Home Advocacy Public Policy Council Update New England April 2021

Public Policy Council Update New England - April 2021

From the Chair

I am pleased to share updates from the AUA Public Policy Council that may benefit the New England Section’s members. Our updates include information on our success with the National Cancer Institute’s updated K08 Award percent requirements.

We also share registration information on the Virtual Annual Urology Advocacy Summit.

Registration for Virtual Annual Urology Advocacy Summit Launched

Make plans now to join the AUA in July when we bring Washington, DC to you with the Virtual Annual Urology Advocacy Summit! The month of July will feature several advocacy-related events, including a Virtual Hill Day on July 21 that will provide direct opportunities to connect with key federal lawmakers and their staff on the topics impacting your practice and patients. The AUA Summit’s keynote speaker is Ashish Jha, MD, MPH – the Dean at Brown University’s School of Public Health. Featured on MSNBC and CNN, Dr. Jha is a world authority on the COVID-19 pandemic, so he brings unique insights to topics currently impacting healthcare and the future of healthcare in a post-COVID world.

The event is free to all domestic AUA members. Register today!

NCI Reduces K08 Award Percent Effort Requirements - Thanks AUA for Valuable Input

On April 14, the National Cancer Institute (NCI) officially changed their rules to allow K08 applicants to apply for awards at 50% effort. The AUA received the follow response from NCI Center for Cancer Training Director Oliver Bogler:

“I particularly appreciate that you gathered input from across your organization and included it in your reply…. Your response informed the decision to make the changes outlined in the recently published NOT-CA-21-054. NCI will now allow surgeon-scientist applicants to reduce the percent effort required for conducting research career development on a K08 award below 75% (nine person-months), but no lower than 50% (six person-month).”

This has been part of a long standing and ongoing effort within the AUA to work with federal research institutions to offer feedback on award mechanisms to ensure the conduciveness of urologic research.

On February 11, the AUA responded to the National Cancer Institute (NCI) Request for Information (RFI) from on lowing percent efforts from 75% to 50% within the Mentored Clinical Scientist Research Career Development Awards (K08). Based on an AUA survey, with more than 200 AUA member respondents, the AUA advocated for a reduction of the percent effort to 50%. Currently, many applicants do not attempt to apply for these grants because their institutions will not allow them to spend 75% of their time in the lab and only 25% in clinic.

The lowering of the percent effort to 50% will allow more surgeon-scientist to apply, and to address major needs in moving research discoveries forward into clinical practice.

AUA Continues Series of Virtual Meetings with Freshman Lawmakers

The AUA continued its series of meetings with first-year lawmakers in the U.S. House of Representatives. The goal is to introduce urology and the AUA’s top advocacy initiatives, such as addressing physician workforce shortages, enhancing access to prostate cancer screening, expanding access to telehealth services and increasing federal research funding. Over the past few weeks, the AUA specifically met with staff in the offices of Representatives Randy Feenstra (R-IA-04), Andrew Garbarino (R-NY-02), Bob Good (R- VA-05), Nancy Mace (R-SC-01), Lisa McClain (R-MI-10), Matt Rosendale (R-MT-At Large), Marilyn Strickland (D-WA-10) Mariannette Jane Miller-Meeks (R-IA-02), Nikema Williams (D-GA-05), Young Kim (R-CA-39), and Michelle Steel (R-CA-48).

AUA Telehealth Task Force Meets Senate Staff on CONNECT Act

On April 2, members of the Urology Telehealth Task Force met virtually with healthcare policy staff from the office of Senator Brian Schatz (D-HI) on the reintroduction of the Creating Opportunities Now for Necessary and Effective Care Technologies for Health Act (CONNECT) Act. Public Policy Council Chair Dr. Eugene Rhee and Urology Telehealth Task Force Chair Dr. Aaron Spitz highlighted payment parity for telehealth services, the continuation of audio-only telehealth visits beyond the public health emergency and the elimination of the originating site requirement as the primary policy initiatives supported by the AUA. Senator Schatz’s staff was very receptive to those issues and expressed support for inclusion in the upcoming legislation.

A previous version of the CONNECT Act introduced in 2019 during the last Congress contained sections to loosen the originating site requirement, but was limited in scope. With the onset of the pandemic, proposed telehealth legislation has dramatically changed due to the obvious benefits now enjoyed by patients no matter their location. Congress and the Centers for Medicare & Medicaid Services continue to discuss what provisions require legislation, and what issues the agency can regulate under current law.

