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42 U.S.C. § 233 — Civil actions or proceedings against com-

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42 U.S.C. § 233 — Civil actions or proceedings against com-

Page 92 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 233 other administrative expenses incident to the work: Provided, That the Administrator of Gen- eral Services shall prepare the plans and speci- fications, make all necessary contracts, and su- pervise construction. (July 3, 1946, ch. 538, § 11, 60 Stat. 425; June 30, 1949, ch. 288, title I, § 103(a), 63 Stat. 380.) Editorial Notes REFERENCES IN TEXT This Act, referred to in text, is act July 3, 1946, ch. 538, 60 Stat. 421, known as the National Mental Health Act, which enacted sections 232 and 242a of this title, amended sections 201, 209, 210, 215, 218, 219, 241, 244, and 246 of this title, and enacted provisions set out as notes under section 201 of this title. For complete classifica- tion of this Act to the Code, see Short Title of 1946 Amendment note set out under section 201 of this title and Tables. CODIFICATION Section was enacted as a part of the National Mental Health Act, and not as a part of the Public Health Service Act which comprises this chapter. Statutory Notes and Related Subsidiaries CHANGE OF NAME ‘‘Secretary of Health and Human Services’’ sub- stituted for ‘‘Secretary of Health, Education, and Wel- fare’’ pursuant to section 509(b) of Pub. L. 96–88, which is classified to section 3508(b) of Title 20, Education. TRANSFER OF FUNCTIONS Functions of Federal Works Agency and of all agen- cies thereof, together with functions of Federal Works Administrator transferred to Administrator of General Services by section 103(a) of act June 30, 1949. Both Fed- eral Works Agency and office of Federal Works Admin- istrator abolished by section 103(b) of that act. See His- torical and Revision Notes under section 303(b) of Title 40, Public Buildings, Property, and Works. Section 303(b) of T

