Dr. Dowling is president of Dowling Medical Director Services, a private health care consulting firm specializing in quality improvement, clinical informatics, and health care policy affecting specialty care. He is the former medical director of a large, 

Robert A. Dowling, MD

Approximately 10.1 million Americans 12 years and older misused opioids in 2019.

 That same year, nearly 50,000 people in the United States died from opioid-involved overdoses.

 The CDC estimates that in 2019, more than 150 million opioid prescriptions were written at a rate of 46.7 prescriptions per 100 persons in this country.

 Although this number has declined from its peak 9 years ago, the opioid crisis remains a serious public health concern.

All but one state in the US (Missouri) have implemented prescription drug monitoring programs to help identify misuse by patients and reportedly improve outcomes and prevent deaths. In this article, I will focus on the urologist’s role as a responsible opioid prescriber in this crisis—and how you can determine whether your prescribing habits are in line with your peers.

The management of postoperative pain, the understanding of potential addiction, and the potential contribution by surgeons to long-term use of opioids has changed dramatically over the past 30 years. It has been estimated that 6% to 9% of urologic surgery patients show evidence of persistent opioid use 3 months after their surgery.

 In a study of 91,000 male patients in Canada undergoing minor urologic surgery (vasectomy, transurethral resection of the prostate, urethrotomy, hydrocelectomy, spermatocelectomy, and circumcision), Welk et al demonstrated that filling an opioid prescription was common (35%) and that although only 2% of those patients showed persistent use 9 to 15 months later, this represented a 43% increased odds of persistent use compared with patients who did not fill a prescription.

Contemporary standards for use of opioids acknowledge the very real risk of persistent use. The American Urological Association (AUA) has issued a position statement on opioid prescribing

 that states in part: “Given increased accessibility of addictive opioids, the [AUA] strongly believes urologists have a responsibility to minimize their patients’ pain and also address serious risks of overprescribing opioids.…When opioids are necessary, [prescribe] the lowest dose and lowest potency to adequately control pain from surgery and other conditions [and discontinue] as soon as possible. Nonnarcotic methods of managing pain, including anti-inflammatories, acetaminophen, and nonmedication approaches, should be used when appropriate and adequate.…The [FDA] recommends all providers counsel patients and/or their caregivers about the safe use of opioids, serious risks, [and] proper storage and disposal with every prescription.”

Many resources are widely available to efficiently accomplish this patient counseling.

 Urologists prescribe opioids most frequently for acute pain, including postoperative discomfort, and should have no issue with these best practices outlined by public health officials and our own specialty society.

Opioids for chronic pain are outside the scope of most urologists, and those who do manage chronic opioid use should familiarize themselves with guidelines and requirements in their local jurisdiction. For example, in Texas, a physician treating chronic pain must develop a written treatment plan, obtain informed consent, and use a written pain management agreement between the physician and the patient outlining patient responsibilities.

The Centers for Medicare & Medicaid Services (CMS) has released 2018 data on the opioid prescribing rates of providers in the Medicare Part D program. (You can view your individual data at 

https://data.cms.gov/d/j2ra-95gh/visualization

.) Keep in mind, however, that Part D prescribing and dispensing habits may not be generalizable to all patients in a urology practice.

In 2018, 1.2 million providers submitted more than 69 million opioid claims in the Medicare Part D program at an average rate of 80 claims per provider. Opioid prescribing rate is measured as the percentage of opioid claims among all Part D claims, and it averages 9% for all specialties. The specialties with the highest opioid prescribing rates are hand surgeons (55%), podiatric assistants (54%), and pain management providers (50%). Urology ranks 64th among specialties in opioid prescribing rate. The specialties with the highest number of opioid claims per provider are pain management (1326), anesthesia (495), and physical medicine and rehabilitation (431); these 4 specialties account for 16% of all opioid claims in Part D in 2018 

In the 2018 CMS opioid data set, 10,754 urologists identified as prescribers, with 7142 identified on an opioid claim. Collectively, urologists prescribed less than 1% of all opioids (417,700 claims) in Part D in 2018. The average opioid prescribing rate for all urologists was 4.9%, and for those with at least 1 opioid claim, it was 5.7%. The average number of opioid claims for urologists prescribing any opioid was 58. These metrics are well below the national average for all specialties. Only 43 urologists were identified with long-acting opioid claims in 2018

The opioid crisis has not affected all states evenly, and opioid dispensing rates/person vary widely across the US. The CDC publishes dispensing data by state and by county, and 11 states have rates over 64 per 100 persons.

