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

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.

 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.

Articles

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

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

"Clinicians are challenged to remain up-to-date and informed…” begins the new clinical guideline on advanced prostate cancer released by the American Urological Association, American Society for Radiation Oncology, and Society of Urologic Oncology in June 2020.

 However, significant burnout affecting urologists,

 time pressure, bureaucratic tasks, rapidly evolving diagnostic and treatment advances, and the inherent resistance to the rationalization of skills combine to make it even harder to incorporate new guidelines into clinical practice.

Clinical guidelines are formulated and graded on scientific evidence (or expert opinion) derived from research involving populations, and clinicians treat individual patients based on personal experience in addition to the science; these competing perspectives may result in a lack of adherence to clinical guidelines, sometimes written off to “the art of medicine.” Some guidelines lead to the development of “clinical pathways” used by decision support tools, payers, and public health experts. No guideline is intended to be a rigid rule for 100% of situations, but measuring adherence can sometimes be leveraged to identify outliers for closer examination. In this article, against the backdrop of a new guideline for advanced prostate cancer, I will discuss how you might measure adherence to guidelines in your own practice using some simple examples.

Advanced prostate cancer is a segment of the typical urology practice that lends itself to a focus on adherence to guidelines: The disease is common in a urology practice, the diagnostic testing choices and results are discrete, the clinical status is well defined (symptom status, tumor marker status, metastatic status, castrate sensitivity status), and the therapeutic options have clear indications. Many guideline statements are unambiguous, and there is a well-developed algorithm for quick reminders. The examples below each provide an opportunity for measurement:

• “Clinicians should not offer first-generation antiandrogens (bicalutamide, flutamide, nilutamide) in combination with luteinizing hormone-releasing hormone (LHRH) agonists in patients with metastatic hormone-sensitive PC (mHSPC), except to block testosterone flare.”

• “In metastatic castrate-resistant PC (mCRPC) patients, clinicians should obtain baseline labs (eg, prostate-specific antigen [PSA], testosterone, lactate dehydrogenase [LDH], hemoglobin, alkaline phosphatase level) and review location of metastatic disease (bone, lymph node, visceral)...”

• “In patients with mCRPC, clinicians should offer germline and somatic tumor genetic testing to identify DNA repair deficiency mutations and microsatellite instability status that may inform prognosis and counseling regarding family risk as well as potential targeted therapies.”

• “Clinicians should discuss the risk of osteoporosis associated with androgen deprivation therapy (ADT) and should assess the risk of fragility fracture in patients with APC.”

• “Clinicians should prescribe a bone-protective agent (denosumab or zoledronic acid) for mCRPC patients with bony metastases to prevent skeletal-related events.”

How do you measure adherence to guidelines in your practice? Most urology practices have 2 sources of information: their practice management (PM) (billing) system and their electronic health record (EHR) system. The former was not designed for measuring clinical performance, but it does have the capability, when properly used, to do just that. For example, the guideline statement “Clinicians should prescribe a bone-protective agent (denosumab or zoledronic acid) for mCRPC patients with bony metastases to prevent skeletal-related events” has 3 discrete elements that could contribute to a straightforward analysis: (1) a clinical status of CRPC, (2) presence of bone metastases, and (3) administration of an injectable drug typically acquired and billed by the practice. If these discrete elements could be reliably identified in the PM data, then that system could be leveraged to measure adherence to guidelines: Find all patients with CRPC, metastatic to bone, who have received denosumab (sum A); find all patients with CRPC, metastatic to bone (sum B); calculate adherence (A divided by B).

In my experience, many urologists are not disciplined about coding for CRPC (

International Classification of Diseases, Tenth Revision

, code Z19.2) or bone metastases (C79.51), probably because there was never an incentive to code beyond prostate cancer (C61). However, measuring adherence to guidelines presents an excellent incentive to do so. Certified coders in your office can be trained to enter this information. Once the data are being reliably populated, measuring adherence to this guideline will be easy in the PM system using commonly available stock reports (billing records) that can be dimensioned by physician, location, time period, and even insurance payer.