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Page 92 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 233 other administrative expenses incident to the work: Provided, That the Administrator of Gen- eral Services shall prepare the plans and speci- fications, make all necessary contracts, and su- pervise construction. (July 3, 1946, ch. 538, § 11, 60 Stat. 425; June 30, 1949, ch. 288, title I, § 103(a), 63 Stat. 380.) Editorial Notes REFERENCES IN TEXT This Act, referred to in text, is act July 3, 1946, ch. 538, 60 Stat. 421, known as the National Mental Health Act, which enacted sections 232 and 242a of this title, amended sections 201, 209, 210, 215, 218, 219, 241, 244, and 246 of this title, and enacted provisions set out as notes under section 201 of this title. For complete classifica- tion of this Act to the Code, see Short Title of 1946 Amendment note set out under section 201 of this title and Tables. CODIFICATION Section was enacted as a part of the National Mental Health Act, and not as a part of the Public Health Service Act which comprises this chapter. Statutory Notes and Related Subsidiaries CHANGE OF NAME ‘‘Secretary of Health and Human Services’’ sub- stituted for ‘‘Secretary of Health, Education, and Wel- fare’’ pursuant to section 509(b) of Pub. L. 96–88, which is classified to section 3508(b) of Title 20, Education. TRANSFER OF FUNCTIONS Functions of Federal Works Agency and of all agen- cies thereof, together with functions of Federal Works Administrator transferred to Administrator of General Services by section 103(a) of act June 30, 1949. Both Fed- eral Works Agency and office of Federal Works Admin- istrator abolished by section 103(b) of that act. See His- torical and Revision Notes under section 303(b) of Title 40, Public Buildings, Property, and Works. Section 303(b) of Title 40 was amended generally by Pub. L. 109–313, § 2(a)(1), Oct. 6, 2006, 120 Stat. 1734, and, as so amended, no longer relates to the Federal Works Agen- cy and Commissioner of Public Buildings. See 2006 Amendment note under section 303 of Title 40. EFFECTIVE DATE OF TRANSFER OF FUNCTIONS Transfer of functions by act June 30, 1949, effective July 1, 1949, see section 605, formerly section 505, of act June 30, 1949, ch. 288, 63 Stat. 403; renumbered by act Sept. 5, 1950, ch. 849, § 6(a), (b), 64 Stat. 583. Executive Documents TRANSFER OF FUNCTIONS Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and em- ployees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855, 80 Stat. 1610, set out as a note under section 202 of this title. § 233. Civil actions or proceedings against com- missioned officers or employees (a) Exclusiveness of remedy The remedy against the United States pro- vided by sections 1346(b) and 2672 of title 28, or by alternative benefits provided by the United States where the availability of such benefits precludes a remedy under section 1346(b) of title 28, for damage for personal injury, including death, resulting from the performance of med- ical, surgical, dental, or related functions, in- cluding the conduct of clinical studies or inves- tigation, by any commissioned officer or em- ployee of the Public Health Service while acting within the scope of his office or employment, shall be exclusive of any other civil action or proceeding by reason of the same subject-matter against the officer or employee (or his estate) whose act or omission gave rise to the claim. (b) Attorney General to defend action or pro- ceeding; delivery of process to designated of- ficial; furnishing of copies of pleading and process to United States attorney, Attorney General, and Secretary The Attorney General shall defend any civil action or proceeding brought in any court against any person referred to in subsection (a) of this section (or his estate) for any such dam- age or injury. Any such person against whom such civil action or proceeding is brought shall deliver within such time after date of service or knowledge of service as determined by the At- torney General, all process served upon him or an attested true copy thereof to his immediate superior or to whomever was designated by the Secretary to receive such papers and such per- son shall promptly furnish copies of the pleading and process therein to the United States attor- ney for the district embracing the place wherein the proceeding is brought, to the Attorney Gen- eral, and to the Secretary. (c) Removal to United States district court; pro- cedure; proceeding upon removal deemed a tort action against United States; hearing on motion to remand to determine availability of remedy against United States; remand to State court or dismissal Upon a certification by the Attorney General that the defendant was acting in the scope of his employment at the time of the incident out of which the suit arose, any such civil action or proceeding commenced in a State court shall be removed without bond at any time before trial by the Attorney General to the district court of the United States of the district and division embracing the place wherein it is pending and the proceeding deemed a tort action brought against the United States under the provisions of title 28 and all references thereto. Should a United States district court determine on a hearing on a motion to remand held before a trial on the merit that the case so removed is one in which a remedy by suit within the mean- ing of subsection (a) of this section is not avail- able against the United States, the case shall be remanded to the State Court: Provided, That where such a remedy is precluded because of the availability of a remedy through proceedings for compensation or other benefits from the United States as provided by any other law, the case shall be dismissed, but in the event the running of any limitation of time for commencing, or fil- ing an application or claim in, such proceedings for compensation or other benefits shall be deemed to have been suspended during the pend- ency of the civil action or proceeding under this section. Page 93 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 233 (d) Compromise or settlement of claim by Attor- ney General The Attorney General may compromise or set- tle any claim asserted in such civil action or proceeding in the manner provided in section 2677 of title 28 and with the same effect. (e) Assault or battery For purposes of this section, the provisions of section 2680(h) of title 28 shall not apply to as- sault or battery arising out of negligence in the performance of medical, surgical, dental, or re- lated functions, including the conduct of clinical studies or investigations. (f) Authority of Secretary or designee to hold harmless or provide liability insurance for assigned or detailed employees The Secretary or his designee may, to the ex- tent that he deems appropriate, hold harmless or provide liability insurance for any officer or employee of the Public Health Service for dam- age for personal injury, including death, neg- ligently caused by such officer or employee while acting within the scope of his office or em- ployment and as a result of the performance of medical, surgical, dental, or related functions, including the conduct of clinical studies or in- vestigations, if such employee is assigned to a foreign country or detailed to a State or polit- ical subdivision thereof or to a non-profit insti- tution, and if the circumstances are such as are likely to preclude the remedies of third persons against the United States described in section 2679(b) of title 28, for such damage or injury. (g) Exclusivity of remedy against United States for entities deemed Public Health Service employees; coverage for services furnished to individuals other than center patients; appli- cation process; subrogation of medical mal- practice claims; applicable period; entity and contractor defined (1)(A) For purposes of this section and subject to the approval by the Secretary of an applica- tion under subparagraph (D), an entity described in paragraph (4), and any officer, governing board member, or employee of such an entity, and any contractor of such an entity who is a physician or other licensed or certified health care practitioner (subject to paragraph (5)), shall be deemed to be an employee of the Public Health Service for a calendar year that begins during a fiscal year for which a transfer was made under subsection (k)(3) (subject to para- graph (3)). The remedy against the United States for an entity described in paragraph (4) and any officer, governing board member, em- ployee, or contractor (subject to paragraph (5)) of such an entity who is deemed to be an em- ployee of the Public Health Service pursuant to this paragraph shall be exclusive of any other civil action or proceeding to the same extent as the remedy against the United States is exclu- sive pursuant to subsection (a). (B) The deeming of any entity or officer, gov- erning board member, employee, or contractor of the entity to be an employee of the Public Health Service for purposes of this section shall apply with respect to services provided— (i) to all patients of the entity, and (ii) subject to subparagraph (C), to individ- uals who are not patients of the entity. (C) Subparagraph (B)(ii) applies to services provided to individuals who are not patients of an entity if the Secretary determines, after re- viewing an application submitted under sub- paragraph (D), that the provision of the services to such individuals— (i) benefits patients of the entity and gen- eral populations that could be served by the entity through community-wide intervention efforts within the communities served by such entity; (ii) facilitates the provision of services to patients of the entity; or (iii) are otherwise required under an employ- ment contract (or similar arrangement) be- tween the entity and an officer, governing board member, employee, or contractor of the entity. (D) The Secretary may not under subpara- graph (A) deem an entity or an officer, gov- erning board member, employee, or contractor of the entity to be an employee of the Public Health Service for purposes of this section, and may not apply such deeming to services de- scribed in subparagraph (B)(ii), unless the entity has submitted an application for such deeming to the Secretary in such form and such manner as the Secretary shall prescribe. The application shall contain detailed information, along with supporting documentation, to verify that the entity, and the officer, governing board member, employee, or contractor of the entity, as the case may be, meets the requirements of subpara- graphs (B) and (C) of this paragraph and that the entity meets the requirements of paragraphs (1) through (4) of subsection (h). (E) The Secretary shall make a determination of whether an entity or an officer, governing board member, employee, or contractor of the entity is deemed to be an employee of the Public Health Service for purposes of this section with- in 30 days after the receipt of an application under subparagraph (D). The determination of the Secretary that an entity or an officer, gov- erning board member, employee, or contractor of the entity is deemed to be an employee of the Public Health Service for purposes of this sec- tion shall apply for the period specified by the Secretary under subparagraph (A). (F) Once the Secretary makes a determination that an entity or an officer, governing board member, employee, or contractor of an entity is deemed to be an employee of the Public Health Service for purposes of this section, the deter- mination shall be final and binding upon the Secretary and the Attorney General and other parties to any civil action or proceeding. Except as provided in subsection (i), the Secretary and the Attorney General may not determine that the provision of services which are the subject of such a determination are not covered under this section. (G) In the case of an entity described in para- graph (4) that has not submitted an application under subparagraph (D): (i) The Secretary may not consider the enti- ty in making estimates under subsection (k)(1). (ii) This section does not affect any author- ity of the entity to purchase medical mal- practice liability insurance coverage with Fed- Page 94 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 233 1 See References in Text notes below. eral funds provided to the entity under section 254b, 254b, or 256a of this title.1 (H) In the case of an entity described in para- graph (4) for which an application under sub- paragraph (D) is in effect, the entity may, through notifying the Secretary in writing, elect to terminate the applicability of this sub- section to the entity. With respect to such elec- tion by the entity: (i) The election is effective upon the expira- tion of the 30-day period beginning on the date on which the entity submits such notification. (ii) Upon taking effect, the election termi- nates the applicability of this subsection to the entity and each officer, governing board member, employee, and contractor of the enti- ty. (iii) Upon the effective date for the election, clauses (i) and (ii) of subparagraph (G) apply to the entity to the same extent and in the same manner as such clauses apply to an enti- ty that has not submitted an application under subparagraph (D). (iv) If after making the election the entity submits an application under subparagraph (D), the election does not preclude the Sec- retary from approving the application (and thereby restoring the applicability of this sub- section to the entity and each officer, gov- erning board member, employee, and con- tractor of the entity, subject to the provisions of this subsection and the subsequent provi- sions of this section). (2) If, with respect to an entity or person deemed to be an employee for purposes of para- graph (1), a cause of action is instituted against the United States pursuant to this section, any claim of the entity or person for benefits under an insurance policy with respect to medical mal- practice relating to such cause of action shall be subrogated to the United States. (3) This subsection shall apply with respect to a cause of action arising from an act or omission which occurs on or after January 1, 1993. (4) An entity described in this paragraph is a public or non-profit private entity receiving Federal funds under section 254b of this title. (5) For purposes of paragraph (1), an individual may be considered a contractor of an entity de- scribed in paragraph (4) only if— (A) the individual normally performs on av- erage at least 321⁄2 hours of service per week for the entity for the period of the contract; or (B) in the case of an individual who nor- mally performs an average of less than 321⁄2 hours of services per week for the entity for the period of the contract, the individual is a licensed or certified provider of services in the fields of family practice, general internal med- icine, general pediatrics, or obstetrics and gynecology. (h) Qualifications for designation as Public Health Service employee The Secretary may not approve an application under subsection (g)(1)(D) unless the Secretary determines that the entity— (1) has implemented appropriate policies and procedures to reduce the risk of malpractice and the risk of lawsuits arising out of any health or health-related functions performed by the entity; (2) has reviewed and verified the professional credentials, references, claims history, fitness, professional review organization findings, and license status of its physicians and other li- censed or certified health care practitioners, and, where necessary, has obtained the per- mission from these individuals to gain access to this information; (3) has no history of claims having been filed against the United States as a result of the ap- plication of this section to the entity or its of- ficers, employees, or contractors as provided for under this section, or, if such a history ex- ists, has fully cooperated with the Attorney General in defending against any such claims and either has taken, or will take, any nec- essary corrective steps to assure against such claims in the future; and (4) will fully cooperate with the Attorney General in providing information relating to an estimate described under subsection (k). (i) Authority of Attorney General to exclude health care professionals from coverage (1) Notwithstanding subsection (g)(1), the At- torney General, in consultation with the Sec- retary, may on the record determine, after no- tice and opportunity for a full and fair hearing, that an individual physician or other licensed or certified health care practitioner who is an offi- cer, employee, or contractor of an entity de- scribed in subsection (g)(4) shall not be deemed to be an employee of the Public Health Service for purposes of this section, if treating such in- dividual as such an employee would expose the Government to an unreasonably high degree of risk of loss because such individual— (A) does not comply with the policies and procedures that the entity has implemented pursuant to subsection (h)(1); (B) has a history of claims filed against him or her as provided for under this section that is outside the norm for licensed or certified health care practitioners within the same spe- cialty; (C) refused to reasonably cooperate with the Attorney General in defending against any such claim; (D) provided false information relevant to the individual’s performance of his or her du- ties to the Secretary, the Attorney General, or an applicant for or recipient of funds under this chapter; or (E) was the subject of disciplinary action taken by a State medical licensing authority or a State or national professional society. (2) A final determination by the Attorney Gen- eral under this subsection that an individual physician or other licensed or certified health care professional shall not be deemed to be an employee of the Public Health Service shall be effective upon receipt by the entity employing such individual of notice of