Technical revisions to medical criteria for determinations of disability. Final rules

These final rules make a number of technical revisions to the Listing of Impairments (the listings). We use the listings when you claim benefits based on disability under titles II and XVI of the Social Security Act (the Act). We are making these revisions to reflect advances in medical knowledge, treatment and terminology, to clarify certain criteria in the listings, to remove listings that we rarely use, and to add new listings consistent with current medical practice. We are making these individual technical revisions in order to improve our medical listings and make them easier to understand and use.     

Disability determinations by state agency disability examiners. Final rules

We are revising our rules on a temporary basis to permit State agency disability examiners to make fully favorable determinations in certain claims for disability benefits under titles II and XVI of the Social Security Act (Act) without the approval of a State agency medical or psychological consultant. These changes apply only to claims we consider under our rules for quick disability determinations (QDD) or under our compassionate allowance initiative.     

Modification of certain medical standards and procedures and duration of certain medical certificates. Final rule

This rule extends the duration of first- and third-class medical certificates for certain individuals. A first-class medical certificate is required when exercising airline transport pilot privileges and at least a third-class medical certificate when exercising private pilot privileges. Certain conforming amendments to medical certification procedures and some general editorial amendments are also adopted. The intent of this action is to improve the efficiency of the medical certification program and service provided to medical certificate applicants.     

Amendments to sterility test requirements for biological products. Final rule

The Food and Drug Administration (FDA) is amending the sterility test requirements for biological products. This rule provides manufacturers of biological products greater flexibility, as appropriate, and encourages use of the most appropriate and state-of-the-art test methods for assuring the safety of biological products. FDA is taking this action as part of its ongoing efforts to comprehensively review and, as necessary, revise its regulations related to biological products.     

Requiring use of electronic services by certain claimant representatives. Final rules

We are revising our rules to require that claimant representatives use our electronic services as they become available on matters for which the representatives request direct fee payment. In the future, we will publish a notice in the Federal Register when we require representatives who request direct fee payment on a matter to use our available electronic services. We are also adding the requirement to use our available electronic services on matters for which the representative requests direct fee payment as an affirmative duty in our representative conduct rules. These revisions reflect the increased use of technology in representatives' business practices. We expect that the use of electronic services will improve our efficiency by allowing us to manage our workloads more effectively. These rules do not require claimants to use our available electronic services directly; they only require their representatives to use the services on matters for which the representatives request direct fee payment.     

Revisions to rules of conduct and standards of responsibility for representatives. Final rules

We are revising our rules of conduct and standards of responsibility for representatives. These revisions further clarify our expectations regarding representatives' obligations to competently represent their clients and constitute official notice concerning our requirements and procedures. We are also updating other rules about the representation of parties. These changes are necessary because our current regulations are insufficient to address some representative conduct that is inappropriate, but has technically fallen outside the scope of our regulations. These changes will allow us to better protect the integrity of our administrative process, ensure that claimants receive competent and effective representation, and further clarify representatives' responsibilities in their dealings with us and with claimants.     

Amendments to the quick disability determination process. Final rule

We are amending our regulations to extend the quick disability determination process (QDD), which is operating now in the Boston region, to all of the State disability determination services (DDSs). We also are removing from the QDD process the existing requirements that each State DDS maintain a separate QDD unit and that each case referred under QDD be adjudicated within 20 days. These actions stem from our continuing effort to improve our disability adjudication process.     

Grants and subgrants to for-profit organizations--HHS. Final rules

This announces HHS's final decision to make for-profit organizations eligible for grants in all programs in which grants to those organizations are consistent with legislative intent and program purposes. For all such programs which we have identified and which still have regulatory bars to grants to for-profit organizations, this removes the bars. This also (1) makes HHS's Department-wide grants administration regulations, 45 CFR Part 74, apply to grants and subgrants to for-profit organizations and (2) adds to those regulations additional provisions for grants and subgrants to for-profit organizations. These actions reflect a reversal of the long standing HHS policy of not making grants to for-profit organizations even in programs where they are not barred by law. The new policy is intended to increase competition. This is likely to help the affected HHS programs achieve their objectives better, because they will be able to select from among a greater number of proposed projects.     

Medicare program; criteria and procedures for extending coverage to certain devices and related services--HCFA. Final rule with comment period

This final rule establishes in regulations that certain devices with an investigational device exemption (IDE) approved by the Food and Drug Administration (FDA) and certain services related to those devices may be covered under Medicare. Specifically, it sets forth the process by which the FDA will assist HCFA in identifying non-experimental investigational devices that are potentially covered under Medicare. This rule responds to the mandate that Federal agencies streamline their regulatory processes to make them less burdensome and more customer-focused. It is intended to provide Medicare beneficiaries with greater access to advances in medical technology and encourage clinical researchers to conduct high quality studies of newer technologies.     

