UNITED STATES CODE
Title 45 - Public Welfare
Subtitle A - Department of Health and Human Services
SUBCHAPTER A - GENERAL ADMINISTRATION
PART 2 - TESTIMONY BY EMPLOYEES AND PRODUCTION OF DOCUMENTS IN PROCEEDINGS WHERE THE UNITED STATES IS NOT A PARTY
§ 2.1 Scope, purpose, and applicability.
§ 2.2 Definitions.
§ 2.3 Policy on Presentation of testimony and production of documents.
§ 2.4 Procedures when voluntary testimony is requested or when an employee is subpoenaed.
§ 2.5 Subpoenas duces tecum.
§ 2.6 Certification and authentication of records.
PART 3 - CONDUCT OF PERSONS AND TRAFFIC ON THE NATIONAL INSTITUTES OF HEALTH FEDERAL ENCLAVE
Subpart A - General
§ 3.1 Definitions.
§ 3.2 Applicability.
§ 3.3 Compliance.
§ 3.4 False reports and reports of injury or damage.
§ 3.5 Lost and found, and abandoned property.
§ 3.6 Nondiscrimination.
Subpart B - Traffic Regulations
§ 3.21 Emergency vehicles.
§ 3.22 Request for identification.
§ 3.23 Parking.
§ 3.24 Parking permits.
§ 3.25 Servicing of vehicles.
§ 3.26 Speed limit.
§ 3.27 Bicycles.
Subpart C - Facilities and Grounds
§ 3.41 Admission to facilities or grounds.
§ 3.42 Restricted activities.
§ 3.43 Removal of property.
§ 3.44 Solicitation.
Subpart D - Penalties
§ 3.61 Penalties.
PART 4 - SERVICE OF PROCESS
§ 4.1 Suits against the Department and its employees in their official capacities.
§ 4.2 Other process directed to the Department or Secretary.
§ 4.3 Process against Department officials in their individual capacities.
§ 4.4 Acknowledgement of mailed process.
§ 4.5 Effect of regulations.
§ 4.6 Materials related to petitions under the National Vaccine Injury Compensation Program.
§ 4.7 Congressional subpoenas directed to the Department or Secretary.
PART 5 - FREEDOM OF INFORMATION REGULATIONS
Subpart A - General Information About Freedom of Information Act Requests
§ 5.1 Purpose.
§ 5.2 Presumption of openness and proactive disclosures.
§ 5.3 Definitions.
§ 5.4 Regulatory scope.
§ 5.5 Interrelationship between the FOIA and the Privacy Act of 1974.
Subpart B - How to Request Records under FOIA
§ 5.21 Who can file a FOIA request?
§ 5.22 What do I include in my FOIA request?
§ 5.23 Where do I send my FOIA request?
§ 5.24 How does HHS process my FOIA request?
§ 5.25 How does HHS handle requests that involve more than one OpDiv, StaffDiv, or Federal agency?
§ 5.26 How does HHS determine estimated completion dates for FOIA requests?
§ 5.27 How do I request expedited processing?
§ 5.28 How does HHS respond to my request?
§ 5.29 How may I request assistance with the FOIA process?
Subpart C - Exemptions to Disclosure
§ 5.31 What are the reasons records may be withheld?
§ 5.32 Records not subject to the requirements of the FOIA - law enforcement exclusions.
Subpart D - Confidential Commercial Information
§ 5.41 How does a submitter identify records containing confidential commercial information?
§ 5.42 How does HHS process FOIA requests for confidential commercial information?
Subpart E - Fees
§ 5.51 General information on fees for all FOIA requests.
§ 5.52 What is the FOIA fee schedule for obtaining records?
§ 5.53 How does HHS calculate FOIA fees for different categories of requesters?
§ 5.54 How may I request a fee waiver?
Subpart F - Appeals
§ 5.61 When may I appeal HHS's FOIA determination?
§ 5.62 How do I file an appeal?
§ 5.63 How does HHS process appeals?
§ 5.64 What avenues are available to me if I disagree with HHS's appeal decision?
Subpart G - Records Retention
§ 5.71 How does HHS retain FOIA records?
PART 5b - PRIVACY ACT REGULATIONS
§ 5b.1 Definitions.
§ 5b.2 Purpose and scope.
§ 5b.3 Policy.
§ 5b.4 Maintenance of records.
§ 5b.5 Notification of or access to records.
§ 5b.6 Special procedures for notification of or access to medical records.
§ 5b.7 Procedures for correction or amendment of records.
§ 5b.8 Appeals of refusals to correct or amend records.
§ 5b.9 Disclosure of records.
§ 5b.10 Parents and guardians.
§ 5b.11 Exempt systems.
§ 5b.12 Contractors.
§ 5b.13 Fees.
PART 7 - EMPLOYEE INVENTIONS
§ 7.0 Who are employees.
§ 7.1 Duty of employee to report inventions.
§ 7.3 Determination as to domestic rights.
§ 7.4 Option to acquire foreign rights.
§ 7.7 Notice to employee of determination.
§ 7.8 Employee's right of appeal.
PART 9 - USE OF HHS RESEARCH FACILITIES BY ACADEMIC SCIENTISTS, ENGINEERS, AND STUDENTS
§ 9.1 Purpose.
§ 9.2 Policy.
§ 9.3 Delegations of authority.
§ 9.4 Criteria.
§ 9.5 Restrictions.
PART 12 - DISPOSAL AND UTILIZATION OF SURPLUS REAL PROPERTY FOR PUBLIC HEALTH PURPOSES
§ 12.1 Definitions.
§ 12.2 Scope.
§ 12.3 General policies.
§ 12.4 Limitations.
§ 12.5 Awards.
§ 12.6 Notice of available property.
§ 12.7 Applications for surplus real property.
§ 12.8 Assignment of surplus real property.
§ 12.9 General disposal terms and conditions.
§ 12.10 Compliance with the National Environmental Policy Act of 1969 and other related Acts (environmental impact).
§ 12.11 Special terms and conditions.
§ 12.12 Utilization.
§ 12.13 Form of conveyance.
§ 12.14 Compliance inspections and reports.
§ 12.15 Reports to Congress.
PART 12a - USE OF FEDERAL REAL PROPERTY TO ASSIST THE HOMELESS
§ 12a.1 Definitions.
§ 12a.2 Applicability.
§ 12a.3 Collecting the information.
§ 12a.4 Suitability determination.
§ 12a.5 Real property reported excess to GSA.
§ 12a.6 Suitability criteria.
§ 12a.7 Determination of availability.
§ 12a.8 Public notice of determination.
§ 12a.9 Application process.
§ 12a.10 Action on approved applications.
§ 12a.11 Unsuitable properties.
§ 12a.12 No applications approved.
PART 13 - IMPLEMENTATION OF THE EQUAL ACCESS TO JUSTICE ACT IN AGENCY PROCEEDINGS
Subpart A - General Provisions
§ 13.1 Purpose of these rules.
§ 13.2 When these rules apply.
§ 13.3 Proceedings covered.
§ 13.4 Eligibility of applicants.
§ 13.5 Standards for awards.
§ 13.6 Allowable fees and expenses.
§ 13.7 Studies, exhibits, analyses, engineering reports, tests and projects.
Subpart B - Information Required from Applicants
§ 13.10 Contents of application.
§ 13.11 Net worth exhibits.
§ 13.12 Documentation of fees and expenses.
Subpart C - Procedures for Considering Applications
§ 13.21 Filing and service of pleadings.
§ 13.22 When an application may be filed.
§ 13.23 Responsive pleadings.
§ 13.24 Settlements.
§ 13.25 Further proceedings.
§ 13.26 Decisions.
§ 13.27 Agency review.
§ 13.28 Judicial review.
§ 13.29 Payment of award.
§ 13.30 Designation of adjudicative officer.
PART 15 - UNIFORM RELOCATION ASSISTANCE AND REAL PROPERTY ACQUISITION FOR FEDERAL AND FEDERALLY ASSISTED PROGRAMS
§ 15.1 Uniform relocation assistance and real property acquisition.
PART 16 - PROCEDURES OF THE DEPARTMENTAL GRANT APPEALS BOARD
§ 16.1 What this part does.
§ 16.2 Definitions.
§ 16.3 When these procedures become available.
§ 16.4 Summary of procedures below.
§ 16.5 How the Board operates.
§ 16.6 Who represents the parties.
§ 16.7 The first steps in the appeal process: The notice of appeal and the Board's response.
§ 16.8 The next step in the appeal process: Preparation of an appeal file and written argument.
§ 16.9 How the Board will promote development of the record.
§ 16.10 Using a conference.
§ 16.11 Hearing.
§ 16.12 The expedited process.
§ 16.13 Powers and responsibilities.
§ 16.14 How Board review is limited.
§ 16.15 Failure to meet deadlines and other requirements.
§ 16.16 Parties to the appeal.
§ 16.17 Ex parte communications (communications outside the record).
§ 16.18 Mediation.
§ 16.19 How to calculate deadlines.
§ 16.20 How to submit material to the Board.
§ 16.21 Record and decisions.
§ 16.22 The effect of an appeal.
§ 16.23 How long an appeal takes.
PART 17 - RELEASE OF ADVERSE INFORMATION TO NEWS MEDIA
§ 17.1 Definition.
§ 17.2 Basic policy.
§ 17.3 Precautions to be taken.
§ 17.4 Regulatory investigations and trial-type proceedings.
§ 17.5 Context to be reflected.
§ 17.6 Advance notice.
§ 17.7 Retractions or corrections.
PART 18 - OFFICIAL SYMBOL, LOGO, AND SEAL
§ 18.1 Description of the Symbol, Logo, and Seal.
PART 30 - CLAIMS COLLECTION
Subpart A - General Provisions
§ 30.1 Purpose, authority, and scope.
§ 30.2 Definitions.
§ 30.3 Antitrust, fraud, exception in the account of an accountable official, and interagency claims excluded.
§ 30.4 Compromise, waiver, or disposition under other statutes not precluded.
§ 30.5 Other administrative remedies.
§ 30.6 Form of payment.
§ 30.7 Subdivision of claims.
§ 30.8 Required administrative proceedings.
§ 30.9 No private rights created.
Subpart B - Standards for the Administrative Collection of Debts
§ 30.10 Collection activities.
§ 30.11 Demand for payment.
§ 30.12 Administrative offset.
§ 30.13 Debt reporting and use of credit reporting agencies.
§ 30.14 Contracting with private collection contractors and with entities that locate and recover unclaimed assets.
§ 30.15 Suspension or revocation of eligibility for loans and loan guarantees, licenses, permits, or privileges.
§ 30.16 Liquidation of collateral.
§ 30.17 Collection in installments.
§ 30.18 Interest, penalties, and administrative costs.
§ 30.19 Review of cost effectiveness of collection.
§ 30.20 Taxpayer information.
Subpart C - Debt Compromise
§ 30.21 Scope and application.
§ 30.22 Bases for compromise.
§ 30.23 Enforcement policy.
§ 30.24 Joint and several liability.
§ 30.25 Further review of compromise offers.
§ 30.26 Consideration of tax consequences to the Government.
§ 30.27 Mutual release of the debtor and the Government.
Subpart D - Suspending and Terminating Collection Activities
§ 30.28 Scope and application.
§ 30.29 Suspension of collection activity.
§ 30.30 Termination of collection activity.
§ 30.31 Exception to termination.
§ 30.32 Discharge of indebtedness; reporting requirements.
Subpart E - Referrals to the Department of Justice
§ 30.33 Prompt referral.
§ 30.34 Claims Collection Litigation Report.
§ 30.35 Preservation of evidence.
§ 30.36 Minimum amount of referrals.
PART 31 - TAX REFUND OFFSET
§ 31.1 Purpose and scope.
§ 31.2 Definitions.
§ 31.3 General rule.
§ 31.4 Certification and referral of debt.
§ 31.5 Notice.
§ 31.6 Review of Departmental records.
§ 31.7 Review of a determination that a debt is past-due and legally enforceable.
PART 32 - ADMINISTRATIVE WAGE GARNISHMENT
§ 32.1 Purpose and scope.
§ 32.2 Definitions.
§ 32.3 General rule.
§ 32.4 Notice.
§ 32.5 Hearing.
§ 32.6 Withholding order.
§ 32.7 Certification by employer.
§ 32.8 Amounts withheld.
§ 32.9 Financial hardship.
§ 32.10 Refunds.
§ 32.11 Ending garnishment.
§ 32.12 Right of action.
PART 33 - SALARY OFFSET
§ 33.1 Purpose, authority, and scope.
§ 33.2 Definitions.
§ 33.3 General rule.
§ 33.4 Notice requirements before offset.
§ 33.5 Review of department records relating to the debt.
§ 33.6 Hearings.
§ 33.7 Obtaining the services of a hearing official.
§ 33.8 Voluntary repayment agreement in lieu of salary offset.
§ 33.9 Special review.
§ 33.10 Procedures for salary offset.
§ 33.11 Salary offset when the Department is the creditor agency but not the paying agency.
§ 33.12 Salary offset when the Department is the paying agency but not the creditor agency.
§ 33.13 Interest, penalties, and administrative costs.
§ 33.14 Non-waiver of rights.
§ 33.15 Refunds.
§ 33.16 Additional administrative collection action.
PART 34 - CLAIMS FILED UNDER THE MILITARY PERSONNEL AND CIVILIAN EMPLOYEES ACT
§ 34.1 Purpose and scope.