such determination, and shall apply only to acts or omissions occur- ring after the date such notice is received. (j) Remedy for denial of hospital admitting privi- leges to certain health care providers In the case of a health care provider who is an officer, employee, or contractor of an entity de- Page 95 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 233 scribed in subsection (g)(4), section 254h(e) of this title shall apply with respect to the pro- vider to the same extent and in the same man- ner as such section applies to any member of the National Health Service Corps. (k) Estimate of annual claims by Attorney Gen- eral; criteria; establishment of fund; transfer of funds to Treasury accounts (1)(A) For each fiscal year, the Attorney Gen- eral, in consultation with the Secretary, shall estimate by the beginning of the year the amount of all claims which are expected to arise under this section (together with related fees and expenses of witnesses) for which payment is expected to be made in accordance with section 1346 and chapter 171 of title 28 from the acts or omissions, during the calendar year that begins during that fiscal year, of entities described in subsection (g)(4) and of officers, employees, or contractors (subject to subsection (g)(5)) of such entities. (B) The estimate under subparagraph (A) shall take into account— (i) the value and frequency of all claims for damage for personal injury, including death, resulting from the performance of medical, surgical, dental, or related functions by enti- ties described in subsection (g)(4) or by offi- cers, employees, or contractors (subject to subsection (g)(5)) of such entities who are deemed to be employees of the Public Health Service under subsection (g)(1) that, during the preceding 5-year period, are filed under this section or, with respect to years occurring before this subsection takes effect, are filed against persons other than the United States, (ii) the amounts paid during that 5-year pe- riod on all claims described in clause (i), re- gardless of when such claims were filed, ad- justed to reflect payments which would not be permitted under section 1346 and chapter 171 of title 28, and (iii) amounts in the fund established under paragraph (2) but unspent from prior fiscal years. (2) Subject to appropriations, for each fiscal year, the Secretary shall establish a fund of an amount equal to the amount estimated under paragraph (1) that is attributable to entities re- ceiving funds under each of the grant programs described in paragraph (4) of subsection (g), but not to exceed a total of $10,000,000 for each such fiscal year. Appropriations for purposes of this paragraph shall be made separate from appro- priations made for purposes of sections 254b, 254b and 256a of this title.1 (3) In order for payments to be made for judg- ments against the United States (together with related fees and expenses of witnesses) pursuant to this section arising from the acts or omis- sions of entities described in subsection (g)(4) and of officers, governing board members, em- ployees, or contractors (subject to subsection (g)(5)) of such entities, the total amount con- tained within the fund established by the Sec- retary under paragraph (2) for a fiscal year shall be transferred not later than the December 31 that occurs during the fiscal year to the appro- priate accounts in the Treasury. (l) Timely response to filing of action or pro- ceeding (1) If a civil action or proceeding is filed in a State court against any entity described in sub- section (g)(4) or any officer, governing board member, employee, or any contractor of such an entity for damages described in subsection (a), the Attorney General, within 15 days after being notified of such filing, shall make an appearance in such court and advise such court as to wheth- er the Secretary has determined under sub- sections (g) and (h), that such entity, officer, governing board member, employee, or con- tractor of the entity is deemed to be an em- ployee of the Public Health Service for purposes of this section with respect to the actions or omissions that are the subject of such civil ac- tion or proceeding. Such advice shall be deemed to satisfy the provisions of subsection (c) that the Attorney General certify that an entity, of- ficer, governing board member, employee, or contractor of the entity was acting within the scope of their employment or responsibility. (2) If the Attorney General fails to appear in State court within the time period prescribed under paragraph (1), upon petition of any entity or officer, governing board member, employee, or contractor of the entity named, the civil ac- tion or proceeding shall be removed to the ap- propriate United States district court. The civil action or proceeding shall be stayed in such court until such court conducts a hearing, and makes a determination, as to the appropriate forum or procedure for the assertion of the claim for damages described in subsection (a) and issues an order consistent with such deter- mination. (m) Application of coverage to managed care plans (1) An entity or officer, governing board mem- ber, employee, or contractor of an entity de- scribed in subsection (g)(1) shall, for purposes of this section, be deemed to be an employee of the Public Health Service with respect to services provided to individuals who are enrollees of a managed care plan if the entity contracts with such managed care plan for the provision of services. (2) Each managed care plan which enters into a contract with an entity described in sub- section (g)(4) shall deem the entity and any offi- cer, governing board member, employee, or con- tractor of the entity as meeting whatever mal- practice coverage requirements such plan may require of contracting providers for a calendar year if such entity or officer, governing board member, employee, or contractor of the entity has been deemed to be an employee of the Public Health Service for purposes of this section for such calendar year. Any plan which is found by the Secretary on the record, after notice and an opportunity for a full and fair hearing, to have violated this subsection shall upon such finding cease, for a period to be determined by the Sec- retary, to receive and to be eligible to receive any Federal funds under titles XVIII or XIX of the Social Security Act [42 U.S.C. 1395 et seq., 1396 et seq.]. (3) For purposes of this subsection, the term ‘‘managed care plan’’ shall mean health mainte- Page 96 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 233 nance organizations and similar entities that contract at-risk with payors for the provision of health services or plan enrollees and which con- tract with providers (such as entities described in subsection (g)(4)) for the delivery of such services to plan enrollees. (n) Report on risk exposure of covered entities (1) Not later than one year after December 26, 1995, the Comptroller General of the United States shall submit to the Congress a report on the following: (A) The medical malpractice liability claims experience of entities that have been deemed to be employees for purposes of this section. (B) The risk exposure of such entities. (C) The value of private sector risk-manage- ment services, and the value of risk-manage- ment services and procedures required as a condition of receiving a grant under section 254b, 254b, or 256a of this title.1 (D) A comparison of the costs and the bene- fits to taxpayers of maintaining medical mal- practice liability coverage for such entities pursuant to this section, taking into ac- count— (i) a comparison of the costs of premiums paid by such entities for private medical malpractice liability insurance with the cost of coverage pursuant to this section; and (ii) an analysis of whether the cost of pre- miums for private medical malpractice li- ability insurance coverage is consistent with the liability claims experience of such enti- ties. (2) The report under paragraph (1) shall in- clude the following: (A) A comparison of— (i) an estimate of the aggregate amounts that such entities (together with the offi- cers, governing board members, employees, and contractors of such entities who have been deemed to be employees for purposes of this section) would have directly or indi- rectly paid in premiums to obtain medical malpractice liability insurance coverage if this section were not in effect; with (ii) the aggregate amounts by which the grants received by such entities under this chapter were reduced pursuant to subsection (k)(2). (B) A comparison of— (i) an estimate of the amount of privately offered such insurance that such entities (to- gether with the officers, governing board members, employees, and contractors of such entities who have been deemed to be employees for purposes of this section) pur- chased during the three-year period begin- ning on January 1, 1993; with (ii) an estimate of the amount of such in- surance that such entities (together with the officers, governing board members, employ- ees, and contractors of such entities who have been deemed to be employees for pur- poses of this section) will purchase after De- cember 26, 1995. (C) An estimate of the medical malpractice liability loss history of such entities for the 10-year period preceding October 1, 1996, in- cluding but not limited to the following: (i) Claims that have been paid and that are estimated to be paid, and legal expenses to handle such claims that have been paid and that are estimated to be paid, by the Federal Government pursuant to deeming entities as employees for purposes of this section. (ii) Claims that have been paid and that are estimated to be paid, and legal expenses to handle such claims that have been paid and that are estimated to be paid, by private medical malpractice liability insurance. (D) An analysis of whether the cost of pre- miums for private medical malpractice liabil- ity insurance coverage is consistent with the liability claims experience of entities that have been deemed as employees for purposes of this section. (3) In preparing the report under paragraph (1), the Comptroller General of the United States shall consult with public and private entities with expertise on the matters with which the re- port is concerned. (o) Volunteer services provided by health profes- sionals at free clinics (1) For purposes of this section, a free clinic health professional shall in providing a quali- fying health service to an individual, or an offi- cer, governing board member, employee, or con- tractor of a free clinic shall in providing serv- ices for the free clinic, be deemed to be an em- ployee of the Public Health Service for a cal- endar year that begins during a fiscal year for which a transfer was made under paragraph (6)(D). The preceding sentence is subject to the provisions of this subsection. (2) In providing a health service to an indi- vidual, a health care practitioner shall for pur- poses of this subsection be considered to be a free clinic health professional if the following conditions are met: (A) The service is provided to the individual at a free clinic, or through offsite programs or events carried out by the free clinic. (B) The free clinic is sponsoring the health care practitioner pursuant to paragraph (5)(C). (C) The service is a qualifying health service (as defined in paragraph (4)). (D) Neither the health care practitioner nor the free clinic receives any compensation for the service from the individual or from any third-party payor (including reimbursement under any insurance policy or health plan, or under any Federal or State health benefits program). With respect to compliance with such condition: (i) The health care practitioner may re- ceive repayment from the free clinic for rea- sonable expenses incurred by the health care practitioner in the provision of the service to the individual. (ii) The free clinic may accept voluntary donations for the provision of the service by the health care practitioner to the indi- vidual. (E) Before the service is provided, the health care practitioner or the free clinic provides written notice to the individual of the extent to which the legal liability of the health care practitioner is limited pursuant to this sub- Page 97 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 233 section (or in the case of an emergency, the written notice is provided to the individual as soon after the emergency as is practicable). If the individual is a minor or is otherwise le- gally incompetent, the condition under this subparagraph is that the written notice be provided to a legal guardian or other person with legal responsibility for the care of the in- dividual. (F) At the time the service is provided, the health care practitioner is licensed or certified in accordance with applicable law regarding the provision of the service. (3)(A) For purposes of this subsection, the term ‘‘free clinic’’ means a health care facility operated by a nonprofit private entity meeting the following requirements: (i) The entity does not, in providing health services through the facility, accept reim- bursement from any third-party payor (includ- ing reimbursement under any insurance policy or health plan, or under any Federal or State health benefits program). (ii) The entity, in providing health services through the facility, either does not impose charges on the individuals to whom the serv- ices are provided, or imposes a charge accord- ing to the ability of the individual involved to pay the charge. (iii) The entity is licensed or certified in ac- cordance with applicable law regarding the provision of health services. (B) With respect to compliance with the condi- tions under subparagraph (A), the entity in- volved may accept voluntary donations for the provision of services. (4) For purposes of this subsection, the term ‘‘qualifying health service’’ means any medical assistance required or authorized to be provided in the program under title XIX of the Social Se- curity Act [42 U.S.C. 1396 et seq.], without re- gard to whether the medical assistance is in- cluded in the plan submitted under such pro- gram by the State in which the health care practitioner involved provides the medical as- sistance. References in the preceding sentence to such program shall as applicable be consid- ered to be references to any successor to such program. (5) Subsection (g) (other than paragraphs (3) through (5)) and subsections (h), (i), and (l) apply to a health care practitioner for purposes of this subsection to the same extent and in the same manner as such subsections apply to an officer, governing board member, employee, or con- tractor of an entity described in subsection (g)(4), subject to paragraph (6) and subject to the following: (A) The first sentence of paragraph (1) ap- plies in lieu of the first sentence of subsection (g)(1)(A). (B) This subsection may not be construed as deeming any free clinic to be an employee of the Public Health Service for purposes of this section. (C) With respect to a free clinic, a health care practitioner is not a free clinic health professional unless the free clinic sponsors the health care practitioner. For purposes of this subsection, the free clinic shall be considered to be sponsoring the health care practitioner if— (i) with respect to the health care practi- tioner, the free clinic submits to the Sec- retary an application meeting the require- ments of subsection (g)(1)(D); and (ii) the Secretary, pursuant to subsection (g)(1)(E), determines that the health care practitioner is deemed to be an employee of the Public Health Service. (D) In the case of a health care practitioner who is determined by the Secretary pursuant to subsection (g)(1)(E) to be a free clinic health professional, this subsection applies to the health care practitioner (with respect to the free clinic sponsoring the health care prac- titioner pursuant to subparagraph (C)) for any cause of action arising from an act or omis- sion of the health care practitioner occurring on or after the date on which the Secretary makes such determination. (E) Subsection (g)(1)(F) applies to a health care practitioner for purposes of this sub- section only to the extent that, in providing health services to an individual, each of the conditions specified in paragraph (2) is met. (6)(A) For purposes of making payments for judgments against the United States (together with related fees and expenses of witnesses) pur- suant to this section arising from the acts or omissions of free clinic health professionals, there is authorized to be appropriated $10,000,000 for each fiscal year. (B) The Secretary shall establish a fund for purposes of this subsection. Each fiscal year amounts appropriated under subparagraph (A) shall be deposited in such fund. (C) Not later than May 1 of each fiscal year, the Attorney General, in consultation with the Secretary, shall submit to the Congress a report providing an estimate of the amount of claims (together with related fees and expenses of wit- nesses) that, by reason of the acts or omissions of free clinic health professionals, will be paid pursuant to this section during the calendar year that begins in the following fiscal year. Subsection (k)(1)(B) applies to the estimate under the preceding sentence regarding free clinic health professionals to the same extent and in the same manner as such subsection ap- plies to the estimate under such subsection re- garding officers, governing board members, em- ployees, and contractors of entities described in subsection (g)(4). (D) Not later than December 31 of each fiscal year, the Secretary shall transfer from the fund under subparagraph (B) to the appropriate ac- counts in the Treasury an amount equal to the estimate made under subparagraph (C) for the calendar year beginning in such fiscal year, sub- ject to the extent of amounts in the fund. (7)(A) This subsection takes effect on the date of the enactment of the first appropriations Act that makes an appropriation under paragraph (6)(A), except as provided in subparagraph (B)(i). (B)(i) Effective on August 21, 1996— (I) the Secretary may issue regulations for carrying out this subsection, and the Sec- retary may accept and consider applications submitted pursuant to paragraph (5)(C); and Page 98 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 233 (II) reports under paragraph (6)(C) may be submitted to the Congress. (ii) For the first fiscal year for which an ap- propriation is made under subparagraph (A) of paragraph (6), if an estimate under subparagraph (C) of such paragraph has not been made for the calendar year beginning in such fiscal year, the transfer under subparagraph (D) of such para- graph shall be made notwithstanding the lack of the estimate, and the transfer shall be made in an amount equal to the amount of such appro- priation. (p) Administration of smallpox countermeasures by health professionals (1) In general For purposes of this section, and subject to other provisions of this subsection, a covered person shall be deemed to be an employee of the Public Health Service with respect to li- ability arising out of administration of a cov- ered countermeasure against smallpox to an individual during the effective period of a dec- laration by the Secretary under paragraph (2)(A). (2) Declaration by Secretary concerning coun- termeasure against smallpox (A) Authority to issue declaration (i) In general The Secretary may issue a declaration, pursuant to this paragraph, concluding that an actual or potential bioterrorist in- cident or other actual or potential public health emergency makes advisable the ad- ministration of a covered countermeasure to a category or categories of individuals. (ii) Covered countermeasure The Secretary shall specify in such dec- laration the substance or substances that shall be considered covered counter- measures (as defined in paragraph (7)(A)) for purposes of administration to individ- uals during the effective period of the dec- laration. (iii) Effective period The Secretary shall specify in such dec- laration the beginning and ending dates of the effective period of the declaration, and may subsequently amend such declaration to shorten or extend such effective period, provided that the new closing date is after the date when the declaration is amended. (iv) Publication The Secretary shall promptly publish each such declaration and amendment in the Federal Register. (B) Liability of United States only for admin- istrations within scope of declaration Except as provided in paragraph (5)(B)(ii), the United States shall be liable under this subsection with respect to a claim arising out of the administration of a covered coun- termeasure to an individual only if— (i) the countermeasure was administered by a qualified person, for a purpose stated in paragraph (7)(A)(i), and during the effec- tive period of a declaration by the Sec- retary under subparagraph (A) with re- spect to such countermeasure; and (ii)(I) the individual was within a cat- egory of individuals covered by the dec- laration; or (II) the qualified person administering the countermeasure had reasonable grounds to believe that such individual was within such category. (C) Presumption of administration within scope of declaration in case of accidental vaccinia inoculation (i) In general If vaccinia vaccine is a covered counter- measure specified in a declaration under subparagraph (A), and an individual to whom the vaccinia vaccine is not adminis- tered contracts vaccinia, then, under the circumstances specified in clause (ii), the individual— (I) shall be rebuttably presumed to have contracted vaccinia from an indi- vidual to whom such vaccine was admin- istered as provided by clauses (i) and (ii) of subparagraph (B); and (II) shall (unless such presumption is rebutted) be deemed for purposes of this subsection to be an individual to whom a covered countermeasure was adminis- tered by a qualified person in accordance with the terms of such declaration and as described by subparagraph (B). (ii) Circumstances in which presumption applies The presumption and deeming stated in clause (i) shall apply if— (I) the individual contracts vaccinia during the effective period of a declara- tion under subparagraph (A) or by the date 30 days after the close of such pe- riod; or (II) the individual has resided with, or has had contact with, an individual to whom such vaccine was administered as provided by clauses (i) and (ii) of sub- paragraph (B) and contracts vaccinia after such date. (D) Acts and omissions deemed to be within scope of employment (i) In general In the case of a claim arising out of al- leged transmission of vaccinia from an in- dividual described in clause (ii), acts or omissions by such individual shall be deemed to have been taken within the scope of such individual’s office or employ- ment for purposes of— (I) subsection (a); and (II) section 1346(b) and chapter 171 of title 28. (ii) Individuals to whom deeming applies An individual is described by this clause if— (I) vaccinia vaccine was administered to such individual as provided by sub- paragraph (B); and (II) such individual was within a cat- egory of individuals covered by a dec- laration under subparagraph (A)(i). Page 99 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 233 (3) Exhaustion; exclusivity; offset (A) Exhaustion (i) In general A person may not bring a claim under this subsection unless such person has ex- hausted such remedies as are available under part C of this subchapter, except that if the Secretary fails to make a final determination on a request for benefits or compensation filed in accordance with the requirements of such part within 240 days after such request was filed, the individual may seek any remedy that may be avail- able under this section. (ii) Tolling of statute of limitations The time limit for filing a claim under this subsection, or for filing an action based on such claim, shall be tolled during the pendency of a request for benefits or compensation under part C of this sub- chapter. (iii) Construction This subsection shall not be construed as superseding or otherwise affecting the ap- plication of a requirement, under chapter 171 of title 28, to exhaust administrative remedies. (B) Exclusivity The remedy provided by subsection (a) shall be exclusive of any other civil action or proceeding for any claim or suit this sub- section encompasses, except for a proceeding under part C of this subchapter. (C) Offset The value of all compensation and benefits provided under part C of this subchapter for an incident or series of incidents shall be off- set against the amount of an award, com- promise, or settlement of money damages in a claim or suit under this subsection based on the same incident or series of incidents. (4) Certification of action by Attorney General Subsection (c) applies to actions under this subsection, subject to the following provi- sions: (A) Nature of certification The certification by the Attorney General that is the basis for deeming an action or proceeding to be against the United States, and for removing an action or proceeding from a State court, is a certification that the action or proceeding is against a covered person and is based upon a claim alleging personal injury or death arising out of the administration of a covered countermeasure. (B) Certification of Attorney General conclu- sive The certification of the Attorney General of the facts specified in subparagraph (A) shall conclusively establish such facts for purposes of jurisdiction pursuant to this sub- section. (5) Covered person to cooperate with United States (A) In general A covered person shall cooperate with the United States in the processing and defense of a claim or action under this subsection based upon alleged acts or omissions of such person. (B) Consequences of failure to cooperate Upon the motion of the United States or any other party and upon finding that such person has failed to so cooperate— (i) the court shall substitute such person as the party defendant in place of the United States and, upon motion, shall re- mand any such suit to the court in which it was instituted if it appears that the court lacks subject matter jurisdiction; (ii) the United States shall not be liable based on the acts or omissions of such per- son; and (iii) the Attorney General shall not be obligated to defend such action. (6) Recourse against covered person in case of gross misconduct or contract violation (A) In general Should payment be made by the United States to any claimant bringing a claim under this subsection, either by way of ad- ministrative determination, settlement, or court judgment, the United States shall have, notwithstanding any provision of State law, the right to recover for that por- tion of the damages so awarded or paid, as well as interest and any costs of litigation, resulting from the failure of any covered person to carry out any obligation or respon- sibility assumed by such person under a con- tract with the United States or from any grossly negligent, reckless, or illegal con- duct or willful misconduct on the part of such person. (B) Venue The United States may maintain an action under this paragraph against such person in the district court of the United States in which such person resides or has its prin- cipal place of business. (7) Definitions As used in this subsection, terms have the following meanings: (A) Covered countermeasure The term ‘‘covered countermeasure’’ or ‘‘covered countermeasure against smallpox’’, means a substance that is— (i)(I) used to prevent or treat smallpox (including the vaccinia or another vac- cine); or (II) used to control or treat the adverse effects of vaccinia inoculation or of admin- istration of another covered counter- measure; and (ii) specified in a declaration under para- graph (2). (B) Covered person The term ‘‘covered person’’, when used with respect to the administration of a cov- ered countermeasure, means a person who is— (i) a manufacturer or distributor of such countermeasure; (ii) a health care entity under whose aus- pices— Page 100 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 233 2 So in original. Probably should be ‘‘subclause’’. (I) such countermeasure was adminis- tered; (II) a determination was made as to whether, or under what circumstances, an individual should receive a covered countermeasure; (III) the immediate site of administra- tion on the body of a covered counter- measure was monitored, managed, or cared for; or (IV) an evaluation was made of wheth- er the administration of a counter- measure was effective; (iii) a qualified person who administered such countermeasure; (iv) a State, a political subdivision of a State, or an agency or official of a State or of such a political subdivision, if such State, subdivision, agency, or official has established requirements, provided policy guidance, supplied technical or scientific advice or assistance, or otherwise super- vised or administered a program with re- spect to administration of such counter- measures; (v) in the case of a claim arising out of alleged transmission of vaccinia from an individual— (I) the individual who allegedly trans- mitted the vaccinia, if vaccinia vaccine was administered to such individual as provided by paragraph (2)(B) and such in- dividual was within a category of indi- viduals covered by a declaration under paragraph (2)(A)(i); or (II) an entity that employs an indi- vidual described by clause (I) 2 or where such individual has privileges or is oth- erwise authorized to provide health care; (vi) an official, agent, or employee of a person described in clause (i), (ii), (iii), or (iv); (vii) a contractor of, or a volunteer working for, a person described in clause (i), (ii), or (iv), if the contractor or volun- teer performs a function for which a per- son described in clause (i), (ii), or (iv) is a covered person; or (viii) an individual who has privileges or is otherwise authorized to provide health care under the auspices of an entity de- scribed in clause (ii) or (v)(II). (C) Qualified person The term ‘‘qualified person’’, when used with respect to the administration of a cov- ered countermeasure, means a licensed health professional or other individual who— (i) is authorized to administer such countermeasure under the law of the State in which the countermeasure was adminis- tered; or (ii) is otherwise authorized by the Sec- retary to administer such countermeasure. (D) Arising out of administration of a cov- ered countermeasure The term ‘‘arising out of administration of a covered countermeasure’’, when used with respect to a claim or liability, includes a claim or liability arising out of— (i) determining whether, or under what conditions, an individual should receive a covered countermeasure; (ii) obtaining informed consent of an in- dividual to the administration of a covered countermeasure; (iii) monitoring, management, or care of an immediate site of administration on the body of a covered countermeasure, or evaluation of whether the administration of the countermeasure has been effective; or (iv) transmission of vaccinia virus by an individual to whom vaccinia vaccine was administered as provided by paragraph (2)(B). (q) Health professional volunteers at public or non-profit private entities (1) For purposes of this section, a health pro- fessional volunteer at a deemed entity described in subsection (g)(4) shall, in providing a health professional service eligible for funding under section 254b of this title to an individual, be deemed to be an employee of the Public Health Service for a calendar year that begins during a fiscal year for which a transfer was made under paragraph (4)(C). The preceding sentence is sub- ject to the provisions of this subsection. (2) In providing a health service to an indi- vidual, a health care practitioner shall for pur- poses of this subsection be considered to be a health professional volunteer at an entity de- scribed in subsection (g)(4) if the following con- ditions are met: (A) The service is provided to the individual at the facilities of an entity described in sub- section (g)(4), or through offsite programs or events carried out by the entity. (B) The entity is sponsoring the health care practitioner pursuant to paragraph (3)(B). (C) The health care practitioner does not re- ceive any compensation for the service from the individual, the entity described in sub- section (g)(4), or any third-party payer (in- cluding reimbursement under any insurance policy or health plan, or under any Federal or State health benefits program), except that the health care practitioner may receive re- payment from the entity described in sub- section (g)(4) for reasonable expenses incurred by the health care practitioner in the provi- sion of the service to the individual, which may include travel expenses to or from the site of services. (D) Before the service is provided, the health care practitioner or the entity described in subsection (g)(4) posts a clear and conspicuous notice at the site where the service is provided of the extent to which the legal liability of the health care practitioner is limited pursuant to this subsection. (E) At the time the service is provided, the health care practitioner is licensed or certified in accordance with applicable Federal and State laws regarding the provision of the serv- ice. (F) At the time the service is provided, the entity described in subsection (g)(4) maintains Page 101 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 233 relevant documentation certifying that the health care practitioner meets the require- ments of this subsection. (3) Subsection (g) (other than paragraphs (3) and (5)) and subsections (h), (i), and (l) apply to a health care practitioner for purposes of this subsection to the same extent and in the same manner as such subsections apply to an officer, governing board member, employee, or con- tractor of an entity described in subsection (g)(4), subject to paragraph (4), and subject to the following: (A) The first sentence of paragraph (1) ap- plies in lieu of the first sentence of subsection (g)(1)(A). (B) With respect to an entity described in subsection (g)(4), a health care practitioner is not a health professional volunteer at such en- tity unless the entity sponsors the health care practitioner. For purposes of this subsection, the entity shall be considered to be sponsoring the health care practitioner if— (i) with respect to the health care practi- tioner, the entity submits to the Secretary an application meeting the requirements of subsection (g)(1)(D); and (ii) the Secretary, pursuant to subsection (g)(1)(E), determines that the health care practitioner is deemed to be an employee of the Public Health Service. (C) In the case of a health care practitioner who is determined by the Secretary pursuant to subsection (g)(1)(E) to be a health profes- sional volunteer at such entity, this sub- section applies to the health care practitioner (with respect to services performed on behalf of the entity sponsoring the health care prac- titioner pursuant to subparagraph (B)) for any cause of action arising from an act or omis- sion of the health care practitioner occurring on or after the date on which the Secretary makes such determination. (D) Subsection (g)(1)(F) applies to a health care practitioner for purposes of this sub- section only to the extent that, in providing health services to an individual, each of the conditions specified in paragraph (2) is met. (4)(A) Amounts in the fund established under subsection (k)(2) shall be available for transfer under subparagraph (C) for purposes of carrying out this subsection. (B)(i) Not later than May 1 of each fiscal year, the Attorney General, in consultation with the Secretary, shall submit to the Congress a report providing an estimate of the amount of claims (together with related fees and expenses of wit- nesses) that, by reason of the acts or omissions of health professional volunteers, will be