ICYMI: Updates from the AUA Policy & Advocacy Brief blog

AUA Interviews Representative David McKinley on Student Loan Forgiveness Bill

On March 30, the AUA released a special edition of the AUA Inside Tract podcast. It is an interview between former AUA Holtgrewe Legislative Fellow, Joshua Langston, MD, and Representative David McKinley (R-WV-01), sponsor of the rural physician student loan forgiveness bill. The podcast also highlights that it is a special edition of the AUA Inside Tract, as part of the Policy & Advocacy Resident Workgroup’s efforts to educate residents and fellows on advocacy issues important to urology.

Listen to the pocast

AUAPAC Attends Fundraiser for Representative from Kentucky

On March 23, AUAPAC participated in a virtual fundraiser for Representative Brett Guthrie (R-KY-02). Earlier this year, Congressman Guthrie was appointed as the Ranking Member of the House Energy & Commerce Subcommittee on Health. The Health Subcommittee has jurisdiction on AUA-championed legislation such as the U.S. Preventive Services Task Force Transparency and Accountability Act and the specialty physician student loan forgiveness bill (H.R. 944). Representative Guthrie also championed the AUA-supported urotrauma legislation from original introduction through passage as part of the Fiscal Year 2016 National Defense Authorization Act.

For more information on AUAPAC activities, please visit www.MyAUAPAC.org.

AUA Hosts Congressional Briefing on Prostate and Kidney Cancer Research Funded Through Department of Defense (DOD)

The AUA, KidneyCAN and ZERO: The End of Prostate Cancer jointly hosted a congressional briefing to educate and raise awareness about the Kidney Cancer Research Program (KCRP) and Prostate Cancer Research Program (PCRP), as well as ensure robust and sustained funding for these urologic programs. The March 16 briefing targeted members of Congress and congressional staffers.

As part of the briefing, the following panel of experts shared their experiences and the important work conducted through the Congressionally Directed Medical Research Programs (CDMRP):

  • Dr. Scott K. Swanson, President, AUA Board of Directors and urologist at Mayo Clinic
  • Representative Rosa DeLauro (D-CT-03), Chair, House Committee on Appropriations
  • Dr. Carolyn Best, Director of Research, AUA
  • Mr. Anthony Minter, prostate cancer patient and Consumer Reviewer for PCRP
  • Dr. Hyung Kim, Director of the Cedars-Sinai Academic Urology Program, Associate Director of Surgical Research in the Samuel Oschin Comprehensive Cancer Center and KCRP peer reviewer
  • Dr. Brandon Manley, Genitourinary Oncologist at Moffitt Cancer Center, and recipient of multiple KCRP awards

As background, the CDMRP originated in 1992 via a Congressional appropriation, through the Department of Defense, to foster novel approaches to biomedical research. These programs focus on military medical research, cancer research and other disease- and injury-specific research. All the programs managed by CDMRP share the common goal of filling gaps in research by funding high impact, high risk and high gains projects that lead to improvements in patient care, breakthrough technologies and resources for clinical benefit.

View a recording of the briefing.

Below are insurance updates from national insurance carriers. If you have questions about insurer issues, contact Ray Wezik at rwezik@auanet.org.

Aetna

Aetna reviewed its Benign Prostatic Hyperplasia Medical Policy clarifying that Rezum system is also known as convective radiofrequency transurethral water vapor therapy, and removing HCPCS code C9747.

Read the update.

BCBS Federal Employee Plan

BCBS Federal Employee Plan reviewed its Botox Prior Authorization (PA) Criteria adding neurogenic detrusor overactivity as an approved indication and the following approval criteria:

  • For prior-approval and renewal, 5-17 years of age
  • For prior approval and renewal, patient must have the following:
    • For prior approval and renewal, neurogenic detrusor overactivity (NDO)
    • For prior-approval, inadequate response or intolerance to an anticholinergic
    • For prior-approval and renewal, no dual therapy with other botulinum toxins

Read the update.

CGS Administrators

CGS Administrators retired its Genomic Health Oncotype DX Prostate Cancer Assay (MoIDX) (J15) (L36206) Local Coverage Determination (LCD) stating this LCD is being retired because the information in this policy has been incorporated within the new LCD for Prostate Cancer Genomic Classifier Assay for Men with Localized Disease (MoIDX) (L38303).
Read the update.

CGS Administrators retired its Oncotype DX Genomic Prostate Score (MolDX) (L37354) Local Coverage Determination (LCD) stating that this LCD is being retired because the information in this policy has been incorporated within the new LCD for “Prostate Cancer Genomic Classifier Assay for Men with Localized Disease” (MoIDX) (L38303).
Read the update.