§ 34.2 Definitions.
§ 34.3 Filing procedures and time limits.
§ 34.4 Allowable claims.
§ 34.5 Unallowable claims.
§ 34.6 Reconsideration or appeal.
§ 34.7 Payment procedures.
§ 34.8 Computation of award and settlement.
§ 34.9 Claims involving carriers or insurers.
PART 35 - TORT CLAIMS AGAINST THE GOVERNMENT
Subpart A - General
§ 35.1 Scope of regulations.
Subpart B - Procedures
§ 35.2 Administrative claim; when presented; place of filing.
§ 35.3 Administrative claim; who may file.
§ 35.4 Administrative claims; evidence and information to be submitted.
§ 35.5 Investigation, examination, and determination of claims.
§ 35.6 Final denial of claim.
§ 35.7 Payment of approved claims.
§ 35.8 Release.
§ 35.9 Penalties.
§ 35.10 Limitation on Department's authority.
PART 36 - INDEMNIFICATION OF HHS EMPLOYEES
§ 36.1 Policy.
PART 46 - PROTECTION OF HUMAN SUBJECTS
Subpart A - Basic HHS Policy for Protection of Human Research Subjects
§ 46.101 To what does this policy apply?
§ 46.102 Definitions.
§ 46.103 Assuring compliance with this policy - research conducted or supported by any Federal Department or Agency.
§§ 46.104-46.106 [Reserved]
§ 46.107 IRB membership.
§ 46.108 IRB functions and operations.
§ 46.109 IRB review of research.
§ 46.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.
§ 46.111 Criteria for IRB approval of research.
§ 46.112 Review by institution.
§ 46.113 Suspension or termination of IRB approval of research.
§ 46.114 Cooperative research.
§ 46.115 IRB records.
§ 46.116 General requirements for informed consent.
§ 46.117 Documentation of informed consent.
§ 46.118 Applications and proposals lacking definite plans for involvement of human subjects.
§ 46.119 Research undertaken without the intention of involving human subjects.
§ 46.120 Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal Department or Agency.
§ 46.121 [Reserved]
§ 46.122 Use of Federal funds.
§ 46.123 Early termination of research support: Evaluation of applications and proposals.
§ 46.124 Conditions.
Subpart B - Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
§ 46.201 To what do these regulations apply?
§ 46.202 Definitions.
§ 46.203 Duties of IRBs in connection with research involving pregnant women, fetuses, and neonates.
§ 46.204 Research involving pregnant women or fetuses.
§ 46.205 Research involving neonates.
§ 46.206 Research involving, after delivery, the placenta, the dead fetus or fetal material.
§ 46.207 Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates.
Subpart C - Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
§ 46.301 Applicability.
§ 46.302 Purpose.
§ 46.303 Definitions.
§ 46.304 Composition of Institutional Review Boards where prisoners are involved.
§ 46.305 Additional duties of the Institutional Review Boards where prisoners are involved.
§ 46.306 Permitted research involving prisoners.
Subpart D - Additional Protections for Children Involved as Subjects in Research
§ 46.401 To what do these regulations apply?
§ 46.402 Definitions.
§ 46.403 IRB duties.
§ 46.404 Research not involving greater than minimal risk.
§ 46.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects.
§ 46.406 Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject's disorder or condition.
§ 46.407 Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.
§ 46.408 Requirements for permission by parents or guardians and for assent by children.
§ 46.409 Wards.
Subpart E - Registration of Institutional Review Boards
§ 46.501 What IRBs must be registered?
§ 46.502 What information must be provided when registering an IRB?
§ 46.503 When must an IRB be registered?
§ 46.504 How must an IRB be registered?
§ 46.505 When must IRB registration information be renewed or updated?
PART 50 - U.S. EXCHANGE VISITOR PROGRAM - REQUEST FOR WAIVER OF THE TWO-YEAR FOREIGN RESIDENCE REQUIREMENT
§ 50.1 Authority.
§ 50.2 Exchange Visitor Waiver Review Board.
§ 50.3 Policy.
§ 50.4 Waivers for research.
§ 50.5 Waivers for the delivery of health care service.
§ 50.6 Procedures for submission of application to HHS.
§ 50.7 Personal hardship, persecution and visa extension considerations.
§ 50.8 Compliance.
PART 51 - CRITERIA FOR EVALUATING COMPREHENSIVE PLAN TO REDUCE RELIANCE ON ALIEN PHYSICIANS
§ 51.1 Purpose.
§ 51.2 Application.
§ 51.3 Who is eligible to apply?
§ 51.4 How will the plans be evaluated?
PART 57 - VOLUNTEER SERVICES
§ 57.1 Applicability.
§ 57.2 Definitions.
§ 57.3 Volunteer service programs.
§ 57.4 Acceptance and use of volunteer services.
§ 57.5 Services and benefits available to volunteers.
PART 60 - NATIONAL PRACTITIONER DATA BANK
Subpart A - General Provisions
§ 60.1 The National Practitioner Data Bank.
§ 60.2 Applicability.
§ 60.3 Definitions.
Subpart B - Reporting of Information
§ 60.4 How information must be reported.
§ 60.5 When information must be reported.
§ 60.6 Reporting errors, omissions, revisions or whether an action is on appeal.
§ 60.7 Reporting medical malpractice payments.
§ 60.8 Reporting licensure actions taken by Boards of Medical Examiners.
§ 60.9 Reporting licensure and certification actions taken by states.
§ 60.10 Reporting Federal licensure and certification actions.
§ 60.11 Reporting negative actions or findings taken by peer review organizations or private accreditation entities.
§ 60.12 Reporting adverse actions taken against clinical privileges.
§ 60.13 Reporting Federal or state criminal convictions related to the delivery of a health care item or service.
§ 60.14 Reporting civil judgments related to the delivery of a health care item or service.
§ 60.15 Reporting exclusions from participation in Federal or state health care programs.
§ 60.16 Reporting other adjudicated actions or decisions.
Subpart C - Disclosure of Information by the National Practitioner Data Bank
§ 60.17 Information which hospitals must request from the National Practitioner Data Bank.
§ 60.18 Requesting information from the National Practitioner Data Bank.
§ 60.19 Fees applicable to requests for information.
§ 60.20 Confidentiality of National Practitioner Data Bank information.
§ 60.21 How to dispute the accuracy of National Practitioner Data Bank information.
§ 60.22 Immunity.
PART 63 - GRANT PROGRAMS ADMINISTERED BY THE OFFICE OF THE ASSISTANT SECRETARY FOR PLANNING AND EVALUATION
Subpart A - General
§ 63.1 Purpose and scope.
§ 63.2 Eligibility for award.
§ 63.3 Program announcements and solicitations.
§ 63.4 Cooperative arrangements.
§ 63.5 Effective date of approved grant.
§ 63.6 Evaluation of applications.
§ 63.7 Disposition of applications.
§ 63.8 Supplemental regulations and grant conditions.
Subpart B - Financial Provisions
§ 63.16 Scope of subpart.
§ 63.17 Amount of award.
§ 63.18 Limitations on costs.
§ 63.19 Budget revisions and minor deviations.
§ 63.20 Period during which grant funds may be obligated.
§ 63.21 Obligation and liquidation by grantee.
§ 63.22 Cost sharing.
§ 63.23 Telecommunications Demonstration Grants.
Subpart C - Special Provisions
§ 63.30 Scope of subpart.
§ 63.31 Protection of human subjects.
§ 63.32 Data collection instruments.
§ 63.33 Treatment of animals.
§ 63.34 Principal investigators.
§ 63.35 Dual compensation.
§ 63.36 Fees to Federal employees.
§ 63.37 Leasing facilities.
§ 63.38 Publications.
§ 63.39 Religious worship or instruction.
PART 73 - STANDARDS OF CONDUCT
Subpart A - General Provisions
§ 73.735-101 Purpose.
§ 73.735-102 Definitions.
§ 73.735-103 Applicability.
Subpart B - Responsibilities
§ 73.735-201 Employees and supervisors.
§ 73.735-202 Management officials.
Subpart C - Conduct on the Job
§ 73.735-301 Courtesy and consideration for others.
§ 73.735-302 Support of department programs.
§ 73.735-303 Use of government funds.
§ 73.735-304 Use of government property.
§ 73.735-305 Conduct in Federal buildings.
§ 73.735-306 Sexual harassment.
§ 73.735-307 Use of official information.
Subpart D - Financial Obligations
§ 73.735-401 General provisions.
Subpart E - Gifts, Entertainment, and Favors
§ 73.735-501 Prohibited acceptance of gifts, entertainment, and favors.
§ 73.735-502 Permissible acceptance of gifts, entertainment, and favors.
§ 73.735-503 Criminal provisions relating to gifts, entertainment, and favors.
§ 73.735-504 Gifts to official superiors.
§ 73.735-505 Acceptance of awards and prizes.
§ 73.735-506 Gifts and decorations from foreign governments.
§ 73.735-507 Acceptance of travel and subsistence.
§ 73.735-508 Other prohibitions.
Subpart F - Political Activity
§ 73.735-601 Applicability.
§ 73.735-602 Permissible activities.
§ 73.735-603 Prohibited activities.
Subpart G - Outside Activities
§ 73.735-701 General provisions.
§ 73.735-702 Criminal prohibitions on outside activities.
§ 73.735-703 Statutory prohibitions related to employment by a foreign government.
§ 73.735-704 Professional and consultative services.
§ 73.735-705 Writing and editing.
§ 73.735-706 Teaching, lecturing, and speechmaking.
§ 73.735-707 Holding office in professional societies.
§ 73.735-708 Administrative approval of certain outside activities.
§ 73.735-709 Annual reporting of outside activities.
§ 73.735-710 Maintenance of records.
Subpart H - Financial Interest
§ 73.735-801 Participation in matters affecting a personal financial interest.
§ 73.735-802 Executive order prohibitions.
§ 73.735-803 Prohibition against involvement in financial transactions based on information obtained through Federal employment.
§ 73.735-804 Waiver of the prohibitions in this subpart.
§ 73.735-805 Advice and guidance on conflicts matters.
§ 73.735-806 Documentation and publication of opinions.
Subpart I - Reporting Financial Interests
§ 73.735-901 Reporting requirement of the Ethics in Government Act of 1978.
§ 73.735-902 Reporting requirements for certain employees not covered by the Ethics in Government Act of 1978.
§ 73.735-903 Action if conflicts of interest or possible conflicts are noted.
§ 73.735-904 Resolution of apparent or actual conflicts of interest.
Subpart J - Provisions Relating to Experts, Consultants and Advisory Committee Members
§ 73.735-1001 Coverage.
§ 73.735-1002 Ethical standards of conduct.
§ 73.735-1003 Conflicts of interest statutes.
§ 73.735-1004 Requesting waivers or exemptions.
§ 73.735-1005 Salary from two sources.
§ 73.735-1006 Reporting financial interests.
§ 73.735-1007 Political activity.
Subpart K - Special Government Employees Other Than Consultants
§ 73.735-1101 General provision.
Subpart L - Disciplinary Action
§ 73.735-1201 General provisions.
Subpart M - Reporting Violations
§ 73.735-1301 Responsibility for reporting possible criminal violations.
§ 73.735-1302 Responsibility for reporting allegations of misconduct.
§ 73.735-1303 Prohibition of reprisals.
§ 73.735-1304 Referral of matters arising under the standards of this part.
Subpart N - Conduct and Responsibilities of Former Employees
§ 73.735-1401 Prohibitions against post-employment conflicts of interest.
PART 73a - STANDARDS OF CONDUCT: FOOD AND DRUG ADMINISTRATION SUPPLEMENT
Subpart A - General Provisions
§ 73a.735-101 Principles and purpose.
§ 73a.735-103 Responsibilities.
§ 73a.735-104 Advice and guidance.
Subpart B - Miscellaneous Provisions
§ 73a.735-201 Control activity employees formerly associated with organizations subject to FDA regulation.
Subpart D - Outside Employment
§ 73a.735-401 General provisions.
Subpart E - Financial Interests
§ 73a.735-501 General provisions.
§ 73a.735-502 Employees in regulatory activities.
§ 73a.735-504 Exceptions.
Subpart J - Statements of Employment and Financial Interests
§ 73a.735-1004 Submission and review of statements.
PART 73b - DEBARMENT OR SUSPENSION OF FORMER EMPLOYEES
§ 73b.1 Scope.
§ 73b.2 Rules and regulations.
§ 73b.3 Reports of violations.
§ 73b.4 Proceedings.
§ 73b.5 Hearings.
PART 75 - UNIFORM ADMINISTRATIVE REQUIREMENTS, COST PRINCIPLES, AND AUDIT REQUIREMENTS FOR HHS AWARDS
Subpart A - Acronyms and Definitions
§ 75.1 Acronyms.
§ 75.2 Definitions.
Subpart B - General Provisions
§ 75.100 Purpose.
§ 75.101 Applicability.
§ 75.102 Exceptions.
§ 75.103 Authorities.
§ 75.104 Supersession.
§ 75.105 Effect on other issuances.
§ 75.106 Agency implementation.
§ 75.107 OMB responsibilities.
§ 75.108 Inquiries.
§ 75.109 Review date.
§ 75.110 Effective/Applicability date.
§ 75.111 English language.
§ 75.112 Conflict of interest.