Tribal Self-Governance Amendments of 2000. Final rule

The Secretary of the Department of Health and Human Services (DHHS) hereby issues this final rule to implement Title V of the Tribal Self-Governance Amendments of 2000 (the Act). The final rule has been negotiated among representatives of Self-Governance and non-Self- Governance Tribes and the DHHS. The final rule includes provisions governing how DHHS/Indian Health Service (IHS) carries out its responsibility to Indian Tribes under the Act and how Indian Tribes carry out their responsibilities under the Act. As required by section 517 (b) of the Act, the Department has developed this final rule with active Tribal participation of Indian Tribes, inter-Tribal consortia, Tribal organizations and individual Tribal members, using the guidance of the Negotiated Rulemaking Act.     

Reinstatement of entitlement to disability benefits. Final rules

We are publishing final rules regarding the Reinstatement of Entitlement (Expedited Reinstatement) provision in section 112 of the Ticket to Work and Work Incentives Improvement Act of 1999. This provision allows former Social Security disability and Supplemental Security Income (SSI) disability or blindness beneficiaries, whose entitlement or eligibility had been terminated due to their work activity, to have their entitlement or eligibility reinstated in a timely fashion if they become unable to do substantial gainful work. These rules provide beneficiaries an additional incentive to return to work.     

Compensation for certain undiagnosed illnesses--VA. Final rule

This document adopts as a final rule the provisions of an interim final rule which amended the Department of Veterans Affairs (VA) adjudication regulations regarding compensation for disabilities resulting from undiagnosed illnesses suffered by Persian Gulf Veterans. This amendment is necessary to expand the period within which such disabilities must become manifest to a compensable degree in order for entitlement for compensation to be established. The intended effect of this amendment is to ensure that veterans with compensable disabilities due to undiagnosed illnesses that may be related to active service in the Southwest Asia theater of operations during the Persian Gulf War may qualify for benefits.     

Compensation for certain undiagnosed illnesses--VA. Final rule

This document amends the Department of Veterans Affairs (VA) adjudication regulations to authorize compensation for disabilities resulting from the undiagnosed illnesses of Persian Gulf veterans. This amendment provides the necessary regulatory framework to allow the Secretary to pay compensation under the authority granted by the Persian Gulf War.     

Eligibility rules for special emergency paging--FCC. Final rule

This action modifies 90.38 of the Commission's Rules by expanding the eligibility of end users to which special emergency paging licensees can provide service. Hospital paging systems could not be used to inform participants in an organ donor program of the availability of a suitable organ. The Commission has decided that patients actively awaiting an organ transplant should be eligible under the Special Emergency Radio Service to receive paging service.     

Continuing disability review failure to cooperate process. Final rules

We are amending our regulations to provide that we will suspend your disability benefits before we make a determination during a continuing disability review (CDR) under title II and title XVI of the Social Security Act (the Act) when you fail to comply with our request for necessary information. Should you remain non-compliant for a period of one year following your suspension, we will then terminate your disability benefits. Although our current title XVI regulations generally provide for the termination of payments after 12 months of suspension, we are amending our regulations by adding this policy to our title II regulations and by restating it in the title XVI CDR regulatory provisions.     

Medicare program: review of national coverage determinations and local coverage determinations. Final rule

This final rule will create a new process to allow certain Medicare beneficiaries to challenge national coverage determinations (NCDs) and local coverage determinations (LCDs). It will implement portions of section 522 of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000. The right to challenge NCDs and LCDs will be distinct from the existing appeal rights that Medicare beneficiaries have for the adjudication of Medicare claims.     

Claimant identification pilot projects. Final rules

We are revising our regulations that pertain to the processing of initial claims for disability benefits under title II (Social Security Disability Insurance) and title XVI (Supplemental Security Income) of the Social Security Act (the Act). We will be conducting pilot projects wherein we will request photographic identification from individuals filing for title II and title XVI disability and blindness benefits in specified geographic areas covered by the pilot projects. In addition, we will require individuals to allow us to take their photograph and we will make these photographs a part of the claims folder. We will permit an exception to the photograph requirement when an individual has a sincere religious objection. This process will strengthen the integrity of the disability claims process by helping to ensure that the individual filing the application is the same individual examined by the consultative examination (CE) physician.