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LOBBYING REPORT |
Lobbying Disclosure Act of 1995 (Section 5) - All Filers Are Required to Complete This Page
2. Address
Address1 | 1000 NORTH OAK AVENUE |
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City | MARSHFIELD |
State | WI |
Zip Code | 54449 |
Country | USA |
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5. Senate ID# 57830-12
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6. House ID# 352550000
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TYPE OF REPORT | 8. Year | 2012 |
Q1 (1/1 - 3/31) | Q2 (4/1 - 6/30) | Q3 (7/1 - 9/30) | Q4 (10/1 - 12/31) |
9. Check if this filing amends a previously filed version of this report
10. Check if this is a Termination Report | Termination Date | |
11. No Lobbying Issue Activity |
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12. Lobbying | 13. Organizations | ||||||||
INCOME relating to lobbying activities for this reporting period was: | EXPENSE relating to lobbying activities for this reporting period were: | ||||||||
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Provide a good faith estimate, rounded to the nearest $10,000, of all lobbying related income for the client (including all payments to the registrant by any other entity for lobbying activities on behalf of the client). | 14. REPORTING Check box to indicate expense accounting method. See instructions for description of options. | ||||||||
Method A.
Reporting amounts using LDA definitions only
Method B. Reporting amounts under section 6033(b)(8) of the Internal Revenue Code Method C. Reporting amounts under section 162(e) of the Internal Revenue Code |
Signature | Digitally Signed By: Brent V. Miller, Director of Federal Government Relations |
Date | 04/18/2012 |
LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.
15. General issue area code BUD
16. Specific lobbying issues
Budget Control Act (S. 365, PL 112-25) provisions requiring mandatory sequestration of federal funding if Congress does not act to implement deficit reduction.
Medicare Payment Advisory Commission recommendations regarding reform of the Sustainable Growth Rate (SGR) formula of the Medicare physician fee schedule, and offsets to fund the reforms.
The House Republican fiscal 2013 budget blueprint, (H. Con. Res. 112), called "the Path To Prosperity" written by Rep. Paul Ryan
Afterschool Health Services Program
The primary focus is an Afterschool Health Services Program, which provides the infrastructure for communities to work collaboratively to improve health of youth in afterschool settings. This approach recognizes afterschool programs as a credible venue for health improvement as our nation moves forward with health care reform. This approach also takes into account the research base that demonstrates that a quality education is a number one determinant to good health. Marshfield Clinic will support legislation to implement quality services in afterschool settings that include case management of individual youth to promote academic success, personal/social development and health/wellness. This will include access to clinical services designed to meet the identified needs of enrolled youth i.e. early and periodic screening, well-child visits, immunizations, behavioral health appointments/treatment plan compliance, dental screening and sealants, asthma case management; Evidence-based programs, practices and policies targeting identified health priorities i.e. alcohol and other substance use and addiction, high-risk sexual behavior, intentional and unintentional injuries and violence, overweight, obesity and lack of physical activity, tobacco use and exposure; Release of information forms and written consents signed by parents prior to services.
Healthy Lifestyles Program
There is a need for strategic action at the federal level to counter the obesity epidemic in our nation. Chronic diseases related to obesity such as diabetes, heart disease, high blood pressure and certain cancers are the leading causes of premature death and disability. Unless the obesity epidemic can be curbed, the life expectancy of future generations will be compromised. Programs, practices and policy approaches that have been effective in the adult population such as employee wellness and policies promoting physical activity must be implemented early in life to redirect obesity inducing habits and behaviors in children. Marshfield Clinic will support legislation to implement policies that take a comprehensive approach to obesity prevention, addressing nutrition and physical activity in a broad variety of environments including communities, businesses and schools.
Medicaid Block Grants
On March 29, the House approved Rep. Paul Ryans budget proposal for FY 2013, entitled "The Path to Prosperity. Ryan's proposal does not have the force of law but of special interest is Ryans proposal for Medicaid block grants which will come before the Energy and Commerce Committee. Under the Ryan proposal, starting in 2013, the federal share of all Medicaid payments would be paid to the states as a block grant. Chairman Ryan has projected savings to federal government that would result from reduced funding to states.
