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Board of Medical Assistance Services

General Notice
Public Notice - Intent to Amend State Plan - Clinical Trials
Date Posted: 12/9/2021
Expiration Date: 4/30/2022
Submitted to Registrar for publication: YES
No comment forum defined for this notice.

LEGAL NOTICE

COMMONWEALTH OF VIRGINIA

DEPARTMENT OF MEDICAL ASSISTANCE SERVICES

NOTICE OF INTENT TO AMEND

(Pursuant to §1902(a)(13) of the Act (U.S.C. 1396a(a)(13))

THE VIRGINIA STATE PLAN FOR MEDICAL ASSISTANCE 

This Notice was posted on December 9, 2021 

The Virginia Department of Medical Assistance Services (DMAS) hereby affords the public notice of its intention to amend the Virginia State Plan for Medical Assistance to provide for changes to the Methods and Standards for Establishing Payment Rates — Other Types of Care (12 VAC 30-80).  

This notice is intended to satisfy the requirements of 42 C.F.R. § 447.205 and of § 1902(a)(13) of the Social Security Act, 42 U.S.C. § 1396a(a)(13).  A copy of this notice is available for public review from Emily McClellan, DMAS, 600 Broad Street, Suite 1300, Richmond, VA  23219, or via e-mail at: Emily.McClellan@dmas.virginia.gov 

This notice is available for public review on the Regulatory Town Hall on the General Notices page, found at:  https://townhall.virginia.gov/L/generalnotice.cfm

Methods & Standards for Establishing Payment Rates-Other Types of Care (12 VAC 30-80)  

The state plan is being revised to include reimbursement for coverage for routine patient costs furnished in connection with a member’s participation in a qualifying clinical trial in accordance with the Centers for Medicare and Medicaid Services (CMS) State Medicaid Director (SMD) letter #21-005.  Per the SMD letter, DMAS will cover any item or service provided to the individual under the qualifying clinical trial, including any item or service provided to prevent, diagnose, monitor, or treat complications resulting from participation in the qualifying clinical trial, to the extent that the provision of such items or services to the beneficiary would otherwise be covered outside the course of participation in the qualifying clinical trial under the state plan or waiver, including a demonstration project under section 1115 of the Social Security Act. Such routine services and costs also include any item or service required to administer the investigational item or service.

Costs for these changes are indeterminate at this time. However, DMAS does not anticipate a change in total annual expenditures.

 


Contact Information
Name / Title: Emily McClellan  / Regulatory Manager
Address: Division of Policy and Research
600 E. Broad St., Suite 1300
Richmond, 23219
Email Address: Emily.McClellan@dmas.virginia.gov
Telephone: (804)371-4300    FAX: (804)786-1680    TDD: (800)343-0634