128 
tion of responsibility of each party for the claimant’s 
harm. 
(e) STATE FLEXIBILITY.—No provision of this sec-
tion shall be construed to preempt any State law (whether 
effective before, on, or after the date of the enactment of 
this Act) that specifies a particular monetary amount of 
economic or noneconomic damages (or the total amount 
of damages) that may be awarded in a health care lawsuit, 
regardless of whether such monetary amount is greater 
or lesser than is provided for under this section. 
SEC. 233. MAXIMIZING PATIENT RECOVERY. 
(a) COURT SUPERVISION OF SHARE OF DAMAGES 
ACTUALLY PAID TO CLAIMANTS.—In any health care law-
suit, the court shall supervise the arrangements for pay-
ment of damages to protect against conflicts of interest 
that may have the effect of reducing the amount of dam-
ages awarded that are actually paid to claimants. In par-
ticular, in any health care lawsuit in which the attorney 
for a party claims a financial stake in the outcome by vir-
tue of a contingent fee, the court shall have the power 
to restrict the payment of a claimant’s damage recovery 
to such attorney, and to redirect such damages to the 
claimant based upon the interests of justice and principles 
of equity. In no event shall the total of all contingent fees 
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for representing all claimants in a health care lawsuit ex-
ceed the following limits: 
(1) Forty percent of the first $50,000 recovered 
by the claimant(s). 
(2) Thirty-three and one-third percent of the 
next $50,000 recovered by the claimant(s). 
(3) Twenty-five percent of the next $500,000 
recovered by the claimant(s). 
(4) Fifteen percent of any amount by which the 
recovery by the claimant(s) is in excess of $600,000. 
(b) APPLICABILITY.—The limitations in this section 
shall apply whether the recovery is by judgment, settle-
ment, mediation, arbitration, or any other form of alter-
native dispute resolution. In a health care lawsuit involv-
ing a minor or incompetent person, a court retains the 
authority to authorize or approve a fee that is less than 
the maximum permitted under this section. The require-
ment for court supervision in the first two sentences of 
subsection (a) applies only in civil actions. 
(c) STATE FLEXIBILITY.—No provision of this sec-
tion shall be construed to preempt any State law (whether 
effective before, on, or after the date of the enactment of 
this Act) that specifies a lesser percentage or lesser total 
value of damages which may be claimed by an attorney 
representing a claimant in a health care lawsuit. 
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SEC. 234. AUTHORIZATION OF PAYMENT OF FUTURE DAM-
AGES TO CLAIMANTS IN HEALTH CARE LAW-
SUITS. 
(a) IN GENERAL.—In any health care lawsuit, if an 
award of future damages, without reduction to present 
value, equaling or exceeding $50,000 is made against a 
party with sufficient insurance or other assets to fund a 
periodic payment of such a judgment, the court shall, at 
the request of any party, enter a judgment ordering that 
the future damages be paid by periodic payments, in ac-
cordance with the Uniform Periodic Payment of Judg-
ments Act promulgated by the National Conference of 
Commissioners on Uniform State Laws. 
(b) APPLICABILITY.—This section applies to all ac-
tions which have not been first set for trial or retrial be-
fore the effective date of this Act. 
(c) STATE FLEXIBILITY.—No provision of this sec-
tion shall be construed to preempt any State law (whether 
effective before, on, or after the date of the enactment of 
this Act) that specifies periodic payments for future dam-
ages at any amount other than $50,000 or that mandates 
such payments absent the request of either party. 
SEC. 235. PRODUCT LIABILITY FOR HEALTH CARE PRO-
VIDERS. 
A health care provider who prescribes, or who dis-
penses pursuant to a prescription, a medical product ap-
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proved, licensed, or cleared by the Food and Drug Admin-
istration shall not be named as a party to a product liabil-
ity lawsuit involving such product and shall not be liable 
to a claimant in a class action lawsuit against the manu-
facturer, distributor, or seller of such product. 
SEC. 236. DEFINITIONS. 
In this Act: 
(1) ALTERNATIVE DISPUTE RESOLUTION SYS-
TEM; ADR.—The term ‘‘alternative dispute resolution 
system’’ or ‘‘ADR’’ means a system that provides 
for the resolution of health care lawsuits in a man-
ner other than through a civil action brought in a 
State or Federal court. 
(2) CLAIMANT.—The term ‘‘claimant’’ means 
any person who brings a health care lawsuit, includ-
ing a person who asserts or claims a right to legal 
or equitable contribution, indemnity, or subrogation, 
arising out of a health care liability claim or action, 
and any person on whose behalf such a claim is as-
serted or such an action is brought, whether de-
ceased, incompetent, or a minor. 
(3) COLLATERAL
SOURCE
BENEFITS.—The 
term ‘‘collateral source benefits’’ means any amount 
paid or reasonably likely to be paid in the future to 
or on behalf of the claimant, or any service, product, 
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or other benefit provided or reasonably likely to be 
provided in the future to or on behalf of the claim-
ant, as a result of the injury or wrongful death, pur-
suant to— 
(A) any State or Federal health, sickness, 
income-disability, accident, or workers’ com-
pensation law; 
(B) any health, sickness, income-disability, 
or accident insurance that provides health bene-
fits or income-disability coverage; 
(C) any contract or agreement of any 
group, organization, partnership, or corporation 
to provide, pay for, or reimburse the cost of 
medical, hospital, dental, or income-disability 
benefits; and 
(D) any other publicly or privately funded 
program. 
(4) CONTINGENT FEE.—The term ‘‘contingent 
fee’’ includes all compensation to any person or per-
sons which is payable only if a recovery is effected 
on behalf of one or more claimants. 
(5) ECONOMIC DAMAGES.—The term ‘‘economic 
damages’’ means objectively verifiable monetary 
losses incurred as a result of the provision or use of 
(or failure to provide or use) health care services or 
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based, or the number of claimants, plaintiffs, de-
fendants, or other parties, or the number of claims 
or causes of action, in which the claimant alleges a 
health care liability claim. Such term does not in-
clude a claim or action which is based on criminal 
liability; which seeks civil fines or penalties paid to 
Federal, State, or local government; or which is 
grounded in antitrust. 
(8) HEALTH
CARE
LIABILITY
ACTION.—The 
term ‘‘health care liability action’’ means a civil ac-
tion brought in a State or Federal court or pursuant 
to an alternative dispute resolution system, against 
a health care provider regardless of the theory of li-
ability on which the claim is based, or the number 
of plaintiffs, defendants, or other parties, or the 
number of causes of action, in which the claimant al-
leges a health care liability claim. 
(9) HEALTH
CARE
LIABILITY
CLAIM.—The 
term ‘‘health care liability claim’’ means a demand 
by any person, whether or not pursuant to ADR, 
against a health care provider, including, but not 
limited to, third-party claims, cross-claims, counter- 
claims, or contribution claims, which are based upon 
the provision or use of (or the failure to provide or 
use) health care services or medical products, re-
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gardless of the theory of liability on which the claim 
is based, or the number of plaintiffs, defendants, or 
other parties, or the number of causes of action. 
(10) HEALTH
CARE
PROVIDER.—The term 
‘‘health care provider’’ means any person or entity 
required by State or Federal laws or regulations to 
be licensed, registered, or certified to provide health 
care services, and being either so licensed, reg-
istered, or certified, or exempted from such require-
ment by other statute or regulation, as well as any 
other individual or entity defined as a health care 
provider, health care professional, or health care in-
stitution under State law. 
(11) HEALTH
CARE
SERVICES.—The term 
‘‘health care services’’ means the provision of any 
goods or services (including safety, professional, or 
administrative services directly related to health 
care) by a health care provider, or by any individual 
working under the supervision of a health care pro-
vider, that relates to the diagnosis, prevention, or 
treatment of any human disease or impairment, or 
the assessment or care of the health of human 
beings. 
(12) MEDICAL PRODUCT.—The term ‘‘medical 
product’’ means a drug, device, or biological product 
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intended for humans, and the terms ‘‘drug’’, ‘‘de-
vice’’, and ‘‘biological product’’ have the meanings 
given such terms in sections 201(g)(1) and 201(h) 
of the Federal Food, Drug and Cosmetic Act (21 
U.S.C. 321(g)(1) and (h)) and section 351(a) of the 
Public Health Service Act (42 U.S.C. 262(a)), re-
spectively, including any component or raw material 
used therein, but excluding health care services. 
(13) 
NONECONOMIC
DAMAGES.—The 
term 
‘‘noneconomic damages’’ means damages for phys-
ical and emotional pain, suffering, inconvenience, 
physical impairment, mental anguish, disfigurement, 
loss of enjoyment of life, loss of society and compan-
ionship, loss of consortium (other than loss of do-
mestic service), hedonic damages, injury to reputa-
tion, and all other nonpecuniary losses of any kind 
or nature incurred as a result of the provision or use 
of (or failure to provide or use) health care services 
or medical products, unless otherwise defined under 
applicable State law. 
(14) RECOVERY.—The term ‘‘recovery’’ means 
the net sum recovered after deducting any disburse-
ments or costs incurred in connection with prosecu-
tion or settlement of the claim, including all costs 
paid or advanced by any person. Costs of health care 
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137 
incurred by the plaintiff and the attorneys’ office 
overhead costs or charges for legal services are not 
deductible disbursements or costs for such purpose. 
(15) REPRESENTATIVE.—The term ‘‘represent-
ative’’ means a legal guardian, attorney, person des-
ignated to make decisions on behalf of a patient 
under a medical power of attorney, or any person 
recognized in law or custom as a patient’s agent. 
(16) STATE.—The term ‘‘State’’ means each of 
the several States, the District of Columbia, the 
Commonwealth of Puerto Rico, the Virgin Islands, 
Guam, American Samoa, the Northern Mariana Is-
lands, the Trust Territory of the Pacific Islands, and 
any other territory or possession of the United 
States, or any political subdivision thereof. 
SEC. 237. EFFECT ON OTHER LAWS. 
(a) VACCINE INJURY.— 
(1) To the extent that title XXI of the Public 
Health Service Act establishes a Federal rule of law 
applicable to a civil action brought for a vaccine-re-
lated injury or death— 
(A) this Act does not affect the application 
of the rule of law to such an action; and 
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(B) any rule of law prescribed by this sub-
title in conflict with a rule of law of such title 
XXI shall not apply to such action. 
(2) If there is an aspect of a civil action 
brought for a vaccine-related injury or death to 
which a Federal rule of law under title XXI of the 
Public Health Service Act does not apply, then this 
subtitle or otherwise applicable law (as determined 
under this subtitle) will apply to such aspect of such 
action. 
(b) OTHER FEDERAL LAW.—Except as provided in 
this section, nothing in this subtitle shall be deemed to 
affect any defense available to a defendant in a health care 
lawsuit or action under any other provision of Federal law. 
SEC. 238. RULES OF CONSTRUCTION. 
(a) HEALTH CARE LAWSUITS.—Unless otherwise 
specified in this subtitle, the provisions governing health 
care lawsuits set forth in this subtitle preempt, subject to 
subsections (b) and (c), State law to the extent that State 
law prevents the application of any provisions of law estab-
lished by or under this subtitle. The provisions governing 
health care lawsuits set forth in this subtitle supersede 
chapter 171 of title 28, United States Code, to the extent 
that such chapter— 
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(1) provides for a greater amount of damages 
or contingent fees, a longer period in which a health 
care lawsuit may be commenced, or a reduced appli-
cability or scope of periodic payment of future dam-
ages, than provided in this subtitle; or 
(2) prohibits the introduction of evidence re-
garding collateral source benefits, or mandates or 
permits subrogation or a lien on collateral source 
benefits. 
(b) PROTECTION OF STATES’ RIGHTS AND OTHER 
LAWS.—Any issue that is not governed by any provision 
of law established by or under this subtitle (including 
State standards of negligence) shall be governed by other-
wise applicable State or Federal law. 
(c) STATE FLEXIBILITY.—No provision of this sub-
title shall be construed to preempt any defense available 
to a party in a health care lawsuit under any other provi-
sion of State or Federal law. 
SEC. 239. EFFECTIVE DATE. 
This subtitle shall apply to any health care lawsuit 
brought in a Federal or State court, or subject to an alter-
native dispute resolution system, that is initiated on or 
after the date of the enactment of this subtitle, except that 
any health care lawsuit arising from an injury occurring 
prior to the date of the enactment of this subtitle shall 
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be governed by the applicable statute of limitations provi-
sions in effect at the time the cause of action accrued. 
SEC. 240. LIMITATION ON EXPERT WITNESS TESTIMONY. 
