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Biosimilars: Safe, Effective, & May Reduce Patient Costs
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Thursday, May 19, 2022



MLN Matters® Articles




Biosimilars: Safe, Effective, & May Reduce Patient Costs

Biosimilars are safe and effective for treating many illnesses, including chronic skin diseases, inflammatory bowel diseases, arthritis, kidney conditions, diabetes, and cancer. Get an FDA Overview of Biosimilar Products. Bookmark FDA’s Biosimilars webpage and materials for health care providers and patients.

Additional FDA resources you may find helpful:


PECOS Scroll Functionality

Starting July 5, PECOS will validate that you’ve read and acknowledged certification terms and conditions before you electronically submit your Medicare enrollment application. You must review and scroll through each text box with certification requirements before you can click accept on the following pages:

  • Submission
  • Home
  • Remote E-sign


Clinical Laboratory Improvement Amendments: Unpaid Certificate Fees

If your laboratory gets a pink slip with a bill for a Clinical Laboratory Improvement Amendments (CLIA) fee, pay it within 2 weeks of the notice date. If you don’t pay it within this time, your CLIA certificate will terminate and you can’t test or get paid for testing. The fastest way to credit your account is to pay at pay.gov.


Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSDB)

See attachment I of the instruction to your Medicare Administrative Contractor to learn about changes to the MPFSDB:

  • New HCPCS and CPT codes
  • New G codes for the 180-day monitoring period for continuous glucose monitoring
  • Codes that are no longer valid

These changes are effective for dates of service on and after January 1, 2022.


Mental Health: Help Address Disparities

Depression affects about 16 million American adults every year. Frequency varies by age, sex, race, ethnicity, and geographic area. During Mental Health Month, learn about preventive services, including depression screening and alcohol misuse screening & counseling, and find out how to advance health equity.

Medicare covers preventive services, and your patients pay nothing if you accept assignment. Learn how to check eligibility (PDF) for preventive services. If you need help, contact your eligibility service provider.

More Information: 



Collaborative Patient Care is a Provider Partnership

Learn about coverage criteria and documentation when you partner with others to care for your patient (PDF):

  • If you don’t provide enough information to support medical necessity when you refer or write orders, the other provider or supplier may not get paid, which can cause delays or no treatment for your patient
  • You must provide documentation and information to other health care providers to support their claims for services or items
  • You can give protected health information, without patient authorization, to other health care providers covered under the privacy rule to carry out treatment, payment, or health care operations


MLN Matters® Articles

Elimination of Certificates of Medical Necessity & Durable Medical Equipment Information Forms

Effective January 1, 2023, CMS is discontinuing certificates of medical necessity (CMNs) and durable medical equipment (DME) information forms (DIFs) (PDF):

  • For services on or after January 1, 2023: Don’t submit CMN or DIF forms or their electronic claim data elements with the claims, or we’ll reject your claims and return them to you
  • For services before January 1, 2023: Submit CMN and DIF forms or their electronic claim data elements with the claims, if required


International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determination (NCDs)–October 2022 Update

Learn about changes effective October 1, 2022 (PDF):

  • New codes
  • National coverage decision coding revisions
  • Coding feedback

There aren't any policy changes in this update.


Revisions to Medicare Part B Coverage of Pneumococcal Vaccinations for the Medicare Benefit Policy Manual Chapter 15, Section

Learn about updated Medicare coverage for pneumococcal vaccinations (PDF) to align with the Advisory Committee on Immunization Practices recommendations, which vary based on patient age and risk factors. Check eligibility (PDF) to see if your patients got their pneumococcal shot. If you need help, contact your eligibility service provider.



Chronic Care Management Services — Revised

Learn about billing and coding changes (PDF):

  • In 2021, CMS added 5 codes to report principal care management services provided by staff under physician supervision
  • Starting in 2022, Rural Health Clinics and Federally Qualified Health Centers can bill chronic care management and transitional care management services for the same patient during the same time
  • Starting in 2022, 99439 replaced G2058


Home Health Quality Reporting Program: Draft OASIS-E Guidance Manual

CMS posted a draft guidance manual (PDF) for version E of the Outcome and Assessment Information Set (OASIS) data set, effective January 1, 2023.

More Information:


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