows for fairly clean long-term epidemiologic data.”

Julia Breyer Lewis, MD, professor of medicine, nephrology, and hypertension at Vanderbilt University Medical Center in Nashville, Tennessee, said the new findings support the well-established benefit of RAS inhibitors in slowing progression of CKD. Issues related to starting or discontinuing RAS inhibitors in patients with advanced CKD are important to address in more heterogeneous populations and ideally in prospective studies, Dr Breyer Lewis said. ■

Apixaban vs warfarin or atrial fibrillation decreased the risk for CKD progression.

The rate of CKD progression in events per 100 patients per year was 11.4 for apixaban users compared with 12.0 for warfarin users, according to the investigators. Compared with warfarin, apixaban was significantly associated with a 10% decreased risk for CKD progression.

Apixaban was not associated with a lower risk for kidney failure compared with warfarin.

Combined with the results of other studies, Dr Wetmore’s team noted, “our results suggest that apixaban may be associated with superior long-term renal outcomes relative to warfarin in this population, but this cannot be definitively determined in the absence of data from clinical trials.” ■

Renal & Urology News will provide news coverage of the National Kidney Foundation’s 2021 Virtual Spring Clinical Meetings, April 6 to 10. Go to www.renalandurologynews.com for daily reports on noteworthy studies.

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Commentary

BY JUSTIN DUBIN, MD, AND SANOJ PUNNEN, MD, MAS

Time to Say Goodbye to the DRE for Prostate Cancer Screening

S

creening and assessing for prostate cancer (PCa) is a major component of a urologist’s practice.

For most urologists, part of this process includes the digital rectal examination (DRE). It is the first exam urologists learn because for a long time, DREs were the best and only means to screen for and detect PCa. The DRE is so ingrained in urology culture that it’s often joked about in film and television—so much so that it’s been called “the urologist’s handshake.”

In the 1990s the discovery of the prostate specific antigen (PSA) blood test helped physicians identify PCa earlier in its course. Imperfect and somewhat controversial, PSA testing has become the gold standard for PCa screening.

However, since the initial adoption of PSA into urologic practice, other major advances in PCa detection such as the 4K score and multi-parametric magnetic resonance imaging (MRI) of the prostate have now become available.

Despite these advancements, most urologists continue to perform DREs on men seeking PCa screening and evaluation. But does the DRE provide helpful information for decision-making or is it an obsolete practice perpetuated by historical dogmatism? We believe it’s the latter and that it’s time to say goodbye to the DRE for PCa screening.

Limited Value in Decision-Making When assessing the value of any medical exam, we must evaluate if it can help guide medical decision-making. For any exam to be useful, it must be accurate. A previous review article found that the DRE detected a mere 28.6% of prostate tumors.1 This means that a negative (normal) DRE does not mean you don’t have PCa. In fact, the DRE misses the majority of prostate tumors, and most providers realize that a negative DRE does not tell us much.

Now some may argue, “What if I feel a nodule? Surely, that means the patient likely has prostate cancer and needs a biopsy.” Well, according to

data collected from the Prostate, Lung, Colorectal, and Ovarian (PLCO) screening trial, only 2% of men with a normal PSA and abnormal DRE were diagnosed with clinically significant PCa.2 So if a negative DRE doesn’t help us feel confident that we can avoid a biopsy, and a positive DRE doesn’t help us feel confident that we need to do one, then why should physicians perform the DRE at all?

We shouldn’t. Since PSA screening became the norm, physicians have used PSA levels, not the DRE, as the main determining factor in decision-making for PCa screening. The data overwhelmingly supports PSA measurements as a more accurate and objective test for PCa screening. This is reflected in the fact that the American Urological Association (AUA) guidelines for PCa screening only recommend PSA screening and not the DRE as a primary screening tool.

The guidelines state that the DRE actually has no proven benefit as a primary screening test.3

Quick, Cheap, but With Drawbacks Many physicians would argue that the DRE is a quick, cheap and largely painless exam. So what is the harm in doing it? Well, the DRE is invasive, requiring digital penetration into the rectum.

To many men, the prospect of having this performed can be daunting. One study looking at the perception of pain and discomfort during the DRE found that 73% of patients reported moderate to high discomfort and 61% reported pain.4 In fact, one study demonstrated that only 78% of men would participate in PCa screening that included both a PSA and DRE compared to 100% of men who said they would participate in PCa screening that included only a PSA test. According to the study, in a sample of 10,000 men, a PSA test alone would have detected 27 more cancers and avoided 560 negative biopsies.5 “Do no harm” is the foundation of the doctor’s code, and when it comes to the DRE, we are not sure that code is

Justin Dubin, MD

being followed, as the DRE appears to be more of a barrier to prostate cancer screening than a helpful tool to facilitate decision making.

Not Completely Obsolete We are not saying that the DRE has become completely obsolete. It still has value in certain areas, such as assessing amenability for surgery in patients with known high-risk cancer or those who may require a postradiation prostatectomy. For PCa screening, however, we think it provides limited helpful information and potentially some risks. As the technology continues to evolve, the DRE will become more outdated.

More and more literature supports the use of the prostate MRI, which has become the go-to test prior to a biopsy.

Compared to the illuminating information we get from an MRI, the DRE is merely a finger in the dark.

As COVID-19 has thrust us forward into the era of telehealth, a change from which we are unlikely to fully return, the DRE no longer even fits into the clinical workflow. Requiring patients to take time off of work to drive to an office where they are potentially put at risk to be exposed to COVID-19 just to be subjected to a DRE makes little sense when a telehealth appointment from home or work to review your lab results is just as effective.

