Studies are beginning to suggest that COVID-19’s impact on men’s health might go beyond the lungs, heart, and kidneys. According to recently published studies, having COVID-19 could have lasting impacts on fertility and sexual function.

Ranjith Ramasamy, MD, associate professor and director of the University of Miami Miller School of Medicine’s Reproductive Urology Program, is uncovering what he says are clear links between COVID-19 infection and men’s sexual health.

“We know the COVID-19 virus can remain inside the testis long after the initial infection in asymptomatic men. We know the COVID-19 virus can decrease sperm count for up to 3 to 6 months. And we know the COVID-19 virus can affect the blood vessels and be present in the penis up to 7 to 9 months after the initial infection and can lead to erectile dysfunction,” Ramasamy said.

Getting the mRNA COVID-19 vaccine does not appear to impact fertility and should be encouraged, according to Ramasamy, who has published several articles on COVID-19 and men’s sexual health, including the research letter, “Sperm parameters before and after COVID-19 mRNA vaccination” published June 17 in

Findings from early studies looking at male infertility post–COVID-19 infection are concerning, reassuring, conflicting, and inconclusive.

COVID-19 does not appear to get into the semen, according to urologist James M. Hotaling, MD, MS, FECSM, medical director of the fertility integrated practice unit and director of the Men’s Health program at the University of Utah, Salt Lake City.

Hotaling and coauthors in China conducted an observational study of 34 adult Chinese males who received a diagnosis of COVID-19 and found severe acute respiratory syndrome (SARS)-CoV-2 was not detected in the men’s semen 1 month after COVID-19 diagnosis.

Current evidence suggests a low likelihood of SARS-CoV-2 transmission through the seminal fluid. There are limited data characterizing SARS-CoV-2 infection’s impact on male reproductive hormones and semen parameters. And data suggesting SARS-CoV-2 gets into testes are inconclusive, according to Hotaling.

Data regarding the short- and long-term impacts of SARS-CoV-2 on male reproductive health remain largely inconclusive and need further long-term study, Hotaling and colleagues reported in a review of the literature published April 2021 in 

But Ramasamy and other investigators are finding causes for concern.

A study published earlier this year in the 

 by Ramasamy et al looked at testis tissue collected from autopsies of 6 COVID-19 positive and 3 COVID-19 negative men. The investigators found 3 of the 6 COVID-19–positive biopsies had normal spermatogenesis and 3 had impaired spermatogenesis. Electron microscopy showed the COVID-19 virus in testis tissue of 1 COVID-19–positive autopsy case.

The novel COVID-19 virus has an affinity for angiotensin converting enzyme-2 (ACE-2) receptors. Since ACE-2 receptor expression is high in the testes, the study authors hypothesized that COVID-19 can be present in testes tissue of infected patients. This study suggests that the male reproductive tract, specifically the testes, may be the target of COVID-19 infection. They found an inverse association between ACE-2 receptor levels and spermatogenesis, suggesting a possible mechanism of how COVID-19 can cause infertility, according to the study.

Investigators in China also found evidence that SARS-CoV-2 can infect the testis and germ cells, suggesting a potential impact on spermatogenesis and male fertility.

“Nevertheless, further study is essential to reveal the underlying mechanism of SARS-CoV-2 infection of testicular cells and the correlation of testis infection with the clinical course of COVID-19,” according to the correspondence published December 14, 2020, in 

Although more quality research is needed to confirm these results, the findings make sense when one thinks about COVID-19 infection basics, according to Hossein Sadeghi-Nejad, MD, FACS, professor of Surgery/Urology at Rutgers New Jersey Medical School and Hackensack University Medical Center.

Infection from SARS-CoV-2 causes an exaggerated inflammatory response leading to immunosuppression. The body releases cytokines that mainly affect lung tissue but also lead to extrapulmonary effects, he said.

For example, some studies are showing overall testosterone levels can be lower in patients who get COVID-19. Investigators of a single-center cohort study of patients with COVID-19 found lower testosterone concentrations during hospitalization were associated with increased disease severity and inflammation in men.

Still unclear is whether the decrease in testosterone is an adaptive or maladaptive COVID-19 response.

The reason for the likelihood of lower testosterone levels in COVID-19 patients is that SARS CoV-2 gets into the system is through ACE-2, which has been expressed in Leydig cells and Sertoli cells, according to Sadeghi-Nejad.

Damage to Leydig cells may lead to testosterone deficiency, he said.

