		II
		111th CONGRESS
		1st Session
		S. 1131
		IN THE SENATE OF THE UNITED
		  STATES

			May 21, 2009
			Mr. Wyden (for himself,
			 Mr. Burr, Mr.
			 Whitehouse, and Mr. Cardin)
			 introduced the following bill; which was read twice and referred to the
			 Committee on
			 Finance

		A BILL
		To amend title XVIII of the Social Security
		  Act to provide certain high cost Medicare beneficiaries suffering from multiple
		  chronic conditions with access to coordinated, primary care medical services in
		  lower cost treatment settings, such as their residences, under a plan of care
		  developed by a team of qualified and experienced health care
		  professionals.

		1.Short titleThis Act may be cited as the
			 Independence at Home Act of
			 2009.
		2.FindingsCongress makes the following
			 findings:
			(1)According to the November 2007
			 Congressional Budget Office Long Term Outlook for Health Care Spending, unless
			 changes are made to the way health care is delivered, growing demand for
			 resources caused by rising health care costs and to a lesser extent the
			 nation’s expanding elderly population will confront Americans with increasingly
			 difficult choices between health care and other priorities. However,
			 opportunities exist to constrain health care costs without adverse health care
			 consequences.
			(2)Medicare beneficiaries with multiple
			 chronic conditions account for a disproportionate share of Medicare spending
			 compared to their representation in the overall Medicare population, and
			 evidence suggests that such patients often receive poorly coordinated care,
			 including conflicting information from health providers and different diagnoses
			 of the same symptoms.
			(3)People with chronic conditions account for
			 76 percent of all hospital admissions, 88 percent of all prescriptions filled,
			 and 72 percent of physician visits.
			(4)Studies show that hospital utilization and
			 emergency room visits for patients with multiple chronic conditions can be
			 reduced and significant savings can be achieved through the use of
			 interdisciplinary teams of health care professionals caring for patients in
			 their places of residence.
			(5)The Independence at Home Act creates a
			 chronic care coordination pilot project to bring primary care medical services
			 to the highest cost Medicare beneficiaries with multiple chronic conditions in
			 their home or place of residence so that they may be as independent as possible
			 for as long as possible in a comfortable setting.
			(6)The Independence at Home Act generates
			 savings by providing better, more coordinated care across all treatment
			 settings to the highest cost Medicare beneficiaries with multiple chronic
			 conditions, reducing duplicative and unnecessary services, and avoiding
			 unnecessary hospitalizations, nursing home admissions, and emergency room
			 visits.
			(7)The Independence at Home Act holds
			 providers accountable for improving beneficiary outcomes, ensuring patient and
			 caregiver satisfaction, and achieving cost savings to Medicare on an annual
			 basis.
			(8)The Independence at Home Act creates
			 incentives for practitioners and providers to develop methods and technologies
			 for providing better and lower cost health care to the highest cost Medicare
			 beneficiaries with the greatest incentives provided in the case of highest cost
			 beneficiaries.
			(9)The Independence at Home Act contains the
			 central elements of proven home-based primary care delivery models that have
			 been utilized for years by the Department of Veterans Affairs and house
			 calls programs across the country to deliver coordinated care for
			 chronic conditions in the comfort of a patient’s home or place of
			 residence.
			3.Establishment of voluntary Independence at
			 Home chronic care coordination pilot project under traditional Medicare
			 fee-for-service program
			(a)In generalTitle XVIII of the Social Security Act is
			 amended—
				(1)by amending subsection (c) of section 1807
			 (42 U.S.C. 1395b–8) to read as follows:

						(c)Independence at Home chronic care
				coordination pilot projectA
				pilot project for Independence at Home chronic care coordination programs for
				high cost Medicare beneficiaries with multiple chronic conditions is set forth
				in section 1807A.
						;
				and
				(2)by inserting after section 1807 the
			 following new section:

						1807A.Independence at Home chronic care coordination pilot
		  project(a)Implementation
								(1)In generalThe Secretary shall provide for the phased
				in development, implementation, and evaluation of Independence at Home programs
				described in this section to meet the following objectives:
									(A)To improve patient outcomes, compared to
				comparable beneficiaries who do not participate in such a program, through
				reduced hospitalizations, nursing home admissions, or emergency room visits,
				increased symptom self-management, and similar results.
									(B)To improve satisfaction of patients and
				caregivers, as demonstrated through a quantitative pre-test and post-test
				survey developed by the Secretary that measures patient and caregiver
				satisfaction of care coordination, educational information, timeliness of
				response, and similar care features.
									(C)To achieve a minimum of 5 percent cost
				savings in the care of beneficiaries under this title suffering from multiple
				high cost chronic diseases.
									(2)Initial implementation (phase I)
									(A)In generalIn carrying out this section and to the
				extent possible, the Secretary shall enter into agreements with at least two
				unaffiliated Independence at Home organizations in each of the 13 highest cost
				States (based on average per capita expenditures per State under this title),
				in the District of Columbia, and in 13 additional States that are
				representative of other regions of the United States and include medically
				underserved rural and urban areas, to provide chronic care coordination
				services for a period of three years or until those agreements are terminated
				by the Secretary. Such agreements under this paragraph shall continue in effect
				until the Secretary makes the determination described in paragraph (3) or until
				those agreements are supplanted by new agreements under such paragraph. The
				phase of implementation under this paragraph is referred to in this section as
				the initial implementation phase or phase
				I.
									(B)PreferenceIn selecting Independence at Home
				organizations under this paragraph, the Secretary shall give a preference, to
				the extent practicable, to organizations that—
										(i)have documented experience in furnishing
				the types of services covered by this section to eligible beneficiaries in the
				home or place of residence using qualified teams of health care professionals
				that are directed by individuals who have the qualifications of Independence at
				Home physicians, or in cases when such direction is provided by an Independence
				at Home physician to a physician assistant who has at least one year of
				experience providing gerontological medical and related services for
				chronically ill individuals in their homes, or other similar qualification as
				determined by the Secretary to be appropriate for the Independence at Home
				program, by the physician assistant acting under the supervision of an
				Independence at Home physician and as permitted under State law, or
				Independence at Home nurse practitioners;
										(ii)have the capacity to provide services
				covered by this section to at least 150 eligible beneficiaries; and
										(iii)use electronic medical records, health
				information technology, and individualized plans of care.
										(3)Expanded implementation phase (Phase
				II)
									(A)In generalFor periods beginning after the end of the
				3-year initial implementation period under paragraph (2), subject to
				subparagraph (B), the Secretary shall renew agreements described in paragraph
				(2) with Independence at Home organization that have met all 3 objectives
				specified in paragraph (1) and enter into agreements described in paragraph (2)
				with any other organization that is located in any State or the District of
				Columbia, that was not an Independence at Home organization during the initial
				implementation period, and that meets the qualifications of an Independence at
				Home organization under this section. The Secretary may terminate and not renew
				such an agreement with an organization that has not met such objectives during
				the initial implementation period. The phase of implementation under this
				paragraph is referred to in this section as the expanded
				implementation phase or phase II.
									(B)ContingencyThe expanded implementation under
				subparagraph (A) shall not occur if the Secretary finds, not later than 60 days
				after the date of issuance of the independent evaluation under paragraph (5),
				that continuation of the Independence at Home project is not in the best
				interest of beneficiaries under this title or in the best interest of Federal
				health care programs.
									(4)EligibilityNo organization shall be prohibited from
				participating under this section during expanded implementation phase under
				paragraph (3) (and, to the extent practicable, during initial implementation
				phase under paragraph (2)) because of its small size as long as it meets the
				eligibility requirements of this section.
								(5)Independent evaluations
									(A)In generalThe Secretary shall contract for an
				independent evaluation of the initial implementation phase under paragraph (2)
				with an interim report to Congress to be provided on such evaluation as soon as
				practicable after the first year of such phase and a final report to be
				provided to Congress as soon as practicable following the conclusion of the
				initial implementation phase, but not later than 6 months following the end of
				such phase. Such an evaluation shall be conducted by individuals with knowledge
				of chronic care coordination programs for the targeted patient population and
				demonstrated experience in the evaluation of such programs.
									(B)Information to be includedEach such report shall include an
				assessment of the following factors and shall identify the characteristics of
				individual Independence at Home programs that are the most effective in
				producing improvements in—
										(i)beneficiary, caregiver, and provider
				satisfaction;
										(ii)health outcomes appropriate for patients
				with multiple chronic diseases; and
										(iii)cost savings to the program under this
				title, such as in reducing—
											(I)hospital and skilled nursing facility
				admission rates and lengths of stay;
											(II)hospital readmission rates; and
											(III)emergency department visits.
											(C)Breakdown by conditionEach such report shall include data on
				performance of Independence at Home organizations in responding to the needs of
				eligible beneficiaries with specific chronic conditions and combinations of
				conditions, as well as the overall eligible beneficiary population.
									(6)Agreements
									(A)In generalThe Secretary shall enter into agreements,
				beginning not later than one year after the date of the enactment of this
				section, with Independence at Home organizations that meet the participation
				requirements of this section, including minimum performance standards developed
				under subsection (e)(3), in order to provide access by eligible beneficiaries
				to Independence at Home programs under this section.
									(B)AuthorityIf the Secretary deems it necessary to
				serve the best interest of the beneficiaries under this title or the best
				interest of Federal health care programs, the Secretary may—
										(i)require screening of all potential
				Independence at Home organizations, including owners (such as through
				fingerprinting, licensure checks, site-visits, and other database checks),
				before entering into an agreement;
										(ii)require a provisional period during which a
				new Independence at Home organization would be subject to enhanced oversight
				(such as prepayment review, unannounced site visits, and payment caps);
				and
										(iii)require applicants to disclose previous
				affiliation with entities that have uncollected Medicare or Medicaid debt, and
				authorize the denial of enrollment if the Secretary determines that these
				affiliations pose undue risk to the program.
										(7)RegulationsAt least three months before entering into
				the first agreement under this section, the Secretary shall publish in the
				Federal Register the specifications for implementing this section. Such
				specifications shall describe the implementation process from initial to final
				implementation phases, including how the Secretary will identify and notify
				potential enrollees and how and when beneficiaries may enroll and disenroll
				from Independence at Home programs and change the programs in which they are
				enrolled.
								(8)Periodic progress reportsSemi-annually during the first year in
				which this section is implemented and annually thereafter during the period of
				implementation of this section, the Secretary shall submit to the Committees on
				Ways and Means and Energy and Commerce of the House of Representatives and the
				Committee on Finance of the Senate a report that describes the progress of
				implementation of this section and explaining any variation from the
				Independence at Home program as described in this section.
								(9)Annual best practices
				conferenceDuring the initial
				implementation phase and to the extent practicable at intervals thereafter, the
				Secretary shall provide for an annual Independence at Home teleconference for
				Independence at Home organizations to share best practices and review treatment
				interventions and protocols that were successful in meeting all 3 objectives
				specified in paragraph (1).
								(b)DefinitionsFor purposes of this section:
								(1)Activities of daily livingThe term activities of daily
				living means bathing, dressing, grooming, transferring, feeding, or
				toileting.
								(2)CaregiverThe term caregiver means, with
				respect to an individual with a qualifying functional impairment, a family
				member, friend, or neighbor who provides assistance to the individual.
								(3)Eligible beneficiary
									(A)In generalThe term eligible beneficiary
				means, with respect to an Independence at Home program, an individual
				who—
										(i)is entitled to benefits under part A and
				enrolled under part B, but not enrolled in a plan under part C;
										(ii)has a qualifying functional impairment and
				has been diagnosed with two or more of the chronic conditions described in
				subparagraph (C); and
										(iii)within the 12 months prior to the
				individual first enrolling with an Independence at Home program under this
				section, has received benefits under part A for the following services:
											(I)Non-elective inpatient hospital
				services.
											(II)Services in the emergency department of a
				hospital.
											(III)Any one of the following:
												(aa)Skilled nursing or sub-acute rehabilitation
				services in a Medicare-certified nursing facility.
												(bb)Comprehensive acute rehabilitation facility
				or Comprehensive outpatient rehabilitation facility services.
												(cc)Skilled nursing or rehabilitation services
				through a Medicare-certified home health agency.
												(B)DisqualificationsSuch term does not include an
				individual—
										(i)who is receiving benefits under section
				1881;
										(ii)who is enrolled in a PACE program under
				section 1894;
										(iii)who is enrolled in (and is not disenrolled
				from) a chronic care improvement program under section 1807;
										(iv)who within a 12-month period has been a
				resident for more than 90 days in a skilled nursing facility, a nursing
				facility (as defined in section 1919), or any other facility identified by the
				Secretary;
										(v)who resides in a setting that presents a
				danger to the safety of in-home health care providers and primary caregivers;
				or
										(vi)whose enrollment in an Independence at Home
				program the Secretary determines would be inappropriate.
										(C)Chronic conditions describedThe chronic conditions described in this
				subparagraph are the following:
										(i)Congestive heart failure.
										(ii)Diabetes.
										(iii)Chronic obstructive pulmonary
				disease.
										(iv)Ischemic heart disease.
										(v)Peripheral arterial disease.
										(vi)Stroke.
										(vii)Alzheimer’s Disease and other dementias
				designated by the Secretary.
										(viii)Pressure ulcers.
										(ix)Hypertension.
										(x)Neurodegenerative diseases designated by
				the Secretary which result in high costs under this title, including amyotropic
				lateral sclerosis (ALS), multiple sclerosis, and Parkinson’s disease.
										(xi)Any other chronic condition that the
				Secretary identifies as likely to result in high costs to the program under
				this title when such condition is present in combination with one or more of
				the chronic conditions specified in the preceding clauses.
										(4)Independence at home
				assessmentThe term
				Independence at Home assessment means a determination of
				eligibility of an individual for an Independence at Home program as an eligible
				beneficiary (as defined in paragraph (3)), a comprehensive medical history,
				physical examination, and assessment of the beneficiary’s clinical and
				functional status that—
									(A)is conducted in person by an
				individual—
										(i)who—
											(I)is an Independence at Home physician or an
				Independence at Home nurse practitioner; or
											(II)a physician assistant, nurse practitioner,
				or clinical nurse specialist, as defined in section 1861(aa)(5), who is
				employed by an Independence at Home organization and is supervised by an
				Independence at Home physician or Independence at Home nurse practitioner;
				and
											(ii)does not have an ownership interest in the
				Independence at Home organization unless the Secretary determines that it is
				impracticable to preclude such individual’s involvement; and
										(B)includes an assessment of—
										(i)activities of daily living and other
				co-morbidities;
										(ii)medications and medication
				adherence;
										(iii)affect, cognition, executive function, and
				presence of mental disorders;
										(iv)functional status, including mobility,
				balance, gait, risk of falling, and sensory function;
										(v)social functioning and social
				integration;
										(vi)environmental needs and a safety
				assessment;
										(vii)the ability of the beneficiary’s primary
