Industry News, May 2021

The summary of events and newsworthy items for the month of May is provided on the following pages.  In most instances, the link to the full document of information is provided.  Any of the contents may be further discussed by reaching out to Revenue Cycle Coding Strategies LLC.

FDA Approves New PET Imaging Agent for Prostate Cancer

The U.S. Food and Drug Administration (FDA) has approved the first commercially available PSMA PET imaging agent to detect prostate cancer.

The radiotracer, PYLARIFY® (piflufolastat F-18), is manufactured by Lantheus Holdings based in North Billerica, Massachusetts. The imaging agent will be used to identify suspected metastasis or disease recurrence in patients with known current or previous malignant disease. The new technique uses a tracer molecule that looks for a protein found on prostate cancer cells called prostate-specific membrane antigen, or PSMA. The tracer is injected into the bloodstream, which highlights those cells during a PET scan.

The product will be offered immediately in parts of the mid-Atlantic and southern regions of the U.S. Availability is expected to expand swiftly over the next six months, with broad availability by the end of 2021.

Mary Anne Heino, president and CEO of Lantheus, stated: “We believe PYLARIFY® represents a paradigm shift in the identification and management of patients with suspected metastasis or recurrent prostate cancer, providing more accurate and earlier detection of disease than conventional imaging so that doctors, along with patients and their families, can make more informed treatment decisions.”

Prostate cancer often spreads to the bones, which can make it difficult to detect using traditional imaging techniques. More than 30,000 men die of the disease each year.

For additional information, read the press release here.

CMS Removes Internet-Only Manual Guidance

The Centers for Medicare and Medicaid Services (CMS) has removed certain sections of Chapter 12 of the Internet-Only Manual (IOM) Publication. Specifically, Sections 30.6.1B and 30.6.13.H have been removed regarding guidance on shared/split visits as well as Section 30.6.12 on critical care guidance.  CMS emphasizes the removal of these sections does not indicate the services will no longer be covered but rather the removal is in response to a petition by the U.S Department of Health and Human Services (HHS).  The petition by HHS was pursuant to the Good Guidance Practices Regulation and CMS states guidance on these topics will be published in future rulemaking. CMS will continue to cover these services in the interim provided the situation meets any Current Procedural Terminology (CPT®) guidance and documentation meets medical necessity guidelines.  WPS has an informational YouTube video regarding the removal of the guidance and provides further information.

Retroactive Status Indicator Change

The status indicator (SI) for HCPCS code Q5122 (Injection, pegfilgrastim-apgf, biosimilar, (nyvepria), 0.5 mg) will be changed from status indicator “E2” to “K.” The change in the SI will be retroactive for the period of January 1, 2021, through March 31, 2021. The change in SI will change the injection from non-payable to separately payable for this time period. Several Medicare Administrative Contractors (MACs) have stated claims will only be adjusted when brought to their attention. Contact your MAC to ensure proper adjustment to applicable claims. Refer to the April 2021 Update of the Hospital Outpatient Prospective Payment System (OPPS) MLN Matters article for more information.

CMS Issues First Round of Price Transparency Warnings

The price transparency rule, which went into effect January 1, 2021, requires hospitals to publish a machine-readable filed that outlines their payer-negotiated payment rates.  Also required as part of the rule, hospitals must provide a tool that allows consumers to search and view the prices of 300 shoppable medical services. The Centers for Medicare and Medicaid Services (CMS) has been conducting audits of hospitals’ websites as well as reviewing complaint submissions since the rule went into effect. CMS began sending out warning letters to those hospitals they have found to be noncompliant of the federal rule. Hospitals who receive a warning have a 90-day period to address the deficiencies outlined in the letter. After the 90-day period, CMS may close its inquiry, deliver a second warning letter, or request a corrective action plan from the hospital. Failing to comply with the rules could result in a fine for the offending hospital of up to $300 per day.

Ensure Price Transparency Compliance with these Resources:
•	Hospitals
•	Machine-readable File Guide

While there has been overall resistance in implementing the price transparency rule, hospitals have also cited difficulty implementing the requirements of the rule based on the ambiguity of the rules’ language, difficulty with the machine-readable file requirements, or the cost to the hospital to implement all aspects of the rule.  CMS has yet to reach the point in The Hospital Price Transparency final ruling which specifies that facilities that incur a monetary penalty will also be publicly named on CMS’ website, however, they will continue to monitor facilities and enact the enforcement process as necessary with noncompliant hospitals. 