Measuring adherence to other guidelines may require reporting out of your EHR system, and some EHR vendors make that easier than others. Fortunately, the data needed for this exercise are generally discrete, not dependent on physician documentation style, and easily available in many EHRs: prescriptions, lab results, x-ray results. For example, measuring adherence to “Clinicians should not offer first-generation antiandrogens (bicalutamide, flutamide, nilutamide) in combination with LHRH agonists in patients with mHSPC, except to block testosterone flare” could begin with a simple prescription utilization report for these drugs; this report could be enhanced to identify mHSPC if physicians coded for hormone status and metastatic status in the EHR (see above). While there are no reliable benchmarks for this kind of analysis, a peer comparison in a group practice can identify outliers for further chart review. Chart review of average or above-average physicians is generally not needed.

Leveraging lab results may be slightly more complicated, but it can be simplified. The guideline statement “In mCRPC patients, clinicians should obtain baseline labs (eg, PSA, testosterone, LDH, hemoglobin, alkaline phosphatase level)” obviously requires the ability to measure the presence or absence of these labs. All EHRs offer the ability to store, and theoretically report on, discrete lab results. One challenge, though, is that some lab results may return more discretely to the EHR than others, depending upon the performing location and interface; nondiscrete results may not be visible in the EHR unless the physician manually enters the information. The best way to avoid this common pitfall is to measure orders, not results; orders are the best reflection of the clinician’s intent and adherence to guidelines, and they do not depend on discrete results. Some smaller, niche, or older EHR systems do not offer reporting on discrete orders, but most do.

Measuring order utilization for testosterone in mCRPC patients

To simplify measuring adherence to this guideline, I recommend measuring order utilization for testosterone in mCRPC patients; you can determine a time window (testosterone order date through mCRPC first diagnosis date) to apply your own definition of “baseline,” keeping in mind that a castrate level of testosterone is technically needed to even establish a diagnosis; the order date should or may precede the mCRPC first diagnosis date. Keep it simple at first.

Leveraging radiology results is a more challenging exercise in reporting on clinical data. Only the most sophisticated EHR systems store a result discretely; most results come in as documents in different formats or are scanned with different labels. Standardization in labeling scan documents can help, but it is difficult to monitor and enforce. Again, the best answer is to leverage orders. The guideline statement “Clinicians should discuss the risk of osteoporosis associated with ADT and should 

 in patients with APC” requires a definition of risk assessment for measuring adherence. The gold standard to assess this risk is the Fracture Risk Assessment (FRAX) tool, US version, which includes a measurement of bone mineral density using dual-energy x-ray absorptiometry (DEXA) scan (

https://www.sheffield.ac.uk/FRAX/tool.aspx?country=9

). So, to simplify measurement of adherence to this guideline, measure order utilization of DEXA scan in a population of patients on ADT using the time window of your choice. There is no firm consensus on when, or how often, to repeat DEXA scan in this guideline; keep it simple, measure consistently across physicians, and identify and drill down on outliers only.

Bottom line: Clinical guidelines are not rigid standards, but they draw on the available evidence to support best practices. Tools exist to simplify the measurement of adherence to clinical guidelines in your practice using your existing systems and reporting capabilities at nominal cost. Start simple, measure consistently, validate the results, leverage peer comparisons (“apples to apples”), accept that information based on data is imperfect and that adherence will rarely be 100%, focus on outliers only, and provide feedback to improve data collection. Be transparent and patient with those you are trying to educate or influence.

1. Advanced prostate cancer: AUA/ASTRO/SUO guideline. American Urological Association. 2020. Accessed June 27, 2020. 

https://www.auanet.org/guidelines/advanced-prostate-cancer

2. Guimond-Franc J, McNeil B, Schlossberg S, et al. Urologist burnout: frequency, causes, and potential solutions to an unspoken entity. 

. 2018;12(4):137-142. doi:10.5489/cuaj.4668

Against the backdrop of a new guideline for advanced prostate cancer, Robert A. Dowling, MD, describes how you might measure adherence to guidelines in your own practice.