§ 75.113 Mandatory disclosures.
Subpart C - Pre-Federal Award Requirements and Contents of Federal Awards
§ 75.200 Purpose.
§ 75.201 Use of grant agreements (including fixed amount awards), cooperative agreements, and contracts.
§ 75.202 Requirement to provide public notice of Federal financial assistance programs.
§ 75.203 Notices of funding opportunities.
§ 75.204 HHS funding agency review of merit of proposals.
§ 75.205 HHS awarding agency review of risk posed by applicants.
§ 75.206 Standard application requirements, including forms for applying for HHS financial assistance, and state plans.
§ 75.207 Specific award conditions.
§ 75.208 Certifications and representations.
§ 75.209 Pre-award costs.
§ 75.210 Information contained in a Federal award.
§ 75.211 Public access to Federal award information.
§ 75.212 Reporting a determination that a recipient is not qualified for a Federal award.
§ 75.213 Suspension and debarment.
§ 75.214 Metric system of measurement.
§ 75.215 Disclosure of lobbying activities.
§ 75.216 Special provisions for awards to commercial organizations as recipients.
§ 75.217 Special provisions for awards to Federal agencies.
§ 75.218 Participation by faith-based organizations.
PART 77 - REMEDIAL ACTIONS APPLICABLE TO LETTER OF CREDIT ADMINISTRATION
§ 77.1 Purpose.
§ 77.2 Scope.
§ 77.3 Conditions that may give rise to remedial actions.
§ 77.4 Remedial actions.
§ 77.5 Remedial action procedures.
§ 77.6 Emergency procedures.
PART 78 - CONDITIONS FOR WAIVER OF DENIAL OF FEDERAL BENEFITS
§ 78.1 Applicability.
§ 78.2 Definitions.
§ 78.3 Benefits not denied to rehabilitated offenders.
PART 79 - PROGRAM FRAUD CIVIL REMEDIES
§ 79.1 Basis and purpose.
§ 79.2 Definitions.
§ 79.3 Basis for civil penalties and assessments.
§ 79.4 Investigation.
§ 79.5 Review by the reviewing official.
§ 79.6 Prerequisites for issuing a complaint.
§ 79.7 Complaint.
§ 79.8 Service of complaint.
§ 79.9 Answer.
§ 79.10 Default upon failure to file an answer.
§ 79.11 Referral of complaint and answer to the ALJ.
§ 79.12 Notice of hearing.
§ 79.13 Parties to the hearing.
§ 79.14 Separation of functions.
§ 79.15 Ex parte contacts.
§ 79.16 Disqualification of reviewing official or ALJ.
§ 79.17 Rights of parties.
§ 79.18 Authority of the ALJ.
§ 79.19 Prehearing conferences.
§ 79.20 Disclosure of documents.
§ 79.21 Discovery.
§ 79.22 Exchange of witness lists, statements and exhibits.
§ 79.23 Subpoenas for attendance at hearing.
§ 79.24 Protective order.
§ 79.25 Fees.
§ 79.26 Form, filing and service of papers.
§ 79.27 Computation of time.
§ 79.28 Motions.
§ 79.29 Sanctions.
§ 79.30 The hearing and burden of proof.
§ 79.31 Determining the amount of penalties and assessments.
§ 79.32 Location of hearing.
§ 79.33 Witnesses.
§ 79.34 Evidence.
§ 79.35 The record.
§ 79.36 Post-hearing briefs.
§ 79.37 Initial decision.
§ 79.38 Reconsideration of initial decision.
§ 79.39 Appeal to authority head.
§ 79.40 Stays ordered by the Department of Justice.
§ 79.41 Stay pending appeal.
§ 79.42 Judicial review.
§ 79.43 Collection of civil penalties and assessments.
§ 79.44 Right to administrative offset.
§ 79.45 Deposit in Treasury of United States.
§ 79.46 Compromise or settlement.
§ 79.47 Limitations.
PART 80 - NONDISCRIMINATION UNDER PROGRAMS RECEIVING FEDERAL ASSISTANCE THROUGH THE DEPARTMENT OF HEALTH AND HUMAN SERVICES EFFECTUATION OF TITLE VI OF THE CIVIL RIGHTS ACT OF 1964
§ 80.1 Purpose.
§ 80.2 Application of this regulation.
§ 80.3 Discrimination prohibited.
§ 80.4 Assurances required.
§ 80.5 Illustrative application.
§ 80.6 Compliance information.
§ 80.7 Conduct of investigations.
§ 80.8 Procedure for effecting compliance.
§ 80.9 Hearings.
§ 80.10 Decisions and notices.
§ 80.11 Judicial review.
§ 80.12 Effect on other regulations; forms and instructions.
§ 80.13 Definitions.
PART 81 - PRACTICE AND PROCEDURE FOR HEARINGS UNDER PART 80 OF THIS TITLE
Subpart A - General Information
§ 81.1 Scope of rules.
§ 81.2 Records to be public.
§ 81.3 Use of gender and number.
§ 81.4 Suspension of rules.
Subpart B - Appearance and Practice
§ 81.11 Appearance.
§ 81.12 Authority for representation.
§ 81.13 Exclusion from hearing for misconduct.
Subpart C - Parties
§ 81.21 Parties; General Counsel deemed a party.
§ 81.22 Amici curiae.
§ 81.23 Complainants not parties.
Subpart D - Form, Execution, Service and Filing of Documents
§ 81.31 Form of documents to be filed.
§ 81.32 Signature of documents.
§ 81.33 Filing and service.
§ 81.34 Service - how made.
§ 81.35 Date of service.
§ 81.36 Certificate of service.
Subpart E - Time
§ 81.41 Computation.
§ 81.42 Extension of time or postponement.
§ 81.43 Reduction of time to file documents.
Subpart F - Proceedings Prior to Hearing
§ 81.51 Notice of hearing or opportunity for hearing.
§ 81.52 Answer to notice.
§ 81.53 Amendment of notice or answer.
§ 81.54 Request for hearing.
§ 81.55 Consolidation.
§ 81.56 Motions.
§ 81.57 Responses to motions and petitions.
§ 81.58 Disposition of motions and petitions.
Subpart G - Responsibilities and Duties of Presiding Officer
§ 81.61 Who presides.
§ 81.62 Designation of hearing examiner.
§ 81.63 Authority of presiding officer.
Subpart H - Hearing Procedures
§ 81.71 Statement of position and trial briefs.
§ 81.72 Evidentiary purpose.
§ 81.73 Testimony.
§ 81.74 Exhibits.
§ 81.75 Affidavits.
§ 81.76 Depositions.
§ 81.77 Admissions as to facts and documents.
§ 81.78 Evidence.
§ 81.79 Cross-examination.
§ 81.80 Unsponsored written material.
§ 81.81 Objections.
§ 81.82 Exceptions to rulings of presiding officer unnecessary.
§ 81.83 Official notice.
§ 81.84 Public document items.
§ 81.85 Offer of proof.
§ 81.86 Appeals from ruling of presiding officer.
Subpart I - The Record
§ 81.91 Official transcript.
§ 81.92 Record for decision.
Subpart J - Posthearing Procedures, Decisions
§ 81.101 Posthearing briefs: Proposed findings and conclusions.
§ 81.102 Decisions following hearing.
§ 81.103 Exceptions to initial or recommended decisions.
§ 81.104 Final decisions.
§ 81.105 Oral argument to the reviewing authority.
§ 81.106 Review by the Secretary.
§ 81.107 Service on amici curiae.
Subpart K - Judicial Standards of Practice
§ 81.111 Conduct.
§ 81.112 Improper conduct.
§ 81.113 Ex parte communications.
§ 81.114 Expeditious treatment.
§ 81.115 Matters not prohibited.
§ 81.116 Filing of ex parte communications.
Subpart L - Posttermination Proceedings
§ 81.121 Posttermination proceedings.
Subpart M - Definitions
§ 81.131 Definitions.
PART 83 - REGULATION FOR THE ADMINISTRATION AND ENFORCEMENT OF SECTIONS 799A AND 845 OF THE PUBLIC HEALTH SERVICE ACT
Subpart A - Purposes; Definitions; Coverage
§ 83.1 Purposes.
§ 83.2 Definitions.
§ 83.3 Remedial and affirmative actions.
§ 83.4 Coverage.
§ 83.5 Effect of title IX of the Education Amendments of 1972.
§§ 83.6-83.9 [Reserved]
Subpart B - Discrimination in Admissions Prohibited
§ 83.10 General obligations.
§ 83.11 Discriminatory acts prohibited.
§ 83.12 Recruitment.
§ 83.13 State law and licensure requirements.
§ 83.14 Development and dissemination of nondiscrimination policy.
§ 83.15 Designation by entity of responsible employee and adoption of grievance procedures.
§§ 83.16-83.19 [Reserved]
Subpart C - Procedures [Interim]
§ 83.20 Interim procedures.
PART 84 - NONDISCRIMINATION ON THE BASIS OF HANDICAP IN PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE
Subpart A - General Provisions
§ 84.1 Purpose.
§ 84.2 Application.
§ 84.3 Definitions.
§ 84.4 Discrimination prohibited.
§ 84.5 Assurances required.
§ 84.6 Remedial action, voluntary action, and self-evaluation.
§ 84.7 Designation of responsible employee and adoption of grievance procedures.
§ 84.8 Notice.
§ 84.9 Administrative requirements for small recipients.
§ 84.10 Effect of State or local law or other requirements and effect of employment opportunities.
Subpart B - Employment Practices
§ 84.11 Discrimination prohibited.
§ 84.12 Reasonable accommodation.
§ 84.13 Employment criteria.
§ 84.14 Preemployment inquiries.
§§ 84.15-84.20 [Reserved]
Subpart C - Accessibility
§ 84.21 Discrimination prohibited.
§ 84.22 Existing facilities.
§ 84.23 New construction.
§§ 84.24-84.30 [Reserved]
Subpart D - Preschool, Elementary, and Secondary Education
§ 84.31 Application of this subpart.
§ 84.32 Location and notification.
§ 84.33 Free appropriate public education.
§ 84.34 Educational setting.
§ 84.35 Evaluation and placement.
§ 84.36 Procedural safeguards.
§ 84.37 Nonacademic services.
§ 84.38 Preschool and adult education.
§ 84.39 Private education.
§ 84.40 [Reserved]
Subpart E - Postsecondary Education
§ 84.41 Application of this subpart.
§ 84.42 Admissions and recruitment.
§ 84.43 Treatment of students; general.
§ 84.44 Academic adjustments.
§ 84.45 Housing.
§ 84.46 Financial and employment assistance to students.
§ 84.47 Nonacademic services.
§§ 84.48-84.50 [Reserved]
Subpart F - Health, Welfare, and Social Services
§ 84.51 Application of this subpart.
§ 84.52 Health, welfare, and other social services.
§ 84.53 Drug and alcohol addicts.
§ 84.54 Education of institutionalized persons.
§ 84.55 Procedures relating to health care for handicapped infants.
§§ 84.56-84.60 [Reserved]
Subpart G - Procedures
§ 84.61 Procedures.
PART 85 - ENFORCEMENT OF NONDISCRIMINATION ON THE BASIS OF HANDICAP IN PROGRAMS OR ACTIVITIES CONDUCTED BY THE DEPARTMENT OF HEALTH AND HUMAN SERVICES
§ 85.1 Purpose.
§ 85.2 Application.
§ 85.3 Definitions.
§§ 85.4-85.10 [Reserved]
§ 85.11 Self-evaluation.
§ 85.12 Notice.
§§ 85.13-85.20 [Reserved]
§ 85.21 General prohibitions against discrimination.
§§ 85.22-85.30 [Reserved]
§ 85.31 Employment.
§§ 85.32-85.40 [Reserved]
§ 85.41 Program accessibility: Discrimination prohibited.
§ 85.42 Program accessibility: Existing facilities.
§ 85.43 Program accessibility: New construction and alterations.
§§ 85.44-85.50 [Reserved]
§ 85.51 Communications.
§§ 85.52-85.60 [Reserved]
§ 85.61 Compliance procedures.
§ 85.62 Coordination and compliance responsibilities.
PART 86 - NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE
Subpart A - Introduction
§ 86.1 Purpose and effective date.
§ 86.2 Definitions.
§ 86.3 Remedial and affirmative action and self-evaluation.
§ 86.4 Assurance required.
§ 86.5 Transfers of property.
§ 86.6 Effect of other requirements.
§ 86.7 Effect of employment opportunities.
§ 86.8 Designation of responsible employee and adoption of grievance procedures.
§ 86.9 Dissemination of policy.
Subpart B - Coverage
§ 86.11 Application.
§ 86.12 Educational institutions controlled by religious organizations.
§ 86.13 Military and merchant marine educational institutions.
§ 86.14 Membership practices of certain organizations.
§ 86.15 Admissions.
§ 86.16 Educational institutions eligible to submit transition plans.
§ 86.17 Transition plans.
§§ 86.18-86.20 [Reserved]
Subpart C - Discrimination on the Basis of Sex in Admission and Recruitment Prohibited
§ 86.21 Admission.
§ 86.22 Preference in admission.
§ 86.23 Recruitment.
§§ 86.24-86.30 [Reserved]
Subpart D - Discrimination on the Basis of Sex in Education Programs or Activities Prohibited
§ 86.31 Education programs or activities.
§ 86.32 Housing.
