The Centers for Medicare & Medicaid Services (CMS) finalized new rules which require physicians and, when applicable, other eligible professionals who write prescriptions for Part D drugs to be enrolled in an approved status or to have a valid opt-out affidavit on file for their prescriptions to covered under Medicare Part D.
According to CMS, prescribers of Part D drugs must submit their Medicare enrollment applications or opt-out affidavits to their Medicare administrative contractors (MAC) by June 1, 2015, to ensure that MACs have sufficient time to process the applications or affidavits.
Medicare patients’ prescription drug claims will be denied by their Part D plans, beginning December 1, 2015, if the prescriber does not have a valid enrollment or opt-out status with Medicare.
Provider Action Needed
The Centers for Medicare & Medicaid Services (CMS) finalized CMS-4159-F “Medicare
Program; Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and
the Medicare Prescription Drug Benefit Programs” on May 23, 2014. This rule requires
physicians and, when applicable, other eligible professionals who write prescriptions for
Part D drugs to be enrolled in an approved status or to have a valid opt-out affidavit on file
for their prescriptions to be covered under Part D. The final regulation stated that the effective date for this requirement would be June 1, 2015. However, CMS is announcing that it will delay enforcement of the requirements in 42 CFR 423.120(c)(6)until December 1, 2015. Nevertheless, prescribers of Part D drugs must submit their Medicare enrollment applications or opt-out affidavits to their Part B Medicare Administrative Contractors (MACs) by June 1, 2015, or earlier, to ensure that MACs have sufficient time to process the applications or opt out affidavits and avoid their patients’ prescription drug claims from being denied by their Part D plans, beginning December 1, 2015. Note that enrollment functions for physicians and other prescribers are handled by Part B MACs.
If you write prescriptions for covered Part D drugs and you are not enrolled in Medicare in
an approved status or have a valid record of opting out, you need to submit an enrollment
application or an opt out affidavit to your Medicare Administrative Contractor (MAC) by
June 1, 2015, or earlier. You may submit your enrollment application electronically using the Internet
-based Provider Enrollment, Chain, and Ownership System (PECOS) located at https://pecos.cms.hhs.gov/pecos/login.do or by completing the paper CMS-855I or CMS-855O application, which is available at http://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/CMS-
Forms-List.html on the CMS website. Note that an application fee is not required as part of your application submission. If you wish to enroll to be reimbursed for the covered services furnished to Medicare beneficiaries, you must complete the CMS-855I application. The CMS-855O, which is a
shorter, abbreviated form, should only be completed if you are seeking to enroll solely to order and refer and/or prescribe Part D drugs. (While the CMS-855O form states it is for physicians and non-
physician practitioners who want to order and refer, it is appropriate for use by prescribers, who also want to enroll to prescribe Part D drugs.) If you do not see your specialty listed on either of the applications, select the Undefined Physician/Non-Physician Type option and identify your specialty in the space provided.
If you are a physician or eligible professional who wants to opt out of Medicare, you must submit an opt-out affidavit to the MAC within your specific jurisdiction. Your opt-out information must be current (an affidavit must be completed every 2 years, and a National Provider Identifier (NPI)
is required to be submitted on the affidavit). For more information on the opt-out process, refer to
MLN Matters® article SE1311, titled “Opting out of Medicare and/or Electing to Order and Refer Services,” which is available at http://www.cms.gov/Outreach-and-Education/Medicare-Learning-
Network-MLN/MLNMattersArticles/downloads/SE1311.pdf on the CMS website.
In an effort to prepare the prescribers and Part D sponsors for the December 1, 2015 enforcement date, CMS is making available an enrollment file that identifies physician and eligible professional who are enrolled in Medicare in an approved or opt out status. The first iteration of the enrollment file is now available at https://data.cms.gov/dataset/Medicare-Individual-Provider-List/u8u9-2upx on the CMS website. The file contains production data but is considered a test file since the Part D prescriber enrollment requirement is not yet applicable. An updated enrollment file will be generated every two weeks and continue through the December 1, 2015 enforcement date. The file displays physician and eligible professional eligibility as of and after November 1, 2014,(i.e., currently enrolled, new approvals, or changes from opt-out to enrolled as of November 1, 2014). Any periods, prior to November 1, 2014, for which a physician or eligible professional was not enrolled in an approved or opt-out status will not be displayed on the enrollment file. However, any periods after November 1, 2014, for which a physician or eligible professional was not enrolled in an approved or opt-out status will be on the file with its respective end dates for that given provider. For opted out providers, the opt out flag will display a Y/N (Yes/No) value to indicate the periods the provider was opted out of Medicare. The file will include the provider’s:
• (NPI);
• First and Last Names;
• Effective and End Dates; and
• Opt Out Flag
After the enforcement date of December 1, 2015, the applicable effective dates on the file
will be adjusted to December 1, 2015, and it will no longer be considered a test file. All
inactive periods prior to December 1, 2015, will be removed from the file and it will only
contain active and inactive enrollment or opt out periods as of December 1, 2015, and after.
The file will continue to be generated every two weeks, with a purposeful goal toward more
frequent updates on a set schedule. Part D sponsors may utilize the file to determine a
prescriber’s Medicare enrollment or opt out status when processing Part D pharmacy claims.
The file will not validate the provider’s ability to prescribe under applicable laws.