How to use data to measure adherence to clinical guidelines in prostate cancer

Growth in drug costs and spending for Medicare beneficiaries continues to be an area of concern for patients, policy makers, and regulators. In an article last year,1 I reported that for 7 of 16 drugs commonly administered in the office by urologists, spending increased faster than Part B drug spending overall. There have been no significant regulatory changes that have directly affected Medicare Part B drug policy in 2019. In this article, I update the spending and costs for Medicare Part B drugs commonly used by urologists in the office setting.

The Centers for Medicare & Medicaid Services recently released detailed drug spending data for the years 2014-2018 (Medicare Part B Drug Spending Dashboard. Centers for Medicare & Medicaid Services. December 17, 2019. Accessed May 11, 2020. https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Information-on-Prescription-Drugs/MedicarePartB.html). “Spending” in this context includes the estimated total costs including deductible, coinsurance, and Medicare spending. Total spending in 2018 for the Part B program was $33.3 billion, up 9.3% from 2017. Spending on any single drug may increase because of increased utilization, increased price, or both. Let’s take a closer look at some individual drugs that urologists typically use in their practice (it is not possible using these data to determine what fraction of spending is “ordered” by urologists, or the indication for any individual drug).

Of 17 common drugs used in the urology office for Medicare beneficiaries 

 the drug with the largest 2018 total spent was denosumab ($1.42 billion). In 2018, utilization for denosumab increased 12.4%, spending per dose increased 1.79%, and total spending increased 14.39% compared with 2017. Denosumab spending has increased 4.53% per year over the past 5 years and continues to be the target of automated medical review in some areas of the country.

The drug with the largest annual growth in spending per dose unit among this selected group is mitomycin (54.18% annual growth over the past 5 years); spending per dose on mitomycin increased 13.4% in 2018 alone. Although overall usage of mitomycin and gemcitabine (Gemzar) declined in 2018 compared with 2017, the impact of the recent bacillus Calmette-Guérin shortage will probably result in greater utilization of mitomycin and gemcitabine in 2019 reports.

Among the same set of drugs, spending on onabotA was $348 million, up 7.1% over 2017 and due primarily to increased utilization. The annualized growth in spending/dose (a surrogate for price) for onabotA has been just 1.7% over the past 5 years.

, leuprolide acetate was still the most common drug with spending in 2018 of $272 million (1.7% higher than 2017). Over the last 5 years, growth in spending per dose has decreased 1.3% annually. Spending on triptorelin pamoate decreased sharply (26%) in 2018, whereas the price of goserelin (Zoladex) rose almost 16%, increasing spending on that drug by 3.8% over 2017.

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 as mentioned earlier.

The bottom line: of 17 Part B drugs commonly used by urologists, only 3 drugs increased in spending faster than Part B spending overall in 2018. The drug with the largest total spending is denosumab, and the drug with the largest annual growth in spending per dose over the last 5 years is mitomycin (54.2%). Urologists should be familiar with the average sales price and trends of the common Medicare Part B drugs administered to their patients.

1. Dowling, Robert A. CMS data reveal trends in Part B drug spending. 

Mitomycin sees the largest annual growth in spending per dose over the past 5 years, Robert A. Dowling, MD, reports.

Denosumab tops spending for common urology Part B drugs

In a previous column, “Disaster preparation: Make sure your practice is ready” (December 2018, p. 37), I wrote: “Natural disasters serve as a reminder that most urology practices are small businesses and should have a basic plan in place for dealing with events that cause the temporary or permanent closure of the office. Your plan should address the needs of patients, staff, providers, and the business. Benjamin Franklin said, ‘By failing to prepare, you are preparing to fail.’ While the chances are small you will face a natural disaster, preparation is your best defense.”

Of course, I had no idea that 1 year later we would face a global pandemic that, as I write this article, has disproportionately affected the U.S. and has claimed some 25,000 U.S. lives as of mid-April. No medical practice could have anticipated the scale of this disruption, and it is likely that many small businesses will not survive. It is widely believed an economic recession awaits those businesses that do survive the next few months.

In this article, I will offer a possible vision of what urology practice could look like in the near and intermediate future, and why. I will also share several lessons for urology practices that have come out of the present situation.