				caregiver to assist with the beneficiary’s care as well as the caregiver’s own
				physical and emotional capacity, education, and training;
										(viii)whether, in the professional judgment of
				the individual conducting the assessment, the beneficiary is likely to benefit
				from an Independence at Home program;
										(ix)whether the conditions in the beneficiary’s
				home or place of residence would permit the safe provision of services in the
				home or residence, respectively, under an Independence at Home program;
										(x)whether the beneficiary has a designated
				primary care physician whom the beneficiary has seen in an office-based setting
				within the previous 12 months; and
										(xi)other factors determined appropriate by the
				Secretary.
										(5)Independence at Home care
				teamThe term
				Independence at Home care team—
									(A)means, with respect to a participant, a
				team of qualified individuals that provides services to the participant as part
				of an Independence at Home program; and
									(B)includes an Independence at Home physician
				or an Independence at Home nurse practitioner and an Independence at Home
				coordinator (who may also be an Independence at Home physician or an
				Independence at Home nurse practitioner).
									(6)Independence at Home
				coordinatorThe term
				Independence at Home coordinator means, with respect to a
				participant, an individual who—
									(A)is employed by an Independence at Home
				organization and is responsible for coordinating all of the services of the
				participant’s Independence at Home plan;
									(B)is a licensed health professional, such as
				a physician, registered nurse, nurse practitioner, clinical nurse specialist,
				physician assistant, or other health care professional as the Secretary
				determines appropriate, who has at least one year of experience providing and
				coordinating medical and related services for individuals in their homes;
				and
									(C)serves as the primary point of contact
				responsible for communications with the participant and for facilitating
				communications with other health care providers under the plan.
									(7)Independence at home
				organizationThe term
				Independence at Home organization means a provider of services, a
				physician or physician group practice, a nurse practitioner or nurse
				practitioner group practice which receives payment for services furnished under
				this title (other than only under this section) and which—
									(A)has entered into an agreement under
				subsection (a)(2) to provide an Independence at Home program under this
				section;
									(B)(i)provides all of the services of the
				Independence at Home plan in a participant’s home or place of residence,
				or
										(ii)if the organization is not able to provide
				all such services in such home or residence, has adequate mechanisms for
				ensuring the provision of such services by one or more qualified
				entities;
										(C)has Independence at Home physicians,
				clinical nurse specialists, nurse practitioners, or physician assistants
				available to respond to patient emergencies 24 hours a day, seven days a
				week;
									(D)accepts all eligible beneficiaries from the
				organization’s service area, as determined under the agreement with the
				Secretary under this section, except to the extent that qualified staff are not
				available; and
									(E)meets other requirements for such an
				organization under this section.
									(8)Independence at Home
				physicianThe term
				Independence at Home physician means a physician who—
									(A)is employed by or affiliated with an
				Independence at Home organization, as required under paragraph (7)(C), or has
				another contractual relationship with the Independence at Home organization
				that requires the physician to make in-home visits and to be responsible for
				the plans of care for the physician’s patients;
									(B)is certified—
										(i)by the American Board of Family Physicians,
				the American Board of Internal Medicine, the American Osteopathic Board of
				Family Physicians, the American Osteopathic Board of Internal Medicine, the
				American Board of Emergency Medicine, or the American Board of Physical
				Medicine and Rehabilitation; or
										(ii)by a Board recognized by the American Board
				of Medical Specialties and determined by the Secretary to be appropriate for
				the Independence at Home program;
										(C)has—
										(i)a certification in geriatric medicine as
				provided by American Board of Medical Specialties; or
										(ii)passed the clinical competency examination
				of the American Academy of Home Care Physicians and has substantial experience
				in the delivery of medical care in the home, including at least two years of
				experience in the management of Medicare patients and one year of experience in
				home-based medical care including at least 200 house calls; and
										(D)has furnished services during the previous
				12 months for which payment is made under this title.
									(9)Independence at Home nurse
				practitionerThe term
				Independence at Home nurse practitioner means a nurse practitioner
				who—
									(A)is employed by or affiliated with an
				Independence at Home organization, as required under paragraph (7)(C), or has
				another contractual relationship with the Independence at Home organization
				that requires the nurse practitioner to make in-home visits and to be
				responsible for the plans of care for the nurse practitioner’s patients;
									(B)practices in accordance with State law
				regarding scope of practice for nurse practitioners;
									(C)is certified—
										(i)as a Gerontologic Nurse Practitioner by the
				American Academy of Nurse Practitioners Certification Program or the American
				Nurses Credentialing Center; or
										(ii)as a family nurse practitioner or adult
				nurse practitioner by the American Academy of Nurse Practitioners Certification
				Board or the American Nurses Credentialing Center and holds a certificate of
				Added Qualification in gerontology, elder care or care of the older adult
				provided by the American Academy of Nurse Practitioners, the American Nurses
				Credentialing Center or a national nurse practitioner certification board
				deemed by the Secretary to be appropriate for an Independence at Home program;
				and
										(D)has furnished services during the previous
				12 months for which payment is made under this title.
									(10)Independence at Home planThe term Independence at Home
				plan means a plan established under subsection (d)(2) for a specific
				participant in an Independence at Home program.
								(11)Independence at Home programThe term Independence at Home
				program means a program described in subsection (d) that is operated by
				an Independence at Home organization.
								(12)ParticipantThe term participant means an
				eligible beneficiary who has voluntarily enrolled in an Independence at Home
				program.
								(13)Qualified entityThe term qualified entity
				means a person or organization that is licensed or otherwise legally permitted
				to provide the specific service (or services) provided under an Independence at
				Home plan that the entity has agreed to provide.
								(14)Qualifying functional
				impairmentThe term
				qualifying functional impairment means an inability to perform,
				without the assistance of another person, two or more activities of daily
				living.
								(15)Qualified individualThe term qualified individual
				means a individual that is licensed or otherwise legally permitted to provide
				the specific service (or services) under an Independence at Home plan that the
				individual has agreed to provide.
								(c)Identification and enrollment of
				prospective program participants
								(1)Notice to eligible independence at home
				beneficiariesThe Secretary
				shall develop a model notice to be made available to Medicare beneficiaries
				(and to their caregivers) who are potentially eligible for an Independence at
				Home program by participating providers and by Independence at Home programs.
				Such notice shall include the following information:
									(A)A description of the potential advantages
				to the beneficiary participating in an Independence at Home program.
									(B)A description of the eligibility
				requirements to participate.
									(C)Notice that participation is
				voluntary.
									(D)A statement that all other Medicare
				benefits remain available to beneficiaries who enroll in an Independence at
				Home program.
									(E)Notice that those who enroll in an
				Independence at Home program will be responsible for copayments for house calls
				made by Independence at Home physicians, physician assistants, or by
				Independence at Home nurse practitioners, except that such copayments may be
				reduced or eliminated at the discretion of the Independence at Home physician,
				physician assistant, or Independence at Home nurse practitioner involved in
				accordance with subsection (f).
									(F)A description of the services that could be
				provided.
									(G)A description of the method for
				participating, or withdrawing from participation, in an Independence at Home
				program or becoming no longer eligible to so participate.
									(2)Voluntary participation and
				choiceAn eligible
				beneficiary may participate in an Independence at Home program through
				enrollment in such program on a voluntary basis and may terminate such
				participation at any time. Such a beneficiary may also receive Independence at
				Home services from the Independence at Home organization of the beneficiary’s
				choice but may not receive Independence at Home services from more than one
				Independence at Home organization at a time.
								(d)Independence at Home program
				requirements
								(1)In generalEach Independence at Home program shall,
				for each participant enrolled in the program—
									(A)designate—
										(i)an Independence at Home physician or an
				Independence at Home nurse practitioner; and
										(ii)an Independence at Home coordinator;
										(B)have a process to ensure that the
				participant received an Independence at Home assessment before enrollment in
				the program;
									(C)with the participation of the participant
				(or the participant’s representative or caregiver), an Independence at Home
				physician, a physician assistant under the supervision of an Independence at
				Home physician and as permitted under State law, or an Independence at Home
				nurse practitioner, and the Independence at Home coordinator, develop an
				Independence at Home plan for the participant in accordance with paragraph
				(2);
									(D)ensure that the participant receives an
				Independence at Home assessment at least every 6 months after the original
				assessment to ensure that the Independence at Home plan for the participant
				remains current and appropriate;
									(E)implement all of the services under the
				participant’s Independence at Home plan and in instances in which the
				Independence at Home organization does not provide specific services within the
				Independence at Home plan, ensure that qualified entities successfully provide
				those specific services; and
									(F)provide for an electronic medical record
				and electronic health information technology to coordinate the participant’s
				care and to exchange information with the Medicare program and electronic
				monitoring and communication technologies and mobile diagnostic and therapeutic
				technologies as appropriate and accepted by the participant.
									(2)Independence at home plan
									(A)In generalAn Independence at Home plan for a
				participant shall be developed with the participant, an Independence at Home
				physician, a physician assistant under the supervision of an Independence at
				Home physician and as permitted under State law, an Independence at Home nurse
				practitioner, or an Independence at Home coordinator, and, if appropriate, one
				or more of the participant’s caregivers and shall—
										(i)document the chronic conditions,
				co-morbidities, and other health needs identified in the participant’s
				Independence at Home assessment;
										(ii)determine which services under an
				Independence at Home plan described in subparagraph (C) are appropriate for the
				participant; and
										(iii)identify the qualified entity responsible
				for providing each service under such plan.
										(B)Communication of individualized
				independence at home plan to the independence at home coordinatorIf the individual responsible for
				conducting the participant’s Independence at Home assessment and developing the
				Independence at Home plan is not the participant’s Independence at Home
				coordinator, the Independence at Home physician or Independence at Home nurse
				practitioner is responsible for ensuring that the participant’s Independence at
				Home coordinator has such plan and is familiar with the requirements of the
				plan and has the appropriate contact information for all of the members of the
				Independence at Home care team.
									(C)Services provided under an independence at
				home planAn Independence at
				Home organization shall coordinate and make available through referral to a
				qualified entity the services described in the following clauses (i) through
				(iii) to the extent they are needed and covered by under this title and shall
				provide the care coordination services described in the following clause (iv)
				to the extent they are appropriate and accepted by a participant:
										(i)Primary care services, such as physician
				visits, diagnosis, treatment, and preventive services.
										(ii)Home health services, such as skilled
				nursing care and physical and occupational therapy.
										(iii)Phlebotomy and ancillary laboratory and
				imaging services, including point of care laboratory and imaging
				diagnostics.
										(iv)Care coordination services, consisting
				of—
											(I)Monitoring and management of medications by
				a pharmacist who is certified in geriatric pharmacy by the Commission for
				Certification in Geriatric Pharmacy or possesses other comparable certification
				demonstrating knowledge and expertise in geriatric pharmacotherapy, as well as
				assistance to participants and their caregivers with respect to selection of a
				prescription drug plan under part D that best meets the needs of the