(a) IN GENERAL.—No person in a health care profes-
sion requiring licensure under the laws of a State shall 
be competent to testify in any court of law to establish 
the following facts— 
(1) the recognized standard of acceptable pro-
fessional practice and the specialty thereof, if any, 
that the defendant practices, which shall be the type 
of acceptable professional practice recognized in the 
defendant’s community or in a community similar to 
the defendant’s community that was in place at the 
time the alleged injury or wrongful action occurred; 
(2) that the defendant acted with less than or 
failed to act with ordinary and reasonable care in ac-
cordance with the recognized standard; and 
(3) that as a proximate result of the defend-
ant’s negligent act or omission, the claimant suf-
fered injuries which would not otherwise have oc-
curred, 
unless the person was licensed to practice, in the State 
or a contiguous bordering State, a profession or specialty 
which would make the person’s expert testimony relevant 
to the issues in the case and had practiced this profession 
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or specialty in one of these States during the year pre-
ceding the date that the alleged injury or wrongful act 
occurred. 
(b) APPLICABILITY.—The requirements set forth in 
subsection (a) shall also apply to expert witnesses testi-
fying for the defendant as rebuttal witnesses. 
(c) WAIVER AUTHORITY.—The court may waive the 
requirements in this subsection if it determines that the 
appropriate witnesses otherwise would not be available. 
SEC. 241. COMMUNICATIONS FOLLOWING UNANTICIPATED 
OUTCOME. 
(a) PROVIDER COMMUNICATIONS.—In any health 
care liability action, any and all statements, affirmations, 
gestures, or conduct expressing apology, fault, sympathy, 
commiseration, condolence, compassion, or a general sense 
of benevolence which are made by a health care provider 
or an employee of a health care provider to the patient, 
a relative of the patient, or a representative of the patient 
and which relate to the discomfort, pain, suffering, injury, 
or death of the patient as the result of the unanticipated 
outcome of medical care shall be inadmissible for any pur-
pose as evidence of an admission of liability or as evidence 
of an admission against interest. 
(b) STATE FLEXIBILITY.—No provision of this sec-
tion shall be construed to preempt any State law (whether 
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effective before, on, or after the date of the enactment of 
this Act) that makes additional communications inadmis-
sible as evidence of an admission of liability or as evidence 
of an admission against interest. 
SEC. 242. EXPERT WITNESS QUALIFICATIONS. 
(a) IN GENERAL.—In any health care lawsuit, an in-
dividual shall not give expert testimony on the appropriate 
standard of practice or care involved unless the individual 
is licensed as a health professional in one or more States 
and the individual meets the following criteria: 
(1) If the party against whom or on whose be-
half the testimony is to be offered is or claims to be 
a specialist, the expert witness shall specialize at the 
time of the occurrence that is the basis for the law-
suit in the same specialty or claimed specialty as the 
party against whom or on whose behalf the testi-
mony is to be offered. If the party against whom or 
on whose behalf the testimony is to be offered is or 
claims to be a specialist who is board certified, the 
expert witness shall be a specialist who is board cer-
tified in that specialty or claimed specialty. 
(2) During the 1-year period immediately pre-
ceding the occurrence of the action that gave rise to 
the lawsuit, the expert witness shall have devoted a 
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majority of the individual’s professional time to one 
or more of the following: 
(A) The active clinical practice of the same 
health profession as the defendant and, if the 
defendant is or claims to be a specialist, in the 
same specialty or claimed specialty. 
(B) The instruction of students in an ac-
credited health professional school or accredited 
residency or clinical research program in the 
same health profession as the defendant and, if 
the defendant is or claims to be a specialist, in 
an accredited health professional school or ac-
credited residency or clinical research program 
in the same specialty or claimed specialty. 
(3) If the defendant is a general practitioner, 
the expert witness shall have devoted a majority of 
the witness’s professional time in the 1-year period 
preceding the occurrence of the action giving rise to 
the lawsuit to one or more of the following: 
(A) Active clinical practice as a general 
practitioner. 
(B) Instruction of students in an accred-
ited health professional school or accredited 
residency or clinical research program in the 
same health profession as the defendant. 
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(b) LAWSUITS AGAINST ENTITIES.—If the defendant 
in a health care lawsuit is an entity that employs a person 
against whom or on whose behalf the testimony is offered, 
the provisions of subsection (a) apply as if the person were 
the party or defendant against whom or on whose behalf 
the testimony is offered. 
(c) POWER OF COURT.—Nothing in this subsection 
shall limit the power of the trial court in a health care 
lawsuit to disqualify an expert witness on grounds other 
than the qualifications set forth under this subsection. 
(d) LIMITATION.—An expert witness in a health care 
lawsuit shall not be permitted to testify if the fee of the 
witness is in any way contingent on the outcome of the 
lawsuit. 
(e) STATE FLEXIBILITY.—No provision of this sec-
tion shall be construed to preempt any State law (whether 
effective before, on, or after the date of the enactment of 
this Act) that places additional qualification requirements 
upon any individual testifying as an expert witness. 
SEC. 243. AFFIDAVIT OF MERIT. 
(a) REQUIRED FILING.—Subject to subsection (b), 
the plaintiff in a health care lawsuit alleging negligence 
or, if the plaintiff is represented by an attorney, the plain-
tiff’s attorney shall file simultaneously with the health 
care lawsuit an affidavit of merit signed by a health pro-
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fessional who meets the requirements for an expert wit-
ness under section 242 of this Act. The affidavit of merit 
shall certify that the health professional has reviewed the 
notice and all medical records supplied to him or her by 
the plaintiff’s attorney concerning the allegations con-
tained in the notice and shall contain a statement of each 
of the following: 
(1) The applicable standard of practice or care. 
(2) The health professional’s opinion that the 
applicable standard of practice or care was breached 
by the health professional or health facility receiving 
the notice. 
(3) The actions that should have been taken or 
omitted by the health professional or health facility 
in order to have complied with the applicable stand-
ard of practice or care. 
(4) The manner in which the breach of the 
standard of practice or care was the proximate cause 
of the injury alleged in the notice. 
(5) A listing of the medical records reviewed. 
(b) FILING EXTENSION.—Upon motion of a party for 
good cause shown, the court in which the complaint is filed 
may grant the plaintiff or, if the plaintiff is represented 
by an attorney, the plaintiff’s attorney an additional 28 
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days in which to file the affidavit required under sub-
section (a). 
(c) STATE FLEXIBILITY.—No provision of this sec-
tion shall be construed to preempt any State law (whether 
effective before, on, or after the date of the enactment of 
this Act) that establishes additional requirements for the 
filing of an affidavit of merit or similar pre-litigation docu-
mentation. 
SEC. 244. NOTICE OF INTENT TO COMMENCE LAWSUIT. 
(a) ADVANCE NOTICE.—A person shall not com-
mence a health care lawsuit against a health care provider 
unless the person has given the health care provider 90 
days written notice before the action is commenced. 
(b) EXCEPTIONS.—A health care lawsuit against a 
health care provider filed within 6 months of the statute 
of limitations expiring as to any claimant, or within 1 year 
of the statute of repose expiring as to any claimant, shall 
be exempt from compliance with this section. 
(c) STATE FLEXIBILITY.—No provision of this sec-
tion shall be construed to preempt any State law (whether 
effective before, on, or after the date of the enactment of 
this Act) that establishes a different time period for the 
filing of written notice. 
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TITLE III—PRESCRIPTION DRUG 
COMPETITION 
Subtitle A—Eliminating Delays of 
Generic Drugs and Biosimilar 
Products 
SEC. 301. ACTIONS FOR DELAYS OF GENERIC DRUGS AND 
BIOSIMILAR BIOLOGICAL PRODUCTS. 
(a) DEFINITIONS.—In this section— 
(1) the term ‘‘covered product’’— 
(A) means— 
(i) any drug approved under sub-
section (b) or (j) of section 505 of the Fed-
eral Food, Drug, and Cosmetic Act (21 
U.S.C. 355) or biological product licensed 
under subsection (a) or (k) of section 351 
of the Public Health Service Act (42 
U.S.C. 262); 
(ii) any combination of a drug or bio-
logical product described in clause (i); or 
(iii) when reasonably necessary to 
demonstrate sameness, biosimilarity, or 
interchangeability for purposes of section 
505 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355), or section 351 
of the Public Health Service Act (42 
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U.S.C. 262), as applicable, any product, 
including any device, that is marketed or 
intended for use with such drug or biologi-
cal product; and 
(B) does not include any drug or biological 
product that the Secretary has determined to be 
currently in shortage and that appears on the 
drug shortage list in effect under section 506E 
of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 356e), unless the shortage will not 
be promptly resolved— 
(i) as demonstrated by the fact that 
the drug or biological product has been in 
shortage for more than 6 months; or 
(ii) as otherwise determined by the 
Secretary; 
(2) the term ‘‘device’’ has the meaning given 
the term in section 201 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321); 
(3) the term ‘‘eligible product developer’’ means 
a person that seeks to develop a product for ap-
proval pursuant to an application for approval under 
subsection (b)(2) or (j) of section 505 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355) or 
for licensing pursuant to an application under sec-
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tion 351(k) of the Public Health Service Act (42 
U.S.C. 262(k)); 
(4) the term ‘‘license holder’’ means the holder 
of an application approved under subsection (c) or 
(j) of section 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355) or the holder of a li-
cense under subsection (a) or (k) of section 351 of 
the Public Health Service Act (42 U.S.C. 262) for 
a covered product; 
(5) the term ‘‘REMS’’ means a risk evaluation 
and mitigation strategy under section 505–1 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355–1); 
(6) the term ‘‘REMS with ETASU’’ means a 
REMS that contains elements to assure safe use 
under section 505–1 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355–1); 
(7) the term ‘‘Secretary’’ means the Secretary 
of Health and Human Services; 
(8) the term ‘‘single, shared system of elements 
to assure safe use’’ means a single, shared system 
of elements to assure safe use under section 505–1 
of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355–1); and 
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(9) the term ‘‘sufficient quantities’’ means an 
amount of a covered product that allows the eligible 
product developer to— 
(A) conduct testing to support an applica-
tion— 
(i) for approval under subsection 
(b)(2) or (j) of section 505 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 
355); or 
(ii) for licensing under section 351(k) 
of the Public Health Service Act (42 
U.S.C. 262(k)); and 
(B) fulfill any regulatory requirements re-
lating to such an application for approval or li-
censing. 
(b) CIVIL ACTION FOR FAILURE TO PROVIDE SUFFI-
CIENT QUANTITIES OF A COVERED PRODUCT.— 
(1) IN GENERAL.—An eligible product developer 
may bring a civil action against the license holder 
for a covered product seeking relief under this sub-
section in an appropriate district court of the United 
States alleging that the license holder has declined 
to provide sufficient quantities of the covered prod-
uct to the eligible product developer on commercially 
reasonable, market-based terms. 
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(2) ELEMENTS.— 
(A) IN GENERAL.—To prevail in a civil ac-
tion brought under paragraph (1), an eligible 
product developer shall prove, by a preponder-
ance of the evidence— 
(i) that— 
(I) the covered product is not 
subject to a REMS with ETASU; or 
(II) if the covered product is sub-
ject to a REMS with ETASU— 
(aa) the eligible product de-
veloper has obtained a covered 
product authorization from the 
Secretary in accordance with sub-
paragraph (B); and 
(bb) the eligible product de-
veloper has provided a copy of 
the covered product authorization 
to the license holder; 
(ii) that, as of the date on which the 
civil action is filed, the product developer 
has not obtained sufficient quantities of 
the covered product on commercially rea-
sonable, market-based terms; 
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(iii) that the eligible product developer 
has requested to purchase sufficient quan-
tities of the covered product from the li-
cense holder; and 
(iv) that the license holder has not de-
livered to the eligible product developer 
sufficient quantities of the covered product 
on commercially reasonable, market-based 
terms— 
(I) for a covered product that is 
not subject to a REMS with ETASU, 
by the date that is 31 days after the 
date on which the license holder re-
ceived the request for the covered 
product; and 
(II) for a covered product that is 
subject to a REMS with ETASU, by 
31 days after the later of— 
(aa) the date on which the 
license holder received the re-
quest for the covered product; or 
(bb) the date on which the 
license holder received a copy of 
the covered product authorization 
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issued by the Secretary in ac-
cordance with subparagraph (B). 
(B) AUTHORIZATION FOR COVERED PROD-
UCT SUBJECT TO A REMS WITH ETASU.— 
(i) REQUEST.—An eligible product de-
veloper may submit to the Secretary a 
written request for the eligible product de-
veloper to be authorized to obtain suffi-
cient quantities of an individual covered 
product subject to a REMS with ETASU. 
(ii) AUTHORIZATION.—Not later than 
90 days after the date on which a request 
under clause (i) is received, the Secretary 
shall, by written notice, authorize the eligi-
ble product developer to obtain sufficient 
quantities of an individual covered product 
subject to a REMS with ETASU for pur-
poses of— 
(I) development and testing that 
does not involve human clinical trials, 
if the eligible product developer has 
agreed to comply with any conditions 
the Secretary determines necessary; or 
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(II) development and testing that 
involves human clinical trials, if the 
eligible product developer has— 
(aa)(AA) submitted proto-
cols, 
informed 
consent 
docu-
ments, and informational mate-
rials for testing that include pro-
tections that provide safety pro-
tections comparable to those pro-
vided by the REMS for the cov-
ered product; or 
(BB) otherwise satisfied the 
Secretary that such protections 
will be provided; and 
(bb) met any other require-
ments the Secretary may estab-
lish. 
