Look at the shameless bribes used to get wavering Democratic senators to vote for the healthcare bill. These bribes were so outrageous--even by Washington standards--they each earned a nickname:
The Louisiana Purchase: Sen. Landrieu was
promised an additional $300 million in Medicaid funding for Louisiana.
The Cornhusker Kickback: Sen. Ben Nelson secured exemptions for Nebraska's Medicaid payments worth around $100 million.
The U-Con: Sen. Dodd was promised $100
million for a medical center in CT.
Gator Aid: Sen. Bill Nelson inserted a grandfather clause that would protect Florida's Medicare Advantage program, a $2.5-$3 billion buyoff.
Additionally, Democratic senators from NE, VT, MA, MI, CT, MT,
SD, ND, and HI secured bonuses in the Medicare payments for hospitals in their states worth more than $2 billion. Although the so-called "reconciliation bill" stripped out some of these abuses, they were only removed due to widespread public outrage.
In the past six years as insurance commissioner, I’ve seen first hand what insurance companies will do if you let them, and it’s time to stop the practice of denying care, denying claims, and putting profits ahead of patients! We need a real patient’s
bill of rights to let people choose their own doctors and know about all available medical treatments, not just the cheapest. I’ve had a lot of practice lately taking on powerful interests.
Source: www.nelsonforsenate.com, “On Health Care”
, Sep 20, 2000
Voted NO on the Ryan Budget: Medicare choice, tax & spending cuts.
Proponent's Arguments for voting Yes:
[Sen. DeMint, R-SC]: The Democrats have Medicare on a course of bankruptcy. Republicans are trying to save Medicare & make sure there are options for seniors in the future. Medicare will not be there 5 or 10 years from now. Doctors will not see Medicare patients at the rate [Congress will] pay.
[Sen. Ayotte, R-NH]: We have 3 choices when it comes to addressing rising health care costs in Medicare. We can do nothing & watch the program go bankrupt in 2024. We can go forward with the President's proposal to ration care through an unelected board of 15 bureaucrats. Or we can show real leadership & strengthen the program to make it solvent for current beneficiaries, and allow future beneficiaries to make choices.
Opponent's Arguments for voting No:
[Sen. Conrad, D-ND]: In the House Republican budget plan, the first thing they do is cut $4 trillion in revenue over the next 10 years. For the wealthiest among us, they
give them an additional $1 trillion in tax reductions. To offset these massive new tax cuts, they have decided to shred the social safety net. They have decided to shred Medicare. They have decided to shred program after program so they can give more tax cuts to those who are the wealthiest among us.
[Sen. Merkley, D-TK]: The Republicans chose to end Medicare as we know it. The Republican plan reopens the doughnut hole. That is the hole into which seniors fall when, after they have some assistance with the first drugs they need, they get no assistance until they reach a catastrophic level. It is in that hole that seniors have had their finances devastated. We fixed it. Republicans want to unfix it and throw seniors back into the abyss. Then, instead of guaranteeing Medicare coverage for a fixed set of benefits for every senior--as Medicare does now--the Republican plan gives seniors a coupon and says: Good luck. Go buy your insurance. If the insurance goes up, too bad.
Status: Failed 40-57
Congressional Summary:Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to provide for the regulation of tobacco products by the Secretary of Health and Human Services through the Food and Drug Administration (FDA). Defines a tobacco product as any product made or derived from tobacco that is intended for human consumption. Excludes from FDA authority the tobacco leaf and tobacco farms.
Opponent's argument to vote No:Rep. HEATH SHULER (D, NC-11): Putting a dangerous, overworked FDA in charge of tobacco is a threat to public safety. Last year, the FDA commissioner testified that he had serious concerns that this bill could undermine the public health role of the FDA. And the FDA Science Board said the FDA's inability to keep up with scientific advancements means that Americans' lives will be at risk.
Proponent's argument to vote Yes:
Rep. HENRY WAXMAN (D, CA-30): The bill before us, the Waxman-Platts bill, has been carefully crafted over more than a decade, in close consultation with the public health community. It's been endorsed by over 1,000 different public health, scientific, medical, faith, and community organizations.
Sen. HARRY REID (D, NV): Yesterday, 3,500 children who had never smoked before tried their first cigarette. For some, it will also be their last cigarette but certainly not all. If you think 3,500 is a scary number, how about 3.5 million. That is a pretty scary number. That is how many American high school kids smoke--3.5 million. Nearly all of them aren't old enough to buy cigarettes. It means we have as many boys and girls smoking as are participating in athletics in high schools. We have as many as are playing football, basketball, track and field, and baseball combined.