				participant’s chronic conditions.
											(II)Coordination of all medical treatment
				furnished to the participant, regardless of whether such treatment is covered
				and available to the participant under this title.
											(III)Self-care education and preventive care
				consistent with the participant’s condition.
											(IV)Education for primary caregivers and family
				members.
											(V)Caregiver counseling services and
				information about, and referral to, other caregiver support and health care
				services in the community.
											(VI)Referral to social services, such as
				personal care, meals, volunteers, and individual and family therapy.
											(VII)Information about, and access to, hospice
				care.
											(VIII)Pain and palliative care and end-of-life
				care, including information about developing advanced directives and physicians
				orders for life sustaining treatment.
											(3)Primary treatment role within an
				Independence at Home care teamAn Independence at Home physician, a
				physician assistant under the supervision of an Independence at Home physician
				and as permitted under State law, or an Independence at Home nurse practitioner
				may assume the primary treatment role as permitted under State law.
								(4)Additional responsibilities
									(A)Outcomes reportEach Independence at Home organization
				offering an Independence at Home program shall monitor and report to the
				Secretary, in a manner specified by the Secretary, on—
										(i)patient outcomes;
										(ii)beneficiary, caregiver, and provider
				satisfaction with respect to coordination of the participant’s care; and
										(iii)the achievement of mandatory minimum
				savings described in subsection (e)(6).
										(B)Additional requirementsEach such organization and program shall
				provide the Secretary with listings of individuals employed by the
				organization, including contract employees, and individuals with an ownership
				interest in the organization and comply with such additional requirements as
				the Secretary may specify.
									(e)Terms and conditions
								(1)In generalAn agreement under this section with an
				Independence at Home organization shall contain such terms and conditions as
				the Secretary may specify consistent with this section.
								(2)Clinical, quality improvement, and
				financial requirementsThe
				Secretary may not enter into an agreement with such an organization under this
				section for the operation of an Independence at Home program unless—
									(A)the program and organization meet the
				requirements of subsection (d), minimum quality and performance standards
				developed under paragraph (3), and such clinical, quality improvement,
				financial, program integrity, and other requirements as the Secretary deems to
				be appropriate for participants to be served; and
									(B)the organization demonstrates to the
				satisfaction of the Secretary that the organization is able to assume financial
				risk for performance under the agreement with respect to payments made to the
				organization under such agreement through available reserves, reinsurance, or
				withholding of funding provided under this title, or such other means as the
				Secretary determines appropriate.
									(3)Minimum quality and performance
				standards
									(A)In generalThe Secretary shall develop mandatory
				minimum quality and performance standards for Independence at Home
				organizations and programs.
									(B)Standards to be includedSuch standards shall include measures
				of—
										(i)improvement in participant outcomes;
										(ii)improvement in satisfaction of the
				beneficiary, caregiver, and provider involved; and
										(iii)cost savings consistent with paragraph
				(6).
										(C)Minimum participation
				standardSuch standards shall
				include a requirement that, for any year after the first year and except as the
				Secretary may provide for a program serving a rural area, an Independence at
				Home program had an average number of participants during the previous year of
				at least 100 participants.
									(4)Term of agreement and
				modificationThe agreement
				under this subsection shall be, subject to paragraphs (3)(C) and (5), for a
				period of three years, and the terms and conditions may be modified during the
				contract period by the Secretary as necessary to serve the best interest of the
				beneficiaries under this title or the best interest of Federal health care
				programs or upon the request of the Independence at Home organization.
								(5)Termination and non-renewal of
				agreement
									(A)In generalIf the Secretary determines that an
				Independence at Home organization has failed to meet the minimum performance
				standards under paragraph (3) or other requirements under this section, or if
				the Secretary deems it necessary to serve the best interest of the
				beneficiaries under this title or the best interest of Federal health care
				programs, the Secretary may terminate the agreement of the organization at the
				end of the contract year.
									(B)Required termination where risk to health
				or safety of a participantThe Secretary shall terminate an agreement
				with an Independence at Home organization at any time the Secretary determines
				that the care being provided by such organization poses a threat to the health
				and safety of a participant.
									(C)Termination by Independence at Home
				organizationsNotwithstanding
				any other provision of this subsection, an Independence at Home organization
				may terminate an agreement with the Secretary under this section to provide an
				Independence at Home program at the end of a contract year if the organization
				provides to the Secretary and to the beneficiaries participating in the program
				notification of such termination more than 90 days before the end of such year.
				Paragraphs (6), (8), and (9)(B) shall apply to the organization until the date
				of termination.
									(D)Notice of involuntary
				terminationThe Secretary
				shall notify the participants in an Independence at Home program as soon as
				practicable if a determination is made to terminate an agreement with the
				Independence at Home organization involuntarily as provided in subparagraphs
				(A) and (B). Such notice shall inform the beneficiary of any other Independence
				at Home organizations that might be available to the beneficiary.
									(6)Mandatory minimum savings
									(A)Required
										(i)In generalUnder an agreement under this subsection,
				each Independence at Home organization shall ensure that during any year of the
				agreement for its Independence at Home program, there is an aggregate savings
				in the cost to the program under this title for participating beneficiaries, as
				calculated under subparagraph (B), that is not less than 5 percent of the
				product described in clause (ii) for such participating beneficiaries and
				year.
										(ii)Product describedThe product described in this clause for
				participating beneficiaries in an Independence at Home program for a year is
				the product of—
											(I)the estimated average monthly costs that
				would have been incurred under parts A and B (and, to the extent cost
				information is available, part D) if those beneficiaries had not participated
				in the Independence at Home program; and
											(II)the number of participant-months for that
				year.
											(B)Computation of aggregate savings
										(i)Model for calculating savingsThe Secretary shall contract with a
				nongovernmental organization or academic institution to independently develop
				an analytical model for determining whether an Independence at Home program
				achieves at least savings required under subparagraph (A) relative to costs
				that would have been incurred by Medicare in the absence of Independence at
				Home programs. The analytical model developed by the independent research
				organization for making these determinations shall utilize state-of-the-art
				econometric techniques, such as Heckman’s selection correction methodologies,
				to account for sample selection bias, omitted variable bias, or problems with
				endogeneity.
										(ii)Application of the modelUsing the model developed under clause (i),
				the Secretary shall compare the actual costs to Medicare of beneficiaries
				participating in an Independence at Home program to the predicted costs to
				Medicare of such beneficiaries to determine whether an Independence at Home
				program achieves the savings required under subparagraph (A).
										(iii)Revisions of the modelThe Secretary shall require that the model
				developed under clause (i) for determining savings shall be designed according
				to instructions that will control, or adjust for, inflation as well as risk
				factors including, age, race, gender, disability status, socioeconomic status,
				region of country (such as State, county, metropolitan statistical area, or zip
				code), and such other factors as the Secretary determines to be appropriate,
				including adjustment for prior health care utilization. The Secretary may add
				to, modify, or substitute for such adjustment factors if such changes will
				improve the sensitivity or specificity of the calculation of costs
				savings.
										(iv)Participant-monthIn making the calculation described in
				subparagraph (A), each month or part of a month in a program year that a
				beneficiary participates in an Independence at Home program shall be counted as
				a participant-month.
										(C)Notice of savings calculationNo later than 30 days before the beginning
				of the first year of the pilot project under this section and 120 days before
				the beginning of any Independence at Home program year after the first such
				year, the Secretary shall publish in the Federal Register a description of the
				model developed under subparagraph (B)(i) and information for calculating
				savings required under subparagraph (A), including any revisions, sufficient to
				permit Independence at Home organizations to determine the savings they will be
				required to achieve during the program year to meet the savings requirement
				under subparagraph (A). In order to facilitate this notice, the Secretary may
				designate a single annual date for the beginning of all Independence at Home
				program years that shall not be later than one year from the date of enactment
				of this section.
									(7)Manner of paymentSubject to paragraph (8), payments shall be
				made by the Secretary to an Independence at Home organization at a rate
				negotiated between the Secretary and the organization under the agreement
				for—
									(A)Independence at Home assessments;
				and
									(B)on a per-participant, per-month basis for
				the items and services required to be provided or made available under
				subsection (d)(2)(C)(iv).
									(8)Ensuring mandatory minimum
				savingsThe Secretary shall
				require any Independence at Home organization that fails in any year to achieve
				the mandatory minimum savings described in paragraph (6) to provide those
				savings by refunding payments made to the organization under paragraph (7)
				during such year.
								(9)Budget neutral payment condition
									(A)In generalUnder this section, the Secretary shall
				ensure that the cumulative, aggregate sum of Medicare program benefit
				expenditures under parts A, B, and D for participants in Independence at Home
				programs and funds paid to Independence at Home organizations under this
				section, shall not exceed the Medicare program benefit expenditures under such
				parts that the Secretary estimates would have been made for such participants
				in the absence of such programs.
									(B)Treatment of savings
										(i)Initial implementation phaseIf an Independence at Home organization
				achieves aggregate savings in a year in the initial implementation phase in
				excess of the mandatory minimum savings described in paragraph (6)(A)(ii), 80
				percent of such aggregate savings shall be paid to the organization and the
				remainder shall be retained by the programs under this title during the initial
				implementation phase.
										(ii)Expanded implementation phaseIf an Independence at Home organization
				achieves aggregate savings in a year in the expanded implementation phase in
				excess of 5 percent of the product described in paragraph (6)(A)(ii)—
											(I)insofar as such savings do not exceed 25
				percent of such product, 80 percent of such aggregate savings shall be paid to
				the organization and the remainder shall be retained by the programs under this
				title; and
											(II)insofar as such savings exceed 25 percent
				of such product, in the Secretary’s discretion, 50 percent of such excess
				aggregate savings shall be paid to the organization and the remainder shall be
				retained by the programs under this title.
											(f)Waiver of coinsurance for house
				callsA physician, physician
				assistant, or nurse practitioner furnishing services related to the
				Independence at Home program in the home or residence of a participant in an
				Independence at Home program may waive collection of any coinsurance that might
				otherwise be payable under section 1833(a) with respect to such services but
				only if the conditions described in section 1128A(i)(6)(A) are met.
							(g)ReportNot later than three months after the date
				of receipt of the independent evaluation provided under subsection (a)(5) and
				each year thereafter during which this section is being implemented, the
				Secretary shall submit to the Committees of jurisdiction in Congress a report
				that shall include—
								(1)whether the Independence at Home programs
				under this section are meeting the minimum quality and performance standards in
				(e)(3);
								(2)a comparative evaluation of Independence at
				Home organizations in order to identify which programs, and characteristics of
				those programs, were the most effective in producing the best participant
				outcomes, patient and caregiver satisfaction, and cost savings; and
								(3)an evaluation of whether the participant
				eligibility criteria identified beneficiaries who were in the top ten percent
				of the highest cost Medicare
				beneficiaries.
								.
				(b)Conforming amendmentSection 1833(a) of such Act (42 U.S.C.
			 1395l(a)) is amended, in the matter before paragraph (1), by inserting
			 and section 1807A(f) after section 1876.