paid pursuant to this section during the calendar year that begins in the following fiscal year. (ii) Subsection (k)(1)(B) applies to the esti- mate under clause (i) regarding health profes- sional volunteers to the same extent and in the same manner as such subsection applies to the estimate under such subsection regarding offi- cers, governing board members, employees, and contractors of entities described in subsection (g)(4). (iii) The report shall include a summary of the data relied upon for the estimate in clause (i), including the number of claims filed and paid from the previous calendar year. (C) Not later than December 31 of each fiscal year, the Secretary shall transfer from the fund under subsection (k)(2) to the appropriate ac- counts in the Treasury an amount equal to the estimate made under subparagraph (B) for the calendar year beginning in such fiscal year, sub- ject to the extent of amounts in the fund. (5)(A) This subsection shall take effect on Oc- tober 1, 2017, except as provided in subparagraph (B). (B) Effective on December 13, 2016— (i) the Secretary may issue regulations for carrying out this subsection, and the Sec- retary may accept and consider applications submitted pursuant to paragraph (3)(B); and (ii) reports under paragraph (4)(B) may be submitted to Congress. (July 1, 1944, ch. 373, title II, § 224, formerly § 223, as added Pub. L. 91–623, § 4, Dec. 31, 1970, 84 Stat. 1870; renumbered § 224, Pub. L. 92–157, title III, § 301(c), Nov. 18, 1971, 85 Stat. 463; amended Pub. L. 102–501, §§ 2–4, Oct. 24, 1992, 106 Stat. 3268–3270; Pub. L. 103–183, title VII, § 706(a), Dec. 14, 1993, 107 Stat. 2241; Pub. L. 104–73, §§ 2–5(b), 6–11, Dec. 26, 1995, 109 Stat. 777–781; Pub. L. 104–191, title I, § 194, Aug. 21, 1996, 110 Stat. 1988; Pub. L. 104–299, § 4(a)(1), Oct. 11, 1996, 110 Stat. 3644; Pub. L. 107–251, title VI, § 601(a), Oct. 26, 2002, 116 Stat. 1664; Pub. L. 107–296, title III, § 304(c), Nov. 25, 2002, 116 Stat. 2165; Pub. L. 108–20, § 3(a)–(i), Apr. 30, 2003, 117 Stat. 646–648; Pub. L. 108–163, § 2(m)(1), Dec. 6, 2003, 117 Stat. 2023; Pub. L. 111–148, title X, § 10608(a), Mar. 23, 2010, 124 Stat. 1014; Pub. L. 114–255, div. B, title IX, § 9025, Dec. 13, 2016, 130 Stat. 1254; Pub. L. 117–180, div. D, title III, § 301, Sept. 30, 2022, 136 Stat. 2136.) Editorial Notes REFERENCES IN TEXT The references to section 254b of this title the first place appearing in subsecs. (g)(1)(G)(ii), (k)(2), and (n)(1)(C), were in the original references to section 329, meaning section 329 of act July 1, 1944, which was omit- ted in the general amendment of subpart I (§ 254b et seq.) of part D of subchapter II of this chapter by Pub. L. 104–299, § 2, Oct. 11, 1996, 110 Stat. 3626. Section 256a of this title, referred to in subsecs. (g)(1)(G)(ii), (k)(2), and (n)(1)(C), was repealed by Pub. L. 104–299, § 4(a)(3), Oct. 11, 1996, 110 Stat. 3645. The Social Security Act, referred to in subsecs. (m)(2) and (o)(4), is act Aug. 14, 1935, ch. 531, 49 Stat. 620. Titles XVIII and XIX of the Act are classified generally to subchapters XVIII (§ 1395 et seq.) and XIX (§ 1396 et seq.), respectively, of chapter 7 of this title. For complete classification of this Act to the Code, see section 1305 of this title and Tables. AMENDMENTS 2022—Subsec. (g)(1)(H)(iv). Pub. L. 117–180, § 301(b)(1), substituted ‘‘this section).’’ for ‘‘this section.’’ Subsec. (k)(3). Pub. L. 117–180, § 301(b)(2), inserted ‘‘governing board members,’’ after ‘‘officers,’’. Subsec. (p)(7)(A)(i)(II). Pub. L. 117–180, § 301(b)(3), re- aligned margin. Subsec. (q)(5)(A). Pub. L. 117–180, § 301(b)(4), struck out ‘‘and paragraph (6)’’ after ‘‘subparagraph (B)’’. Subsec. (q)(6). Pub. L. 117–180, § 301(a), struck out par. (6) which read as follows: ‘‘Beginning on October 1, 2022, this subsection shall cease to have any force or effect.’’ 2016—Subsec. (q). Pub. L. 114–255 added subsec. (q). 2010—Subsec. (o)(1). Pub. L. 111–148 inserted ‘‘, or an officer, governing board member, employee, or con- Page 102 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 233 tractor of a free clinic shall in providing services for the free clinic,’’ after ‘‘to an individual’’. 2003—Subsec. (g)(1)(G)(ii). Pub. L. 108–163 substituted ‘‘254b’’ for ‘‘254c, 254b(h)’’ before ‘‘, or’’. Subsec. (k)(2). Pub. L. 108–163 substituted ‘‘254b’’ for ‘‘254c, 254b(h)’’ before ‘‘and’’. Subsec. (n)(1)(C). Pub. L. 108–163 substituted ‘‘254b’’ for ‘‘254c, 254b(h)’’ before ‘‘, or’’. Subsec. (p)(2)(A)(ii). Pub. L. 108–20, § 3(i), substituted ‘‘paragraph (7)(A)’’ for ‘‘paragraph(8)(A)’’. Subsec. (p)(2)(C)(ii)(II). Pub. L. 108–20, § 3(a), sub- stituted ‘‘has resided with, or has had contact with,’’ for ‘‘resides or has resided with’’. Subsec. (p)(2)(D). Pub. L. 108–20, § 3(b), added subpar. (D). Subsec. (p)(3). Pub. L. 108–20, § 3(c), amended heading and text of par. (3) generally. Prior to amendment, text read as follows: ‘‘The remedy provided by subsection (a) of this section shall be exclusive of any other civil ac- tion or proceeding for any claim or suit this subsection encompasses.’’ Subsec. (p)(5). Pub. L. 108–20, § 3(d), substituted ‘‘Cov- ered person’’ for ‘‘Defendant’’ in heading. Subsec. (p)(7)(A)(i)(II). Pub. L. 108–20, § 3(e), amended subcl. (II) generally. Prior to amendment, subcl. (II) read as follows: ‘‘vaccinia immune globulin used to control or treat the adverse effects of vaccinia inocula- tion; and’’. Subsec. (p)(7)(B). Pub. L. 108–20, § 3(f)(1), substituted ‘‘means a person’’ for ‘‘includes any person’’ in intro- ductory provisions. Subsec. (p)(7)(B)(ii). Pub. L. 108–20, § 3(f)(2), sub- stituted ‘‘auspices—’’ for ‘‘auspices’’, designated ‘‘such countermeasure was administered;’’ as subcl. (I), and added subcls. (II) to (IV). Subsec. (p)(7)(B)(iv) to (viii). Pub. L. 108–20, § 3(f)(3), (4), added cls. (iv) to (viii) and struck out former cl. (iv) which read as follows: ‘‘an official, agent, or employee of a person described in clause (i), (ii), or (iii).’’ Subsec. (p)(7)(C). Pub. L. 108–20, § 3(g), substituted ‘‘individual who—’’ for ‘‘individual who’’, designated ‘‘is authorized to administer such countermeasure under the law of the State in which the counter- measure was administered.’’ as cl. (i), substituted ‘‘; or’’ for period at end of cl. (i), and added cl. (ii). Subsec. (p)(7)(D). Pub. L. 108–20, § 3(h), added subpar. (D). 2002—Subsecs. (g)(1)(G)(ii), (k)(2), (n)(1)(C). Pub. L. 107–251 substituted ‘‘254b(h)’’ for ‘‘256’’. Subsec. (p). Pub. L. 107–296 added subsec. (p). 1996—Subsec. (g)(4). Pub. L. 104–299 substituted ‘‘under section 254b of this title.’’ for ‘‘under any of the following grant programs:’’ and struck out subpars. (A) to (D) which read as follows: ‘‘(A) Section 254b of this title (relating to grants for migrant health centers). ‘‘(B) Section 254c of this title (relating to grants for community health centers). ‘‘(C) Section 256 of this title (relating to grants for health services for the homeless). ‘‘(D) Section 256a of this title (relating to grants for health services for residents of public housing).’’ Subsec. (o). Pub. L. 104–191 added subsec. (o). 1995—Subsec. (g)(1). Pub. L. 104–73, §§ 3(1), 4, 5(a), des- ignated existing provisions as subpar. (A), inserted ‘‘and subject to the approval by the Secretary of an ap- plication under subparagraph (D)’’ after ‘‘For purposes of this section’’, substituted ‘‘an entity described in paragraph (4), and any officer, governing board mem- ber, or employee of such an entity, and any contractor of such an entity who is a physician or other licensed or certified health care practitioner (subject to para- graph (5)), shall be deemed to be an employee of the Public Health Service for a calendar year that begins during a fiscal year for which a transfer was made under subsection (k)(3) (subject to paragraph (3)). The remedy against the United States for an entity de- scribed in paragraph (4) and any officer, governing board member, employee, or contractor’’ for ‘‘, an enti- ty described in paragraph (4) and any officer, employee, or contractor (subject to paragraph (5)) of such an enti- ty who is a physician or other licensed or certified health care practitioner shall be deemed to be an em- ployee of the Public Health Service for a calendar year that begins during a fiscal year for which a transfer of the full amount estimated under subsection (k)(1)(A) of this section was made under subsection (k)(3) of this section (subject to paragraph (3)). The remedy against the United States for an entity described in paragraph (4) and any officer, employee, or contractor’’, and added subpars. (B) to (H). Subsec. (g)(3). Pub. L. 104–73, § 2(a), struck out at end ‘‘This subsection shall not apply with respect to a cause of action arising from an act or omission which occurs on or after January 1, 1996.’’ Subsec. (g)(5)(B). Pub. L. 104–73, § 8, amended subpar. (B) generally. Prior to amendment, subpar. (B) read as follows: ‘‘in the case of an individual who normally per- forms on average less than 321⁄2 hours of services per week for the entity for the period of the contract and is a licensed or certified provider of obstetrical serv- ices— ‘‘(i) the individual’s medical malpractice liability insurance coverage does not extend to services per- formed by the individual for the entity under the con- tract, or ‘‘(ii) the Secretary finds that patients to whom the entity furnishes services will be deprived of obstet- rical services if such individual is not considered a contractor of the entity for purposes of paragraph (1).’’ Subsec. (h). Pub. L. 104–73, § 5(b)(1), in introductory provisions substituted ‘‘The Secretary may not approve an application under subsection (g)(1)(D) unless the Secretary determines that the entity—’’ for ‘‘Notwith- standing subsection (g)(1) of this section, the Sec- retary, in consultation with the Attorney General, may not deem an entity described in subsection (g)(4) of this section to be an employee of the Public Health Service Act for purposes of this section unless the entity—’’. Subsec. (h)(4). Pub. L. 104–73, § 5(b)(2), substituted ‘‘will fully cooperate’’ for ‘‘has fully cooperated’’. Subsec. (i)(1). Pub. L. 104–73, § 9, substituted ‘‘may on the record determine, after notice and opportunity for a full and fair hearing’’ for ‘‘may determine, after no- tice and opportunity for a hearing’’. Subsec. (k)(1)(A). Pub. L. 104–73, § 2(b)(1), substituted ‘‘For each fiscal year’’ for ‘‘For each of the fiscal years 1993, 1994, and 1995’’ and struck out ‘‘(except that an es- timate shall be made for fiscal year 1993 by December 31, 1992, subject to an adjustment within 90 days there- after)’’ after ‘‘beginning of the year’’. Subsec. (k)(2). Pub. L. 104–73, §§ 2(b)(2), 10, substituted ‘‘for each fiscal year’’ for ‘‘for each of the fiscal years 1993, 1994, and 1995’’ and ‘‘$10,000,000’’ for ‘‘$30,000,000’’. Subsec. (k)(3). Pub. L. 104–73, § 3(2), which directed amendment of subsec. (k)(3) by inserting ‘‘governing board member,’’ after ‘‘officer,’’, could not be executed because ‘‘officer,’’ did not appear. Subsec. (l). Pub. L. 104–73, § 6, added subsec. (l). Subsec. (m). Pub. L. 104–73, § 7, added subsec. (m). Subsec. (n). Pub. L. 104–73, § 11, added subsec. (n). 1993—Subsec. (k)(2). Pub. L. 103–183 inserted at end ‘‘Appropriations for purposes of this paragraph shall be made separate from appropriations made for purposes of sections 254b, 254c, 256 and 256a of this title.’’ 1992—Subsecs. (g) to (k). Pub. L. 102–501 added sub- secs. (g) to (k). Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 2010 AMENDMENT Pub. L. 111–148, title X, § 10608(b), Mar. 23, 2010, 124 Stat. 1014, provided that: ‘‘The amendment made by this section [amending this section] shall take effect on the date of enactment of this Act [Mar. 23, 2010] and apply to any act or omission which occurs on or after that date.’’ EFFECTIVE DATE OF 2003 AMENDMENTS Pub. L. 108–163, § 3, Dec. 6, 2003, 117 Stat. 2023, provided that: ‘‘This Act [see Short Title of 2003 Amendments Page 103 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 234 note set out under section 201 of this title] is deemed to have taken effect immediately after the enactment of Public Law 107–251 [Oct. 26, 2002].’’ Pub. L. 108–20, § 3(j), Apr. 30, 2003, 117 Stat. 649, pro- vided that: ‘‘This section [amending this section] shall take effect as of November 25, 2002.’’ EFFECTIVE DATE OF 2002 AMENDMENT Amendment by Pub. L. 107–296 effective 60 days after Nov. 25, 2002, see section 4 of Pub. L. 107–296, set out as an Effective Date note under section 101 of Title 6, Do- mestic Security. EFFECTIVE DATE OF 1996 AMENDMENT Pub. L. 104–299, § 5, Oct. 11, 1996, 110 Stat. 3645, as amended by Pub. L. 104–208, div. A, title I, § 101(e) [title V, § 521], Sept. 30, 1996, 110 Stat. 3009–233, 3009–275, pro- vided that: ‘‘This Act [enacting sections 254b and 254c of this title, amending this section and sections 256c, 1395x, and 1396d of this title, repealing sections 256 and 256a of this title, and enacting provisions set out as notes under sections 201 and 254b of this title] and the amendments made by this Act shall become effective on October 1, 1996.’’ [Pub. L. 104–208, div. A, title I, § 101(e) [title V, § 521], Sept. 30, 1996, 110 Stat. 3009–233, 3009–275, provided that the amendment made by that section is effective on the day after Oct. 11, 1996.] EFFECTIVE DATE OF 1995 AMENDMENT Pub. L. 104–73, § 5(c), Dec. 26, 1995, 109 Stat. 779, pro- vided that: ‘‘If, on the day before the date of the enact- ment of this Act [Dec. 26, 1995], an entity was deemed to be an employee of the Public Health Service for pur- poses of section 224(g) of the Public Health Service Act [42 U.S.C. 233(g)], the condition under paragraph (1)(D) of such section (as added by subsection (a) of this sec- tion) that an application be approved with respect to the entity does not apply until the expiration of the 180-day period beginning on such date.’’ EFFECTIVE DATE OF 1992 AMENDMENT Pub. L. 102–501, § 6, Oct. 24, 1992, 106 Stat. 3272, pro- vided that: ‘‘The amendments made by this Act [amending this section] shall take effect on the date of the enactment of this Act [Oct. 24, 1992].’’ REPORT ON RISK EXPOSURE OF COVERED ENTITIES Pub. L. 102–501, § 5, Oct. 24, 1992, 106 Stat. 3271, pro- vided that the Attorney General, by Apr. 1, 1995, and in consultation with the Secretary of Health and Human Services, was to submit a report to Congress on the medical malpractice liability claims experience of enti- ties subject to subsec. (g) of this section, including their risk exposure and the effect of liability protec- tions on costs incurred. § 234. Health care professionals assisting during a public health emergency (a) Limitation on liability Notwithstanding any other provision of law, a health care professional who is a member of the Medical Reserve Corps under section 300hh–15 of this title or who is included in the Emergency System for Advance Registration of Volunteer Health Professionals under section 247d–7b of this title and who— (1) is responding— (A) to a public health emergency deter- mined under section 247d(a) of this title, dur- ing the initial period of not more than 90 days (as determined by the Secretary) of the public health emergency determination (ex- cluding any period covered by a renewal of such determination); or (B) to a major disaster or an emergency as declared by the President under section 5170 of this title or under section 1621 of title 50 during the initial period of such declaration; (2) is alleged to be liable for an act or omis- sion— (A) during the initial period of a deter- mination or declaration described in para- graph (1) and related to the treatment of in- dividuals in need of health care services due to such public health emergency, major dis- aster, or emergency; (B) in the State or States for which such determination or declaration is made; (C) in the health care professional’s capac- ity as a member of the Medical Reserve Corps or a professional included in the Emergency System for Advance Registra- tion of Volunteer Health Professionals under section 247d–7b of this title; and (D) in the course of providing services that are within the scope of the license, registra- tion, or certification of the professional, as defined by the State of licensure, registra- tion, or certification; and (3) prior to the rendering of such act or omission, was authorized by the State’s au- thorization of deploying such State’s Emer- gency System for Advance Registration of Volunteer Health Professionals described in section 247d–7b of this title or the Medical Re- serve Corps established under section 300hh–15 of this title, to provide health care services, shall be subject only to the State liability laws of the State in which such act or omission oc- curred, in the same manner and to the same ex- tent as a similar health care professional who is a resident of such State would be subject to such State laws, except with respect to the licensure, registration, and certification of such indi- vidual. (b) Volunteer Protection Act Nothing in this section shall be construed to affect an individual’s right to protections under the Volunteer Protection Act of 1997 [42 U.S.C. 14501 et seq.]. (c) Preemption This section shall supersede the laws of any State that would subject a health care profes- sional described in subsection (a) to the liability laws of any State other than the State liability laws to which such individual is subject pursu- ant to such subsection. (d) Definitions In this section: (1) The term ‘‘health care professional’’ means an individual licensed, registered, or certified under Federal or State laws or regu- lations to provide health care services. (2) The term ‘‘health care services’’ means any services provided by a health care profes- sional, or by any individual working under the supervision of a health care professional, that relate to— (A) the diagnosis, prevention, or treatment of any human disease or impairment; or (B) the assessment or care of the health of human beings.