(iii) NOTICE.—A covered product au-
thorization issued under this subparagraph 
shall state that the provision of the covered 
product by the license holder under the 
terms of the authorization will not be a 
violation of the REMS for the covered 
product. 
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(3) AFFIRMATIVE DEFENSE.—In a civil action 
brought under paragraph (1), it shall be an affirma-
tive defense, on which the defendant has the burden 
of persuasion by a preponderance of the evidence— 
(A) that, on the date on which the eligible 
product developer requested to purchase suffi-
cient quantities of the covered product from the 
license holder— 
(i) neither the license holder nor any 
of its agents, wholesalers, or distributors 
was engaged in the manufacturing or com-
mercial marketing of the covered product; 
and 
(ii) neither the license holder nor any 
of its agents, wholesalers, or distributors 
otherwise had access to inventory of the 
covered product to supply to the eligible 
product developer on commercially reason-
able, market-based terms; or 
(B) that— 
(i) the license holder sells the covered 
product through agents, distributors, or 
wholesalers; 
(ii) the license holder has placed no 
restrictions, explicit or implicit, on its 
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agents, distributors, or wholesalers to sell 
covered products to eligible product devel-
opers; and 
(iii) the covered product can be pur-
chased by the eligible product developer in 
sufficient quantities on commercially rea-
sonable, market-based terms from the 
agents, distributors, or wholesalers of the 
license holder. 
(4) REMEDIES.— 
(A) IN GENERAL.—If an eligible product 
developer prevails in a civil action brought 
under paragraph (1), the court shall— 
(i) order the license holder to provide 
to the eligible product developer without 
delay sufficient quantities of the covered 
product on commercially reasonable, mar-
ket-based terms; 
(ii) award to the eligible product de-
veloper reasonable attorney fees and costs 
of the civil action; and 
(iii) award to the eligible product de-
veloper a monetary amount sufficient to 
deter the license holder from failing to pro-
vide other eligible product developers with 
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sufficient quantities of a covered product 
on commercially reasonable, market-based 
terms, if the court finds, by a preponder-
ance of the evidence— 
(I) that the license holder delayed 
providing sufficient quantities of the 
covered product to the eligible product 
developer without a legitimate busi-
ness justification; or 
(II) that the license holder failed 
to comply with an order issued under 
clause (i). 
(B) MAXIMUM
MONETARY
AMOUNT.—A 
monetary amount awarded under subparagraph 
(A)(iii) shall not be greater than the revenue 
that the license holder earned on the covered 
product during the period— 
(i) beginning on— 
(I) for a covered product that is 
not subject to a REMS with ETASU, 
the date that is 31 days after the date 
on which the license holder received 
the request; or 
(II) for a covered product that is 
subject to a REMS with ETASU, the 
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date that is 31 days after the later 
of— 
(aa) the date on which the 
license holder received the re-
quest; or 
(bb) the date on which the 
license holder received a copy of 
the covered product authorization 
issued by the Secretary in ac-
cordance with paragraph (2)(B); 
and 
(ii) ending on the date on which the 
eligible product developer received suffi-
cient quantities of the covered product. 
(C) AVOIDANCE
OF
DELAY.—The court 
may issue an order under subparagraph (A)(i) 
before conducting further proceedings that may 
be necessary to determine whether the eligible 
product developer is entitled to an award under 
clause (ii) or (iii) of subparagraph (A), or the 
amount of any such award. 
(c) LIMITATION OF LIABILITY.—A license holder for 
a covered product shall not be liable for any claim arising 
out of the failure of an eligible product developer to follow 
adequate safeguards to assure safe use of the covered 
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product during development or testing activities described 
in this section, including transportation, handling, use, or 
disposal of the covered product by the eligible product de-
veloper. 
(d) RULE OF CONSTRUCTION.— 
(1) DEFINITION.—In this subsection, the term 
‘‘antitrust laws’’— 
(A) has the meaning given the term in 
subsection (a) of the first section of the Clayton 
Act (15 U.S.C. 12); and 
(B) includes section 5 of the Federal 
Trade Commission Act (15 U.S.C. 45) to the 
extent that such section applies to unfair meth-
ods of competition. 
(2) ANTITRUST LAWS.—Nothing in this section 
shall be construed to limit the operation of any pro-
vision of the antitrust laws. 
SEC. 302. REMS APPROVAL PROCESS FOR SUBSEQUENT 
FILERS. 
Section 505–1 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355–1) is amended— 
(1) in subsection (g)(4)(B)— 
(A) in clause (i) by striking ‘‘or’’ after the 
semicolon; 
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(B) in clause (ii) by striking the period at 
the end and inserting ‘‘; or’’; and 
(C) by adding at the end the following: 
‘‘(iii) accommodate different approved 
risk evaluation and mitigation strategies 
for a reference drug product and a drug 
that is the subject of an abbreviated new 
drug application.’’; and 
(2) in subsection (i)(1), by striking subpara-
graph (B) and inserting the following: 
‘‘(B) Elements to assure safe use, if re-
quired under subsection (f) for the listed drug 
in accordance with the following: 
‘‘(i) Subject to clause (ii), a drug that 
is the subject of an abbreviated new drug 
application may use— 
‘‘(I) a single, shared system with 
the listed drug under subsection (f); 
or 
‘‘(II) a different, comparable as-
pect of the elements to assure safe use 
under subsection (f). 
‘‘(ii) The Secretary may require a 
drug that is the subject of an abbreviated 
new drug application and the listed drug to 
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use a single, shared system under sub-
section (f), if the Secretary determines 
that no different, comparable aspect of the 
elements to assure safe use could satisfy 
the requirements of subsection (f).’’. 
Subtitle B—Increasing Access to 
Drugs and Biosimilar Products 
SEC. 311. EXPEDITED DEVELOPMENT AND PRIORITY RE-
VIEW FOR GENERIC COMPLEX DRUG PROD-
UCTS. 
Subchapter A of chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend-
ed by adding at the end the following: 
‘‘SEC. 524B. EXPEDITED DEVELOPMENT AND PRIORITY RE-
VIEW FOR GENERIC COMPLEX DRUG PROD-
UCTS. 
‘‘(a) ESTABLISHMENT OF PROGRAM.—The Secretary 
shall establish a program to expedite the development of, 
and provide priority review under section 505(j) for, ge-
neric complex drug products. 
‘‘(b) REQUEST FOR DESIGNATION.—A sponsor of a 
generic complex drug product may request that the Sec-
retary designate such product for expedited development 
and priority review under this section. 
‘‘(c) DESIGNATION PROCESS.— 
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‘‘(1) IN GENERAL.—Not later than 60 calendar 
days after the receipt of a request under subsection 
(c), the Secretary shall determine whether the prod-
uct that is the subject of the request meets the cri-
teria under subsection (e) to be considered a generic 
complex drug product. If the Secretary determines 
that the product meets the criteria, the Secretary 
shall designate the product for expedited develop-
ment and priority review. 
‘‘(2) REVIEW.—Review of a request under sub-
section (b) shall be undertaken by a team that is 
composed of experienced staff and senior managers 
of the Food and Drug Administration. 
‘‘(3) WITHDRAWAL.—The Secretary may not 
withdraw a designation granted under this section 
on the basis of the criteria under subsection (e) no 
longer applying because of the subsequent clearance 
or approval of any other product. 
‘‘(d) EXPEDITED DEVELOPMENT AND PRIORITY RE-
VIEW GUIDANCE.— 
‘‘(1) CONTENT.—Not later than December 31, 
2021, the Secretary shall issue guidance on the im-
plementation of this section. Such guidance shall— 
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‘‘(A) set forth the process by which a per-
son may seek a designation under subsection 
(c); 
‘‘(B) provide a template for requests under 
subsection (b); 
‘‘(C) identify the criteria the Secretary will 
use in evaluating a request for designation 
under this section; and 
‘‘(D) identify the criteria and processes the 
Secretary will use to expedite the development 
and review of products designated under this 
section. 
‘‘(2) PROCESS.—Prior to finalizing the guid-
ance under paragraph (1), the Secretary shall seek 
public comment on a draft version of that guidance. 
‘‘(e) GENERIC
COMPLEX
DRUG
PRODUCT
DE-
FINED.—In this section, the term ‘generic complex drug 
product’ means a product that represents a complex ther-
apy that consists of or includes a drug for approval under 
section 505(j) and that— 
‘‘(1)(A) contains complex active ingredients 
(such as peptides, polymeric compounds, complex 
mixtures of active ingredients, and naturally sourced 
ingredients); 
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‘‘(B) is composed of complex formulations (such 
as liposomes or colloids); 
‘‘(C) requires a complex route of delivery (such 
as locally acting drugs such as dermatological prod-
ucts and complex ophthalmological products and otic 
dosage forms that are formulated as suspensions, 
emulsions, or gels); or 
‘‘(D) involves a complex dosage form (such as 
transdermals, metered dose inhalers, or extended re-
lease injectables); 
‘‘(2) presents as a complex drug-device com-
bination product (such as auto injectors or metered 
dose inhalers); or 
‘‘(3) is a product that would benefit from early 
scientific engagement due to complexity or uncer-
tainty concerning the approval pathway under sec-
tion 505(j).’’. 
SEC. 312. INCREASING PHARMACEUTICAL OPTIONS TO 
TREAT AN UNMET MEDICAL NEED. 
Subsection (b) of section 506 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 356) is amended by 
adding at the end the following: 
‘‘(4) UNMET MEDICAL NEED.—For purposes of 
paragraph (1), a drug shall be deemed to address an 
unmet medical need for a disease or condition if 
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fewer than 3 available drugs exist for the treatment 
of such disease or condition.’’. 
SEC. 313. PREEMPTION OF STATE BARRIERS TO THE SUB-
STITUTION OF BIOSIMILAR PRODUCTS. 
No State, or any political subdivision thereof, may, 
under any circumstances, prohibit a pharmacy or phar-
macist from dispensing, in place of a biological reference 
product, any biosimilar that the Food and Drug Adminis-
tration has designated as an interchangeable product for 
that biological reference product. 
Subtitle C—Limiting Exclusivity 
Periods Delaying Competition 
SEC. 321. LIMITING EXCLUSIVITY PERIODS FOR DRUGS 
TREATING RARE DISEASES AND CONDITIONS. 
(a) IN GENERAL.—Subsection (a) of section 527 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360cc) is amended to read as follows: 
‘‘(a) EXCLUSIVITY.— 
‘‘(1) IN GENERAL.—Except as provided in sub-
section (b), if the Secretary approves an application 
filed pursuant to section 505, or issues a license 
under section 351 of the Public Health Service Act, 
for a drug designated under section 526 for a rare 
disease or condition, the Secretary may not approve 
an application filed pursuant to section 505, or issue 
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a license under section 351 of the Public Health 
Service Act, for the same drug for the same disease 
or condition for a person who is not the holder of 
such approved application or of such license until 
the expiration of the exclusivity period described in 
paragraph (2). 
‘‘(2) EXCLUSIVITY
PERIOD
DESCRIBED.—The 
exclusivity period described in this paragraph, with 
respect to a drug designated under section 526 for 
a rare disease or condition, is— 
‘‘(A) a single 7-year period of exclusivity 
with respect to the first designation of such 
drug under such section for that rare disease or 
condition; or 
‘‘(B) in the case of a drug that has pre-
viously received a period of exclusivity under 
paragraph (1), a single 3-year period of exclu-
sivity with respect to any subsequent designa-
tion of such drug under such section for any 
other rare disease or condition. 
‘‘(3) LIMITATION.—In the case of a drug that 
has received two periods of exclusivity pursuant to 
paragraph (1), no additional exclusivity period under 
this section is available with respect to such drug, 
regardless of whether such drug has been designated 
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under section 526 for a rare disease or condition 
that is distinct from the rare disease or condition for 
which such exclusivity periods were granted.’’. 
(b) CONFORMING AMENDMENTS.— 
(1) Section 505(j)(5)(B)(iv)(II)(dd)(AA) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360cc) is amended by striking ‘‘7-year period’’ and 
inserting ‘‘exclusivity period’’. 
(2) Section 505A(b)(1)(A)(ii) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360cc) is 
amended by striking ‘‘rather than seven years;’’ and 
inserting ‘‘, or three years and six months, rather 
than seven years or three years, respectively;’’. 
(3) Section 505A(c)(1)(A)(ii) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360cc) is 
amended by striking ‘‘rather than seven years;’’ and 
inserting ‘‘, or three years and six months, rather 
than seven years or three years, respectively;’’. 
(4) Section 505E(a) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360cc) is amended by 
striking ‘‘7-year period’’ and inserting ‘‘exclusivity 
periods’’. 
(5) Section 527(b) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360cc) is amended by 
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striking ‘‘the 7-year period’’ and inserting ‘‘any ex-
clusivity period’’. 
