🏥PRCDA Expansion for Shoshone-Bannock Tribes in Idaho
Notice is hereby given that the Indian Health Service (IHS) has decided to expand the geographic boundaries of the Purchased/ Referred Care Delivery Area (PRCDA) for the Shoshone-Bannock Tribes of the Fort Hall Indian Reservation in Idaho (Shoshone-Bannock Tribes or Tribe) to include the Idaho counties of Ada, Bear Lake, Blaine, Bonneville, Butte, Canyon, Cassia, Custer, Elmore, Franklin, Fremont, Gem, Gooding, Jefferson, Jerome, Madison, Minidoka, Oneida, Payette, Teton, Twin Falls, and Washington. The final PRCDA for the Shoshone- Bannock Tribes now includes the Idaho counties of Ada, Bannock, Bear Lake, Bingham, Blaine, Bonneville, Butte, Canyon, Caribou, Cassia, Custer, Elmore, Franklin, Fremont, Gem, Gooding, Jefferson, Jerome, Lemhi, Madison, Minidoka, Oneida, Payette, Power, Teton, Twin Falls, and Washington. The sole purpose of this expansion is to authorize additional Shoshone-Bannock Tribal members and beneficiaries to receive Purchased/Referred Care (PRC) services.
Learn More🏥HUD Eliminates Green MIP for Healthcare Facilities
On May 19, 2022, HUD proposed MIP reductions to achieve green and energy-efficiency buildings for FHA-insured loans on properties under specific Office of Healthcare insurance programs (the 2022 notice). This notice eliminates the Green and Energy Efficient MIP category for Healthcare Facilities, and all projects will be subject to the rate that had been previously established through Federal Register notice for such FHA-insured loans.
Learn More📄FDA Issues Guidance on Conducting Remote Regulatory Assessments
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Conducting Remote Regulatory Assessments--Question and Answers." The final guidance describes FDA's current thinking regarding its use of remote regulatory assessments (RRAs) and provides answers to frequently asked questions. FDA has used RRAs to conduct oversight, mitigate risk, meet critical public health needs, and help evaluate compliance of FDA- regulated products with applicable regulatory requirements.
Learn More🧪FDA Classifies Herpes Simplex Virus Assay as Class II Device
The Food and Drug Administration (FDA, the Agency, or we) is classifying the herpes simplex virus nucleic acid-based assay for central nervous system infections into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the herpes simplex virus nucleic acid-based assay for central nervous system infections. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Learn More🏥Public Comment Request on Organ Procurement Data System Regulations
In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.
Learn More🏥Notice on ACHC Hospice Accreditation Program and Public Comment
This proposed notice acknowledges the receipt of an application from the Accreditation Commission for Health Care, for continued recognition as a national accrediting organization for hospices that wish to participate in the Medicare or Medicaid programs.
Learn More🏥Marketplace Integrity and Affordability Regulations Overview
This final rule revises standards relating to denial of coverage for failure to pay past-due premium; excludes Deferred Action for Childhood Arrivals recipients from the definition of "lawfully present;" establishes the evidentiary standard HHS uses to assess an agent's, broker's, or web-broker's potential noncompliance; revises the Exchange automatic reenrollment hierarchy; revises standards related to the annual open enrollment period and special enrollment periods; revises standards relating to failure to file and reconcile, income eligibility verifications for premium tax credits and cost-sharing reductions, annual eligibility redeterminations, de minimis thresholds for the actuarial value for plans subject to essential health benefits (EHB) requirements, and income-based cost-sharing reduction plan variations. This final rule also revises the premium adjustment percentage methodology and prohibits issuers of coverage subject to EHB requirements from providing coverage for specified sex-trait modification procedures as an EHB.
Learn More🏥OPM Seeks Comments on CAHPS Enrollee Survey Renewal
Healthcare and Insurance, Office of Personnel Management (OPM) offers the general public and other federal agencies the opportunity to comment on the administration of the Consumer Assessment of Healthcare Providers and Systems (CAHPS[supreg]) survey for the Federal Employees Health Benefits (FEHB) and the Postal Service Health Benefits (PSHB) Programs. CAHPS[supreg] surveys ask consumers and patients to report on and evaluate their experiences with health care. These surveys cover topics that are important to consumers and focus on aspects of quality that consumers are best qualified to assess, such as the communication skills of providers and ease of access to health care services.
Learn More🩺FDA Announces Regulatory Review Period for EDWARDS SAPIEN Device
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for EDWARDS SAPIEN 3 TRANSCATHETER PULMONARY VALVE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of patents which claim that medical device.
Learn More💊FDA Notice on Regulatory Review Period for FILSPARI Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for FILSPARI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
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