On July 2, 2020, the Centers for Medicare and Medicaid Services (CMS) released guidance documents on the allowance of telehealth encounters for the Eligible Professional and Eligible Clinician electronic clinical quality measures (eCQMs) used in CMS quality reporting programs for the 2020 and 2021 performance periods. The guidance applies to eCQMs used in the:

  • Quality Payment Program: The Merit-based Incentive Payment System (MIPS) and Advanced Alternative Payment Models (Advanced APMs)
  • APM: Comprehensive Primary Care Plus (CPC+)
  • APM: Primary Care First (PCF)
  • Medicaid Promoting Interoperability Program for Eligible Professionals


Continue Reading CMS Releases Guidance on the Allowance of Telehealth Encounters in eCQMs

On May 17, 2020 Connecticut Governor Ned Lamont – in conjunction with the Department of Public Health (DPH) – released a guidance document for resuming non-emergency dental procedures (the “Guidance”). The Guidance notes that while dental practices were never subject to an executive order to close, the governor’s office and DPH had both strongly encouraged the suspension of all elective procedures and routine non-emergency care. Accordingly, as certain businesses in the state begin to reopen starting on May 20th, the Guidance is designed to inform dental practitioners on preparation and policies for expanding services beyond emergency-only care to include elective procedures and routine hygiene and health exams. The document details policies for expanding offered procedures and notes that dental practices that cannot meet the guidelines “are strongly advised to delay expansion of their operations beyond urgent care until they are able to meet these guidelines.”
Continue Reading Connecticut Governor Lamont Releases Guidance for Dentists Expanding Services Beyond Emergency-Only Care

On March 21, 2018, the Food and Drug Administration (FDA) published two guidance documents addressing postmarketing safety reporting requirements (PMSR) for combination products.  The FDA had previously issued a Final Rule on PMSR for combination products on December 20, 2016 (PMSR Final Rule).

By way of background, combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. Because PMSR regulations for medical products in different categories are individualized (for example, PMSR are different for drugs than they are for medical devices and biological products), the two new guidance documents clarify the PMSR requirements that apply when a product is comprised of multiple medical categories. According to the FDA, these documents were issued in an effort to further interpret the Final Rule by ensuring consistent and complete reporting while simultaneously avoiding duplication in reports.
Continue Reading FDA Provides Guidance on Postmarketing Safety Reporting for Combination Products

This week, the U.S. Food & Drug Administration (FDA) published draft guidance, describing FDA’s policy and process for evaluating bulk drug substances used in compounding by outsourcing facilities that are registered under Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). 
Continue Reading FDA’s New Draft Guidance on Bulk Drug Substances in Compounding