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Breaking 340 News

Circuit Court: CMS Has Authority To Cut 340B Hospitals’ Drug Pay

The U.S. Court of Appeals for the District of Columbia Circuit sided with CMS on Friday (July 31) as two judges said the agency has authority to cut 340B hospitals’ Part B drug reimbursement rates by almost 30%, reversing a federal district court decision that struck the cuts.

Sanofi To Require 340B Data Or Cut Off Contract Pharmacies’ Discounts

Focus On COVID-19

CMS Extends COVID-19 Relief Deadline Again For Medicaid Providers

With relatively few providers receiving distributions under the Medicaid and Children’s Health Insurance Program provider relief pot, CMS is extending the deadline to apply again and is reopening the so-called general distribution to certain Medicare providers.

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Latest News

Nursing Homes, Hospices, Inpatient Psych Facilities Get Pay Raises

CMS on Friday (July 31) finalized fiscal 2021 pay policies for nursing homes, hospices and inpatient psychiatric facilities, all of which can expect to see pay bumps come Oct. 1 albeit slightly less than previously proposed.

Groups Debate Whether House Cannabis Bill Would Hinder FDA Oversight

The House on Friday (July 31) passed 217-197 a fiscal 2021 funding bill containing a cannabis provision that one group argued would effectively prevent FDA from enforcing product safety standards.

FDA Increases Generic Application Fees, Lowers Others, For Fiscal 2021

FDA will increase its generic drug user fee application and drug master file fees in fiscal 2021 while reducing overall generic program and facility fees across the board, the agency announced Friday (July 31).

HHS Commits To Pay Sanofi/GSK $2.1B For Coronavirus Vaccine

The government committed to pay Sanofi and GlaxoSmithKline $2.1 billion to develop and make 100 million doses of coronavirus vaccine, HHS and the Department of Defense announced Friday (July 31), and Sanofi said more than half of the award is for the vaccine’s development. T

CMS Seeks Input On Exceptions To Controlled Substances Electronic Rx

CMS on Thursday (July 30) released a request for information on whether the agency should grant Part D providers exceptions to electronic prescribing requirements for controlled substances and under what circumstances.

FDA Slashes Biosimilar Development Program Fees For Fiscal 2021

FDA plans to reduce fees for its biosimilar product development (BPD) program in fiscal 2021 and to keep overall biosimilar user fee program and application fees at their fiscal 2020 levels, the agency announced Thursday (July 30).

OMB Reviewing FDA’s Proposed Rule To Amend ‘Intended Use’ Definition

The White House budget office is reviewing an FDA proposed rule that clarifies what kind of evidence the agency will consider when determining a product’s intended use.

HHS Report Details Uptick In Medicare Telehealth Usage

HHS this week released a report showing that traditional Medicare saw a dramatic increase in telehealth usage due to the COVID-19 pandemic, particularly in larger urban areas, and, while use has leveled off, the report finds physicians still expect more than 20% of their visits will be via telehealth post-pandemic.

District Judge Blocks Public Charge Rule Throughout COVID-19 Emergency

A federal district judge Wednesday (July 29) blocked the Trump administration from implementing, enforcing or applying the Public Charge Rule nationwide throughout the declared COVID-19 public health emergency, siding with three states and the city of New York.

CMS Ends Flexibility On Document Verification For Special Enrollment

CMS will no longer let consumers enroll in an Affordable Care Act plan through healthcare.gov without document verification, ending flexibility the agency had offered for the past few months, the agency confirms to Inside Health Policy.