Sanoj Punnen, MD, MAS

In the end, when evaluating the DRE as a valid tool for PCa screening, we ask both patients and physicians to consider what merits, if any, there really are in performing it. If the DRE presents a barrier to care, causes pain in two-thirds of patients, and ultimately cannot even provide us with any sound guidance in decision-making, then we really need to ask ourselves exactly why it is we’re still doing it. ■ Justin Dubin, MD, is chief urology resident and Sanoj Punnen, MD, MAS, is an associate professor in the department of urology at the University of Miami M ­ iller School of Medicine in Miami, Florida.

REFERENCES 1. Jones D, Friend C, Dreher A, Allgar V, Macleod U. The diagnostic test accuracy of rectal examination for prostate cancer diagnosis in symptomatic patients: a systematic review. BMC Fam Pract.

2018;19(1):79. doi:10.1186/s12875-018-0765-y 2. Cui T, Kovell RC, Terlecki RP. Is it time to abandon the digital rectal examination? Lessons from the PLCO Cancer Screening Trial and peer-reviewed literature. Curr Med Res Opin. 2016;32(10):16631669. doi:10.1080/03007995.2016.1198312 3. American Urological Association. AUA Clinical ­Guidelines: Early Detection of Prostate Cancer. https://www.auanet.org/guidelines/prostate-cancerearly-detection-guideline2018 4. Romero FR, Romero AW, Brenny Filho T, et al.

Patients’ perceptions of pain and discomfort during digital rectal exam for prostate cancer screening.

Arch Esp Urol. 2008;61(7):850-854. doi:10.4321/ s0004-06142008000700018 5. Nagler HM, Gerber EW, Homel P, et al. Digital rectal examination is barrier to population-based prostate cancer screening. Urology. 2005;65(6):1137-1140. doi:10.1016/j.urology.2004.12.021

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Diet-PCa link continued from page 1

associated only with earlier-onset (younger than 65 years) aggressive PCa. Each 1 SD increase was significantly associated with a 20% and 22% increased risk for advanced and fatal PCa, respectively.

An inflammatory diet was not associated with PCa risk in the overall cohort, but was significantly associated with earlier-onset lethal PCa. “Avoiding dietary patterns with insulinemic or inflammatory potential may be beneficial for the prevention of clinically relevant prostate cancer, especially among younger men,” Dr Fu and colleagues concluded.

The investigators noted that hyperinsulinemia and inflammation are interrelated biologic pathways that link diet with the risk for several cancers, with some evidence suggesting that these may also increase PCa risk.

Hyperinsulinemia may promote tumor progression directly through insulin receptors or regulation of insulinlike growth factors and their binding proteins, which are involved in cell proliferation and survival, the investigators explained.

High Mg ups death risk continued from page 1

with hypermagnesemia and 287 w ­ ithout it. The study found no significant associations between hypomagnesemia (less than 1.69 mg/dL) and either CV events or all-cause mortality.

“In the past decade, recommendations to supplement dietary magnesium intake to patients with chronic kidney disease have appeared in the literature,” Dr Galán and colleagues wrote. “Our study suggests that these recommendations should be applied cautiously, if at all.”

Advanced RCC diagnoses continued from page 1

with increased Medicaid uptake by patients of low-income (absolute percentage change [APC] +11.0%), middle-income (APC +4.20%), and highincome (APC +4.00%). Concurrently, the uninsured rate declined by a significant 1.14% more among expansion than non-expansion states, he noted.

In Medicaid-expansion states, the proportion of patients diagnosed with stage 1 or 2 RCC after ACA implementation increased by 4.6% among

Progression Risk Lowered The study by Dr Gregg and colleagues, which included 410 men on AS for localized PCa, found that increased adherence to a Mediterranean diet, as assessed by a food frequency q ­ uestionnaire

­completed at baseline, was ­associated with a decreasing risk for Gleason grade group (GG) progression.

The diet is characterized by an emphasis on fruits, vegetables, grains, and fish and limited intake of meat and dairy food items, moderate intake of alcohol, and a healthy balance of monounsaturated fats relative to saturated fat.

Of the 410 study participants, 358 (87.3%) had GG1 and 52 (12.7%) had GG2 disease based on their diagnostic prostate biopsy. Over a median followup period of 36 months, 76 patients (18.5%) experienced GG progression.

In adjusted analyses, each 1-unit increase in Mediterranean diet score was associated with a 12% decreased risk for GG progression overall and a 36% and 18% decreased risk among non-White men and men without diabetes, respectively, the investigators reported online in Cancer.

“Our findings suggest that consistently following a diet rich in plant foods, fish and a healthy balance of monounsaturated fats may be beneficial for men diagnosed with earlystage prostate cancer,” Dr Gregg, assistant professor of urology, said in a press release from MD Anderson Cancer Center.

Possible Mechanisms A number of mechanisms support a potential protective effect of the Mediterranean diet in localized PCa, according to the authors. For example, they noted that the antioxidant and anti-inflammatory properties of the Mediterranean diet via a variety of plant foods and healthy balance of fats “may collectively support a systemic and tumor environment that inhibits progression.”

At baseline, the 410 participants filled out a 170-item food frequency questionnaire. Based on their responses, investigators calculated a Mediterranean diet score (0 to 9) for each patient across 9 energy-adjusted food groups. They assigned a value of 1 for each beneficial dietary component (vegetables, fruits, whole grains, legumes, and fish) whose consumption was at or above the median and 1 for each detrimental component (meat and dairy products) at or below the median. A fat intake ratio (monounsaturated to saturated fatty acids) at or above the median had a value of 1.