Premium support
On March 29, the House approved Rep. Paul Ryans budget proposal for FY 2013, entitled "The Path to Prosperity. Ryan's budget does not have the force of law but tees up consideration of various reform proposals which may be considered later this year. With regard to health care, the Ryan plan calls for a major withdrawal of the federal government from the financing of health care. One health provision of the proposal calls for conversion of the current Medicare to a premium support program. For people now 55 or younger, the traditional Medicare program a defined benefit plan would cease to exist and, starting in 2023, would be converted to a defined contribution program which has been described as a premium support program.
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Centers For Medicare and Medicaid Services (CMS), Health & Human Services - Dept of (HHS), Medicare Payment Advisory Commission (MedPAC)
18. Name of each individual who acted as a lobbyist in this issue area
First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
Brent |
Miller |
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19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.
15. General issue area code MMM
16. Specific lobbying issues
The following bullet points summarize the objectives of the Marshfield Clinics Health Policy Agenda:
value-based purchasing of health services including bonus payments for high value Medicare Advantage programs;
establishment and funding of comparative effectiveness research;
new formulas for aligning Medicare reimbursement with value;
bonus payments for efficient providers;
bonus payments for primary care providers;
financing for the adoption and utilization of health information technology;
repeal and reform of the Medicare sustainable growth rate mechanism for updating physician payments;
improved reimbursement for the CMS Physician Group Practice (PGP) demonstration;
expansion of the PGP demonstration methodology into a national accountable care organization program to extend the physician group practice demonstration;
Adequate funding for CMS;
Adequate funding for community health centers;
Funding for after-school programs
Integration of Medical and dental care and records
Meaningful use of HIT;
Funding for medical simulation training
Personalized medicine
Healthy lifestyles programs
Budget Control Act (S. 365, PL 112-25) provisions requiring mandatory sequestration of federal funding if Congress does not act to implement deficit reduction. Medicare Payment Advisory Commission recommendations regarding reform of the Sustainable Growth Rate (SGR) formula of the Medicare physician fee schedule, and offsets to fund the reforms.
H.R.3682 : Patient Centered Healthcare Savings Act of 2011
Sponsor: Rep Duffy, Sean P. - Marshfield Clinic, the corporate sponsor of Security Health Plan, a five star Medicare Advantage program, opposes provisions which promote the sale of insurance across state lines but do not address the disparities in existing state law which would allow other insurance entities to circumvent Wisconsin law.
HR 3630 the House Payroll Tax holiday bill H.R.3630 Temporary Payroll Tax Cut Continuation Act of 2011 Sponsor: Rep Camp, Dave. The bill also included a "doc fix" - a 1% increase in Medicare physician payment for 2012 and 2013; The bill also extends through 2012 the floor at 1.0 on the work geographic index in the formula for determining relative values for physicians' services for the Medicare physician payment; and directed MEDPAC to assess whether any geographic adjustment is needed under Medicare to distinguish the difference in work effort by geographic area, and if so, what that level should be and were it should be applied. The bill also revises Medicare hospital outpatient department (OPD) payment amounts for evaluation and management services, bringing them into parity with physician E&M payments.
H.R.3765 Temporary Payroll Tax Cut Continuation Act of 2011 Sponsor: Rep Camp, Dave two month extension Medicare physician payment increase.
Value Based Purchasing
The concept of value-based health care purchasing is that buyers should hold providers of health care accountable for both cost and quality of care. Value-based purchasing brings together information on the quality of health care, including patient outcomes and health status, with data on the dollar outlays going towards health. It focuses on managing the use of the health care system to reduce inappropriate care and to identify and reward the best-performing providers. Recommendations:
Medicare and other payors must capture the data on performance measures utilizing available claims-based data, and/or data recoverable through enhanced IT functions, and validate performance improvement.
Implement quality/efficiency based payments for physician services as soon as possible.
Implement bundled payments for episodes of care.
