Ross E. Weber

, 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

Articles

"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.

Prostate cancer screening bills face government-funded opposition

Having contributed health policy updates to 

® for more than 10 years, a decade-long search of the AACU’s archive yields only 1 headline that references Medicaid. In November 2014, when provisions of the Affordable Care Act related to Medicaid expansion were only 10 months old, the 

 the pressure applied by state hospital associations for lawmakers to broaden eligibility requirements for their health care safety net programs. At the time, 25 states and the District of Columbia had approved laws to that end. Now, 7 years later, that number has increased to 

. This reminiscence is noteworthy in light of a 

 on the Medicaid-to-Medicare reimbursement ratio and statistics on Medicaid patients’ access to urological care.

 published the latest results of an examination of Medicaid and Medicare physician fees dating back nearly 30 years. The authors, led by the Urban Institute’s Stephen Zuckerman, reported that Medicaid physician fees averaged 78% of Medicare physician fees for common non-primary care, non-obstetric procedures in 2019.

For all the tracked procedures, the Medicaid-to-Medicare fee index reached 0.72 in 2019, up from 0.66 in 2012 and very near the 2008, pre-Great Recession, ratio of 0.75. The study’s authors went on to relate these figures to physician practice patterns and public policy.

“Historically, low Medicaid fees have limited physicians’ participation in the program,” they wrote. Continuing, they expressed concern that Medicaid buy-in proposals in several states, “would pay physicians according to the state’s Medicaid fee schedule or negotiate a new fee schedule with those fees as a starting point. This approach would keep costs low but could limit physicians’ willingness to accept the new coverage.”

2017 American Urological Association (AUA) Census

 only barely bears out this claim. Medicaid covers about 1 and 5 people living in the United States, totaling approximately 40 million adults and 31 million children. Sixty-nine percent of those beneficiaries are enrolled in managed care plans and, according to the 2017 AUA Census, nearly 75% of urologists accept Medicaid managed care plans. That would seem to suggest that there isn’t a widespread lack of access to urologic care. Having said that, the same AUA survey finds 90% of urologists accept Medicare Advantage, thus suggesting some discernment when it comes to including Medicaid managed care in a practice’s payment mix.

 of urological surgeons indicates a bit more selectivity. Six hundred and fifty urologists surveyed by Overholser et al found 58.3% accepted some or all Medicaid insurance plans. Drilling down to individual states, the 2016 Overholser study reported the percentage of urologists accepting Medicaid varied by state, ranging from 10% to 90%.

That considerable variance in provider participation is not surprising given the sizable difference in 

, Alaska and Montana Medicaid reimbursement is 126% of Medicare and 109% of Medicare, respectively, whereas Rhode Island and New Jersey meagerly reimburse physicians at 38% and 42% of the Medicare rate.

Florida urologist Kevin Lee, MD, FACS, takes Medicaid in his private practice and finds, "Some of us don't mind the lower payments. The bigger problem, though, is the cost of oncological meds. Reimbursement for those therapies is always much lower than the price we paid in advance."

Upon taking office, President Biden took steps to, in his way of thinking, support the Medicaid program. Many experts expect the Biden administration to reverse several of his predecessor’s policies, including block grant funding and work requirements. Jocelyn Guyer, managing director at Manatt Health, the firm where President Biden’s Centers for Medicare & Medicaid Services Administrator appointee most recently worked, is 

 by HealthPayerIntelligence as saying, “The administration is sending an incredibly powerful signal about where they're heading on Medicaid policy and a return to viewing Medicaid as a key, foundational piece of the Affordable Care Act and a primary vehicle for coverage for people, particularly during the pandemic.”

A 2017 survey found approximately 75% of urologists accepted Medicaid managed care and 90% accepted Medicare Advantage, “suggesting some discernment when it comes including Medicaid managed care in a practice’s payment mix,” writes Ross E. Weber of the AACU.

Medicaid-to-Medicare reimbursement ratio nears pre-Great Recession level

Stymied by Congress and dissatisfied with the pharmaceutical industry’s unwillingness to propose transformative programs to rein in the cost of prescription drugs, President Trump has lately redoubled his executive actions to promote transparency and cut prices.

