113 HR 672 IH: Prescription Drug Abuse Prevention and Treatment Act of 2013
U.S. House of Representatives
2013-02-13
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
113th CONGRESS
1st Session
H. R. 672
IN THE HOUSE OF REPRESENTATIVES

February 13, 2013
Mr. Rahall introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned

A BILL
To provide for increased Federal oversight of prescription opioid treatment and assistance to States in reducing opioid abuse, diversion, and deaths.

1.Short titleThis Act may be cited as the Prescription Drug Abuse Prevention and Treatment Act of 2013.
2.FindingsCongress makes the following findings:
(1)Nonmedical use of prescription pain relievers is a matter of increasing public health concern. According to the Substance Abuse and Mental Health Services Administration, the proportion of all substance abuse treatment admissions aged 12 or older that reported any pain reliever abuse increased more than 400 percent between 1998 and 2008, from 2.2 to 9.8 percent.
(2)In 2008, among the population of the United States aged 12 or older, nonmedical use of prescription pain relievers was the second most prevalent type of illicit drug use, after marijuana use.
(3)When used properly under medical supervision, prescription opiates enable individuals with chronic pain to lead productive lives. However, when taken without a physician’s oversight and direction, opiates can cause serious adverse health effects, resulting in dependence, abuse, and death.
(4)As with any controlled substance, there is a risk of abuse of methadone and other opiates.
(5)Methadone is an extensively tested, federally approved, and widely accepted method of treating addiction to prescription pain relievers or opiates.
(6)For more than 30 years, this synthetic prescription drug has been used for pain management and treatment for addiction to heroin, morphine, and other opioid drugs.
(7)The efficacy and lower cost of methadone has resulted in its being prescribed for pain management.
(8)Prescriptions for methadone have increased by nearly 700 percent from 1998 through 2006.
(9)According to the Centers for Disease Control and Prevention, the number of poisoning deaths involving methadone increased nearly 7-fold from almost 790 in 1999 to almost 5,420 in 2006, which is the most rapid increase among opioid analgesics and other narcotics involved in poisoning deaths.
(10)The age-specific rates of methadone death are higher for persons age 35 to 44 and 45 to 54 than for other age groups. However, the rate of methadone deaths in younger individuals (age 15 to 24) increased 11-fold from 1999 through 2005.
(11)Deaths from methadone and other opiates may actually be underreported. There is no comprehensive database of drug-related deaths in the United States.
(12)The lack of standardized reporting by Medical Examiners precludes a uniform definition of cause of death on death certificates.
(13)The Controlled Substances Act (21 U.S.C. 801 et seq.) requires that every person who dispenses or who proposes to dispense controlled narcotics, including methadone, whether for pain management or opioid treatment obtain a registration from Drug Enforcement Administration. Unfortunately there is no requirement as a condition of receiving the registration that these practitioners receive any education on the use of these controlled narcotics, including methadone.
(14)Current Federal oversight of methadone and other opioids is inadequate to address the growing number of opioid-related overdoses and deaths.
(15)Federal legislation is needed to avert opioid abuse, misuse, and death, without reducing patient access to needed care.
3.Consumer education campaignPart A of title V of the Public Health Service Act (42 U.S.C. 290aa et seq.) is amended by adding at the end the following:

506C.Consumer education campaign
(a)In generalThe Administrator shall award grants to States and nonprofit entities for the purpose of conducting culturally sensitive consumer education about opioid abuse, including methadone abuse. Such education shall include information on the dangers of opioid abuse, how to prevent opioid abuse including through safe disposal of prescription medications and other safety precautions, and detection of early warning signs of addiction.
(b)EligibilityTo be eligible to receive a grant under subsection (a), an entity shall—
(1)be a State or nonprofit entity; and
(2)submit to the Administrator an application at such time, in such manner, and containing such information as the Administrator may require.
(c)PriorityIn awarding grants under this section, the Administrator shall give priority to applicants that are States or communities with a high incidence of abuse of methadone and other opioids, and opioid-related deaths.
(d)EvaluationsThe Administrator shall develop a process to evaluate the effectiveness of activities carried out by grantees under this section at reducing abuse of methadone and other opioids.
(e)Authorization of appropriationsThere is authorized to be appropriated to carry out this section $15,000,000 for each of fiscal years 2014 through 2018..
4.Practitioner education
(a)Education requirements
(1)Registration considerationSection 303(f) of the Controlled Substances Act (21 U.S.C. 823(f)) is amended by inserting after paragraph (5) the following:

(6)The applicant's compliance with the training requirements described in subsection (g)(3) during any previous period in which the applicant has been subject to such training requirements..
(2)Training requirementsSection 303(g) of the Controlled Substances Act (21 U.S.C. 823(g)) is amended by adding at the end the following:

(3)
(A)To be registered to prescribe or otherwise dispense methadone or other opioids, a practitioner described in paragraph (1) shall comply with the 16-hour training requirement of subparagraph (B) at least once during each 3-year period.
(B)The training requirement of this subparagraph is that the practitioner has completed not less than 16 hours of training (through classroom situations, seminars at professional society meetings, electronic communications, or otherwise) with respect to—
(i)the treatment and management of opioid-dependent patients;
(ii)pain management treatment guidelines; and
(iii)early detection of opioid addiction, including through such methods as Screening, Brief Intervention, and Referral to Treatment (SBIRT),that is provided by the American Society of Addiction Medicine, the American Academy of Addiction Psychiatry, the American Medical Association, the American Osteopathic Association, the American Psychiatric Association, the American Academy of Pain Management, the American Pain Society, the American Academy of Pain Medicine, the American Board of Pain Medicine, the American Society of Interventional Pain Physicians, or any other organization that the Secretary determines is appropriate for purposes of this subparagraph..
(b)Requirements for participation in opioid treatment programsEffective July 1, 2014, a physician practicing in an opioid treatment program shall comply with the requirements of section 303(g)(3) of the Controlled Substances Act (as added by subsection (a)) with respect to required minimum training at least once during each 3-year period.
(c)DefinitionIn this section, the term opioid treatment program has the meaning given such term in section 8.2 of title 42, Code of Federal Regulations (or any successor regulation).
(d)FundingThe Drug Enforcement Administration shall fund the enforcement of the requirements specified in section 303(g)(3) of the Controlled Substances Act (as added by subsection (a)) through the use of a portion of the licensing fees paid by controlled substance prescribers under the Controlled Substances Act (21 U.S.C. 801 et seq.).
5.Moratorium on methadone hydrochloride tablets
(a)In generalNotwithstanding any other provision of law, during the period beginning on the date of enactment of this Act and ending on the date described in subsection (b), no individual or entity may prescribe or otherwise dispense a 40-mg diskette of methadone unless such prescription or dispensation is consistent with the methadone 40-mg diskette policy of the Drug Enforcement Administration as in effect on the date of enactment of this Act, except that such prohibition shall extend to hospitals unless such hospitals provide for direct patient supervision with respect to such methadone.
(b)Ending date of moratoriumThe moratorium under subsection (a) shall cease to have force and effect—
(1)on the date that the Controlled Substances Clinical Standards Commission publishes in the Federal Register dosing guidelines for all forms of methadone, in accordance with section 506D(b)(1)(A) of the Public Health Service Act (as added by section 7); and
(2)if, as part of such dosing guidelines, such Commission finds that 40-mg diskettes of methadone are safe and clinically appropriate.
6.Operation of opioid treatment programsSection 303 of the Controlled Substances Act (21 U.S.C. 823) is amended by adding at the end the following:

(i)
(1)An opioid treatment program that is registered under this section, and that closes for business on any weekday or weekend day, including a Federal or State holiday, shall comply with the requirements of this subsection.
(2)The program shall make acceptable arrangements for each patient who is restricted, by Federal regulation or guideline or by the determination of the program medical director, from having a take home dose of a controlled substance related to the treatment involved, to receive a dose of that substance under appropriate supervision during the closure.
(3)The Administrator of the Substance Abuse and Mental Health Services Administration shall issue a notice that references regulations on acceptable arrangements under this subsection, or shall promulgate regulations on such acceptable arrangements..
7.Establishment of the Controlled Substances Clinical Standards CommissionPart A of title V of the Public Health Service Act (42 U.S.C. 290aa et seq.), as amended by section 3, is further amended by adding at the end the following:

506D.Establishment of the Controlled Substances Clinical Standards Commission
(a)In generalThe Secretary shall establish a Controlled Substances Clinical Standards Commission (referred to in this section as the Commission), to be composed of representatives from the Administration, the Centers for Disease Control and Prevention, the Food and Drug Administration, the Pain Management Consortia of the National Institutes of Health, and other agencies that the Secretary may deem necessary, to develop—
(1)appropriate and safe dosing guidelines for all forms of methadone, including recommendations for maximum daily doses of all forms as provided for in subsection (b)(1);
(2)benchmark guidelines for the reduction of methadone abuse, as provided for in subsection (b)(2);
(3)appropriate conversion factors for use by health care providers in transitioning patients from one opioid to another;
(4)specific guidelines for initiating pain management with methadone that prescribing practitioners shall comply with in order to meet certification requirements set forth in part C of the Controlled Substances Act (21 U.S.C. 821 et seq.); and
(5)patient and practitioner education guidelines for both methadone maintenance therapy and pain management that apply to safe and effective use and include detoxification.
(b)Guidelines
(1)Publication of dosing guidelines
(A)In generalNot later than 2 years after the date of enactment of this section, the Commission established under subsection (a) shall publish in the Federal Register—
(i)safe and clinically appropriate dosing guidelines for all forms of methadone used for both pain management and opioid treatment programs, including recommendations for maximum daily doses of all forms, including recommendations for the induction process for patients who are newly prescribed methadone;
(ii)requirements for individual patient care plans, including initial and follow-up patient physical examination guidelines, and recommendations for screening patients for chronic or acute medical conditions that may cause an immediate and adverse reaction to methadone;
(iii)appropriate conversion factors for use by health care providers in transitioning patients from one opioid to another;
(iv)specific guidelines for initiating pain management with methadone, that prescribing physicians or other clinicians shall comply with in order to meet Drug Enforcement Administration certification and re-certification requirements; and
(v)consensus guidelines for pain management with prescription opioid drugs.
(B)Updating of guidelinesNot later than 3 years after the publication of guidelines under subparagraph (A), and at least every 3 years thereafter, the Commission shall update such guidelines.
(2)Publication of benchmark guidelines
(A)In generalNot later than 3 years after the date of enactment of this section, the Commission established under subsection (a) shall publish in the Federal Register—
(i)the initial benchmark guidelines for the reduction of methadone abuse to be used—
(I)by opioid treatment programs in providing methadone therapy; and
(II)by entities in the initial accreditation or certification, and the re-accreditation and re-certification, of such opioid treatment programs;
(ii)a model policy for dispensing methadone to be used by pharmacists that dispense methadone, which should include education and training guidelines for such pharmacists;
(iii)the continuing education guidelines that all prescribers shall comply with in order to meet Drug Enforcement Administration certification and re-certification requirements, as set forth in section 303(g)(3) of the Controlled Substances Act (21 U.S.C. 823(g)(3)), which should include a minimum of 16 training hours at least every 3 years that include the integration of both addiction and pain management curricula; and
(iv)patient education guidelines for both opioid treatment programs and pain management, including recommendations for patient counseling prior to and during opioid addiction treatment or treatment for pain.
(B)Updating of guidelinesNot later than 1 year after the publication of guidelines under subparagraph (A), and at least annually thereafter, the Commission shall update the guidelines published under clauses (iii) and (iv) of such subparagraph.
(3)ConsultationIn developing and publishing the guidelines under this section, the Commission shall consult with relevant professional organizations with expertise in the area of addiction, relevant professional organizations with expertise in the area of pain management, physician groups, pharmacy groups (including the National Association of Boards of Pharmacy), patient representatives, and any other organization that the Secretary determines is appropriate for purposes of this section.
(c)WebsiteNot later than 180 days after the date of enactment of this section, the Commission shall establish and operate a Commission website.
(d)Methadone toolkitNot later than 1 year after the date of enactment of this section, the Commission shall establish, and distribute to practitioners that are registered to prescribe or otherwise dispense methadone, a methadone toolkit. The Commission shall make the components of the toolkit that are available in electronic form available on the Commission website.
(e)Practitioner education programThe Commission shall develop a practitioner education program that shall be used for the practitioner education described in section 303(g)(3) of the Controlled Substances Act, and shall make such program available to providers of such practitioner education.
(f)Authorization of appropriationsThere is authorized to be appropriated to carry out this section such sums as may be necessary for each of fiscal years 2014 through 2018..
8.Prescription monitoring programSection 399O of the Public Health Service Act (42 U.S.C. 280g–3) is amended—
(1)in subsection (d)(1), by inserting (including prescribers of methadone) after dispensers;
(2)in subsection (e), by adding at the end the following:

(5)Subject to the requirements of section 543, the State shall, at the request of a Federal, State, or local officer whose duties include enforcing laws relating to drugs, provide to such officer information from the database relating to an individual who is the subject of an active drug-related investigation conducted by the officer's employing government entity.; and
(3)by striking subsection (n) and inserting the following:

(n)AppropriationsThere is authorized to be appropriated to carry out this section $25,000,000 for each of fiscal years 2014 through 2018..
9.Mortality reportingPart A of title V of the Public Health Service Act (42 U.S.C. 290aa et seq.), as amended by section 7, is further amended by adding at the end the following:

506E.Mortality reporting
(a)Model Opioid Treatment Program Mortality Report
(1)In generalNot later than July 1, 2014, the Secretary, acting through the Administrator, shall require that a Model Opioid Treatment Program Mortality Report be completed and submitted to the Administrator for each individual who dies while receiving treatment in an opioid treatment program.
(2)Requirement of States that receive funding for the Controlled Substance Monitoring ProgramAs a condition for receiving funds under section 399O, each State shall require that any individual who signs a death certificate where an opioid drug is detected in the body of the deceased, or where such drug is otherwise associated with the death, report such death to the Administrator by submitting a Model Opioid Treatment Program Mortality Report described in paragraph (3). Such report shall be submitted to the Administrator on or before the later of—
(A)90 days after the date of signing the death certificate; or
(B)as soon as practicable after the date on which the necessary postmortem and toxicology reports become available to such individual, as required by the Secretary.
(3)DevelopmentThe Administrator, in consultation with State and local medical examiners, prescribing physicians, hospitals, and any other organization that the Administrator determines appropriate, shall develop a Model Opioid Treatment Program Mortality Report to be used under paragraphs (1) and (2).
(b)National Opioid Death Registry
(1)In generalNot later than July 1, 2014, the Administrator shall establish and implement, through the National Center for Health Statistics, a National Opioid Death Registry (referred to in this subsection as the Registry) to track opioid-related deaths and information related to such deaths.
(2)ConsultationIn establishing the uniform reporting criteria for the Registry, the Director of the Centers for Disease Control and Prevention shall consult with the Administrator, State and local medical examiners, prescribing physicians, hospitals, and any other organization that the Director determines is appropriate for purposes of this subsection.
(3)RequirementsThe registry shall be designed as a uniform reporting system for opioid-related deaths and shall require the reporting of information with respect to such deaths, including—
(A)the particular drug formulation used at the time of death;
(B)the dosage level;
(C)a description of the circumstances surrounding the death in relation to the recommended dosage involved;
(D)a disclosure of whether the medication involved can be traced back to a physician’s prescription;
(E)a disclosure of whether the individual was in an opioid treatment program at the time of death;
(F)the age and sex of the individual; and
(G)other non-personal information such as that included in filed National Association of Medical Examiners Pediatric Toxicology Registry case reports as required under the privacy standard for the de-identification of health information pursuant to the regulations contained in part 164 of title 45, Code of Federal Regulations.
(4)AuthorizationThere is authorized to be appropriated $5,000,000 for each of fiscal years 2014 through 2018 to carry out this subsection.
(c)Report on Registry informationNot later than the January 1 of the first fiscal year beginning 2 years after the date of enactment of this section, and each January 1 thereafter, the Director of the Centers for Disease Control and Prevention shall submit to the Secretary a report, based on information contained in the Registry described in subsection (b), concerning the number of methadone-related deaths in the United States for the year for which the report is submitted..
10.Additional reportingPart A of title V of the Public Health Service Act (42 U.S.C. 290aa et seq.), as amended by section 9, is further amended by adding at the end the following:

