Ross E. Weber

The Centers for Medicare & Medicaid Services (CMS) and several agencies released an “interim final rule” on September 30, 2021, that outlines the process by which out-of-network reimbursement disputes between providers and payers will be adjudicated under federal law. The proposed surprise billing regulations have been met with scorn from the provider community because key provisions contradict the carefully crafted compromise approved by Congress in the final weeks of 2020.

Throughout 2020, several US House and Senate committees held separate hearings on surprise billing as the public increasingly demanded relief from unexpected medical bills for services provided at in-network facilities. The leaders of those committees largely had their own conception of how to address the problem and by December, despite public pressure, it appeared no legislation would be passed before Congress adjourned and a new president took office.

Disagreement within the political parties and among the 4 congressional committees largely centered around what sort of guidelines would be used to determine reimbursement for nonemergency services provided by out-of-network providers at in-network facilities. Early proposals that set a benchmark rate based on the median local in-network charges were ultimately rejected because lawmakers came to understand that in-network charges do not reflect real-world payment rates. In the end, the bipartisan agreement established a process in which outside adjudicators would decide payment rates through arbitration. In-network charges would not be ignored, however, as the law required arbiters to consider the median in-network rate, among several other bits of information submitted by the parties, in making their determination.

The delicate balance that had been achieved in the No Surprises Act was clumsily upended by the regulations released by the Biden administration on September 30. Instead of seeing the median in-network rate as just 1 piece of information to review in the arbitration process, the proposed rule directs the arbiter to consider the amount used by insurers for patient cost-sharing purposes—identified as the “qualifying payment amount”—to be the primary factor in determining the total payment to out-of-network providers. In so doing, the all-important arbitration process would be carried out in a way that places a thumb on the scale in favor of health insurers.

Thunderous opposition from physicians and health systems noted the rule would have far-reaching, disastrous implications. In a news release, the Texas Medical Association (TMA) alleged, “the administration’s short-sighted approach will make it harder for patients to access care by driving down reimbursement rates and encouraging insurance companies to continue narrowing their networks. It will be difficult for small physician groups to keep caring for patients.”1 In another news release, the American Medical Association (AMA) called the interim final rule “an undeserved gift to the insurance industry that will reduce health care options for patients.”

In the release, AMA President Gerald A. Harmon, MD, said the regulation “disregards the insurance industry’s role in creating the problem of surprise billing at the expense of independent physician practices whose ability to negotiate provider network contracts continues to erode.”

“Congress appreciated the negative consequences of national price setting for health care services and spent considerable time and effort developing a robust independent dispute resolution process to maintain market balance and preserve access to care, which the Administration apparently ignored,” Harmon added.

Beyond press releases and stern statements, action is being taken on several fronts to change the proposed regulations.

The AACU joined 1 effort calling for the administration to remove the directive that arbiters anchor their determination to the qualifying payment amount, and instead let them consider all allowable information submitted by the parties to support their offer. The draft joint letter insists that the signatories are not asking for a delay or undoing of any of the patient protections in the No Surprises Act. It simply calls on the rule to be corrected to align with congressional intent.

The federal government has also been taken to court by the TMA over its interpretation of the law. The TMA’s lawsuit seeks to strike the section of the regulations that ties arbiters’ decisions to the insurance companies’ qualifying payment amount because that figure “warps a reference point crucial to the dispute resolution process,” according to an article in 

In a statement, TMA President Linda Villareal, MD, concluded, “We are disappointed the Biden administration ignored congressional intent and essentially set up the arbitration system to operate like a casino, with health insurers playing the role of the house. Everyone knows the house always wins. With the current rule, patients, physicians, and our country lose.”

1. TMA sues feds over unfair rule for surprise billing law. News release. Texas Medical Association. October 29, 2021. Accessed November 15, 2021. https://www.texmed.org/Template.aspx?id=58062

2. Surprise billing regulation is a surprise gift to insurance industry. News release. American Medical Association. October 2021. Accessed November 15, 2021. https://www.ama-assn.org/press-center/press-releases/surprise-billing-regulation-surprise-gift-insurance-industry

3. Johnson B. Texas medical association sues federal government over surprise billing rule. 

. October 29, 2021. Accessed November 15, 2021. https://thetexan.news/texas-medical-association-sues-federal-government-over-surprise-billing-rule/

Articles

"The AACU joined 1 effort calling for the administration to remove the directive that arbiters anchor their determination to the qualifying payment amount, and instead let them consider all allowable information submitted by the parties to support their offer," says Ross E. Weber of the AACU.

