Study: Tamiflu Too Risky & Ineffective for Use by Children

Antiviral treatments such as Tamiflu should not be administered to children under the age of 12 because the risks of the drugs outweigh the possible benefits in lessening symptoms of swine flu, according to a studypublished in the British Medical Journal.

Although antiviral drugs can shorten the duration of the flu in children by an average of 1.5 days, they fail to fight certain effects of the infection, having little effect on the risk of asthma flare-ups, for instance. In fact, the drugs can bring dangerous side effects like vomiting, which can be dangerous because it puts children at risk of dehydration. In the research review, scientists looked at four trials of 1,766 children treated with antivirals, including 1,243 with confirmed flu, and three trials of 863 who were exposed to flu but didn’t exhibit symptoms and were treated with antivirals preventively. Only one trial looked at children with asthma [CBC]. Overuse of antivirals can also increase the risk of viral strains that become resistant to such treatments.

Although the study was based on clinical data collected from children with the seasonal flu, not swine flu, co-author Matthew Thompson said there was no reason to think the conclusions would not also apply to the current relatively mild outbreak of swine flu [Reuters]. The most common side effects of Tamiflu were vomiting, nausea, and abdominal pain, while Relenza, an antiviral that is inhaled, most often caused nausea and headache, according to the study.

In regards to using the drugs to prevent the spread of swine flu, the researchers found that 13 people need to be treated to prevent one additional case, meaning antivirals reduce transmission by 8% [BBC], according to the study, a rather small effect. That indicates that antivirals should not be used prophylactically, but rather to alleviate symptoms in severe cases of flu in adults.

Related Content:
80beats: Swine Flu Vaccine Trials Begin in Australia; U.S. Up Soon
80beats: Killer Flu Strains Lurk & Mutate for Years Before They Go Pandemic
80beats: How the Federal Government is Preparing for Possible Swine Flu Emergency

AMA ADVOCACY UPDATE

July 31, 2009

House Energy and Commerce Committee mark up resumes

Yesterday, the House Committee on Energy and Commerce resumed its mark up of H.R. 3200, the American Affordable Health Choices Act of 2009, working late into the night considering amendments. Key amendments of particular interest to physicians were voted on during the debate on the following issues:

Comparative effectiveness:

An amendment offered by Rep. Michael Rogers (R-Mich.) was adopted to clarify that comparative effectiveness research could not be used by the federal government to deny or ration care. A second amendment was adopted, sponsored by Rep. Phil Gingrey, MD (R-Ga.), stating that the Centers for Medicare and Medicaid Services may not use federally-funded clinical comparative effectiveness research data to make Medicare coverage determinations on the basis of cost. A third amendment authored by Rep. Chris Murphy (D-Conn.) was adopted specifying that the work performed by the Center for Comparative Effectiveness must be based on consultation with, and review by, appropriate trade associations and professional membership societies.

Medicaid and Children’s Health Insurance Program (CHIP):

The Committee adopted an amendment offered by Rep. Murphy to ensure adequate Medicaid payment rates. Rep. Jerry McNerney (D-Calif.) and Rep. Murphy offered an amendment, which was adopted, specifying that coverage waiting periods under the CHIP program do not apply to children who lose health insurance coverage, who are under 2 years of age, or for whom health insurance coverage is unaffordable. An amendment offered by Reps. Joe Barton (R-Texas) and Nathan Deal (R-Ga.) to allow CHIP and Medicaid funds to be used to purchase private health insurance coverage was defeated.

Medical home:

Rep. Donna Christensen, MD (D-VI) successfully offered two amendments to provisions related to a community-based medical home pilot program requiring the Secretary to: (1) seek to eliminate racial, ethnic, gender, and geographic health disparities through the pilots; and (2) select one of the U.S. territories as a pilot location.

Medicare physician payment

: Rep. Michael Burgess, MD (R-Texas) offered an amendment, which was defeated, that would have replaced the sustainable growth rate (SGR) system with Medicare physician payment updates based on the Medicare Economic Index.

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American Medical Association 2009 1

Public health insurance option:

An amendment offered by Rep. Burgess, requiring provider payment rates under a public plan option to be negotiated and not based on rates paid by another public program, was defeated. This issue is expected to be considered again in an upcoming vote on the compromise agreement reached between committee chair Henry Waxman and members of the Blue Dog Coalition. A second amendment offered by Rep. Burgess to eliminate the public plan option was also defeated.