§ 86.33 Comparable facilities.
§ 86.34 Access to course offerings.
§ 86.35 Access to schools operated by L.E.A.s.
§ 86.36 Counseling and use of appraisal and counseling materials.
§ 86.37 Financial assistance.
§ 86.38 Employment assistance to students.
§ 86.39 Health and insurance benefits and services.
§ 86.40 Marital or parental status.
§ 86.41 Athletics.
§ 86.42 Textbooks and curricular material.
§§ 86.43-86.50 [Reserved]
Subpart E - Discrimination on the Basis of Sex in Employment in Education Programs or Activities Prohibited
§ 86.51 Employment.
§ 86.52 Employment criteria.
§ 86.53 Recruitment.
§ 86.54 Compensation.
§ 86.55 Job classification and structure.
§ 86.56 Fringe benefits.
§ 86.57 Marital or parental status.
§ 86.58 Effect of State or local law or other requirements.
§ 86.59 Advertising.
§ 86.60 Pre-employment inquiries.
§ 86.61 Sex as a bona-fide occupational qualification.
§§ 86.62-86.70 [Reserved]
Subpart F - Procedures [Interim]
§ 86.71 Interim procedures.
PART 87 - EQUAL TREATMENT FOR FAITH-BASED ORGANIZATIONS
§ 87.1 Definitions.
§ 87.2 Applicability.
§ 87.3 Grants.
PART 88 - ENSURING THAT DEPARTMENT OF HEALTH AND HUMAN SERVICES FUNDS DO NOT SUPPORT COERCIVE OR DISCIMINATORY POLICIES OR PRACTICES IN VIOLATION OF FEDERAL LAW
§ 88.1 Purpose.
§ 88.2 Complaint handling and investigating.
PART 89 - ORGANIZATIONAL INTEGRITY OF ENTITIES IMPLEMENTING PROGRAMS AND ACTIVITIES UNDER THE LEADERSHIP ACT
§ 89.1 Applicability and requirements.
§ 89.2 Definitions.
§ 89.3 Organizational integrity of recipients.
PART 90 - NONDISCRIMINATION ON THE BASIS OF AGE IN PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE
Subpart A - General
§ 90.1 What is the purpose of the Age Discrimination Act of 1975?
§ 90.2 What is the purpose of these regulations?
§ 90.3 What programs or activities does the Age Discrimination Act of 1975 cover?
§ 90.4 How are the terms in these regulations defined?
Subpart C - What are the Responsibilities of the Federal Agencies?
§ 90.31 Issuance of regulations.
§ 90.32 Review of agency policies and administrative practices.
§ 90.33 Interagency cooperation.
§ 90.34 Agency reports.
Subpart D - Investigation, Conciliation and Enforcement Procedures
§ 90.41 What is the purpose of this subpart?
§ 90.42 What responsibilities do recipients and agencies have generally to ensure compliance with the Act?
§ 90.43 What specific responsibilities do agencies and recipients have to ensure compliance with the Act?
§ 90.44 Compliance reviews.
§ 90.45 Information requirements.
§ 90.46 Prohibition against intimidation or retaliation.
§ 90.47 What further provisions must an agency make in order to enforce its regulations after an investigation indicates that a violation of the Act has been committed?
§ 90.48 Alternate funds disbursal procedure.
§ 90.49 Remedial and affirmative action by recipients.
§ 90.50 Exhaustion of administrative remedies.
Subpart E - Future Review of Age Discrimination Regulations
§ 90.61 Review of general regulations.
§ 90.62 Review of agency regulations.
PART 91 - NONDISCRIMINATION ON THE BASIS OF AGE IN PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE FROM HHS
Subpart A - General
§ 91.1 What is the purpose of the Age Discrimination Act of 1975?
§ 91.2 What is the purpose of HHS' age discrimination regulations?
§ 91.3 To what programs or activities do these regulations apply?
§ 91.4 Definition of terms used in these regulations.
Subpart B - Standards for Determining Age Discrimination
§ 91.11 Rules against age discrimination.
§ 91.12 Definitions of normal operation and statutory objective.
§ 91.13 Exceptions to the rules against age discrimination: Normal operation or statutory objective of any program or activity.
§ 91.14 Exceptions to the rules against age discrimination: Reasonable factors other than age.
§ 91.15 Burden of proof.
§ 91.16 Affirmative action by recipient.
§ 91.17 Special benefits for children and the elderly.
§ 91.18 Age distinctions contained in HHS regulations.
Subpart C - Duties of HHS Recipients
§ 91.31 General responsibilities.
§ 91.32 Notice to subrecipients and beneficiaries.
§ 91.33 Assurance of compliance and recipient assessment of age distinctions.
§ 91.34 Information requirements.
Subpart D - Investigation, Conciliation, and Enforcement Procedures
§ 91.41 Compliance reviews.
§ 91.42 Complaints.
§ 91.43 Mediation.
§ 91.44 Investigation.
§ 91.45 Prohibition against intimidation or retaliation.
§ 91.46 Compliance procedure.
§ 91.47 Hearings, decisions, post-termination proceedings.
§ 91.48 Remedial action by recipient.
§ 91.49 Alternate funds disbursal procedure.
§ 91.50 Exhaustion of administrative remedies.
PART 92 - NONDISCRIMINATION ON THE BASIS OF RACE, COLOR, NATIONAL ORIGIN, SEX, AGE, OR DISABILITY IN HEALTH PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE AND HEALTH PROGRAMS OR ACTIVITIES ADMINISTERED BY THE DEPARTMENT OF HEALTH AND HUMAN SERVICES OR ENTITIES ESTABLISHED UNDER TITLE I OF THE PATIENT PROTECTION AND AFFORDABLE CARE ACT
Subpart A - General Provisions
§ 92.1 Purpose and effective date.
§ 92.2 Application.
§ 92.3 Relationship to other laws.
§ 92.4 Definitions.
§ 92.5 Assurances required.
§ 92.6 Remedial action and voluntary action.
§ 92.7 Designation of responsible employee and adoption of grievance procedures.
§ 92.8 Notice requirement.
Subpart B - Nondiscrimination Provisions
§ 92.101 Discrimination prohibited.
Subpart C - Specific Applications to Health Programs and Activities
§ 92.201 Meaningful access for individuals with limited English proficiency.
§ 92.202 Effective communication for individuals with disabilities.
§ 92.203 Accessibility standards for buildings and facilities.
§ 92.204 Accessibility of electronic and information technology.
§ 92.205 Requirement to make reasonable modifications.
§ 92.206 Equal program access on the basis of sex.
§ 92.207 Nondiscrimination in health-related insurance and other health-related coverage.
§ 92.208 Employer liability for discrimination in employee health benefit programs.
§ 92.209 Nondiscrimination on the basis of association.
Subpart D - Procedures
§ 92.301 Enforcement mechanisms.
§ 92.302 Procedures for health programs and activities conducted by recipients and State-based Marketplaces.
§ 92.303 Procedures for health programs and activities administered by the Department.
PART 93 - NEW RESTRICTIONS ON LOBBYING
Subpart A - General
§ 93.100 Conditions on use of funds.
§ 93.105 Definitions.
§ 93.110 Certification and disclosure.
Subpart B - Activities by Own Employees
§ 93.200 Agency and legislative liaison.
§ 93.205 Professional and technical services.
§ 93.210 Reporting.
Subpart C - Activities by Other than Own Employees
§ 93.300 Professional and technical services.
Subpart D - Penalties and Enforcement
§ 93.400 Penalties.
§ 93.405 Penalty procedures.
§ 93.410 Enforcement.
Subpart E - Exemptions
§ 93.500 Secretary of Defense.
Subpart F - Agency Reports
§ 93.600 Semi-annual compilation.
§ 93.605 Inspector General report.
PART 94 - RESPONSIBLE PROSPECTIVE CONTRACTORS
§ 94.1 Purpose.
§ 94.2 Applicability.
§ 94.3 Definitions.
§ 94.4 Responsibilities of Institutions regarding Investigator financial conflicts of interest.
§ 94.5 Management and reporting of financial conflicts of interest.
§ 94.6 Remedies.
PART 95 - GENERAL ADMINISTRATION - GRANT PROGRAMS (PUBLIC ASSISTANCE, MEDICAL ASSISTANCE AND STATE CHILDREN'S HEALTH INSURANCE PROGRAMS)
Subpart A - Time Limits for States To File Claims
§ 95.1 Scope.
§ 95.4 Definitions.
§ 95.7 Time limit for claiming payment for expenditures made after September 30, 1979.
§ 95.10 Time limit for claiming payment for expenditures made before October 1, 1979.
§ 95.11 Payment of claims subject to appropriations restrictions.
§ 95.13 In which quarter we consider an expenditure made.
§ 95.19 Exceptions to time limits.
§ 95.22 Meaning of good cause.
§ 95.25 When to request a waiver for good cause.
§ 95.28 What a waiver request for good cause must include.
§ 95.31 Where to send a waiver request for good cause.
§ 95.34 The decision to waive the time limit for good cause.
Subpart E - Cost Allocation Plans
§ 95.501 Purpose.
§ 95.503 Scope.
§ 95.505 Definitions.
§ 95.507 Plan requirements.
§ 95.509 Cost allocation plan amendments and certifications.
§ 95.511 Approval of the cost allocation plan or plan amendment.
§ 95.515 Effective date of a cost allocation plan amendment.
§ 95.517 Claims for Federal financial participation.
§ 95.519 Cost disallowance.
Subpart G - Equipment Acquired Under Public Assistance Programs
§ 95.701 Purpose and scope of subpart.
§ 95.703 Definitions.
§ 95.705 Equipment costs - Federal financial participation.
§ 95.707 Equipment management and disposition.
PART 96 - BLOCK GRANTS
Subpart A - Introduction
§ 96.1 Scope.
§ 96.2 Definitions.
§ 96.3 Information collection approval numbers.
Subpart B - General Procedures
§ 96.10 Prerequisites to obtain block grant funds.
§ 96.11 Basis of award to the States.
§ 96.12 Grant payment.
§ 96.13 Reallotments.
§ 96.14 Time period for obligation and expenditure of grant funds.
§ 96.15 Waivers.
§ 96.16 Applicability of title XVII of the Reconciliation Act (31 U.S.C. 7301-7305).
§ 96.17 Annual reporting requirements.
§ 96.18 Participation by faith-based organizations.
Subpart C - Financial Management
§ 96.30 Fiscal and administrative requirements.
§ 96.31 Audits.
§ 96.32 Financial settlement.
§ 96.33 Referral of cases to the Inspector General.
Subpart D - Direct Funding of Indian Tribes and Tribal Organizations
§ 96.40 Scope.
§ 96.41 General determination.
§ 96.42 General procedures and requirements.
§ 96.43 Procedures during FY 1982.
§ 96.44 Community services.
§ 96.45 Preventive health and health services.
§ 96.46 Substance abuse prevention and treatment services.
§ 96.47 Primary care.
§ 96.48 Low-income home energy assistance.
§ 96.49 Due date for receipt of all information required for completion of tribal applications for the low-income home energy assistance block grants.
Subpart E - Enforcement
§ 96.50 Complaints.
§ 96.51 Hearings.
§ 96.52 Appeals.
§ 96.53 Length of withholding.
Subpart F - Hearing Procedure
§ 96.60 Scope.
§ 96.61 Initiation of hearing.
§ 96.62 Presiding officer.
§ 96.63 Communications to presiding officer.
§ 96.64 Intervention.
§ 96.65 Discovery.
§ 96.66 Hearing procedure.
§ 96.67 Right to counsel.
§ 96.68 Administrative record of a hearing.
Subpart G - Social Services Block Grants
§ 96.70 Scope.
§ 96.71 Definitions.
§ 96.72 Transferability of funds.
§ 96.73 Sterilization.
§ 96.74 Annual reporting requirements.
Subpart H - Low-income Home Energy Assistance Program
§ 96.80 Scope.
§ 96.81 Carryover and reallotment.
§ 96.82 Required report on households assisted.
§ 96.83 Increase in maximum amount that may be used for weatherization and other energy-related home repair.
§ 96.84 Miscellaneous.
§ 96.85 Income eligibility.
§ 96.86 Exemption from requirement for additional outreach and intake services.
§ 96.87 Leveraging incentive program.
§ 96.88 Administrative costs.
§ 96.89 Exemption from standards for providing energy crisis intervention assistance.
Subpart I - Community Services Block Grants
§ 96.90 Scope.
§ 96.91 Audit requirement.
§ 96.92 Termination of funding.
Subpart J - Primary Care Block Grants
§ 96.100 Scope.
§ 96.101 Review of a State decision to discontinue funding of a community health center.
§ 96.102 Carryover of unobligated funds.
Subpart K - Transition Provisions
§ 96.110 Scope.
§ 96.111 Continuation of pre-existing regulations.
§ 96.112 Community services block grant.
Subpart L - Substance Abuse Prevention and Treatment Block Grant
§ 96.120 Scope.
§ 96.121 Definitions.
§ 96.122 Application content and procedures.
§ 96.123 Assurances.
§ 96.124 Certain allocations.
§ 96.125 Primary prevention.
§ 96.126 Capacity of treatment for intravenous substance abusers.
§ 96.127 Requirements regarding tuberculosis.
§ 96.128 Requirements regarding human immunodeficiency virus.
§ 96.129 Revolving funds for establishment of homes in which recovering substance abusers may reside.