CGS Administrators reviewed its Prostate Cancer Genomic Classifier Assay for Men with Localized Disease (MoIDX) (J15) (A58371) Local Coverage Article (LCA) adding the following CPT code:

  • 0047U – Oncology (prostate), mRNA, gene expression profiling by real-time RT-PCR of 17 genes (12 content and 5 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a risk score

Read the update.

Humana

Humana reviewed its Fluorescence In Situ (FISH) for Noncancer Indications Policy removing the policy statement for Y chromosome microdeletion analysis in men with nonobstructive azoospermia or severe oligozoospermia (less than 5 million sperm/mL) prior to assisted reproductive technologies (when not contractually excluded).
Read the update.

Humana reviewed its Laboratory Analysis for Prostate Cancer Policy removing general criteria for genetic and pharmacogenomics tests to be applied when disease- or gene-specific criteria are not available on a medical coverage policy.
Read the update.

Humana has updated their Botox policy with changes to criteria and indications.

  • Humana has added neurogenic detrusor overactivity in members 5 years of age and older as a medically necessary indication with the following criteria:
    • The member has had previous treatment, contraindication, or intolerance with one muscarinic receptor antagonists (e.g., oxybutynin, trospium).
  • The following limitations apply to Botox (onabotulinumtoxinA) when used in the treatment of urinary incontinence:
    • Acute urinary tract infections and/or acute urinary retention
    • Use of botox (onabotulinumtoxinA) in combination with other anticholinergic agents
  • Humana amended language for urinary incontinence usage from “with two formulary muscarinic receptor antagonists” to “with two muscarinic receptor antagonists”.
    • Criteria for Botox utilization for urinary incontinence now reads: “The member has had previous treatment, contraindication, or intolerance with two muscarinic receptor antagonists (e.g., oxybutynin, trospium)*.”
    • Asterisk notifies that this does not apply to Medicare medical requests.

Read the update.

Palmetto

Palmetto retired its Oncotype DX Genomic Prostate Score (MolDX) (JJ, JM) (A56285) Local Coverage Article (LCA) stating this article is being retired because the information in this article has been incorporated within the article for “Prostate Cancer Genomic Classifier Assay for Men with Localized Disease” (MoIDX) (A58343).
Read the update.

Palmetto retired its Oncotype DX Genomic Prostate Score (MolDX) (JJ, JM) (L37262) Local Coverage Determination (LCD) stating that this LCD is being retired because the information in this policy has been incorporated within the LCD for “Prostate Cancer Genomic Classifier Assay for Men with Localized Disease” (MoIDX) (L38292).
Read the update.

Palmetto retired its Oncotype DX Prostate Cancer Assay (MolDX) (JJ, JM) (L36153) Local Coverage Determination (LCD) stating that this LCD is being retired because the information in this policy has been incorporated within the new LCD for “Prostate Cancer Genomic Classifier Assay for Men with Localized Disease” (MoIDX) (L38292).
Read the update.

Palmetto reviewed its Prostate Cancer Genomic Classifier Assay for Men with Localized Disease (MolDX) (JJ, JM) (A58343) Local Coverage Article (LCA) adding the following CPT code:

  • 0047U – Oncology (prostate), mRNA, gene expression profiling by real-time RT-PCR of 17 genes (12 content and 5 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a risk score.

Read the update.

United Healthcare

United Healthcare reviewed its Prostate Surgery (Commercial and Commercial West) Medical Policy adding documentation requirements section, including requirements for the following procedures:

  • Transurethral ablation
  • Cryoablation of the prostate
  • Surgical-radical prostatectomy
  • Prostatic urethral lift

Read the update. (Commercial)
Read the update. (Commercial West)

United Healthcare reviewed its Biofeedback Therapy for the Treatment of Urinary Incontinence (NCD 30.1.1) (Medicare Advantage) Policy removing CPT code 90911.
Read the update.

United Healthcare reviewed its Molecular Oncology Testing for Cancer Diagnosis, Prognosis, and Treatment Decisions (Value & Balance Exchange) Policy revising examples of not medically necessary cancer panels adding ExoDX Prostate IntelliScore (EPI).
Read the update.

United Healthcare reviewed its Prostate Services and Procedures (Medicare Advantage) Policy revising guidelines for fluid jet system for treatment of benign prostatic hyperplasia (BPH) revising language to indicate LCDs/LCAs exist for all states/territories and compliance with these policies is required where applicable and removing default guidelines for states/territories with no LCDs/LCAs.
Read the update.

