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AHA Comments on the Remanufacturing of Medical Devices, Draft Guidance for Industry and FDA Staff
AHA comments on the Remanufacturing of Medical Devices, Draft Guidance for Industry and Food and Drug Administration Staff.
AHRMM LUC Comments to the FDA’s Draft Guidance for Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices
The AHRMM LUC members submitted comments and recommendations to the FDA's Draft Guidance for Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices. They recommend that information related to all Class I Medical Devices be included in the GUDID without exception.
AHA Comments on CMS Proposal on Accrediting Organization Oversight
AHA comments on CMS’ proposals to strengthen the agency’s oversight of accrediting organizations.
AHA Letter to UnitedHealthcare RE: Molecular Pathology Reimbursement Policy
AHA addresses UnitedHealthcare’s implementation of its Molecular Pathology Reimbursement Policy on April 1, 2024.
AHA Responds to CMS’ Requirement to Report Telehealth Provider Home Addresses
Waivers allowed practitioners to render telehealth services from their home without having to report their home address on Medicare enrollment or claims forms. Beginning Jan. 1, 2024, these providers will be required to report their home address on enrollment and claims forms.
AHA Expresses Concerns with Veterans Affairs’ Third-party Audit and Appeals Process
AHA members have expressed significant concerns about Cotiviti’s audit and appeals process, including its inadequate appeals procedures, the scope of audits being performed and the untenable timelines that are being executed. Therefore, we urge the VA to issue proposed rulemaking not only to allow for public input but also to formalize clear standards and expectations governing the audit and appeals processes.
AHA Responds to Senate RFI on Health Data Privacy
AHA comments on the Senate request for information on data privacy and the Health Insurance Portability and Accountability Act of 1996 (HIPAA).
AHA Comments on IRS' Elective Payment of Applicable Credit Proposed Rule
The IRA, through the transferability provisions under Section 6418 and, in particular, the elective direct pay provisions of Section 6417, has provided new opportunities for the healthcare sector to engage in important clean energy initiatives.
FTC Urged to Extend Comment Period for Draft Merger Guidelines
The AHA joins the U.S. Chamber of Commerce and other organizations in urging the Federal Trade Commission to extend for at least 60 days the comment period for their draft guidance revising how they review mergers and acquisitions to determine compliance with federal antitrust laws.