Moderate alcohol consumption (up to 13 drinks per week) was assigned a score of 1, whereas no alcohol consumption or consumption greater than 13 drinks per week was assigned a score of 0. ■

The study included 746 patients with CKD who had a mean age of 70 years at baseline. Of these, 45.2% had stage 3 CKD and 35.9% had stage 4 CKD. The cohort had a mean serum magnesium level of 2.09 mg/dL at baseline. During a mean follow-up period of 42.6 months, 341 patients (45.7%) experienced either a cardiovascular event, initiation of kidney replacement therapy (KRT), or death. A total of 104 patients (13.9%) died, with CV events identified as the cause of death for 68 patients (65.1%).

In addition, 221 patients (29.6%) had a fatal or nonfatal CV event: 75 (33.9%)

had ischemic heart disease, 29 (11.8%) had a stroke, 25 (11.3%) were diagnosed with peripheral vascular disease, and 95 (42.9%) had congestive heart failure.

KRT was initiated in 145 patients (19.4%), but the study found no association between serum magnesium levels and KRT initiation.

With respect to associations between medication use and serum magnesium levels, Dr Galán and colleagues found that only calcitriol therapy was significantly associated with higher serum magnesium levels, whereas treatment with calcium supplements and proton

pump inhibitors were significantly associated with lower serum magnesium levels.

Study limitations included its observational design the use of only a single baseline measurement of serum magnesium, Dr Galán’s team noted. The main strength of the study was its inclusion of the largest cohort to date of patients with stage 3 and 4 CKD that examined serum magnesium levels and their consequences, according to the authors.

Another strength was the use of propensity score matching “to overcome some of the limitations that are inherent to any observational study.” ■

low-income patients and 1.6% among middle-income patients, with corresponding decreases in the proportion of patients diagnosed with stage 3 or 4 RCC, Dr Javier-DesLoges reported.

By comparison, in non-expansion states, the proportion of patients ­diagnosed with stage 1 or 2 RCC did not change significantly among low-income patients after ACA went into effect, but rose by 1.40% among middle-income patients, with a corresponding decrease in the diagnosis of stage 3 or 4 RCC. The association between low income and premature death also decreased

Trend most evident among low-income patients in states that expanded Medicaid.

patients and attenuation of income status as a risk [factor] for mortality in these patients with RCC,” Dr JavierDesLoges said.

The new study is not the first to document a downward stage migration of cancer following ACA implementation. Last year, investigators published study findings in JAMA Surgery showing that Medicaid expansion under the ACA was significantly associated with a reduced incidence of advanced-stage breast cancer, especially among Black women and women younger than 50 years. ■

An inflammatory diet may contribute to PCa etiology through tissue-level inflammation, “as prostatitis is particularly common among younger and middle-aged men and inflammation is frequently observed in prostate tumor biopsies,” they wrote. In addition, various studies have documented associations between circulating inflammatory biomarkers and PCa risk.

Inflammatory diet was associated with earlier-onset lethal prostate cancer.

Dr Fu’s team stated that, to their knowledge, their investigation “is the first prospective cohort study examining dietary insulinemic potential and prostate cancer development and progression.”

after ACA implementation, according to both intent-to-treat and adjusted Cox regression analyses.

“Our findings suggest that ACA implementation has an immediate and sustained impact on downward stage migration in low/middle-income

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n FEATURE

Uptake of Novel PCa Treatment Modalities Varies by Region Reasons cited include cost of new technologies and differences in marketplace competition

BY JODY A. CHARNOW

I

nnovative technology-based approaches to the diagnosis and treatment of prostate cancer (PCa) are not adopted at the same rate or extent across the United States. Studies have documented regional differences in the uptake of novel modalities and techniques such as robotic-assisted radical prostatectomy (RARP),1-3 magnetic resonance imaging (MRI) of the prostate prior to prostate biopsy,4 multiparametric MRI (mpMRI) of the prostate for patients on active surveillance (AS),5 MRI/ultrasoundguided prostate biopsy,6 stereotactic body radiation therapy (SBRT),7,8 and proton beam therapy (PBT).9 Data also reveal significant regional variation in the cost of RARP compared with open surgery.

Men in the Northeast are more likely than those in the West to have prostate magnetic resonance imaging scans prior to prostate biopsy, data show.

© ZEPHYR / SCIENCE SOURCE

Robotic Surgery Adoption of RARP grew rapidly in the United States, with the proportion of radical prostatectomy (RP) cases performed robotically by board-certified urologists rising from 22% of cases in 2003 to 85% in 2013, according to a study published in Urologic Oncology.10 Uptake of RARP varied by region, however. In a study of 221,637 patients who underwent various types of surgery from January 1, 2010, to December 31, 2011 — including 30,345 patients who underwent RP — the proportion of RP cases performed robotically was highest in the West (71.8%), followed by 68.6%, 66.3%, and 65.3% in the Midwest, Northeast, and South, respectively, according to study findings published in JAMA Surgery. On multivariable analysis, men in the Midwest, South, and West were 56%, 43%, and 12% more likely to undergo RARP, respectively, compared with those in the Northeast, but the differences were not statistically significant.

The study looked at the effect of regional hospital competition and hospital financial status on the use of robotic-assisted surgery, not just for RP but also for nephrectomy, hysterectomy, and oophorectomy.