Following the issuance of wide-ranging executive orders throughout 2020, more formal rules were announced November 20 “to very dramatically lower the price of prescription drugs for the American people, especially for our cherished seniors,” 

. One of the regulations limits rebates paid to pharmacy benefit managers (PBMs) in Medicare (an advocacy priority for the American Association of Clinical Urologists promoted via participation in the Alliance for Transparent and Affordable Prescriptions) and another, known as “most favored nation,” pegs the price of certain drugs to their price in other developed countries.

The middlemen that manage insurers’ pharmacy benefits are stunningly successful in gobbling up the discounts drug makers intend to offer patients. A 2018 analysis found that insurers got $89 billion in rebates from drug companies in 2016. Efforts to increase transparency are slowly advancing through state legislatures and the US Supreme Court will soon rule on an Arkansas law that regulates PBM payments to pharmacies. Fiercehealthcare 

, “The rebate rule will replace the safe harbor for Part D rebates, meaning they could be targeted under the federal anti-kickback law, with a new safe harbor that applies only to discounts offered at the point of sale.” The administration estimates that under the new rule, rebates totaling close to $40 billion will reach patients, resulting in an average discount of nearly 30% for brand drugs.

Opponents say the move will actually increase costs for Medicare beneficiaries because insurers use the rebates to lower premiums. America’s Health Insurance Plans, the industry’s trade group, asserts, “Drug prices are out of control because Big Pharma alone sets and controls drug prices, not because health insurance providers and our PBM partners negotiate discounts and rebates to reduce drug prices.”

The AACU, for one, associates itself with the Alliance for Transparent and Affordable Prescriptions whose president said, "For far too long, the PBM industry has been generating significant profits while patients struggle to afford the cost of prescription drugs. PBMs owe it to patients to pass along savings and the rebates received on to the patient."

Providers, payers, and the pharmaceutical industry alike take issue with the president’s other late-term regulation that ties reimbursement of Medicare Part B drugs to an international standard. The 

, “The intent is to cap the cost of those drugs at the lowest price that drug manufacturers receive in other countries and to pay providers a flat add-on amount for each dose of a drug, instead of a percentage of each drug’s cost.”

The mandatory payment model will focus on 50 single-source drugs, including biosimilars, that most impact Medicare spending. Centers for Medicare & Medicaid Services Administrator Seema Verma said, “While there are market forces and negotiations that serve to reduce cost in other parts of the health care system, it just doesn’t exist in Part B.”

Physicians were quick to refute the notion that they are primarily driven by a profit motive. Drug makers, meanwhile, assert that price controls from other countries will suppress investment in research and discovery of advanced therapies. The most favored nation proposal is also opposed by senators in the president’s own party. While drafting the bipartisan Prescription Drug Pricing Reduction Act of 2019 (S. 2543), most Republicans on the Senate Finance Committee backed an amendment to block the administration from taking such an action.

The prospect of either rule taking effect—rebates in 2022 and most favored nation in 2021—is unclear. Reuters reports that economic analysts do not expect them to survive court challenges or a new administration.Addressing the prospect of legal battles, Secretary of Health and Human Services Alex Azar said, “We feel that both regulations are extremely strong and any industry challenging them is declaring themselves at odds with American patients.” President-elect Biden, meanwhile, is known to oppose the rebate proposal, believing that insurers would likely hike premiums to cover some of their losses. The most favored nation proposal, on the other hand, is something Democrats support. Indeed, that policy was included in a prescription drug bill passed by the Democrat-controlled House of Representatives last year.

Whatever may happen to these efforts in the future, it is clear that President Trump was determined to follow through on a promise made during his first campaign. The actions demonstrate, according to the president himself, “I have been loyal to our patients and our people that need [prescription drugs] and devoted myself completely to fighting for the American people. You see that. This is not an easy thing to do.”

"The middlemen that manage insurers’ pharmacy benefits are stunningly successful in gobbling up the discounts drug makers intend to offer patients," writes Ross E. Weber of the AACU.








Ross E. Weber

Articles

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

Prostate cancer screening bills face government-funded opposition

Medicaid-to-Medicare reimbursement ratio nears pre-Great Recession level

Lame-duck deeds demonstrate president’s drive to deliver on drug prices