		II
		112th CONGRESS
		1st Session
		S. 1278
		IN THE SENATE OF THE UNITED STATES

			June 23, 2011
			Ms. Snowe (for herself,
			 Mr. Roberts, Mr. Cornyn, Mr.
			 Boozman, Mr. Blunt, and
			 Mr. Barrasso) introduced the following
			 bill; which was read twice and referred to the
			 Committee on
			 Finance

		A BILL
		To amend the Internal Revenue Code of 1986 to repeal the
		  excise tax on indoor tanning services.

		1.Repeal
			 of excise tax on indoor tanning services
			(a)In
			 generalSubtitle D of the Internal Revenue Code of 1986 is
			 amended by striking chapter 49 and by striking the item relating to such
			 chapter in the table of chapters of such subtitle.
			(b)Effective
			 dateThe amendments made by this section shall apply to services
			 performed after the date of the enactment of this Act.


114 HR 2631 IH: Regulatory Predictability for Business Growth Act of 2015
U.S. House of Representatives
2015-06-03
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

		I
		114th CONGRESS
		1st Session
		H. R. 2631
		IN THE HOUSE OF REPRESENTATIVES

			June 3, 2015
			Mr. Russell introduced the following bill; which was referred to the Committee on the Judiciary

		A BILL
		To require notice and comment for certain interpretive rules.

 1.Short titleThis Act may be cited as the Regulatory Predictability for Business Growth Act of 2015. 2.Requiring notice and comment for certain interpretive rulesSubchapter II of chapter 5 of title 5, United States Code, is amended—
 (1)in section 551— (A)in paragraph (13), by striking and at the end;
 (B)in paragraph (14), by striking the period at the end and inserting a semicolon; and (C)by adding at the end the following:

 (15)longstanding interpretive rule means an interpretive rule that has been in effect for not less than 1 year; and (16)revise means, with respect to an interpretive rule, altering or otherwise changing any provision of a longstanding interpretive rule that conflicts, or is in any way inconsistent with, any provision in a subsequently promulgated interpretive rule.; and
 (2)in section 553— (A)in subsection (b), following the flush text, in subparagraph (A), by striking interpretative rules and inserting an interpretive rule of an agency, unless the interpretive rule revises a longstanding interpretive rule of the agency; and
 (B)in subsection (d)(2), by striking interpretative rules and inserting an interpretive rule of an agency, unless the interpretive rule revises a longstanding interpretive rule of the agency, and.


116 S5082 IS: Expanding COVID–19 Testing Capacity Act of 2020
U.S. Senate
2020-12-21
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

II
116th CONGRESS2d Session
S. 5082
IN THE SENATE OF THE UNITED STATES

December 21, 2020
Ms. Warren introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions

A BILL
To provide Federal support for COVID–19 testing, and for other purposes.

1.Short title; table of contents
(a)Short titleThis Act may be cited as the Expanding COVID–19 Testing Capacity Act of 2020. (b)Table of contentsThe table of contents for the Act is as follows:

Sec. 1. Short title; table of contents.
Sec. 2. Definitions.
Sec. 3. Federal manufacturing of COVID–19 diagnostic tests.
Sec. 4. COVID–19 testing for covered Federal employees.
Sec. 5. Federal distribution of COVID–19 tests to qualified entities.
Sec. 6. Supplemental grants for COVID–19 testing.
Sec. 7. Reports and guidance on COVID–19 diagnostic testing.
Sec. 8. Demographic and geographic data collection.
2.DefinitionsIn this Act: (1)Associated medical suppliesThe term associated medical supplies means any product necessary for the development and administration of COVID–19 diagnostic tests, including chemical reagents, test swabs, and personal protective equipment (including surgical masks, surgical gowns, face shields, gloves, and N95 masks).
(2)COVID–19 diagnostic testThe term COVID–19 diagnostic test means a test— (A)that is an in vitro diagnostic product (as defined in section 809.3 of title 21, Code of Federal Regulations, or any successor thereto) for the detection of SARS–CoV–2 or the diagnosis of COVID–19; and
(B)the administration of which— (i)is approved, cleared, or authorized under section 510(k), 513, 515, or 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k), 360c, 360e, 360bbb–3); or
(ii)the developer has received an emergency use authorization under section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3), unless and until the emergency use authorization request under such section 564. (3)COVID–19 pandemicThe term COVID–19 pandemic means the period beginning on the date that the public health emergency with respect to COVID–19 took effect, and ending on the date that is 6 months after the date on which the public health emergency declaration with respect to COVID–19 terminates.
(4)Indian TribeExcept as otherwise provided, the term Indian Tribe has the meaning given the term Indian tribe in section 4 of the Indian Self-Determination and Education Assistance Act (25 U.S.C. 5304). (5)Public health emergency with respect to COVID–19The term public health emergency with respect to COVID–19 means the public health emergency declared by the Secretary under section 319 of the Public Health Service Act (21 U.S.C. 247d) on January 31, 2020, with respect to COVID–19.
(6)SecretaryThe term Secretary means the Secretary of Health and Human Services. (7)Tribal organizationExcept as otherwise provided, the term Tribal organization has the meaning given the term tribal organization in section 4 of the Indian Self-Determination and Education Assistance Act (25 U.S.C. 5304).
(8)Urban Indian organizationThe term urban Indian organization has the meaning given the term in section 4 of the Indian Health Care Improvement Act (25 U.S.C. 1603). 3.Federal manufacturing of COVID–19 diagnostic tests (a)In generalAs soon as practicable after the date of enactment of this Act, but no later than 15 days after such date of enactment, the Secretary shall begin the process of manufacturing, or contracting with entities for the manufacture of, COVID–19 diagnostic tests and associated medical supplies, with a particular focus on extraction-free highly sensitive molecular tests, pooled highly sensitive molecular tests, low-cost rapid antigen test, low-cost highly sensitive molecular tests, assays that can use a variety of reagents, and other products as determined by the Secretary. The Secretary shall continue such process until the end of the COVID–19 pandemic.
(b)Submission of applicationsFor each COVID–19 diagnostic test and associated drug or device that the Secretary intends to market, or contract with another entity for the marketing of, the Secretary shall— (1)submit an application under subsection (b) or (j) of section 505 or section 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355, 360e) or subsection (a) or (j) of section 351 of the Public Health Service Act (42 U.S.C. 262), submit a notification under section 510(k) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k)), or submit a request for classification under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(f)(2)) (or enter into a contract with another entity to submit such an application, notification, or request);
(2)request an emergency use authorization of the product under section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3) (or enter into a contract with another entity to submit an application for such use); or (3)obtain from the holder of an application approved under subsection (c) or (j) of section 505 or section 515 of the Federal Food, Drug, and Cosmetic Act or subsection (a) or (k) of section 351 of the Public Health Service Act, or cleared under section 510(k) of the Federal Food, Drug, and Cosmetic Act, rights to manufacture such product.
(c)Provision of productsWith respect to COVID–19 diagnostic tests and associated drugs and devices manufactured pursuant to subsection (a), the Secretary shall— (1)provide such COVID–19 diagnostic tests and associated medical supplies at no cost to Federal, State, local, territorial, and Native health programs, and other domestic health care providers, including domestic commercial health care providers, as determined by the Secretary; and
(2)sell additional tests and associated drugs and devices, at-cost, to other commercial entities and international entities not described in paragraph (1). (d)Obtaining rights To manufacture and market (1)In generalWhen necessary to fulfill the Secretary’s duties under this section, the Secretary shall acquire the rights to manufacture and market COVID–19 diagnostic tests and associated drugs and devices as authorized under this section.
(2)Licensing authority
(A)In generalNotwithstanding any other provision of law, the Secretary may issue licenses, as useful for fulfilling the duties under this Act, allowing the Department of Health and Human Services to practice or have practiced (which may include licensure of retroactive practice) any invention in the United States or territories of the United States, including making, using, offering to sell or selling, importing, or exporting such invention, to reference or rely upon clinical trial data submitted to a regulatory authority or the grant of marketing approval, and to access and use otherwise confidential information, including know-how, related to the manufacture of COVID–19 diagnostic tests and associated medical supplies. (B)Non-voluntary licensingFor any license that involves a non-voluntary authorization to use patented inventions, regulatory test data, data, know-how or other intellectual property rights, the license shall provide for reasonable remuneration to rights holders such as a reasonable royalty on the sales of product, a 1-time payment, or some combination, provided that the combined royalty payments to all rights holders shall not exceed the percentage of sales that is the average percent of all royalty payments reported to the Internal Revenue Service by companies in the pharmaceutical and medicines sector, North American Industry Classification System code 325410, provided that when products are distributed for free, the royalty shall be based upon the cost of goods. When there are multiple rights holders, the allocation of the total royalty payments shall be determined by—
(i)agreement among the rights holders; (ii)allocation by arbitration among the rights holders; or
(iii)if neither clause (i) nor (ii) applies, by the Secretary. (3)TransparencySubject to paragraph (4), the Secretary shall post any contract agreement under subsection (a) or license issued under paragraph (2)(A) on the public internet website of the Department of Health and Human Services, on the date on which such agreement or license takes effect.
(4)Protected informationIn carrying out this section, the Secretary shall enforce applicable law concerning the protection of confidential commercial information and trade secrets. (e)Pricing determinations (1)At-cost priceIn determining an at-cost price for COVID–19 diagnostic tests and associated medical supplies for purposes of subsection (c)(2), the Secretary shall consider—
(A)the cost to the Federal Government of manufacturing the applicable COVID–19 diagnostic test or associated drug or device; and (B)the cost to acquire or manufacture under subparagraph (A) the applicable COVID–19 diagnostic test or associated drug or device.
(2)TransparencyAll prices charged for COVID–19 diagnostic tests and associated medical supplies shall be made publicly available by the Secretary. (f)Awarding contracts (1)PriorityIn awarding contracts under this section, the Secretary shall prioritize entities manufacturing COVID–19 diagnostic tests or associated medical supplies using components originating from, and manufactured in, the United States.
(2)Contract requirementsAll contracts issued under this section shall include a requirement that the contract recipients reasonably price products produced under the contract. (g)Report to the President and CongressThe Secretary shall prepare and submit to the President, the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on Energy and Commerce of the House of Representatives, a monthly report during the COVID–19 pandemic, and a final report 3 months after such pandemic has concluded, that includes—
(1)an assessment of the major supply chain challenges facing health care facilities, medical providers, the Federal Government, State, local, territorial, and Tribal governments, and the private sector in COVID–19 diagnostic tests and associated medical supplies; and (2)a description of the authorization or approval status and available supply of all COVID–19 diagnostic tests and associated medical supplies for which manufacturing has been authorized under this section, including products for which the Secretary has submitted an application for approval, a notification for clearance, or a request for classification to the Food and Drug Administration but has not yet received approval, clearance, or classification, and products for which the Secretary has received approval, clearance, or classification, from the Food and Drug Administration but are not being manufactured.
(h)Proceeds from salesThere are authorized to be appropriated to the Secretary for each fiscal year, for purposes of carrying out this section, an amount equal to the proceeds from the sale of COVID–19 diagnostic tests and associated medical supplies described in subsection (c)(2) in the previous fiscal year. 4.COVID–19 testing for covered Federal employees (a)DefinitionsIn this section:
(1)AgencyThe term agency— (A)means—
(i)each agency, office, or other establishment in the executive, legislative, or judicial branch of the Federal Government, including— (I)an Executive agency, as that term is defined in section 105 of title 5, United States Code;
(II)a military department, as that term is defined in section 102 of title 5, United States Code; (III)the Federal Aviation Administration;
(IV)the Transportation Security Administration; (V)the Department of Veterans Affairs;
(VI)the Government Accountability Office; (VII)the Library of Congress;
(VIII)the Postal Service; (IX)the House of Representatives;
(X)the Senate; and (XI)the Architect of the Capitol;
(ii)the District of Columbia courts and the District of Columbia Public Defender Service; or (iii)an—
(I)Indian Tribe or Tribal organization carrying out a contract or compact under the Indian Self-Determination and Education Assistance Act (25 U.S.C. 5301 et seq.); (II)Indian Tribe or Tribal organization that receives a grant under the Tribally Controlled Schools Act of 1988 (25 U.S.C. 2501 et seq.); or
(III)Indian Tribe or Tribal organization (as defined in section 5212 of the Tribally Controlled Schools Act of 1988 (25 U.S.C. 2511)) that receives a grant under that Act (25 U.S.C. 2501 et seq.); and (B)does not include a nonappropriated fund instrumentality under the jurisdiction of the Armed Forces.
(2)Covered dutyThe term covered duty means all work performed by a Federal employee, except duties that a Federal employee performs while teleworking from a residence. (3)Federal employeeThe term Federal employee means—
(A)an individual who engages in covered duties on behalf of an agency at any time during the COVID–19 pandemic, or an individual classified as an independent contractor by the agency who engages in covered duties during such period;  (B)includes—
(i)any person performing work for an agency who engages in covered duties during the COVID–19 pandemic, regardless of whether such person is classified as an independent contractor by the agency; and (ii)any paid or unpaid intern, fellow, trainee, or other person performing work for an agency who engages in covered duties during the COVID–19 pandemic; and
(C)does not include any employee of a Federal contractor.  (4)Timely mannerThe term timely manner, with respect to the administration of a COVID–19 diagnostic test, means within 24 hours of the administration of such test.
(b)Federal employee COVID–19 testing
(1)In generalNot later than 30 days after the date of enactment of this Act, each agency shall begin to— (A)conduct or contract with entities to conduct COVID–19 diagnostic tests for Federal employees employed by the agency at no cost to the employee, regardless of whether such employees exhibit symptoms of COVID–19, provided at locations accessible to the Federal employees;
(B)provide each Federal employee employed by the agency with the results of the diagnostic tests, regardless of the results, including an interpretation of what the test means in the employee’s preferred language, in a timely manner;  (C)submit the results of such tests to relevant Federal, State, local, territorial, and Tribal public health officials; and
(D)publish the aggregate results of such diagnostic tests in accordance with section 8. (2)Time periodEach agency shall continue the activities described in subparagraphs (A), (B), and (C) of paragraph (1) throughout the duration of the COVID–19 pandemic.
(3)Minimum wage and overtimeNotwithstanding any other provision of law, for any individual employed by a contractor or subcontractor, and who performs work assisted in whole or in part by funding under this section, with respect to such employment, such individual shall— (A)be paid a wage of not less than $15 per hour; and