Implement FFS reimbursement for the value added through care management and coordination of services.
Improve reimbursement for primary care services.
Variations in Health Care Service and Distribution
Research conducted the Medicare Payment Advisory commission and the Dartmouth School of Medicine has documented glaring variations in how medical resources are distributed and used in the United States. Medicare pays many hospitals and their doctors much more than what it pays the most efficient and effective health care institutions to treat chronically ill people, yet they still get worse results. The extent of variation in Medicare spending, and the evidence that more care does not result in better outcomes, should lead us to ask if some chronically ill Americans are getting more care than they actually want or need. Caring for people with chronic disease now accounts for more than 75 percent of all health-care spending. Over-use and overspending is not just a Medicare problemthe health-care system as a whole lacks efficient, effective ways of caring for people with severe chronic illnesses. If the U.S. health care system mirrored the practice patterns of the most efficient/effective health care institutions, Medicare and other payors could save billions of dollars annually.
Sustainable Growth Rate
Medicares SGR mechanism unfairly links physician payment updates to factors unrelated to patients needs and the cost of providing patient care. For years the Marshfield Clinic has watched Medicare physician payments atrophy in proportion to the cost of providing Medicare Services. In 2010 the Clinic recovered only 52.45% of the Medicare Allowable Costs of serving Medicare patients. In 2009 the Clinic lost 49.6 cents on each dollar of care provided. As payments have deteriorated in both the Medicare and Medicaid sector, the Clinic has documented increasing patient counts as other physicians and providers in the communities that we serve turn patients away. The difficulty of correctly updating physician fees is complicated by problems with the fee schedule regarding resource use, compensation for care coordination, and volume growth that point to Mispricing related to the value of physician services; inaccuracy of practice expense (overhead) calculations; and increasing variation in the volumes of services provided in different regions of the country. Uncertainty about the Medicare/Medicaid revenue stream complicates Clinic efforts to provide services where they are needed. Stability, adequacy, and predictability in payment should be the highest priority for Congress to assure high quality efficient care for all patients, but especially for the 20% of the population that is chronically ill and responsible for 75% of Medicare spending.
Medicare Payment Inequities
In the traditional fee-for-service system Medicare currently reimburses for units of service, in a manner that promotes service utilization without regard to quality. This has had the effect of economically stimulating growth in the numbers of supply-sensitive services provided by physicians. The Update formula for physician services is inequitable because it treats all physicians and regions of the country alike regardless of their individual volume influencing behavior. If the problem of cost is related to the volume of services provided, shouldnt payment be volume adjusted for specific localities? Why should conservative practices and States be punished for the excessive volume of other localities?
Payment Equity for Physician Work
There is no difference in the work of physicians in different locations regardless of where the work occurs. We believe that physician work should not be adjusted for geographic location. What is the rational for paying physicians more in many geographic areas when those same areas have apparently ample numbers of physicians and their wages are trending below physician wages in other areas? Should the Medicare program subsidize physicians who chose to live in high cost areas? Recommendation: the geographic adjustment of physician work should be eliminated entirely on a Budget neutral basis.
Payment Fairness for Practice Costs
The formulas by which Medicares payments are calculated are widely variable throughout Medicare localities, and are based upon outdated data assumptions regarding the cost and organization of medical practice. Medicares physician fee schedule, which specifies the amount that Medicare will pay for each physician service, includes adjustments that are ostensibly made to ensure that the fees paid reflect systematic and enduring variation in geographic practice-related costs. Currently, CMS uses the median hourly earnings of four occupational classes -- Clerical Workers, Registered Nurses, Licensed Practical Nurses, and Medical Technicians -- found in physician offices as proxy non-physician wage input cost measures. These proxy occupational classes, which were the most common employees in physician practices in the 1980s, are now only a subset of non-physician employees in physician practices. The practice of medicine has changed substantially since the proxy measurement formulae were established. Recommendation: Congress should require CMS to administratively revise its measurement of cost of practice to assure the validity and fairness of payments.