Medical liability:

Rep. Burgess offered an amendment that would have implemented federal medical liability tort reforms, including a $250,000 cap on noneconomic damages. This amendment was defeated. A second amendment, offered by Rep. Deal, that would have provided liability protections to physicians who transfer EMTALA patients to more appropriate health care facilities was also defeated. Rep. Bart Gordon (D-Texas) is expected to offer three additional medical liability amendments for the committee’s consideration today.

The committee is scheduled to resume its mark up of H.R. 3200 at 10:00 ET this morning. Please go to

www.energycommerce.house.gov to track amendments and votes throughout this process.

Senate Finance Committee mark up postponed until fall. Physicians groups need to work Senate offices on Medicare physician payment issue

Bipartisan negotiations between members of the Senate Finance Committee are ongoing, and committee chair Max Baucus (D-Mont.) announced yesterday that the panel would be unable to mark up a bill before Congress returns from its summer recess in September. He pledged that negotiators will continue to meet during the month of August to resolve their differences.

Details of agreements that have been reached thus far began to emerge this week, although no information is available in writing. It has been reported that negotiators have scaled back the Medicare physician payment relief in the compromise package to a one-year temporary halt to the payment cuts being produced by the SGR formula. Currently, the committee proposal would provide a 0.5 percent Medicare physician payment update in 2010, in lieu of a scheduled 21.5% cut. The AMA and its coalition partners will be working over the August recess on strategies to secure a repeal of the irrational Medicare physician payment formula this year. This includes laying the ground work for a Senate floor amendment to replace the SGR. As previously reported, the House health reform package (H.R. 3200) would erase the SGR debt and establish a new Medicare physician payment formula. The Obama Administration has taken a number of steps this year to facilitate efforts to replace the SGR with a new payment formula. During August, physician groups will need to educate Senators on the need to scrap the SGR instead of creating another temporary "patch."

AMA eVoice® Alert

Aug. 1, 2009

House Energy and Commerce Committee concludes health system reform mark up

The House Energy and Commerce Committee met throughout the day on Friday to mark up H.R. 3200, the “American Affordable Health Choices Act of 2009,” completing its work at 9:00 p.m. last night. The bill was approved by a vote of 31 to 28, with five Democrats voting against it.

The long anticipated Blue Dog agreement was adopted late in the day as an amendment offered by Rep. Mike Ross (D-Ark.). Highlights of that agreement include:

• Public Plan Option: Requires the Secretary of Health and Human Services (HHS) to negotiate payment rates in the public plan, so that they would not be lower than Medicare or higher than the average rates paid by private plans in the Health Insurance Exchange. Requirements for physicians and other providers to opt-out of participating in the public plan are specified.
• CO-OP: Establishes a Consumer Operated and Oriented Plan (CO-OP) program, through which grants and loans will be made for the creation and initial operation of not-for-profit, member-run health insurance co-ops that provide insurance through the exchange.
• Subsidies and mandates: Those who are offered insurance by their employers would be ineligible for subsidies (affordability credits) in the exchange unless their premiums equal more than 12 percent of their income. More small businesses would be exempt from the pay-or-play mandate.
• Medicaid: Reduces federal responsibility payments (FMAP) for required Medicaid expansions from 100 percent to 90 percent beginning in 2015.
• End-of-life planning: Provides for dissemination of information on end-of-life planning by qualified health benefits plan (QHBP) entities, including option to establish advanced directives and physicians’ orders for life-sustaining treatment. Specifies that the QHBP entity shall not promote suicide, assisted suicide or the active hastening of death (consistent with state law) and that the information shall not presume the withdrawal of treatment. Prohibits promotion of assisted suicide.
• Center for Medicare and Medicaid Payment Innovation: A Center for Medicare and Medicaid Payment Innovation would be established to test the effect of payment models on spending and quality of life under the Medicare and Medicaid programs. The Secretary may implement the model on a nationwide basis if it improves quality without increasing spending and/or reduces spending without reducing quality.

Descriptions of other amendments of interest that were considered yesterday follow. (The list is not exhaustive.)