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 1395 — Conditions of participation for home health agencies; home health quality

**(a) Conditions of participation; protection of individual rights; notification of State entities; use of home health aides; medical equipment; individual’s plan of care; compliance with Federal, State, and local laws and regulations** The conditions of participation that a home health agency is required to meet under this subsection are as follows: (1) The agency protects and promotes the rights of each individual under its care, including each of the following rights: (A) The right to be fully informed in advance about the care and treatment to be provided by the agency, to be fully informed in advance of any changes in the care or treatment to be provided by the agency that may affect the individual’s well-being, and (except with respect to an individual adjudged incompetent) to participate in planning care and treatment or changes in care or treatment. (B) The right to voice grievances with respect to treatment or care that is (or fails to be) furnished without discrimination or reprisal for voicing grievances. (C) The right to confidentiality of the clinical records described in section 1395x(o)(3) of this title. (D) The right to have one’s property treated with respect. (E) The right to be fully informed orally and in writing (in advance of coming under the care of the agency) of— (i) all items and services furnished by (or under arrangements with) the agency for which payment may be made under this subchapter, (ii) the coverage available for such items and services under this subchapter, subchapter XIX, and any other Federal program of which the agency is reasonably aware, (iii) any charges for items and services not covered under this subchapter and any charges the individual may have to pay with respect to items and services furn