Medicare Advantage
The Medicare Advantage program provides a capitated reimbursement to health plans for all Medicare benefits provided to enrolled beneficiaries. Corresponding mechanisms for rewarding value in the Medicare Advantage program should offer incentives for those plans that demonstrate superior patient care performance. Performance bonuses should be provided for plans that:
Achieve predetermined quality performance targets;
Adopt health information technology;
Meet standards for care coordination; and
Provide data on comparative effectiveness.
Accountable Care Organizations
One important delivery system reform is the Medicare Shared Savings Program under section 3022 of the Affordable Care Act, which promotes the formation and operation of accountable care organizations (ACOs). Under this provision, groups of providers meeting the criteria specified by the Secretary may work together to manage and coordinate care for Medicare beneficiaries through an [ACO]. An ACO may receive payments for shared savings if the ACO meets certain quality performance standards and cost savings requirements established by the Secretary.
The basic shared savings model outlined in the statute provides a bonus payment to ACOs that meet quality targets and keep spending for the population for whom the ACO is responsible below a target level. The amount of the bonus payment will depend on the amount of savings and the proportion of the savings allocated to the ACO and Medicare ACOs should report a focused set of quality indicators that reflect the outcomes ACOs are designed to achieve: keeping the population healthy, better care coordination to reduce unnecessary and sometimes harmful spending, and better patient experience. New measures may be necessary for ACOs because the current measures reflect the limitations and incentives of the current FFS payment system. A focused set of measures would help assure Medicare that the ACO is doing its job and help assure beneficiaries that they are receiving high quality care.
Adequate Funding for CMS
The problems facing the Medicare program stem from the nations earliest attempts to make health care services broadly available nationwide without disturbing the economic incentives that were then in place. The federal government developed formulae to evaluate the cost of providing services in different practice settings and in different geographic locations. Those formulae measure resource inputs that have changed over the +40 year life of the program. To ensure affordable access to Medicare services throughout the country Medicare must take steps to refine its measures of the cost of providing services so that Medicares overwhelming financial dominance does not interfere with affordable access in markets that have changed very much since the program began. Congress must ensure that CMS has adequate funding to provide oversight of its many programs, including its measurement of resource and input costs.
Community Health Centers Under Health Reform
The Affordable Care Act included provisions relating to community health centers, including $11 billion in new funding for the community health center program over the next five years and $1.5 billion over the next five years to expand the National Health Service Corp. While these are mandatory funding levels, it is possible that the Congress might cut the base funding levels for community health centers and the National Health Service Corp effectively diminishing the impact of the reform legislation. As reform is rolled out there are key payment protections and improvements for community health centers. For example, the Act requires that health centers receive no less than their Medicaid rate from private insurers offering plans through the new health insurance exchanges and it requires that these plans must contract with health centers. Other provisions add preventive services to the federally qualified health center Medicare payment rate and eliminates the outdated Medicare payment cap on FQHC payments. This will begin to modernize the health center Medicare payments to insure health centers are able to provide highest quality care to Medicare beneficiaries. Historically, Family Health Center and Marshfield Clinic have not attempted to access cost-based reimbursement under Medicare because of these payment caps.
Dental Access and Integration with Traditional Medicine
The Institute of Medicine (IOM) released a report, Dental Education at the Crossroads: Challenges and Change in January 1995 which called for a strong cohesion between medicine and dentistry. The IOM report states that "Dentistry will and should become more closely integrated with medicine and the health care system on all levels: research, education, and patient care." The National Institutes of Health has supported research documenting the importance of oral health in the context of general health and well being. Studies have demonstrated numerous oral-systemic interactions that underscore the need for more integrated care delivery. As our nation embraces EHR technologies, science underscores the need to fully incorporate oral health within an integrated EHR. Marshfield Clinic is simultaneously addressing the issue of dental access and integration with traditional medicine. Family Health Center of Marshfield, Inc. (FHC) in partnership with Marshfield Clinic has been serving low-income, underinsured and uninsured individuals since March 1974. Using technology to integrate medical and dental health records holds great promise to improve the quality, safety, efficiency, effectiveness and continuity of patient care by enhancing communication and teamwork between physicians and dentists. A comprehensive approach to primary care delivery, demonstrated by Marshfield Clinic and community health centers nationwide, can best be supported with an equally comprehensive EHR infrastructure for both medical and dental records.
