January 2021 - AUA Public Policy Council Update for MAS
From the Chair
I am pleased to share updates from the AUA Public Policy Council that may benefit your Section members. Our updates include information on updated 2021 RVU impact tables as well as advocacy with the Centers for Medicare & Medicaid Services to delay the Most Favored Nation Model and address the burden caused by repeat prior authorization requests for chronic conditions.
Consolidated Appropriations Act Modifies Medicare Payments
On December 27, the Consolidated Appropriations Act, 2021 modified the Calendar Year (CY) 2021 Medicare Physician Fee Schedule (MPFS). The impacts are as follows:
- Provided a 3.75 percent increase in MPFS payments for CY 2021.
- Suspended the 2 percent payment adjustment (sequestration) through March 31, 2021.
- Reinstated the 1.0 floor on the work Geographic Practice Cost Index through CY 2023.
- Delayed implementation of the inherent complexity add-on code for evaluation and management services (G2211) until CY 2024.
The Centers for Medicare and Medicaid Services (CMS) has recalculated the MPFS payment rates and conversion factor to reflect these changes. The AUA has updated the impact tables based on the revised MPFS conversion factor for CY 2021 at 34.8931.
To view the updated impact tables, click here.
AUA, Coalition Address Most Favored Nation (MFN) Model for Medicare Part B Drugs
In late December, the AUA joined the Part B Access for Seniors and Physicians (ASP) Coalition in a letter to Senate Majority Leader Mitch McConnell (R-KY), Senate Minority Leader Chuck Schumer (D-NY), House of Representatives Speaker Nancy Pelosi (D-CA-12) and House Minority Leader Kevin McCarthy (R-CA-23). The letter called for immediate action to delay the Centers for Medicare & Medicaid Innovation Services (CMMI) at the Centers for Medicare & Medicare Services (CMS) from moving forward with implementation of the Most Favored Nation (MFN) Model for Medicare Part B drugs, which was set to begin on January 1, 2021.
CMS has acknowledged the model could cause nearly one out of every five beneficiaries to lose access to their treatments by the third year of implementation. This policy may require urologists and other providers to decide between accepting reimbursement rates lower than the price they will pay for drugs or choosing less optimal treatments for their patients.
The letter called on congressional leadership to immediately delay the implementation of the MFN Model. Since the issuance of the letter, a federal judge has issued a preliminary injunction, which prohibits CMS from implementing the MFN Model based on a failure to follow notice and comment procedures under the Administrative Procedure Act (APA). Most notably, the order vacates the MFN in its entirety pending completion of the notice and comment process under the APA.
For a copy of the letter, please contact AUA Policy & Advocacy Director Ray Wezik at rwezik@AUAnet.org.
AUA Comments on CMS Prior Authorization Burden Reduction Proposed Rule
On January 4, the AUA commented on CMS’ prior authorization burden reduction rule, asking the agency to clarify whether the 72-hour timeline for expedited review includes both weekends and holidays; a concern raised with CMS in previous meetings with AUA members on physician burden reduction. Additionally, the AUA urged CMS to consider the burden caused by repeat prior authorization requests for chronic conditions.
The proposed rule, entitled “Medicaid Program; Patient Protection and Affordable Care Act; Reducing Provider and Patient Burden by Improving Prior Authorization Processes, and Promoting Patients’ Electronic Access to Health Information for Medicaid Managed Care Plans, State Medicaid Agencies, CHIP Agencies and CHIP Managed Care Entities, and Issuers of Qualified Health Plans on the Federally Facilitated Exchanges; Health Information Technology Standards and Implementation Specifications [CMS-9123-P],” proposes to set a maximum response time of 72 hours from payers for expedited prior authorization requests, and a maximum response time of 7 days for standard prior authorization requests. Additionally, the rule seeks to reduce provider administrative burden with standardized integrated systems for the sharing of electronic health records of patients over years and across different providers and payers.
The letter is attached. CMS has recently released the final rule and the AUA will analysis that rule and provide an update.
Below are insurance updates from national insurance carriers. If you have questions about insurer issues, contact Keith Hawman at firstname.lastname@example.org
Aetna reviewed its Jevtana (Commercial) Policy with the following changes:
- Added compendial use regarding treatment of Jevtana as a subsequent treatment for castration-resistant distant metastatic disease which has been previously treated with Xtandi or Zytiga
- Revised FDA-indication from hormone-refractory metastatic prostate cancer to metastatic castration-resistant prostate cancer.