For all of these operations, robotic-­ assisted procedures were more likely to be performed in competitive markets.

“Although patient characteristics are associated with the use of robotic-assisted surgery, our findings suggest that regional market forces also influence care,” Graham M. Tooker, MD, of the University of Maryland School of Medicine in Baltimore, and colleagues wrote. “Patients treated at hospitals located in competitive regional markets are more likely to undergo robotic-assisted surgery.”

Cost of RARP vs Open RP The difference in the cost between RARP and open RP (ORP) also varies by geographic region. In a study of 24,636 RARP and 13,590 ORP patients identified using

the National Inpatient Sample (NIS) database (2009 to 2011), RARP was 43.3% more costly in the Midwest, 37.2% more costly in the South, and 39.1% more costly in the West, investigators reported in Clinical Genitourinary Cancer.2 In contrast, the cost of RARP in the Northeast was 12.8% less than for ORP. “In our study we found that the cost of RARP continues to exceed that of ORP, despite the increase in volume of RARP performed nationwide,” the authors wrote. “Notwithstanding, a regional comparison of costs surprisingly demonstrated that RARP is now a less expensive procedure than ORP in the Northeast region of the United States.”

The authors said they could only speculate that ORP in the Northeast might be reserved for more advanced cases or preference for ORP compared with other regions, and noted that the lower cost of RARP compared with ORP in the Northeast “might not be because of the decreased cost of robotic surgery,

but rather might reflect the higher cost of ORP in that region.”2 Regional differences in the added costs of RARP compared with ORP also emerged in a separate study of 83,693 men in the NIS database who underwent RP from 2008 to 2015.3 Of these, 51,363 (61.4%) underwent RARP. Overall, the median total hospital charges were higher for RARP compared with ORP ($11,898 vs $10,162). In adjusted analyses, RARP was associated with higher total hospital charges compared with ORP ($3124 more for each RARP), investigators reported in the World Journal of Urology.

Additional charges for RARP vs ORP were highest in the West ($4610), followed by the Midwest ($3278), the South ($2906), and the Northeast ($2216), the investigators reported.

Prostate MRI Adoption of prostate MRI prior to biopsy of the gland is among the newer developments for which significant regional disparities exist, according to study data presented during the American Urological Association’s 2020 virtual annual meeting.4 The study, by investigators at Weill Cornell Medical College in New York City, included 82,483 men undergoing prostate biopsy who were identified using Surveillance, Epidemiology, and End Results (SEER)Medicare linked data. Overall, MRI use prior to biopsy increased from 0.51% in 2008 to 9.15% in 2015 (and from 1.35% to 25.5% among men with a negative prior biopsy), but the odds of undergoing MRI varied geographically.

Compared with men undergoing biopsy in the West, those in the Northeast had significant 3.5-fold increased odds and those in the Midwest had significant

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40% decreased odds of undergoing prostate MRI, the study found.

“For both prostate diagnosis and treatment, there has been evidence demonstrating significant geographic variation in practice patterns,” said urologic oncologist Jim C. Hu, MD, MPH, a senior author on the study. “For instance, in the 1980s it was shown that radical prostatectomy was more likely to be performed in the West rather than the Northeast. In terms of our study, several factors may influence early adoption of prostate MRI in one region vs another. There were innovators and early adopters of prostate MRI and targeted biopsy in New York City, and others in the region likely were ‘following the leader.’ If early adopters are absent in a particular geographic region, then there will be less pressure on providers there to play catchup.”

Active Surveillance With mpMRI The extent to which mpMRI is used for AS also depends on geographic region, according to a study of 9467 men on AS for localized PCa diagnosed from 2008 to 2013.5 Of these men, 1289 (14%) had mpMRI scans and 8178 (86%) did not. The proportion of men undergoing mpMRI was 49% and 28% in the West and Northeast, respectively, compared with 14% and 9% in the South and Midwest, Mina M. Fam, MD, of the University of Pittsburgh Medical Center in Pennsylvania, and colleagues reported in Urology. Compared with men in the Northeast, those in the South, Midwest, and West had significant 60%, 65%, and 25% lower odds of undergoing mpMRI, respectively, in adjusted analyses.

The investigators explained that the Northeast and West contain markets with high hospital and physician capacity in close geographic proximity, which results in significant market competition.

“This competition may drive increased adoption of new technologies in order to gain a competitive advantage and increase market share,” they wrote.

“Thus, the market dynamic of these regions may explain the greater use of mpMRI compared to other regions.”

MRI/US-Guided Prostate Biopsy Geographic disparity is evident as well in the use of MRI/ultrasound-guided prostate biopsy in the diagnosis and staging of PCa, according to the results of a national survey published in Current Urology.6 The survey, which was conducted in 2016, showed that 68% of urologists in the Northeast and 65% of those in the Midwest reported ­performing MRI/ultrasound-guided

biopsy compared with 44% and 53% in the West and South, respectively.

“This may represent differing opinions between institutions on the value of MRI/ [ultrasound] technology or may reflect the use of MRI/[ultrasound] fusion biopsy as a means for practices to remain competitive in tighter markets,” the authors noted.