Meaningful Use of Health Information Technology
The accelerating growth in new medical knowledge, coupled with the birth of new sciences, such as genomics and personalized medicine, suggests that physicians, nurses, and other healthcare professionals will invariably continue to fall further and further behind in their ability to keep up with the latest discoveries and approved treatments. As information technology has sparked this explosive growth in knowledge, only information technology can provide an adequate response. By using evidence-based knowledge embedded in clinical decision support deployed within a well-designed workflow, physicians can manage the ever changing and growing knowledge base critical to the delivery of effective and efficient healthcare. Health IT on a broad basis is still in its infancy. Looking to what can be achieved in the future due to implementation of these systems should be our focus, and an ongoing oversight function of the Office of the National Coordinator for HIT which must be closely integrated with Medicare reimbursement.
Personalized Medicine
Personalized medicine is the concept that envisions an individually tailored approach to detecting, preventing, and treating disease based on a person's specific genetic profile. If the multiple population groups in the United States and elsewhere in the world are to benefit fully and fairly from such research, a national resource operated as a trust for the public good must be established to conduct a large population-based cohort study that includes full representation of minority populations. Marshfield Clinic has developed a comprehensive bio-bank, consisting of DNA samples from 20,000+ individuals. The samples, often from extended families, have been linked electronically to medical records for more than 20 years of medical history. Further development of this public health infrastructure is in the national interest. The Federal government should make critical investments in the enabling tools and resources essential to moving beyond genomic discoveries to personalized medicine services of patient and public benefit.
Medical Simulation Training
The Accreditation Council on Graduate Medical Education (ACGME) Program Requirements for Resident Education in Internal Medicine has recommended that residency programs need to "Provide residents with access to training using simulation". The need for medical simulation is great; medical errors continue to kill approximately 98,000 people annually. Over the past decade, this amounts to almost a staggering one million accidental patient deaths. These errors cost the US approximately $17-$29 billion annually. Medical errors are highly preventable through the use of modeling and simulation in medical education. Simulation will enhance technical and communication skills of physicians and other medical providers in high fatality, low frequency skills, such as emergency cricothyroidotomy, and amniocentesis and physician re-entry skill verification, such as pelvic exam and central line placement. Simulation experiences also provide the opportunity to enhance team communication and patient to provider communication through the recreation of uncommon or stressful scenarios such as obtaining a sexual health history or abuse/neglect screening. Marshfield Clinic will support legislation to initiate, maintain and grow medical simulation programs through the identification of simulation centers of excellence, advancement of simulation technologies, allocation of grant funds for institutions who train healthcare providers and call together key leaders to discuss the direction of medical simulation
Medicaid Block Grants
On March 29, the House approved Rep. Paul Ryans budget proposal for FY 2013, entitled "The Path to Prosperity. Ryan's proposal does not have the force of law but of special interest is Ryans proposal for Medicaid block grants which will come before the Energy and Commerce Committee. Under the Ryan proposal, starting in 2013, the federal share of all Medicaid payments would be paid to the states as a block grant. Chairman Ryan has projected savings to federal government that would result from reduced funding to states.
Premium support
On March 29, the House approved Rep. Paul Ryans budget proposal for FY 2013, entitled "The Path to Prosperity. Ryan's budget does not have the force of law but tees up consideration of various reform proposals which may be considered later this year. With regard to health care, the Ryan plan calls for a major withdrawal of the federal government from the financing of health care. One health provision of the proposal calls for conversion of the current Medicare to a premium support program. For people now 55 or younger, the traditional Medicare program a defined benefit plan would cease to exist and, starting in 2023, would be converted to a defined contribution program which has been described as a premium support program.