Cancelation, postponement of elective procedures

In early March 2020, the U.S. Centers for Disease Control and Prevention, many specialty societies, and many state governors called for canceling or postponing elective procedures, surgeries, and non-urgent outpatient visits. The initial rationale for these recommendations was to preserve valuable resources, but as the virus spread through communities, the broader concern focused on not exposing people to each other and “flattening the curve” of patients requiring those precious resources.

Niche urology practices that have focused primarily or entirely on elective care (vasectomy, erectile dysfunction, uncomplicated BPH) will be significantly impacted. Other practices that have not pursued an intentional strategy may have never understood until recently exactly how much of their practice involved elective, non-urgent care.

While the definition of elective is obvious in some cases, there has been considerable debate as to what other procedures or visits can be postponed without jeopardizing the health of the patient. Prostatectomy for intermediate-risk prostate cancer? A routine visit for active surveillance? A visit for a patient on intermittent androgen deprivation therapy?

We don’t know the answers to these questions because, generally, these types of procedures are scheduled according to personal habits or loose guidelines, not a firm knowledge of the impact of delay. The first major lesson of this crisis is that practices will develop a clearer understanding of what proportion of their business depends on truly elective, semi-urgent, and truly urgent presenting problems, and thus how vulnerable they are to a persistent economic recession. That understanding may guide a strategy for diversification of the business.

Similarly, urology practices tend to think of their business as divided into new patients and established patients. Mature practices may be full of established patients who come in for their “annual visit”; at the other end of the spectrum is the young practice where almost every patient is “new.”

In general, new patients have problems requiring diagnostic evaluation and treatment-bigger sources of revenue for a practice than well-established patients. Some practices are intentional in creating and maintaining a balance of new versus established patients, discharging enough patients in a clinically appropriate way to make room for new patients. The second major lesson of this crisis is that a practice full of annual established patient visits is vulnerable to disruption and that the true value of a practice is to the patient with new and/or acute problems that can only be addressed by a urologist. This understanding may inform a review of your own control over the practice and whether there is an opportunity to restrike the balance of patients.

Urologists may also categorize their skills, and thus their practice, as cognitive and procedural; indeed, this mix of medicine and surgery is often what attracts physicians to the specialty. It is a diversification that may also serve to temper the disruption of the current crisis.

The Centers for Medicare & Medicaid Services (CMS) has issued several waivers and other flexibilities to address the public health emergency. Notable among these changes are those that expand access to telehealth for patients and their providers. Many commercial payers have followed suit, though each with slightly different rules for conducting and billing for the visit. This represents a lifeline for the cognitive side of the urology practice. Many new and established patient visits can now be conducted with the patient and the physician remote from each other using interactive audiovisual technology, in many cases for the same reimbursement as if patient and provider were face to face.

Adoption of this interim solution has been rapid, even as the bugs are still being worked out. The third major lesson of this crisis is that many patients and their problems can be adequately assessed and treated without the need to physically touch the patient. This disruptive innovation is likely to forever change the urology practice, if the flexibilities and reimbursement rules become permanent. The urology office of the future may be primarily designed, built, and operated for the procedural aspects of care, resembling an ambulatory surgery center more than a traditional office. The term “office visit” may be replaced by “tele home visit” as patients come to expect this new normal.

Transitioning staff to ‘remote’ status

Finally, the national efforts to address the public health emergency have resulted in a surge of “remote” workers in the patient care field. It is now apparent that schedulers, call center employees, billing personnel, administrative staff, and even providers do not necessarily need to be in the office to do their jobs in a urology practice. The fourth major lesson of this crisis is that there are opportunities for efficiency and cost savings by transitioning employees to part- or full-time remote offices. The urology office of the future may have less square footage devoted to “the back office.”

Bottom line: One of the tools to deal with uncertainty is to see the possibilities. When the acute public health emergency is over and the future is more certain than it is today, the possibilities include having a practice that does not rely as heavily on elective visits and procedures, cultivates patients that truly need the skills of a urologist, thins out the unnecessary annual visits, and embraces virtual visits using modern technology.

Replacing office visits with virtual visits may become the new normal, writes Robert A. Dowling, MD.

Robert A. Dowling, MD

Articles

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

How to use data to measure adherence to clinical guidelines in prostate cancer

Denosumab tops spending for common urology Part B drugs

Four lessons urology practices can learn from the pandemic