There are about 2 dozen peer-reviewed articles containing research or findings regarding COVID-19 and erectile dysfunction (ED), according to Martin Gross, MD, assistant professor at Dartmouth-Hitchcock Medical Center and codirector of the Dartmouth-Hitchcock Men’s Health Center.

“They predominantly include case reports, observational studies, survey data, expert opinions, and review articles. These types of articles tend to be on the lower end of scientific rigor,” Gross said. “We don’t know much about the relationship between ED and COVID-19 at this point.”

A study by Ramasamy et al, published in July in the 

nalyzing penile tissue from COVID-19 patients who recovered and subsequently developed ED, was novel and interesting, according to Gross.

It was the first study to demonstrate the presence of the COVID-19 virus in the penis up to 9 months after the initial infection and suggests that endothelial dysfunction from the virus could contribute to ED.

Omer Raheem, MD, MSc, assistant professor of urology and director of men’s health at Tulane University School of Medicine, New Orleans, Louisiana, said he found it interesting that 1 of the 2 men Ramasamy and colleagues studied was hospitalized for COVID-19 infection, whereas the other had only mild COVID-19 symptoms, yet both men developed severe erectile dysfunction.

This study suggests that widespread endothelial cell dysfunction from COVID-19 infection can contribute to erectile dysfunction. Larger prospective studies are warranted to further validate this finding, Raheem said.

“From patient’s perspective, albeit not conclusive, there is some evidence suggesting the potentially negative impact of COVID-19 infection on male reproductive function and overall men’s health. Likewise, COVID-19–infected or COVID-19–recovered men should be aware of the possible risk of developing erectile dysfunction, male infertility, and hypogonadism, owing to the adverse effect of the SARS-CoV-2 virus on testicular Sertoli and Leydig cells via ACE-2 binding. And obviously those symptomatic men should seek urologic consultation to evaluate and treat these conditions,” Raheem said.

Although the link between COVID-19 infection, endothelial damage, and ED is interesting, the finding should be further evaluated in larger studies and viewed cautiously, according Sadeghi-Nejad.

“Endothelial damage is not restricted to COVID-19. Endothelial dysfunction is seen in many of our patients who have erectile dysfunction, which we know to be a neurovascular problem,” Sadeghi-Nejad said.

There are conflicting data about whether sexual activity increased or decreased during the pandemic, according to Sadeghi-Nejad.

Many surveys on sexual activity during quarantining suggest decreased activity, possibly because the studies included younger patients with children living at home. Other studies on older patients showed increased activity.

Interestingly, investigators studying US sales of phosphodiesterase-5 (PDE5) inhibitors show sales of the medications spiked during lockdowns.

Turkish authors of a paper published earlier this year in 

 reported a significant increase in andrological diagnoses during the pandemic, compared with before it.

“There was a statistically significant increase in the number of patients diagnosed with male reproductive or sexual health problems during the COVID-19 pandemic period,” according to the authors. “The number of patients diagnosed with erectile dysfunction during the pandemic was also significantly higher than [in] the pre–COVID-19 pandemic period.”

The paper’s authors suggest that although these problems are multifactorial, psychogenic factors might be a significant trigger.

In other research, the PDE5 inhibitors men use to treat erectile dysfunction could also treat COVID-19. These medications, the authors wrote, have anti-inflammatory, antioxidant, immune response regulation, and antiapoptotic properties.

“A lot of the paper was theoretical but solidly grounded in physiology and pharmacology,” Gross said. “These studies are all interesting to some degree, but they are snapshots in time that may lose relevance down the road.”

Counseling patients about COVID-19’s potential impact on sexual health and fertility might start with encouraging patients to get vaccinated.

“I recommend that all couples trying to conceive get the vaccine. And that it is safe,” Hotaling said.

Men who have acute COVID-19 infections and see a decline in spermatogenesis should consider waiting 3 to 6 months before planning fertility treatment so their sperm counts can recover, according to Ramasamy.

Sadeghi-Nejad cites American Society of Reproductive Medicine recommendations regarding shared decision-making and detailed discussions, including not withholding the vaccine from patients who are planning to conceive, those who are already undergoing fertility treatment, and pregnant patients. These groups should be encouraged to receive vaccination if there are no other contraindications.

Gross, however, said he questions the value of further research on the link between ED and COVID-19, and a COVID-19 diagnosis does not change his approach to ED treatment.