Reference: Family Smoking Prevention and Tobacco Control Act;
; vote number 2009-S207
on Jun 11, 2009
Voted YES on expanding the Children's Health Insurance Program.
Reauthorizes State Children's Health Insurance Program (SCHIP) through FY2013 at increased levels.
Gives states the option to cover targeted low-income pregnant women
Phases out coverage for nonpregnant childless adults.
Proponent's argument to vote Yes:
Rep. FRANK PALLONE (D, NJ-6): In the last Congress, we passed legislation that enjoyed bipartisan support as well as the support of the American people. Unfortunately, it did not enjoy the support of the President, who vetoed our bill twice, and went on to proclaim that uninsured children can simply go to the emergency room to have their medical needs met. As the Nation moves deeper into a recession and unemployment rates continue to rise, millions of Americans are joining the ranks of the uninsured, many of whom are children. We can't delay. We must enact this legislation now.
Opponent's argument to vote No:Rep. ROY BLUNT (R, MI-7):
This bill doesn't require the States to meet any kind of threshold standard that would ensure that States were doing everything they could to find kids who needed insurance before they begin to spend money to find kids who may not have the same need. Under the bill several thousands of American families would be poor enough to qualify for SCHIP and have the government pay for their health care, but they'd be rich enough to still be required to pay the alternative minimum tax. The bill changes welfare participation laws by eliminating the 5-year waiting period for legal immigrants to lawfully reside in the country before they can participate in this program. In the final bill, we assume that 65% of the children receiving the benefit wouldn't get the benefit anymore. It seems to me this bill needs more work, would have benefited from a committee hearing. It doesn't prioritize poor kids to ensure that they get health care first.
Reference: SCHIP Reauthorization Act;
; vote number 2009-S031
on Jan 29, 2009
Voted YES on overriding veto on expansion of Medicare.
Extends Medicare to cover additional preventive services.
Includes body mass index and end-of-life planning among initial preventive physical examinations.
Eliminates by 2014 [the currently higher] copayment rates for Medicare psychiatric services.
Pres. GEORGE W. BUSH's veto message (argument to vote No):
I support the primary objective of this legislation, to forestall reductions in physician payments. Yet taking choices away from seniors to pay physicians is wrong. This bill is objectionable, and I am vetoing it because:
It would harm beneficiaries by taking private health plan options away from them.
It would undermine the Medicare prescription drug program.
It is fiscally irresponsible, and it would imperil the long-term fiscal soundness of Medicare by using short-term budget gimmicks that do not solve the problem.
In addition, H.R. 6331 would delay important reforms like the Durable Medical
Equipment, Prosthetics, Orthotics, and Supplies competitive bidding program. Changing policy in mid-stream is also confusing to beneficiaries who are receiving services from quality suppliers at lower prices. In order to slow the growth in Medicare spending, competition within the program should be expanded, not diminished.
Proponent's argument to vote Yes: Sen. PATTY MURRAY (D, WA): President Bush vetoed a bill that would make vital improvements to the program that has helped ensure that millions of seniors and the disabled can get the care they need. This bill puts an emphasis on preventive care that will help our seniors stay healthy, and it will help to keep costs down by enabling those patients to get care before they get seriously ill. This bill will improve coverage for low-income seniors who need expert help to afford basic care. It will help make sure our seniors get mental health care.
Reference: Medicare Improvements for Patients and Providers Act;
; vote number 2008-S177
on Jul 15, 2008
Voted NO on means-testing to determine Medicare Part D premium.
CONGRESSIONAL SUMMARY: To require wealthy Medicare beneficiaries to pay a greater share of their Medicare Part D premiums.
SUPPORTER'S ARGUMENT FOR VOTING YES: Sen. ENSIGN: This amendment is to means test Medicare Part D the same way we means test Medicare Part B. An individual senior making over $82,000 a year, or a senior couple making over $164,000, would be expected to pay a little over $10 a month extra. That is all we are doing. This amendment saves a couple billion dollars over the next 5 years. It is very reasonable. There is nothing else in this budget that does anything on entitlement reform, and we all know entitlements are heading for a train wreck in this country. We ought to at least do this little bit for our children for deficit reduction.
OPPONENT'S ARGUMENT FOR VOTING NO: Sen. BAUCUS: The problem with this amendment is exactly what the sponsor said: It is exactly like Part B. Medicare Part B is a premium that is paid with respect to doctors' examinations and Medicare reimbursement. Part D is the drug benefit. Part D premiums vary significantly nationwide according to geography and according to the plans offered. It is nothing like Part B.
