13-770 Code Vt. R. 13-170-770-X - PHARMACY ADMINISTRATION (7700)

Section 7701 Pharmaceutical Manufacturer Fee

Act 80, of the 2007 legislative session, an Act relating to increasing transparency of prescription drug pricing and information, established a manufacturer fee under 33 V.S.A. § 2004. A fee shall be collected annually by the Agency of Human Services from each pharmaceutical manufacturer or labeler of prescription drugs that are paid for by the Office of Vermont Health Access for individuals participating in Medicaid, the Vermont Health Access Plan (VHAP), Dr. Dynasaur, VPharm, VHAP-Pharmacy, VScript, or VScript Expanded. The fee shall be 0.5 percent of the previous calendar year's prescription drug spending by the office and shall be assessed based on manufacturer labeler codes as used in the Medicaid rebate program. The fee shall be deposited in the evidence-based education and advertising fund established by 33 V.S.A. § 2004a. This fee shall fund activities, including the evidence-based education program, established by 18 V.S.A. § 4622.

The evidence-based education program will provide information and education on the therapeutic and cost-effective use of prescription drugs, as well as the collection and analysis of information on pharmaceutical marketing activities under sections 4632 and 4633 of Title 18, and analysis of drug data needed by the attorney general's office for enforcement activities concerning prescription drugs.

The OVHA shall annually provide the manufacturer or labeler with a written bill in the amount of 0.5 percent of the payments made on claims submitted during the previous calendar year regarding the manufacturer's or labeler's prescription drugs. This amount will be based on paid claims data (data used to reimburse pharmacies) under the state's programs. The manufacturer or labeler shall remit the invoiced amount according to instructions provided by OVHA.

In the event the manufacturer or labeler believes an error in billing has occurred, the manufacturer or labeler must notify the OVHA in writing within thirty days of the receipt of the bill. This notification must be accompanied by written materials setting forth the basis for the requested review. The billing data will be verified and adjusted if appropriate, which may include a credit as to the amount of the bill, or a refund of amounts paid.

The OVHA shall maintain electronic claims records for five quarters after the end of a billing calendar year that will permit the manufacturer labeler to verify through an audit process the billing invoices provided by the OVHA.

Section 7702 Telemonitoring

(10/29/2014, 14-05P)

Home telemonitoring is a health service that requires scheduled remote monitoring of data related to an individual's health, and transmission of the data from the individual's home to a licensed home health agency. Scheduled periodic reporting of the individual's data to the licensed physician is required, even when there have been no readings outside the parameters established in the physician's orders. Telemonitoring providers must be available 24 hours per day, 7 days a week.

7702.1 Eligibility and Conditions for Coverage (10/29/2014, 14-05P)

Home telemonitoring services will be a benefit for individuals with primary Vermont Medicaid or non-homebound individuals with dual Medicare and Medicaid who are served by Vermont Home Health Agencies in accordance with clinical coverage guidelines, as updated annually and described in the Provider Manual.

7702.2 Qualified Providers (10/29/2014, 14-05P)

Qualified providers are home health agencies enrolled with Vermont Medicaid.

Qualified providers must follow data parameters established by a licensed physician's plan of care.

Qualified providers must use the following licensed health care professionals to review data: registered nurse (RN), nurse practitioner (NP), clinical nurse specialist (CNS), licensed practical nurse (LPN) under the supervision of a RN, or physician assistant (P A). In the event of a measurement outside of the established individual's parameters, the provider shall use the health care professionals noted above to be responsible for reporting the data to a physician.

The data transmission must comply with standards set by the Health Insurance Portability and Accountability Act (HIPAA).

7702.3 Reimbursement (10/29/2014, 14-05P)

Reimbursement for telemonitoring services is described in the Provider Manual and updated annually.


13-770 Code Vt. R. 13-170-770-X
EFFECTIVE DATE: November 1, 2008 Secretary of State Rule Log #08-043 [7701]
AMENDED: October 29, 2014 Secretary of State Rule Log #14-036 [7702]

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