“It would be presumptuous to think that our little corner of medicine has any relevance to the bigger COVID-19 picture. And lots of conditions cause ED; let’s try and tackle those first,” Gross said. “I have never found a good reason to wait to treat any patient’s erectile dysfunction. If a patient has a problem, hears his options, and is healthy enough and wants to proceed with some or all of these options, then I’m happy to help. If patients aren’t healthy enough or otherwise prepared to move forward with treatment, then we can wait until they’re ready.”

Questions remain about how the virus invades the immune system and can stay in organs for such a long time, as well as whether any impact from COVID-19 on male fertility or sexual function is permanent, according to Ramasamy.

More data should be coming out soon, according to Hotaling.

“Some of the big IVF groups are tracking their outcomes where the men or women have had COVID-19. A lot of these big claims databases will release their data from 2020 sometime between now and the end of the year,” Hotaling said. “There are a lot of studies out of Europe that I’ve seen tracking cohorts of patients who had COVID-19.”

Ongoing and long-term studies to evaluate the potential impact of the COVID-19 infection on men’s health are needed as we emerge from COVID-19 pandemic and monitor the novel COVID-19 Delta variant, Raheem said.

1. Gonzalez DC, Nassau DE, Khodamoradi K, et al. Sperm parameters before and after COVID-19 mRNA vaccination.

 Published online June 17, 2021. doi:10.1001/jama.2021.9976

2. Pan F, Xiao X, Guo J, et al. No evidence of severe acute respiratory syndrome-coronavirus 2 in semen of males recovering from coronavirus disease 2019. 

 2020;113(6):1135-1139. doi:10.1016/j.fertnstert.2020.04.024

3. Patel DP, Punjani N, Guo J, Alukal JP, Li PS, Hotaling JM. The impact of SARS-CoV-2 and COVID-19 on male reproduction and men’s health. 

 2021;115(4):813-823. doi:10.1016/j.fertnstert.2020.12.033

4. Achua JK, Chu KY, Ibrahim E, et al. Histopathology and ultrastructural findings of fatal COVID-19 infections on testis. 

 2021;39(1):65-74. doi:10.5534/wjmh.200170

5. Ma X, Guan C, Chen R, et al. Pathological and molecular examinations of postmortem testis biopsies reveal SARS-CoV-2 infection in the testis and spermatogenesis damage in COVID-19 patients. 

. 2021;18(2):487-489. doi:10.1038/s41423-020-00604-5

6. Dhindsa S, Zhang N, McPhaul MJ, et al. Association of circulating sex hormones with inflammation and disease severity in patients with COVID-19.

. 2021;4(5):e2111398. doi:10.1001/jamanetworkopen.2021.11398

7. Stolk RF, van Leeuwen HJ, Kox M, et al. The chicken or the egg: low testosterone predisposes for COVID-19 or COVID-19 induces a decrease in testosterone? 

 2021;25(1):237. doi:10.1186/s13054-021-03664-9

8. Kresch E, Achua J, Saltzman R, et al. COVID-19 endothelial dysfunction can cause erectile dysfunction: histopathological, immunohistochemical, and ultrastructural study of the human penis. 

. 2021;39(3):466-469. doi:10.5534/wjmh.210055

9. Hernandez I, Gul Z, Gellad WF, Davies BJ. Marked increase in sales of erectile dysfunction medication during COVID-19. 

10. Duran MB, Yildirim O, Kizilkan Y, et al. Variations in the number of patients presenting with andrological problems during the coronavirus disease 2019 pandemic and the possible reasons for these variations: a multicenter study. 

 2021;9(1):100292. doi:10.1016/j.esxm.2020.100292

11. Mostafa T. Could oral phosphodiesterase 5 inhibitors have a potential adjuvant role in combating COVID-19 infection?. 

2021;9(1):15-22. doi:10.1016/j.sxmr.2020.08.006

12. ASRM issues statement on COVID-19 vaccines, joins other OB/GYN groups on community-wide statement. News release. American Society for Reproductive Medicine. Dec 16, 2020. Accessed July 13, 2021. https://bit.ly/3BbJ5Bq

Articles

According to recently published studies, having COVID-19 could have lasting impacts on fertility and sexual function.

COVID-19 and men’s health: What we know so far

Payments from industry—pharmaceutical manufacturers and device companies—to physicians continue to be examined by the federal government, policy makers, and watchdog agencies. Speaker programs appear to be under special scrutiny.

 In July 2020, 1 company agreed to pay $678 million to settle charges of paying more than $100 million to physicians for alleged sham speaker programs.