§ 96.130 State law regarding sale of tobacco products to individuals under age of 18.
§ 96.131 Treatment services for pregnant women.
§ 96.132 Additional agreements.
§ 96.133 Submission to Secretary of Statewide assessment of needs.
§ 96.134 Maintenance of effort regarding State expenditures.
§ 96.135 Restrictions on expenditure of grant.
§ 96.136 Independent peer review.
§ 96.137 Payment schedule.
PART 97 - CONSOLIDATION OF GRANTS TO THE INSULAR AREAS
§ 97.10 What is a consolidated grant?
§ 97.11 Which jurisdictions may apply for a consolidated grant?
§ 97.12 Which grants may be consolidated?
§ 97.13 How does an insular area apply for a consolidated grant?
§ 97.14 How will grant awards be made?
§ 97.15 For what purposes can grant funds be used?
§ 97.16 What fiscal, matching and administrative requirements apply to grantees?
PART 98 - CHILD CARE AND DEVELOPMENT FUND
Subpart A - Goals, Purposes and Definitions
§ 98.1 Purposes.
§ 98.2 Definitions.
§ 98.3 Effect on State law.
Subpart B - General Application Procedures
§ 98.10 Lead Agency responsibilities.
§ 98.11 Administration under contracts and agreements.
§ 98.12 Coordination and consultation.
§ 98.13 Applying for Funds.
§ 98.14 Plan process.
§ 98.15 Assurances and certifications.
§ 98.16 Plan provisions.
§ 98.17 Period covered by Plan.
§ 98.18 Approval and disapproval of Plans and Plan amendments.
§ 98.19 Requests for temporary relief from requirements.
Subpart C - Eligibility for Services
§ 98.20 A child's eligibility for child care services.
§ 98.21 Eligibility determination processes.
Subpart D - Program Operations (Child Care Services) - Parental Rights and Responsibilities
§ 98.30 Parental choice.
§ 98.31 Parental access.
§ 98.32 Parental complaints.
§ 98.33 Consumer and provider education.
§ 98.34 Parental rights and responsibilities.
Subpart E - Program Operations (Child Care Services) - Lead Agency and Provider Requirements
§ 98.40 Compliance with applicable State and local regulatory requirements.
§ 98.41 Health and safety requirements.
§ 98.42 Enforcement of licensing and health and safety requirements.
§ 98.43 Criminal background checks.
§ 98.44 Training and professional development.
§ 98.45 Equal access.
§ 98.46 Priority for child care services.
§ 98.47 List of providers.
§ 98.48 Nondiscrimination in admissions on the basis of religion.
§ 98.49 Nondiscrimination in employment on the basis of religion.
Subpart F - Use of Child Care and Development Funds
§ 98.50 Child care services.
§ 98.51 Services for children experiencing homelessness.
§ 98.52 Child care resource and referral system.
§ 98.53 Activities to improve the quality of child care.
§ 98.54 Administrative costs.
§ 98.55 Matching fund requirements.
§ 98.56 Restrictions on the use of funds.
§ 98.57 Cost allocation.
Subpart G - Financial Management
§ 98.60 Availability of funds.
§ 98.61 Allotments from the Discretionary Fund.
§ 98.62 Allotments from the Mandatory Fund.
§ 98.63 Allotments from the Matching Fund.
§ 98.64 Reallotment and redistribution of funds.
§ 98.65 Audits and financial reporting.
§ 98.66 Disallowance procedures.
§ 98.67 Fiscal requirements.
§ 98.68 Program integrity.
Subpart H - Program Reporting Requirements
§ 98.70 Reporting requirements.
§ 98.71 Content of report.
Subpart I - Indian Tribes
§ 98.80 General procedures and requirements.
§ 98.81 Application and Plan procedures.
§ 98.82 Coordination.
§ 98.83 Requirements for tribal programs.
§ 98.84 Construction and renovation of child care facilities.
Subpart J - Monitoring, Non-compliance and Complaints
§ 98.90 Monitoring.
§ 98.91 Non-compliance.
§ 98.92 Penalties and sanctions.
§ 98.93 Complaints.
Subpart K - Error Rate Reporting
§ 98.100 Error Rate Report.
§ 98.101 Case Review Methodology.
§ 98.102 Content of Error Rate Reports.
PART 99 - PROCEDURE FOR HEARINGS FOR THE CHILD CARE AND DEVELOPMENT FUND
Subpart A - General
§ 99.1 Scope of rules.
§ 99.2 Presiding officer.
§ 99.3 Records to be public.
§ 99.4 Suspension of rules.
§ 99.5 Filing and service of papers.
Subpart B - Preliminary Matters - Notice and Parties
§ 99.11 Notice of hearing or opportunity for hearing.
§ 99.12 Time of hearing.
§ 99.13 Place.
§ 99.14 Issues at hearing.
§ 99.15 Request to participate in hearing.
Subpart C - Hearing Procedures
§ 99.21 Authority of presiding officer.
§ 99.22 Rights of parties.
§ 99.23 Discovery.
§ 99.24 Evidentiary purpose.
§ 99.25 Evidence.
§ 99.26 Unsponsored written material.
§ 99.27 Official transcript.
§ 99.28 Record for decision.
Subpart D - Posthearing Procedures, Decisions
§ 99.31 Posthearing briefs.
§ 99.32 Decisions following hearing.
§ 99.33 Effective date of Assistant Secretary's decision.
PART 100 - INTERGOVERNMENTAL REVIEW OF DEPARTMENT OF HEALTH AND HUMAN SERVICES PROGRAMS AND ACTIVITIES
§ 100.1 What is the purpose of these regulations?
§ 100.2 What definitions apply to these regulations?
§ 100.3 What programs and activities of the Department are subject to these regulations?
§ 100.4 [Reserved]
§ 100.5 What is the Secretary's obligation with respect to Federal interagency coordination?
§ 100.6 What procedures apply to the selection of programs and activities under these regulations?
§ 100.7 How does the Secretary communicate with state and local officials concerning the Department's programs and activities?
§ 100.8 How does the Secretary provide states an opportunity to comment on proposed Federal financial assistance and direct Federal development?
§ 100.9 How does the Secretary receive and respond to comments?
§ 100.10 How does the Secretary make efforts to accommodate intergovernmental concerns?
§ 100.11 What are the Secretary's obligations in interstate situations?
§ 100.12 How may a state simplify, consolidate, or substitute federally required state plans?
§ 100.13 May the Secretary waive any provision of these regulations?
PART 101 - DESCRIBING AGENCY NEEDS
Subpart B - Definitions
§ 101.20 Definitions.
Subpart C - Placement of Rated Orders
§ 101.30 Delegations of authority.
§ 101.31 Priority ratings.
§ 101.32 Elements of a rated order.
§ 101.33 Acceptance and rejection of rated orders.
§ 101.34 Preferential scheduling.
§ 101.35 Extension of priority ratings.
§ 101.36 Changes or cancellations of priority ratings and rated orders.
§ 101.37 Use of rated orders.
§ 101.38 Limitations on placing rated orders.
Subpart D - Special Priorities Assistance
§ 101.40 General provisions.
§ 101.41 Requests for priority rating authority.
§ 101.42 Examples of assistance.
§ 101.43 Criteria for assistance.
§ 101.44 Instances where assistance may not be provided.
Subpart E - Allocation Actions
§ 101.50 Policy.
§ 101.51 General procedures.
§ 101.52 Controlling the general distribution of a material in the civilian market.
§ 101.53 Types of allocation orders.
§ 101.54 Elements of an allocation order.
§ 101.55 Mandatory acceptance of an allocation order.
§ 101.56 Changes or cancellations of an allocation order.
Subpart F - Official Actions
§ 101.60 General provisions.
§ 101.61 Rating Authorizations.
§ 101.62 Directives.
§ 101.63 Letters and Memoranda of Understanding.
Subpart G - Compliance
§ 101.70 General provisions.
§ 101.71 Audits and investigations.
§ 101.72 Compulsory process.
§ 101.73 Notification of failure to comply.
§ 101.74 Violations, penalties, and remedies.
§ 101.75 Compliance conflicts.
Subpart H - Adjustments, Exceptions, and Appeals
§ 101.80 Adjustments or exceptions.
§ 101.81 Appeals.
Subpart I - Miscellaneous Provisions
§ 101.90 Protection against claims.
§ 101.91 Records and reports.
§ 101.92 Applicability of this part and official actions.
§ 101.93 Communications.
PART 102 - ADJUSTMENT OF CIVIL MONETARY PENALTIES FOR INFLATION
§ 102.1 Applicability.
§ 102.2 Applicability date.
§ 102.3 Penalty adjustment and table.
SUBCHAPTER B - REQUIREMENTS RELATING TO HEALTH CARE ACCESS
PART 144 - REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE
Subpart A - General Provisions
§ 144.101 Basis and purpose.
§ 144.102 Scope and applicability.
§ 144.103 Definitions.
Subpart B - Qualified State Long-Term Care Insurance Partnerships: Reporting Requirements for Insurers
§ 144.200 Basis.
§ 144.202 Definitions.
§ 144.204 Applicability of regulations.
§ 144.206 Reporting requirements.
§ 144.208 Deadlines for submission of reports.
§ 144.210 Form and manner of reports.
§ 144.212 Confidentiality of information.
§ 144.214 Notifications of noncompliance with reporting requirements.
PART 146 - REQUIREMENTS FOR THE GROUP HEALTH INSURANCE MARKET
Subpart A - General Provisions
§ 146.101 Basis and scope.
Subpart B - Requirements Relating to Access and Renewability of Coverage, and Limitations on Preexisting Condition Exclusion Periods
§ 146.111 Preexisting condition exclusions.
§ 146.113 Rules relating to creditable coverage.
§ 146.115 Certification and disclosure of previous coverage.
§ 146.117 Special enrollment periods.
§ 146.119 HMO affiliation period as an alternative to a preexisting condition exclusion.
§ 146.120 Interaction with the Family and Medical Leave Act. [Reserved]
§ 146.121 Prohibiting discrimination against participants and beneficiaries based on a health factor.
§ 146.122 Additional requirements prohibiting discrimination based on genetic information.
§ 146.125 Applicability dates.
Subpart C - Requirements Related to Benefits
§ 146.130 Standards relating to benefits for mothers and newborns.
§ 146.136 Parity in mental health and substance use disorder benefits.
Subpart D - Preemption and Special Rules
§ 146.143 Preemption; State flexibility; construction.
§ 146.145 Special rules relating to group health plans.
Subpart E - Provisions Applicable to Only Health Insurance Issuers
§ 146.150 Guaranteed availability of coverage for employers in the small group market.
§ 146.152 Guaranteed renewability of coverage for employers in the group market.
§ 146.160 Disclosure of information.
Subpart F - Exclusion of Plans and Enforcement
§ 146.180 Treatment of non-Federal governmental plans.
PART 147 - HEALTH INSURANCE REFORM REQUIREMENTS FOR THE GROUP AND INDIVIDUAL HEALTH INSURANCE MARKETS
§ 147.100 Basis and scope.
§ 147.102 Fair health insurance premiums.
§ 147.103 State reporting.
§ 147.104 Guaranteed availability of coverage.
§ 147.106 Guaranteed renewability of coverage.
§ 147.108 Prohibition of preexisting condition exclusions.
§ 147.110 Prohibiting discrimination against participants, beneficiaries, and individuals based on a health factor.
§ 147.116 Prohibition on waiting periods that exceed 90 days.
§ 147.120 Eligibility of children until at least age 26.
§ 147.126 No lifetime or annual limits.
§ 147.128 Rules regarding rescissions.
§ 147.130 Coverage of preventive health services.
§ 147.131 Exemption and accommodations in connection with coverage of preventive health services.
§ 147.136 Internal claims and appeals and external review processes.
§ 147.138 Patient protections.
§ 147.140 Preservation of right to maintain existing coverage.
§ 147.145 Student health insurance coverage.
§ 147.150 Coverage of essential health benefits.
§ 147.160 Parity in mental health and substance use disorder benefits.
§ 147.200 Summary of benefits and coverage and uniform glossary.
PART 148 - REQUIREMENTS FOR THE INDIVIDUAL HEALTH INSURANCE MARKET
Subpart A - General Provisions
§ 148.101 Basis and purpose.
§ 148.102 Scope, applicability, and effective dates.
Subpart B - Requirements Relating to Access and Renewability of Coverage
§ 148.120 Guaranteed availability of individual health insurance coverage to certain individuals with prior group coverage.
§ 148.122 Guaranteed renewability of individual health insurance coverage.
§ 148.124 Certification and disclosure of coverage.
§ 148.126 Determination of an eligible individual.
§ 148.128 State flexibility in individual market reforms - alternative mechanisms.
Subpart C - Requirements Related to Benefits
§ 148.170 Standards relating to benefits for mothers and newborns.
§ 148.180 Prohibition of discrimination based on genetic information.
Subpart D - Preemption; Excepted Benefits
§ 148.210 Preemption.
§ 148.220 Excepted benefits.
Subpart E - Grants to States for Operation of Qualified High Risk Pools
§ 148.306 Basis and scope.
§ 148.308 Definitions.
§ 148.310 Eligibility requirements for a grant.
§ 148.312 Amount of grant payment.
§ 148.314 Periods during which eligible States may apply for a grant.
§ 148.316 Grant application instructions.
