Summary
Congress is in recess until after the elections on November 12, but there are increasing calls for them to return early and pass emergency funding to cover the disasters caused by Hurricanes Helene and Milton in Florida, North Carolina, South Carolina, Georgia, Tennessee and Virginia. In recent weeks President Joe Biden has called on lawmakers to return to Capitol Hill “immediately” to provide additional funding, and last Wednesday Democrats on the House Small Business Committee put out a statement urging Speaker Mike Johnson (R-LA) to “call the House back into session so we may begin to work on, a bipartisan basis, the SBA’s request for additional disaster funding.”
State officials are still assessing the damage, and the Administration is working on submitting an official request to Congress detailing what resources are needed to help affected states. Speaker Johnson has insisted that Congress will provide additional funds upon return in November and that the Federal Emergency Management Agency (FEMA) has the resources necessary until then.
Prior to recessing, Congress included in the Continuing Resolution (CR) a provision that allowed FEMA to tap into an additional $20.3 billion. FEMA officials have indicated that they currently have $11 billion of those funds remaining, and that should last them until Congress returns in November and passes additional emergency funding. Congress did not, however, include any additional funding for the Small Business Administration’s (SBA) disaster loan program, that provides disaster victims with low-interest loans to help with expenses such as home repair or replacement, personal property, vehicles, mitigation, business losses, and working capital for individuals, small businesses, and most private nonprofits. It has been reported that the SBA will run out of funding well before the Congress is scheduled to reconvene. Democrats on the Small Business Committee stated that they are looking for other ways to support the disaster loan program, “including the reprogramming of appropriated funds, to ensure there is no gap in service”, but SBA has said it can’t make new loans without additional funding from Congress.
It is unlikely that Congressional leadership will call Congress back early to pass additional funding, but emergency assistance has jumped to the top of a long list of to-do items for when Congress does return post-election.
So far, the Biden-Harris Administration has approved more than $1.8 billion in assistance for hurricane response and recovery efforts, including over $911 million for those affected by Hurricane Helene and over $620 million for those affected by Hurricane Milton from FEMA. Other federal agencies are taking steps to support health care providers in affected areas, including the following:
- The Centers for Medicare and Medicaid Services (CMS) is providing certain flexibilities related to provider and supplier fee-for-service (FFS) Medicare debt due to Hurricane Helene:
- Accelerated and advance payments: Payments may be granted at the National Provider Identifier (NPI) or Provider Transaction Access Number (PTAN) level in amounts equal to a percentage of the preceding 90 days of claims and will be repaid through automatic recoupment from Medicare claims for 90 days following issuance. This applies to Medicare providers/suppliers in good standing that are located in or furnishing services within a FEMA designated disaster area.
- Flexibility for existing extended repayment schedules (ERS): Those repaying debt under an ERS at the maximum 60-month term may restructure the payment schedule for two payments during the approved period without additional financial documentation. Those repaying debt under an ERS for less than a 60-month term may request an additional two months be added. The two months will be interest only payments, or $0 payments, with remaining payment adjusted.
- Disrupted debt communications: Providers/suppliers may request demand letters be rescinded and reissued when mail service has been reestablished if a letter regarding repayment or overpayment is not received due to Postal Service delivery disruptions.
- The Food and Drug Administration (FDA) announced temporary policies for compounding certain parenteral drug products due to the impact of the hurricanes on one of the nation’s largest manufacturers of certain intravenous and peritoneal dialysis solutions, the Baxter International’s North Cove facility. The guidance describes the agency’s regulatory and enforcement priorities regarding the compounding for parenteral drugs by outsourcing facilities and pharmacy compounders, and the policies will remain in effect only for the duration of the supply disruption.
Additionally, the FDA has conducted scientific and regulatory assessments to facilitate the temporary importation of intravenous and peritoneal fluids, and to date, has provided regulatory discretion for 23 different product lines at five international Baxter facilities.
- CDC issued a Health Alert Network Advisory (HAN) regarding disruptions in availability of peritoneal dialysis and intravenous solutions from the Baxter International’s North Cove facility in North Carolina, due to Hurricane Helene. The HAN provides recommendations for health care providers, pharmacists, health care facilities, dialysis facilities, and state and local health departments.
- The Administration for Strategic Preparedness and Response (ASPR) has deployed approximately 370 medical, public health, and disaster response personnel to support North Carolina communities as part of the government-wide response to the devastation caused by the hurricane. Additionally, ASPR has deployed approximately 150 responders, along with medical equipment and supplies, to help protect the delivery of health care services in Florida.
Regulatory Update
The Office of Management and Budget (OMB) completed reviewing proposed rule titled, “Enhancing Coverage of Preventive Services under the Affordable Care Act.” Our summary is forthcoming
Medicare
- Physician Payment – The final rule would make changes to the Medicare physician fee schedule for calendar year 2025 (November 2024).
- Outpatient Payment – The final rule would make changes to the Medicare hospital outpatient prospective payment system for calendar year 2025 (November 2024).
- Home Health – The final rule would make changes to the Medicare home health prospective payment system for calendar year 2025 (November 2024).
- ESRD – The final rule would make changes to the Medicare End-Stage Renal Disease (ESRD) payment system for calendar year 2025 (November 2024).
- Medicare Advantage – The proposed rule would make policy and technical changes to the Medicare Advantage, Medicare Prescription Drug Benefit, and Medicare Cost Plan Programs, and PACE for contract year 2026 (September 2024).
Other Topics
- Healthcare System Resiliency and Modernization – The proposed rule would revise and update national emergency preparedness requirements for Medicare- and Medicaid-participating providers and suppliers (was set for December 2023).
- Retail Pharmacy Standards – The final rule would require pharmacies and vendors to modify the currently adopted National Council for Prescription Drug Programs (NCPDP) standards to the Telecommunications Standard Implementation Guide Version F6 (F6); Batch Standard Implementation Guide version 15; and Batch Standard Subrogation Implementation Guide version 10 (was set for February 2024).
- Organ Transplants – The final rule would establish a new mandatory Medicare payment model, the Increasing Organ Transplant Access Model (IOTA Model), that would test whether performance-based incentive payments paid to or owed by participating kidney transplant hospitals increase access to kidney transplants for patients with end-stage renal disease (ESRD) while preserving or enhancing the quality of care and reducing Medicare expenditures.