Yehuda A. Sugarman

Based on a partnership with Urology Times, articles from the American Association of Clinical Urologists (AACU) provide updates on legislative processes and issues affecting urologists. We welcome your comments and suggestions. Contact the AACU government affairs office at 847-517-1050 or info@aacuweb.org

With the exception of a few uncalled House races and 2 Senate runoff races scheduled for January 5 in Georgia, the outcomes of the 2020 election are largely now determined: A new Democratic president, a slightly narrower majority for Democrats in the House of Representatives, and pending the outcome of the Georgia runoffs, a likely Republican-controlled Senate.

Such a scenario would mean the continuation of divided government in Washington for at least the next 2 years, likely halting, or at least scaling back, an ambitious health policy agenda envisioned by Democrats under a Biden administration. Creating a public option government health plan is probably off the table, as is lowering the eligibility age for Medicare to 60, which could expand the population of beneficiaries by more than 20 million Americans.

With a GOP-controlled Senate and Democrat-controlled House, the most plausible path for President-elect Biden to advance his health care agenda will be via administrative action, such as executive orders and regulatory rulemaking. For example, he is likely to roll back Medicaid work requirements sought by the Trump administration and bolster the Affordable Care Act in several areas. Some of these actions, however, are required to undergo the full regulation-writing process and comment period, which can take many months, occasionally years.

There are also some limited areas, including surprise medical billing, prescription drug pricing, and a shift to value-based care, where policymakers may be willing to work together to advance policies broadly supported by the electorate. Whether their popularity with voters will be enough to break the partisan gridlock on Capitol Hill, however, remains to be seen.

Lawmakers have gotten close to reaching a deal on surprise billing a couple of times over the last 12 months, but ultimately failed to agree on how exactly to protect patients from bills incurred when they receive care from a doctor or hospital not in their insurer’s network. More than 2 dozen states have enacted protections to address surprise medical billing, but Congress has not passed such a measure. At issue is how to resolve payment disputes that arise between providers and insurers.

One possible solution would require insurers to pay for out-of-network care at a benchmark rate, such as the average Medicare price for the service in a specific geographic area. Providers oppose this proposal as it would drastically lower reimbursement. Instead, they back arbitration under which an independent third party determines the amount insurers must pay out-of-network providers.

There are a lot of factors that favor action on this issue. Voters 

 legislation that would limit patients’ exposure to charges from non-network providers. At a time when millions of people have lost their employer-sponsored insurance due to the pandemic’s financial effects and thousands are admitted to hospitals every day due to COVID-19, there is increased pressure on Congress to address the issue. President-elect Biden has talked about the need to protect patients from hospital bills incurred when the patient doesn’t have control over which provider he or she sees (ie, emergency transport and surgery), but has not addressed the issue of payment disputes.

 health costs over the past decade has been the rising cost of prescription drugs. There is bipartisan support in Congress for measures aimed at lowering drug prices, but so far efforts have stalled amid opposition from the pharmaceutical and insurance industries. There are numerous approaches to addressing the issue and dozens of lawmakers on both sides of the aisle who view it as a top priority.

Notably, Medicare is still barred from negotiating prescription drug prices directly with drug companies even though the drugs account for nearly 20% of Medicare’s overall spending each year. Instead, pharmacy benefit managers are in charge of acquiring drugs for the Part D prescription drug benefit. The President-elect has promised to work with Congress to eliminate the exception so that Medicare can negotiate drug prices directly with pharmaceutical companies the same way private insurers do—a reform that could save Medicare, according to some estimates, 

President-elect Biden supports limiting launch prices for drugs that don’t face competition by establishing an independent review board to assess a drug’s value based on the average price in other countries, also called “external reference pricing.” He also supports limiting drug price increases to inflation, capping out-of-pocket drug costs for Medicare Part D, allowing drug importation from other countries, and eliminating drug companies’ advertising tax breaks, which equaled $6 billion in 2016.

The transition from Medicare fee-for-service to value-based care has received strong bipartisan support. Payment models under which physicians are reimbursed based on the value, rather than the volume, of their services allow providers to deliver better-quality, lower-cost care. Although COVID-19 has slowed the progress that has been made toward implementing alternative reimbursement models, it has also exposed some of the 

Over the coming years, the federal government will need to find methods for cutting costs after spending trillions on the COVID-19 response. The continued adoption of value-based care will help achieve that goal as providers agree to take on more financial risk in order to preserve resources and avoid payment cuts.

