Medicare Part B Drugs Regulations

Regulations related to Medicare Part B Drugs are referenced below.  Select CTRL + F and enter the page numbers to find the specific section in the regulation. 

• CMS-1770-P:  Medicare and Medicaid Programs; CY 2023 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Medicare and Medicaid Provider Enrollment Policies, Including for Skilled Nursing Facilities; Conditions of Payment for Suppliers of Durable Medicaid Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); and Implementing Requirements for Manufacturers of Certain Single-Dose Container or Single-Use Package Drugs To Provide Refunds With Respect to Discarded Amounts.  Proposed rule published Friday, July 29, 2022.

• CY 2022 Final Rule (CMS-1751-F):  Medicare Program; CY 2022 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Provider Enrollment Regulation Updates; and Provider and Supplier Prepayment and Post-Payment Medical Review Requirements.  Final rule published November 19, 2021.

• CMS-1751-P:  Medicare Program; CY 2022 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Provider Enrollment Regulation Updates; Provider and Supplier Prepayment and Post-Payment Medical Review Requirements.  Proposed rule published Friday, July 23, 2021.

• CY 2021 Final Rule (CMS-1734-F):  Medicare Program; CY 2021 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Medicaid Promoting Interoperability Program Requirements for Eligible Professionals; Quality Payment Program; Coverage of Opioid Use Disorder Services Furnished by Opioid Treatment Programs; Medicare Enrollment of Opioid Treatment Programs; Electronic Prescribing for Controlled Substances for a Covered Part D Drug; Payment for Office/Outpatient Evaluation and Management Services; Hospital IQR Program; Establish New Code Categories; Medicare Diabetes Prevention Program (MDPP) Expanded Model Emergency Policy; Coding and Payment for Virtual Check-in Services Interim Final Rule Policy; Coding and Payment for Personal Protective Equipment (PPE) Interim Final Rule Policy; Regulatory Revisions in Response to the Public Health Emergency (PHE) for COVID–19; and Finalization of Certain Provisions from the March 31st, May 8th and September 2nd Interim Final Rules in Response to the PHE for COVID–19.  Final rule published December 28, 2020.

• CMS-1734-P:  Medicare Program; CY 2021 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Medicaid Promoting Interoperability Program Requirements for Eligible Professionals; Quality Payment Program; Coverage of Opioid Use Disorder Services Furnished by Opioid Treatment Programs; Medicare Enrollment of Opioid Treatment Programs; Electronic Prescribing for Controlled Substances for a Covered Part D Drug Under a Prescription Drug Plan or an MA–PD Plan; Payment for Office/Outpatient Evaluation and Management Services; Hospital IQR Program; Establish New Code Categories; and Medicare Diabetes Prevention Program (MDPP) Expanded Model Emergency Policy. Proposed rule published Monday, August 17, 2020.

• CY 2019 Final Rule (CMS-1693-F): Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2019; Medicare Shared Savings Program Requirements; Quality Payment Program; Medicaid Promoting Interoperability Program; Quality Payment Program—Extreme and Uncontrollable Circumstance Policy for the 2019 MIPS Payment Year; Provisions from the Medicare Shared Savings Program—Accountable Care Organizations—Pathways to Success; and Expanding the Use of Telehealth Services for the Treatment of Opioid Use Disorder Under the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act. Final rule published November 23, 2018. [Please see pages 83 FR 59661—59666 for the preamble that addresses application of an add-on percentage for certain wholesale acquisition cost (WAC)-based payments; also see pages 83 FR 60031—60032 for the regulatory impact analysis.] CMS 1693-F -Text Version

• CY 2018 Final Rule (CMS–1676–F): Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2018; Medicare Shared Savings Program Requirements; and Medicare Diabetes Prevention Program. Final rule published November 15, 2017. [Please see pages 82 FR 53180—53181 for the preamble that addresses payment for infusion drugs furnished through an item of durable medical equipment (DME) and 82 FR 53182—53187 for the preamble that addresses payment for biosimilar biological products; also see pages 82 FR 53347—53349 for the regulatory impact analysis of these topics.] CMS 1676-F -Text version

• CY 2016 Final Rule (CMS-1631-FC): Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2016. Final Rule published November 16, 2015. [Please see pages 80 FR 71096—71101 for the preamble that addresses payment for biosimilar biological products; also see page 80 FR 71362 for the regulatory impact analysis.]