(6) Section 351(m)(2)(B) of the Public Health 
Service Act (42 U.S.C. 262) is amended by striking 
‘‘rather than 7 years’’ and inserting ‘‘or 3 years and 
6 months, rather than 7 years or 3 years, respec-
tively’’. 
(7) Section 351(m)(3)(B) of the Public Health 
Service Act (42 U.S.C. 262) is amended by striking 
‘‘rather than 7 years’’ and inserting ‘‘or 3 years and 
6 months, rather than 7 years or 3 years, respec-
tively’’. 
SEC. 322. LIMITING EXCLUSIVITY FOR BIOSIMILAR PROD-
UCTS. 
Paragraph (7) of section 351(k) of the Public Health 
Service Act (42 U.S.C. 262(k)) is amended in subpara-
graph (A), by striking ‘‘12’’ and inserting ‘‘5’’. 
Subtitle D—Congressional Review 
of Agency Rulemaking 
SEC. 331. CONGRESSIONAL REVIEW OF THE FOOD AND 
DRUG ADMINISTRATION RULEMAKING. 
(a) CONGRESSIONAL REVIEW.—Part I of title 5, 
United States Code, is amended by adding at the end the 
following: 
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‘‘CHAPTER 10—CONGRESSIONAL REVIEW 
OF FOOD AND DRUG ADMINISTRATION 
RULEMAKING 
‘‘Sec. 
‘‘920. Applicability. 
‘‘921. Congressional review. 
‘‘922. Congressional approval procedure for major rules. 
‘‘923. Congressional disapproval procedure for nonmajor rules. 
‘‘924. Definitions. 
‘‘925. Judicial review. 
‘‘926. Exemption for monetary policy. 
‘‘927. Effective date of certain rules. 
‘‘928. Regulatory cut-go requirement. 
‘‘929. Review of rules currently in effect. 
‘‘§ 920. Applicability 
‘‘This chapter applies in lieu of chapter 8 with respect 
to the Food and Drug Administration. 
‘‘§ 921. Congressional review 
‘‘(a)(1)(A) Before a rule may take effect, the Food 
and Drug Administration shall satisfy the requirements 
of section 928 and shall publish in the Federal Register 
a list of information on which the rule is based, including 
data, scientific and economic studies, and cost-benefit 
analyses, and identify how the public can access such in-
formation online, and shall submit to each House of the 
Congress and to the Comptroller General a report con-
taining— 
‘‘(i) a copy of the rule; 
‘‘(ii) a concise general statement relating to the 
rule; 
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‘‘(iii) a classification of the rule as a major or 
nonmajor rule, including an explanation of the clas-
sification specifically addressing each criteria for a 
major rule contained within sections 924(2)(A), 
924(2)(B), and 924(2)(C); 
‘‘(iv) a list of any other related regulatory ac-
tions intended to implement the same statutory pro-
vision or regulatory objective as well as the indi-
vidual and aggregate economic effects of those ac-
tions; and 
‘‘(v) the proposed effective date of the rule. 
‘‘(B) On the date of the submission of the report 
under subparagraph (A), the Food and Drug Administra-
tion shall submit to the Comptroller General and make 
available to each House of Congress— 
‘‘(i) a complete copy of the cost-benefit analysis 
of the rule, if any, including an analysis of any jobs 
added or lost, differentiating between public and pri-
vate sector jobs; 
‘‘(ii) the Food and Drug Administration’s ac-
tions pursuant to sections 603, 604, 605, 607, and 
609 of this title; 
‘‘(iii) the Food and Drug Administration’s ac-
tions pursuant to sections 202, 203, 204, and 205 
of the Unfunded Mandates Reform Act of 1995; and 
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‘‘(iv) any other relevant information or require-
ments under any other Act and any relevant Execu-
tive orders. 
‘‘(C) Upon receipt of a report submitted under sub-
paragraph (A), each House shall provide copies of the re-
port to the chairman and ranking member of each stand-
ing committee with jurisdiction under the rules of the 
House of Representatives or the Senate to report a bill 
to amend the provision of law under which the rule is 
issued. 
‘‘(2)(A) The Comptroller General shall provide a re-
port on each major rule to the committees of jurisdiction 
by the end of 15 calendar days after the submission or 
publication date. The report of the Comptroller General 
shall include an assessment of the Food and Drug Admin-
istration’s compliance with procedural steps required by 
paragraph (1)(B) and an assessment of whether the major 
rule imposes any new limits or mandates on private-sector 
activity. 
‘‘(B) The Food and Drug Administration shall co-
operate with the Comptroller General by providing infor-
mation relevant to the Comptroller General’s report under 
subparagraph (A). 
‘‘(3) A major rule relating to a report submitted 
under paragraph (1) shall take effect upon enactment of 
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a joint resolution of approval described in section 922 or 
as provided for in the rule following enactment of a joint 
resolution of approval described in section 922, whichever 
is later. 
‘‘(4) A nonmajor rule shall take effect as provided 
by section 923 after submission to Congress under para-
graph (1). 
‘‘(5) If a joint resolution of approval relating to a 
major rule is not enacted within the period provided in 
subsection (b)(2), then a joint resolution of approval relat-
ing to the same rule may not be considered under this 
chapter in the same Congress by either the House of Rep-
resentatives or the Senate. 
‘‘(b)(1) A major rule shall not take effect unless the 
Congress enacts a joint resolution of approval described 
under section 922. 
‘‘(2) If a joint resolution described in subsection (a) 
is not enacted into law by the end of 70 session days or 
legislative days, as applicable, beginning on the date on 
which the report referred to in section 921(a)(1)(A) is re-
ceived by Congress (excluding days either House of Con-
gress is adjourned for more than 3 days during a session 
of Congress), then the rule described in that resolution 
shall be deemed not to be approved and such rule shall 
not take effect. 
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‘‘(c)(1) Notwithstanding any other provision of this 
section (except subject to paragraph (3)), a major rule 
may take effect for one 90-calendar-day period if the 
President makes a determination under paragraph (2) and 
submits written notice of such determination to the Con-
gress. 
‘‘(2) Paragraph (1) applies to a determination made 
by the President by Executive order that the major rule 
should take effect because such rule is— 
‘‘(A) necessary because of an imminent threat 
to health or safety or other emergency; 
‘‘(B) necessary for the enforcement of criminal 
laws; 
‘‘(C) necessary for national security; or 
‘‘(D) issued pursuant to any statute imple-
menting an international trade agreement. 
‘‘(3) An exercise by the President of the authority 
under this subsection shall have no effect on the proce-
dures under section 922. 
‘‘(d)(1) In addition to the opportunity for review oth-
erwise provided under this chapter, in the case of any rule 
for which a report was submitted in accordance with sub-
section (a)(1)(A) during the period beginning on the date 
occurring— 
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‘‘(A) in the case of the Senate, 60 session days; 
or 
‘‘(B) in the case of the House of Representa-
tives, 60 legislative days, 
before the date the Congress is scheduled to adjourn a 
session of Congress through the date on which the same 
or succeeding Congress first convenes its next session, sec-
tions 922 and 923 shall apply to such rule in the suc-
ceeding session of Congress. 
‘‘(2)(A) In applying sections 922 and 923 for pur-
poses of such additional review, a rule described under 
paragraph (1) shall be treated as though— 
‘‘(i) such rule were published in the Federal 
Register on— 
‘‘(I) in the case of the Senate, the 15th 
session day; or 
‘‘(II) in the case of the House of Rep-
resentatives, the 15th legislative day, 
after the succeeding session of Congress first con-
venes; and 
‘‘(ii) a report on such rule were submitted to 
Congress under subsection (a)(1) on such date. 
‘‘(B) Nothing in this paragraph shall be construed 
to affect the requirement under subsection (a)(1) that a 
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report shall be submitted to Congress before a rule can 
take effect. 
‘‘(3) A rule described under paragraph (1) shall take 
effect as otherwise provided by law (including other sub-
sections of this section). 
‘‘§ 922. Congressional approval procedure for major 
rules 
‘‘(a)(1) For purposes of this section, the term ‘joint 
resolution’ means only a joint resolution addressing a re-
port classifying a rule as major pursuant to section 
921(a)(1)(A)(iii) that— 
‘‘(A) bears no preamble; 
‘‘(B) bears the following title (with blanks filled 
as appropriate): ‘Approving the rule submitted by 
lll relating to lll.’; 
‘‘(C) includes after its resolving clause only the 
following (with blanks filled as appropriate): ‘That 
Congress approves the rule submitted by lll re-
lating to lll.’; and 
‘‘(D) is introduced pursuant to paragraph (2). 
‘‘(2) After a House of Congress receives a report 
classifying a rule as major pursuant to section 
921(a)(1)(A)(iii), the majority leader of that House (or 
his or her respective designee) shall introduce (by request, 
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if appropriate) a joint resolution described in paragraph 
(1)— 
‘‘(A) in the case of the House of Representa-
tives, within 3 legislative days; and 
‘‘(B) in the case of the Senate, within 3 session 
days. 
‘‘(3) A joint resolution described in paragraph (1) 
shall not be subject to amendment at any stage of pro-
ceeding. 
‘‘(b) A joint resolution described in subsection (a) 
shall be referred in each House of Congress to the commit-
tees having jurisdiction over the provision of law under 
which the rule is issued. 
‘‘(c) In the Senate, if the committee or committees 
to which a joint resolution described in subsection (a) has 
been referred have not reported it at the end of 15 session 
days after its introduction, such committee or committees 
shall be automatically discharged from further consider-
ation of the resolution and it shall be placed on the cal-
endar. A vote on final passage of the resolution shall be 
taken on or before the close of the 15th session day after 
the resolution is reported by the committee or committees 
to which it was referred, or after such committee or com-
mittees have been discharged from further consideration 
of the resolution. 
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‘‘(d)(1) In the Senate, when the committee or com-
mittees to which a joint resolution is referred have re-
ported, or when a committee or committees are discharged 
(under subsection (c)) from further consideration of a 
joint resolution described in subsection (a), it is at any 
time thereafter in order (even though a previous motion 
to the same effect has been disagreed to) for a motion 
to proceed to the consideration of the joint resolution, and 
all points of order against the joint resolution (and against 
consideration of the joint resolution) are waived. The mo-
tion is not subject to amendment, or to a motion to post-
pone, or to a motion to proceed to the consideration of 
other business. A motion to reconsider the vote by which 
the motion is agreed to or disagreed to shall not be in 
order. If a motion to proceed to the consideration of the 
joint resolution is agreed to, the joint resolution shall re-
main the unfinished business of the Senate until disposed 
of. 
‘‘(2) In the Senate, debate on the joint resolution, 
and on all debatable motions and appeals in connection 
therewith, shall be limited to not more than 2 hours, which 
shall be divided equally between those favoring and those 
opposing the joint resolution. A motion to further limit 
debate is in order and not debatable. An amendment to, 
or a motion to postpone, or a motion to proceed to the 
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consideration of other business, or a motion to recommit 
the joint resolution is not in order. 
‘‘(3) In the Senate, immediately following the conclu-
sion of the debate on a joint resolution described in sub-
section (a), and a single quorum call at the conclusion of 
the debate if requested in accordance with the rules of the 
Senate, the vote on final passage of the joint resolution 
shall occur. 
‘‘(4) Appeals from the decisions of the Chair relating 
to the application of the rules of the Senate to the proce-
dure relating to a joint resolution described in subsection 
(a) shall be decided without debate. 
‘‘(e) In the House of Representatives, if any com-
mittee to which a joint resolution described in subsection 
(a) has been referred has not reported it to the House 
at the end of 15 legislative days after its introduction, 
such committee shall be discharged from further consider-
ation of the joint resolution, and it shall be placed on the 
appropriate calendar. On the second and fourth Thursdays 
of each month it shall be in order at any time for the 
Speaker to recognize a Member who favors passage of a 
joint resolution that has appeared on the calendar for at 
least 5 legislative days to call up that joint resolution for 
immediate consideration in the House without intervention 
of any point of order. When so called up a joint resolution 
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shall be considered as read and shall be debatable for 1 
hour equally divided and controlled by the proponent and 
an opponent, and the previous question shall be considered 
as ordered to its passage without intervening motion. It 
shall not be in order to reconsider the vote on passage. 
If a vote on final passage of the joint resolution has not 
been taken by the third Thursday on which the Speaker 
may recognize a Member under this subsection, such vote 
shall be taken on that day. 
‘‘(f)(1) If, before passing a joint resolution described 
in subsection (a), one House receives from the other a 
joint resolution having the same text, then— 
‘‘(A) the joint resolution of the other House 
shall not be referred to a committee; and 
‘‘(B) the procedure in the receiving House shall 
be the same as if no joint resolution had been re-
ceived from the other House until the vote on pas-
sage, when the joint resolution received from the 
other House shall supplant the joint resolution of 
the receiving House. 
‘‘(2) This subsection shall not apply to the House of 
Representatives if the joint resolution received from the 
Senate is a revenue measure. 
‘‘(g) If either House has not taken a vote on final 
passage of the joint resolution by the last day of the period 
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described in section 921(b)(2), then such vote shall be 
taken on that day. 