WPS Government Health Administrators

WPS Government Health Administrators retired its Bladder Tumor Marker FISH Billing and Coding Guidelines Update (MolDX) (A56332) Local Coverage Article (LCA) effective February 25.
Read the update.

Local and Regional Updates

The following are updates in your section. The AUA routinely monitors state legislative, regulatory, and insurance policy trends. Please contact AUA State Advocacy Manager Catherine Hendricks at chendricks@AUAnet.org for more information on any of these issues. In addition, check out our interactive map on the AUA State Advocacy Webpage for the most updated information on bill status.

State Legislative Trends

  • Connecticut Introduces Cost-Sharing and Step-Therapy Bills – the AUA has met with the Centers for Medicare & Medicaid Services (CMS) to address various regulatory barriers to care, including step-therapy;
  • Maine Enacts COVID-19 Insurance Coverage Law and Introduces Several Telehealth Bills;
  • Massachusetts Introduces Biomarker Bills;
  • Rhode Island No-Cost Sharing Prostate Cancer Screening Bills Close to Enactment – expanding access to prostate cancer screening is a top AUA state advocacy initiative;
  • Rhode Island also Holds Two Intersex Bills for Further Study – the AUA advocates for medical decision-making for children remaining the responsibility of parents and should not be legislated; and
  • Vermont Enacts Audio-Only Telehealth Laws – the AUA continues to support the full expansion of telehealth services post the current public health emergency and, on a national level, has also met with the CMS to urge the adoption of audio-only visits.

Conneticut

H.B. 5572 - Restricitve Covenants
Introduced by Representative Charlie Stallworth (D), H.B. 5572 seeks to amend state law to prohibit the use of non-compete clauses in physician contracts. The bill was referred to the Joint Committee on Public Health.
Read the bill.

H.B. 6622 - Cost-Sharing
Introduced by, and referred to, the Joint Committee on Insurance and Real Estate, H.B. 6622 seeks to limit the circumstances in which a health carrier may remove a prescription drug from a formulary or move a prescription drug to a different cost-sharing tier during a plan year.
Read the bill.

S.B. 99 - Restrictive Covenants
Introduced by Senator Saud Anwar (D), S.B. 99 seeks to amend state law to prohibit the use of non-compete clauses in physician contracts. The bill was referred to the Joint Committee on Public Health.
Read the bill.

S.B 1003 - Cost-Sharing
Introduced by, and referred to, the Joint Committee on Insurance and Real Estate, S.B. 1003 seeks to require health carriers and pharmacy benefits managers to give credit for payments made by third parties for the amount of, or any portion of the amount of, an enrollee’s cost-sharing liability.
Read the bill.

S.B. 1045 - Step-Therapy
Introduced by Senator Martin Looney (D), S.B. 1045 seeks to amend state insurance law to prohibit certain insurance carriers from requiring the use of step-therapy; refines the definition of “clinical peer” for the purpose of adverse determination and utilization review; and places the burden of proving medical services that were not medically necessary on the insurer. The bill was referred to the Joint Committee on Insurance and Real Estate.
Read the bill.

Maine

L.D. 1 - COVID-19 (ENACTED)
Introduced by Representative Troy Jackson (D), L.D. 1 seeks to require health insurance carriers to provide coverage for COVID-19 screening, testing and immunization services and eliminates cost-sharing requirements for those services. The bill also seeks to amend current law regarding extended prescriptions, not to exceed a 180-day supply. The bill became law without Governor Janet Mills’ (D) signature.
Read the bill.

L.D. 683 - Certificate of Need
Introduced by Representative Laurel Libby (R), L.D. 683 seeks to repeal the requirements for a certificate of need issued by the Department of Health and Human Services when offering a new healthcare service by a healthcare facility. The bill has not yet been referred to a committee.
Read the bill.

L.D. 691 - Certificate of Need
Introduced by Representative Laurel Libby (R), L.D. 691 seeks to repeal the requirements for a certificate of need issued by the Department of Health and Human Services for the establishment of new healthcare facilities. The bill has not yet been referred to a committee.
Read the bill.

L.D. 790 - Pelvic Exams
Introduced by Representative Vicki Doudera (D), L.D. 790 clarifies that written informed consent is not required for pelvic, rectal or prostate examinations performed on a conscious patient; in such cases, the informed consent must be obtained orally. The bill has not yet been referred to a committee.
Read the bill.