§ 148.318 Grant application review.
§ 148.320 Grant awards.
PART 149 - REQUIREMENTS FOR THE EARLY RETIREE REINSURANCE PROGRAM
Subpart A - General Provisions
§ 149.1 Purpose and basis.
§ 149.2 Definitions.
Subpart B - Requirements for Eligible Employment-Based Plans
§ 149.30 General requirements.
§ 149.35 Requirements to participate.
§ 149.40 Application.
§ 149.41 Consequences of Non-Compliance, Fraud, or Similar Fault.
§ 149.45 Funding limitation.
Subpart C - Reinsurance Amounts
§ 149.100 Amount of reimbursement.
§ 149.105 Transition provision.
§ 149.110 Negotiated price concessions.
§ 149.115 Cost threshold and cost limit.
Subpart D - Use of Reimbursements
§ 149.200 Use of reimbursements.
Subpart E - Reimbursement Methods
§ 149.300 General reimbursement rules.
§ 149.310 Timing.
§ 149.315 Reimbursement conditioned upon available funds.
§ 149.320 Universe of claims that must be submitted.
§ 149.325 Requirements for eligibility of claims.
§ 149.330 Content of claims.
§ 149.335 Documentation of costs of actual claims involved.
§ 149.340 Rule for insured plans.
§ 149.345 Use of information provided.
§ 149.350 Maintenance of records.
Subpart F - Appeals
§ 149.500 Appeals.
§ 149.510 Content of request for appeal.
§ 149.520 Review of appeals.
Subpart G - Disclosure of Data Inaccuracies
§ 149.600 Sponsor's duty to report data inaccuracies.
§ 149.610 Secretary's authority to reopen and revise a reimbursement determination.
Subpart H - Change of Ownership Requirements
§ 149.700 Change of ownership requirements.
PART 150 - CMS ENFORCEMENT IN GROUP AND INDIVIDUAL INSURANCE MARKETS
Subpart A - General Provisions
§ 150.101 Basis and scope.
§ 150.103 Definitions.
Subpart B - CMS Enforcement Processes for Determining Whether States Are Failing To Substantially Enforce PHS Act Requirement
§ 150.201 State enforcement.
§ 150.203 Circumstances requiring CMS enforcement.
§ 150.205 Sources of information triggering an investigation of State enforcement.
§ 150.207 Procedure for determining that a State fails to substantially enforce PHS Act requirements.
§ 150.209 Verification of exhaustion of remedies and contact with State officials.
§ 150.211 Notice to the State.
§ 150.213 Form and content of notice.
§ 150.215 Extension for good cause.
§ 150.217 Preliminary determination.
§ 150.219 Final determination.
§ 150.221 Transition to State enforcement.
Subpart C - CMS Enforcement With Respect to Issuers and Non-Federal Governmental Plans - Civil Money Penalties
§ 150.301 General rule regarding the imposition of civil money penalties.
§ 150.303 Basis for initiating an investigation of a potential violation.
§ 150.305 Determination of entity liable for civil money penalty.
§ 150.307 Notice to responsible entities.
§ 150.309 Request for extension.
§ 150.311 Responses to allegations of noncompliance.
§ 150.313 Market conduct examinations.
§ 150.315 Amount of penalty - General.
§ 150.317 Factors CMS uses to determine the amount of penalty.
§ 150.319 Determining the amount of the penalty - mitigating circumstances.
§ 150.321 Determining the amount of penalty - aggravating circumstances.
§ 150.323 Determining the amount of penalty - other matters as justice may require.
§ 150.325 Settlement authority.
§ 150.341 Limitations on penalties.
§ 150.343 Notice of proposed penalty.
§ 150.345 Appeal of proposed penalty.
§ 150.347 Failure to request a hearing.
Subpart D - Administrative Hearings
§ 150.401 Definitions.
§ 150.403 Scope of ALJ's authority.
§ 150.405 Filing of request for hearing.
§ 150.407 Form and content of request for hearing.
§ 150.409 Amendment of notice of assessment or request for hearing.
§ 150.411 Dismissal of request for hearing.
§ 150.413 Settlement.
§ 150.415 Intervention.
§ 150.417 Issues to be heard and decided by ALJ.
§ 150.419 Forms of hearing.
§ 150.421 Appearance of counsel.
§ 150.423 Communications with the ALJ.
§ 150.425 Motions.
§ 150.427 Form and service of submissions.
§ 150.429 Computation of time and extensions of time.
§ 150.431 Acknowledgment of request for hearing.
§ 150.435 Discovery.
§ 150.437 Submission of briefs and proposed hearing exhibits.
§ 150.439 Effect of submission of proposed hearing exhibits.
§ 150.441 Prehearing conferences.
§ 150.443 Standard of proof.
§ 150.445 Evidence.
§ 150.447 The record.
§ 150.449 Cost of transcripts.
§ 150.451 Posthearing briefs.
§ 150.453 ALJ decision.
§ 150.455 Sanctions.
§ 150.457 Review by Administrator.
§ 150.459 Judicial review.
§ 150.461 Failure to pay assessment.
§ 150.463 Final order not subject to review.
§ 150.465 Collection and use of penalty funds.
PART 152 - PRE-EXISTING CONDITION INSURANCE PLAN PROGRAM
Subpart A - General Provisions
§ 152.1 Statutory basis.
§ 152.2 Definitions.
Subpart B - PCIP Program Administration
§ 152.6 Program administration.
§ 152.7 PCIP proposal process.
Subpart C - Eligibility and Enrollment
§ 152.14 Eligibility.
§ 152.15 Enrollment and disenrollment process.
Subpart D - Benefits
§ 152.19 Covered benefits.
§ 152.20 Prohibitions on pre-existing condition exclusions and waiting periods.
§ 152.21 Premiums and cost-sharing.
§ 152.22 Access to services.
Subpart E - Oversight
§ 152.26 Appeals procedures.
§ 152.27 Fraud, waste, and abuse.
§ 152.28 Preventing insurer dumping.
Subpart F - Funding
§ 152.32 Use of funds.
§ 152.33 Initial allocation of funds.
§ 152.34 Reallocation of funds.
§ 152.35 Insufficient funds.
Subpart G - Relationship to Existing Laws and Programs
§ 152.39 Maintenance of effort.
§ 152.40 Relation to State laws.
Subpart H - Transition to Exchanges
§ 152.44 End of PCIP program coverage.
§ 152.45 Transition to the exchanges.
PART 153 - STANDARDS RELATED TO REINSURANCE, RISK CORRIDORS, AND RISK ADJUSTMENT UNDER THE AFFORDABLE CARE ACT
Subpart A - General Provisions
§ 153.10 Basis and scope.
§ 153.20 Definitions.
Subpart B - State Notice of Benefit and Payment Parameters
§ 153.100 State notice of benefit and payment parameters.
§ 153.110 Standards for the State notice of benefit and payment parameters.
Subpart C - State Standards Related to the Reinsurance Program
§ 153.200 [Reserved]
§ 153.210 State establishment of a reinsurance program.
§ 153.220 Collection of reinsurance contribution funds.
§ 153.230 Calculation of reinsurance payments made under the national contribution rate.
§ 153.232 Calculation of reinsurance payments made under a State additional contribution rate.
§ 153.234 Eligibility under health insurance market rules.
§ 153.235 Allocation and distribution of reinsurance contributions
§ 153.240 Disbursement of reinsurance payments.
§ 153.250 Coordination with high-risk pools.
§ 153.260 General oversight requirements for State-operated reinsurance programs.
§ 153.265 Restrictions on use of reinsurance funds for administrative expenses.
§ 153.270 HHS audits of State-operated reinsurance programs.
Subpart D - State Standards Related to the Risk Adjustment Program
§ 153.300 [Reserved]
§ 153.310 Risk adjustment administration.
§ 153.320 Federally certified risk adjustment methodology.
§ 153.330 State alternate risk adjustment methodology.
§ 153.340 Data collection under risk adjustment.
§ 153.350 Risk adjustment data validation standards.
§ 153.360 Application of risk adjustment to the small group market.
§ 153.365 General oversight requirements for State-operated risk adjustment programs.
Subpart E - Health Insurance Issuer and Group Health Plan Standards Related to the Reinsurance Program
§ 153.400 Reinsurance contribution funds.
§ 153.405 Calculation of reinsurance contributions.
§ 153.410 Requests for reinsurance payment.
§ 153.420 Data collection.
Subpart F - Health Insurance Issuer Standards Related to the Risk Corridors Program
§ 153.500 Definitions.
§ 153.510 Risk corridors establishment and payment methodology.
§ 153.520 Attribution and allocation of revenue and expense items.
§ 153.530 Risk corridors data requirements.
§ 153.540 Compliance with risk corridors standards.
Subpart G - Health Insurance Issuer Standards Related to the Risk Adjustment Program
§ 153.600 [Reserved]
§ 153.610 Risk adjustment issuer requirements.
§ 153.620 Compliance with risk adjustment standards.
§ 153.630 Data validation requirements when HHS operates risk adjustment.
Subpart H - Distributed Data Collection for HHS-Operated Programs
§ 153.700 Distributed data environment.
§ 153.710 Data requirements.
§ 153.720 Establishment and usage of masked enrollee identification numbers.
§ 153.730 Deadline for submission of data.
§ 153.740 Failure to comply with HHS-operated risk adjustment and reinsurance data requirements.
PART 154 - HEALTH INSURANCE ISSUER RATE INCREASES: DISCLOSURE AND REVIEW REQUIREMENTS
Subpart A - General Provisions
§ 154.101 Basis and scope.
§ 154.102 Definitions.
§ 154.103 Applicability.
Subpart B - Disclosure and Review Provisions
§ 154.200 Rate increases subject to review.
§ 154.205 Unreasonable rate increases.
§ 154.210 Review of rate increases subject to review by CMS or by a State.
§ 154.215 Submission of rate filing justification.
§ 154.220 Timing of providing the rate filing justification.
§ 154.225 Determination by CMS or a State of an unreasonable rate increase.
§ 154.230 Submission and posting of Final Justifications for unreasonable rate increases.
Subpart C - Effective Rate Review Programs
§ 154.301 CMS's determinations of Effective Rate Review Programs.
PART 155 - EXCHANGE ESTABLISHMENT STANDARDS AND OTHER RELATED STANDARDS UNDER THE AFFORDABLE CARE ACT
Subpart A - General Provisions.
§ 155.10 Basis and scope.
§ 155.20 Definitions.
Subpart B - General Standards Related to the Establishment of an Exchange
§ 155.100 Establishment of a State Exchange.
§ 155.105 Approval of a State Exchange.
§ 155.106 Election to operate an Exchange after 2014.
§ 155.110 Entities eligible to carry out Exchange functions.
§ 155.120 Non-interference with Federal law and non-discrimination standards.
§ 155.130 Stakeholder consultation.
§ 155.140 Establishment of a regional Exchange or subsidiary Exchange.
§ 155.150 Transition process for existing State health insurance exchanges.
§ 155.160 Financial support for continued operations.
§ 155.170 Additional required benefits.
Subpart C - General Functions of an Exchange
§ 155.200 Functions of an Exchange.
§ 155.205 Consumer assistance tools and programs of an Exchange.
§ 155.206 Civil money penalties for violations of applicable Exchange standards by consumer assistance entities in Federally-facilitated Exchanges.
§ 155.210 Navigator program standards.
§ 155.215 Standards applicable to Navigators and Non-Navigator Assistance Personnel carrying out consumer assistance functions under §§ 155.205(d) and (e) and 155.210 in a Federally-facilitated Exchange and to Non-Navigator Assistance Personnel funded through an Exchange Establishment Grant.
§ 155.220 Ability of States to permit agents and brokers to assist qualified individuals, qualified employers, or qualified employees enrolling in QHPs.
§ 155.221 Standards for HHS-approved vendors to perform audits of agents and brokers participating in direct enrollment.
§ 155.222 Standards for HHS-approved vendors of Federally-facilitated Exchange training for agents and brokers.
§ 155.225 Certified application counselors.
§ 155.227 Authorized representatives.
§ 155.230 General standards for Exchange notices.
§ 155.240 Payment of premiums.
§ 155.260 Privacy and security of personally identifiable information.
§ 155.270 Use of standards and protocols for electronic transactions.
§ 155.280 Oversight and monitoring of privacy and security requirements.
§ 155.285 Bases and process for imposing civil penalties for provision of false or fraudulent information to an Exchange or improper use or disclosure of information.
Subpart D - Exchange Functions in the Individual Market: Eligibility Determinations for Exchange Participation and Insurance Affordability Programs
§ 155.300 Definitions and general standards for eligibility determinations.
§ 155.302 Options for conducting eligibility determinations.
§ 155.305 Eligibility standards.
§ 155.310 Eligibility process.
§ 155.315 Verification process related to eligibility for enrollment in a QHP through the Exchange.
§ 155.320 Verification process related to eligibility for insurance affordability programs.
§ 155.330 Eligibility redetermination during a benefit year.
§ 155.335 Annual eligibility redetermination.
§ 155.340 Administration of advance payments of the premium tax credit and cost-sharing reductions.
§ 155.345 Coordination with Medicaid, CHIP, the Basic Health Program, and the Pre-existing Condition Insurance Plan.
§ 155.350 Special eligibility standards and process for Indians.
§ 155.355 Right to appeal.