CMS Reviews Expansion of Coverage for Low-Dose CT Lung Cancer Screening (LDCT)

At the request of the American College of Radiology and others, the Centers for Medicare and Medicaid Services (CMS) is officially reviewing Medicare reimbursement policies for low-dose CT lung cancer screening.

CMS has convened a National Coverage Analysis of LDCT following recently updated advice from the U.S. Preventative Services Task Force (USPSTF). The update lowers the smoking history requirements and recommended screening age for the disease, which allows adults ages 50-80 who smoke or have quit smoking within 15 years to be eligible for the screening. Physicians and specialty societies have urged CMS to update their coverage policies for LDCT to align with these new recommendations.

The expanded coverage “would help ease lung cancer outcomes disparities — particularly among women, Black men, and those in rural areas,” said ACR Lung Cancer Screening Steering Committee Chair Dr. Debra Dyer.

CMS is soliciting comments through June 17 and plans to reach a decision by November 2021. According to the notice, the process is set to be completed before February 2022.

To review the current policy or make a public comment on the revised policy, please visit this link.

NGS Reconsiders PET/CT Reimbursement

In response to the Society of Nuclear Medicine & Molecular Imaging and American College of Radiology’s request for reimbursement reconsideration, National Government Services (NGS) has agreed to look into the issue of setting different PET reimbursement rates.  In a letter submitted in May from multiple radiology advocates, several concerns were outlined related to the payment for myocardial positron emission tomography which included receiving extra compensation for more complicated procedures and avoiding any new restrictions on office-based delivery of these procedures. Based on the fact that there is a hierarchy in complexity, time, and resource costs within the PET family of codes, the radiology advocates encouraged NGS to create a hierarchy of reimbursement as well. The letter suggested utilizing the simplest, least pricey procedure as a starting point and increasing reimbursement a specified percentage based on the increase in complexity, time and resources needed in comparison to the base procedure. Stephen Boren, MD, medical director of NGS stated, “We agree that PET CT should be reimbursed higher than PET alone. We will be making some changes in reimbursement.”

Physicians Push UHC to Change Prior Authorization Processes for Radiation Therapy

United Healthcare (UHC) announced, effective April 1, 2021, prior authorization would be required for some outpatient radiation therapies.  Briefly following the announcement, which included directions to submit all requests through the Prior Authorization and Notification Tool, providers started experiencing issues with the utilization and burdensome process of the prior authorization tool.  Multiple associations united together in an effort to persuade UHC to modify their arduous prior authorization processes for vital radiation therapy services. The American College of Radiology ® (ACR®), the American Society for Radiation Oncology (ASTRO), and the Association of Community Cancer Centers (ACC) submitted a letter to UHC regarding concern for their prior authorization processes and recommendations to improve their prior authorization tool for radiation oncology.  In the letter, the associations outlined their concern for the prior authorization tool that seemingly increases provider burden and has the potential to delay care for cancer patients.  The letter addresses specific concerns with the tool such as the necessity for the provider to establish needed energy level for treatment before the planning has been completed. The associations also pointed to the improbability for clinical staff to be able to complete prior authorization without extensive input from the provider.  While the letter praises UHC for taking steps to extract the most foundational information in an authorization request, such as only requiring prior authorization for radiation therapy treatment delivery codes, the letter also urges UHC to take meaningful steps in reducing burden by ensuring the prior authorization tool only asks questions necessary to determine if the authorization request is appropriate. 

Palmetto Issues Reminder on MUE Denials for Drugs

Medically Unlikely Edit (MUE) denials for drugs may be due the inaccurately billing the appropriate number of units. It is likely the MUE limits for drugs are based on the manufacturer’s package insert for the recommended dose.  If receiving drug MUE denials, it is recommended to:

  • Verify charges are being entered correctly
  • Ensure the unit conversion factors are correct for the drug description
  • Determine if there is a medically necessary reason to exceed the recommended dosage
  • Ensure the correct modifiers are being used
    • JW- required for claims with unused drugs or biologicals
  • Contact your Medicare Administrative Contractor (MAC) if you believe an MUE is unreasonable

Even if all appropriate steps are followed, it is possible to still see MUE denials for drugs. If a drug is denied, it is recommended to file an appeal with documentation to include physician orders, the dosage and amount of the drug given, amount of drug waste, and any other pertinent information to support the charges.  Visit Palmetto’s guidance, which also includes billing with JW modifier examples, for further information.

