CMS Publishes Proposed Changes to Medicare Parts C and D

by King & Spalding

CMS recently published a proposed rule covering a number of policy changes to the Medicare Advantage (Part C or MA) and the Medicare Prescription Drug Benefit (Part D) Programs.  The proposed rule, which generally would affect plans beginning in 2015, is estimated to save $1.3 billion between 2015 and 2019, according to CMS. Comments on the proposed rule must be received no later than 5 p.m. on March 7, 2014. 

Among the major changes, CMS proposes to:

  • Establish U.S. citizenship and lawful presence as eligibility requirements for enrollment in MA and Part D plans;
  • Implement new criteria for covered drug categories or classes of clinical concern;
  • Implement the Affordable Care Act requirement that MA organizations and Part D sponsors report and return identified Medicare overpayments;
  • Restrict prescription drug plan sponsors to offering no more than two Part D plans in the same service area;
  • Require that physicians or non-physician practitioners who write prescriptions for covered Part D drugs be enrolled in Medicare for their prescriptions to be covered under Part D; and
  • Revise the definition of “negotiated prices” such that all price concessions from pharmacies are reported by Part D sponsors in a more uniform manner, which will benefit competition.

Currently, Part D sponsors are required to include on their formularies all or substantially all drugs in the following six classes or categories: antidepressants; antipsychotics; anticonvulsants; immunosuppressants for transplant rejection; antiretrovirals; and antineoplastics.  The Affordable Care Act required that those classes or categories remain in place until the Secretary established new criteria to identify drug categories or classes of clinical concern.  In the proposed rule, CMS noted concerns that this type of open coverage of certain drug categories and classes is (i) financially disadvantageous, limiting the ability of Part D sponsors to negotiate price concessions in exchange for formulary placement of drugs in these categories or classes and (ii) potentially facilitating of overutilization of drugs within the protected categories or classes, both of which can lead to increased Part D costs. 

CMS now proposes generally to limit protected classes or categories to “those for which access to all drugs in a category or class for a typical individual with a disease or condition treated by the drugs in such class is required within 7 days and more specific formulary requirements would not be sufficient to meet the host of specific applications of the drugs within the category or class.”  With guidance from a panel convened by CMS, CMS has proposed to (i) require formulary inclusion of all drugs within the antineoplastic, anticonvulsant, and antiretroviral drug classes (subject to proposed exceptions), (ii) no longer require all drugs from the antidepressant and immunosuppressant drug classes to be on all Part D formularies, and (iii) although they do not meet CMS’s criteria for clinical concern, retain antipsychotics in a protected class through 2015 while CMS continues its evaluation of these drugs to determine, among other things, whether additional transition is needed for individuals taking these medications.

Comments on the proposed rule must be received no later than 5 p.m. on March 7, 2014.  A CMS Fact Sheet on the proposed rule is available here, and a summary of CMS’s proposals in the rule to combat Part D fraud and abuse is available here

Reporter, Christina A. Gonzalez, Houston, +1 713 276 7340,

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© King & Spalding | Attorney Advertising

Written by:

King & Spalding

King & Spalding on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
Privacy Policy (Updated: October 8, 2015):

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.


JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at:

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.