506F.Additional reporting
(a)Report on methadone usage
(1)In generalNot later than January 1 of the first fiscal year beginning 2 years after the date of enactment of this section, and each January 1 thereafter, the Administrator and the Commissioner of Food and Drugs shall submit to the Secretary a report containing detailed statistics on methadone usage for opioid treatment and pain management. Such statistics shall include—
(A)information on the distribution of prescribed doses of methadone at federally qualified health centers, opioid treatment clinics, other health-related clinics, physician offices, pharmacies, and hospitals; and
(B)information relating to adverse health events resulting from such methadone usage.
(2)Availability of informationThe Secretary shall make the reports submitted under paragraph (1) available to the general public, including through the use of the Internet website of the Department of Health and Human Services.
(b)Annual report on effectivenessNot later than September 30, 2014, and annually thereafter until September 30, 2016, the Secretary shall submit to the appropriate committees of Congress, a report concerning the effectiveness of the methadone maintenance therapy program. Such report shall evaluate the success of efforts to reduce opioid addiction and methadone-related deaths, including the impact of health care provider and patient education.
(c)Authorization of appropriationsThere is authorized to be appropriated to carry out this section such sums as may be necessary for each of fiscal years 2014 through 2018..
11.Development of prescription drug abuse prevention and treatment quality measures across each relevant provider settingSubpart I of part D of title IX of the Public Health Service Act (42 U.S.C. 299b-31 et seq.) is amended by adding at the end the following:

932.Development of prescription drug abuse prevention and treatment quality measures across each relevant provider setting
(a)In generalThe Secretary, acting through the Director of the Agency for Healthcare Research and Quality and in consultation with the Director of the Centers for Disease Control and Prevention, the Administrator of the Substance Abuse and Mental Health Services Administration, and the Director of the Centers for Medicare & Medicaid Services, shall require the development and application of specific prescription drug abuse prevention and treatment quality measures for each relevant health care provider setting, as identified by the Director.
(b)DisseminationNot later than April 1, 2016, the Secretary shall disseminate the quality measure requirements developed under subsection (a) to all affected providers.
(c)Types of measuresQuality measures developed under this section may be structure-oriented (such as the required presence of a hospital-based treatment program), process-oriented (such as requiring patients to be informed of the addictive qualities of the medication being prescribed), or outcome-oriented (such as assessing family satisfaction with care)..


110 HR 2914 IH: Medicare IVIG Access Act of

U.S. House of Representatives
2007-06-28
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
		110th CONGRESS
		1st Session
		H. R. 2914
		IN THE HOUSE OF REPRESENTATIVES

			June 28, 2007
			Mr. Brady of Texas
			 (for himself, Mr. Israel,
			 Mrs. Blackburn,
			 Mr. Burgess,
			 Mrs. Cubin,
			 Mr. English of Pennsylvania,
			 Mr. Herger,
			 Mr. Hinchey,
			 Mr. Meeks of New York,
			 Mr. McNulty,
			 Mr. Nunes,
			 Mr. Paul, Mr. Ramstad, Mr.
			 Sessions, Mrs. Tauscher,
			 Ms. Roybal-Allard,
			 Mr. Smith of New Jersey, and
			 Mr. Young of Florida) introduced the
			 following bill; which was referred to the Committee on Energy and Commerce, and in
			 addition to the Committee on Ways and
			 Means, for a period to be subsequently determined by the
			 Speaker, in each case for consideration of such provisions as fall within the
			 jurisdiction of the committee concerned

		A BILL
		To amend title XVIII of the Social Security Act to
		  improve access of Medicare beneficiaries to immune globulins.

		1.Short title; table of
			 contents
			(a)Short
			 titleThis Act may be cited
			 as the Medicare IVIG Access Act of
			 2007.
			(b)Table of
			 contentsThe table of contents of this Act is as follows:

					Sec. 1. Short title; table of contents.
					Sec. 2. Findings.
					Sec. 3. Medicare payment for immune globulins.
					Sec. 4. Coverage and payment of intravenous immune globulin in
				the home.
					Sec. 5. Patient access surveys and reports.