Stereotactic Body Radiation Therapy Regional differences also have emerged in studies of innovative radiation treatment modalities for PCa. For example, a cohort study of 106,926 patients who received definitive radiation therapy for localized PCa diagnosed from 2010 to 2015 found that patients treated at facilities in the Mid-Atlantic and South Atlantic regions had significant 3.3-fold and 1.7-fold increased odds of receiving SBRT compared with those treated at New England facilities, investigators reported in JAMA Network Open.7 In a separate study of 274,466 men diagnosed with localized PCa from 2004 to 2012 and who received radiation therapy as their initial treatment, investigators found that compared with patients in the South, those in the Northeast had 32% increased odds and those in the Midwest and West had significant 24% and 56% decreased odds of undergoing SBRT, respectively, according to study findings published in Cancer.8

Proton Beam Therapy PBT is another advanced treatment modality whose diffusion has been greater in some regions than others. Of the 37 PBT centers currently in operation in the United States, according to the National Association for Proton Therapy, 16 are on the East Coast (including 5 in Florida, the most of any state). In contrast, the entire West Coast has only 3 (2 in California and 1 in Washington), and large swaths of the nation between the East and West coasts lack a single center. PBT use for localized PCa has occurred at different rates across the United States, according to an analysis of NCDB data from 2004 to 2013.9 The Southern region experienced the largest proportional increase in PBT use among the various regions in the United States, from 0% in 2004 and 2005 to 7.1% of all external beam radiation therapy (EBRT) cases in 2013, Arya Amina, MD, of the University of Colorado School of Medicine in Aurora, and colleagues reported in Urologic Oncology. In addition, PBT use rose most dramatically in the Southern region, from 0% in 2004 to 44% of all PBT cases nationally in 2013. The Western region had the highest ­proportion of PBT cases in the United

States until 2011. That year, the proportion dropped to 40.2% from 51.3% in 2010, making the Southern region the leader in PBT cases (47.5% of PBT cases).

By 2013, facilities in the West and South contributed a similar proportion of patients treated with PBT: 44.5% and 43.9%, respectively. The Eastern and Midwestern regions contributed 9.7% and 2.0%, respectively, the researchers reported.

“To our knowledge, our analysis is the first assessment of regional PBT usage trends in the United States, showing that the increase in PBT use over the past decade reflects the development of proton therapy centers in the Southern region, while usage in other regions [has] remained relatively stable,” they wrote.

By 2013, nearly half of all PBT for localized PCa was delivered in the Southern region, “likely reflecting a predisposition toward early adoption of available technology and clinical investigation among large academic medical centers in the region.”

J. Kellogg Parsons, MD, MHS, professor of urology at the University of California, San Diego, and author of a 2014 paper in JAMA Surgery titled “Diffusion of Surgical Innovations, Patient Safety, and Minimally Invasive Radical Prostatectomy,”11 suggests that provider access to new medical technologies and the availability of other specialists needed to use those technologies are among the factors that influence their uptake and could explain regional variation in uptake of innovative approaches to patient care. For example, urologists who want to incorporate mpMRI into their diagnostic approach to PCa need access to both the technological capability to do the scans properly and radiologists with the skill to interpret the scans, Dr Parsons said.

The cost of new technologies for patients and providers also may influence their uptake in a region. For example, he said, urologists often have to demonstrate to third-party payers the clinical evidence supporting prostate MRI to persuade them to cover the procedure. These interactions with insurers are time consuming and pull urologists away from their clinical duties, he said. Regional differences in the extent to which haggling with insurers is a problem could affect uptake of prostate MRI in those places, he added.

“Another component of regional variation, and this is purely anecdotal, is how much patients drive preferences,” Dr Parsons said. “You can make an argument, anecdotally, that men with prostate cancer in southern California, where I practice, are going to approach newer technologies and seek out newer

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technologies in ways that might be different from men [with prostate cancer] in other parts of the country.”

Mark S. Litwin, MD, MPH, professor and chair of urology at David Geffen School of Medicine at the University of California, Los Angeles (UCLA), and professor of health policy and management at the UCLA Fielding School of Public Health, said geographic differences in the diffusion of new medical technologies mostly relates to physician factors, such as willingness and wherewithal to learn a new surgical or diagnostic technique. “It really comes down in part to just how user-friendly this technology is for the doctors who are responsible for operationalizing it,” Dr Litwin said.

Other physician factors include physician age and how much time has elapsed since physicians received their medical training. “The earlier they are out from their training, the more open they are to novel improvements, and the farther out they are, as a general rule, the more set in their ways they get,” Dr Litwin said.

Marketplace competition also could explain why uptake of some technologies is greater in some places than others.

For example, in areas served by multiple hospitals, all of those institutions might acquire an innovative machine to compete for patients. ■ REFERENCES 1. Wright JD, Tergas AI, Hou JY et al. Effect of regional hospital competition and hospital financial status on the use of robotic-assisted surgery. JAMA Surg. 2016;151: 612-620. doi:10.1001/jamasurg.2015.5508 2. Faiena I, Dombrovskiy VY, Modi PK, et al. Regional cost variations of robot-assisted radical prostatectomy compared with open radical prostatectomy. Clin Genitourin Cancer. 2015;13:447-452. doi:10.1016/j.clgc.2015.05.004 3. Preisser F, Nazzani S, Mazzone E, et al. Regional differences in total hospital charges between open and robotically assisted radical prostatectomy in the United States. World J Urol. 2019;37:1305-1313. doi:10.1007/s00345-018-2525-y 4. Gaffney CD, Berg RWV, Cai P, et al. Increasing utilization of magnetic resonance imaging (MRI) prior to prostate biopsy in black and non-black men: An analysis of the SEER-Medicare cohort. Presented at: AUA Virtual Experience 2020, May 15. Poster MP42-18.