- Revised criterion language for continuation of therapy, from ‘who have not experienced disease progression or an unacceptable toxicity’ to ‘when there is no evidence of unacceptable toxicity or disease progression while on the current regimen’.
Aetna revised its Nerve Conduction Studies Policy removing the following CPT code:
- 0438T – Transperineal placement of biodegradable material, peri-prostatic (via needle), single or multiple, includes image guidance
Aetna reviewed its Botulinum Toxin Policy revising criteria extensively, with changes to indications for OnabotulinumtoxinA: achalasia, blepharospasm, cervical dystonia, migraine prophylaxis, chronic, overactive bladder with urinary incontinence.
Aetna reviewed its Urinary Incontinence (Commercial) Policy revising medically necessary criterion regarding usage of periurethral injection, by adding Bulkamid to the list of FDA cleared bulking agents.
Aetna reviewed its Urological Supplies (Commercial) Policy with the following changes:
- Adding the following not medically necessary criterion:
- PureWick urine collection system for the management of urinary incontinence
- Added covered HCPCS codes including:
- K1010, K1011, and K1012
- Added the following not covered HCPCS code:
Aetna reviewed its Neurogenic Bladder, Selected Treatments (Commercial) Policy adding an additional experimental and investigational therapy for the treatment of urogenic bladder:
- Transcranial magnetic stimulation
Aetna reviewed its Tumor Markers (Commercial) Policy adding the following to experimental and investigational tests:
- Decipher Bladder
- Urinary steroid profile for the management of adrenal malignancies (Mayo Clinic Laboratories)
Cigna reviewed its Genetic Testing (Collateral File) Policy removing the Decipher Prostate Cancer Test.
Humana released its new Erleada (Commercial) Policy creating an individual policy for Commercial line of business which was previously addressed in a comprehensive policy for Medicare, KY Medicaid, and Commercial lines of business. The new policy added the following criteria:
- For non‐metastatic castration‐resistant prostate cancer, the member has an intolerance or contraindication to both Xtandi and Nubeqa
- For metastatic castration‐sensitive prostate cancer, the member has an intolerance or contraindication to Xtandi
Effective December 5, Noridian retired the following LCDs due to lack of evidence of current need(s) for the education and/or edits or in some cases because the material is addressed by a National Coverage Determination (NCD), a coverage provision in a CMS interpretative manual, another LCD or an article, that retirement does not mean that medical necessity has changed or that the LCD no longer reflects appropriate criteria, and that the guidance in the retired LCD may be helpful in assessing medical necessity.
- Decipher Biopsy Prostate Cancer Classifier Assay for Men with Favorable Intermediate Risk Disease (MolDX) (L38147) Local Coverage Determination (LCD)
- Decipher Biopsy Prostate Cancer Classifier Assay for Men with Favorable Intermediate Risk Disease (MolDX) (JF) (L38149) Local Coverage Determination (LCD)
- Decipher Biopsy Prostate Cancer Classifier Assay for Very Low and Low Risk Disease (MolDX) (JE) (L37818) Local Coverage Determination (LCD)
- Decipher Biopsy Prostate Cancer Classifier Assay for Very Low and Low Risk Disease (MolDX) (JF) (L37820) Local Coverage Determination (LCD)
- Decipher Prostate Cancer Classifier Assay (MolDX) (JE) (L36343) Local Coverage Determination (LCD)
- Decipher Prostate Cancer Classifier Assay (MolDX) (JF) (L36345) Local Coverage Determination (LCD)
Effective December 6, Noridian retired the following LCAs due to lack of evidence of current problems or CMS may have issued guidance regarding national coverage, however it is still the responsibility of providers to maintain correct performance, coding, billing, and medical necessity under Medicare. This responsibility for correct claims submission is unchanged whether or not there is a coverage article in place.
