Regulation Training_SOW_12.22.2023_Final.pdf

December 22, 2023

Statement of Work

1. PURPOSE:

The purpose of this Statement of Work (SOW) is to have a contractor assist CMS with educating Medicare Drug Rebate and Negotiations Group (MDRNG) personnel on regulation drafting, processing, and analysis. This time sensitive need emerged when the Office of General Counsel (OGC) advised CMS to codify the inflation rebate program through rulemaking in calendar year 2024. The training shall provide tools and techniques for multiple divisions within MDRNG to learn the process for drafting federal regulations, including preamble, regulation text, and impact analyses, as well as reviewing and responding to public comments. The training shall also provide information on the form and style of writing federal documents. The course the contractor shall provide is Regulatory Drafting & Processing which shall be held virtually from January 22 through January 23, 2024.

Class: Regulatory Drafting & Processing

Length: 2 days

Dates: January 22 – 23, 2024

Participants: 25

2. BACKGROUND:

MDRNG requires support from the contractor through both educational and experiential opportunities related to the development, processing, and analysis of federal regulatory guidelines and standards. The services being requested are coordination, communication, and processing of regulatory guidance through virtual event services. The courses provided shall teach MDRNG’s current and future staff about the standards, implementation of policy, and coordinated efforts to ensure analysis is thorough and meets the standards of federal regulatory practices.

3. SCOPE:

OGC advised CMS to codify the inflation rebate program through rulemaking in calendar year 2024. CMS is dependent on regulatory development and implementation of federal policy to ensure the functionality of the Inflation Reduction Act (IRA) through both purpose and mission. The working session will be attended by 25 staff from the Division of Policy, Division of Data Assessment and Analytics, and the Division of Manufacturer Data and Inflation Rebate Operations. These individuals will ensure IRA policies are developed, implemented, and revised as needed for the overall effectiveness of the statute and its intentions set forth by Congress. The event, provided virtually, will enable participants to learn and utilize skills in immediate fashion to perform imperative tasks.

4. ROLES & RESPONSIBILITIES:

The contractor shall provide the materials and services in connection with this Agreement as an independent contractor. The contractor and any third parties it contracts with are responsible for taxes on amounts they receive in connection with the contract.

• Handle communication, speakers, virtual meeting tool, registration and activities for the event including:

o Secure and schedule all speakers o Set up the agenda o Establish website access for registration through TRG.

o Send confirmation emails to registrants.

o Provide a list of registrants’ names to CMS for awareness.

o Create and maintain the agenda for the program.

o Provide all tutorials for attendees.

o Provide CMS with slides and recordings after the event.

o Conduct a post event survey and provide results to CMS event lead.

Period of Performance:

January 22, 2024 through January 23, 2024

5. CONTACTS:

Contracting Officers Representative (COR) Kyle Fletcher CMS Contracting Office Representative 667-414-0316

Education event coordinator:

Rebecca Cole Medicare Drug Rebate and Negotiations Group 410-786-1589

6. PRIVACY ACT:

This Agreement has been reviewed for Privacy Act implications. All parties agree to maintain compliance with the provisions of the Privacy Act of 1974 and applicable systems security requirements.

INFORMATION SECURITY: The Federal Information Security Act (FISMA) requires all federal agencies to protect the confidentiality, integrity and availability of federal information and information systems from unauthorized access disclosure, duplication, modification, diversion, destruction, loss, misuse or theft- whether accidental or intentional. The security controls to provide the protections shall be risk-based and business-driven with implementation achieved through a defense-in- depth structure. Access to all information shall be limited on a least privilege and a need- to-know basis. Guidance on implementing the requirements of FISMA can be found in:

• The Office of Management and Budget (0MB) Circular No. A-130, revised.

"Management of Federal Information Resources" ; Appendix III, " Security of Federal Information Systems" (http://www.whitehouse.gov/omb/circulars ), CMS Information Security and Privacy Contract Requirements

CMS includes an Information Security clause/provision to safeguard information and information systems that support the operations and assets of the agency, including those provided or managed by contractors (including subcontractors) on behalf of the agency.

Click here for more information: http://www.cms.gov/Research-Statistics-Data-and- Systems/CMS-Information-Technology/InformationSecurity/Information-Security- Library.html

7. SECTION 508 Information and Community TECHNOLOGY Under the revised 508 compliance requirements, when providing hosting services for electronic content provided by the agency, the offeror shall not implement the hosting services in a manner that reduces the existing level of conformance of the electronic content with applicable Revised 508 Standards. Throughout the life of the contract, the agency reserves the right to perform testing on a vendor or contractor's hosted solution to verify conformance with this requirement.

For more information, please click the link below.

https://buyaccessible.gov/index.php http://www.whitehouse.gov/omb/circulars https://www.cms.gov/Research-Statistics-Data-and-Systems/CMS-Information-Technology/InformationSecurity/Information-Security-Library.html https://www.cms.gov/Research-Statistics-Data-and-Systems/CMS-Information-Technology/InformationSecurity/Information-Security-Library.html https://www.cms.gov/Research-Statistics-Data-and-Systems/CMS-Information-Technology/InformationSecurity/Information-Security-Library.html https://buyaccessible.gov/index.php

Statement of Work