Surprise billing regulation stuns providers, rejects congressional intent

As lawmakers in Washington debate a “human infrastructure” package and whether to expand Medicare to include dental, vision, and hearing benefits, vitally important and timely work has been undertaken to prevent looming cuts to the program as it currently exists. Most notably for clinical urologists, the AACU is pushing back against a 3.75% reduction to Medicare payments that was proposed for 2022. Coupled with cuts that had previously been delayed, physicians face a 9.75% Medicare pay cut starting January 1.

The proposed 2022 Medicare Physician Fee Schedule “paints a bleak picture for patients” according to United Specialists for Patient Access (USPA), a coalition of providers involved in office-based specialty care.

The main driver of cuts in the 2022 proposal is a change in how costs directly assumed by a physician while providing a service (ie, practice expenses) are calculated. Year-to-year, these costs must be “budget neutral.” This year, because the Centers for Medicare & Medicaid Services (CMS) proposes to increase the clinical labor cost component of practice expenses, an equal offset must be generated by reductions to medical supplies and equipment costs. In practice, AACU President Elliott Lieberman, MD, warns this would result in significantly reduced “reimbursement of many office- and hospital-based procedures performed by urologists, such as prostatic urethral lift, transurethral destruction of prostate tissue by radiofrequency-generated water vapor thermotherapy, and other minimally invasive prostate therapies.”

Over 70 members of Congress led by UROPAC-supported Rep. Bobby Rush (D-IL) and Rep. Gus Bilirakis (R-FL) signed a letter urging CMS to postpone the changes to clinical labor costs.

 The lawmakers expressed concern that “budget neutrality” is a driver of health system consolidation that will ultimately result in increased costs to the Medicare program. Moreover, they called for fundamental reform to the Medicare physician fee schedule to address another imminent pay cut that has been the focus of recent AACU advocacy efforts. In several calls to action, the AACU urged urologists to support congressional action to extend relief from an earlier 3.75% physician fee schedule cutback as well as the 2% Medicare sequester and an up to 4% Medicare pay cut triggered by the American Rescue Plan.

Other aspects of the 2022 Medicare proposal were warmly received by physicians. The AACU, for one, voiced support for continuing to base evaluation and management services based on either the total time spent with patients during their visit or the medical decision-making associated with a patient visit. On the telehealth front, CMS plans to retain all services previously added to the Medicare telehealth services list on a temporary basis until the end of calendar year 2023. The agency also indicated support for making permanent the waivers Congress issued addressing payment parity, originating site, and geographic site. The proposal notes, however, that maintaining that flexibility, as well as coverage for audio-only services, depends on congressional action.

With a temporary payment boost set to expire at the end of the year, Medicare reimbursements face a 3.75% decrease. When you add another 2% with the Medicare sequester and additional cuts of up to 4% under the American Rescue Plan, urologists face a nearly 10% decrease in Medicare reimbursement. Instead of stopping these cuts, Congress is considering adding benefits that will cost an additional $358 billion, according to a 2019 congressional report. Absent urgent congressional action, the pace of health care industry consolidation will quicken and patients will wind up being cared for at higher cost settings, further threatening the viability of the Medicare program itself. All is not lost, however…amidst this absurdity, urologists are providing high-quality, cost-efficient, and patient-centered care.

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 for more information.

1. Garcia M. Op-Ed: CMS must eliminate cuts and reform the Physician Fee Schedule. United Specialists for Patient Access. Accessed October 5, 2021. https://www.uspaccess.org/oped-drmarkgarcia

2. Lieberman E. Letter RE: File Code CMS–1751–P. Medicare Program; CY 2022 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Provider Enrollment Regulation Updates; Provider and Supplier Prepayment and Post-Payment Medical Review Requirements. September 13, 2021. Accessed October 5, 2021. https://aacuweb.org/docs/news/20210913-cy2022-mpfs-comment-letter.aspx

3. Rush BL, Bilirakis GM, DeFazio PA, et al. Letter RE: CY 2022 Payment Policies under the Physician Fee Schedule. September 13, 2021. Accessed October 5, 2021. https://rush.house.gov/sites/evo-subsites/rush.house.gov/files/evo-media-document/CMS%20Letter%202021%20PFS%20Rule.pdf

4. Looming threats to Medicare could affect patient access to care. Patients Action Network. Accessed October 5, 2021. https://patientsactionnetwork.com/action-center?vvsrc=%2fCampaigns%2f87837%2fRespond

A “perfect storm” of Medicare cuts threatens patient care.