Although the President-elect has not commented directly on value-based care, his health plan includes several proposals aimed at closing gaps in health care among racial groups. Alternative payment models could help close racial disparities and gaps in health care by paying providers for taking an active role in addressing disparities that exist between patients based on their race, ethnicity, gender, or sexual orientation. The individuals tapped to fill top posts at HHS and CMS may provide a clue as to how aggressive the incoming administration will be in advancing new payment models.

In the immediate term, the Biden administration will take executive action to roll back some of the more controversial health care regulations implemented under President Trump. Assuming Congress does not come to an agreement during the current lame-duck session, 1 of the first orders of business is likely to be enacting a new COVID-19 relief package, which will include a variety of provisions that impact providers and patients.

There is also strong support in Congress for addressing health care price transparency and further expanding access to telehealth, items President-Elect Biden would certainly support. As for the portions of Biden’s health care agenda that are more controversial, such as increasing ACA premium subsidies for the middle-class and lowering the age for Medicare eligibility, legislative success may hinge on the long-shot possibilities of Democrats winning both Georgia runoff elections or a newfound willingness on the part of Democratic and Republican leadership to find compromise, perhaps by trading increased health care spending for cuts in other areas.

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"Although the President-elect has not commented directly on value-based care, his health plan includes several proposals aimed at closing gaps in health care among racial groups," writes Yehuda A. Sugarman of the American Association of Clinical Urologists.

Biden signals focus on common-ground health policies

The US House and Senate are far from reaching consensus on a fourth coronavirus relief package, but the passage of the Health and Economic Recovery Omnibus Emergency Solutions Act (

), or HEROES Act, in the US House of Representatives on May 15, 2020, may provide some clues as to what physicians can expect, or perhaps hope for, in a final package. The $3 trillion supplemental spending package covers many sectors of the economy, including much-needed assistance to state and local governments. Similar to previous relief packages, it also includes considerable investment in the US health care system and coronavirus disease 2019 (COVID-19) response efforts.

$100 billion appropriation for Provider Relief Fund

The provision of the HEROES Act with the most direct impact on health care providers is an appropriation of $100 billion, on top of the $175 billion that has already been appropriated, for the Provider Relief Fund. The fund, initially established under the Coronavirus Aid, Relief, and Economic Security (CARES) Actpassed in April, has provided 2 rounds of payments to hospitals and providers for COVID-19–related expenses and lost revenue.

In addition, the bill provides new guidance clarifying how funds from the program should be allocated to recipients. Following the first distribution of provider relief funds on April 10, there was considerable confusion and criticism surrounding the formula used to determine how much each provider received. Thus, regulators codified a new algorithm into the HEROES Act that will provide the Department of Health & Human Services with a more equitable and efficient system for distributing relief funds to providers.

Under the new guidance, providers would be required to apply for grants, on a quarterly basis, for all expenses and lost revenue relating to COVID-19 via a new program established at the Health Resources and Services Administration. Eligible expenses would be reimbursed at 100% whereas lost revenue would be reimbursed at 60%, with the latter being dependent on the availability of funds. The program does not require providers to pay back the funds they receive, with the caveat that they may not submit bill balances (surprise billing) to their uninsured patients.

The HEROES Act makes key improvements to the Medicare Accelerated and Advance Payment (AAP) Programs, which have provided necessary liquidity for many Medicare providers and suppliers impacted by the pandemic. According to 

 released by the Centers for Medicare & Medicaid Services (CMS) in early May, about $19.6 million in loans were allocated for urologists as part of AAP. (The $100 billion in total AAP loans provided by CMS is separate from and in addition to the $100 billion in grants distributed to providers as part of the CARES Act, which do not need to be repaid.)

If HEROES is enacted, the terms of those loans would be considerably more favorable for the entities receiving payments. The bill would lower the interest rate on loans from above 10% to 1%, extend the repayment period (1 year before claims are offset and 2 years to repay the full outstanding balance), and reduce the per-claim recoupment rate to no more than 25% of Medicare reimbursement claims. It also would ensure that Part B premiums are not adversely impacted by this program.

A less publicized, but important, measure in the act would postpone implementation of the 

Medicaid Fiscal Accountability Regulation

 (MFAR) until after the end of the COVID-19 emergency. The controversial MFAR rule, proposed in November 2019, tightens regulations surrounding state-based Medicaid supplemental payment programs, which could lead to significant Medicaid cuts.

States and provider groups have opposed MFAR, arguing that it undermines existing financing and supplemental payment arrangements, will increase state budget deficits, and jeopardizes access to care for Medicaid patients, particularly in underserved areas. Postponing MFAR would help preserve Medicaid programs and prevent additional regulatory burdens at a time when many physician practices are struggling to meet the needs of their patients and staff.

