Final Standards for Allergen Extract Compounding under USP Chapter 797 The long-awaited new USP Chapter 797 standards on sterile compounding were released June 1 and take effect Dec. 1. Read the final approved USP letter here. Have questions? Attend the AAOA…
- Senate Republicans released an updated version of the CARES Act on Sunday, March 22nd. The amended package is estimated at $1.8 trillion, with the text available here. The funding provisions are included in Division B, which is available here. The updated summary from Senate Republicans is here.
- After two failed procedural votes on Sunday evening and Monday afternoon, negotiations continued through Monday on a bill that could gain the 60 votes needed to pass the procedural hurdle. Majority Leader McConnell said that a vote may not occur until Friday or Saturday.
- On the other side of the Capitol, Speaker Pelosi released a separate version of the phase 3 stimulus package in the House earlier on Monday, the Take Responsibility for Workers and Families Act. The bill provides additional appropriations funding for each of the 12 appropriations bills, including Labor, Health and Human Services appropriations. The bill also includes provisions related to paid sick leave, protecting the health care workforce and related economic provisions. We are providing summaries of a few key health care items below, and we will send a link to the updated bill text when we receive it.
- Coverage of Testing and Treatment: the bill would extend coverage of COVID-19 testing and treatment for Medicaid, Medicare and private health insurance plans. It also provides optional coverage for uninsured individuals under Medicaid.
- Other Health Care Provisions:
- Extends funding for Community Health Centers, the National Health Service Corps, Teaching Centers that Operate GME Programs, the Special Diabetes Program and the Special Diabetes Program for Indians through November 30, 2020. This is a change from the Senate version that provided for a two-year extension.
- Requires Part D plans to allow beneficiaries to obtain up to three-month supply of their Part D prescription drugs during the COVID-19 public health emergency.
- Clarifies coverage requirements for in vitro diagnostic tests in compliance with the Food and Drug Administration’s (FDA) guidance on diagnostic tests for COVID-19 during a public health emergency.
- Includes a Sense of Congress that during the COVID-19 pandemic health care providers should refrain from balance billing consumers for out-of-network claims related to COVID-19 testing or treatment, and insurance companies should do their utmost to secure access to in-network treatment for their plan participants.
- Allows for the National Disaster Medical System to reimburse for the cost of COVID-19 treatment expenses.
- Provides additional support for public health data and surveillance systems, as well as the public health workforce.
- Establishes a loan program to help eligible health care organizations with anticipated revenue loss or higher operating costs as a result of COVID-19.
- Today Senators Chris Murphy (D-CT) and Brian Schatz (D-HI) introduced the “Medical Supply Chain Emergency Act” that would force implementation of the Defense Production Act (DPA) of 1950. The bill would require the President to use authorities under the DPA to require emergency production of medical equipment to address the COVID-19 outbreak. Learn more here. A House companion bill is expected to be introduced in the coming days.
- CMS released COVID-19 checklists and toolkits for state Medicaid and CHIP programs to help speed states’ access to emergency flexibilities and resources. A link to these resources can be found here: https://www.cms.gov/newsroom/press-releases/trump-administration-releases-covid-19-checklists-and-tools-accelerate-relief-state-medicaid-chip.
- On March 22nd, CMS announced it is granting exceptions from reporting requirements and extensions for clinicians participating in Medicare quality reporting programs for upcoming measure reporting and data submission. More details can be found here: https://www.cms.gov/newsroom/press-releases/cms-announces-relief-clinicians-providers-hospitals-and-facilities-participating-quality-reporting.
- Provider Programs:
- ESRD Quality Incentive Program: 2019 Q4 data submission is optional. CMS will not count data from January 1, 2020 through June 30, 2020.
- Quality Payment Program and the Medicare Shared Savings Program: 2019 data submission deadline is extended by a month until April 30, 2020. Providers who don’t report by April 30 will qualify for the automatic extreme and uncontrollable circumstances policy and will receive a neutral payment adjustment for the 2021 MIPS payment year. Options for the 2020 performance year are still being evaluated.
- Hospital Programs:
- ASC Quality Reporting Program: deadlines for October 1, 2019 to December 1, 2019 (Q4) data submission is optional. Data does not need to be submitted for January 1, 2020 to June 30, 2020.
- Provider Programs: