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Department of Health and Human Services, 10-144, Chapter 275 – Reporting Requirements for Pharmaceutical Manufacturers and Labelers, and Office of the Attorney General, 26-239, Chapter 111 – Reporting Requirements for Pharmaceutical Manufacturers and Labelers. |
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Concise Summary: This rulemaking clarifies Maine requirements for clinical trial registration and results reporting, compatible with Federal reporting requirements and with the capabilities of the publicly funded website www.ClinicalTrials.gov. It requires posting of past reports on the publicly funded website. The rule modifies the scope of the trials required to be registered and reported, and it clarifies the requirements of reporting post hoc analysis trial results and of updating trial results. It also extends the time anticipated for posting of submissions of results to the publicly funded website. This rulemaking provide contact information and clarifies the application of penalty for violations. The Department proposes other minor technical, grammatical and structural changes within this rulemaking. This rule change is not anticipated to have any adverse impact on small business. Seehttp://www.maine.gov/dhhs/oms/rules/provider_rules_policies.html for rules and related rulemaking documents.
Deadline for Comments: Comments must be received by midnight July 13, 2009 | ||
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Chapter 104, Section 4, Maine Part D Wrap Benefits |
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CONCISE SUMMARY: The Department of Heath and Human Services gives notice of a final rule Maine State Services Manual, Chapter 104, Section 4, Maine Part D Wrap Benefits. In order to comply with the federal guidelines that determine the Part D Benefit parameters, the member co-payment for generic drugs has increased from $2.25 to $2.40 per prescription. This rule is required to comply with federal guidelines. The Part D Wrap Benefit covers this co-payment for eligible beneficiaries. The new co-pay amount is reflected in the Appendix to this rule. EFFECTIVE DATE: March 29, 2009 |
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