 In November 2020, the Office of Inspector General (OIG) for the US Department of Health and Human Services issued a Special Fraud Alert regarding industry-sponsored speaker programs.

 That alert reads, in part: “OIG has significant concerns about companies offering or paying remuneration (and HCPs [health care providers] soliciting or receiving remuneration) in connection with speaker programs. Based on our investigations and enforcement actions, this remuneration is often offered or paid to induce (or solicited or received in return for) ordering or prescribing items paid for by Federal health care programs. If the requisite intent is present, both the company and the HCPs may be subject to criminal, civil, and administrative enforcement actions.”

In April 2021, a paper linking Open Payments data to Medicare Part B payment data demonstrated that payments from medical device companies generally exceed that of drug companies and appear to be targeted at surgical specialists who are high billers in the Medicare Part B program.

 The Physician Payments Sunshine Act (Section 6002 of the Affordable Care Act) requires that manufacturers of “covered drugs, devices, biologicals, and medical supplies” report payments and other transfers of value to physicians to the Centers for Medicare and Medicaid Services (CMS), which in turn publishes this information. It also requires that manufacturers and group purchasing organizations (GPOs) report physician (or their family) ownership and investment interests. These requirements stem from a concern that payments to individuals could influence or incentivize behavior and a belief that public reporting might deter inappropriate behaviors or relationships. More than 1 study has shown an association between payments and physician behavior.

 On June 30, 2021, CMS released its annual update of Open Payments financial data (calendar year 2020).7 In this article, I will review some information and analysis about the payments to urologists reported under this surveillance program.

In 2020, $9.1 billion in payments or investment value was reported by 1621 unique companies to physicians, teaching hospitals, and other entities. The total amount of general payments to 487,000 individual physician recipients was $2 billion, down from $2.3 billion to 617,000 physicians in 2019. A total of 7922 urologists received a total of $22,861,359 (1.13%) of those general payments from 361 unique manufacturers; total general payments to urologists were down 40% from the previous year. The largest single payment to a urologist was $523,338.17, and the average payment to a urologist in 2020 was $211.17 (up 16%); average and total payments to urologists have been increasing an average of about 7% per year over the last 5 years. In 2020, 35 urologists each received more than $100,000 (average, $271,000 in this subgroup) and collectively represented 42% of all payments to urologists 

. The maximum number of payments to a single urologist in 2020 was 501 (almost all associated with a single medical device totaling over $500,000). As in past years, most of the 2020 payments to urologists came in the form of cash 

, and were compensation for consulting fees, services other than consulting, food and beverage, and royalty or license. Services other than consulting (this category includes speaker programs) dropped sharply in 2020 (about $10 million or 60%) from the previous year, possibly reflecting the impact of the COVID-19 pandemic on meetings and speaker programs.

CMS requires manufacturers and GPOs to associate a general payment with a drug, biologic, device, or medical supply where appropriate (many payments are uncategorized). General payments associated with devices comprised the largest category—$12,686,907.22 from 138 manufacturers to over 6000 urologists—over half of all general payments. Four products (UroLift, Cook medical extractors, da Vinci Surgical System, and Titan) accounted for over half of all payments. Payments associated with drugs and biologics totaled about $5.3 million, down 50% from the previous year; 4 prostate cancer drugs (enzalutamide [Xtandi], apalutamide [Erleada], darolutamide [Nubeqa], and sipuleucel-T [Provenge]) accounted for over half of 2020 total payments in this category.

The Open Payments program tracks payments associated with ownership interest in 2 ways. First, some of the general payments to physicians are categorized as “Current or prospective ownership or investment interest.” In 2020, $807,964 in ownership or investment interest was paid from 9 entities to 51 urologists. Most of these payments appear to come from limited liability companies. The largest single ownership payment to a urologist was $235,000 and was uncategorized.

The second way that payments related to physician ownership are reported is by the “value of interest,” defined as “the current cumulative value of ownership or investment interest held by the physician (or the physician’s immediate family members) in the Applicable Manufacturer or GPO as of the most recent feasible valuation date preceding the reporting date.” A total of $1.12 billion of value was reported in 2020 for all physicians, and $36 million (3%) of that was attributed to 445 urologists from 15 entities. Most of the dollars reported of this type are from a single entity totaling $30 million in value of interest (more than double the 2019 value for that entity) and distributed among 254 individual urologists; the value of interest for each urologist in that entity ranges from $3.5 million to $16,000 and was primarily held as common stock.