Second, any change in Part D is required to be in any Medicare bill if it comes up. We may want to make other Medicare changes. We don't want to be restricted to means testing.
Third, this should be considered broad health care reform, at least Medicare reform, and not be isolated in this case. LEGISLATIVE OUTCOME:Amendment rejected, 42-56
Voted NO on allowing tribal Indians to opt out of federal healthcare.
CONGRESSIONAL SUMMARY:TRIBAL MEMBER CHOICE PROGRAM: Members of federally-recognized Indian Tribes shall be provided the opportunity to voluntarily enroll, with a risk-adjusted subsidy for the purchase of qualified health insurance in order to--
improve Indian access to high quality health care services;
provide incentives to Indian patients to seek preventive health care services;
create opportunities for Indians to participate in the health care decision process;
encourage effective use of health care services by Indians; and
allow Indians to make health care coverage & delivery decisions & choices.
SUPPORTER'S ARGUMENT FOR VOTING YES:Sen. COBURN: The underlying legislation, S.1200, does not fix the underlying problems with tribal healthcare. It does not fix rationing. It does not fix waiting lines. It does not fix the inferior quality that is being applied to a lot of Native Americans and Alaskans in this country. It does not fix
any of those problems. In fact, it authorizes more services without making sure the money is there to follow it.
Those who say a failure to reauthorize the Indian Health Care Improvement Act is a violation of our trust obligations are correct. However, I believe simply reauthorizing this system with minor modifications is an even greater violation of that commitment.
OPPONENT'S ARGUMENT FOR VOTING NO:Sen. DORGAN: It is not more money necessarily that is only going to solve the problem. But I guarantee you that less money will not solve the problem. If you add another program for other Indians who can go somewhere else and be able to present a card, they have now taken money out of the system and purchased their own insurance--then those who live on the reservation with the current Indian Health Service clinic there has less money. How does that work to help the folks who are stranded with no competition?
Voted YES on adding 2 to 4 million children to SCHIP eligibility.
Allows State Children's Health Insurance Programs (SCHIP), that require state legislation to meet additional requirements imposed by this Act, additional time to make required plan changes. Pres. Bush vetoed this bill on Dec. 12, 2007, as well as a version (HR976) from Feb. 2007.
Proponents support voting YES because:
Rep. DINGELL: This is not a perfect bill, but it is an excellent bipartisan compromise. The bill provides health coverage for 3.9 million children who are eligible, yet remain uninsured. It meets the concerns expressed in the President's veto message [from HR976]:
It terminates the coverage of childless adults.
It targets bonus payments only to States that increase enrollments of the poorest uninsured children, and it prohibits States from covering families with incomes above $51,000.
It contains adequate enforcement to ensure that only US citizens are covered.
Opponents recommend voting NO because:
Rep. DEAL: This bill
[fails to] fix the previous legislation that has been vetoed:
On illegal immigration: Would the verification system prevent an illegal alien from fraudulently using another person's name to obtain SCHIP benefits? No.
On adults in SCHIP: Up to 10% of the enrollees in SCHIP will be adults, not children, in the next 5 years, and money for poor children shouldn't go to cover adults.
On crowd-out: The CBO still estimates there will be some 2 million people who will lose their private health insurance coverage and become enrolled in a government-run program.
Veto message from President Bush:
Like its predecessor, HR976, this bill does not put poor children first and it moves our country's health care system in the wrong direction. Ultimately, our goal should be to move children who have no health insurance to private coverage--not to move children who already have private health insurance to government coverage. As a result, I cannot sign this legislation.
Reference: Children's Health Insurance Program Reauthorization Act;
Bill H.R. 3963
; vote number 2007-403
on Nov 1, 2007
Voted YES on requiring negotiated Rx prices for Medicare part D.
Would require negotiating with pharmaceutical manufacturers the prices that may be charged to prescription drug plan sponsors for covered Medicare part D drugs.
Proponents support voting YES because:
This legislation is an overdue step to improve part D drug benefits. The bipartisan bill is simple and straightforward. It removes the prohibition from negotiating discounts with pharmaceutical manufacturers, and requires the Secretary of Health & Human Services to negotiate. This legislation will deliver lower premiums to the seniors, lower prices at the pharmacy and savings for all taxpayers.