As physician practices begin to reopen for nonurgent procedures and surgeries, providers will be at an increased risk of contracting the novel coronavirus. HEROES seeks to address this by requiring the Occupational Safety and Health Administration (OSHA) to issue emergency temporary standards for certain at-risk industries, including employees in the health care sector who are at “occupational risk of exposure” to COVID-19. Within 2 years, OSHA would be required to develop a permanent infectious disease standard.

In the interim, the temporary standards would require covered employers to protect workers from exposure to COVID-19 by developing and implementing an infectious disease control plan that is at least as protective as the measures issued by any OSHA state plan to protect workers from novel pathogens. HEROES also contains whistleblower protections for workers who report health and safety hazards, including a lack of personal protective equipment, in the workplace.

Various health care organizations and medical groups including the American Medical Association, the American Hospital Association, the Association of American Medical Colleges, and the American College of Physicians have endorsed the HEROES Act in whole or in part.

Although the Senate is not expected to take up the House-passed act for consideration, they will likely consider some additional form of relief. The provider community should stay engaged in the process and advocate for the inclusion of the measures discussed in this article in whatever legislative package emerges from the Senate.

"The HEROES Act makes key improvements to the Medicare Accelerated and Advance Payment Programs," writes Yehuda A. Sugarman of the AACU.

House-passed HEROES Act promises relief for physicians

Based on a partnership with Urology Times, articles from the American Association of Clinical Urologists (AACU) provide updates on legislative processes and issues affecting urologists. We welcome your comments and suggestions. Contact the AACU government affairs office at 847-517-1050 or 

One of the most significant regulatory measures in 2019 was the proposed rule from the Centers for Medicare & Medicaid Services (CMS) that would fundamentally alter the way in which the physician self-referral law, or “Stark law,” has traditionally been applied.

In an effort to strengthen the voice of urology and present a united voice, three national urology societies-AACU, AUA, and LUGPA-coordinated their comments to CMS, echoing support for most of the provisions in the rule while also incorporating feedback specific to each group’s advocacy goals.

The Stark law, enacted in 1989, generally prohibits physicians from referring patients for certain services reimbursable by Medicare if they or an immediate family member has a financial relationship with the provider performing the referred service.

The law made sense at a time when Medicare primarily reimbursed physicians based on a fee-for-service payment system. Today, however, Medicare and other payers promote alternative payment models under which physicians are reimbursed based on the value, rather than the volume, of their services. This allows providers to deliver better-quality, lower-cost care.

AACU annual meeting promotes advocacy, unity, political action

Although the Stark law, as it’s currently interpreted, contains certain exceptions for value-based arrangements, the part of the law that prohibits physician referrals is so broad that it discourages many physicians from participating in these types of arrangements out of fear of violating the law and facing stiff penalties.

 to Congress, CMS itself recognized that the law was inhibiting the transition to more innovative care delivery models by preventing physicians from coordinating care with other health care providers and implementing other value-adding activities.

“Although we expect that some arrangements may be structured to satisfy the requirements of an applicable exception to the physician self-referral law and not violate the Federal anti-kickback statute, the fraud and abuse laws may serve as an impediment to robust, innovative programs that align providers by using financial incentives to achieve quality standards, generate cost savings, and reduce waste,” the agency wrote.

Over the last few years, CMS has tried to address this problem by creating a variety of waivers, or exceptions, to Stark that allow providers to participate in the types of clinical and financial integration envisioned by MACRA-the 2015 law that replaced the Sustainable Growth Rate formula. But the process of structuring a financial arrangement to comply with all the requirements of a particular waiver and then demonstrating the legality of that arrangement to CMS creates an “undue impact and burden” of compliance, as the agency has noted in its recent regulatory filings.

 in support of its “Patients over Paperwork” initiative that would significantly modify the scope of the Stark law and alleviate its compliance requirements.

The proposed revisions would establish new exceptions to Stark, simplify qualification requirements for waivers, and create greater flexibility overall for physicians who participate in value-based arrangements. Notably, the new exceptions under Stark would be permanent and apply to care that is provided not only to Medicare beneficiaries but other patients as well.

The rule also provides guidance and clarification of fundamental Stark law terminology and requirements. For example, the new definition of “commercially reasonable” (compensation arrangements) does not depend on valuation or require profitability. Rather, it recognizes that certain arrangements may be commercially reasonable as long as they “further a legitimate business purpose of the parties,” such as helping a colleague satisfy licensure requirements or fulfilling a community need.

An additional change clarifies the “volume or value” standard-a term that has long vexed both health care providers and enforcement agencies. Under the new rule, CMS would analyze the mathematical formula used to calculate compensation and allow the volume or value of referrals to be taken into consideration 

 when that formula “includes the physician’s referrals to the entity as a variable” that directly correlates the compensation with the physician’s referrals.