The final type of payments in the Open Payments program are payments associated with research, almost all of which are received by teaching hospitals, not individual physicians. Payments to physicians for 2020 total about $73 million, $467,000 (0.56%) of which went to 84 urologists from 20 manufacturers in an average amount of $1980. The maximum amount of research payments reported to a single urologist in 2020 was $122,423.

Bottom line: General payments from manufacturers to urologists in 2020 reported to and by CMS under the Sunshine Act are sharply down from the previous year, represent a small fraction of general payments to all physicians, and average $211 per urologist. Most of these payments are from device manufacturers, and payments are concentrated in just a handful of individual companies, drugs, devices, physician recipients, and disease states. Prostate cancer (drugs), benign prostatic hyperplasia (devices),and overactive bladder (drugs) continue to be associated with most of the collective payments in the specialty. The reported value of cumulative interest/stock of urologists rose sharply from about $21 million in 2019 to more than $36 million in 2020. Research payments to urologists in 2019 were negligible. The majority of urologists appear in the payment data, but payments are generally small. •

1. Adashi EY, Cohen IG. Industry-sponsored speaker programs—end of the line? 

. 2021;325(18):1835-1836. doi:10.1001/jama.2020.26580

2. Acting Manhattan U.S. Attorney announces $678 million settlement of fraud lawsuit against Novartis Pharmaceuticals for operating sham speaker programs through which it paid over $100 million to doctors to unlawfully induce them to prescribe Novartis drugs. News release. The United States Attorney’s Office, Southern District of New York. July 1, 2020. Accessed July 12, 2021. https://bit.ly/3wCD1hJ

3. Special fraud alert: speaker programs. Department of Health and Human Services Office of the Inspector General. November 16, 2020. Accessed July 12, 2021. https://bit.ly/3wBqfQJ

4. Bergman A, Grennan M, Swanson A. Medical device firm payments to physicians exceed what drug companies pay physicians, target surgical specialists. 

2021;40(4)603-612. doi:10.1377/hlthaff.2020.01785

5. Annapureddy AR, Henien S, Wang Y, et al. Association between industry payments to physicians and device selection in ICD implantation. 

2020;324(17):1755-1764. doi:10.1001/jama.2020.17436

6. Mitchell AP, Trivedi NU, Gennarelli RL, et al. Are financial payments from the pharmaceutical industry associated with physician prescribing? A systematic review.

 2021;174(3):353-361. doi:10.7326/M20-5665

7. What is open payments? Centers for Medicare & Medicaid Services. Updated June 30, 2021. Accessed July 12, 2021. https://go.cms.gov/2VKzcu9

All tables and figures are adapted from an analysis of open payments data downloaded from https://www.cms.gov/openpayments/explore-the-data/dataset-downloads by the author, Robert Dowling, MD.

Prostate cancer, BPH, and OAB products are linked with a majority of payments.

Industry payments to urologists see sharp decline in 2020

The Centers for Medicare & Medicaid Services (CMS) released its proposed rules for the Medicare Physician Fee Schedule on July 13, 2021, and for the Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System on July 19, 2021. In this article, we will highlight a few items of note for the physician fee schedule.

This year’s proposed rule, as usual, is a mixed bag for urology. A very important takeaway is that this is a proposed rule and not the final rule, and we will not know for certain the actual effects on urology until the final rule is published. We have seen years in which there were significant changes and 180-degree turns between the proposed and final rules. Therefore, please take a deep breath when reading this article, because there will be a comment period when individuals, groups, and 

societies are able to give feedback to CMS on how the proposed policies will affect their groups. These comments will allow CMS to better understand some of the downstream effects of its proposed policies. CMS is required by law to acknowledge and respond to each comment directly or grouped with similar comments submitted. We encourage reaching out to your society with comments about the rule and to consider submitting comments directly to Medicare. For instructions on how to submit comments to CMS and to read the full rule, use this link: 

https://public-inspection.federalregister.gov/2021-14973.pdf

The conversion factor is projected to decrease by 3.89%, which directly affects physician payment for work performed to Medicare and Medicare Advantage plans. This decrease is primarily due to the expiration of a 1-time contribution from the Trust Fund as part of the Consolidated Appropriations Act, 2021, which lifted the conversion factor by 3.75% for the 2021 calendar year only. As the changes to urology as a specialty code RVU changes net a 0% change when volume of services are considered across all urologists, the net decrease for Urology as a specialty will be 3.89%. However, the impact to each urology practice will vary based on case mix.

