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Washington Healthcare Update - February 2021 #1 | McGuireWoods Consulting

No Time to Lose: Solutions to Increase COVID-19 Vaccinations in the States
The House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations will hold a hearing on COVID-19 vaccine distribution and administration.
Find more details here.
Wednesday, February 3
Road to Recovery – Ramping Up COVID-19 Vaccines, Testing, and Medical Supply Chain
The House Committee on Energy and Commerce, Subcommittee on Health will hold a hearing on the federal government’s handling of COVID-19 vaccine development, testing and the medical supply chain.
Find more details here.
Congress
Rep. Underwood Reintroduces Bill Enhancing ACA Credits
On Jan. 19, Rep. Lauren Underwood (D-IL) reintroduced legislation to expand and enhance the Affordable Care Act’s (ACA) tax credits, also included in President Biden’s health reform agenda. The Health Care Affordability Act of 2021 would increase the generosity of the existing tax credits for consumer ....

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Washington Healthcare Update - January 2021 #3 | McGuireWoods Consulting

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This week in Washington: President Joe Biden begins his term and Congress begins work to confirm cabinet secretaries.
Congress
Administration
HHS Delays Trump Administration Final Rule on Health Clinics’ 340B Drug Discounts
CMS Releases an Informational Bulletin on the Extension of Grace Period Related to the Four Walls Requirement for IHS/Tribal Facilities
CMS: Part D Senior Savings Model – CY 2022 Pharmaceutical Manufacturer RFA Released
CMS: Applications for MIPS Exceptions Due to COVID-19 Now Due Feb. 1
Proposed Rules
Final Rules/Guidance
HHS: Final Rule Sets Term Limits for Agency Policy Directors ....

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Washington Healthcare Update - December 2020 #3 | McGuireWoods Consulting

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This week in Washington: Washington waited for a COVID-19 stimulus and omnibus appropriations bill ahead of the holiday recess, and a deal was struck Sunday night; Attached to the COVID-19 relief provisions and omnibus appropriations bill are a number of health provisions.
House/Senate
Administration
CMS: New Model Option for Medicaid Managed Care Organizations Serving Beneficiaries Dually Eligible for Medicare and Medicaid
CMS: Applications for MIPS Exceptions Due to COVID-19 Now Due Feb. 1
CMS Office of the Actuary Releases 2019 National Health Expenditures
CMS: FY 2021 ICD-10-CM Diagnosis Codes ....

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FDA Issues New Guidance on Drug Naming | Mintz - Trademark & Copyright Viewpoints

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Last week, the Food and Drug Administration (“FDA”) issued a pair of Guidance for Industry documents outlining best practices for developing proprietary names (i.e. brand names) for prescription and nonprescription human drug products. The documents provide the agency’s current framework and recommendations for the notoriously unpredictable approval process for drug brand names that do not contribute to medication errors, particularly those attributable to nomenclature issues.
Prescription human drugs: “Best Practices in Developing Proprietary Names for Human Prescription Drug Products” updates the FDA’s prior guidance on this topic. The document provides an overview of the FDA’s objective and review process concerning proprietary names for human prescription drug or biologic products, along with recommendations for the sponsor’s name development process. The guidance sets forth objective criteria ....

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FDA Issues New Guidance on Drug Naming

FDA Issues New Guidance on Drug Naming
Thursday, December 17, 2020
Last week, the Food and Drug Administration (“FDA”) issued a pair of Guidance for Industry documents outlining best practices for developing proprietary names (i.e. brand names) for prescription and nonprescription human drug products. The documents provide the agency’s current framework and recommendations for the notoriously unpredictable approval process for drug brand names that do not contribute to medication errors, particularly those attributable to nomenclature issues.
Prescription human drugs: “Best Practices in Developing Proprietary Names for Human Prescription Drug Products” updates the FDA’s prior guidance on this topic. The document provides an overview of the FDA’s objective and review process concerning proprietary names for human prescription drug or biologic products, along with recommendations for the sponsor’s name development process. The guidan ....

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