L.D. 849 - Telehealth
Introduced by Representative Kristi Mathieson (D), L.D. 849 seeks to make permanent, the authorization of telehealth provided through executive order during the COVID-19 emergency, including healthcare services provided by telephone and reimbursement for audio-only services as though it was an in-person visit. A health insurer may not establish separate deductible limits for telehealth services. The bill has not yet been referred to a committee.
Read the bill.

L.D. 932 - Certificate of Need
Introduced by Representative Laurel Libby (R), L.D. 932 seeks to repeal the requirements for certificate of need issued by the Department of Health and Human Services prior to any increase in the licensed beds by a hospital. The bill has not yet been referred to a committee.
Read the bill.

L.D. 1007 - Telehealth
Introduced by Representative Laurel Libby (R), L.D. 1007 seeks to make permanent, the governor’s executive order allowing health care professionals to provide healthcare through the use of all modes of telehealth, including visual and audio, audio-only or other electronic media. The bill also clarifies these services must be covered by insurance as they would be provided in person. The bill has not yet been referred to a committee.
Read the bill.

L.D. 1194 - Telehealth
Introduced by Representative Laurel Libby (R), L.D. 1194 seeks to amend state telehealth law to include audio-only and authorize licensing for out-of-state and recently retired physicians, physician assistants and nurses. The bill was referred to the Joint Committee on Health Coverage, Insurance and Financial Services.
Read the bill.

L.D. 1361 - Telehealth
Introduced by Senator Trey Stewart (R), L.D. 1361 seeks to amend state telehealth law to remove the exclusion for audio-only telephone, email, or texting communications; and repeals the provisions requiring the registration of out-of-state physicians with the requirement the physician hold an unrestricted license in their own state. The bill was referred to the Joint Committee on Health Coverage, Insurance and Financial Services.
Read the bill.

Massachusetts

H.D. 2194 - Biomarker
Introduced by Representative Meghan Kilcoyne (D), H.D. 2194 seeks to prohibit prior authorization for biomarker testing for patients with advanced or metastatic stage 3 or 4 cancer, thus ensuring that patients with advanced and metastatic cancer can receive biomarker testing at diagnosis without further delays caused by prior authorization. The bill has not yet been referred to a committee.
Read the bill.

S.B. 1084 - Biomarker
Introduced by Representative Susan Moran (D), S.B. 1084 seeks to prohibit prior authorization for biomarker testing for patients with advanced or metastatic stage 3 or 4 cancer, thus ensuring that patients with advanced and metastatic cancer can receive biomarker testing at diagnosis without further delays caused by prior authorization. The bill has not yet been referred to a committee.
Read the bill.

Rhode Island

H. 5432 - Prostate Cancer
Introduced by Representative Mia Ackerman (D), A. 5432 seeks to remove the cost-sharing requirements for prostate cancer screenings when the services are delivered within the health insurer’s provider network. The bill passed the House and Senate and now awaits further consideration by Governor Daniel McKee (D).
Read the bill

H. 6171 - Intersex
Introduced by Representative Rebecca Kislak (D), H. 6171 seeks to prohibit surgery for physical sex characteristics in children under 12 years of age, except to address an immediate risk of physical harm. This act would further provide for a private course of action for violations with a 10-year statute of limitations. The House Judiciary Committee recommended the measure be held for further study.
Read the bill.

S. 383 - Prostate Cancer
Introduced by Senator Maryellen Goodwin (D), S. 383 seeks to remove the cost-sharing requirements for prostate cancer screenings when the services are delivered within the health insurer’s provider network. The bill passed the House and Senate and now awaits further consideration by Governor Daniel McKee (D).
Read the bill.

S. 496 - Provider Contract
Introduced by Senator Walter Felag (D), S. 496 seeks to amend state insurance law, including: allowing alterations to drug coverage only at the time of coverage renewal; and mandating that any modifications of coverage to remove a drug from a formulary, prior authorization requirement, step-therapy, quantity limit, or moving a drug to a higher cost-sharing must be done is writing. The bill has not yet been referred to a committee.
Read the bill.

S. 593 - Intersex
Introduced by Senator Tiara Mack (D), S. 593 seeks to prohibit physical sex characteristics surgery for children under 12 years of age, except to address an immediate risk of physical harm. This act would further provide for a private course of action for violations with a 10-year statute of limitations. The Senate Health and Human Services Committee recommended the measure be held for further study.
Read the bill.

Vermont

S. 117 - Telehealth (ENACTED)
Introduced in the Senate Health and Welfare Committee, S. 117 seeks to require insurance coverage of audio-only telehealth services and outlines the qualifications. Governor Phil Scott (R) signed the bill on March 29.
Read the bill.