‘‘(h) This section and section 923 are enacted by 
Congress— 
‘‘(1) as an exercise of the rulemaking power of 
the Senate and House of Representatives, respec-
tively, and as such is deemed to be part of the rules 
of each House, respectively, but applicable only with 
respect to the procedure to be followed in that 
House in the case of a joint resolution described in 
subsection (a) and superseding other rules only 
where explicitly so; and 
‘‘(2) with full recognition of the Constitutional 
right of either House to change the rules (so far as 
they relate to the procedure of that House) at any 
time, in the same manner and to the same extent as 
in the case of any other rule of that House. 
‘‘§ 923. 
Congressional 
disapproval 
procedure 
for 
nonmajor rules 
‘‘(a) For purposes of this section, the term ‘joint res-
olution’ means only a joint resolution introduced in the 
period beginning on the date on which the report referred 
to in section 921(a)(1)(A) is received by Congress and 
ending 60 days thereafter (excluding days either House 
of Congress is adjourned for more than 3 days during a 
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181 
session of Congress), the matter after the resolving clause 
of which is as follows: ‘That Congress disapproves the 
nonmajor rule submitted by the lll relating to 
lll, and such rule shall have no force or effect.’ (The 
blank spaces being appropriately filled in). 
‘‘(b) A joint resolution described in subsection (a) 
shall be referred to the committees in each House of Con-
gress with jurisdiction. 
‘‘(c) In the Senate, if the committee to which is re-
ferred a joint resolution described in subsection (a) has 
not reported such joint resolution (or an identical joint 
resolution) at the end of 15 session days after the date 
of introduction of the joint resolution, such committee may 
be discharged from further consideration of such joint res-
olution upon a petition supported in writing by 30 Mem-
bers of the Senate, and such joint resolution shall be 
placed on the calendar. 
‘‘(d)(1) In the Senate, when the committee to which 
a joint resolution is referred has reported, or when a com-
mittee is discharged (under subsection (c)) from further 
consideration of a joint resolution described in subsection 
(a), it is at any time thereafter in order (even though a 
previous motion to the same effect has been disagreed to) 
for a motion to proceed to the consideration of the joint 
resolution, and all points of order against the joint resolu-
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tion (and against consideration of the joint resolution) are 
waived. The motion is not subject to amendment, or to 
a motion to postpone, or to a motion to proceed to the 
consideration of other business. A motion to reconsider the 
vote by which the motion is agreed to or disagreed to shall 
not be in order. If a motion to proceed to the consideration 
of the joint resolution is agreed to, the joint resolution 
shall remain the unfinished business of the Senate until 
disposed of. 
‘‘(2) In the Senate, debate on the joint resolution, 
and on all debatable motions and appeals in connection 
therewith, shall be limited to not more than 10 hours, 
which shall be divided equally between those favoring and 
those opposing the joint resolution. A motion to further 
limit debate is in order and not debatable. An amendment 
to, or a motion to postpone, or a motion to proceed to 
the consideration of other business, or a motion to recom-
mit the joint resolution is not in order. 
‘‘(3) In the Senate, immediately following the conclu-
sion of the debate on a joint resolution described in sub-
section (a), and a single quorum call at the conclusion of 
the debate if requested in accordance with the rules of the 
Senate, the vote on final passage of the joint resolution 
shall occur. 
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‘‘(4) Appeals from the decisions of the Chair relating 
to the application of the rules of the Senate to the proce-
dure relating to a joint resolution described in subsection 
(a) shall be decided without debate. 
‘‘(e) In the Senate, the procedure specified in sub-
section (c) or (d) shall not apply to the consideration of 
a joint resolution respecting a nonmajor rule— 
‘‘(1) after the expiration of the 60 session days 
beginning with the applicable submission or publica-
tion date; or 
‘‘(2) if the report under section 921(a)(1)(A) 
was submitted during the period referred to in sec-
tion 921(d)(1), after the expiration of the 60 session 
days beginning on the 15th session day after the 
succeeding session of Congress first convenes. 
‘‘(f) If, before the passage by one House of a joint 
resolution of that House described in subsection (a), that 
House receives from the other House a joint resolution 
described in subsection (a), then the following procedures 
shall apply: 
‘‘(1) The joint resolution of the other House 
shall not be referred to a committee. 
‘‘(2) With respect to a joint resolution described 
in subsection (a) of the House receiving the joint 
resolution— 
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‘‘(A) the procedure in that House shall be 
the same as if no joint resolution had been re-
ceived from the other House; but 
‘‘(B) the vote on final passage shall be on 
the joint resolution of the other House. 
‘‘§ 924. Definitions 
‘‘For purposes of this chapter: 
‘‘(1) The term ‘major rule’ means any rule of 
the Food and Drug Administration, including an in-
terim final rule, that the Administrator of the Office 
of Information and Regulatory Affairs of the Office 
of Management and Budget finds has resulted in or 
is likely to result in— 
‘‘(A) an annual cost on the economy of 
$100,000,000 or more, adjusted annually for 
inflation; 
‘‘(B) a major increase in costs or prices for 
consumers, 
individual 
industries, 
Federal, 
State, or local government agencies, or geo-
graphic regions; or 
‘‘(C) significant adverse effects on competi-
tion, employment, investment, productivity, in-
novation, or on the ability of United States- 
based enterprises to compete with foreign-based 
enterprises in domestic and export markets. 
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‘‘(2) The term ‘nonmajor rule’ means any rule 
of the Food and Drug Administration that is not a 
major rule. 
‘‘(3) The term ‘rule’ has the meaning given 
such term in section 551, except that such term does 
not include— 
‘‘(A) any rule of particular applicability; 
‘‘(B) any rule relating to agency manage-
ment or personnel; or 
‘‘(C) any rule of agency organization, pro-
cedure, or practice that does not substantially 
affect the rights or obligations of non-agency 
parties. 
‘‘(4) The term ‘submission date or publication 
date’, except as otherwise provided in this chapter, 
means— 
‘‘(A) in the case of a major rule, the date 
on which the Congress receives the report sub-
mitted under section 921(a)(1); and 
‘‘(B) in the case of a nonmajor rule, the 
later of— 
‘‘(i) the date on which the Congress 
receives the report submitted under section 
921(a)(1); and 
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‘‘(ii) the date on which the nonmajor 
rule is published in the Federal Register, if 
so published. 
‘‘§ 925. Judicial review 
‘‘(a) No determination, finding, action, or omission 
under this chapter shall be subject to judicial review. 
‘‘(b) Notwithstanding subsection (a), a court may de-
termine whether the Food and Drug Administration has 
completed the necessary requirements under this chapter 
for a rule to take effect. 
‘‘(c) The enactment of a joint resolution of approval 
under section 922 shall not be interpreted to serve as a 
grant or modification of statutory authority by Congress 
for the promulgation of a rule, shall not extinguish or af-
fect any claim, whether substantive or procedural, against 
any alleged defect in a rule, and shall not form part of 
the record before the court in any judicial proceeding con-
cerning a rule except for purposes of determining whether 
or not the rule is in effect. 
‘‘§ 926. Exemption for monetary policy 
‘‘Nothing in this chapter shall apply to rules that con-
cern monetary policy proposed or implemented by the 
Board of Governors of the Federal Reserve System or the 
Federal Open Market Committee. 
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‘‘§ 927. Effective date of certain rules 
‘‘Notwithstanding section 921, any rule other than a 
major rule which the Food and Drug Administration for 
good cause finds (and incorporates the finding and a brief 
statement of reasons therefore in the rule issued) that no-
tice and public procedure thereon are impracticable, un-
necessary, or contrary to the public interest, shall take ef-
fect at such time as the Food and Drug Administration 
determines. 
‘‘§ 928. Regulatory cut-go requirement 
‘‘In making any new rule, the Food and Drug Admin-
istration shall identify a rule or rules that may be amend-
ed or repealed to completely offset any annual costs of 
the new rule to the United States economy. Before the 
new rule may take effect, the Food and Drug Administra-
tion shall make each such repeal or amendment. In mak-
ing such an amendment or repeal, the Food and Drug Ad-
ministration shall comply with the requirements of sub-
chapter II of chapter 5, but the Food and Drug Adminis-
tration may consolidate proceedings under subchapter 
with proceedings on the new rule. 
‘‘§ 929. Review of rules currently in effect 
‘‘(a) ANNUAL REVIEW.—Beginning on the date that 
is 6 months after the date of enactment of this section 
and annually thereafter for the 9 years following, the Food 
and Drug Administration shall designate not less than 10 
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percent of eligible rules made by the Food and Drug Ad-
ministration for review, and shall submit a report includ-
ing each such eligible rule in the same manner as a report 
under section 921(a)(1). Section 921, section 922, and 
section 923 shall apply to each such rule, subject to sub-
section (c) of this section. No eligible rule previously des-
ignated may be designated again. 
‘‘(b) SUNSET
FOR
ELIGIBLE
RULES
NOT
EX-
TENDED.—Beginning after the date that is 10 years after 
the date of enactment of this section, if Congress has not 
enacted a joint resolution of approval for that eligible rule, 
that eligible rule shall not continue in effect. 
‘‘(c) CONSOLIDATION; SEVERABILITY.—In applying 
sections 921, 922, and 923 to eligible rules under this sec-
tion, the following shall apply: 
‘‘(1) The words ‘take effect’ shall be read as 
‘continue in effect’. 
‘‘(2) Except as provided in paragraph (3), a 
single joint resolution of approval shall apply to all 
eligible rules in a report designated for a year, and 
the matter after the resolving clause of that joint 
resolution is as follows: ‘That Congress approves the 
rules submitted by the ll for the year ll.’ (The 
blank spaces being appropriately filled in). 
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‘‘(3) It shall be in order to consider any amend-
ment that provides for specific conditions on which 
the approval of a particular eligible rule included in 
the joint resolution is contingent. 
‘‘(4) A member of either House may move that 
a separate joint resolution be required for a specified 
rule. 
‘‘(d) DEFINITION.—In this section, the term ‘eligible 
rule’ means a rule that is in effect as of the date of enact-
ment of this section.’’. 
(b) BUDGETARY EFFECTS OF RULES SUBJECT TO 
SECTION 922 OF TITLE 5, UNITED STATES CODE.—Sec-
tion 257(b)(2) of the Balanced Budget and Emergency 
Deficit Control Act of 1985 is amended by adding at the 
end the following new subparagraph: 
‘‘(E) BUDGETARY
EFFECTS
OF
RULES 
SUBJECT TO SECTION 922 OF TITLE 5, UNITED 
STATES CODE.—Any rules subject to the con-
gressional approval procedure set forth in sec-
tion 922 of chapter 8 of title 5, United States 
Code, affecting budget authority, outlays, or re-
ceipts shall be assumed to be effective unless it 
is not approved in accordance with such sec-
tion.’’. 
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(c) GOVERNMENT ACCOUNTABILITY OFFICE STUDY 
OF RULES.— 
(1) IN GENERAL.—The Comptroller General of 
the United States shall conduct a study to deter-
mine, as of the date of the enactment of this Act— 
(A) how many rules (as such term is de-
fined in section 924 of title 5, United States 
Code) of the Food and Drug Administration 
were in effect; 
(B) how many major rules (as such term 
is defined in section 924 of title 5, United 
States Code) of the Food and Drug Administra-
tion were in effect; and 
(C) the total estimated economic cost im-
posed by all such rules. 
(2) REPORT.—Not later than 1 year after the 
date of the enactment of this Act, the Comptroller 
General of the United States shall submit a report 
to Congress that contains the findings of the study 
conducted under paragraph (1). 
(d) EFFECTIVE DATE.—Subsections (a) and (b), and 
the amendments made by such sections, shall take effect 
beginning on the date that is 1 year after the date of en-
actment of this Act. 
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SEC. 332. GOVERNMENT ACCOUNTABILITY OFFICE STUDY 
OF RULES. 
(a) IN GENERAL.—The Comptroller General of the 
United States shall conduct a study to determine, as of 
the date of the enactment of this Act— 
(1) how many rules (as such term is defined in 
section 804 of title 5, United States Code) were in 
effect; 
(2) how many major rules (as such term is de-
fined in section 804 of title 5, United States Code) 
were in effect; and 
(3) the total estimated economic cost imposed 
by all such rules. 
(b) REPORT.—Not later than 1 year after the date 
of the enactment of this Act, the Comptroller General of 
the United States shall submit a report to Congress that 
contains the findings of the study conducted under sub-
section (a). 
Subtitle E—Medicare Prescription 
Drug Competition 
SEC. 341. MEDICARE DRUG COVERAGE. 
Notwithstanding any other provision of law, the Sec-
retary of Health and Human Services may alter the reim-
bursement mechanism for prescription drugs provided 
through the Medicare Part B program by reimbursing at 
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a rate that, based on ASP+6% in the year of implementa-
tion of this Act, grows at CPI. 
SEC. 342. PBM TRANSPARENCY AND ELIMINATION OF DIR 
FEES. 