Practice expense geographic practice cost index (GPCI) adjustment: Retroactively effective from Jan. 1, 2010, HHS is required to revise the calculation method of the practice expense (PE) portion of the GPCI. This revision results in increased PE GPCIs for certain rural areas Statutory provisions to extend these additional payments lapse in 2012 and must be extended for 2013.
CMS Physician Group Practice Demonstration On September 27, 2002 the Centers for Medicare and Medicaid Services initially published a notice in the Federal Register informing interested parties of an opportunity to submit proposals for participation in the Medicare Physician Group Practice Demonstration (PGP) project to test a hybrid payment methodology that combines Medicare fee-for-service payments with a bonus pool derived from savings achieved by improvements in patient care management. Marshfield Clinic was selected by CMS to participate in the demonstration program, effective April 1, 2005 and has been involved as a participant working with CMS ever since. Marshfield Clinic supports CMS determination to extend this program, and transition these organizations into Accountable care Organizations. Section 1301 of the House bill HR 3962, the Affordable Health Care for America Act, and Section 3022 of the Senate bill HR 3590, the Patient Protections and Affordable Care Act.
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Centers For Medicare and Medicaid Services (CMS), Health & Human Services - Dept of (HHS), Medicare Payment Advisory Commission (MedPAC)
18. Name of each individual who acted as a lobbyist in this issue area
First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
Brent |
Miller |
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19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.
15. General issue area code HCR
16. Specific lobbying issues
Privacy and Security provisions of ARRA
The American Recovery and Reinvestment Act expands current Federal privacy and security protections for health information. Marshfield clinic has specific concerns about:
Providing transparency to patients by allowing them to request an audit trail showing all disclosures
of their health information- including treatment, payment and operations- made through an electronic record. Electronic health record (EHR) users or maintainers must provide requesting individuals with an accounting of protected health information disclosures made during the three years prior to the request (but only for as much of that three year period during which the EHR was in use). Marshfield Clinic is concerned about the potential costs and administrative burdens of this provision.
Covered entities must comply with requests to restrict the disclosure of an individuals protected health information if the disclosure is to a health plan for purposes of carrying out payment or health care operations and the information pertains solely to a health care item or service paid for out-of-pocket by the individual. Marshfield Clinic is concerned about the potential costs and administrative burdens of this provision.
In using, disclosing or requesting protected health information, covered entities must limit themselves, to the extent practicable, to limited data sets or the minimum necessary information. Marshfield Clinic is concerned about the potential costs and administrative burdens of this provision.
Marshfield Clinic supports provisions strengthening enforcement of Federal privacy and security laws by increasing penalties for violations and providing greater resources for enforcement and oversight activities.
Meaningful Use of health information technology
On December 30, 2009, the Centers for Medicare & Medicare Services (CMS) and the ONC released two regulations required by the American Recovery and Reinvestment Act that lay the foundation for meaningful use of certified electronic health record (EHR) technology. A proposed rule issued by CMS outlines proposed provisions governing the EHR incentive programs, including defining the central concept of meaningful use of EHR technology. An interim final regulation (IFR) issued by ONC sets initial standards, implementation specifications, and certification criteria for EHR technology. Marshfield Clinic is vendor of a proprietary electronic medical record, and closely follows federal developments of the HHS office of the national coordinator and the it HIT Policy and Standards Committees to assure meaningful use of electronic medical records and efficient standards for certification and interoperability of unrelated systems.
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Centers For Medicare and Medicaid Services (CMS), Health & Human Services - Dept of (HHS)
18. Name of each individual who acted as a lobbyist in this issue area
First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
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19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.
15. General issue area code PHA
16. Specific lobbying issues
Leukemia drug shortages are reaching crises dimensions, especially the recent shortage of cytarabine. In the United States, about 10,000 individuals are diagnosed with AML every year. Cytarabine is the backbone of AML therapy and is the basis for its cure. Without this drug patient outcomes are limited. We raised the concerns of shortages experienced by the Clinic to Senate and FDA
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Food & Drug Administration (FDA)
18. Name of each individual who acted as a lobbyist in this issue area
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19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
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