Rapid Device Coverage Rule Sees Further Delay

The Medicare Coverage of Innovative Technology (MCIT) regulatory rule, originally set to go into effect March 15, 2021, that would speed up Medicare coverage of devices approved via the Food and Drug Administration’s (FDA) “breakthrough” pathway was originally delayed until May 15, is now delayed until December 15, 2021.  Traditionally, it would take a year or more to get Medicare coverage for new devices after FDA approval or clearance. The delayed rule would allow devices approved under the FDA breakthrough pathway to simultaneously be granted national Medicare coverage for four years.  The initial delay in the rule implementation opened a 30-day public comment period which resulted in numerous comments in response to the delay. CMS has outlined the following issues with the MCIT Final Rule in support of further delaying the effective date:

  • It does not require evidence that MCIT devices benefit the Medicare beneficiary population;
  • The final rule removes the ability for CMS to deny coverage when it becomes apparent that a device can be harmful to the Medicare population;
  • It only provides coverage of MCIT devices and does not provide a clear path for appropriate coding and payment;
  • It did not account for costs associated with reasonable and necessary services and supplies for use of the breakthrough device;
  • Commenters expressed concerns about codifying the definition of “reasonable and necessary”

It is unclear the future of this regulatory rule, but CMS did state they are considering the appropriate next steps while maintaining the best interest of all Medicare stakeholders.

Affiliated Providers Potentially Affected by CAAP Offsets

As the repayment period for the COVID-19 Accelerated/Advanced Payment (CAAP) has begun, providers affiliated with entities that received CAAP payments could be affected by refund offsets.  CMS has the authority to adjust payments to affiliated providers based on their Tax Identification Number (TIN) regardless of their billing number, NPI number, internal organizational structure of physical location. For additional information, visit the Accelerated and Advance Payment Repayment and Recovery FAQs or discuss how refund offsets may affect your Medicare remits with your organization’s designated point of contact for CAAP request(s).

Modifier Lookup Tool

Incorrect modifier utilization continually serves as one of the top claim submission errors for providers. Novitas has developed a modifier lookup tool to assist providers in navigating the modifier selection process. The Part B resource outlines the definitions, indicators, payer information and more for all Medicare-accepted modifiers to assist the provider in determining the most appropriate modifier(s) to apply based on circumstance and medical documentation.

CERT Denials Receive Insufficient Responses

In response to Comprehensive Error Rate Testing (CERT) contractors continually receiving insufficient responses for medical record requests, WPS has issued information regarding the topic to assist providers to avoid common issues.  CERT contractors receive responses for medical record requests that direct them to contact the location a service was rendered.  When this happens, CERT will issue an error finding and instruct the Medicare Administrative Contractor (MAC) to recoup the Medicare payment. Even when the service is performed at a location other than the physician’s office, it is the responsibility of the billing provider to submit signed and dated medical record documentation when requested by CERT contractors.  It is recommended providers review all documentation prior to submittal to CERT for necessary provider signatures, orders, and any additional documentation to support the medical necessity of the service(s) billed. Additionally, providers can obtain the status of their CERT reviews by using the CERT Claim Look-up Tool.

USPSTF Lowers Age for Colon Cancer Screening; Endorses CT Colonography

The U.S. Preventative Services Task Force (USPSTF) recently released updated guidelines which lower the recommended age for colon cancer screening from 50 to 45, per a recent statement published in the Journal of the American Medical Association (JAMA).

The new guidelines, released May 18, recommend that adults aged 45 to 75 be screened for the disease, while those aged 76 – 85 should be screening based on their individual risk. The USPSTF recommends either a standard colonoscopy or other method, such as CT colonography, to be used.

“Far too many people in the U.S. are not receiving this lifesaving preventive service,” said Dr. Michael Barry, Task Force vice chair.

To read the full statement, please click here.

LCD & LCA Updates

A variety of relevant Local Coverage Determinations (LCDs) and Articles (LCAs) have been updated across various Medicare Administrative Contractors (MACs). Please see below for the most up to date versions.

Novitas Solutions

  • Biomarkers for Oncology LCA (A52986)
  • Hydration Therapy LCD (A34960)
  • Approved Drugs and Biologicals; Includes Cancer Chemotherapeutic Agents (A53049)


  • Complex Drug Administration Coding LCA (A58620)
  • Bevacizumab and biosimilars LCA (A52370)
  • Bortezomib LCA (A52371)
  • Filgrastim, Pegfilgrastim, Tbo-filgrastim and biosimilars LCA (A52408)
  • Infliximab and biosimilars (A52423)
  • Intravenous Immune Globulin (IVIG) LCA (A52446)
  • Paclitaxel (e.g., Taxol®/Abraxane™) LCA (A52450)
  • Rituximab, biosimilars and Rituximab and hyaluronidase human (Rituxan Hycela™) LCA (A52452)