The average number of claims per urology provider ranked by state correlates generally with the dispensing data (high rates in the same states), and urologists do not appear to prescribe opioids evenly across the US (per provider) either. If we examine the entire Medicare Part D prescriber database for 2018, we can see the opioid drugs most commonly prescribed by urologists—hydrocodone/acetaminophen and oxycodone HCl/acetaminophen—collectively account for approximately 75% of all opioid prescriptions 

Bottom line: The Medicare Part D data demonstrate that urologists collectively prescribe opioids in numbers and rates lower than the national average of all specialties and unevenly across the US. Very few urologists are linked to claims for long-acting opioids. Urologists should be aware of the small but significant risk of opioid prescription that leads to persistent use or even abuse and follow specialty guidelines for counseling and prescribing. Medicare Part D data on each individual prescriber is readily available to urologists, patients, and the public.

1. Help and resources: national opioids crisis. US Department of Health and Human Services. Accessed April 5, 2021. 

2. Opioid overdose crisis. National Institute on Drug Abuse. March 11, 2021. Accessed April 5, 2021. 

3. U.S. opioid dispensing rate maps. CDC. Updated December 7, 2020. Accessed April 5, 2021. 

4. Ziegelmann MJ, Findlay BL, Britton CJ, Habermann EB. Opioid prescribing after urologic surgery: we are part of the problem and part of the solution-an invited commentary on “an opioid prescription for men undergoing minor urologic surgery is associated with an increased risk of new persistent opioid use.” 

 2020;9(3):997-1000. doi:10.21037/tau-2020-05

5. Welk B, McClure JA, Clarke C, Vogt K, Campbell J. An opioid prescription for men undergoing minor urologic surgery is associated with an increased risk of new persistent opioid use. 

 2020;77(1):68-75. doi:10.1016/j.eururo.2019.08.031

6. AUA position statement: opioid use. American Urological Association. August 2018. Updated January 2019. Accessed April 5, 2021. 

7. Prescription opioids: what you need to know. CDC. Accessed April 5, 2021. 

8. Texas administrative code. Texas Secretary of State. Updated July 13, 2020. 

https://texreg.sos.state.tx.us/public/readtac$ext.TacPage?sl=R&app=9&p_dir=&p_rloc=&p_tloc=&p_ploc=&pg=1&p_tac=&ti=22&pt=9&ch=170&rl=3

9. Medicare Part D opioid prescriber summary file 2018. Centers for Medicare & Medicaid Services (CMS). January 7, 2021. Accessed April 5, 2021. 

10. U.S. state opioid dispensing rates, 2018. CDC. Updated December 7, 2020. Accessed April 5, 2021. 

11. Part D prescriber data CY 2018. CMS. Updated December 3, 2020. Accessed April 5, 2021. 

Articles

Determine whether your prescribing habits are in line with your peers.

The urologist’s role as a responsible opioid prescriber

Increased drug costs and spending for Medicare beneficiaries have been an area of concern for patients, their physicians, policy makers, and regulators for several years. Medicare pays for most drugs through either the Part B program (generally injectable medications purchased by providers and administered in a clinical setting) or the Part D program (generally prescribed oral and patient-administered medications). A previous article discussed the most common Part D drugs prescribed by urologists from a program and cost perspective.

 This article discusses them from a prescribing (and sometimes dispensing) perspective.

The Centers for Medicare & Medicaid Services (CMS) recently released detailed provider Part D drug prescribing and utilization data for 2018.

 It is important to remember that only approximately two-thirds of Medicare beneficiaries are enrolled in Part D, and prescribing patterns in this program may not be generalizable to all patients in your practice. Total spending in 2018 for the Part D program was $168 billion, up more than 10% from 2017. The total cost is based on the amount paid by the Part D plan, the Medicare beneficiary, government subsidies, and any other third-party payers. Total cost for 9944 unique urologists’ prescribed part D drugs was more than $1.5 billion, or 0.9% of the total program cost. Eleven drugs account for 80% of this spending. The drugs most frequently prescribed by urologists (measured in 30-day fills) were tamsulosin (7,462,775), followed by finasteride (4,791,306), oxybutynin chloride (1,557,233), and mirabegron (Myrbetriq) (1,060,529). The drug with the highest urology spend was mirabegron ($373,568,075), followed by enzalutamide (Xtandi) ($225,705,747), solifenacin succinate (VesIcare) ($154,886,101), and abiraterone acetate (Zytiga) ($140,410,379). 