(a) PROHIBITING MEDICARE PDP SPONSORS AND 
MA–PD ORGANIZATIONS FROM RETROACTIVELY REDUC-
ING PAYMENT ON CLEAN CLAIMS SUBMITTED BY PHAR-
MACIES.— 
(1) IN GENERAL.—Section 1860D–12(b)(4)(A) 
of the Social Security Act (42 U.S.C. 1395w– 
112(b)(4)(A)) is amended by adding at the end the 
following new clause: 
‘‘(iv) PROHIBITING RETROACTIVE RE-
DUCTIONS
IN
PAYMENTS
ON
CLEAN 
CLAIMS.—Each contract entered into with 
a PDP sponsor under this part with re-
spect to a prescription drug plan offered 
by such sponsor shall provide that after 
the date of receipt of a clean claim sub-
mitted by a pharmacy, the PDP sponsor 
(or an agent of the PDP sponsor) may not 
retroactively reduce payment on such claim 
directly or indirectly through aggregated 
effective rate or otherwise except in the 
case such claim is found to not be a clean 
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claim (such as in the case of a claim lack-
ing required substantiating documentation) 
during the course of a routine audit as 
permitted pursuant to written agreement 
between the PDP sponsor (or such an 
agent) and such pharmacy. The previous 
sentence shall not prohibit any retroactive 
increase in payment to a pharmacy pursu-
ant to a written agreement between a PDP 
sponsor (or an agent of such sponsor) and 
such pharmacy.’’. 
(2) EFFECTIVE DATE.—The amendment made 
by subsection (a) shall apply with respect to con-
tracts entered into on or after January 1, 2021. 
(b) ELIMINATION OF DIR FEES.— 
(1) PHARMACY
BENEFITS
MANAGER
STAND-
ARDS UNDER THE MEDICARE PROGRAM FOR PRE-
SCRIPTION DRUG PLANS AND MA–PD PLANS.— 
(A) IN
GENERAL.—Section 1860D–12(b) 
of the Social Security Act (42 U.S.C. 1395w– 
112(b)) is amended by adding at the end the 
following new paragraph: 
‘‘(7) PHARMACY
BENEFITS
MANAGER
TRANS-
PARENCY
REQUIREMENTS.—Each contract entered 
into with a PDP sponsor under this part with re-
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spect to a prescription drug plan offered by such 
sponsor or with an MA organization offering an 
MA–PD plan under part C shall provide that the 
sponsor or organization, respectively, may not enter 
into a contract with any pharmacy benefits manager 
(referred to in this paragraph as a ‘PBM’) to man-
age the prescription drug coverage provided under 
such plan, or to control the costs of the prescription 
drug coverage under such plan, unless the PBM ad-
heres to the following criteria when handling person-
ally identifiable utilization and claims data or other 
sensitive patient data: 
‘‘(A) The PBM may not transmit any per-
sonally identifiable utilization, protected health 
information, or claims data, with respect to a 
plan enrollee, to a pharmacy owned by a PBM 
if the plan enrollee has not voluntarily elected 
in writing or via secure electronic means to fill 
that particular prescription at the PBM-owned 
pharmacy. 
‘‘(B) The PBM may not require that a 
plan enrollee use a retail pharmacy, mail order 
pharmacy, specialty pharmacy, or other phar-
macy entity providing pharmacy services in 
which the PBM has an ownership interest or 
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that has an ownership interest in the PBM, or 
provide an incentive to a plan enrollee to en-
courage the enrollee to use a retail pharmacy, 
mail order pharmacy, specialty pharmacy, or 
other pharmacy entity providing pharmacy serv-
ices in which the PBM has an ownership inter-
est or that has an ownership interest in the 
PBM, if the incentive is applicable only to such 
pharmacies.’’. 
(B) REGULAR UPDATE OF PRESCRIPTION 
DRUG PRICING STANDARD.—Paragraph (6) of 
section 1860D–12(b) of the Social Security Act 
(42 U.S.C. 1395w–112(b)) is amended to read 
as follows: 
‘‘(6) REGULAR
UPDATE
OF
PRESCRIPTION 
DRUG PRICING STANDARD.— 
‘‘(A) IN GENERAL.—If the PDP sponsor of 
a prescription drug plan (or MA organization 
offering an MA–PD plan) uses a standard for 
reimbursement (as described in subparagraph 
(B)) of pharmacies based on the cost of a drug, 
each contract entered into with such sponsor 
under this part (or organization under part C) 
with respect to the plan shall provide that the 
sponsor (or organization) shall— 
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‘‘(i) update such standard not less fre-
quently than once every 7 days, beginning 
with an initial update on January 1 of 
each year, to accurately reflect the market 
price of acquiring the drug; 
‘‘(ii) disclose to applicable pharmacies 
and the contracting entities of such phar-
macies the sources used for making any 
such update immediately without require-
ment of request; 
‘‘(iii) if the source for such a standard 
for reimbursement is not publicly available, 
disclose to the applicable pharmacies and 
the respective contracting entities of such 
pharmacies all individual drug prices to be 
so updated in advance of the use of such 
prices for the reimbursement of claims; 
‘‘(iv) establish a process to appeal, in-
vestigate, and resolve disputes regarding 
individual drug prices that are less than 
the pharmacy acquisition price for such 
drug, which must be adjudicated within 7 
days of the pharmacy filing its appeal; and 
‘‘(v) provide all such pricing data in 
an .xml spreadsheet format or a com-
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parable easily accessible and complete 
spreadsheet format. 
‘‘(B) 
PRESCRIPTION
DRUG
PRICING 
STANDARD
DEFINED.—For purposes of sub-
paragraph (A), a standard for reimbursement 
of a pharmacy is any methodology or formula 
for varying the pricing of a drug or drugs dur-
ing the term of the pharmacy reimbursement 
contract that is based on the cost of the drug 
involved, including drug pricing references and 
amounts that are based upon average wholesale 
price, wholesale average cost, average manufac-
turer price, average sales price, maximum al-
lowable cost (MAC), or other costs, whether 
publicly available or not.’’. 
(C) EFFECTIVE DATE.—The amendments 
made by this section shall apply to plan years 
beginning on or after January 1, 2020. 
(2) REGULAR UPDATE OF PRESCRIPTION DRUG 
PRICING STANDARD UNDER TRICARE RETAIL PHAR-
MACY
PROGRAM.—Section 1074g(d) of title 10, 
United States Code, is amended by adding at the 
end the following new paragraph: 
‘‘(3) To the extent practicable, with respect to the 
TRICARE retail pharmacy program described in sub-
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section (a)(2)(E)(ii), the Secretary shall ensure that a con-
tract entered into with a TRICARE managed care support 
contractor includes requirements described in section 
1860D–12(b)(6) of the Social Security Act (42 U.S.C. 
1395w–112(b)(6)) to ensure the provision of information 
regarding the pricing standard for prescription drugs.’’. 
(3) PRESCRIPTION
DRUG
TRANSPARENCY
IN 
THE FEDERAL EMPLOYEES HEALTH BENEFITS PRO-
GRAM.— 
(A) IN GENERAL.—Section 8902 of title 5, 
United States Code, is amended by adding at 
the end the following new subsections: 
‘‘(p) A contract may not be made or a plan approved 
under this chapter under which a carrier has an agree-
ment with a pharmacy benefits manager (in this sub-
section referred to as a ‘PBM’) to manage prescription 
drug coverage or to control the costs of the prescription 
drug coverage unless the carrier and PBM adhere to the 
following criteria: 
‘‘(1) The PBM may not transmit any personally 
identifiable utilization, protected health information, 
or claims data with respect to an individual enrolled 
under such contract or plan to a pharmacy owned by 
the PBM if the individual has not voluntarily elected 
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in writing or via secure electronic means to fill that 
particular prescription at such a pharmacy. 
‘‘(2) The PBM may not require that an indi-
vidual enrolled under such contract or plan use a re-
tail pharmacy, mail order pharmacy, specialty phar-
macy, or other pharmacy entity providing pharmacy 
services in which the PBM has an ownership interest 
or that has an ownership interest in the PBM or 
provide an incentive to a plan enrollee to encourage 
the enrollee to use a retail pharmacy, mail order 
pharmacy, specialty pharmacy, or other pharmacy 
entity providing pharmacy services in which the 
PBM has an ownership interest or that has an own-
ership interest in the PBM, if the incentive is appli-
cable only to such pharmacies. 
‘‘(q)(1) If a contract made or plan approved under 
this chapter provides for a standard for reimbursement 
(as described in paragraph (2)) with respect to a prescrip-
tion drug plan, such contract or plan shall provide that 
the applicable carrier— 
‘‘(A) update such standard not less frequently 
than once every 7 days, beginning with an initial up-
date on January 1 of each year, to accurately reflect 
the market price of acquiring the drug; 
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200 
‘‘(B) disclose to applicable pharmacies and the 
contracting entities of such pharmacies the sources 
used for making any such update immediately with-
out requirement of request; 
‘‘(C) if the source for such a standard for reim-
bursement is not publicly available, disclose to the 
applicable pharmacies and contracting entities of 
such pharmacies all individual drug prices to be so 
updated in advance of the use of such prices for the 
reimbursement of claims; 
‘‘(D) establish a process to appeal, investigate, 
and resolve disputes regarding individual drug prices 
that are less than the pharmacy acquisition price for 
such drug, which must be adjudicated within 7 days 
of the pharmacy filing its appeal; and 
‘‘(E) provide all such pricing data in an .xml 
spreadsheet format or a comparable easily accessible 
and complete spreadsheet format. 
‘‘(2) For purposes of paragraph (1), a standard for 
reimbursement of a pharmacy is any methodology or for-
mula for varying the pricing of a drug or drugs during 
the term of the pharmacy reimbursement contract that is 
based on the cost of the drug involved, including drug pric-
ing references and amounts that are based upon average 
wholesale price, wholesale average cost, average manufac-
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201 
turer price, average sales price, maximum allowable cost, 
or other costs, whether publicly available or not.’’. 
(B) APPLICATION.—The amendment made 
by subparagraph (A) shall apply to any contract 
entered into under section 8902 of title 5, 
United States Code, on or after the date of en-
actment of this section. 
SEC. 343. SUNSET OF LIMIT ON MAXIMUM REBATE AMOUNT 
FOR SINGLE SOURCE DRUGS AND INNO-
VATOR MULTIPLE SOURCE DRUGS. 
Section 1927(c)(2)(D) of the Social Security Act (42 
U.S.C. 1396r–8(c)(2)(D)) is amended by inserting after 
‘‘December 31, 2009,’’ the following: ‘‘and before Decem-
ber 31, 2024,’’. 
SEC. 344. REGULATION OF MANUFACTURER-SPONSORED 
COPAY CONTRIBUTIONS. 
Notwithstanding any other provision of law, the Sec-
retary of Health and Human Services may establish a 
mechanism prohibiting drug manufacturers from contrib-
uting financially to patient copays, and establish a system 
of penalizing such behavior. 
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SEC. 345. DATA REPORTING TO IMPROVE THE TRANS-
PARENCY REGARDING HOW 340B HOSPITAL 
COVERED ENTITIES PROVIDE CARE FOR PA-
TIENTS. 
Section 340B of the Public Health Service Act (42 
U.S.C. 256b) is amended by adding at the end the fol-
lowing new subsection: 
‘‘(f) DATA REPORTING TO IMPROVE THE TRANS-
PARENCY REGARDING HOW HOSPITAL COVERED ENTI-
TIES PROVIDE CARE FOR PATIENTS.— 
‘‘(1) IN GENERAL.—Beginning on the date that 
is 14 months after the date of the enactment of this 
subsection, and annually thereafter, subject to sub-
paragraph (C), a covered entity described in sub-
paragraph (L) or (M) of subsection (a)(4), unless 
otherwise indicated, shall report on the following, 
with respect to the previous year, in such a manner 
and form as specified by the Secretary: 
‘‘(A) The following information: 
‘‘(i) With respect to such covered enti-
ty and with respect to each child site of 
such entity (as referenced in paragraph 
(11)), the number and percentage of indi-
viduals who are dispensed or administered 
drugs that are subject to an agreement 
under this section, organized by form of 
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health insurance coverage of such individ-
uals (including at least by the Medicare 
program under title XVIII of the Social 
Security Act, the Medicaid program under 
title XIX of such Act, health insurance 
coverage offered in the individual or group 
market or a group health plan (as such 
terms are defined in section 2791), and 
uninsured). 
‘‘(ii) With respect to each such child 
site of such entity, the total costs incurred 
at each such site and the cost incurred at 
each such site for charity care as defined 
in line 23 of worksheet S–10 to the Medi-
care cost report or in any successor form. 
‘‘(B) The aggregate amount of gross reim-
bursement received by each such covered entity 
(including child sites of such entity) described 
in such subparagraph (L) or (M) for all drugs 
purchased that are subject to an agreement 
under this section and the entity’s aggregate 
acquisition cost for such drugs. 