Medicare pay cuts loom as Congress contrarily considers new benefits 

, 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 for more information.

The public health emergency induced by the COVID-19 pandemic necessitated changes to the health care delivery system that loosened up regulations to ensure adequate access to care. Many of these changes, particularly in the telehealth and scope-of-practice arenas, had been long sought by providers and patients. On the scope-of-practice front, regulators issued emergency rules to allow nurse practitioners and physician assistants to work without physician oversight and newly graduated medical students were thrown into practice under new non-physician provider licenses.

Today, as confirmed COVID-19 cases and hospitalizations decline in the United States, questions have arisen as to whether the genie needs to be placed back in the bottle.

The telehealth issues are largely being addressed collaboratively amongst providers, payers, patients, and policymakers. In stark contrast, non-physician providers are taking aggressive steps to institutionalize practices that will, in the long term, compromise patient safety.

Nurses, pharmacists, and physician assistants can provide important services that enhance access to care, particularly in underserved and rural areas. Nurse practitioners themselves use this argument when inciting legislators to allow them to practice without physician supervision. They insist that independent practice will mitigate medical deserts. There is mounting evidence, though, that despite these promises, nurse practitioners and others are not providing care in rural and other underserved areas. AMA data show that in states that have allowed NPs to practice independent of physician supervision, the non-physician providers have not chosen to locate or practice in underserved or rural areas.

 They are concentrated in the same areas as their physician counterparts.

Nonetheless, NPs are approaching a tipping point in their perilous pursuit of unsupervised practice. With 23 states granting full practice authority, they will soon be able to boast that half of all jurisdictions allow NPs to practice without physician supervision.

 addressing various scope of practice issues had been approved by legislatures in 31 states. Physicians successfully safeguarded patient safety in several states, whether by defeating or improving legislation. The AMA itself reports “key victories in CO (PAs), FL (optometrist), FL (APRN), FL (PAs), Maine (APRN), MD (podiatrist "physician" bill), MS (APRN), SD (PAs) to name a few.”

Arkansas, meanwhile, is 1 state were lawmakers have consistently compromised patient safety by expanding myriad providers’ authority. In 2019, they allowed optometrists to perform several laser surgical procedures. This year, new laws were enacted that:

• recognize APRNs as a primary care provider (HB 1254)

• remove supervision requirements for CNRAs (HB 1198)

• authorize pharmacy techs to administer vaccines and immunizations (HB 1135)

• grant certified nurse midwives "full practice authority" (HB 1215), and

• allow pharmacists to diagnose, treat, and provide medication for certain conditions (HB 1246).

In a vain attempt to close the barn door after the horse has bolted, the legislature also approved a measure to impose review requirements for future scope of practice expansions (HB 1180).

Arkansas is not the first state to grant pharmacists what is, essentially, a license to practice medicine. Reform in this area first began in 2009 when laws were expanded to allow pharmacists to deliver the H1N1 influenza vaccine, according to health care consultant Nick Diamond, as 

 Some states have continued expanding these laws in the years since, Diamond continued, leading to a patchwork of state laws. COVID-19 added fuel to the fire and brought the federal government into the mix.

Several months into the public health emergency, the US Department of Health and Human Services declared that pharmacists and pharmacy interns may administer COVID-19 testing, deliver recommended routine vaccinations to children aged 3 to 18 years, and order and deliver a COVID-19 vaccine to patients over the age of 3. The American Medical Association balked at this “end-run around scope-of-practice laws,” suggesting that the guidelines would cause children to skip regular examinations and comprehensive preventive care.

 AMA President Susan R. Bailey, MD, warned, “Pediatricians’ and family physicians’ practices are open and ready to provide the comprehensive preventive care parents and patients expect.”