(B)if such individual is paid at a rate that is the full-time equivalent of less than $51,000 per year, receive overtime pay of one-and-one-half times the individual's regular rate of pay for all hours worked in excess of 40 hours per workweek.  (c)Frequency and location of COVID–19 diagnostic testingIn administering COVID–19 tests pursuant to subsection (b), each agency shall provide COVID–19 diagnostic tests at frequencies and locations recommended by the State, local, territorial or Tribal public health officials with jurisdiction over the geographic areas in which the applicable Federal employees work, or, if a national testing strategy is developed by Federal officials, in compliance with the national testing strategy.
(d)Authorization of AppropriationsThere is authorized to be appropriated to each Federal agency such sums as may be necessary to procure and administer the COVID–19 diagnostic tests required under this section.  5.Federal distribution of COVID–19 tests to qualified entities (a)DefinitionsIn this section:
(1)COVID–19 testingThe term COVID–19 testing has the meaning given such term in interim final rules promulgated by the Secretary within 15 days of the date of enactment of this Act. (2)Essential workThe term essential work means any work that—
(A)is performed during the period of the COVID–19 pandemic; (B)cannot be performed while teleworking from a residence; and
(C)
(i)involves— (I)regular in-person interactions with patients, the public, or coworkers of the individual performing the work; or
(II)regular physical handling of items that were handled by, or are to be handled by patients, the public, or coworkers of the individual performing the work; and (ii)is in the area of—
(I)first responder work, in the public sector or private sector, including services in response to emergencies that have the potential to cause death or serious bodily injury, such as police, fire, emergency medical, protective, child maltreatment, domestic violence, and correctional services (including activities carried out by employees in fire protection activities, as defined in section 3(y) of the Fair Labor Standards Act of 1938 (29 U.S.C. 203(y)) and activities of law enforcement officers, as defined in section 1204(6) of the Omnibus Crime Control and Safe Streets Act of 1968 (34 U.S.C. 10284(6))); (II)health care work physically provided in inpatient settings (including hospitals and other inpatient post-acute care settings such as nursing homes, inpatient rehabilitation facilities, and other related settings) and other work physically performed in such inpatient settings that supports or is in furtherance of such health care work physically provided in inpatient settings;
(III)health care work physically provided in outpatient settings (including at physician offices, community health centers, Tribal clinics, rural health clinics and other clinics, hospital outpatient departments, freestanding emergency departments, health centers, ambulatory surgical centers, dialysis centers, dental offices, and other related settings), and other work physically performed in such outpatient settings that supports or is in furtherance of such health care work physically provided in outpatient settings; (IV)pharmacy work, physically performed in pharmacies, drug stores, or other retail facilities specializing in medical goods and supplies;
(V)any work physically performed in a facility that performs medical testing and diagnostic services, including laboratory processing, medical testing services, imaging services, or related activities; (VI)home- and community-based health care work, including home health care, residential care, assistance with activities of daily living, and any services provided by direct care workers (as defined in section 799B of the Public Health Service Act (42 U.S.C. 295p)), personal care aides, community health aides and community health aides participating in the Community Health Representative Program or the Community Health Aide Program under the Indian Health Care Improvement Act (25 U.S.C. 1601 et seq.), job coaches, or supported employment providers, and any other provision of care to individuals in their homes by direct service providers, personal care attendants, and home health aides;
(VII)biomedical research; (VIII)behavioral health work requiring physical interaction with individuals, including mental health services and substance use disorder prevention, treatment, and recovery services;
(IX)nursing care and residential work physically provided in a facility; (X)family care, including child care services, in-home child care services such as nanny services, and care services provided by family members to other family members;
(XI)social services work, including social work, case management, social and human services, child welfare, family services, shelter and services for people who have experienced intimate partner violence or sexual assault, services for individuals who are homeless, child services, community food and housing services, and other emergency social services; (XII)public health work conducted at a State, local, territorial, or Tribal government public health agency, including epidemiological activities, surveillance, contact tracing, data analysis, statistical research, health education, and other disease detection, prevention, and response methods;
(XIII)work conducted at a hospital, clinic, triage center, or other permanent or temporary health facility operated by the Indian Health Service, an Indian Tribe, Tribal organization, or urban Indian organization; (XIV)grocery work physically performed at grocery stores, supermarkets, convenience stores, corner stores, drug stores, retail facilities specializing in medical goods and supplies, bodegas, or another location where individuals purchase non-prepared food items;
(XV)restaurant work, including carry-out, drive-thru, or food delivery work, requiring physical interaction with individuals or food products; (XVI)food production work involving the physical interaction with food products, including all agricultural work, farming, harvesting, fishing, forestry, ranching, processing, canning, slaughtering, packaging, baking, butchering, and other food production work, such as any service or activity described in section 3(f) of the Fair Labor Standards Act of 1938 (29 U.S.C. 203(f)) or section 3121(g) of the Internal Revenue Code of 1986, and the handling, planting, drying, packing, packaging, processing, freezing, or grading prior to delivery for storage of any agricultural or horticultural commodity in its unmanufactured state;
(XVII)transportation work, including— (aa)any services in public transportation, as defined in section 5302(14) of title 49, United States Code;
(bb)any private transportation of people, such as transportation provided by air, rail, bus, taxicab, personal car or truck, non-motorized vehicle, or otherwise, including all services performed by individuals working in or on such vehicles, vehicle depots, or transit facilities; (cc)any services in passenger rail transportation, including commuter rail, intercity passenger rail, or Amtrak, including services performed by employees of contractors of such entities;
(dd)any services in the transportation of persons, property, or mail by an aircraft of an air carrier conducting operations under part 121 of title 14, Code of Federal Regulations (or successor regulations), or a foreign air carrier within, to, or from the United States, either on board an aircraft or on the ground at an airport, including services performed by employees of contractors of air carriers, or foreign air carriers, as described in section 4111(3) of the CARES Act (15 U.S.C. 9071(3)); (ee)any services as an aircraft mechanic or technician who performs maintenance, repair, or overhaul work on an aircraft of an air carrier conducting operations under such part 121 or foreign air carrier within the United States;
(ff)services as maritime workers who qualify as seamen under section 10101(3) of title 46, United States Code, and other maritime employees including— (AA)longshoremen, harbor workers and shipbuilders covered under section 2(3) of the Longshore and Harbor Workers' Compensation Act (33 U.S.C. 902(3)) involved in the transportation of merchandise or passengers by water; and
(BB)shipbuilders and ship repairers who are working for an employer performing shipbuilding or ship repair work under contract or subcontract to the Departments of Defense, Energy or Homeland Security for military or other national security purposes;  (gg)services as maritime transportation workers supporting or enabling transportation functions, including such services as—
(AA)barge workers, tug operators, and port and facility security personnel; (BB)marine dispatchers; and
(CC)workers who repair and maintain marine vessels (including the equipment and infrastructure that enables operations that encompass movement of cargo and passengers); and (hh)work physically performed in a warehouse or other facility in warehousing (including all services performed by individuals picking, sorting, packing, and shipping in warehouses), storage, distribution, or call center support facilities, and other essential operational support functions that are necessary to accept, store, and process goods, and that facilitate the goods' transportation and delivery;
(XVIII)cleaning work and building maintenance work physically performed on the grounds of a facility, including all custodial or janitorial services, security services, and repair and maintenance services;  (XIX)work in the collection, removal, transport, storage, or disposal of residential, industrial, or commercial solid waste and recycling, including services provided by individuals who drive waste or recycling trucks, who pick up waste or recycling from residential or commercial locations, or who work at waste or recycling centers or landfills;
(XX)work in the gathering, processing, disseminating, and delivery of news and information that serves the public interest to the public through mass media, including television, radio, and newspapers; (XXI)any work performed by an employee of a State, locality, or Tribal government, that is determined to be essential work by the highest authority of such State, locality, or Tribal government;
(XXII)educational work, school nutrition work, and other work required to operate a school facility, including early childhood and after-school enrichment programs, preschool programs, elementary and secondary education, and higher education; (XXIII)laundry work, including work in laundromats, laundry service companies, and dry cleaners;
(XXIV)elections work physically performed at polling places or otherwise amongst the public, including public-sector elections personnel and private-sector elections personnel; (XXV)hazardous materials management, response, and cleanup work associated with any other essential work covered under this paragraph, including health care waste (including medical, pharmaceuticals, and medical material production), and testing operations (including laboratories processing test kits);
(XXVI)disinfection work for all facilities and modes of transportation involved in other essential work covered under this paragraph; (XXVII)work in critical clinical research, development, and testing necessary for COVID–19 response that involves physical interaction with hazardous materials, such as samples of COVID–19;
(XXVIII)work in mortuary, funeral, cremation, burial, cemetery, and related services; (XXIX)work requiring physical interactions with patients in physical therapy, occupational therapy, speech-language pathology, and respiratory therapy and other therapy services;
(XXX)dental care work requiring physical interaction with patients; (XXXI)work performed by employees of the United States Postal Service;
(XXXII)work at hotel and commercial lodging facilities that are used for COVID–19 mitigation and containment measures; and (XXXIII)work installing or repairing a telecommunications line or equipment.
(3)Essential workerThe term essential worker means an individual whose work and duties include essential work, including individuals that are employees of employers and individuals performing any services or labor for remuneration, regardless of whether such individual is classified as an independent contractor by the employer. (4)Qualified entityThe term qualified entity means—
(A)a congregate care setting, including any skilled nursing facilities, assisted living facilities, prisons and jails, residential behavioral health care and psychiatric facilities, and facilities providing services for aging adults and people with disabilities; (B)an education center, including any childcare facilities, elementary and secondary schools that have resumed (or plan to resume within 30 days of receipt of items under subsection (b)) any form of in-person instruction, and colleges and universities that have resumed (or plan to resume within 30 days of receipt of items under subsection (b)) any form of in-person instruction or on-campus housing;
(C)a community center, such as State and local government buildings, religious centers, and nonprofit service organizations; (D)a prison, jail, or youth detention facility;
(E)a hospital, community health center, Tribal or Indian Health Service clinic or hospital, or other medical facility; (F)a small business;
(G)a business that employs essential workers;  (H)a homeless shelter or entity supporting individuals living in housing funded with support from the Department of Housing and Urban Development, including housing provided under the supportive housing for the elderly program under section 202 of the Housing Act of 1959 (12 U.S.C. 1701q); or
(I)another entity, as determined by the Secretary, that could serve as a COVID–19 diagnostic testing site. (5)Timely mannerThe term timely manner, with respect to the administration of a COVID–19 diagnostic test, means within 24 hours of the administration of such test.
(b)Distribution of COVID–19 diagnostic tests
(1)In generalWithin 40 days of the date of enactment of this Act, the Secretary shall— (A)begin distributing COVID–19 diagnostic tests and associated medical supplies, including tests and medical supplies manufactured under section 3, to qualified entities via State, local, territorial, and Tribal governments for the purpose of—
(i)providing COVID–19 diagnostic testing to essential workers and individuals served by qualified entities, at no cost to the essential workers and individuals, regardless of whether such workers and individuals exhibit symptoms of COVID–19, at locations accessible to the essential workers and individuals in the course of their work; (ii)providing essential workers and individuals served by qualified entities with the results of the diagnostic tests, regardless of the results, including an interpretation of what the test means in the employee’s preferred language, in a timely manner;