			2.Findings
			(a)FindingsCongress
			 finds the following:
				(1)Intravenous immune globulin (IVIG) is a
			 human blood plasma derived product, which over the past 25 years has become an
			 invaluable therapy for many primary immunodeficiency diseases, as well as a
			 number of neurological, autoimmune, and other chronic conditions and illnesses.
			 For many of these disorders, IVIG is the most effective and viable treatment
			 available, and has dramatically improved the quality of life for persons with
			 these conditions and has become a life-saving therapy for many.
				(2)The Food and Drug Administration (FDA)
			 recognizes each IVIG brand as a unique biologic. The differences in basic
			 fractionation and the addition of various modifications for further
			 purification, stabilization and virus inactivation/removal yield clearly
			 different biological products. As a result, IVIG therapies are not
			 interchangeable, with patient tolerance differing from one IVIG brand to
			 another.
				(3)The report of the Office of the Assistant
			 Secretary for Planning and Evaluation (ASPE), Department of Health and Human
			 Services (DHHS), Analysis of Supply, Distribution, Demand, and Access
			 Issues Associated with Immune Globulin Intravenous (IGIV), issued in
			 May 2007, found that IVIG manufacturing is complex and requires substantial
			 upfront cash outlay and planning and takes between seven and 12 months from
			 plasma collection at donor centers to FDA lot release.
				(4)The Medicare
			 Prescription Drug, Improvement, and Modernization Act of 2003 changed
			 Medicare’s reimbursement methodology for IVIG from average wholesale price
			 (AWP) to average sales price plus 6 percent (ASP+6), effective January 1, 2005,
			 for physicians, and January 1, 2006, for hospital outpatient departments,
			 thereby reducing reimbursement rates paid to these providers of IVIG on behalf
			 of Medicare beneficiaries.
				(5)An Office of the
			 Inspector General (OIG) April 2007 report, Intravenous Immune Globulin:
			 Medicare Payment and Availability, found that Medicare reimbursement for IVIG
			 was inadequate to cover the cost many providers must pay for the product.
			 During the third quarter of 2006, 44 percent of IVIG sales to hospitals and 41
			 percent of sales to physicians by the three largest distributors occurred at
			 prices above Medicare payment amounts.
				(6)The ASPE report notes that after the new
			 reimbursement rules for physicians was instituted in 2005, 42 percent of
			 Medicare beneficiaries who had received their IVIG treatment in their
			 physician’s office at the end of 2004 were shifted to the hospital outpatient
			 setting by the beginning of 2006. This shift in site of care has resulted in
			 lack of continuity of care and adverse impact on health outcomes and quality of
			 life.
				(7)The OIG also
			 reported that 61 percent of responding physicians indicated that they had sent
			 patients to hospitals for IVIG treatment, largely because of their inability to
			 purchase IVIG at prices below the Medicare payment amounts. In addition, OIG
			 found that some physicians had stopped providing IVIG to Medicare beneficiaries
			 altogether.
				(8)The OIG’s 2007
			 report concluded that whatever improvement some providers saw in the
			 relationship of Medicare reimbursement for IVIG to prices paid during the first
			 three quarters of 2006 would be eroded if manufacturers were to increase prices
			 for IVIG in the future.
				(9)The Centers for
			 Medicare & Medicaid Services, in recognition of dislocations experienced by
			 patients and providers in obtaining IVIG since the change to the ASP+6
			 reimbursement methodology, has provided during 2006 and 2007 a temporary
			 additional payment for IVIG preadministration-related services to compensate
			 physicians and hospital outpatient departments for the extra resources they
			 have had to expend in locating and obtaining appropriate IVIG products and in
			 scheduling patient infusions.
				(10)Approximately 10,000 Medicare beneficiaries
			 receive IVIG treatment for their primary immunodeficiency disease in a variety
			 of different settings. They have no other effective treatment for their
			 condition.
				(11)The Medicare Modernization Act of 2003
			 (MMA) established an IVIG home infusion benefit for persons with primary
			 immunodeficiency disease (PIDD), paying only for IVIG and specifically
			 excluding coverage of items and services related to administration of the
			 product.
				(12)The ASPE report,
			 Analysis of Supply, Distribution, Demand, and Access Issues Associated with
			 Immune Globulin Intravenous (IGIV), found that Medicare’s IVIG home infusion
			 benefit is not designed to reimburse for more than the cost of IVIG and does
			 not cover the cost of infusion services (for example, nursing and clinical
			 services and supplies) in the home. As a consequence, the report found that
			 home infusion providers generally do not accept new PIDD patients with only
			 Medicare coverage. These limitations in service are caused by health care
			 providers(A)not being able to
			 acquire IVIG at prices at or below the Medicare part B reimbursement level, and(B)not being
			 reimbursed for the infusion services provided by a nurse.
						(13)Access to home infusion of IVIG for PIDD
			 patients, who have a genetic or intrinsic defect in their human immune system,
			 will reduce their exposure to infections at a time when their antibodies are
			 compromised and will improve the quality of their care and their health.
				3.Medicare payment
			 for immune globulins
			(a)In
			 generalSection 1842(o)(1)(E)
			 of the Social Security Act (42 U.S.C. 1395u(o)(1)(E)) is amended—
				(1)in paragraph
			 (1)(E)(ii), by inserting before the period the following: , plus an
			 additional amount (if applicable) under paragraph (7);
				(2)in paragraph (7),
			 by striking (6) and inserting (7) and by
			 redesignating it as paragraph (8); and
				(3)by inserting after
			 paragraph (6) the following new paragraph:

						(7)(A)Not later than 6 months after the date of
				the enactment of the Medicare IVIG Access Act of 2007, the Secretary
				shall—
								(i)collect data on the differences, if
				any, between payments to physicians for immune globulins under paragraph
				(1)(E)(ii) and costs incurred by physicians for furnishing these products;
				and
								(ii)review available data, including survey
				data presented by members of the IVIG community on the access of individuals
				eligible for services under this part to immune globulins.
								(B)Upon completion of the review and
				collection of data under subparagraph (A), and not later than 7 months after
				the date of the enactment of this paragraph, the Secretary shall provide, if
				appropriate, to physicians furnishing immune globulins, a payment, in addition
				to the payment provided for in paragraph (1)(E)(ii), for all items related to
				the furnishing of immune globulins, in an amount that the Secretary determines
				to be appropriate.
							(C)In the case of immune globulins
				furnished on or after January 1, 2007, the Secretary shall continue the
				preadministration-related services payment established under the Final
				Physician Fee Schedule Rule issued by the Centers for Medicare & Medicaid
				Services on November 1, 2006 (CMS–1321–FC), until such time as the Secretary
				determines that payment for immune globulins is adequate or until a new payment
				methodology is
				implemented.
							.
				(b)As part of
			 hospital outpatient servicesSection 1833(t)(14) of such Act (42
			 U.S.C. 1395l(t)(14)) is amended—
				(1)in subparagraph
			 (A)(iii), by striking subparagraph (E) and inserting
			 subparagraphs (E) and (I); and
				(2)by adding at the
			 end the following new subparagraph:

						(I)Additional
				payment for immune globulins
							(i)Data collection
				and reviewNot later than 6
				months after the date of the enactment of the Medicare IVIG Access Act of 2007,
				the Secretary shall—
								(I)review available data, including survey
				data presented by members of the IVIG community, on the access of individuals
				eligible for services under this part to immune globulins; and
								(II)collect data on the differences, if any,
				between payments for immune globulins under subparagraph (A)(iii) and costs
				incurred for furnishing these products.
								(ii)Additional
				payment authorityUpon
				completion of the review and collection of data under clause (i), and not later
				than 7 months after the date of the enactment of this subparagraph, the
				Secretary shall provide, if appropriate, to hospitals furnishing immune
				globulins as part of a covered OPD service, a payment, in addition to the
				payment provided for under subparagraph (A)(iii), for all items related to the
				furnishing of immune globulins, in an amount that the Secretary determines to
				be appropriate.
							(iii)Continuation
				of special payment ruleIn the case of immune globulins furnished
				on or after January 1, 2007, the Secretary shall continue the
				preadministration-related services payment established under the Final Hospital
				Outpatient Rule issued by the Centers for Medicare & Medicaid Services
				November 1, 2006 (CMS–1506–FC), until such time as the Secretary determines
				that payment for immune globulins is adequate or until a new payment
				methodology is
				implemented.
							.
				4.Coverage and
			 payment of intravenous immune globulin in the home
			(a)Including
			 coverage of administration
				(1)In
			 generalSection 1861 of the Social Security Act (42 U.S.C. 1395x)
			 is amended—
					(A)in subsection (s)(2)(Z), by inserting
			 before the semicolon at the end the following: , regardless of whether
			 the individual receiving the globulin is eligible to receive home health
			 services under this title; and
					(B)in subsection
			 (zz), by striking but not including items or services related to the
			 administration of the derivative.
					(2)Conforming home
			 health amendmentSection 1814(a) of such Act (42 U.S.C. 1395f(a))
			 is amended by adding at the end the following: An individual eligible
			 for intravenous immune globulin under section 1861(s)(2)(Z) shall not be
			 considered eligible for home health services under paragraph (2)(C) or section
			 1835(a)(2)(A) solely on the basis of meeting the requirements of such
			 subsection or section 1861(zz)..
				(b)Payment for
			 intravenous immune globulin administration in the homeSection
			 1834 of such Act (42 U.S.C. 1395m) is amended by adding at the end the
			 following new subsection:

					(n)Payment for
				intravenous immune globulin in the homeThe Secretary shall review available
				published and unpublished data and information, including the Study of
				Intravenous Immune Globulin Administration Options: Safety, Access, and Cost
				Issues (CMS Contract #500–95–0059), on confirming the appropriateness of
				administration of intravenous immune globulin in the home setting, and (as
				appropriate) calculate the amount, in addition to that made under section
				1842(o)(1)(E)(ii) for immune globulins, that should be paid to providers for
				clinical, compliance, and complication management services for ensuring safe
				and efficacious delivery of immune globulins in the home setting under
				1861(s)(2)(Z). The Secretary shall pay such amounts no later than January 1,
				2008.
					.
			(c)Application of
			 criminal record request provisions to IVIG in-home providersSection 124(i)(1) of the Departments of
			 Commerce, Justice, State, the Judiciary, and Related Agencies Appropriations
			 Act, 1999 (as contained in section 1(b) of Public Law 105–277; 112 Stat.
			 2681–74) is amended by adding at the end the following: Such term
			 includes an entity providing intravenous immune globulin under part B of title
			 XVIII of the Social Security Act in a home..
			(d)Effective
			 dateThe amendments made by subsections (a) and (b) shall apply
			 to intravenous immune globulin administered on or after January 1, 2008.
			5.Patient access
			 surveys and reports
			(a)SurveysThe Secretary of Health and Human Services
			 shall conduct, not later than 3 years after the date of the enactment of this
			 Act, two surveys of Medicare and non-Medicare patients who need immune
			 globulins for the purpose of measuring changes in patient access to those
			 products (and providers furnishing those products), as well as changes in the
			 health care status of those patients. The Secretary may enter into contracts
			 with organizations or entities qualified to conduct such surveys.
			(b)Survey
			 reportsEach of the surveys shall include a report to the
			 Secretary and the Committees on Energy and Commerce and Ways and Means of the
			 House of Representatives and the Committee on Finance of the Senate on findings
			 from the survey, as well as a discussion of reasons for observed changes, if
			 any.
			(c)Congressional
			 reportsOn the basis of findings from such surveys, the Secretary
			 shall submit to Congress reports that include recommendations on necessary
			 adjustments in payments for immune globulins under the Medicare program in
			 order to assure beneficiary access to those products and providers that furnish
			 those products. The first such report shall be submitted no later than 2 years
			 after the date of the enactment of this Act and the second report no later than
			 four years after such date.


114 HR 6474 IH: To eliminate the daily newspaper cross-ownership rule of the Federal Communications Commission.
U.S. House of Representatives
2016-12-07
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.

I114th CONGRESS2d SessionH. R. 6474IN THE HOUSE OF REPRESENTATIVESDecember 7, 2016Mr. Walden (for himself, Mr. Yarmuth, Mr. Gene Green of Texas, Mr. Rush, Mr. Bilirakis, Mr. Olson, and Mr. Guthrie) introduced the following bill; which was referred to the Committee on Energy and CommerceA BILLTo eliminate the daily newspaper cross-ownership rule of the Federal Communications Commission.

		1.Elimination of daily newspaper cross-ownership rule
 (a)No force or effectParagraph (d) of section 73.3555 of title 47, Code of Federal Regulations, shall have no force or effect after the date of the enactment of this Act.
 (b)Removal from rulesNot later than 1 year after the date of the enactment of this Act, the Federal Communications Commission shall complete all actions necessary to remove such paragraph from its rules.


114 HR 4402 : Foreign Fighter Review Act of 2016
U.S. House of Representatives
2016-02-24
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.

		IIB
		114th CONGRESS
		2d Session
		H. R. 4402
		IN THE SENATE OF THE UNITED STATES
		February 24, 2016Received; read twice and referred to the Committee on Homeland Security and Governmental AffairsAN ACT
		To require a review of information regarding persons who have traveled or attempted to travel from
			 the United States to support terrorist organizations in Syria and Iraq,
			 and for other purposes.

 1.Short titleThis Act may be cited as the Foreign Fighter Review Act of 2016. 2.United States Government review of certain foreign fighters (a)ReviewNot later than 30 days after the date of the enactment of this Act, the President, acting through the Secretary of Homeland Security, shall initiate a review of known instances since 2011 in which a person has traveled or attempted to travel to a conflict zone in Iraq or Syria from the United States to join or provide material support or resources to a terrorist organization. Such review shall—
 (1)include relevant unclassified and classified information held by the United States Government related to each instance;
 (2)ascertain which factors, including operational issues, security vulnerabilities, systemic challenges, or other issues that may have undermined efforts to prevent the travel of such persons to a conflict zone in Iraq or Syria from the United States, including the timely identification of suspects, information sharing, intervention, and interdiction; and
 (3)identify lessons learned and areas for improvement to prevent additional travel by such persons to a conflict zone in Iraq or Syria, or other terrorist safe havens abroad, to join or provide material support or resources to a terrorist organization.
 (b)Information sharingIf necessary, the President shall direct the heads of relevant Federal agencies to provide the appropriate information necessary for the Secretary of Homeland Security to complete the review required under subsection (a).
 (c)Submission to CongressNot later than 120 days after the date of the enactment of this Act, the Secretary of Homeland Security shall, consistent with the protection of classified information, submit to the appropriate congressional committees the results of the review required under subsection (a), which may include information on travel routes of greatest concern.
 (d)Prohibition on additional fundingNo additional funds are authorized to be appropriated to carry out this section. (e)DefinitionsIn this section:
 (1)Appropriate congressional committeesThe term appropriate congressional committees means— (A)in the House of Representatives—
 (i)the Committee on Homeland Security; (ii)the Permanent Select Committee on Intelligence;
 (iii)the Committee on the Judiciary; (iv)the Committee on Armed Services;
 (v)the Committee on Foreign Affairs; (vi)the Committee on Financial Services; and
 (vii)the Committee on Appropriations; and (B)in the Senate—
 (i)the Committee on Homeland Security and Governmental Affairs; (ii)the Select Committee on Intelligence;
 (iii)the Committee on the Judiciary; (iv)the Committee on Armed Services;
 (v)the Committee on Foreign Relations; (vi)the Committee on Banking, Housing, and Urban Affairs; and
 (vii)the Committee on Appropriations. (2)Material support or resourcesThe term material support or resources has the meaning given such term in section 2339A of title 18, United States Code.