In terms of state action, Florida serves as a case study. On March 11, 2020, a 

 headline provokingly asked “Who needs a doctor in coronavirus fight?” in an article detailing recent actions of the Florida Legislature to “empower” pharmacists.

 The innocuously named “Act Relating to the Practice of Pharmacy” had passed the House, the Senate, and was signed by the governor on a single day (HB 389). The new law separately addresses the provision of care for chronic and nonchronic conditions. For chronic conditions, a pharmacist may only treat the patients of an MD or DO with whom they have a collaborative agreement. The great worry in terms of chronic conditions, though, is the fact that the statute leaves it to the Board of Pharmacy to create the list of chronic conditions. Nonchronic conditions, on the other hand, are specifically listed in the new law. The concerning part of the nonchronic section is the fact that pharmacists can test, screen for, and treat anyone, provided they have an established written protocol with an MD or DO. In other words, they are not limited to testing/treating only the patients of physicians with whom they have an agreement.

In any examination of scope-of-practice issues in 2021, one cannot ignore the official “rebranding” of PAs. On May 24th, the American Academy of PAs (AAPA) House of Delegates passed a resolution affirming “physician associate” as the official title for the PA profession after “several years of study by an international marketing and communications firm.”

 Weeks later, in the AMA House of Delegates, the AACU co-sponsored a resolution insisting that the title “Physician” not be used in ways that have the potential to mislead patients.

The AMA said the name change is “clearly an attempt” to further move the PA profession toward independent practice.

 To that end, PAs are increasingly rejecting their customarily collaborative approach toward scope-of-practice issues. Instead, they are replicating nurse practitioners’ aggressive push to practice without physician supervision. Utah joined North Dakota earlier this year to essentially eliminate physician supervision (SB 27). A proposal in South Dakota to allow PAs to diagnose and treat patients and prescribe substances without any physician involvement was stopped in committee (HB 1163).

In speaking about PAs rebranding in the AMA House of Delegates, urologist Hans Arora, MD, painted an ominous picture, “Despite all the wins we tout, the state scope [of practice] bills that we beat back, the surveys we do that say the American people trust physicians, the truth is that the rank-and-file physicians—the people we claim to represent—believe that we're losing. We're losing the opportunity to prove that the independent practice of medicine falls under the sole purview of the physician."

O’Reilly KB. Independent practice for NPs fails to solve rural access problems. American Medical Association. August 17, 2020. Accessed July 6, 2021. 

https://www.ama-assn.org/practice-management/scope-practice/independent-practice-nps-fails-solve-rural-access-problems

AMA advocacy 2020-2021 efforts. American Medical Association. June 8, 2021. Accessed July 6, 2021. 

https://www.ama-assn.org/delivering-care/patient-support-advocacy/ama-advocacy-2020-2021-efforts

Mattina C. Keeping up with pharmacists’ changing scope of practice amid COVID-19. 

®. October 21, 2020. Accessed July 6, 2021. 

https://www.ajmc.com/view/keeping-up-with-pharmacists-changing-scope-of-practice-amid-covid-19

O’Reilly KB. COVID-19 doesn’t require end-run around scope-of-practice laws. American Medical Association. June 25, 2020. Accessed July 6, 2021. 

https://www.ama-assn.org/practice-management/scope-practice/covid-19-doesn-t-require-end-run-around-scope-practice-laws

Gross SJ.Who needs a doctor in coronavirus fight? Florida lawmakers empower pharmacists, some nurses. 

https://www.tampabay.com/news/health/2020/03/11/who-needs-a-doctor-in-coronavirus-fight-florida-lawmakers-empower-pharmacists-some-nurses/

AAPA House of Delegates votes to change profession title to physician associate. News release. American Academy of Physician Assistants. May 24, 2021. Accessed July 6, 2021. 

https://www.aapa.org/news-central/2021/05/aapa-house-of-delegates-votes-to-change-profession-title-to-physician-associate/

Bailey SR. Statement on AAPA change of 'physician assistant’ title. American Medical Association. June 3, 2021. Accessed July 6, 2021. 

https://www.ama-assn.org/press-center/ama-statements/statement-aapa-change-physician-assistant-title

"In any examination of scope-of-practice issues in 2021, one cannot ignore the official 'rebranding' of PAs," writes Ross E. Weber of the AACU.

