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United States Code
U.S.C. Title 42-THE PUBLIC HEALTH AND WELFARE
CHAPTER 7-SOCIAL SECURITY
SUBCHAPTER XI-GENERAL PROVISIONS, PEER REVIEW, AND ADMINISTRATIVE SIMPLIFICATION
Part A-General Provisions

42 U.S. Code § 1320a-7i

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Reporting of information relating to drug samples

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42 U.S. Code § 1320a-7i. Reporting of information relating to drug samples

(a) In generalNot later than April 1 of each year (beginning with 2012), each manufacturer and authorized distributor of record of an applicable drug shall submit to the Secretary (in a form and manner specified by the Secretary) the following information with respect to the preceding year:

(1) In the case of a manufacturer or authorized distributor of record which makes distributions by mail or common carrier under subsection (d)(2) of section 353 of title 21, the identity and quantity of drug samples requested and the identity and quantity of drug samples distributed under such subsection during that year, aggregated by—

(A)

the name, address, professional designation, and signature of the practitioner making the request under subparagraph (A)(i) of such subsection, or of any individual who makes or signs for the request on behalf of the practitioner; and

(B)

any other category of information determined appropriate by the Secretary.

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The United States Code on COSMOS is current through Public Law 118-34 (12/26/2023), except for Public Law 118-31.

Part A-General Provisions

§1301 Definitions
§1301-1 Omitted
§1301a Omitted
§1302 Rules and regulations; impact analyses of Medicare and Medicaid rules and regulations on small rural hospitals
§1303 Separability
§1304 Reservation of right to amend or repeal
§1305 Short title of chapter
§1306 Disclosure of information in possession of Social Security Administration or Department of Health and Human Services
§1306a Public access to State disbursement records
§1306b State data exchanges
§1306c Restriction on access to the Death Master File
§1307 Penalty for fraud
§1308 Additional grants to Puerto Rico, Virgin Islands, Guam, and American Samoa; limitation on total payments
§1309 Amounts disregarded not to be taken into account in determining eligibility of other individuals
§1310 Cooperative research or demonstration projects
§1311 Public assistance payments to legal representatives
§1312 Medical care guides and reports for public assistance and medical assistance
§1313 Assistance for United States citizens returned from foreign countries
§1314 Public advisory groups
§1314a Measurement and reporting of welfare receipt
§1314b National Advisory Committee on the Sex Trafficking of Children and Youth in the United States
§1315 Demonstration projects
§1315a Center for Medicare and Medicaid Innovation
§1315b Providing Federal coverage and payment coordination for dual eligible beneficiaries
§1316 Administrative and judicial review of public assistance determinations
§1317 Appointment of the Administrator and Chief Actuary of the Centers for Medicare & Medicaid Services
§1318 Alternative Federal payment with respect to public assistance expenditures
§1319 Federal participation in payments for repairs to home owned by recipient of aid or assistance
§1320 Approval of certain projects
§1320a Uniform reporting systems for health services facilities and organizations
§1320a-1 Limitation on use of Federal funds for capital expenditures
§1320a-1a Transferred
§1320a-2 Effect of failure to carry out State plan
§1320a-2a Reviews of child and family services programs, and of foster care and adoption assistance programs, for conformity with State plan requirements
§1320a-3 Disclosure of ownership and related information; procedure; definitions; scope of requirements
§1320a-3a Disclosure requirements for other providers under part B of Medicare
§1320a-4 Issuance of subpenas by Comptroller General
§1320a-5 Disclosure by institutions, organizations, and agencies of owners, officers, etc., convicted of offenses related to programs; notification requirements; "managing employee" defined
§1320a-6 Adjustments in SSI benefits on account of retroactive benefits under subchapter II
§1320a-6a Interagency coordination to improve program administration
§1320a-7 Exclusion of certain individuals and entities from participation in Medicare and State health care programs
§1320a-7a Civil monetary penalties
§1320a-7b Criminal penalties for acts involving Federal health care programs
§1320a-7c Fraud and abuse control program
§1320a-7d Guidance regarding application of health care fraud and abuse sanctions
§1320a-7e Health care fraud and abuse data collection program
§1320a-7f Coordination of medicare and medicaid surety bond provisions
§1320a-7g Funds to reduce medicaid fraud and abuse
§1320a-7h Transparency reports and reporting of physician ownership or investment interests
§1320a-7i Reporting of information relating to drug samples
§1320a-7j Accountability requirements for facilities
§1320a-7k Medicare and Medicaid program integrity provisions
§1320a-7l Nationwide program for national and State background checks on direct patient access employees of long-term care facilities and providers
§1320a-7m Use of predictive modeling and other analytics technologies to identify and prevent waste, fraud, and abuse in the Medicare fee-for-service program
§1320a-7n Disclosure of predictive modeling and other analytics technologies to identify and prevent waste, fraud, and abuse
§1320a-8 Civil monetary penalties and assessments for subchapters II, VIII and XVI
§1320a-8a Administrative procedure for imposing penalties for false or misleading statements
§1320a-8b Attempts to interfere with administration of this chapter
§1320a-9 Demonstration projects
§1320a-10 Effect of failure to carry out State plan
§1320b Repealed. Pub. L. 93-647, § 3(e)(1), Jan. 4, 1975, 88 Stat. 2349
§1320b-1 Notification of Social Security claimant with respect to deferred vested benefits
§1320b-2 Period within which certain claims must be filed
§1320b-3 Applicants or recipients under public assistance programs not to be required to make election respecting certain veterans’ benefits
§1320b-4 Nonprofit hospital or critical access hospital philanthropy
§1320b-5 Authority to waive requirements during national emergencies
§1320b-6 Exclusion of representatives and health care providers convicted of violations from participation in social security programs
§1320b-7 Income and eligibility verification system
§1320b-8 Hospital protocols for organ procurement and standards for organ procurement agencies
§1320b-9 Improved access to, and delivery of, health care for Indians under subchapters XIX and XXI
§1320b-9a Child health quality measures
§1320b-9b Adult health quality measures
§1320b-10 Prohibitions relating to references to Social Security or Medicare
§1320b-11 Blood donor locator service
§1320b-12 Research on outcomes of health care services and procedures
§1320b-13 Social security account statements
§1320b-14 Outreach efforts to increase awareness of the availability of medicare cost-sharing and subsidies for low-income individuals under subchapter XVIII
§1320b-15 Protection of social security and medicare trust funds
§1320b-16 Public disclosure of certain information on hospital financial interest and referral patterns
§1320b-17 Cross-program recovery of overpayments from benefits
§1320b-18 Repealed. Pub. L. 108-203, title II, § 210(b)(3), Mar. 2, 2004, 118 Stat. 517
§1320b-19 The Ticket to Work and Self-Sufficiency Program
§1320b-20 Work incentives outreach program
§1320b-21 State grants for work incentives assistance to disabled beneficiaries
§1320b-22 Grants to develop and establish State infrastructures to support working individuals with disabilities
§1320b-23 Pharmacy benefit managers transparency requirements
§1320b-24 Consultation with Tribal Technical Advisory Group
§1320b-25 Reporting to law enforcement of crimes occurring in federally funded long-term care facilities
§1320b-26 Funding for providers relating to COVID-19