It is equally important to understand that this legislation does not do certain things. HR4 does not preclude private plans from getting additional discounts on medicines they offer seniors and people with disabilities. HR4 does not establish a national formulary. HR4 does not require price controls. HR4 does not hamstring research and development by pharmaceutical houses.
HR4 does not require using the Department of Veterans Affairs' price schedule.
Opponents support voting NO because:
Does ideological purity trump sound public policy? It shouldn't, but, unfortunately, it appears that ideology would profoundly change the Medicare part D prescription drug program, a program that is working well, a program that has arrived on time and under budget. The changes are not being proposed because of any weakness or defect in the program, but because of ideological opposition to market-based prices. Since the inception of the part D program, America's seniors have had access to greater coverage at a lower cost than at any time under Medicare.
Under the guise of negotiation, this bill proposes to enact draconian price controls on pharmaceutical products. Competition has brought significant cost savings to the program. The current system trusts the marketplace, with some guidance, to be the most efficient arbiter of distribution.
Status: Cloture rejected Cloture vote rejected, 55-42 (3/5ths required)
Reference: Medicare Prescription Drug Price Negotiation Act;
Bill S.3 & H.R.4
; vote number 2007-132
on Apr 18, 2007
Voted NO on limiting medical liability lawsuits to $250,000.
A "cloture motion" cuts off debate. Voting YEA indicates support for the bill as written, in this case to cap medical liability lawsuits. Voting NAY indicates opposition to the bill or a desire to amend it. This bill would "provide improved medical care by reducing the excessive burden the liability system places on the health care delivery system." It would limit medical lawsuit noneconomic damages to $250,000 from the health care provider, and no more than $500,000 from multiple health care institutions.
Proponents of the motion recommend voting YEA because:
Many doctors have had to either stop practicing medicine due to increased insurance premiums.
Patients are affected as well--due to rising malpractice rates, more and more patients are not able to find the medical specialists they need.
The cost of medical malpractice insurance premiums are having wide-ranging effects. It is a national problem, and it is time for a national solution.
I am pleased that
S. 22 extends liability protections to all health care providers and institutions.
These bills are a commonsense solution to a serious problem, and it is time for us to vote up or down on this legislation.
Opponents of the motion recommend voting NAY because:
We have virtually no evidence that caps on economic damages will actually lower insurance rates. And in my view, these caps are not fair to victims.
If we want to reduce malpractice insurance premiums we must address these problems as well as looking closely at the business practices of the insurance companies. What we shouldn't do is limit the recovery of victims of horrible injury to an arbitrarily low sum.
This is obviously a complicated issue. This is the kind of issue that needs to be explored in depth in our committees so that a consensus can emerge. So I will vote no on cloture, and I hope that these bills will go through committees before we begin floor consideration of this important topic.
Voted YES on expanding enrollment period for Medicare Part D.
To provide for necessary beneficiary protections in order to ensure access to coverage under the Medicare part D prescription drug program. Voting YES would extend the 6-month enrollment period for the Prescription Drug Benefit Program to the entire year of 2006 and allows beneficiaries to change plans once in that year, without penalty, after enrollment. Also would fully reimburse pharmacies, states and individuals for cost in 2006 for covered Medicare Part D drugs.
Voted YES on increasing Medicaid rebate for producing generics.
Vote on an amendment that removes an increase in the Medicaid deduction rebate for generic drugs from 11% to 17%. The effect of the amendment, according to its sponsor, is as follows: "This bill eliminates the ability of generic drugs to be sold using Medicaid. Over half the prescription drugs used in Medicaid are generic. Because we have raised the fees so dramatically on what a generic drug company must pay a pharmacy to handle the drug, pharmacies are not going to use the generic. In the long run, that will cost the Medicaid Program billions of dollars. My amendment corrects that situation." A Senator opposing the amendment said: "This bill has in it already very significant incentives for generic utilization through the way we reimburse generics. Brand drugs account for 67% of Medicaid prescriptions, but they also account for 81% of the Medicaid rebates. This is reasonable policy for us, then, to create parity between brand and generic rebates. This amendment would upset that parity."
Voted YES on negotiating bulk purchases for Medicare prescription drug.
Vote to adopt an amendment that would allow federal government negotiations with prescription drug manufactures for the best possible prescription drug prices. Amendment details: To ensure that any savings associated with legislation that provides the Secretary of Health and Human Services with the authority to participate in the negotiation of contracts with manufacturers of covered part D drugs to achieve the best possible prices for such drugs under Medicare Part D of the Social Security Act, that requires the Secretary to negotiate contracts with manufacturers of such drugs for each fallback prescription drug plan, and that requires the Secretary to participate in the negotiation for a contract for any such drug upon the request of a prescription drug plan or an MA-PD plan, is reserved for reducing expenditures under such part.