- Decipher Biopsy Prostate Cancer Classifier Assay for Men with Favorable Intermediate Risk Disease (MolDX) (JF) (A57963) Local Coverage Article (LCA)
- Decipher Biopsy Prostate Cancer Classifier Assay for Men with Favorable Intermediate Risk Disease (MolDX) (A57962) Local Coverage Article (LCA)
- Decipher Biopsy Prostate Cancer Classifier Assay for Men with Very Low and Low Risk Disease (MolDX) (JF) (A57646) Local Coverage Article (LCA)
- Decipher Biopsy Prostate Cancer Classifier Assay for Men with Very Low and Low Risk Disease (MolDX) (JE) (A57645) Local Coverage Article (LCA)
- Decipher Prostate Cancer Classifier Assay (MolDX) (JE) (A57623) Local Coverage Article (LCA)
- Decipher Prostate Cancer Classifier Assay (MolDX) (JF) (A57624) Local Coverage Article (LCA)
Effective December 5, Noridian retired its Oncotype DX AR-V7 Nucleus Detect for Men with Metastatic Castrate Resistant Prostate Cancer (MCRPC) MolDX (JE) (A57601) Local Coverage Article (LCA) and replaced it with A57287 “Billing and Coding: MolDX: Androgen Receptor Variant (AR-V7) Protein Test”.
Effective December 5, Noridian retired its Oncotype DX AR-V7 Nucleus Detect for Men with Metastatic Castrate Resistant Prostate Cancer (MCRPC) MolDX (JF) (A57499) Local Coverage Article (LCA) and replaced it with A57291 “Billing and Coding: MolDX: Androgen Receptor Variant (AR-V7) Protein Test”.
Effective December 6, Noridian released its Response to Comments: Prostate Cancer Genomic Classifier Assay for Men with Localized Disease (MoIDX) (JE) (A58509) – Local Coverage Article (LCA).
Noridian released its Response to Comments: Prostate Cancer Genomic Classifier Assay for Men with Localized Disease (MoIDX) (JE) (A58509) Local Coverage Article (LCA). This LCA is now in effect, beginning, December 6.
United Healthcare published its Medical Policy Update News & Announcements provider bulletin, announcing significant revisions to its Nerve Graft to Restore Erectile Function during Radical Prostatectomy, and Gonadotropin Releasing Hormone Analogs Policies.
United Healthcare reviewed its Molecular Pathology/Molecular Diagnostics/Genetic Testing (Medicare Advantage) Policy revising and expanding the scope of overview section including the Molecular Assays for Prostate Cancer Test.
United Healthcare released the following new policies applicable to multiple states:
- Botulinum Toxins A and B (Value & Balance Exchange) Policy
- Implantable Beta-Emitting Microspheres for Treatment of Malignant Tumors (Value & Balance Exchange) Policy
- Infertility Diagnosis and Treatment (Value & Balance Exchange) Policy
- Infertility Services (Value & Balance Exchange) Policy
- Intensity Modulated Radiation Therapy (Value & Balance Exchange) Policy
- Nerve Graft to Restore Erectile Function During Radical Prostatectomy (Value & Balance Exchange) Policy
- Prostate Surgery (Value & Balance Exchange) Policy
- Proton Beam Radiation Therapy (Value & Balance Exchange) Policy
United Healthcare reviewed its Radiologic Therapeutic Procedures (Medicare) Supporting Coverage Document removing non-metastatic Prostate Cancer from diagnoses requiring individual consideration from Proton Beam Therapy coverage guidelines.
United Healthcare reviewed its Incontinence Supplies (Medicaid) Reimbursement & Billing Document with the following changes to state exceptions:
- Revised Kansas state exception to state per state regulation, home health care & DME providers are required to submit one of the specified diagnosis codes (see policy for specific changes).
UHC Community Plan
United Healthcare released the following new policies:
- Botulinum Toxins A and B Policy
- Carrier Testing for Genetic Diseases Policy
- Implantable Beta-Emitting Microspheres for Treatment of Malignant Tumors Policy
- Intensity-Modulated Radiation Therapy Policy
- Nerve Graft to Restore Erectile Function During Radical Prostatectomy Policy
- Prostate Surgery Policy
- Proton Beam Radiation Therapy Policy
WPS Government Health Administrators
WPS Government Health Administrators reviewed its Molecular Diagnostic Tests (MDT) (MolDX) (J05, J08) (A57772) Local Coverage Article (LCA) updating the following CPT code descriptor:
- 0154U – Oncology (urothelial cancer), RNA, analysis by real-time RT-PCR of the FGFR3 (fibroblast growth factor receptor 3) gene analysis (i.e., p.R248C [c.742C>T], p.S249C [c.746C>G], p.G370C [c.1108G>T], p.Y373C [c.1118A>G], FGFR3-TACC3v1, and FGFR3-TACC3v3) utilizing formalin-fixed paraffin-embedded urothelial cancer tumor tissue, reported as FGFR gene alteration status
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.