The proposed reforms also include new exceptions for financial arrangements under which a physician receives limited remuneration for items or services they provide, as well as exceptions for donations of cyber-security technology to referring physicians, regardless of whether the physician operates in a fee-for-service or value-based payment system. The rule also broadens and makes permanent the exception for sharing of electronic health records.

There are other provisions, as well, that encourage information sharing among physicians. Under the new rule, specialty physicians would be permitted to share data analytics with a patient’s primary care practice for free. Currently, the law requires primary care doctors to pay for the data if they referred the patient to the specialist. This change will enhance care coordination between physicians and improve the quality of care patients receive.

The additional waivers created by CMS’s proposed rule on Stark reflect the need for more pathways for providers to participate in value-based, coordinated care. Urologists in particular apply their expertise to the diagnosis and management of a wide variety of medical conditions and are an integral partner with pathologists, radiologists, oncologists, and various other health care providers. Increasing integration and coordination among these specialists will improve patient care.

Under the current regulations, prostate cancer patients who need to undergo radiation therapy will shuttle back and forth between their urologist’s office and a radiation oncology unit-practices that are usually completely independent of one another. That’s due to the restrictions placed on these practices from entering into joint ventures that create clinical pathways, outcome measures, and greater efficiencies that lower patient costs. The proposed updates to the Stark law may lay the groundwork for new arrangements between urology practices and radiation units in hospitals that allow urologists to receive fair remuneration for their clinical work and risk sharing.

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The proposed revisions to Stark could also help reduce infectious complications stemming from prostate biopsies. If urology practices are permitted to create episodes of care for prostate biopsies that include pathology and advanced imaging, among other things, it could produce enough cost savings to allow hospitals and providers to develop protocols to reduce the occurrence of sepsis after prostate biopsies. Besides the positive impact on quality of care, minimizing infections would drive down the costs associated with prostate biopsies and further encourage migration to value-based arrangements.

Finally, the proposed rule creates three new exceptions under Stark based on the level of financial risk assumed by the payer. While these exceptions allow for greater flexibility and will accelerate the transition to value-based care, they may also further the consolidation of hospital and specialty physician practices. Independent urology practices, especially in smaller communities, are often unable to take on greater financial risk. If they are acquired by hospitals, it will further diminish competition to consolidated hospital systems, which are generally less convenient and more expensive for patients.

Overall, the modifications to Stark that CMS seeks to implement represent a net win for urology and the vast majority of patients, physicians, and other health care providers. As AACU’s 

 stated, “the (reforms) will provide additional space for the types of alternative arrangements among physicians that can enhance care coordination, improve quality and reduce costs.”

The proposed rule, with any policy changes, is expected to be finalized as soon as the first quarter of 2020.

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"Overall, the modifications to Stark that CMS seeks to implement represent a net win for urology and the vast majority of patients, physicians, and other health care providers," writes the AACU's Yehuda A. Sugarman.

Effort to reform Stark law reflects shift to value-based care

National politics, state advocacy issues, and innovative topics in urologic care came together as urologists from every practice setting and at varied points in their careers gathered in Washington for the AACU 2019 annual meeting. Over two days in October, notable speakers and special guests led engaging conversations on public policy, leadership development, and cutting-edge science.

The provision of health care via telemedicine was characterized as the Fourth Industrial Revolution by Southern California Permanente's Eugene Rhee, MD, MBA. Dr. Rhee kicked off the event by applauding these advances, but recognized several obstacles to widespread adoption, including reimbursement. Medicare, in particular, lags behind other payers because restrictive statutes and regulations result in partial payment for services delivered remotely. A robust discussion on technology, cross-state licensure, liability, and reimbursement took place, setting the stage for several sessions geared toward urologists interested in 21st century communication and leadership.

Transition to value-based care requires MACRA reform

LUGPA Health Policy Chair Deepak Kapoor, MD, shared his insights on recent legislative and regulatory proposals, including a rule issued Oct. 9 by the Centers for Medicare & Medicaid Services that, according to CMS Administrator Seema Verma, represents “the most significant changes to the Stark law since its inception.” Dr. Kapoor agreed, and summarized various elements of the rule and the exceptions it creates for physicians who participate in value-based care payment models.

Dr. Kapoor’s presentation also included an analysis of proposed changes to Medicare reimbursement. He argued that despite the widespread attention paid to the annual rules, the proposed changes to CPT codes and other policies will have a relatively minor impact on urology this year.