There was a change in the proposed rule that, if finalized, could significantly change the reimbursement for urology services, which was likely an unintended side effect of what was meant to be a positive change. The way clinical staff has been valued has not been updated in nearly 2 decades, and that work is proposed to be updated starting in 2022. However, due to the need for budget neutrality, this increase in clinical staff value led to a decrease overall in practice expense relative value units (RVUs), with the net effect of possible significant reductions in overall reimbursement of many office- and hospital-based procedures performed by our specialty. For example, although there is no change in the work RVU of most urologic diagnostic and therapeutic urology procedures, the reduction in practice expense due to this change would significantly reduce the nonfacility and facility payment for commonly performed urologic procedures such as prostatic urethral lift (current procedural technology [CPT] codes 52441 and 52442), transurethral destruction of prostate tissue by radiofrequency-generated water vapor thermotherapy (CPT 53854), and other minimally invasive prostate therapies. A table that can be accessed by going to 

. includes a list of procedures commonly billed by urologists with a projected percentage change of >5% (increase or decrease) in the nonfacility (ie, office) and facility (ie, hospital) settings. Once again, please remember that this is a proposed rule and not the final rule.

Each year, the Quality Payment Program (QPP) is updated. For calendar year 2022, CMS is proposing to require clinicians to meet a higher performance threshold to be eligible for incentives. This new threshold aligns with the requirements established for the QPP’s Merit-based Incentive Payment System (MIPS) under the Medicare Access and CHIP Reauthorization Act of 2015.

Additionally, CMS is proposing to change the QPP system in an attempt to make measures broader and more applicable to patient care. The transition is proposed to begin in 2023 with a change to MIPS Value Pathways (MVPs). The initial set of proposed MVP clinical areas includes rheumatology, stroke care and prevention, heart disease, chronic disease management, lower extremity joint repair (eg, knee replacement), emergency medicine, and anesthesia. CMS says MVPs will more effectively measure and compare performance across clinician types and provide clinicians more meaningful feedback.

CMS is proposing to reconcile the difference in the CPT language for in-office shared/split visits that were included in the guidelines for the changed office visit codes. In the proposal, CMS will expand the ability to bill for a shared/split visit to any facility setting and is including critical care codes and the facility-specific evaluation and management (E/M) categories. It is also proposing to allow selection of the appropriate visit level using either medical decision-making or time; however, it will designate that the billing for a qualified health care professional (QHP) such as a physician, physician assistant (PA), or nurse practitioner (NP), must document that they spent the most time on the date of service in providing the E/M service. CMS also has proposed the creation of a new modifier to indicate that the visit was a shared/split visit. This will require both documentation changes and billing changes for those visits in which more than 1 QHP participates in the facility-based E/M service. The billing provider must sign the medical record for the visit and documentation must support the time spent by the billing provider was greater than time spent by the other “employed” practice member(s) sharing/splitting the visit, regardless of how the level of visit was selected.

In the office setting, shared/split visits will not be allowed. CMS has proposed that “incident to” rules will continue to be the appropriate way to classify services provided in the office setting. The time with the patient rule does not appear to apply in the office setting, as “incident to” rules do not require direct patient physician contact in the office setting if the services are provided by an appropriately contracted person in the group, provided the “incident to” rules are met.No changes were proposed to the “incident to” rules. We have seen many practices struggle with “incident to” billing for advanced practice providers (APPs); it is worth reviewing these guidelines and your practices policies every year, including this year and next.

CMS also stated that Medicare will not recognize modifier -52 with E/M codes.

CMS has traditionally classified advanced practice providers (APPs) under a taxonomy code that does not specify the specialty of the PA or NP based on their group’s specialty. In this proposed rule, CMS has indicated that the APP will be considered a specialist designated by their “employer” for the purpose of shared/split billing.

CMS is also proposing to allow PAs to directly participate in the Medicare program. Previously, a PA had to be contracted or employed by another qualified Medicare entity in order to bill Medicare.

These changes in PA status are reflective of the growing contribution that PAs make in the US market for both access to care and the increase in the team approach to health care.

As we have stated previously, Medicare does not have the legislative power to open telehealth provided to patients outside a Medicare-approved facility once the Public Health Emergency (PHE) for COVID-19 expires (now scheduled to end October 18, 2021, but expected to be extended at least through the end of 2021). In this proposed rule, CMS is proposing to expand the number of services covered under telehealth rules both permanently and temporarily.