(iii)submitting the results of such tests to relevant Federal, State, local, territorial, and Tribal public health officials; and (iv)publishing the aggregate results of such diagnostic tests in accordance with section 8; and
(B)hire and deploy employees, or contract with outside entities to hire and deploy employees, as necessary to assist in the distribution, provision, administration of, and data collection regarding COVID–19 diagnostic tests as described in subparagraph (A). (2)EmployeesIn hiring employees, or contracting with outside entities to hire employees, to carry out this subsection, the Secretary shall prioritize, or require contractors to prioritize, hiring individuals from within the communities served by the applicable qualified entity.
(3)Minimum wage and overtimeNotwithstanding any other provision of law, for any individual employed by a contractor or subcontractor, and who performs work assisted in whole or in part by funding under this section, with respect to such employment, such individual shall— (A)be paid a wage of not less than $15 per hour; and
(B)if such individual is paid at a rate that is the full-time equivalent of less than $51,000 per year, receive overtime pay of one-and-one-half times the individual's regular rate of pay for all hours worked in excess of 40 hours per workweek.  (c)Coordination with State, local, territorial, and Tribal governmentsWithin 30 days of the date of enactment of this Act, a representative of each State, local, territorial, and Tribal government shall submit to the Secretary a list of qualified entities in their jurisdiction and a description of employee, resource, and other infrastructure needs necessary for the distribution of COVID–19 diagnostic tests and associated drugs and devices under subsection (b).
(d)Frequency and location of COVID–19 diagnostic testingIn distributing COVID–19 tests under (b), the Secretary shall provide COVID–19 diagnostic tests at frequencies and locations recommended by the State, local, territorial, or Tribal public health officials with jurisdiction over the geographic areas in which qualified entities are located, or, if a national testing strategy is developed by Federal officials, in compliance with the national testing strategy.  (e)Public reportingBeginning 30 days after the date of enactment of this Act and for the duration of the COVID–19 pandemic, the Secretary shall publish weekly, in a machine readable format, the total number of tests distributed to, and the total number of tests administered in, each State, county, territory, and Tribe under subsection (b).
(f)Authorization of appropriationsThere is authorized to be appropriated such sums as may be necessary to carry out this section.  6.Supplemental grants for COVID–19 testing (a)In generalNo later than 30 days after the date of enactment of this Act, the Secretary, acting through the Director of the Centers for Disease Control and Prevention shall—
(1)issue competitive grants to State, local, and territorial governments for the purpose of increasing access to COVID–19 diagnostic testing; and (2)issue noncompetitive and formula-based awards to Indian Tribes and Tribal organizations.
(b)Priority areas and populationsIn issuing grants under subsection (a), the Secretary shall— (1)prioritize areas and populations that have been disproportionately affected by COVID–19, and areas where operationalizing testing programs is not possible with existing resources; and
(2)consider the capacity that States, localities, territories, and Tribes already have at the time of application to conduct widespread COVID–19 diagnostic testing.  (c)Use of fundsGrants awarded under subsection (a) may be used to—
(1)establish new COVID–19 diagnostic testing sites at community centers, such as State, local, territorial, and Tribal government buildings, churches, health centers, clinics, and public parks, subject to Federal quality control standards for laboratory testing; (2)hire State, local, territorial, and Tribal government employees, or contract with outside entities, to assist in the development, distribution, and provision of COVID–19 diagnostic tests within the State, locality, territory, or Tribe;
(3)purchase COVID–19 diagnostic tests and the medical supplies necessary to conduct such tests;  (4)increase the number of COVID–19 diagnostic tests provided at congregate settings, such as—
(A)skilled nursing facilities; (B)assisted living facilities;
(C)childcare facilities; (D)elementary and secondary schools that have resumed, or plan to resume within 30 days, in-person instruction;
(E)colleges and universities that have resumed, or plan to resume within 30 days, in-person instruction or on-campus housing; (F)prisons, jails, and youth detention facilities;
(G)residential behavioral health care and psychiatric facilities; (H)institutions providing services for aging adults and people with intellectual and developmental disabilities, rehabilitation facilities, and group homes; and
(I)homeless shelters; (5)educate the public about the availability of COVID–19 diagnostic tests in their communities and what to do if a positive result is received;
(6)issue subgrants, cooperative agreements, or contracts to labs, hospitals, and other test providers to reduce test processing time; submit the results to State, local, territorial, and Tribal public health officials; and prevent delays in the distribution of testing results, such as through transferring research lab capacity to COVID–19 testing capacity and building new labs to reduce test processing turnaround time; (7)enable the State, locality, territory, or Tribe to detect and identify trends in COVID–19 and develop guidance for communities on how to develop testing programs and expand test capacity;
(8)reduce disparities in access to COVID–19 diagnostic testing among the communities hardest hit by COVID–19; and (9)additional uses, as determined by the Secretary, in accordance with subsection (e).
(d)RequirementAny COVID–19 diagnostic test conducted with the support of a grant awarded under this section shall be provided to patients free of charge and without regard for immigration status. The results shall be submitted to relevant State, local, territorial, and Tribal public health officials.  (e)Minimum wage and overtimeNotwithstanding any other provision of law, for any individual employed by a contractor or subcontractor, and who performs work assisted in whole or in part by funding under this section, with respect to such employment, such individual shall—
(1)be paid a wage of not less than $15 per hour; and (2)if such individual is paid at a rate that is the full-time equivalent of less than $51,000 per year, receive overtime pay of one-and-one-half times the individual's regular rate of pay for all hours worked in excess of 40 hours per workweek.
(f)Additional uses of fundsIn determining appropriate uses of funds under subsection (c)(9), the Secretary shall consider the incidence of COVID–19 in States, localities, territories, and Tribes, the availability and uptake of vaccines for COVID–19 in States, localities, territories, and Tribes, and advancements in COVID–19 diagnostic test technologies.  (g)Authorization of appropriations (1)In generalThere is authorized to be appropriated $25,000,000,000 for fiscal year 2021 for purposes of awarding grants under this section.
(2)Tribal set-asideNot less than 10 percent of the total amount appropriated under paragraph (1) for a fiscal year shall be reserved for noncompetitive awards to— (A)Indian Tribes or Tribal organizations carrying out a contract or compact under the Indian Self-Determination and Education Assistance Act (25 U.S.C. 5301 et seq.);
(B)Indian Tribes or Tribal organizations receiving a grant under the Tribally Controlled Schools Act of 1988 (25 U.S.C. 2501 et seq.); and (C)Indian Tribes or tribal organizations (as defined in section 5212 of the Tribally Controlled Schools Act of 1988 (25 U.S.C. 2511)) receiving grants under that Act (25 U.S.C. 2501 et seq.).
(3)Local government set asideNot less than 30 percent of the total amount appropriated under paragraph (1) for a fiscal year shall be reserved for grants awarded directly to local governments. 7.Reports and guidance on COVID–19 diagnostic testing (a)Updated guidance on COVID–19 rapid diagnostic tests (1)In generalNot later than 30 days after the date of enactment of this Act, the Secretary, acting through the Commissioner of Food and Drugs, shall issue updated guidance on the development of rapid COVID–19 diagnostic tests, the provision of such tests, including in nonclinical environments, and the appropriate collection and electronic reporting of results (including geographic and demographic data, including with respect to race and ethnicity) and data regarding such tests to Federal, State, local, and Tribal public health officials.
(2)Rapid COVID–19 diagnostic testFor purposes of paragraph (1), the term rapid COVID–19 diagnostic test means a COVID–19 diagnostic test that can be performed by a user, with or without the need of a medical professional or medical supervisor, and that can produce results within 1 hour of application. (b)Updated surveillance testing guidance (1)In generalNot later than 30 days after the date of enactment of this Act, the Secretary, acting through the Commissioner of Food and Drugs and in consultation with the Director of the Centers for Disease Control and Prevention, shall issue guidance on COVID–19 surveillance testing best practices. Such guidance shall address how COVID–19 surveillance testing can be used to keep qualified entities, as defined in section 5(a), open to the public, and how tests with differing accuracy standards, including rapid point of care antigen tests and pooled molecular tests, can each be used in COVID–19 surveillance testing at qualified entities among children and adult.
(2)COVID–19 surveillance testingFor purposes of paragraph (1), the term COVID-19 surveillance testing means the ongoing, systematic collection, analysis, and interpretation of COVID–19 diagnostic test results for the purpose of monitoring for a community- or population-level infection and disease, or to characterize the incidence and prevalence of disease. (c)Report on national daily testing benchmarkNot later than 30 days after the date of enactment of this Act, the Secretary, acting through the Commissioner of Food and Drugs and in consultation with the Director of the Centers for Disease Control and Prevention, shall issue recommendations on the total number of COVID–19 diagnostic tests that should be conducted in the United States per day to control the spread of COVID–19, with a focus on the number of tests necessary to protect essential workers, as defined in section 5(a), from COVID–19 infection.
(d)Comparison of COVID–19 diagnostic test performanceNot later than 30 days after the date of enactment of this Act, the Secretary, acting through the Commissioner of Food and Drugs, shall issue a report comparing the performance of COVID–19 diagnostic tests on the market, including a comparison of the differing sensitivity and accuracy of such tests in asymptomatic and symptomatic populations and children and adults. (e)Review of COVID–19 diagnostic test approval pathwaysNot later than 30 days after the date of enactment of this Act, the Secretary, acting through the Commissioner of Food and Drugs, shall review the process for approving COVID–19 diagnostic tests for market, with a particular focus on extraction-free highly sensitive molecular tests, pooled highly sensitive molecular tests, low-cost rapid antigen test, low-cost highly sensitive molecular tests, assays that can use a variety of reagents, and other products as determined by the Secretary, and take steps as necessary to expedite such process, as appropriate.
8.Demographic and geographic data collection
(a)COVID–19 data collectionThe Secretary, acting through the Director of the Centers for Disease Control and Prevention and in consultation with the Administrator of the Centers for Medicare & Medicaid Services and the Director of the Indian Health Service, shall make publicly available on the website of the Centers for Disease Control and Prevention data collected relating to COVID–19 testing from entities receiving Federal funding under this Act, including data disaggregated by race, ethnicity, sex (including sexual orientation and gender identity), age, primary language, socioeconomic status, disability status, pregnancy status, occupation, county, and zip code. (b)Application of standardsTo the extent practicable, data collection under this section shall follow standards developed by the Office of Minority Health of the Department of Health and Human Services and the Centers for Disease Control and Prevention, and shall be collected, analyzed, and reported in accordance with the standards promulgated under section 3101 of the Public Health Service Act (42 U.S.C. 300kk).
(c)TimelineThe data made available under this section shall be updated on a weekly basis throughout the COVID–19 pandemic. (d)PrivacyIn publishing data under this section, the Secretary shall take all necessary steps to protect the privacy of individuals whose information is included in such data, including—
(1)complying with privacy protections provided under the regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. 1320d–2 note) and State law; and  (2)protections from all inappropriate internal use by an entity that collects, stores, or receives the data, including use of such data in determinations of eligibility (or continued eligibility) in health plans, and from inappropriate uses.
(e)Data useNeither the Secretary, nor any other officer or employee of the Federal Government, or local government liaison, may use the information furnished under this legislation for any purpose other than the statistical and public health purposes for which such information is supplied, or make any publication whereby the data furnished by any particular establishment or individual under this Act can be identified, or permit anyone other than the sworn officers and employees of the Department of Health and Human Services to examine the individual reports.