Subpart E - Exchange Functions in the Individual Market: Enrollment in Qualified Health Plans
§ 155.400 Enrollment of qualified individuals into QHPs.
§ 155.405 Single streamlined application.
§ 155.410 Initial and annual open enrollment periods.
§ 155.415 Allowing issuer application assisters to assist with eligibility applications.
§ 155.420 Special enrollment periods.
§ 155.430 Termination of Exchange enrollment or coverage.
Subpart F - Appeals of Eligibility Determinations for Exchange Participation and Insurance Affordability Programs
§ 155.500 Definitions.
§ 155.505 General eligibility appeals requirements.
§ 155.510 Appeals coordination.
§ 155.515 Notice of appeal procedures.
§ 155.520 Appeal requests.
§ 155.525 Eligibility pending appeal.
§ 155.530 Dismissals.
§ 155.535 Informal resolution and hearing requirements.
§ 155.540 Expedited appeals.
§ 155.545 Appeal decisions.
§ 155.550 Appeal record.
§ 155.555 Employer appeals process.
Subpart G - Exchange Functions in the Individual Market: Eligibility Determinations for Exemptions
§ 155.600 Definitions and general requirements.
§ 155.605 Eligibility standards for exemptions.
§ 155.610 Eligibility process for exemptions.
§ 155.615 Verification process related to eligibility for exemptions.
§ 155.620 Eligibility redeterminations for exemptions during a calendar year.
§ 155.625 Options for conducting eligibility determinations for exemptions.
§ 155.630 Reporting.
§ 155.635 Right to appeal.
Subpart H - Exchange Functions: Small Business Health Options Program (SHOP)
§ 155.700 Standards for the establishment of a SHOP.
§ 155.705 Functions of a SHOP.
§ 155.710 Eligibility standards for SHOP.
§ 155.715 Eligibility determination process for SHOP.
§ 155.720 Enrollment of employees into QHPs under SHOP.
§ 155.725 Enrollment periods under SHOP.
§ 155.730 Application standards for SHOP.
§ 155.735 Termination of SHOP enrollment or coverage.
§ 155.740 SHOP employer and employee eligibility appeals requirements.
Subpart K - Exchange Functions: Certification of Qualified Health Plans
§ 155.1000 Certification standards for QHPs.
§ 155.1010 Certification process for QHPs.
§ 155.1020 QHP issuer rate and benefit information.
§ 155.1030 QHP certification standards related to advance payments of the premium tax credit and cost-sharing reductions.
§ 155.1040 Transparency in coverage.
§ 155.1045 Accreditation timeline.
§ 155.1050 Establishment of Exchange network adequacy standards.
§ 155.1055 Service area of a QHP.
§ 155.1065 Stand-alone dental plans.
§ 155.1075 Recertification of QHPs.
§ 155.1080 Decertification of QHPs.
§ 155.1090 Request for reconsideration.
Subpart M - Oversight and Program Integrity Standards for State Exchanges
§ 155.1200 General program integrity and oversight requirements.
§ 155.1210 Maintenance of records.
Subpart N - State Flexibility
§ 155.1300 Basis and purpose.
§ 155.1302 Coordinated waiver process.
§ 155.1304 Definitions.
§ 155.1308 Application procedures.
§ 155.1312 State public notice requirements.
§ 155.1316 Federal public notice and approval process.
§ 155.1320 Monitoring and compliance.
§ 155.1324 State reporting requirements.
§ 155.1328 Periodic evaluation requirements.
Subpart O - Quality Reporting Standards for Exchanges
§ 155.1400 Quality rating system.
§ 155.1405 Enrollee satisfaction survey system.
PART 156 - HEALTH INSURANCE ISSUER STANDARDS UNDER THE AFFORDABLE CARE ACT, INCLUDING STANDARDS RELATED TO EXCHANGES
Subpart A - General Provisions
§ 156.10 Basis and scope.
§ 156.20 Definitions.
§ 156.50 Financial support.
§ 156.80 Single risk pool.
Subpart B - Essential Health Benefits Package
§ 156.100 State selection of benchmark.
§ 156.105 Determination of EHB for multi-state plans.
§ 156.110 EHB-benchmark plan standards.
§ 156.115 Provision of EHB.
§ 156.120 Collection of data to define essential health benefits.
§ 156.122 Prescription drug benefits.
§ 156.125 Prohibition on discrimination.
§ 156.130 Cost-sharing requirements.
§ 156.135 AV calculation for determining level of coverage.
§ 156.140 Levels of coverage.
§ 156.145 Determination of minimum value.
§ 156.150 Application to stand-alone dental plans inside the Exchange.
§ 156.155 Enrollment in catastrophic plans.
Subpart C - Qualified Health Plan Minimum Certification Standards
§ 156.200 QHP issuer participation standards.
§ 156.210 QHP rate and benefit information.
§ 156.215 Advance payments of the premium tax credit and cost-sharing reduction standards.
§ 156.220 Transparency in coverage.
§ 156.225 Marketing and Benefit Design of QHPs.
§ 156.230 Network adequacy standards.
§ 156.235 Essential community providers.
§ 156.245 Treatment of direct primary care medical homes.
§ 156.250 Meaningful access to qualified health plan information.
§ 156.255 Rating variations.
§ 156.260 Enrollment periods for qualified individuals.
§ 156.265 Enrollment process for qualified individuals.
§ 156.270 Termination of coverage or enrollment for qualified individuals.
§ 156.272 Issuer participation for the full plan year.
§ 156.275 Accreditation of QHP issuers.
§ 156.280 Segregation of funds for abortion services.
§ 156.285 Additional standards specific to SHOP.
§ 156.290 Non-certification and decertification of QHPs.
§ 156.295 Prescription drug distribution and cost reporting.
§ 156.298 Meaningful difference standard for Qualified Health Plans in the Federally-facilitated Exchanges.
Subpart D - Standards for Qualified Health Plan Issuers on Federally-Facilitated Exchanges and State-Based Exchanges on the Federal Platform
§ 156.330 Changes of ownership of issuers of Qualified Health Plans in Federally-facilitated Exchanges.
§ 156.340 Standards for downstream and delegated entities.
§ 156.350 Eligibility and enrollment standards for Qualified Health Plan issuers on State-based Exchanges on the Federal platform.
Subpart E - Health Insurance Issuer Responsibilities With Respect to Advance Payments of the Premium Tax Credit and Cost-Sharing Reductions
§ 156.400 Definitions.
§ 156.410 Cost-sharing reductions for enrollees.
§ 156.420 Plan variations.
§ 156.425 Changes in eligibility for cost-sharing reductions.
§ 156.430 Payment for cost-sharing reductions.
§ 156.440 Plans eligible for advance payments of the premium tax credit and cost-sharing reductions.
§ 156.460 Reduction of enrollee's share of premium to account for advance payments of the premium tax credit.
§ 156.470 Allocation of rates for advance payments of the premium tax credit.
§ 156.480 Oversight of the administration of the cost-sharing reductions and advance payments of the premium tax credit programs.
Subpart F - Consumer Operated and Oriented Plan Program
§ 156.500 Basis and scope.
§ 156.505 Definitions.
§ 156.510 Eligibility.
§ 156.515 CO-OP standards.
§ 156.520 Loan terms.
Subpart G - Minimum Essential Coverage
§ 156.600 The definition of minimum essential coverage.
§ 156.602 Other coverage that qualifies as minimum essential coverage.
§ 156.604 Requirements for recognition as minimum essential coverage for types of coverage not otherwise designated minimum essential coverage in the statute or this subpart.
§ 156.606 HHS audit authority.
Subpart H - Oversight and Financial Integrity Standards for Issuers of Qualified Health Plans in Federally-Facilitated Exchanges
§ 156.705 Maintenance of records for Federally-facilitated Exchanges.
§ 156.715 Compliance reviews of QHP issuers in Federally-facilitated Exchanges.
Subpart I - Enforcement Remedies in Federally-Facilitated Exchanges
§ 156.800 Available remedies; Scope.
§ 156.805 Bases and process for imposing civil money penalties in Federally-facilitated Exchanges.
§ 156.806 Notice of non-compliance.
§ 156.810 Bases and process for decertification of a QHP offered by an issuer through a Federally-facilitated Exchange.
§ 156.815 Plan suppression.
Subpart J - Administrative Review of QHP Issuer Sanctions in Federally-Facilitated Exchanges
§ 156.901 Definitions.
§ 156.903 Scope of Administrative Law Judge's (ALJ) authority.
§ 156.905 Filing of request for hearing.
§ 156.907 Form and content of request for hearing.
§ 156.909 Amendment of notice of assessment or decertification request for hearing.
§ 156.911 Dismissal of request for hearing.
§ 156.913 Settlement.
§ 156.915 Intervention.
§ 156.917 Issues to be heard and decided by ALJ.
§ 156.919 Forms of hearing.
§ 156.921 Appearance of counsel.
§ 156.923 Communications with the ALJ.
§ 156.925 Motions.
§ 156.927 Form and service of submissions.
§ 156.929 Computation of time and extensions of time.
§ 156.931 Acknowledgment of request for hearing.
§ 156.935 Discovery.
§ 156.937 Submission of briefs and proposed hearing exhibits.
§ 156.939 Effect of submission of proposed hearing exhibits.
§ 156.941 Prehearing conferences.
§ 156.943 Standard of proof.
§ 156.945 Evidence.
§ 156.947 The record.
§ 156.951 Posthearing briefs.
§ 156.953 ALJ decision.
§ 156.955 Sanctions.
§ 156.957 Review by Administrator.
§ 156.959 Judicial review.
§ 156.961 Failure to pay assessment.
§ 156.963 Final order not subject to review.
Subpart K - Cases Forwarded to Qualified Health Plans and Qualified Health Plan Issuers in Federally-facilitated Exchanges
§ 156.1010 Standards.
Subpart L - Quality Standards
§ 156.1105 Establishment of standards for HHS-approved enrollee satisfaction survey vendors for use by QHP issuers in Exchanges.
§ 156.1110 Establishment of patient safety standards for QHP issuers.
§ 156.1120 Quality rating system.
§ 156.1125 Enrollee satisfaction survey system.
§ 156.1130 Quality improvement strategy.
Subpart M - Qualified Health Plan Issuer Responsibilities
§ 156.1210 Confirmation of HHS payment and collections reports.
§ 156.1215 Payment and collections processes.
§ 156.1220 Administrative appeals.
§ 156.1230 Direct enrollment with the QHP issuer in a manner considered to be through the Exchange.
§ 156.1240 Enrollment process for qualified individuals.
§ 156.1250 Acceptance of certain third party payments.
§ 156.1255 Renewal and re-enrollment notices.
§ 156.1256 Other notices.
PART 157 - EMPLOYER INTERACTIONS WITH EXCHANGES AND SHOP PARTICIPATION
Subpart A - General Provisions
§ 157.10 Basis and scope.
§ 157.20 Definitions.
Subpart C - Standards for Qualified Employers
§ 157.200 Eligibility of qualified employers to participate in a SHOP.
§ 157.205 Qualified employer participation process in a SHOP.
PART 158 - ISSUER USE OF PREMIUM REVENUE: REPORTING AND REBATE REQUIREMENTS
§ 158.101 Basis and scope.
§ 158.102 Applicability.
§ 158.103 Definitions.
Subpart A - Disclosure and Reporting
§ 158.110 Reporting requirements related to premiums and expenditures.
§ 158.120 Aggregate reporting.
§ 158.121 Newer experience.
§ 158.130 Premium revenue.
§ 158.140 Reimbursement for clinical services provided to enrollees.
§ 158.150 Activities that improve health care quality.
§ 158.151 Expenditures related to Health Information Technology and meaningful use requirements.
§ 158.160 Other non-claims costs.
§ 158.161 Reporting of Federal and State licensing and regulatory fees.
§ 158.162 Reporting of Federal and State taxes.
§ 158.170 Allocation of expenses.
Subpart B - Calculating and Providing the Rebate
§ 158.210 Minimum medical loss ratio.
§ 158.211 Requirement in States with a higher medical loss ratio.
§ 158.220 Aggregation of data in calculating an issuer's medical loss ratio.
§ 158.221 Formula for calculating an issuer's medical loss ratio.
§ 158.230 Credibility adjustment.
§ 158.231 Life-years used to determine credible experience.
§ 158.232 Calculating the credibility adjustment.
§ 158.240 Rebating premium if the applicable medical loss ratio standard is not met.
§ 158.241 Form of rebate.
§ 158.242 Recipients of rebates.
§ 158.243 De minimis rebates.
§ 158.244 Unclaimed rebates.
§ 158.250 Notice of rebates.
§ 158.251 Notice of MLR information.
§ 158.260 Reporting of rebates.
§ 158.270 Effect of rebate payments on solvency.
Subpart C - Potential Adjustment to the MLR for a State's Individual Market
§ 158.301 Standard for adjustment to the medical loss ratio.
§ 158.310 Who may request adjustment to the medical loss ratio.
§ 158.311 Duration of adjustment to the medical loss ratio.
§ 158.320 Information supporting a request for adjustment to the medical loss ratio.
§ 158.321 Information regarding the State's individual health insurance market.
§ 158.322 Proposal for adjusted medical loss ratio.
§ 158.323 State contact information.
§ 158.330 Criteria for assessing request for adjustment to the medical loss ratio.
§ 158.340 Process for submitting request for adjustment to the medical loss ratio.