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 1395 — Prohibition against any Federal inter-

Page 2893 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395a (i) shared savings and competitive bidding in FFS Medicare; (ii) use of MA-negotiated rates to set FFS Medicare rates; and (iii) novel approaches to information development and sharing that may enable markets to lower cost and improve quality for FFS Medicare beneficiaries. SEC. 10. Reducing Obstacles to Improved Patient Care. Within 1 year of the date of this order, the Secretary shall propose regulatory changes to the Medicare pro- gram to reduce the burden on providers and eliminate regulations that create inefficiencies or otherwise un- dermine patient outcomes. SEC. 11. Maximizing Freedom for Medicare Patients and Providers. (a) Within 180 days of the date of this order, the Secretary, in coordination with the Commissioner of Social Security, shall revise current rules or policies to preserve the Social Security retirement insurance benefits of seniors who choose not to receive benefits under Medicare Part A, and propose other administra- tive improvements to Medicare enrollment processes for beneficiaries. (b) Within 1 year of the date of this order, the Sec- retary shall identify and remove unnecessary barriers to private contracts that allow Medicare beneficiaries to obtain the care of their choice and facilitate the de- velopment of market-driven prices. SEC. 12. General Provisions. (a) Nothing in this order shall be construed to impair or otherwise affect: (i) the authority granted by law to an executive de- partment or agency, or the head thereof; or (ii) the functions of the Director of the Office of Man- agement and Budget relating to budgetary, administra- tive, or legislative proposals. (b) This order shall be implemented consistent with applicable law and subject to the