‘‘(C) In the case of covered entity de-
scribed in subparagraph (L) of subsection 
(a)(4), at the time of application and recertifi-
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cation (and at least annually thereafter), the 
contract that is the basis for eligibility under 
the requirement under clause (i) of such sub-
paragraph and any modifications to such con-
tract for purposes of review by the Secretary. 
‘‘(D) With respect to such covered entity 
and with respect to each child site of such enti-
ty, the name of all third-party vendors or other 
similar entities that the covered entity contracts 
with to provide services associated with the pro-
gram under this section. 
‘‘(2) AVAILABILITY OF INFORMATION.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
make data reported by covered entities under 
subparagraphs (A), (C), and (D) of paragraph 
(1) available on the public website of the De-
partment of Health and Human Services in an 
electronic and searchable format, which may in-
clude the 340B Office of Pharmacy Affairs In-
formation System or a successor to such sys-
tem. 
‘‘(B) 
FORMAT.—Data 
made 
available 
under subparagraph (A) shall be made available 
in a manner that shows each category of data 
reported both in the aggregate and identified by 
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covered entities described in subparagraphs (L) 
and (M) of subsection (a)(4) and child sites of 
such covered entities. In carrying out this para-
graph, with respect to data reported pursuant 
to paragraph (1)(C), the Secretary shall ensure 
that any proprietary information shall be re-
dacted from contracts submitted pursuant to 
such paragraph (1)(C) before posting such 
data. 
‘‘(3) INTERIM FINAL REGULATIONS.—The Sec-
retary shall issue interim final regulations no later 
than the date that is 6 months after the date of the 
enactment of this subsection, to carry out this sub-
section and shall finalize such regulations prior to 
the end of the moratorium period to which sub-
section (a)(11) applies. 
‘‘(4) REPORTS TO CONGRESS.— 
‘‘(A) OIG REPORT.—Not later than 2 
years after the date of the enactment of this 
subsection, the Office of the Inspector General 
shall submit to Congress a final report on the 
level of charity care provided by covered entities 
described in subparagraphs (L) and (M) of sub-
section (a)(4) and separately by child sites of 
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such covered entities, as reported in paragraph 
(1)(A). 
‘‘(B) GAO REPORTS.— 
‘‘(i) INITIAL REPORT.—Not later than 
1 year after the date of the enactment of 
this subsection, the Comptroller General of 
the United States shall submit to Congress 
a report— 
‘‘(I) analyzing the State and local 
government contracts intended to sat-
isfy the requirement under subsection 
(a)(4)(L)(i) for a covered entity to 
qualify as an entity described in sub-
paragraph (L) of subsection (a)(4); 
‘‘(II) assessing the amount of 
care such contracts obligate such enti-
ty to provide to low-income individuals 
ineligible for Medicare under title 
XVIII of the Social Security Act and 
Medicaid under title XIX of such Act; 
and 
‘‘(III) analyzing how these con-
tracts define low-income individuals 
and whether the Secretary reviews 
such determinations. 
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‘‘(ii) 
SUBSEQUENT
REPORT.—Not 
later than 2 years after the date of the en-
actment of this subsection, the Comptroller 
General of the United States shall submit 
to Congress a final report on the informa-
tion collected under paragraph (1)(B) re-
garding the difference between the aggre-
gate gross reimbursement and aggregate 
acquisition costs received by each such cov-
ered entity (including child sites of such 
entity) for drugs subject to an agreement 
under this section.’’. 
SEC. 346. REQUIRING 340B DRUG DISCOUNT PROGRAM RE-
PORTS BY DSH HOSPITAL COVERED ENTITIES 
ON LOW-INCOME UTILIZATION RATE OF OUT-
PATIENT HOSPITAL SERVICES. 
(a) IN GENERAL.—Section 340B(d)(2) of the Public 
Health Service Act (42 U.S.C. 256b(d)(2)) is amended— 
(1) in subparagraph (B)(i), by inserting before 
the period at the end the following: ‘‘, including, 
with respect to such updates made on or after Janu-
ary 1, 2020, by requiring covered entities described 
in subsection (a)(4)(L) to submit (and to so regu-
larly update) information described in subparagraph 
(C)’’; and 
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(2) by adding at the end the following new sub-
paragraph: 
‘‘(C) INFORMATION ON LOW-INCOME UTI-
LIZATION
RATE
OF
OUTPATIENT
HOSPITAL 
SERVICES.— 
‘‘(i) IN
GENERAL.—For purposes of 
subparagraph (B)(i), the information de-
scribed in this subparagraph, with respect 
to a covered entity described in subsection 
(a)(4)(L) and an update under such sub-
paragraph (B)(i), is— 
‘‘(I) the low-income outpatient 
utilization rate of such covered entity 
for the most recent fiscal year; and 
‘‘(II) the low-income outpatient 
utilization rate of off-site outpatient 
facilities, clinics, eligible off-site loca-
tions, and associated sites of such en-
tity identified as child sites of such 
entity pursuant to the identification 
system under subparagraph (B)(iv) 
for the most recent fiscal year. 
‘‘(ii) LOW-INCOME OUTPATIENT UTI-
LIZATION
RATE
DEFINED.—In this sub-
paragraph, the term ‘low-income outpatient 
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utilization rate’ has the meaning given the 
term ‘low-income utilization rate’ under 
paragraph (3) of section 1923(b) of the 
Social Security Act, except that— 
‘‘(I) clauses (i) and (ii) of sub-
paragraph (A) of such paragraph 
shall be applied as if— 
‘‘(aa) each reference to ‘pa-
tient services’ were a reference to 
‘patient services furnished on an 
outpatient basis’; and 
‘‘(bb) for purposes of clause 
(i)(II) of this subparagraph, each 
reference to ‘hospital’ were a ref-
erence to ‘off-site outpatient fa-
cilities, clinics, eligible off-site lo-
cations, and associated sites of 
the hospital that are identified as 
child sites of the hospital pursu-
ant to the identification system 
under section 340B(d)(2)(B)(iv) 
of the Public Health Service Act’; 
and 
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‘‘(II) clauses (i) and (ii) of sub-
paragraph (B) of such paragraph 
shall be applied as if— 
‘‘(aa) each reference to ‘in-
patient hospital services’ were a 
reference to ‘outpatient hospital 
services’; and 
‘‘(bb) for purposes of clause 
(i)(II) each reference to ‘hos-
pital’s charges’ were a reference 
to ‘charges of the off-site out-
patient facilities, clinics, eligible 
off-site locations, and associated 
sites of the hospital that are 
identified as child sites of the 
hospital pursuant to the identi-
fication system under section 
340B(d)(2)(B)(iv) of the Public 
Health Service Act’.’’. 
(b) ANNUAL REPORTS.—Not later than January 1, 
2021, and annually thereafter, the Administrator of the 
Health Resources and Services Administration shall sub-
mit to Congress a report on information submitted by cov-
ered entities for the previous year pursuant to the amend-
ments made by subsection (a). 
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TITLE IV—PROVIDER 
COMPETITION 
SEC. 401. HOSPITAL CONSOLIDATION. 
(a) AUTHORIZATION OF APPROPRIATIONS.—There is 
authorized to be appropriated $160,000,000 to the Fed-
eral Trade Commission to hire staff to investigate, as con-
sistent with the Sherman Antitrust Act and other relevant 
Federal laws, anti-competitive mergers and practices 
under such laws to the extent such mergers and practices 
relate to providers of inpatient and outpatient health care 
services, as defined by the Secretary of Health and 
Human Services. 
(b) MEDICARE RATES APPLIED TO CERTAIN HHI 
HOSPITALS.— 
(1) IN GENERAL.—Section 1866(a) of the So-
cial Security Act (42 U.S.C. 1395cc(a)) is amend-
ed— 
(A) in paragraph (1)— 
(i) in subparagraph (X), by striking 
‘‘and’’ at the end; 
(ii) in subparagraph (Y), by striking 
the period at the end and inserting ‘‘; 
and’’; and 
(iii) by inserting after subparagraph 
(Y) the following new subparagraph: 
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‘‘(Z) subject to paragraph (4), in the case 
of a hospital in an urban area and with respect 
to which there is a Herfindahl-Hirschman Index 
(HHI) of greater than 4,000 and in the case of 
a hospital in a rural area and with respect to 
which there is Herfindahl-Hirschman Index 
(HHI) of greater than 5,000, to apply the reim-
bursement rate with respect to individuals (re-
gardless of whether such an individual is enti-
tled to or eligible for benefits under this title, 
but excluding individuals eligible for medical as-
sistance under a State plan under title XIX) 
furnished items and services at such hospital 
that would be billable under this title for such 
items and services if furnished by such hospital 
to an individual entitled to or enrolled for bene-
fits under this title.’’; and 
(B) by adding at the end the following new 
paragraph: 
‘‘(4)(A) The requirement under paragraph 
(1)(Z) shall not apply in the case of a hospital in a 
hospital referral region if the HRR market share of 
such hospital (as determined under subparagraph 
(B)) is less than 0.15. 
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‘‘(B) For purposes of subparagraph (A), the 
HRR market share of a hospital in a hospital refer-
ral region is equal to— 
‘‘(i) the total revenue of the hospital, di-
vided by 
‘‘(ii) the total revenue of all hospital in the 
hospital referral region.’’. 
(2) EFFECTIVE DATE.—The amendments made 
by this subsection shall apply with respect to items 
and services furnished on or after January 1, 2021. 
(c) GRANTS FOR HOSPITAL INFRASTRUCTURE IM-
PROVEMENT.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services shall carry out a grant program 
under which the Secretary shall provide grants to el-
igible States, in accordance with this subsection. 
(2) USES.—An eligible State receiving a grant 
under this subsection may use such grant to improve 
the State hospital infrastructure and to supplement 
any other funds provided for a purpose authorized 
under a State or local hospital grant programs 
under State law. 
(3) ELIGIBILITY.— 
(A) IN GENERAL.—An eligible State may 
receive not more than one grant under this sub-
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section with respect to each qualifying criterion 
described in subparagraph (B) that is met by 
the State. 
(B) ELIGIBLE
STATE.—For purposes of 
this subsection, the term ‘‘eligible State’’ means 
a State that meets any one or more of the fol-
lowing qualifying criteria: 
(i) The State does not have in effect 
any State certificate of need law that re-
quires a health care provider to provide to 
a regulatory body a certification that the 
community needs the services provided by 
the health care provider. 
(ii) The State has in effect State 
scope of practice laws that— 
(I) allow advanced practice pro-
viders (such as nurse practitioners, 
advanced practice registered nurses, 
clinical nurse specialists, and physi-
cian assistants) to evaluate patients; 
diagnose, order, and interpret diag-
nostic tests; and initiate and manage 
treatments; or 
(II) provide that the only jus-
tification for limiting the scope of 
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practice of a health care provider is 
safety to the public. 
(iii) The State does not have in effect 
any State laws that require managed care 
plans to accept into the network of such 
plan any qualified provider who is willing 
to accept the terms and conditions of the 
managed care plan. 
(4) FUNDING.—There is authorized to be ap-
propriated 
to 
carry 
out 
this 
subsection 
$1,000,000,000 for each of the fiscal years 2019 
through 2028. Funds appropriated under this para-
graph shall remain available until expended. 
SEC. 402. PRICE TRANSPARENCY. 
Section 1866 of the Social Security Act (42 U.S.C. 
1395cc), as amended by section 401, is further amended— 
(1) in subsection (a)(1)— 
(A) in subparagraph (Y), by striking 
‘‘and’’ at the end; 
(B) in subparagraph (Z), by striking the 
period at the end and inserting ‘‘; and’’; and 
(C) by inserting after subparagraph (Z) 
the following new subparagraph: 
‘‘(AA) in the case of a hospital, to comply with 
the requirement under subsection (l).’’; and 
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(2) by adding at the end the following new sub-
section: 
‘‘(l) REQUIREMENT RELATING TO PUBLISHING CER-
TAIN HOSPITAL PRICES.— 
‘‘(1) IN GENERAL.—For purposes of subsection 
(a)(1)(AA), the requirement described in this sub-
section is, with respect to a hospital and year (begin-
ning with 2021), for the hospital to publicly post, 
through the system established under paragraph (3), 
for each service included in the list published under 
paragraph (2) for such year, the volume-weighted 
average price charged by the hospital to— 
‘‘(A) individuals enrolled during such year 
in group health plans or health insurance cov-
erage offered in the individual or group market 
(as such terms are defined in section 2791 of 
the Public Health Service Act); and 
‘‘(B) individuals who are not enrolled in 
any health insurance coverage or health benefits 
plan and individuals who are enrolled in such 
coverage or plan but such coverage or plan does 
not provide benefits for the service. 
‘‘(2) SERVICES.—For purposes of subsection 
(a)(1)(AA) and this subsection, the Secretary shall, 
for 2021 and each subsequent year, publish a list of 
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the 100 services that are the most highly utilized in 
a hospital-based setting. 
‘‘(3) STANDARDIZED DIGITAL REPORTING SYS-
TEM.—Not later than January 1, 2021, the Sec-
retary shall establish a standardized digital system 
for purposes of paragraph (1).’’. 