5. Fam MM, Yabe JG, Macleod LC, et al. Increasing utilization of multiparametric magnetic resonance imaging in prostate cancer active surveillance. Urology.

2019;130:99-105. doi:10.1016/j.urology.2019.02.037 6. Tooker GM, Truong H, Pinto PA, Siddiqui MM. National survey of patterns employing targeted MRI/ US guided prostate biopsy in the diagnosis and staging of prostate cancer. Curr Urol. 2018;12:97-103. doi:10.1159/000489426 7. Mahese SS, D’Angelo D, Kang J, et al. Trends in the use of stereotactic body radiotherapy for treatment of prostate cancer in the United States. JAMA Netw Open. 2020;3(2):e1920471. doi:10.1001/jamanetworkopen.2019.2071.

8. Baker BR, Basak R, Mohiuddin JJ, Chen RC. Use of stereotactic body radiotherapy for prostate cancer in the United States from 2004 through 2012. Cancer.

2016;122:2234-2241. doi:10.1002/cncr.30034 9. Amini A, Raben D, Crawford ED, et al. Patient characterization and usage trends of proton beam therapy for localized prostate cancer in the United States: A study of the National Cancer Database.

Urol Oncol. 2017;35:438-446. doi:10.1001/ jamanetworkopen.2019.20471 10. Oberlin DT, Flum AS, Lai JD, Meeks JJ. The effect of minimally invasive prostatectomy on practice patterns of American urologists. Urol Oncol. 2016;34:255. e1-255.e5. doi.org/10.1016/j.urolonc.2016.01.008 11. Parsons JK, Messer K, Palazzi K, et al. Diffusion of surgical innovations, patient safety, and minimally invasive radical prostatectomy. JAMA Surg. 2014; 149:845-851. doi:10.1011/jamasurg.2014.31

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New President Takes the Reins at LUGPA The Large Urology Group Practice Association (LUGPA) has elected Jonathan Henderson, MD, to a 2-year term as its president. Dr Henderson is the chief executive officer for Regional Urology in Shreveport, Louisiana. In an interview with Renal & Urology News following LUGPA’s virtual 2020 annual meeting, Dr Henderson discussed the association’s lobbying efforts in Washington, DC, and issues affecting private practice urologists.

Much of the LUGPA annual meeting proceedings dealt with the organization’s advocacy efforts in Washington, DC. What do you see as the main takeaway points?

Dr Henderson: The winds are changing, and CMS [Centers for Medicare and Medicaid Services] and Congress are finally starting to recognize that a level playing field is in the best interest of all patients. The main reason for the existence of LUGPA is twofold. First is our work in Health Policy: fighting to achieve site of service neutrality in CMS payments.

Second, the ongoing effort to maintain and boost the ability for independent urology to thrive. There is no substantially good reason that the average consumer, through CMS, should pay a different price for the same service at 2 different locations. The ripple effect of different payments at different sites is profound. As we’ve seen for the past several years, there continues to be mounting pressure to provide site-ofservice neutrality.

Do you think the change in administration will impact advocacy efforts?

Dr Henderson: No, I don’t think so.

We’ve seen administrations on both sides of the aisle as well as both houses on both sides of the aisle. We’ve

On The Web

worked well with everybody. We don’t consider our issues to really be partisan. They’re American issues. I do not see any change in our activities or our successes.

need for improvement. Our data has been utilized in our member groups around the country for years. It has been used for decisions on physician reimbursement; utilization review; quality improvement; physician education. It helps individual doctors learn from others more efficient processes for treatment of various conditions in the OR, MIPS [Merit-based Incentive Payment System] measures, and so on.

Have any noteworthy practice trends emerged?

Dr Henderson: The entrance of private equity (PE) into our LUGPA community. Virtually every practice has been approached and/or evaluated

by PE. Over a dozen of our practices have entered into PE arrangements with about 5 different PE firms, and this represents somewhere around 300 urologists so far. This is exciting and interesting for anyone who understands free markets, anticipated organic movement. As evidenced by

One of the sessions at the LUGPA annual meeting discussed strategies for dealing with the BCG shortage.

How big a problem has the BCG shortage been for LUGPA member practices? Has it impacted your practice?

Dr Henderson: Every practice in the country has been impacted by the BCG shortage. It is one of the most far-reaching and truly devastating healthcare emergencies our country has experienced. In my practice, we have resorted to a system whereby we dedicate a physician and nurse to maintain a list of patients who would, in normal times, receive BCG. They then triage the patients based on our allocation. Fully two-thirds of the patients who would have been given BCG are now deprived.

You updated members on the findings from LUGPA’s benchmarking initiative. Why is benchmarking important?

Dr Henderson: Benchmarking is the proven method of measuring processes to determine effectiveness and

Site-of-service neutrality will continue to be a LUGPA priority.

—Jonathan Henderson, MD

the American Urological Association census, the trend of urologists to move to hospital-based employment is monumental. For the first time in history, this segment is the largest employment arrangement in our specialty. It has been facilitated, and actually made possible, by predatory hospital practices funded by old CMS policies of largesse from a bygone era when the hospital lobby influenced Congress and CMS to allow different payments for the exact same services based only on site of service. In fact, many times, more efficient [care and] better outcomes occur at nonhospital settings even though CMS reimburses far greater for those lesser outcomes.

Are there downsides to the trend toward hospital-based employment?

Dr Henderson: The landscape changed 30 or 40 years ago. In past times, we had academic practices and private practices. Then we added a third player, which was private but hospitalowned practices. That third player has really been growing for the past 15 to 20 years, and it offers a lot of attractive benefits that some people are drawn to.

