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CMS Finalizes Policies for Medicare Advantage and Part D Plans in 2022, Allows Second Specialty Tier, Releases 2022 Benefit Parameters

On January 15, 2021, the Centers for Medicare & Medicaid Services (CMS) released a final rule containing policies for Medicare Advantage (MA) and Medicare Part D plans in contract year 2022. The rule finalizes policies initially proposed in February 2020. Some policies in that February proposed rule were finalized in previous rulemaking while the remainder [...] Read More

CMS Looks to Expand Use of Value-Based Purchasing, Allowing for Multiple Best Prices; Clarifies Treatment of Patient Assistance and Copay Accumulators

In late December 2020, the Trump Administration released a final rule designed to promote the use of value-based purchasing (VBP) arrangements between drug manufacturers and payers, including Medicaid. The final rule, released by the Centers for Medicare & Medicaid Services (CMS), also contains policies related to line extensions and copay accumulators. The incoming Biden Administration [...] Read More

CMS Releases Final CY 2021 Physician Fee Schedule

On the evening of December 1, 2020, the Centers for Medicare and Medicaid Services (CMS) released the final Physician Fee Schedule (PFS) for calendar year (CY) 2021. The rule includes finalized policies related to telehealth, the Quality Payment Program (QPP), care management and others. The rule has not yet been published in the Federal Register [...] Read More

HHS-OIG Updates Safe Harbors Under Anti- Kickback Statute, Including Adoption of New Value-Based Framework

On November 20, 2020, the Health and Human Services’ Office of Inspector General (OIG) issued a fact sheet and final rule that removes potential regulatory barriers to care coordination and value-based care created by certain key healthcare laws and associated regulations, including the anti-kickback statute (AKS) and Beneficiary Inducements Civil Monetary Penalty (CMP).1 The changes [...] Read More

CMS Updates Minimum Standards of Care for Organ Procurement Organizations, Including Revisions to Outcome Measurements (CMS-3380-F)

On November 20, 2020, the Centers for Medicare & Medicaid Services (CMS) released a fact sheet and final rule that updates the conditions that Organ Procurement Organizations (OPOs) must meet in order to have their services covered by Medicare and Medicaid. Fifty-eight OPOs operate in the U.S. as not-for-profit organizations responsible for recovering organs from [...] Read More

CMS Finalizes CY 2021 ESRD Policies, Incorporating Calcimimetics into PPS and Adding Transitional Add-on Payment to Cover Certain Home Dialysis Machines

On November 2, 2020, the Centers for Medicare & Medicaid Services (CMS) released the final rule that updates the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year (CY) 2021. This rule finalizes changes related to the ESRD PPS, the ESRD Quality Incentive Program (ESRD-QIP), payment for acute kidney injury (AKI), and other [...] Read More

CMS Issues 4th COVID-Specific Rule, Including Coverage, Payment, and Enforcement Policies Regarding COVID-19 Vaccines and Treatments

On the evening of October 28, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a press release, fact sheet, and an unpublished interim final rule with comment period (IFC) on its website related to the COVID-19 public health emergency (PHE). The IFC interprets and implements CARES Act requirements regarding COVID-19 immunizations and treatments, [...] Read More

CMS Releases CY 2021 DMEPOS Proposed Rule: Announces Changes to 2021 Competitive Bidding and Proposes to Classify All CGMs as DME [CMS-1738-P]

On the evening of October 27, 2020, the Centers for Medicare & Medicaid Services (CMS) released the unpublished version and fact sheet of its proposed CY 2021 Durable Medical Equipment, Prosthetics, Orthotics, & Supplies (DMEPOS) rule, which updates DMEPOS coverage and payment policy for CY 2021: Classifies/establishes payment amount for continuous glucose monitors (CGMs) as [...] Read More