Voted YES on $40 billion per year for limited Medicare prescription drug benefit.
S. 1 As Amended; Prescription Drug and Medicare Improvement Act of 2003. Vote to pass a bill that would authorize $400 billion over 10 years to create a prescription drug benefit for Medicare recipients beginning in 2006. Seniors would be allowed to remain within the traditional fee-for-service program or seniors would have the option to switch to a Medicare Advantage program that includes prescription drug coverage. Private insurers would provide prescription drug coverage. Private Insurers would engage in competitive bidding to be awarded two-year regional contracts by the Center for Medicare Choices under the Department of Health and Human Services.Enrolled seniors would pay a $275 deductible and an average monthly premium of $35. Annual drug costs beyond the deductible and up to $4,500 would be divided equally between the beneficiary and the insurer. Beneficiaries with incomes below 160 percent of the poverty level would be eligible for added assistance.
Reference: Medicare Prescription Drug Benefit bill;
; vote number 2003-262
on Jun 26, 2003
Voted YES on allowing reimportation of Rx drugs from Canada.
S. 812, as amended; Greater Access to Affordable Pharmaceuticals Act of 2002. Vote to pass a bill that would permit a single 30-month stay against Food and Drug Administration approval of a generic drug patent when a brand-name company's patent is challenged. The secretary of Health and Human Services would be authorized to announce regulations allowing pharmacists and wholesalers to import prescription drugs from Canada into the United States. Canadian pharmacies and wholesalers that provide drugs for importation would be required to register with Health and Human Services. Individuals would be allowed to import prescription drugs from Canada. The medication would have to be for an individual use and a supply of less than 90-days.
Voted YES on allowing patients to sue HMOs & collect punitive damages.
Vote to provide federal protections, such as access to specialty and emergency room care, and allow patients to sue health insurers in state and federal courts. Economic damages would not be capped, and punitive damages would be capped at $5 million.
Voted NO on funding GOP version of Medicare prescription drug benefit.
Vote to pass an amendment that would make up to $300 billion available for a Medicare prescription drug benefit for 2002 through 2011. The money would come from the budget's contingency fund. The amendment would also require a Medicare overhaul.
Nelson adopted the manifesto, "A New Agenda for the New Decade":
Promote Universal Access and Quality in Health Care That more than 40 million Americans lack health insurance is one of our society’s most glaring inequities. Lack of insurance jeopardizes the health of disadvantaged Americans and also imposes high costs on everyone else when the uninsured lack preventive care and get treatment from emergency rooms. Washington provides a tax subsidy for insurance for Americans who get coverage from their employers but offers nothing to workers who don’t have job-based coverage.
Markets alone cannot assure universal access to health coverage. Government should enable all low-income families to buy health insurance. Individuals must take responsibility for insuring themselves and their families whether or not they qualify for public assistance.
Finally, to help promote higher quality in health care for all Americans, we need reliable information on the quality of health care delivered by health plans and providers; a “patient’s bill of rights” that ensures access to medically necessary care; and a system in which private health plans compete on the basis of quality as well as cost.
Goals for 2010
Reduce the number of uninsured Americans by two-thirds through tax credits, purchasing pools, and other means.
Create a system of reliable “report cards” on the quality of care delivered by health plans and providers.
Source: The Hyde Park Declaration 00-DLC5 on Aug 1, 2000
Rated 100% by APHA, indicating a pro-public health record.
Nelson scores 100% by APHA on health issues
The American Public Health Association (APHA) is the oldest and largest organization of public health professionals in the world, representing more than 50,000 members from over 50 occupations of public health. APHA is concerned with a broad set of issues affecting personal and environmental health, including federal and state funding for health programs, pollution control, programs and policies related to chronic and infectious diseases, a smoke-free society, and professional education in public health.
The following ratings are based on the votes the organization considered most important; the numbers reflect the percentage of time the representative voted the organization's preferred position.
Congressional Summary:The purpose of this Act is to increase diagnosis of Alzheimer's disease and related dementias, leading to better care and outcomes for Americans living with Alzheimer's disease and related dementias. Congress makes the following findings:
As many as half of the estimated 5.2 million Americans with Alzheimer's disease have never received a diagnosis.
An early and documented diagnosis and access to care planning services leads to better outcomes for individuals with Alzheimer's disease.