Drugs prescribed for overactive bladder (OAB) illustrate the nuances of perspective when looking at the data. From a clinical utilization standpoint, oxybutynin is the most commonly prescribed drug by urologists in this class (44%) followed by mirabegron (30%), solifenacin (12%), tolterodine (Detrol LA, Detrol) (6%) and others (

). From a payer perspective (CMS, in this case), mirabegron is the largest spend across all specialties ($1.06 billion, 44% of dollars), followed by solifenacin succinate ($692 million, 29%), oxybutynin ($255 million, 11%), tolterodine ($188 million, 8%) and others (

). From a specialty perspective, urologists prescribe only 27% of dollars in this class: 35% of mirabegron, 22% of solifenacin succinate, 17% of oxybutynin, 29% of fesoterodine fumarate (Toviaz), and 27% of trospium chloride (Sanctura). Finally, 57% of the urology prescribing Part D costs for these OAB drugs was “spent” on mirabegron (

). The patient’s perspective is difficult to generalize, as there are many different plans with different formularies and different cost-sharing structures; generally, the more expensive drugs will cost the patient more and propel them faster to the “coverage gap” (also known as the doughnut hole). In 2018, the spending threshold to enter the gap was $3750, and the patient then assumed 35% of brand-name drug costs until they reached $5000. Individuals enrolled in Medicare Part D plans typically know a lot about the cost of their prescription drugs—because they pay a share.

Urologists might be surprised to know that in 2018 they collectively prescribed less than 5% of sildenafil (Viagra), 10% of abiraterone acetate, and less than 20% of enzalutamide in the Part D program. These are drugs that are commonly dispensed in some urology practices, and urologists are recognized as the experts in prostate cancer, OAB, and men’s health. The drug-prescribing data reflect the reality that urologists prescribed a minority of the medical treatments for these conditions in the Medicare Part D program in 2018.

Did you know you can find your own data? Go to 

https://data.cms.gov/d/mhdd-npjx/visualization

. In the filter area, type in either your name or your national provider identifier number. Your detailed prescribing data are available so you can see how your numbers compare with the aggregate statistics.

Bottom line: Drug costs to the Medicare Part D program as a whole continue to increase each year, but urology accounts for less than 1% of the spending in this program in the most recent available data (2018). Expensive oral drugs are under close scrutiny—especially if there are generic equivalents—and urologists prescribe and, in some cases, dispense some of these drugs. Urologists should be familiar with the costs under their direct or indirect control and their contribution to this important part of health care expenditures in the Medicare program.

 is the president of Dowling Medical Director Services, a private health care consulting firm specializing in quality improvement, clinical informatics, and health care policy affecting specialty care. He is the former medical director of a large, metropolitan single-specialty urology group in Fort Worth, Texas.

1. Dowling RA. Twelve Part D urology meds top $100 million in spending. 

. July 16, 2019. Accessed April 2, 2021. 

2. Part D prescriber data CY 2018. Centers for Medicare & Medicaid Services. Updated December 3, 2020. Accessed April 2, 2021. 

Finasteride, oxybutynin chloride, and mirabegron also rank high in latest data from CMS.

Tamsulosin tops list of Part D drugs prescribed by urologists

Growth in drug costs and spending for Medicare beneficiaries remains an area of concern for patients, policymakers, providers, payers, and regulators. The concerns exist in part because of a perception that the current reimbursement system encourages overutilization and price increases. According to the Centers for Medicare & Medicaid Services (CMS), between 2006 and 2017, Medicare Part B fee-for-service drug spending per enrollee grew at 8.1% annually, more than twice as high as per capita spending on Medicare Part D (3.4%) and nearly 3 times as high as overall retail prescription per capita drug spending (2.9%).

Spending is not increasing for all Part B drugs; in an article last year citing 2018 spending data, I reported that of 17 Part B drugs commonly used by urologists, only 3 drugs increased in spending faster than Part B spending overall.

 In fact, spending on a small number of specialty drugs is driving most of the increases through high prices, high utilization, or both.

Nevertheless, in 2020 CMS finalized a new “1 size fits all” rule—the Most Favored Nation Model for Medicare Part B Drugs and Biologicals—wherein it proposed indexing payments for Part B drugs to the reduced amounts paid by peer countries and testing a flat add-on fee to replace the current model of average sales price plus a percentage. This proposed rule would have a large impact on urology and oncology practices and met fierce resistance from a number of associations; at the time of this writing, CMS has not appealed an injunction that halted implementation of the rule. In this article, I will update the spending and costs for Medicare Part B drugs commonly used by urologists in the office setting in the context of even greater scrutiny by policymakers and regulators.

CMS recently released detailed drug spending data for 2015 to 2019.

 “Spending” in this context includes the estimated total costs, such as deductible, coinsurance, and Medicare spending. Total spending in 2019 for 585 Part B drugs was $37.3 billion, up more than 12% from 2018.3 (Note that CMS revised 2018 total spending figures in 2019; using the revised figure, spending increased over 18%.) Spending on any single drug may increase because of increased utilization, higher price, or both. Although it is not possible using this particular data set to determine what fraction of total spending is accountable to urologists, or the spending by indication for any individual drug, we can examine trends in the drugs commonly administered and billed by urologists in the office setting.

Denosumab has largest total spend among urologists

Seventeen drugs commonly used by urologists account for less than 7% of total Medicare Part B drug spending. Of these 17 drugs used in the urology office for Medicare beneficiaries (

), the drug with the largest 2019 total spend—as in 2018—was denosumab (Xgeva) at $1.6 billion; in 2019, utilization for denosumab increased 9.2%, spending per dose increased 3.75%, and total spending increased 13.3% compared with 2018. Denosumab spending has increased 4.5% per year over the last 5 years. (In a separate data set of provider utilization data, urologists account for 5% of denosumab spending.

) The drug with the largest annual growth in spending per dose unit (price) among this selected group was goserelin acetate (Zoladex) with 14.6% annual growth over the last 5 years. Utilization of mitomycin in 2019 increased sharply from 2018 (77%), possibly due to urologists’ use as an alternative during the BCG shortage. Total spending for mitomycin increased 38.7% over the previous year—the largest increase in this family of 17 drugs. Gemcitabine utilization in 2019 was down more than 3% compared with 2018.

Ten of these 17 common drugs showed increased spending in 2019 over 2018. The spending was driven primarily by increased utilization in 5 (mitomycin, collagenase clostridium histolyticum [Xiaflex], denosumab, leuprolide acetate, and onabotulinumtoxina A), and increased price in 5 (testosterone enanthate, gentamicin sulfate, valrubicin, goserelin acetate, and degarelix acetate). Among the 7 drugs where spending declined in 2019 over 2018, it was mainly because of decreased utilization in 5 (triptorelin pamoate, interferon alfa-2b, histrelin acetate, sipuleucel-T [Provenge], and testosterone cypionate) and mainly to decreased average price in 2 (gemcitabine HCL and ceftriaxone).

), leuprolide acetate was still the most commonly administered drug with spending in 2019 of $302 million (11% higher than 2018). Over the last 5 years, growth in spending per dose of leuprolide acetate has decreased 1.4% annually. In 2019, decreases in total spending on triptorelin pamoate (Trelstar) (–44%) and histrelin acetate (–19%) were driven by sharp declines in utilization (–31 % and –27% respectively).

In general, among these 17 drugs, those with 1 or 2 manufacturers have seen higher annual growth in spending per dose (a surrogate for price) and those with 3 or more manufacturers have seen lower or negative annual growth. Mitomycin is the notable exception to this rule.

Bottom line: Urology practices continue to derive substantial revenue from administering “buy and bill” drugs, including from the Medicare Part B program. Of 17 Part B drugs commonly used by urologists, total spending in 2019 increased for 10 drugs and decreased for 7 drugs over the previous year. Price was the factor driving the change in spending in 7 drugs, and utilization in 10 drugs. Urologists should understand that unsustainable spending increases in the Part B program continue to attract the attention of CMS and other payers and should be alert for future policy changes from CMS and others.

1. Fact sheet: Most favored nation model for Medicare Part B drugs and biologicals interim final rule with comment period. Centers for Medicare & Medicaid Services. November 20, 2020. Accessed February 22, 2021. 

2. Dowling, RA. Denosumab tops spending for common urology Part B drugs. 

®. June 16, 2020. Accessed February 22, 2021. 

3. Medicare Part B drug spending dashboard. Centers for Medicare & Medicaid Services. Updated December 22, 2020. Accessed February 22, 2021. 

4. Medicare provider utilization and payment data. Centers for Medicare & Medicaid Services. Updated December 3, 2020. Accessed February 22, 2021. 

Leuprolide acetate remains the most commonly used androgen suppression drug.