• CY 2013 Final Rule (CMS-1590-FC): Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule, DME Face-to-Face Encounters, Elimination of the Requirement for Termination of Non-Random Prepayment Complex Medical Review and Other Revisions to Part B for CY 2013. Final rule published November 16, 2012.  [Please see pages 77 FR 69140—69147 for the preamble that addresses ASP issues; also see page 77 FR 69352 for the regulatory impact analysis.] CMS-1590-FC - Text version

• CY 2012 Final Rule (CMS–1524–FC and CMS–1436–F): Medicare Program; Payment Policies Under the Physician Fee Schedule, Five-Year Review of Work Relative Value Units, Clinical Laboratory Fee Schedule: Signature on Requisition, and Other Revisions to Part B for CY 2012. Final rule published November 28, 2011.  [Please see pages 76 FR 73287—73298 for the portion of the preamble that addresses ASP issues; also see page 76 FR 73462 for the regulatory impact analysis.] CMS-1524-FC and CMS-1436-FC - Text version

• CMS–1524–P:  Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2012.  Proposed rule published Tuesday, July 19, 2011.  [Please see pages 76 FR 42828-42833 for the portion of the preamble that addresses ASP issues.] CMS-1524-P - Text version

• CY 2011 Final Rule (CMS 1503-FC):  Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2011.  Final rule published November 29, 2010.  [Please see pages 75 FR 73393—73394 for the preamble that addresses payment for biosimilar biological products and 75 FR 73461—73471 for the preamble that addresses other ASP issues; also see page 75 FR 73603—73604 for the regulatory impact analysis of these topics.] CMS-1503-FC - Text version

• CMS–1503–P:  Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2011.  Proposed rule published Tuesday, July 13, 2010.  [Please see page 75 FR 40122 for the portion of the preamble that addresses biosimilar biological products and pages 75 FR 40153-40158 for the portion of the preamble that addresses other ASP issues.] CMS-1503-P - Text version

• CY 2010 Final Rule (CMS–1413–FC): Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2010.  Final rule with comment period published November 25, 2009.  [Please see pages 74 FR 61904—61905 for the portion of the preamble that addresses ASP issues.] CMS-1413-FC - Text version

• CMS–1413–P: Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2010.  Proposed rule published Monday, July 13, 2009.  [Please see page 74 FR 33623 for the portion of the preamble that addresses ASP issues.] CMS-1413-P - Text version

• CY 2009 Final Rule (CMS–1403–FC): Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2009; E-Prescribing Exemption for Computer-Generated Facsimile Transmissions; and Payment for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS).  Final rule with comment period published November 19, 2008.  [Please see pages 73 FR 69751—69753 for the portion of the preamble that addresses ASP issues.] CMS-1403-FC - Text version

• CMS–1403–P: Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2009; and Revisions to the Amendment of the E-Prescribing Exemption for Computer Generated Facsimile Transmissions.  Proposed rule published Monday, July 7, 2008.  [Please see pages 73 FR 38520—38522 for the portion of the preamble that addresses ASP issues.] CMS-1403-P - Text version

• CY 2008 Final Rule (CMS-1385-FC): Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule, and Other Part B Payment Policies for CY 2008; Revisions to the Payment Policies of Ambulance Services Under the Ambulance Fee Schedule for CY 2008; and the Amendment of the E-Prescribing Exemption for Computer Generated Facsimile Transmissions. Final rule with comment period published November 27, 2007. [Please see pages 72 FR 66256—66260 for the portion of the preamble that addresses ASP issues.] CMS-1385-FC - Text version