UROPAC Chair Robert Bass, MD, MBA, highlighted key policy issues that the AACU has been active on, including MACRA reform, reducing the burden of prior authorization, Stark law modernization, and greater transparency within the U.S. Preventive Services Task Force. As Congress addresses these and other issues relevant to the house of medicine, such as prescription drug pricing and surprise medical billing, Dr. Bass assured participants that the urologic community will be well represented.

AACU State Advocacy Network Chair William Reha, MD, MBA, meanwhile, detailed myriad initiatives under the banner, “Virtual Network, Real Results.” Dr. Reha noted that state legislatures introduce an average of more than 125,000 bills per year, or 23 times the number introduced each year in the U.S. Congress. That’s why physician advocacy groups like the AACU and AUA must collaborate with state medical associations and other national specialty physician organizations.

When an issue directly impacts urology, however, Dr. Reha insisted that the AACU moves quickly to "alert, educate, and mobilize the entire urologic community." Campaigns identified by Dr. Reha and AACU State Affairs Manager Ross Weber included: cost-free prostate cancer screening coverage in New York; nursing assistant authority to diagnose and treat UTIs in Connecticut; management of conditions contributing to variations in physical sex characteristics in several states; and a national perspective on medical liability reform and state-funded graduate medical education.

Dr. Thrasher discusses ABU's Life Long Learning program

J. Brantley Thrasher, MD, executive director of the American Board of Urology, followed with an overview of the ABU's Life Long Learning (LLL) program, an initiative launched in 2017 to provide certified urologists with a path for ongoing professional development. A 10-year cycle, LLL is comprised of two levels and contains components such as licensure and peer review, continuing medical education, Practice Assessment Protocols, and videos for patient safety, among others.

Dr. Thrasher assured that through continued collaboration with groups like the AACU and AUA, the program will deliver remediation products to fill knowledge gaps and provide a fair, transparent, and valuable certification process.

American Medical Association President Patrice Harris, MD, selected to deliver the annual Hoffman/Carson Lecture, spoke to the importance of collaboration and unity in the medical advocacy community. The lecture, named for two of the AACU's founding members, provided attendees a rare look into the inner workings and legislative priorities of America’s largest association of physicians. Dr. Harris described the five pillars of the AMA-the House of Delegates, Members, Practice/Business Tools, Research & Education, and Advocacy-and how together they make the AMA “physicians’ most powerful ally in patient care.”

Urologist elected to AMA Board of Trustees

The first day of the meeting closed with the presentation of the inaugural Herb Sohn Award for Excellence in Advocacy to Jeffrey Frankel, MD, and Harry Miller, Jr., MD. Herb Sohn, MD, JD, a past president of the AACU, remained active in politics and the practice of medicine until earlier this year, when he passed away at the age of 92. During his long professional life, Dr. Sohn earned a law degree and ran for Congress several times and once for mayor of Chicago. It was during that 1989 mayoral campaign that Dr. Sohn said, “When one spends his whole lifetime just making money, that is a living; but, when one can serve his community and his fellow beings, that is a life.”

In addition to presentations on public policy and leadership development, the AACU 2019 annual meeting included several sessions dedicated to the art and science of medicine. Vanderbilt Urology was well represented by Nicole Miller, MD, and Melissa Kaufman, MD, PhD, who delivered educational presentations on bladder outlet management and urologic trauma. Duke University's Glenn Preminger, MD, preached the tenets of medical stone management, reminding participants of the risk factors and the latest developments in evaluation techniques and treatment. One attendee described the session as "a spiritual experience," perhaps a testament to the level of analysis Dr. Preminger provided about a disease that is so notoriously difficult to prevent, diagnose, and treat.

Several urologists who attended the meeting remained in Washington for one additional day to meet with key lawmakers about health care policies that could impact the practice of urology. As representatives of UROPAC, the delegation attended nearly 20 meetings with bipartisan candidates from both the Senate and House and from each of the congressional committees with jurisdiction over health care policy. Broadly, the group's goal was to educate lawmakers about the practical impact of existing and proposed laws on their professions and their patients. The urologists also discussed hot-button issues, such as prescription drug prices, "surprise" medical billing, and Stark law modernization, with the legislators.

Held as the AACU concluded its 50th year, the Annual Meeting provided an "opportunity to report on the advocacy successes in this ever-changing political landscape," as stated by Young Urologist Committee Chair Seth Cohen, MD. "This organization can only be as effective as the support the urology community provides it," he said.

National politics, state advocacy issues, and innovative topics in urologic care came together as urologists from every practice setting and at varied points in their careers gathered in Washington for the AACU 2019 annual meeting.