Independent medicine in the United States is the defense against the wholesale shift to single-payer socialized medicine. What people who are hospital employed have to realize is that those of us who maintain our independent practices are actually maintaining their ability to have a good-paying hospital job. Because if we do not have independent practices, they would just be slaves for the hospitals, indentured servants. We have to have those market forces to continue to provide them with reasonable salaries. The house of urology is big enough for everybody to have what fits them best, and while there are some attractive [aspects] to hospital employment, it’s not for everybody, and even for those people who are drawn to it, I would say, “Stop and think about it.” If everybody goes to hospital employment, the hospitals own everybody. ■

Continue the conversation online! We have many experts who weigh in on controversial topics important to you. Catch our discussions at www.renalandurologynews/expertqa.

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Renal & Urology News 15

Ethical Issues in Medicine L

ast spring amid the pandemic, I found myself waiting on a long line outside a national chain grocery store. Like elsewhere, these businesses were restricting the number of customers allowed in the store to reduce exposure. Handwritten signs taped to an adjacent brick wall instructed customers queuing up to maintain 6 feet of distance apart from one another and have adequate face covering to reduce the spread of COVID-19. Another sign below it instructed pregnant customers and those over age 60 to proceed to a separate spot for expedited entrance to the store.

A week later arriving at a big box store, I found that as an essential health care worker I was permitted to advance to the front of the line. I was struck by the difference in rules that afforded advantages to certain shoppers and began to wonder how the stores arrived at them. How the shopping sector decided on priority shoppers was an interesting study in how access to products and services are ordered in a time of crisis and reflects a central ethics tension when addressing scarcity. How do we decide who goes first?

professionals in healthcare, logistics, operations, ethics (and in some cases, the public), but they are all guided by the principles of fairness, transparency, and consistency. To maintain accountability and the public’s trust, the healthcare system should incorporate these key principles when arriving at decisions about prioritizing access to a scarce resource.

What would happen if the healthcare system did not appeal to these basic ethics principles when addressing scarcity in health care? For example, consider why the Advisory Committee on Immunization Practices (ACIP) decided not to recommend prioritizing access to the new COVID vaccines simply on a first-come, first-served basis. This approach would be unfair on its face, as it would exacerbate existing health disparities in care; would not necessarily benefit those who are at highest risk of morbidity and mortality from the disease based on the available evidence; and would lead to greater total harm for the US population. The framework the ACIP developed reflects strong ethics practices in allocation

Identifying a patient’s preferences and goals leads to a care plan that can reflect those goals, and this may improve patient satisfaction.

Guiding Principles Indeed, healthcare professionals have been at the center of decisions about access to healthcare services during the COVID-19 pandemic. From the most extreme decisions about intensive care unit (ICU) beds if their available supply is outstripped by demand, to deciding who receives the COVID vaccine or remdesevir first, to how best to extend the reasonable life of personal protective equipment (PPE), these decisions all revolve around how to make fair and justifiable decisions in the face of scarcity. Each of these decisions is complex and requires the expertise of

and prioritization by resting on an ethical framework that seeks to maximize benefits and minimize harms, promote justice, mitigate health inequities, and promote transparency.1

Bedside Decisions As another example, why have states developed clinical frameworks for addressing scarcity if the demand for resources exceeds the available supply in their healthcare systems? With no transparent system to guide healthcare professionals in the face of extreme resource scarcity, difficult decisions about who among a group of patients

© KATE HISCOCK / GETTY IMAGES

Deciding who gets priority care will be a key ethical consideration in the distribution of the COVID-19 vaccine BY DAVID J. ALFANDRE, MD, MSPH

Principles of fairness are a key part of deciding who gets priority access to a scarce resource.

should be given priority for treatment would fall to a bedside clinician. Such bedside decisions in the context of scarcity would be more likely to be inconsistent, based on incomplete information, subject to unconscious bias, and lack transparency.2 Together, such a process would lead to unfair prioritization of scarce resources.

Better than grappling with the ethical challenges of prioritizing scarce resources is working to avoid a situation when it would be required.3 Augmenting health system capacity through a variety of means helps avoid having to implement a scarce resource allocation protocol. This is what happens when overwhelmed hospitals turn post-anesthesia care units into fully functioning medical ICUs and thus increase the number of beds to care for patients; when states reduce legal barriers for retired nurses and doctors to return to work and thus provide support to hospitals with dwindling staff; or when US companies increase production of ventilators to avoid scarcity, or production of gowns, N95 masks, and gloves to safeguard the essential staff that are needed to fight the pandemic.

To ensure that healthcare professionals can promote equity and public trust, they should familiarize themselves with

the currently authorized frameworks for prioritizing scarce resources and when they are applicable. These frameworks are intended to be transparent to the public, consistently applied, promote equity, and maximize benefit and minimize harms to those most likely to be affected. We can overlook a grocery store for not getting fair prioritization right. The healthcare system and the public it serves has much more to lose. ■ David J. Alfandre, MD, MSPH, is a healthcare ethicist for the National Center for Ethics in Health Care (NCEHC) at the Department of Veterans Affairs (VA) and an Associate Professor in the Department of Medicine and the Department of Population Health at the NYU School of Medicine in New York. The views expressed in this article are those of the author and do not necessarily reflect the position or policy of the NCEHC or the VA. REFERENCES 1. McClung N, Chamberland M, Kinlaw K, et al. The Advisory Committee on Immunization Practices’ Ethical Principles for Allocating Initial Supplies of COVID-19 Vaccine — United States, 2020.