Scope of practice regulation: Time to put the genie back in the bottle

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

In recent years, urologists and patient advocates have promoted proposals to require insurers to cover prostate cancer screening without copay, coinsurance, or cost sharing. These efforts have borne fruit in Maryland and New York, where state laws now place prostate cancer screening on par with breast cancer screening when it comes to cost-free coverage.

It should come as no surprise that health insurance companies are fierce opponents of these campaigns. Chambers of commerce, too, vigorously oppose the benefit mandates that, in the short term, increase insurance premiums. What’s astounding, however, is that most state governments themselves tip the scales toward the defeat of new patient-centered coverage requirements in the form of “mandated benefit review” laws.

The National Conference of State Legislatures reports that at least 30 states have mandate review or mandate evaluation boards to analyze the cost-effectiveness of current and proposed health insurance coverage requirements (See table: 

). These entities, mostly comprised of regulators and economists, are expected to evaluate services recommended by physicians and wished-for by patients based on the proposal’s impact on an insurer’s bottom line. Additional criteria, according to a 

, include social impacts, medical efficacy, political considerations, and quality-of-care impacts. The same study found that fewer than half of the mandated benefit review laws utilized “an ‘evidence-based’ policy approach by requiring consideration of the scientific literature on medical effectiveness.” These actuarial, rather than public health, recommendations undermine proposed services such as prostate cancer screening because the reviews will most certainly say that the new mandate will increase premiums and few politicians want to be accused of increasing health costs when their next election comes along.

Very few new mandated benefit review laws have passed since 2011, when the Affordable Care Act (ACA) largely tied coverage and cost-sharing requirements to the state’s Essential Health Benefits. Those ACA-imposed standards did not stop lawmakers in at least 3 states in 2021: 

Texas has conducted retrospective benefit mandate reviews through the Department of Insurance; ie, after the law has been implemented, agency staff review how it has impacted premiums. This year’s legislation moves the process to the Legislative Budget Board and requires that the review be conducted during the legislative process, well before it becomes law (HB 2600). Minnesota would likewise tweak its current law by requiring the review to be requested before August 1 of the year prior to the legislative session during which is would be considered (SF 146).

Colorado is perhaps the most interesting example of mandated benefit review laws. The state had been an early adopter of the practice, dating back to 1992 when policymakers required proponents of a proposed mandate to assess its potential impact. Eleven years later, a commission was established to conducts its own reviews, but by 2017 that effort had been abandoned. For at least the last 2 years, legislators have attempted to re-impose a semi-independent process, largely at the behest of Governor Jared Polis. In an April 1, 2020, statement, the Democrat Governor called on lawmakers to create a process for actuarial reviews of benefit mandates, warning that without that review, "I will be disinclined to sign future legislation creating new insurance mandates."

The bill introduced this year would require a third-party contractor to conduct up to 5 reviews per year on benefit mandates being proposed through legislation. The review would have to be requested by the proposed bill sponsor and would cover costs for the first 5 years.

Opponents of the legislation asserted that “the emphasis on short term costs would overshadow the need to identify gaps in care” and failure in that area would lead to the escalation of health care disparities in communities of color.

Certainly, lawmakers must consider the fiscal impact of legislation based on several factors, including whether it will place an undue burden on employers and the economy. As it currently stands, more than half the states place their considerable influence toward questioning the importance of patient-centered, medically recommended services. To overcome well-funded business interests and bureaucratic inertia, proponents of equitable prostate cancer screening coverage must essentially clear a high hurdle on a broken ankle. Therefore, as these proposals are introduced in legislatures across the country, it is vital for the entire urologic community to stand up to make their voices heard.

"To overcome well-funded business interests and bureaucratic inertia, proponents of equitable prostate cancer screening coverage must essentially clear a high hurdle on a broken ankle," writes Ross E. Weber of the AACU.

Ross E. Weber

Articles

Surprise billing regulation stuns providers, rejects congressional intent

Medicare pay cuts loom as Congress contrarily considers new benefits

Scope of practice regulation: Time to put the genie back in the bottle

Prostate cancer screening bills face government-funded opposition