U.S. Code Popular Name Table

Popular Names

Americans with Disabilities Act 42 U.S.C. § 12101 et seq.

Anti-Kickback Statute 42 U.S.C. § 1320a–7b(b)

Clayton Act 15 U.S.C. § 12 et seq.

Clean Air Act 42 U.S.C. § 7401 et seq.

Commodity Exchange Act 7 U.S.C. § 1

Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA) 42 U.S.C. § 9601 et seq.

Controlled Substances Act 21 U.S.C. § 801 et seq.

Emergency Medical Treatment and Labor Act (EMTALA) 42 U.S.C. § 1395dd

Fair Credit Reporting Act 15 U.S.C. § 1681

False Claims Act 31 U.S.C. § 3729 et seq.

Federal Food, Drug, and Cosmetic Act 21 U.S.C. § 301 et seq.

Federal Insecticide, Fungicide, and Rodenticide Act 7 U.S.C. § 136 et seq.

Federal Trade Commission Act 15 U.S.C. § 41 et seq.

Foreign corrupt Practices Act 15 U.S.C. § 78dd-1 et seq.

Fraud Enforcement and Recovery Act of 2009 (FERA) 18 U.S.C. § 27

Health Information Technology for Economic and Clinical Health Act (HITECH) 42 U.S.C. § 300jj et seq., 42 U.S.C. § 17901 et seq.

Health Insurance Portability and Accountability Act of 1996 (HIPAA) 42 U.S.C. § 201

National Environmental Policy Act (NEPA) 42 U.S.C. § 4321 et seq.

Patient Protection and Affordable Care Act 42 U.S.C. § 18001 et seq.

Physician Payments Sunshine Act 42 U.S.C. § 1320a–7h

Public Health Service Act 42 U.S.C. § 201 et seq.

Resource Conservation and Recovery Act (RCRA) 42 U.S.C. § 6901 et seq.

Robinson–Patman Act 15 U.S.C. § 13

Sarbanes-Oxley Act 15 U.S.C. § 7201 et seq.

Securities Act of 1933 15 U.S.C. § 77a et seq.

Sentencing Reform Act of 1984 18 U.S.C. § 3551 et seq.

Sherman Act 15 U.S.C. § 1 et seq.

Social Security Act 42 U.S.C. § 301 et seq.

Stark Law 42 U.S.C. § 1395nn

Toxic Substances Control Act 15 U.S.C. § 2601 et seq.

Reporting of information relating to drug samples

42 U.S. Code § 1320a-7i. Reporting of information relating to drug samples

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