	Passed the House of Representatives February 23, 2016.Karen L. Haas,Clerk


109 HCON 108 IH: Expressing the sense of the Congress that the community development block grant program should remain under the administration of the Secretary of Housing and Urban Development.
U.S. House of Representatives
2005-03-17
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.

IV
109th CONGRESS
1st Session
H. CON. RES. 108
IN THE HOUSE OF REPRESENTATIVES

March 17, 2005
Ms. Kilpatrick of Michigan submitted the following concurrent resolution; which was referred to the Committee on Financial Services

CONCURRENT RESOLUTION
Expressing the sense of the Congress that the community development block grant program should remain under the administration of the Secretary of Housing and Urban Development.

Whereas the community development block grant (CDBG) program was established by the Housing and Community Development Act of 1974 as a responsibility of the Secretary of Housing and Urban Development and has been administered by HUD since its inception;
Whereas the CDBG program has been, and currently is, an important and vital tool for improving communities across the United States;
Whereas the CDBG program has been extremely successful because it allows States, cities, and towns the flexibility to determine their own priorities and to develop successful strategies to address their particular community development needs, rather than having such priorities and strategies dictated by the Federal Government;
Whereas the President's Budget of the United States Government for fiscal year 2006 proposes replacing the CDBG program with a grant program to be administered by the Department of Commerce;
Whereas in establishing the community development block grant program, the Congress specified that the primary objective of the program is not only economic development, but the development of viable urban communities through the provision of decent housing and a suitable living environment; and
Whereas replacing the CDBG program with a program administered by the Department of Commerce is inappropriate because the mission of the program would fundamentally be altered from a municipal focus on the revitalization of distressed neighborhoods to a focus on business interests concentrating on economic development projects: Now, therefore, be it

That it is the sense of the Congress that the community development block grant program should remain under the administration of the Secretary of Housing and Urban Development.


		I
		111th CONGRESS
		1st Session
		H. R. 602
		IN THE HOUSE OF REPRESENTATIVES

			January 16, 2009
			Mr. Bishop of Utah
			 introduced the following bill; which was referred to the
			 Committee on Natural
			 Resources

		A BILL
		To provide for the conveyance of the Bureau of Land
		  Management parcels known as the White Acre and Gambel Oak properties and
		  related real property to Park City, Utah, and for other
		  purposes.

		1.Conveyance of land by the
			 Bureau of Land Management to Park City, Utah
			(a)Land
			 TransferNotwithstanding the planning requirements of sections
			 202 and 203 of the Federal Land Policy and Management Act of 1976 (43 U.S.C.
			 1712, 1713), the Secretary of the Interior shall convey, not later than 180
			 days after the date of the enactment of this Act, to Park City, Utah, all
			 right, title, and interest of the United States in and to two parcels of real
			 property located in Park City, Utah, that are currently under the management
			 jurisdiction of the Bureau of Land Management and designated as parcel 8
			 (commonly known as the White Acre parcel) and parcel 16 (commonly known as the
			 Gambel Oak parcel). The conveyance shall be subject to all valid existing
			 rights.
			(b)Deed
			 RestrictionThe conveyance of the lands under subsection (a)
			 shall be made by a deed or deeds containing a restriction requiring that the
			 lands be maintained as open space and used solely for public recreation
			 purposes or other purposes consistent with their maintenance as open space.
			 This restriction shall not be interpreted to prohibit the construction or
			 maintenance of recreational facilities, utilities, or other structures that are
			 consistent with the maintenance of the lands as open space or its use for
			 public recreation purposes.
			(c)ConsiderationAs
			 consideration for the transfer of the land under subsection (a), Park City
			 shall pay to the Secretary of the Interior an amount consistent with
			 conveyances to governmental entities for recreational purposes under the Act of
			 June 14, 1926 (commonly known as the Recreation and Public Purposes Act; 43
			 U.S.C. 869 et seq.).
			2.Sale of Bureau of
			 Land Management land in Park City, Utah, at auction
			(a)Sale of
			 LandNot later than 180 days after the date of the enactment of
			 this Act, the Secretary of the Interior shall offer for sale any right, title,
			 or interest of the United States in and to two parcels of real property located
			 in Park City, Utah, that are currently under the management jurisdiction of the
			 Bureau of Land Management and are designated as parcels 17 and 18 in the Park
			 City, Utah, area. The sale of the land shall be carried out in accordance with
			 the Federal Land Policy and Management Act of 1976 (43 U.S.C. 1701) and other
			 applicable law, other than the planning provisions of sections 202 and 203 of
			 such Act (43 U.S.C. 1712, 1713), and shall be subject to all valid existing
			 rights.
			(b)Method of
			 SaleThe sale of the land under subsection (a) shall be
			 consistent with subsections (d) and (f) of section 203 of the Federal Land
			 Policy and Management Act of 1976 (43 U.S.C. 1713) through a competitive
			 bidding process and for not less than fair market value.
			3.Disposition of
			 land sales proceedsAll
			 proceeds derived from the sale of land described in this Act shall be deposited
			 in the Federal Land Disposal Account established by section 206(a) of the
			 Federal Land Transaction Facilitation Act (43 U.S.C. 2305(a)).