§ 158.341 Treatment as a public document.
§ 158.342 Invitation for public comments.
§ 158.343 Optional State hearing.
§ 158.344 Secretary's discretion to hold a hearing.
§ 158.345 Determination on a State's request for adjustment to the medical loss ratio.
§ 158.346 Request for reconsideration.
§ 158.350 Subsequent requests for adjustment to the medical loss ratio.
Subpart D - HHS Enforcement
§ 158.401 HHS enforcement.
§ 158.402 Audits.
§ 158.403 Circumstances in which a State is conducting audits of issuers.
Subpart E - Additional Requirements on Issuers
§ 158.501 Access to facilities and records.
§ 158.502 Maintenance of records.
Subpart F - Federal Civil Penalties
§ 158.601 General rule regarding the imposition of civil penalties.
§ 158.602 Basis for imposing civil penalties.
§ 158.603 Notice to responsible entities.
§ 158.604 Request for extension.
§ 158.605 Responses to allegations of noncompliance.
§ 158.606 Amount of penalty - general.
§ 158.607 Factors HHS uses to determine the amount of penalty.
§ 158.608 Determining the amount of the penalty - mitigating circumstances.
§ 158.609 Determining the amount of penalty - aggravating circumstances.
§ 158.610 Determining the amount of penalty - other matters as justice may require.
§ 158.611 Settlement authority.
§ 158.612 Limitations on penalties.
§ 158.613 Notice of proposed penalty.
§ 158.614 Appeal of proposed penalty.
§ 158.615 Failure to request a hearing.
PART 159 - HEALTH CARE REFORM INSURANCE WEB PORTAL
§ 159.100 Basis and scope.
§ 159.110 Definitions.
§ 159.120 Data submission for the individual and small group markets.
SUBCHAPTER C - ADMINISTRATIVE DATA STANDARDS AND RELATED REQUIREMENTS
PART 160 - GENERAL ADMINISTRATIVE REQUIREMENTS
Subpart A - General Provisions
§ 160.101 Statutory basis and purpose.
§ 160.102 Applicability.
§ 160.103 Definitions.
§ 160.104 Modifications.
§ 160.105 Compliance dates for implementation of new or modified standards and implementation specifications.
Subpart B - Preemption of State Law
§ 160.201 Statutory basis.
§ 160.202 Definitions.
§ 160.203 General rule and exceptions.
§ 160.204 Process for requesting exception determinations.
§ 160.205 Duration of effectiveness of exception determinations.
Subpart C - Compliance and Investigations
§ 160.300 Applicability.
§ 160.302 [Reserved]
§ 160.304 Principles for achieving compliance.
§ 160.306 Complaints to the Secretary.
§ 160.308 Compliance reviews.
§ 160.310 Responsibilities of covered entities and business associates.
§ 160.312 Secretarial action regarding complaints and compliance reviews.
§ 160.314 Investigational subpoenas and inquiries.
§ 160.316 Refraining from intimidation or retaliation.
Subpart D - Imposition of Civil Money Penalties
§ 160.400 Applicability.
§ 160.401 Definitions.
§ 160.402 Basis for a civil money penalty.
§ 160.404 Amount of a civil money penalty.
§ 160.406 Violations of an identical requirement or prohibition.
§ 160.408 Factors considered in determining the amount of a civil money penalty.
§ 160.410 Affirmative defenses.
§ 160.412 Waiver.
§ 160.414 Limitations.
§ 160.416 Authority to settle.
§ 160.418 Penalty not exclusive.
§ 160.420 Notice of proposed determination.
§ 160.422 Failure to request a hearing.
§ 160.424 Collection of penalty.
§ 160.426 Notification of the public and other agencies.
Subpart E - Procedures for Hearings
§ 160.500 Applicability.
§ 160.502 Definitions.
§ 160.504 Hearing before an ALJ.
§ 160.506 Rights of the parties.
§ 160.508 Authority of the ALJ.
§ 160.510 Ex parte contacts.
§ 160.512 Prehearing conferences.
§ 160.514 Authority to settle.
§ 160.516 Discovery.
§ 160.518 Exchange of witness lists, witness statements, and exhibits.
§ 160.520 Subpoenas for attendance at hearing.
§ 160.522 Fees.
§ 160.524 Form, filing, and service of papers.
§ 160.526 Computation of time.
§ 160.528 Motions.
§ 160.530 Sanctions.
§ 160.532 Collateral estoppel.
§ 160.534 The hearing.
§ 160.536 Statistical sampling.
§ 160.538 Witnesses.
§ 160.540 Evidence.
§ 160.542 The record.
§ 160.544 Post hearing briefs.
§ 160.546 ALJ's decision.
§ 160.548 Appeal of the ALJ's decision.
§ 160.550 Stay of the Secretary's decision.
§ 160.552 Harmless error.
PART 162 - ADMINISTRATIVE REQUIREMENTS
Subpart A - General Provisions
§ 162.100 Applicability.
§ 162.103 Definitions.
Subpart D - Standard Unique Health Identifier for Health Care Providers
§ 162.402 [Reserved]
§ 162.404 Compliance dates of the implementation of the standard unique health identifier for health care providers.
§ 162.406 Standard unique health identifier for health care providers.
§ 162.408 National Provider System.
§ 162.410 Implementation specifications: Health care providers.
§ 162.412 Implementation specifications: Health plans.
§ 162.414 Implementation specifications: Health care clearinghouses.
Subpart E - Standard Unique Health Identifier for Health Plans
§ 162.502 [Reserved]
§ 162.504 Compliance requirements for the implementation of the standard unique health plan identifier.
§ 162.506 Standard unique health plan identifier.
§ 162.508 Enumeration System.
§ 162.510 Full implementation requirements: Covered entities.
§ 162.512 Implementation specifications: Health plans.
§ 162.514 Other entity identifier.
Subpart F - Standard Unique Employer Identifier
§ 162.600 Compliance dates of the implementation of the standard unique employer identifier.
§ 162.605 Standard unique employer identifier.
§ 162.610 Implementation specifications for covered entities.
Subpart I - General Provisions for Transactions
§ 162.900 [Reserved]
§ 162.910 Maintenance of standards and adoption of modifications and new standards.
§ 162.915 Trading partner agreements.
§ 162.920 Availability of implementation specifications and operating rules.
§ 162.923 Requirements for covered entities.
§ 162.925 Additional requirements for health plans.
§ 162.930 Additional rules for health care clearinghouses.
§ 162.940 Exceptions from standards to permit testing of proposed modifications.
Subpart J - Code Sets
§ 162.1000 General requirements.
§ 162.1002 Medical data code sets.
§ 162.1011 Valid code sets.
Subpart K - Health Care Claims or Equivalent Encounter Information
§ 162.1101 Health care claims or equivalent encounter information transaction.
§ 162.1102 Standards for health care claims or equivalent encounter information transaction.
Subpart L - Eligibility for a Health Plan
§ 162.1201 Eligibility for a health plan transaction.
§ 162.1202 Standards for eligibility for a health plan transaction.
§ 162.1203 Operating rules for eligibility for a health plan transaction.
Subpart M - Referral Certification and Authorization
§ 162.1301 Referral certification and authorization transaction.
§ 162.1302 Standards for referral certification and authorization transaction.
Subpart N - Health Care Claim Status
§ 162.1401 Health care claim status transaction.
§ 162.1402 Standards for health care claim status transaction.
§ 162.1403 Operating rules for health care claim status transaction.
Subpart O - Enrollment and Disenrollment in a Health Plan
§ 162.1501 Enrollment and disenrollment in a health plan transaction.
§ 162.1502 Standards for enrollment and disenrollment in a health plan transaction.
Subpart P - Health Care Electronic Funds Transfers (EFT) and Remittance Advice
§ 162.1601 Health care electronic funds transfers (EFT) and remittance advice transaction.
§ 162.1602 Standards for health care electronic funds transfers (EFT) and remittance advice transaction.
§ 162.1603 Operating rules for health care electronic funds transfers (EFT) and remittance advice transaction.
Subpart Q - Health Plan Premium Payments
§ 162.1701 Health plan premium payments transaction.
§ 162.1702 Standards for health plan premium payments transaction.
Subpart R - Coordination of Benefits
§ 162.1801 Coordination of benefits transaction.
§ 162.1802 Standards for coordination of benefits information transaction.
Subpart S - Medicaid Pharmacy Subrogation
§ 162.1901 Medicaid pharmacy subrogation transaction.
§ 162.1902 Standard for Medicaid pharmacy subrogation transaction.
PART 164 - SECURITY AND PRIVACY
Subpart A - General Provisions
§ 164.102 Statutory basis.
§ 164.103 Definitions.
§ 164.104 Applicability.
§ 164.105 Organizational requirements.
§ 164.106 Relationship to other parts.
Subpart C - Security Standards for the Protection of Electronic Protected Health Information
§ 164.302 Applicability.
§ 164.304 Definitions.
§ 164.306 Security standards: General rules.
§ 164.308 Administrative safeguards.
§ 164.310 Physical safeguards.
§ 164.312 Technical safeguards.
§ 164.314 Organizational requirements.
§ 164.316 Policies and procedures and documentation requirements.
§ 164.318 Compliance dates for the initial implementation of the security standards.
Subpart D - Notification in the Case of Breach of Unsecured Protected Health Information
§ 164.400 Applicability.
§ 164.402 Definitions.
§ 164.404 Notification to individuals.
§ 164.406 Notification to the media.
§ 164.408 Notification to the Secretary.
§ 164.410 Notification by a business associate.
§ 164.412 Law enforcement delay.
§ 164.414 Administrative requirements and burden of proof.
Subpart E - Privacy of Individually Identifiable Health Information
§ 164.500 Applicability.
§ 164.501 Definitions.
§ 164.502 Uses and disclosures of protected health information: General rules.
§ 164.504 Uses and disclosures: Organizational requirements.
§ 164.506 Uses and disclosures to carry out treatment, payment, or health care operations.
§ 164.508 Uses and disclosures for which an authorization is required.
§ 164.510 Uses and disclosures requiring an opportunity for the individual to agree or to object.
§ 164.512 Uses and disclosures for which an authorization or opportunity to agree or object is not required.
§ 164.514 Other requirements relating to uses and disclosures of protected health information.
§ 164.520 Notice of privacy practices for protected health information.
§ 164.522 Rights to request privacy protection for protected health information.
§ 164.524 Access of individuals to protected health information.
§ 164.526 Amendment of protected health information.
§ 164.528 Accounting of disclosures of protected health information.
§ 164.530 Administrative requirements.
§ 164.532 Transition provisions.
§ 164.534 Compliance dates for initial implementation of the privacy standards.
SUBCHAPTER D - HEALTH INFORMATION TECHNOLOGY
PART 170 - HEALTH INFORMATION TECHNOLOGY STANDARDS, IMPLEMENTATION SPECIFICATIONS, AND CERTIFICATION CRITERIA AND CERTIFICATION PROGRAMS FOR HEALTH INFORMATION TECHNOLOGY
Subpart A - General Provisions
§ 170.100 Statutory basis and purpose.
§ 170.101 Applicability.
§ 170.102 Definitions.
Subpart B - Standards and Implementation Specifications for Health Information Technology
§ 170.200 Applicability.
§ 170.202 Transport standards and other protocols.
§ 170.204 Functional standards.
§ 170.205 Content exchange standards and implementation specifications for exchanging electronic health information.
§ 170.207 Vocabulary standards for representing electronic health information.
§ 170.210 Standards for health information technology to protect electronic health information created, maintained, and exchanged.
§ 170.299 Incorporation by reference.
Subpart C - Certification Criteria for Health Information Technology
§ 170.300 Applicability.
§§ 170.302-170.306 [Reserved]
§ 170.314 2014 Edition electronic health record certification criteria.
§ 170.315 2015 Edition health IT certification criteria.
Subpart E - ONC Health IT Certification Program
§ 170.500 Basis and scope.
§ 170.501 Applicability.
§ 170.502 Definitions.
§ 170.503 Requests for ONC-AA status and ONC-AA ongoing responsibilities.
§ 170.504 Reconsideration process for requests for ONC-AA status.
§ 170.505 Correspondence.
§ 170.510 Authorization scope for ONC-ACB status.
§ 170.511 Authorization scope for ONC-ATL status.
§ 170.520 Application.
§ 170.523 Principles of proper conduct for ONC-ACBs.
§ 170.524 Principles of proper conduct for ONC-ATLs.
§ 170.525 Application submission.
§ 170.530 Review of application.
§ 170.535 ONC-ACB and ONC-ATL application reconsideration.
§ 170.540 ONC-ACB and ONC-ATL status.
§ 170.545 Complete EHR certification.
§ 170.550 Health IT Module certification.
§ 170.553 [Reserved]
§ 170.555 Certification to newer versions of certain standards.
§ 170.556 In-the-field surveillance and maintenance of certification for Health IT.
§ 170.557 Authorized testing and certification methods.
§ 170.560 Good standing as an ONC-ACB or ONC-ATL.
§ 170.565 Revocation of ONC-ACB or ONC-ATL status.
§ 170.570 Effect of revocation on the certifications issued to Complete EHRs and EHR Module(s).
§ 170.575 Removal of the ONC-AA.
§ 170.580 ONC review of certified health IT.
§ 170.581 Certification ban.
§ 170.599 Incorporation by reference.