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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
- FDA Panel Backs Moderna Vaccine
Proposed Rules
- FDA Issues Draft Guide on Proprietary Naming of Non-Rx Drugs
- CMS Proposes New Rules to Address Prior Authorization
Other
Reports
House/Senate
House and Senate Reach Deal on $900B COVID-19 Relief Package and Omnibus Appropriations Bill; Vote Today
On Dec. 21, the House and Senate reached an agreement on a pandemic rescue measure of $900 billion that will be attached to a $1.4 trillion omnibus spending bill for the fiscal year, and includes a variety of health provisions. The bill is set to be voted on today.
The COVID-19 relief measure includes $286 billion for direct economic relief for workers and families. This bill provides an additional $300 to all workers receiving unemployment assistance for eleven weeks. This bill also extends the pandemic unemployment assistance program, with expanded coverage to the self-employed gig workers and others in non-tradition employment. The bill maximizes the Pandemic Emergency Compensation Program with an additional 13 weeks of benefits. The deal includes over $284 billion dollars to first forgiveness PPP loans, dedicated set asides for very small businesses and lending through community lenders. Other provisions for small businesses include expanded PPP eligibility for 501c(6) non-profits. The bill also includes $3.5 billion for continued small business administration relief payments and $2 billion for enhancements to small business administration lending. The bill also includes funding for schools, rental assistance, nutritional programs, childcare and broadband.
Healthcare Provisions: Among the healthcare provisions is the No Surprise Act, which ends surprise medical billing. In addition, important public health programs are extended for three years. Medicaid DSH payments will not face cuts for three years. Provisions for Medicaid reporting requirements concerning state Medicaid payment and financing data are similar to the proposed medicaid fiscal accountability rule. The legislation also included Medicare extenders for three years. In addition, there were changes to orphan drug requirements and a requirement for labels to be accurate after a brand drug has left the market and other changes affecting generic drugs. More information will be posted as available.
Administration
CMS: New Model Option for Medicaid Managed Care Organizations Serving Beneficiaries Dually Eligible for Medicare and Medicaid
On Dec. 17, the Centers for Medicare and Medicaid Services’s (CMS) Center for Medicare & Medicaid Innovation announced a new option to enable Medicaid Managed Care Organizations (MCOs) to better serve enrollees who are dually eligible for Medicare and Medicaid. Currently, Medicaid MCOs do not have an incentive to coordinate care in a way that reduces Medicare FFS costs for dually eligible beneficiaries. By better aligning incentives, the new option for MCOs to participate in the Global and Professional Options of the Direct Contracting Model is meant to encourage Medicaid MCOs to partner with providers and suppliers and implement care coordination programs that can improve quality and reduce Medicare FFS costs.
Find more information here.
CMS: Applications for MIPS Exceptions Due to COVID-19 Now Due Feb. 1
On Dec. 17, the Centers for Medicare and Medicaid Services (CMS) pushed back the deadline for doctors to apply for extreme and uncontrollable circumstances exceptions from the Merit-based Incentive Payment System to Feb. 1. CMS is reminding providers that that process can include a request to leave out one or more performance categories from their score due to the COVID-19 pandemic. However, the hardship application for the interoperability category will still have a Dec. 31 deadline.
Find more information here.
CMS Office of the Actuary Releases 2019 National Health Expenditures
On Dec. 16, the Office of the Actuary at the Centers for Medicare & Medicaid Services (CMS) announced that the total national health care spending in 2019 grew 4.6 percent, which was similar to the 4.7 percent growth in 2018 and the average annual growth of 4.5 percent since 2016’s data. This report includes health expenditure data though 2019 and therefore does not include any of the effects of the coronavirus disease 2019 (COVID-19) pandemic on health care spending. Future reports for 2020 forward will measure health expenditures based on the latest available data and will reflect the impacts of the pandemic on total health care spending as well as on the distribution of spending among the services, payers and sponsors of health care.
Find more information here.