- 2465 – Medical Licensure ENACTED
In June, Senator Stephen Sweeney (D) introduced S. 2465 requiring any advertisement of health care professionals to include the type of professional license and professional degree the individual received. The bill prohibits a physician from advertising as “board certified” unless the physician is (i) a member of the ABMS or AOA or (ii) a non-member that requires (a) successful completion of a post-graduate training program approved by the Accreditation Council for Graduate Medical Education (ACGME) or the AOA that provides complete training in the specialty or subspecialty certified by the non-ABMS or non-AOA board, (b) certification by an ABMS or AOA board, and (c) successful passage of a specialty exam. Advertisements may not include deceptive or misleading information. Governor Phil Murphy (D) signed S. 2465 on December 14. Read the bill.
Highmark reviewed its Erleada, Nubeqa, Xtandi (Commercial, Healthcare Reform) Policy with the following changes:
- Removed state specific coverage exceptions and added that an exception to some or all of the criteria above may be granted for select members and/or circumstances based on state and/or federal regulations.
- Added that Coverage of oncology medications listed in this policy may be approved on a case-by-case basis per indications supported in the most current NCCN guidelines.
Independence Blue Cross
Independence Blue Cross reviewed its Repair and Replacement of Durable Medical Equipment (DME) Attachment A (Medicare Advantage) Supporting Coverage Document adding the following HCPCS codes:
- K1010 – Indwelling intraurethral drainage device with valve, patient inserted, replacement only, each
- K1011 – Activation device for intraurethral drainage device with valve, replacement only, each
- K1012 – Charger and base station for intraurethral activation device, replacement only
Independence Blue Cross reviewed its eviCore Lab Management Program Attachment A (Commercial) Supporting Coverage Document indicated that the eviCore lab management clinical guidelines will be revised effective January 1, 2021 with the following CPT code added to codes requiring pre-service and prepayment reviews:
- 0228U – Oncology (prostate), multianalyte molecular profile by photometric detection of macromolecules adsorbed on nanosponge array slides with machine learning, utilizing first morning voided urine, algorithm reported as likelihood of prostate cancer
H.B. 1769 – Medical Licensure
Introduced by Representative Nick Freitas (R), H.B. 1769 requiring the board of medicine to issue a license by endorsement to an applicant who holds a valid, unrestricted license in another state if the examinations required by the other board are equal to those required by the Virginia Board. Read the bill.
ICYMI: Updates from the AUA Policy & Advocacy Brief blog
CMS Finalized Changes to E&M Coding for 2021
Eﬀective January 1, 2021, CMS finalized significant changes to the office and outpatient evaluation and management (E&M) services (CPT codes 99202–99215) for both new and established patients. The changes include the following:
- Increased valuations for outpatient E&M services.
- New add-on code for prolonged time.
- Elimination of CPT code 99201.
- Removal of history and exam criteria to select the level of E&M service.
- New documentation requirements allowing providers to bill based on time or medical decision-making.
To view our updated one-pager, click here.
Public Health Emergency Declaration Extended to April 21
The Department of Health and Human Services has extended the COVID-19 Public Health Emergency (PHE) declaration for an additional 90 days beginning January 21, 2021. The extended PHE will run through April 21, 2021 and will include all the telehealth capabilities currently in use, including audio-only visits, as well as the other waivers and flexibilities enacted since the PHE began.
Our best wishes for a Happy New Year,
Kathy and the AUA Public Policy and Advocacy Team
Kathleen Zwarick Shanley, PhD, CAE, ACC
American Urological Association
Chief Policy Officer & Executive Vice President, Public Policy and Advocacy
1000 Corporate Boulevard
Linthicum, MD 21090