The current list of codes considered allowable under telehealth includes 3 separate categories. The category 1 codes are permanent, category 2 codes are expected to become permanent, and category 3 codes are considered to be temporary to help address patient needs during the COVID-19 pandemic. CMS is proposing that all codes from categories 2 and 3 will remain covered services under telehealth rules until 2023 or the end of the calendar year in which the COVID-19 PHE expires, whichever is later.

After the PHE expires, CMS will no longer cover codes 99441 to 99443 (telephone only) visits, but will revert to codes G2250 to G2253 for virtual check-in visits and the codes for virtual management of non-telehealth remote visits. The rules for use of these codes are not proposed to change. Once the PHE ends, you will need to review the requirements for the use of these codes if there is no legislative change to telehealth.

CMS is expanding coverage for remote management of patients based on a series of new codes to be added to CPT for remote therapeutic monitoring (RTM). These codes appear to focus on remote monitoring for disease states related to neurologic and orthopedic surgery and other short-term but higher-risk problems for the which the patient is being treated. These new RTM codes do not appear to require 16 days of monitoring within a month, as required by current remote patient monitoring codes. The RTM codes appear to be intended to fill a coverage gap for some emerging technologies.

There are a number of bills circulating in Washington to permanently expand telehealth coverage to patients in their home; we will continue to monitor the progress of these bills.

Again, we encourage you to comment on those parts of the proposed rules that you feel are incorrect or misguided. Your comments need to be coherent, and keep in mind the overall goals of patient care under the Medicare program. CMS is required to respond to all comments. We would also encourage you to work in conjunction with urology specialty societies such as the American Urological Association, Large Urology Group Practice Association, American Urogynecologic Society, and the American Association of Clinical Urologists, among other societies including state and national organizations that support your positions. And again, please remember that as of now, this is just a proposed rule.

 is compliance officer and medical director of coding and reimbursement, United Urology Group and Chesapeake Urology, Towson, Maryland. 

 is CEO of PRS Urology SC in Denver, Colorado.

The information in this column is designed to be authoritative, and every effort has been made to ensure its accuracy at the time it was written. However, readers are encouraged to check with their individual carrier or private payers for updates and to confirm that this information conforms to their specific rules.

Conversion factor is expected to decrease by 3.89%

2022 CMS proposed rule represents another mixed bag for urologists

, professor and vice chair of urology at Wake Forest Baptist Health High Point Medical Center, Winston-Salem, North Carolina, is a coeditor-in-chief for 

Nocturia, or waking up to urinate at night, continues to be a vexing problem for clinicians and patients. In an earlier review

 and in-depth interview of subject matter expert Jeffrey P. Weiss, MD, PhD, a variety of causes of nocturia were discussed.

Writing a prescription for a malady makes the clinician and patient feel better about doing something for the condition. In a study

 reported on in an article in this month’s issue of 

®, the authors suggest that adding medication (non-antidiuretic) to behavioral therapy does not make a difference in veterans studied over a year. In the detailed analysis of their voiding diaries and metabolic characterization, it was shown that all patients did not have significant high nocturnal volume (< 650 for all) and peripheral edema was present in larger proportion of the behavioral therapy-alone group. Obstructive sleep apnea, another common cause of nocturia, was present in a higher percentage of the same group (not statistically significant)

What is difficult to characterize in this retrospective study, or any study for that matter, is how many patients are following the simple instructions of not drinking the last 2 hours before sleep and leg elevation in the evening hours to alleviate some of the volume-induced first instance of waking up at night. Other unexplored reasons of nocturia are restless leg syndrome, painful conditions, anxiety, etc. In this paired analysis, hopefully they do not affect the data analysis.

So what is the take-home message? By all means, educate patients about causes of nocturia, suggest behavior modifications mentioned above, but don’t throw a drug at them unless there are daytime symptoms of urgency (anticholinergics or β-3 agonists), high postvoid residual (α-blockers), or large volume output at night (desmopressin). Complex interactions between the heart, the kidneys, and the bladder warrant a multidisciplinary approach in patients with nocturia. A personalized treatment should be designed, taking into account gender, comorbidities, and identified etiological factors. This is time-consuming and in the future, bladder mobile apps may help obtain logs and be reminders of the bladder training.

As the Dalai Lama said, “Sleep is the best meditation.”