SEC. 403. REPEALING SHARED SAVINGS INCENTIVES FROM 
MEDICARE SHARED SAVINGS PROGRAM. 
(a) IN GENERAL.—Section 1899 of the Social Secu-
rity Act (42 U.S.C. 1395jjj) is amended— 
(1) in subsection (a)(1)— 
(A) by striking subparagraph (B); and 
(B) by striking ‘‘such program— 
‘‘(A) groups of providers’’ and inserting 
‘‘such program, groups of providers’’; 
(2) in subsection (b)(2)— 
(A) in subparagraph (C), by striking ‘‘that 
would allow the organization to receive and dis-
tribute payments for shared savings under sub-
section (d)(2) to participating providers of serv-
ices and suppliers’’; and 
(B) in subparagraph (E)— 
(i) by striking ‘‘the implementation’’ 
and inserting ‘‘and the implementation’’; 
and 
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(ii) by striking ‘‘, and the determina-
tion of payments for shared savings under 
subsection (d)(2)’’; 
(3) in subsection (d)— 
(A) in paragraph (1)— 
(i) in subparagraph (A), by striking 
‘‘except’’ and all that follows through 
‘‘subparagraph (B)(i).’’; and 
(ii) by striking subparagraph (B); and 
(B) by striking paragraph (2); and 
(4) in subsection (g), by striking paragraph (4) 
and redesignating paragraphs (5) and (6) as para-
graphs (4) and (5), respectively. 
(b) EFFECTIVE DATE.—The amendments made by 
subsection (a) shall take effect on January 1, 2021. 
SEC. 404. REPEAL OF HEALTH CARE REFORM PROVISIONS 
LIMITING MEDICARE EXCEPTION TO THE 
PROHIBITION ON CERTAIN PHYSICIAN RE-
FERRALS FOR HOSPITALS. 
Sections 6001 and 10601 of the Patient Protection 
and Affordable Care Act (Public Law 111–148; 124 Stat. 
684, 1005) and section 1106 of the Health Care and Edu-
cation Reconciliation Act of 2010 (Public Law 111–152; 
124 Stat. 1049) are repealed and the provisions of law 
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amended by such sections are restored as if such sections 
had never been enacted. 
SEC. 405. ADVISORY GROUP ON REDUCING BURDEN OF 
HOSPITAL ADMINISTRATIVE REQUIREMENTS. 
(a) IN GENERAL.—Not later than January 1, 2021, 
the Secretary of Health and Human Services shall convene 
an advisory group to provide, in accordance with this sec-
tion, recommendations on ways the Federal Government 
could reduce the burden of administrative requirements on 
hospitals. 
(b) RECOMMENDATIONS.—Not later than January 1, 
2022, the advisory board convened under this section 
shall— 
(1) submit to the Secretary of Health and 
Human Services recommendations described under 
subsection (a) for executive action and any rec-
ommendations for State actions for potential consid-
eration in making grants under section 2(c) to 
States; and 
(2) submit to Congress recommendations de-
scribed under subsection (a) for legislative proposals. 
(c) MEMBERSHIP.—The advisory board under this 
section shall consist of the following members: 
(1) Three representatives of companies that 
have— 
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(A) geographically distributed workforces; 
(B) at least 10,000 employees; and 
(C) no more than 10 percent of such em-
ployees in any single State. 
(2) Three representatives of health insurance 
issuers and health plans, consisting of— 
(A) one representative of for-profit health 
insurance issuers and health plans with at least 
20,000,000 enrollees in the employer-sponsored 
market; 
(B) one representative of non-profit health 
insurance issuers and health plans operating in 
at least 5 States; and 
(C) one representative of non-profit health 
insurance issuers and health plans operating in 
a rural State (as defined by the Census Bu-
reau). 
(3) Seven public policy experts in the field of 
hospital consolidation. 
SEC. 406. AUTHORITY OF FEDERAL TRADE COMMISSION 
OVER 
CERTAIN 
TAX-EXEMPT 
ORGANIZA-
TIONS. 
Section 4 of the Federal Trade Commission Act (15 
U.S.C. 44) is amended, in the undesignated paragraph re-
lating to the definition of the term ‘‘Corporation’’— 
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(1) by striking ‘‘, and any’’ and inserting ‘‘, 
any’’; and 
(2) by inserting before the period at the end the 
following: ‘‘, and any organization described in sec-
tion 501(c)(3) of the Internal Revenue Code of 1986 
that is exempt from taxation under section 501(a) of 
such Code’’. 
TITLE V—DIGITAL HEALTH 
CARE 
SEC. 501. ACCESS OF INDIVIDUALS TO PROTECTED HEALTH 
INFORMATION. 
The provisions of section 164.524 of title 45, Code 
of Federal Regulations, as in effect on the day before the 
date of the enactment of this Act, shall have the force and 
effect of law. 
SEC. 502. EXPANSION OF COVERAGE OF TELEHEALTH 
SERVICES. 
(a) COVERED SERVICES.—Section 1834(m)(4)(F)(i) 
of the Social Security Act (42 U.S.C. 1395m(m)(4)(F)(i)) 
is amended— 
(1) by striking ‘‘and office’’ and inserting ‘‘of-
fice’’; and 
(2) by inserting: ‘‘respiratory services, audiology 
services (as defined in section 1861(ll)), outpatient 
therapy services (including physical therapy, occupa-
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tional therapy, and speech-language pathology serv-
ices)’’ after ‘‘the Secretary)),’’. 
(b) PROVIDERS.—Subsection (m) of section 1834 of 
such Act (42 U.S.C. 1395m) is amended— 
(1) in paragraph (1), by striking ‘‘or a practi-
tioner (described in section 1842(b)(18)(C))’’ and 
inserting ‘‘, a practitioner (described in section 
1842(b)(18)(C)), or an applicable professional (as 
defined in paragraph (4)(G))’’; 
(2) by striking ‘‘physician or practitioner’’ each 
time it appears in such subsection and inserting 
‘‘physician, practitioner, or applicable professional’’; 
(3) in paragraph (3)(A)— 
(A) in the heading, by striking ‘‘PHYSI-
CIAN AND PRACTITIONER’’ and inserting ‘‘PHY-
SICIAN, PRACTITIONER, AND APPLICABLE PRO-
FESSIONAL’’; and 
(B) by striking ‘‘physicians or practi-
tioners’’ and inserting ‘‘physicians, practi-
tioners, or applicable professionals’’; and 
(4) in paragraph (4), by adding at the end the 
following new subparagraph: 
‘‘(G) APPLICABLE
PROFESSIONAL.—The 
term ‘applicable professional’ means, with re-
spect to services furnished on or after the date 
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that is 6 months after the date of the enact-
ment of this subparagraph, a certified diabetes 
educator or licensed— 
‘‘(i) respiratory therapist; 
‘‘(ii) audiologist; 
‘‘(iii) occupational therapist; 
‘‘(iv) physical therapist; or 
‘‘(v) speech language pathologist.’’. 
(c) HOME-BASED MONITORING SERVICES FOR CON-
GESTIVE HEART FAILURE AND CHRONIC OBSTRUCTIVE 
PULMONARY DISEASE.— 
(1) COVERAGE
OF
REMOTE
PATIENT
MONI-
TORING SERVICES FOR CERTAIN CHRONIC HEALTH 
CONDITIONS.— 
(A) IN GENERAL.—Section 1861(s)(2) of 
the Social Security Act (42 U.S.C. 1395x(s)(2)) 
is amended— 
(i) in subparagraph (GG), by striking 
‘‘and’’ at the end; 
(ii) in subparagraph (HH), by insert-
ing ‘‘and’’ at the end; and 
(iii) by inserting after subparagraph 
(HH) the following new subparagraph: 
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‘‘(II) applicable remote patient monitoring 
services (as defined in paragraph (1)(A) of sub-
section (iii));’’. 
(2) SERVICES
DESCRIBED.—Section 1861 of 
the Social Security Act (42 U.S.C. 1395x) is amend-
ed by adding at the end the following new sub-
section: 
‘‘(kkk) REMOTE PATIENT MONITORING SERVICES 
FOR CHRONIC HEALTH CONDITIONS.— 
‘‘(1)(A) The term ‘applicable remote patient 
monitoring services’ means remote patient moni-
toring services (as defined in subparagraph (B)) fur-
nished to provide for the monitoring, evaluation, and 
management of an individual with a covered chronic 
condition (as defined in paragraph (2)), insofar as 
such services are for the management of such chron-
ic condition. 
‘‘(B) The term ‘remote patient monitoring serv-
ices’ means services furnished through remote pa-
tient monitoring technology (as defined in subpara-
graph (C)). 
‘‘(C) The term ‘remote patient monitoring tech-
nology’ means a coordinated system that uses one or 
more home-based or mobile monitoring devices that 
automatically transmit vital sign data or information 
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on activities of daily living and may include re-
sponses to assessment questions collected on the de-
vices wirelessly or through a telecommunications 
connection to a server that complies with the Fed-
eral regulations (concerning the privacy of individ-
ually identifiable health information) promulgated 
under section 264(c) of the Health Insurance Port-
ability and Accountability Act of 1996, as part of an 
established plan of care for that patient that in-
cludes the review and interpretation of that data by 
a health care professional. 
‘‘(2) For purposes of paragraph (1), the term 
‘covered chronic health condition’ means applicable 
conditions (as defined in and applied under section 
1886(q)(5)) when under chronic care management 
(identified as of July 1, 2015, by HCPCS code 
99490 (and as subsequently modified by the Sec-
retary)). 
‘‘(3)(A) Payment may be made under this part 
for applicable remote patient monitoring services 
provided to an individual during a period of up to 
90 days and such additional period as provided for 
under subparagraph (B). 
‘‘(B) The 90-day period described in subpara-
graph (A), with respect to an individual, may be re-
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newed by the physician who provides chronic care 
management to such individual if the individual con-
tinues to qualify for such management.’’. 
(3) PAYMENT
UNDER
THE
PHYSICIAN
FEE 
SCHEDULE.—Section 1848 of the Social Security 
Act (42 U.S.C. 1395w–4) is amended— 
(A) in subsection (c)— 
(i) in paragraph (2)(B)— 
(I) in clause (ii)(II), by striking 
‘‘and (v)’’ and inserting ‘‘(v), and 
(vii)’’; and 
(II) by adding at the end the fol-
lowing new clause: 
‘‘(vii) BUDGETARY
TREATMENT
OF 
CERTAIN
SERVICES.—The additional ex-
penditures attributable to services de-
scribed in section 1861(s)(2)(II) shall not 
be taken into account in applying clause 
(ii)(II).’’; and 
(ii) by adding at the end the following 
new paragraph: 
‘‘(7) TREATMENT OF APPLICABLE REMOTE PA-
TIENT MONITORING SERVICES.— 
‘‘(A) In determining relative value units 
for applicable remote patient monitoring serv-
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ices (as defined in section 1861(iii)(1)(A)), the 
Secretary, in consultation with appropriate phy-
sician groups, practitioner groups, and supplier 
groups, shall take into consideration— 
‘‘(i) physician or practitioner re-
sources, including physician or practitioner 
time and the level of intensity of services 
provided, based on— 
‘‘(I) the frequency of evaluation 
necessary to manage the individual 
being furnished the services; 
‘‘(II) the complexity of the eval-
uation, including the information that 
must be obtained, reviewed, and ana-
lyzed; and 
‘‘(III) the number of possible di-
agnoses and the number of manage-
ment options that must be considered; 
‘‘(ii) practice expense costs associated 
with such services, including the direct 
costs associated with installation and infor-
mation transmission, costs of remote pa-
tient 
monitoring 
technology 
(including 
equipment and software), device delivery 
costs, and resource costs necessary for pa-
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tient monitoring and followup (but not in-
cluding costs of any related item or non- 
physician service otherwise reimbursed 
under this title); and 
‘‘(iii) malpractice expense resources. 
‘‘(B) Using the relative value units deter-
mined in subparagraph (A), the Secretary shall 
provide for separate payment for such services 
and shall not adjust the relative value units as-
signed to other services that might otherwise 
have been determined to include such separately 
paid remote patient monitoring services.’’; and 
(B) in subsection (j)(3), by inserting 
‘‘(2)(II),’’ after ‘‘health risk assessment),’’. 
SEC. 503. STARK AND AKS EXEMPTIONS. 
Notwithstanding any other provision of law, the Sec-
retary of Health and Human Services may exempt value- 
based arrangements, alternative payment models, and 
technologies (as defined by the Secretary) from any provi-
sion of section 1128B or 1877 of the Social Security Act 
for purposes of maintaining, analyzing, or transferring 
electronic health records. 
SEC. 504. STARK TECHNICAL PENALTY. 
Notwithstanding any other provision of law, the Sec-
retary of Health and Human Services may institute a civil 
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monetary penalty for technical, nonegregious violations of 
section 1877 of the Social Security Act in lieu of any pen-
alty otherwise applicable for such violations under such 
section. 
Æ 
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