MMWR Morb Mortal Wkly Rep 2020;69:1782-1786. doi:10.15585/mmwr.mm6947e3 2. Rosoff PM, Patel KR, Scates A, Rhea G, Bush PW, Govert JA. Coping with critical drug shortages: An ethical approach for allocating scarce resources in hospitals. JAMA Intern Med. 2012;172(19):14941499. doi:10.1001/archinternmed.2012.4367 3. Hick JL, Hanfling D, Wynia MK, Pavia AT. Duty to plan: health care, crisis standards of care, and novel coronavirus SARS-CoV-2. NAM Perspectives. Discussion paper. National Academy of Medicine. Washington, DC. doi:10.31478/202003b.

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Practice Management Proposed modifications to the HIPAA Privacy Rule would strengthen patients’ rights to access their health information BY JOHN SCHIESZER To improve patients’ rights to access their protected health information (PHI), the proposal calls for shortening covered entities’ required response time to no later than 15 calendar days (from the current 30 days) with the opportunity for an extension of no more than 15 calendar days (from the current 30-day extension). Azar said in a press release that the “proposed changes to the HIPAA Privacy Rule will break down barriers that have stood in the way of commonsense care coordination and value-based arrangements for far too long.” A public comment period of 60 days will be held following publication of the NPRM in the Federal Register.

More Latitude for Disclosure OCR Director Roger Severino said the current regulation requires covered healthcare providers to exercise “professional judgment” when making certain disclosures of PHI to an individual’s family members and other caregivers.

He said this could be interpreted as limiting the permission to persons who are licensed or who rely on professional training to determine whether a use or disclosure of PHI is in an individual’s best interests. “This proposed modification would allow providers greater confidence to disclose PHI to family

One proposed change would shorten the timeframe healthcare providers have to respond to patient requests for their health information. is part of the HHS’s Regulatory Sprint to Coordinated Care, initiated under HHS Secretary Alex Azar’s value-based transformation agenda. The proposed changes call for enhancing flexibilities for disclosures in emergency or threatening circumstances, such as the opioid and COVID-19 public health emergencies. Other changes being proposed would reduce administrative burdens on health care providers and health plans that are covered by HIPAA.

members, caregivers, and loved ones of individuals who are in an emergency or may be experiencing a health crisis without undue concerns about violating the HIPAA Rules,” Severino said.

In addition to the proposal to permit certain disclosures based on a good faith belief, the NPRM proposes a new standard to allow covered entities to disclose PHI to prevent harm that is serious and reasonably foreseeable. “OCR has heard many heart wrenching stories

© SHAPECHARGE / GETTY IMAGES

N

ew changes to the Health Insur­ a nce Portability and Account­ ability Act of 1996 (HIPAA) Privacy Rule are in the works to empower patients, improve coordinated care, and reduce regulatory burdens on the healthcare industry.

On December 10, 2020, the Office for Civil Rights (OCR) at the US Department of Health and Human Services (HHS) announced proposed changes to the HIPAA Privacy Rule that strengthen individuals’ rights to access their own health information, including electronic information.

The proposed changes would improve information sharing for care coordination and case management and facilitate greater family and caregiver involvement in the care of individuals experiencing emergencies or health crises. The HHS has issued a Notice of Proposed Rulemaking (NPRM) to modify the Standards for the Privacy of Individually Identifiable Health Information (Privacy Rule) under HIPAA and the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act).

The proposed changes include adding definitions for the terms electronic health record (EHR) and personal health application. This new NPRM

Proposed HIPAA changes would improve information sharing for coordinating healthcare.

of parents and loved ones of patients who are facing a health crisis, such as an opioid overdose, who are not informed of an emergency or life threatening circumstance,” Severino said.

Physician Views Recent HIPAA compliant web solutions have allowed healthcare providers to take advantage of the benefits of new technology without jeopardizing the privacy and security of patient data.

David Parks, MD, medical director and clinical manager for CentralWest Healthcare in St. Louis, Missouri, said with the new EHR systems patients have a portal where they can access most parts of their records and read medical notes. They also can review their own laboratory results. He said these HIPAA rule changes are needed. “I personally think this has started at an appropriate time and it is completely appropriate to do so,” Dr Parks said. “Providers are so rushed due to insurance requirements it is incredibly easy to make documentation mistakes, and this gives the patient a chance to do a double check against the provider and request any appropriate corrections,” Dr Parks said.

Lisa Ravindra, MD, assistant professor of medicine at Rush Medical College

in Chicago, Illinois, an informatics specialist who uses information and communication systems to improve healthcare, said the proposed modifications raise some questions. “The HIPAA Privacy Rule mentions phrases such as removing barriers to coordinated care, reducing administrative burdens, and empowering patients, which to a physician like myself seems like great improvements. However, it’s not clear how much impact this will have on dayto-day practice,” Dr Ravindra said.

At Rush University Medical Center, a form of “open notes” was adopted that allows sharing inpatient, outpatient, and emergency department notes directly with patients through the patient portal, Dr Ravindra said.

“The proposed HIPAA changes further increase patient access to their records by reducing the amount of time that a covered entity has to provide access to personal health information from 30 days to no more than 15,” Dr Ravindra said. “Given that notes are shared automatically with patients now, this is unlikely to affect physicians at my institution.” ■ John Schieszer is a freelance medical writer based in Seattle, Washington.