Applied Policy, Author at Applied Policy

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

HHS Proposes Modifications to the HIPAA Privacy Rule to Support Coordinated Care

On December 10, 2020, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) issued a press release, fact sheet, and an unpublished proposed rule announcing intended changes to the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule.[1] The proposed changes follow a request for information from December [...] Read More

Trump Administration Finalizes Rule to Prevent PBM Rebates Almost Two Years After Initial Proposal

On November 20, 2020, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a final rule that removes the existing legal safe harbor that protects rebates currently negotiated between pharmaceutical manufacturers and Medicare Part D prescription drug plans, either directly or through Pharmacy Benefit Managers (PBMs). To replace this rescinded [...] 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 Physician Self-Referral Regulations to Reflect Medicare’s Transition Toward Value-Based Payment Systems

On November 20, 2020, the Centers for Medicare & Medicaid Services’ (CMS) issued a fact sheet and final rule to modernize and clarify regulations that interpret and implement the physician self-referral law. The intent of the final rule is to balance the reduction of unnecessary physician burden with the goal of removing a physician’s financial [...] 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 Long-Awaited Rule that Provides Additional Flexibility for States with Medicaid & CHIP Managed Care (CMS-2408-F)

On the morning of November 9, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a press release, fact sheet, and a final rule that updates the regulations for Medicaid and Children’s Health Insurance Program (CHIP) managed care programs to address the following policy areas: Setting Actuarially Sound Capitation Rates (Medicaid); Pass-Through Payments (Medicaid); [...] 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 Completes Price Transparency Reform by Issuing Long-Awaited Final Rule for Health Plans

On the morning of October 29, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a press release, fact sheet, and an unpublished final rule on its website that implements the group health plan (“plan”) and health insurance issuer (“issuer”) portions of the Administration’s Executive Order on Improving Price and Quality Transparency (E.O. 13877).[1] [...] Read More

HHS Makes Moves in the Kidney Space: CMS Releases ESRD ETC Model and HRSA Removes Disincentives to Organ Donation

On September 18, 2020, the Centers for Medicare & Medicaid Services (CMS) released its long-awaited Specialty Care Models to Improve Quality of Care and Reduce Expenditures final rule (link) and the Health Resources and Services Administration (HRSA) released its Removing Financial Disincentives to Living Organ Donation final rule (link) and updated guidelines (link). These rules [...] Read More

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