The DRA of 2023 adjusts Medicare payment rates for specific durable medical equipment (DME) items that were part of the 2021 competitive bidding program but for which no supplier contracts were finalized. It directly affects DME suppliers and Medicare beneficiaries by establishing a new 2024 payment formula: 90% of the adjusted payment amount plus 10% of the unadjusted fee schedule for eligible items. The bill also extends a temporary transition rule for non-rural areas through December 31, 2024, while delaying a regulatory change until 2025. These provisions aim to stabilize payments for DME items that did not transition to standard pricing under prior rules.
The ORPHAN Cures Act amends the Drug Price Negotiation Program under the Social Security Act to clarify how orphan drugs (medications for rare diseases affecting fewer than 200,000 people in the U.S.) are treated. It ensures that periods when a drug was designated as an orphan drug are excluded from the time calculation used to determine when the drug can no longer be excluded from price negotiations. The bill also updates the definition to allow a single drug to be designated for multiple rare diseases, rather than just one. This change provides clearer rules for manufacturers and the government regarding orphan drug exclusions in the program.
The Maintaining Investments in New Innovation Act (HR 5547) extends the exclusivity period for certain advanced drugs from 7 to 11 years. It defines an "advanced drug product" as a drug using genetically targeted technology to change how genes work, such as drugs that suppress or activate gene function. The bill amends the Social Security Act to update the definition of "qualifying single source drug" to include these advanced therapies with the longer exclusivity period. This change directly affects drug manufacturers developing such advanced therapies and influences Medicare's drug coverage rules by delaying generic competition for these specific treatments.
This bill imposes U.S. sanctions on foreign individuals and entities that facilitate North Korea's transfer of arms or material support to Russia for use in Russia's invasion of Ukraine. It targets those responsible for such transfers, including foreign financial institutions enabling significant transactions related to these activities, requiring property blocks and visa restrictions. The bill also amends existing North Korea sanctions to explicitly require halting such material support and mandates the President to submit regular reports to Congress on North Korea's involvement and U.S. strategies to counter it.
This bill requires Medicare Part D drug plans (which cover seniors' prescription drugs) to include all cheaper generic drugs and at least two cheaper biosimilars in a "preferred" formulary position starting in 2024. Specifically, plans must list these lower-cost options on a tier with lower patient costs than the original brand-name drug, and cannot impose stricter access rules (like prior authorization) on them compared to the brand-name drug. It directly affects Medicare Part D sponsors and seniors enrolled in these plans by mandating more affordable drug options. The key change is requiring formulary placement and cost-sharing for specific lower-cost generics and biosimilars, without restricting patient access to them relative to brand-name alternatives.
HR 5376, the Share the Savings with Seniors Act, changes Medicare Part D drug cost-sharing rules for specific chronic medications starting in 2025. It limits what seniors pay for certain chronic care drugs (like anticoagulants, blood glucose regulators, and respiratory medications) by capping pre-deductible costs at the drug's net price and requiring coinsurance after the deductible to be based on that net price. This directly affects Medicare Part D beneficiaries taking these defined chronic medications. The bill aims to reduce out-of-pocket costs by tying payment limits to the negotiated drug price rather than list price or other benchmarks.
This bill changes Medicare payment rules for anesthesiologist services in specific rural hospitals. It requires Medicare to pay for anesthesiologist services in qualifying rural hospitals using the same "reasonable cost, pass-through" reimbursement method currently used for certified registered nurse anesthetists (CRNAs), rather than the standard physician payment rate. The bill directly affects rural hospitals and anesthesiologists working in those facilities, ensuring they receive comparable reimbursement to CRNAs under existing rules. The change applies to services provided during cost reporting periods starting after the bill's enactment date. This is a technical adjustment to payment methodology, not a new coverage benefit.
The Preserving Access to Home Health Act of 2023 repeals a 2018 payment adjustment for Medicare home health agencies, restoring prior payment rates for 2024 and subsequent years. It requires the Medicare Payment Advisory Commission (MedPAC) to analyze how home health agencies' financial performance affects access to care, including reviewing spending and utilization data across Medicare, Medicaid, and other payers. Starting in 2025, the bill mandates home health agencies to report detailed data on visit volumes and payments by payer source (Medicare, Medicaid, private insurers) through updated cost reports. This data will help MedPAC assess payment policy impacts on access to home health services for Medicare beneficiaries.
HR 5107, the Pandemic Unemployment Fraud Recoupment Act, extends the statute of limitations for enforcing fraud related to pandemic unemployment benefits from 3 years to 10 years across multiple programs, including Pandemic Unemployment Assistance, Federal Pandemic Unemployment Compensation, and Lost Wages Assistance. It requires states to recover overpayments from individuals who knowingly received benefits they weren’t entitled to, through deductions from future unemployment benefits, while maintaining existing due process protections like hearings before repayment. States may waive repayment if the overpayment wasn’t the individual’s fault or if repayment would be unfair. The bill applies directly to individuals who received pandemic-era unemployment benefits through fraudulent means, ensuring states have a longer timeframe to address these cases under established fraud procedures.
The Breast Cancer Patient Equity Act would require Medicare to cover custom-made breast prostheses for women who have undergone mastectomies, directly affecting Medicare beneficiaries and influencing private insurance coverage practices. Currently, Medicare denies coverage for these prostheses as "not medically necessary" while covering surgical breast reconstruction, creating a gap that disproportionately impacts older and minority women. The bill amends Medicare’s coverage rules to explicitly include custom breast prostheses under the same category as other body part prostheses. This change would address the lack of access to a common, less invasive alternative to surgery for over 100,000 women undergoing mastectomies annually.
The BLUE Pacific Act establishes a comprehensive U.S. strategy to deepen engagement with Pacific Island nations through coordinated assistance across multiple policy areas. It authorizes $250 million annually for fiscal years 2023-2033 to support initiatives in climate resilience, economic development, security capacity building, public health, and democratic governance. The act requires the President to develop a Pacific Islands Partnership Strategy by 2027, with regular congressional reporting, and mandates consultation with Pacific Island nations and regional organizations. This legislation formalizes U.S. efforts to support Pacific Island countries in addressing shared challenges like climate change, economic development, and security while strengthening regional partnerships. The strategy will guide U.S. assistance across multiple agencies to support Pacific Island nations' priorities as outlined in regional frameworks like the 2050 Strategy for the Blue Pacific Continent.
This bill creates a presumption that minerals from the Democratic Republic of Congo (DRC) containing cobalt and lithium, mined with child or forced labor, cannot be imported into the United States. It requires the U.S. government to develop an enforcement strategy to identify and block such imports, including monitoring supply chains and working with international partners. The bill mandates diplomatic efforts to address child and forced labor in the DRC's mining sector and establishes sanctions against foreign entities that facilitate or engage in such labor practices. The focus is on minerals critical for electric vehicles and electronics, which are heavily sourced from the DRC and processed in China, with specific attention to Chinese mining companies like China Molybdenum that dominate the DRC's cobalt sector.