• CMS–1385–P: Medicare Program; Proposed Revisions to Payment Policies Under the Physician Fee Schedule, and Other Part B Payment Policies for CY 2008; Proposed Revisions to the Payment Policies of Ambulance Services Under the Ambulance Fee Schedule for CY 2008; and the Proposed Elimination of the E-Prescribing Exemption for Computer-Generated Facsimile Transmissions.  Proposed rule published Thursday, July 12, 2007.  [Please see pages 71 FR 38149—38153 for the portion of the preamble that addresses ASP issues.] CMS-1385-P - Text version

• CY 2007 Final Rule (CMS-1321-FC and CMS-1317-F): Medicare Program; Revisions to Payment Policies, Five-Year Review of Work Relative Value Units, Changes to the Practice Expense Methodology Under the Physician Fee Schedule, and Other Changes to Payment Under Part B; Revisions to the Payment Policies of Ambulance Services Under the Fee Schedule for Ambulance Services; and Ambulance Inflation Factor Update for CY 2007. Final rule with comment period published December 1, 2006. [Please see pages 71 FR 69665—69681 for the portion of the preamble that addresses ASP issues.] CMS-1321-FC and CMS-1317-F - Text Version

• CMS–1321–P: Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2007 and Other Changes to Payment Under Part B.  Proposed rule published Tuesday, August 22, 2006.  [Please see pages 71 FR 48999- 49004 for the portion of the preamble that addresses ASP issues.] CMS–1321–P - Text version

• CY 2006 Final Rule (CMS–1502–FC and 1325-F):  Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2006 and Certain Provisions Related to the Competitive Acquisition Program of Outpatient Drugs and Biologicals Under Part B.  Final rule with comment published November 21, 2005.  [Please see pages 70 FR 70215—70236 for the portion of the preamble that addresses payment for covered outpatient drugs and biologicals.] CMS–1502–FC and 1325-F - Text version

• CMS–1502–P: Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2006.  Proposed rule published Monday, August 8, 2005.  [Please see pages 70 FR 45842-45849 for the portion of the preamble that addresses payment for covered outpatient drugs and biologicals.] CMS–1502–P - Text version

• CMS–10110:  Agency Information Collection Activities: Proposed Collection; Comment Request published Friday, August 19, 2005.  [70 FR 48770-48771]  CMS–10110 - Text version

• CY 2005 Final Rule (CMS–1429–FC): Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2005.  Final rule published Monday, November 15, 2004.  [Please see pages 69 FR 66299—66314 for the portion of the preamble that addresses payment for covered outpatient drugs and biologicals.] CMS-1429-FC - Text version

• CMS–1380-F (PDF): Medicare Program; Manufacturer Submission of Manufacturer's Average Sales Price (ASP) Data for Medicare Part B Drugs and Biologicals.  Final rule published Thursday, September 16, 2004.  [69 FR 55763—55765] CMS-1380-F - Text version

• CMS-1429-P: Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2005.  Proposed rule published Thursday, August 5, 2004.  [Please see pages 69 FR 47520- 47524 for the portion of the preamble that addresses payment for covered outpatient drugs and biologicals.] CMS-1429-P - Text version

• CMS 1380-IFC: Medicare Program; Manufacturer Submission of Manufacturer's Average Sales Price (ASP) Data for Medicare Part B Drugs and Biologicals.  Interim final rule with comment period published Tuesday, April 6, 2004. [69 FR 17935—17941] CMS-1380-IFC - Text version

• CMS-1372-CN: Medicare Program; Changes to the Medicare Payment for Drugs for Calendar Year 2004; Correction Published March 26, 2004. [69 FR 15703—15729] CMS-1372-CN - Text version

• CMS-1372-IFC:  Medicare Program; Changes to Medicare Payment for Drugs and Physician Fee Schedule Payments for Calendar Year 2004 Published January 7, 2004. [Please see pages 69 FR 1085—1091 for the portion of the preamble that addresses payment for Part B drugs during calendar year 2004.] CMS-1372-IFC - Text version