Combining the existing Medicare benefits of a diagnostic evaluation and care planning into a single package of services would help ensure that individuals receive an appropriate diagnosis as well as critical information about the disease and available care options.
Proponent's argument for bill: (The Alzheimer's Association, alz.org).
The "Health Outcomes, Planning, and Education (HOPE) for Alzheimer's Act" (S.709/H.R. 1507) is one of the Alzheimer's Association's top federal priorities for the 113th Congress. The HOPE for Alzheimer's Act would improve diagnosis of Alzheimer's diseas
Preserve access to Medicaid & SCHIP during economic downturn.
Nelson co-sponsored preserving access to Medicaid & SCHIP in economic downturn
A bill to preserve access to Medicaid and the State Children's Health Insurance Program during an economic downturn.
Economic Recovery in Health Care Act of 2008 - Prohibits finalizing, implementing, enforcing, or otherwise taking any action, prior to April 1, 2009, on any changes to Medicaid programs or State Children's Health Insurance Program (SCHIP).
Amends the U.S. Troop Readiness, Veterans' Care, Katrina Recovery, and Iraq Accountability Appropriations Act of 2007 to extend through April 1, 2009, the moratorium relating to the cost limit for providers.
Amends the Medicare, Medicaid, and SCHIP Extension Act of 2007 to extend through April 1, 2009, the moratorium relating to rehabilitation services, school-based administration, and school-based transportation.
Provides for state fiscal relief through a temporary increase of Medicaid federal medical assistance percentage (FMAP).
Source: Economic Recovery in Health Care Act (S.2819) 2008-S2819 on Apr 7, 2008
Establishment of Office of Health Care Fraud Prevention.
Nelson signed establishing of Office of Health Care Fraud Prevention
There is hereby established, in the Department of H, the Office of the Deputy Secretary for Health Care Fraud Prevention.
The Office shall provide contracts for the design, development, and operation of a predictive model antifraud system, based on the risk level assigned to claims activity, and develop a comprehensive antifraud database for health care activities carried out or managed by Federal health agencies.
The Office shall promulgate and enforce regulations relating to the reporting of data claims to the health care antifraud system.
SPONSOR'S INTRODUCTORY REMARKS:
Sen. LeMIEUX. The current proposal for health care is a $1 trillion proposal. If we spent as much time caring about the money we are spending now, as opposed to the money some in this Chamber want to spend, I suspect we could find plenty of money to either return to the people or to find money for these new programs.
Today, I wish to talk about just such an idea, an idea to recover some of the waste, fraud, and abuse that is currently happening in our current provision of health care--in Medicare and Medicaid. Estimates are that some $60 billion to a staggering $226 billion a year to waste, fraud, and abuse.
This health care proposal that we are discussing in the Senate is $1 trillion over 10 years. That is about $100 billion a year. We may be wasting $226 billion a year. If we captured just half of that, we might be able to pay for this program.
Why can't we do the same thing the credit card companies are doing for health care? Why can't we use a predictive modeling system that says a health care claim is not going to be paid when a red flag comes up? Right now we are on a pay-and-chase system. If we put this predictive modeling system in, it stops the fraud before it happens. The credit card industry benchmark is 0.1% while fraud losses in the health care business run from 3% to 14%.
Source: Prevent Health Care Fraud Act of 2009 (S.2128 & H.R.4222 ) 2009-S2128 on Oct 29, 2009
Expedited licensing for biosimilar products.
Nelson signed Promoting Innovation & Access to Life-Saving Medicine Act
Amends the Public Health Service Act to provide for the licensing of biosimilar and interchangeable biological products.
Allows any person to file an abbreviated biological product application with the Secretary of Health and Human Services. Requires such applications to include information demonstrating a high degree of similarity or interchangeability between the biological product and the licensed biological product (reference product).
Requires the Secretary to:
approve an application and issue a license for a biosimilar product unless the Secretary finds and informs the applicant that the information in the application fails to demonstrate biosimilarity between the biological product and the reference product or the safety, purity, and potency of the biological product; and
establish requirements for the efficient review, approval, suspension, and revocation of abbreviated biological product applications.
Allows an applicant a determination as to the interchangeability of a product and its reference product based on whether a product can be expected to produce the same clinical result as the reference product in any given patient. Grants market exclusivity to any biological product that is determined to be interchangeable for a specified period.
Sets forth provisions governing patent infringement claims involving comparable biological products and legal remedies to expedite the adjudication of patent infringement disputes.
Extends the period for approval of biological products to allow for studies of the use of new biological products in the pediatric population.