1. Daugherty M, Ginzburg N, Byler T. Prevalence of nocturia in US women: results from NHANES. Paper presented at: American Urological Association annual meeting. May 18-21, 2018. Abstract PD32-03

2. Nocturia: How to define it, and how treat it. 

®. August 25, 2020. Accessed July 27, 2021. https://www.urologytimes.com/view/nocturia-how-to-define-it-and-how-to-treat-it

3. Miller CD, Monaghan TF, Robins DJ, Weiss JP. Does traditional pharmacotherapy augment behavioral modification in the treatment of nocturia? 

. Published online May 11, 2021. doi:10.1002/nau.24692

"By all means, educate patients about causes of nocturia, suggest behavior modifications...but don’t throw a drug at them unless there are daytime symptoms of urgency, high postvoid residual, or large volume output at night," writes Gopal H. Badlani, MD. 

Nocturia: Mind vs medication

A colleague shared with me that they created their own estate plan on a website vs using an attorney. Is that a good idea?

Having a good estate plan can be critical to ensure your family is well taken care of after you are gone. Although the quality of online tools continues to improve at a good pace, working with an experienced estate planning attorney remains the best way to ensure assets are distributed according to your wishes and in the most tax-efficient way possible. The drawback to using an attorney is often the cost, as some can charge a significant amount of money for their services. Sometimes people attempt to make an estate plan online without consulting legal and financial professionals to avoid the higher cost. However, everyone’s situation is unique, and using a boilerplate estate plan can lead to mistakes.

Here is a list of potential estate planning mistakes you can help avoid with professional counseling.

Your life and financial circumstances may change, so it’s a good idea to review your estate plan at least once a year. For instance, if any of the following life changes occur, your estate plan should be modified accordingly:

• Your parents have died, so they can no longer be beneficiaries.

• Your children have gotten married and/or had children of their own.

• Your assets have grown or decreased significantly.

• You no longer own a home or you purchased additional property.

For many of the same reasons listed above, make sure the will you drafted many years ago is still applicable. Some people believe that if they scratch out a part of an old will, add information, and initial the document, it will be valid. This is never the case.

Relying only on joint tenancy to avoid probate. 

Many assets are transferred outside wills. For example, assets titled in joint tenancy pass to the surviving joint tenant, not per the terms of your will. Many feel that you and your spouse should own a home as joint tenants to avoid probate. This move actually avoids probate only on the first death. When the surviving spouse dies, the home will typically end up in probate.

 Creating a trust and transferring assets to it may help you avoid probate and save taxes. However, if you have a will and a trust, be sure the documents are aligned so your wishes will ultimately be carried out. If a will and a trust are not in agreement, delays and unnecessary costs may be incurred.

 You want your intentions to be carried out for all assets, including your primary residence, additional residence, bank accounts, brokerage accounts, retirement accounts, and even vehicles. Be sure to make beneficiary designations and properly title accounts. Designate a beneficiary or beneficiaries on all individual retirement accounts, employer-provided retirement plans, and other qualified accounts. Take time annually to review the beneficiary designations as they will control the distribution of those assets.

Not naming successor or contingent beneficiaries. 

Let’s say you name 1 beneficiary on an account and that individual dies. If you do not update the beneficiary designation, there will be no successor to receive the account assets upon your death. It is important to name more than 1 beneficiary on accounts and to keep your designations up to date when named beneficiaries pre-decease you.

Failing to name a person to make health care decisions. 

All 50 states permit you to express your wishes as to medical treatment and to appoint someone to communicate for you in the event you become incapacitated. Depending on the state, these legal documents are known as living wills, medical directives, health care proxies, or advance health care directives. On 1 of these legal documents, designate someone you trust to make sure your wishes are carried out.

Relying on outdated or stale financial powers of attorney. 

You may have selected someone to make financial decisions for you with a power of attorney. However, after you signed the document, your circumstances or your relationship with the person may have changed. Consult with an attorney about how to proceed.

Having a good estate plan is critical and some of these issues can be complex. Going it alone creates opportunities for missteps. Speak with your estate planning expert to ensure you have a proper estate plan in place so that your heirs are taken care of in the way you intend.

The information in this column is designed to be authoritative. The publisher is not engaged in rendering legal, investment, or tax advice. If you would like assistance with your individual investment strategy, please email witz@mediqus.com.

A list of potential estate planning mistakes you can help avoid with professional guidance.

Vol 49 No 08

COVID-19 and men’s health: What we know so far

Industry payments to urologists see sharp decline in 2020

2022 CMS proposed rule represents another mixed bag for urologists

Nocturia: Mind vs medication

Urology Times Money Matters: Estate Planning mistakes to avoid