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

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.

Articles

"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.

What’s your opinion of Medicare for All?

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.

Congress currently faces a long list of health care-related legislative priorities. While surprise medical billing and prescription drug prices are likely to continue garnering the most attention, physician groups will also be pushing for legislative action this year to reform the implementation of MACRA.

When the Medicare Access and CHIP Reauthorization Act (MACRA) was passed in 2015, it represented the most significant change to how physicians and other clinicians are paid under Part B of the Medicare program since it was established in 1965.

The law was passed to address flaws with the Sustainable Growth Rate (SGR) system, a fee-for-service reimbursement model that was used to determine annual physician payment updates. SGR failed in part because the formula did not address quality improvement. Payment rates did not reward providers for adopting proven practices or focusing on prevention and care coordination with other physician practices.

MACRA Title I established a two-track system based on the quality and value of care provided. Under the new Quality Payment Program, or QPP, clinicians can choose to participate in either the 

 (MIPS), under which providers continue to be reimbursed largely through fee for service, or through 

 (APMs) that provide financial incentives for providers to become more responsible for the care they provide.

The law allowed for a 0.5% annual increase in the Physician Fee Schedule from 2015 through 2019, but imposed a 6-year freeze on fee updates from 2020 through 2025. Even during the first 5 years, the modest payment increases have not kept up with inflation. Without a fix to MACRA, Medicare payments will increasingly fall below physician costs, which are estimated to rise by an average of 2.2% per year.

The rise in practice costs is due in part to the increasing number of regulatory requirements that physicians are required to comply with, including health IT regulations, quality reporting requirements, and migration to electronic health records. 

 that providers spent $694 million in 2018 complying with MIPS reporting requirements. 

 of the administrative costs of reporting quality measures are much larger.

, an annual financial review of Medicare’s two trust funds, found that “absent a change in the delivery system or level of update by subsequent legislation, access to Medicare-participating physicians (will) become a significant issue in the long term.”

To address this issue, physician advocacy organizations have been pushing Congress to implement positive payment adjustments for providers to replace the scheduled payment freeze over the next 6 years. A 

 spearheaded by the AMA and sent to congressional leadership in June calls for “a stable and sustainable revenue source that allows (physicians) to sustain their practice and invest in practice improvements.”

Underlying this issue is the fact that Medicare physician pay has barely changed since the beginning of the century. Over the last 15 years, Medicare payments have increased just 6%-0.4% per year on average-while the cost of running a medical practice has increased 30%. Consequently, physicians have experienced a 19% decline in inflation-adjusted pay since 2001.

“Like other attempts at legislating medical economics, MACRA had the noble intention of trying to align clinical practice with the tenets of value-based care delivery,” lamented AACU President Mark Edney, MD, MBA. “Like its predecessors, it was swamped out of the gate, the victim of poor design and unforeseen consequences, and is now a liability to physicians.”

While the impending pay freeze has received the most attention from physician groups in recent months, various other adjustments to MACRA are needed to ensure physicians who participate in the program can be successful moving forward.

For example, the 5% bonus payments providers receive for participating in one of Medicare’s Advanced APMs are scheduled to expire after 2022. The bonus payments were instituted in 2017 as an incentive for clinicians to transition into more innovative payment models and to help them invest in changing the way they deliver care.

The incentive payments, however, were only funded for the first 6 years of the program. Considering only a few Advanced APMs were made available during the first 3 years of the program, 3 more years is not nearly enough time for hundreds of thousands of providers to transition to a value-based care system that requires significant investment in new technologies, workflow systems, personnel, and training.

In 2018, the number of physicians participating in Advanced APMs nearly doubled to 183,306 (from 99,076 in 2017). That is just a small fraction, however, of the approximately 1.3 million providers currently under MACRA.

AACU and other physician advocacy groups have called on Congress to extend the 5% bonus for Advanced APM participants for an additional 6 years. The proposal was discussed at length during a Senate Finance Committee hearing on May 8 focused on MACRA implementation and reform. But so far, no legislation has been introduced in either congressional chamber to address this issue.

There are various other technical changes to MACRA that are needed in order to simplify MIPS and make quality reporting more meaningful. These include: providing scoring flexibility to CMS to allow for multi-category credit; updating the Promoting Interoperability category to allow physicians to use a certified EHR or similar technology; allowing CMS to develop multiple performance thresholds; and removing the requirement that episode-based cost measures account for half of all expenditures under Medicare Parts A and B.

On a positive note, Congress has attempted to address one roadblock to the adoption of value-based care models by removing a statute that restricts integrated health care delivery. The 

Medicare Care Coordination Improvement Act

 (S. 966/H.R. 2282) would modernize the Medicare referral law or “Stark Law” by allowing physicians to enter into agreements with other providers to better coordinate patient care. The legislation is supported by AACU, LUGPA, and the AUA.

Congress must pass Stark Law reform this year, and in coordination with CMS, engage the medical community to update MACRA so that physicians have the support they need to transition to more efficient models of care delivery and better serve Medicare patients.

"Congress must pass Stark Law reform this year, and in coordination with CMS, engage the medical community to update MACRA so that physicians have the support they need to transition to more efficient models of care delivery and better serve Medicare patients," writes Yehuda A. Sugarman of the AACU.

Author | Yehuda A. Sugarman

Articles

House-passed HEROES Act promises relief for physicians

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

AACU annual meeting promotes advocacy, unity, political action

Transition to value-based care requires MACRA reform