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 1396 — Medicaid and CHIP Payment and Access Commission

**(a) Establishment** There is hereby established the Medicaid and CHIP Payment and Access Commission (in this section referred to as “MACPAC”). **(b) Duties** (1) **Review of access policies for all States and annual reports** — MACPAC shall— (A) review policies of the Medicaid program established under this subchapter (in this section referred to as “Medicaid”) and the State Children’s Health Insurance Program established under subchapter XXI (in this section referred to as “CHIP”) affecting access to covered items and services, including topics described in paragraph (2); (B) make recommendations to Congress, the Secretary, and States concerning such access policies; (C) by not later than March 15 of each year (beginning with 2010), submit a report to Congress containing the results of such reviews and MACPAC’s recommendations concerning such policies; and (D) by not later than June 15 of each year (beginning with 2010), submit a report to Congress containing an examination of issues affecting Medicaid and CHIP, including the implications of changes in health care delivery in the United States and in the market for health care services on such programs. (2) **Specific topics to be reviewed** — Specifically, MACPAC shall review and assess the following: (A) *Medicaid and CHIP payment policies* — Payment policies under Medicaid and CHIP, including— (i) the factors affecting expenditures for the efficient provision of items and services in different sectors, including the process for updating payments to medical, dental, and health professionals, hospitals, residential and long-term care providers, providers of home and community based services, Federally-qualified health centers and rural health clinics, managed care entities, and providers of ot

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 1396 — Medicaid and CHIP Payment and Access

Page 4009 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1396 of the enactment of this Act [Oct. 6, 2014], the Sec- retary shall develop and report to Congress on a stra- tegic plan for collecting or otherwise accessing data on race and ethnicity for purposes of specifying quality measures and resource use and other measures under subsections (c) and (d) of section 1899B of the Social Se- curity Act, as added by subsection (a), and, as the Sec- retary determines appropriate, other similar provisions of, including payment adjustments under, title XVIII of such Act (42 U.S.C. 1395 et seq.).’’ SUBCHAPTER XIX—GRANTS TO STATES FOR MEDICAL ASSISTANCE PROGRAMS § 1396. Medicaid and CHIP Payment and Access Commission (a) Establishment There is hereby established the Medicaid and CHIP Payment and Access Commission (in this section referred to as ‘‘MACPAC’’). (b) Duties (1) Review of access policies for all States and annual reports MACPAC shall— (A) review policies of the Medicaid pro- gram established under this subchapter (in this section referred to as ‘‘Medicaid’’) and the State Children’s Health Insurance Pro- gram established under subchapter XXI (in this section referred to as ‘‘CHIP’’) affecting access to covered items and services, includ- ing topics described in paragraph (2); (B) make recommendations to Congress, the Secretary, and States concerning such access policies; (C) by not later than March 15 of each year (beginning with 2010), submit a report to Congress containing the results of such re- views and MACPAC’s recommendations con- cerning such policies; and (D) by not later than June 15 of each year (beginning with 2010), submit a report to Congress containing an examination of issues affecting Medicaid and CHIP, includ- ing the impli

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 14501 — Findings and purpose

**(a) Findings** The Congress finds and declares that— (1) the willingness of volunteers to offer their services is deterred by the potential for liability actions against them; (2) as a result, many nonprofit public and private organizations and governmental entities, including voluntary associations, social service agencies, educational institutions, and other civic programs, have been adversely affected by the withdrawal of volunteers from boards of directors and service in other capacities; (3) the contribution of these programs to their communities is thereby diminished, resulting in fewer and higher cost programs than would be obtainable if volunteers were participating; (4) because Federal funds are expended on useful and cost-effective social service programs, many of which are national in scope, depend heavily on volunteer participation, and represent some of the most successful public-private partnerships, protection of volunteerism through clarification and limitation of the personal liability risks assumed by the volunteer in connection with such participation is an appropriate subject for Federal legislation; (5) services and goods provided by volunteers and nonprofit organizations would often otherwise be provided by private entities that operate in interstate commerce; (6) due to high liability costs and unwarranted litigation costs, volunteers and nonprofit organizations face higher costs in purchasing insurance, through interstate insurance markets, to cover their activities; and (7) clarifying and limiting the liability risk assumed by volunteers is an appropriate subject for Federal legislation because— (A) of the national scope of the problems created by the legitimate fears of volunteers about frivolous, arbitrary, or capricious lawsuits;

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 14501 — Findings and purpose

Page 8640 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 14408 Editorial Notes REFERENCES IN TEXT This chapter, referred to in text, was in the original ‘‘this Act’’, meaning Pub. L. 105–12, Apr. 30, 1997, 111 Stat. 23, known as the Assisted Suicide Funding Re- striction Act of 1997, which is classified principally to this chapter. For complete classification of this Act to the Code, see Short Title note set out under section 14401 of this title and Tables. The District of Columbia Home Rule Act, referred to in text, is Pub. L. 93–198, Dec. 24, 1973, 87 Stat. 774. Title V of the Act was classified to the District of Columbia Code prior to repeal by Pub. L. 105–33, title XI, § 11601, Aug. 5, 1997, 111 Stat. 777. AMENDMENTS 1997—Pub. L. 105–33 substituted ‘‘District of Columbia Home Rule Act’’ for ‘‘District of Columbia Self-Govern- ment and Governmental Reorganization Act’’. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 1997 AMENDMENT Amendment by Pub. L. 105–33 effective Oct. 1, 1997, except as otherwise provided in title XI of Pub. L. 105–33, see section 11721 of Pub. L. 105–33, set out as a note under section 4246 of Title 18, Crimes and Criminal Procedure. § 14408. Relation to other laws The provisions of this chapter supersede other Federal laws (including laws enacted after April 30, 1997) except to the extent such laws specifi- cally supersede the provisions of this chapter. (Pub. L. 105–12, § 10, Apr. 30, 1997, 111 Stat. 29.) Editorial Notes REFERENCES IN TEXT This chapter, referred to in text, was in the original ‘‘this Act’’, meaning Pub. L. 105–12, Apr. 30, 1997, 111 Stat. 23, known as the Assisted Suicide Funding Re- striction Act of 1997, which is classified principally to this chapter. For complete classification of thi

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 233 — National Institute of Mental Health; authorization of appropriation; construction; location

There is authorized to be appropriated a sum not to exceed $7,500,000 for the erection and equipment, for the use of the Public Health Service in carrying out the provisions of this Act, of suitable and adequate hospital buildings and facilities, including necessary living quarters for personnel, and of suitable and adequate laboratory buildings and facilities, and such buildings and facilities shall be known as the National Institute of Mental Health. The Administrator of General Services is authorized to acquire, by purchase, condemnation, donation, or otherwise, a suitable and adequate site or sites, selected on the advice of the Surgeon General of the Public Health Service, in or near the District of Columbia for such buildings and facilities, and to erect thereon, furnish, and equip such buildings and facilities. The amount authorized to be appropriated in this section shall include the cost of preparation of drawings and specifications, supervision of construction, and other administrative expenses incident to the work: Provided, That the Administrator of General Services shall prepare the plans and specifications, make all necessary contracts, and supervise construction.

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