Part B data reveal increased usage of denosumab and mitomycin

On June 30, 2020, the Centers for Medicare and Medicaid Services (CMS) released their annual update of Open Payments Financial Data (calendar year 2019)(

). The Affordable Care Act , Section 6002, also known as the Physician Payments Sunshine Act, requires that manufacturers of “covered drugs, devices, biologicals, and medical supplies” report payments and other transfers of value to physicians to CMS. It also requires that manufacturers and group purchasing organizations (GPOs) report physician or their family ownership and investments interests.

The requirements stem from a concern that payments to individuals could influence or incentivize behavior, and that making payment data public may mitigate such behavior. It remains unclear if either statement is true, and unclear how anyone—such as patients, hospitals, credentialing entities, payers, CMS, regulators, legislators—is using payments data. The recipients of payments are identified by specialty, making it possible to focus on urology. In this article, I will review some summary information and analysis about the payments to urologists reported under this surveillance program.

In 2019, $10 billion in payments or investment value was reported by 1602 unique companies to physicians, teaching hospitals, and other entities; this is an increase of almost 7% in payments compared with 2018 total. The total amount of general payments to individual physician recipients (n = 615,000) was $2.3 billion. 9246 urologists received a total of $38,568,246 of those general payments to physicians, or 1.65% of the total. The largest single payment to a urologist was $2,457,925.50, and the average payment to a urologist in 2019 was $181.72; average and total payments to urologists have been increasing an average of 5% per year over the past 5 years.

In 2019, 62 urologists each received more than $100,000 (average $300,000 in this subgroup) and collectively represented more than 48% of all payments to urologists 

. As in past years, most of the 2019 payments to urologists came in the form of cash, and were compensation for services other than consulting, consulting fees, food and beverage, and royalty or license, for example, speaking engagements 

CMS requires manufacturers and GPOs to associate a general payment with a drug, biologic, device, or medical supply where appropriate 

. General payments to urologists associated with devices comprised the largest collective payments, totaling $18,479,093.91, or almost half of all general payments. Payments associated with drugs and biologics totaled almost $10.5 million, significantly less than in 2018; 3 drug manufacturers accounted for about half of total payments in this category. The database also classifies payments into a product category or therapeutic area; payments to urologists came largely from manufacturers who classified their product as urology, oncology, interventional urology, or male health related. Three products alone used to treat advanced prostate cancer were associated with about half of all payments to urologists (associated with a drug/biological product).

The Open Payments program tracks payments associated with ownership interest in 2 different ways. First, some of the general payments to physicians are categorized as “current or prospective ownership or investment interest.” In 2019, $1,159,024 in ownership or investment interest was paid from 8 entities to 48 urologists. Most of these payments appear to come from limited liability companies.

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.” $1.24 billion of value was reported in 2019 for all physicians, and $21 million (1.69%) of that was attributed to 478urologists from 15 entities. Most of the dollars reported of this payment type are from a single entity totaling $12.9 million and distributed among 256 individual urologists; the value of interest for each urologist in that entity ranges from $1.5 million to $7,000 (mean, $50,000 and median, $37,000) and was primarily held as common stock. Urology ranks eighth among all specialties in total ownership interest dollars in 2019 

The final type of payments in the Open Payments program are payments associated with a research study, almost all of which are received by teaching hospitals—not individual physicians. Payments to physicians for 2019 total just $71 million, $391,000 (0.55%) of which went to 408 urologists from 15 manufacturers in an average amount of $7,250. The maximum amount of research payments reported by a single urologist in 2019 was $97,000.

Bottom line: General payments from manufacturers to urologists in 2019 reported to and by CMS under the Sunshine Act are consistent with past years, represent an appropriately small fraction of general payments to all physicians, and average less than $200 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), BPH (devices), and overactive bladder (drugs) continue to be associated with most of the collective payments in the specialty. Transfers of value classified as “ownership interest” are a small fraction of the 2019 general payments, and cumulative value and interest appears to be held in manufacturers or GPOs by urologists in the same average amount as all physicians. The majority of urologists appear in the payment data, but payments are generally small.

"Three products alone used to treat advanced prostate cancer were associated with about half of all payments to urologists," writes Robert A. Dowling, MD.

Robert A. Dowling, MD

Articles

The urologist’s role as a responsible opioid prescriber

Tamsulosin tops list of Part D drugs prescribed by urologists

Part B data reveal increased usage of denosumab and mitomycin

Open Payments and urology: What do the latest data reveal?