CMS: FY 2021 ICD-10-CM Diagnosis Codes
On Dec. 16, the Centers for Disease Control and Prevention’s (CDC) National Center for Health Statistics (NCHS) is implementing six new diagnosis codes into the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM), effective Jan. 1, 2021. In addition, the Centers for Medicare & Medicaid Services (CMS) is implementing 21 new procedure codes to describe the introduction or infusion of therapeutics, including monoclonal antibodies and vaccines for COVID-19 treatment, into the International Classification of Diseases, Tenth Revision, Procedure Coding System (ICD-10-PCS), also effective Jan. 1, 2021.
Find more information here.
FDA Panel Backs Moderna Vaccine
On Dec. 17, the Food and Drug Administration’s (FDA) vaccine advisory panel voted in favor of authorizing Moderna’s COVID-19 vaccine for emergency use for people 18 and older. The panel voted that the benefits outweigh the risks, but the advisors were mixed on Moderna’s plan to redesign and unblind its trial once an emergency use authorization is issued. Some members of FDA’s vaccine advisory panel said Moderna’s unblinding plan is a reasonable solution for a complicated situation, while others expressed concerns that unblinding participants will affect long-term data collection.
Proposed Rules
FDA Issues Draft Guide on Proprietary Naming of Non-Rx Drugs
On Dec. 11, the Food and Drug Administration (FDA) published a draft guidance that details how sponsors should select and screen proprietary names for nonprescription drugs. The new draft guidance, Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products, makes naming recommendations for drugs that are switched from full-prescription and partial-prescription to nonprescription status. In the draft guide, FDA says drugs that switch from full-prescription to nonprescription status likely can keep the same name. However, drugs that are switched from partial-prescription to nonprescription status may need to have their names changed to avoid causing confusion among consumers.
Find the draft guidance here. Public comments are due by Feb. 8, 2021.
CMS Proposes New Rules to Address Prior Authorization
On Dec. 10, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule that would require payers in Medicaid, CHIP and QHP programs to build application programming interfaces (APIs) to support data exchange and prior authorization. APIs allow two systems, or a payer’s system and a third-party app, to communicate and share data electronically. Payers would be required to implement and maintain these APIs using the Health Level 7 (HL7) Fast Healthcare Interoperability Resources (FHIR) standard.
Find the proposed rule here. Public comments are due by Jan. 4, 2021.
Courts
Find a comprehensive look at “Courts and Healthcare Policy in 2020” here.
Other
MACPAC Releases 2020 Edition of MACStats: Medicaid and CHIP Data Book
On Dec. 16, the Medicaid and CHIP Payment and Access Commission (MACPAC) released the 2020 edition of the MACStats: Medicaid and CHIP Data Book, with updated data on national and state Medicaid and State Children’s Health Insurance Program (CHIP) enrollment, spending, benefits and beneficiaries’ health, service use and access to care. From July 2019 to July 2020, enrollment in Medicaid and CHIP increased by about 5.6 percent, driven in large part by the economic downturn created by the COVID-19 pandemic. Enrollment increased in all states except the District of Columbia and Montana. States where enrollment grew ranged from 0.2 percent in South Carolina to 30.2 percent in Idaho, which adopted the expansion of Medicaid to the new adult group in 2020.
Reports
The Commonwealth Fund: States Need Federal Help to Get COVID-19 Vaccines into Millions of Arms
On Dec. 16, the Commonwealth Fund released a report on how the first COVID-19 vaccine is making its way to frontline providers, and that state and local public health agencies will be largely responsible for broad vaccination of the American public. The report says that an additional $8.4 billion in federal funds are needed to support an effective and equitable vaccine rollout, but so far, only $200 million has been allocated to states. Unless Congress includes public health aid to states in its COVID-19 recovery bill, the report argues that the success of the vaccination effort is at risk.
Find the full report here.
If you have any questions, contact the following individuals atMcGuireWoods Consulting:
Stephanie Kennan, Senior Vice President
Mariam Eatedali, Research Associate
Founded in 1998,McGuireWoods Consulting LLC(MWC) is a full-service public affairs firm offering infrastructure andeconomic development, strategic communications & grassroots, and governmentrelations services. McGuireWoods Consulting is a subsidiary of theMcGuireWoods LLPlaw firm and has been named in The National Law Journal’s special annualreport, “The Influence 50,” for the past several years. In the most recentreport, McGuireWoods Consulting was ranked 15th of the 1,900 governmentrelations firms in Washington, D.C.
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