• Public health plan: Rep. Cliff Stearns (R-Fla.) successfully offered an amendment that would prohibit taxpayer bailouts to subsidize the public plan. An amendment offered by Rep. George Radanovich (R-Calif.) that would have required the public plan to be subject to state taxes and other requirements was defeated. An amendment by Rep. Joe Barton (R-Tex.) was rejected that would have, in lieu of a public health insurance option, expanded state reinsurance programs and state high risk pool programs for those with pre-existing or other high risk conditions, and an amendment by Anthony Weiner (D-N.Y.) was withdrawn that would have established a single payer health care system.
• Medical liability reform: Rep. Doyle (D-Pa.) offered and the committee adopted a block of amendments (not available for review this morning) that included language drafted by Rep. Bart Gordon (D-Tenn.) that provides financial incentives to states that enact certificate of merit and/or early offers programs in medical liability cases.
• Health savings accounts: An amendment to clarify that health savings accounts are qualified health benefits plans that may be offered through the Health Insurance Exchange, sponsored by Rep. Michael Rogers (R-Mich.) was defeated.
• Insurance reforms: An amendment by Rep. Betty Sutton (D-Ohio) was adopted addressing limitations on preexisting condition exclusions in group and individual coverage. The committee rejected an amendment by Rep. Steve Buyer (R-Ind.) that would have allowed providers and health insurers to offer premium discounts, rebates, or modified copayments or deductibles to individuals who participate in health promotion or disease prevention programs.
• Health Benefits Advisory Committee: An amendment by Rep. Greg Walden (R-Ore.) was adopted that would require at least 25 percent of the members of the Health Benefits Advisory Committee to be health care practitioners who practice in a rural area and have done so for at least the previous five years. It also requires that the proportion of Medicare Payment Advisory Commission members who represent rural providers be proportional to the total number of Medicare beneficiaries who reside in rural areas.
• Medicaid and CHIP: Rep. Zack Space (D-Ohio) sponsored an amendment, which was adopted, that prohibits payments under Medicaid and the Children’s Health Insurance Program (CHIP) for undocumented immigrants. An amendment by Rep. Lois Capps (D-Calif.) was adopted that would eliminate copayments for certain Medicaid preventive services. Rep. Eliot Engel (D-N.Y.) successfully offered an amendment to ensure Medicaid coverage of non-emergency transportation to medical necessary services. An amendment by Rep. Peter Welch (D-Vt.) was adopted that would allow a limited exception to the maintenance of effort requirement for Medicaid. An amendment by Rep. Anna Eshoo (D-Calif.) was adopted to clarify Medicaid coverage for citizens of freely associated states (Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau). Another amendment authored by Rep. Donna Christensen (D-V.I.) that would have increased Medicaid payments to the U.S. territories was withdrawn.
• Medicare benefits: Rep. Gene Greene (D-Tex.) offered a block of amendments, all of which were adopted, addressing certain Medicare benefits. One amendment addressed payment for post-mastectomy external breast prosthesis garments. A second amendment adds "presence of impairments" to the assessments for patient-centered and population-based quality measures. The Greene amendments also require the HHS Secretary to report to Congress on Medicare barriers to abdominal aortic aneurysm screening and other preventive services approved by the U.S. Preventive Services Task Force. In addition, the Secretary would be required to make the education of physicians and patients about the risk factors for abdominal aortic aneurysm a priority.
• Medicare payments: An amendment by Rep. Ed Whitfield (Ky.) was adopted to place a moratorium on Medicare payment reductions for several interventional pain management procedures covered under the ambulatory surgery center fee schedule.
• Pharmaceuticals: An amendment by Rep. Bobby Rush (D-Ill.) was adopted that would prohibit current settlement agreements between brand-name and generic pharmaceutical companies where brand companies pay a significant sum to the first generic company that files to challenge the brand company's patent. The Federal Trade Commission would be conferred with enforcement authority to regulate such agreements. Another amendment, offered by Rep. Anna Eshoo (D-Calif.), was adopted that would confer the FDA with authority to establish an abbreviated pathway to approve biosimilars for market.
• Affordability and cost containment: Amendments offered by Rep. Janice Schakowsky (D-Ill.) and Tammy Baldwin (D-Wis.) were adopted to require savings generated through various provisions in the bill to be used to make premiums more affordable for lower income people in the exchange. The amendment offered by Rep. Baldwin would also require the Secretary of HHS to adopt operating rules for specified electronic transactions and to establish a unique health plan identifier system, and would mandate the use of electronic funds transfers under Medicare by 2015. An amendment by Rep. Phil Gingrey, MD (R-Ga.) that was rejected would have required the Secretary to develop a methodology that ensures that any savings to Medicare resulting from the Medicaid and Medicare Improvements included in the bill and amendments shall be used solely for the purpose of improving the affordability of health care for Medicare beneficiaries.AMA
• Physician hospital ownership: Rep. Joe Barton (R-Tex.) offered and withdrew an amendment that would have struck the bill’s restrictions on physician-owned hospitals. After considerable discussion, Committee Chairman Henry Waxman pledged to work with Rep. Barton to develop compromise language for later incorporation into the legislation.

View all the amendments offered during the committee debate.

The Energy and Commerce Committee is the third panel in the House to mark up H.R. 3200. Over the August recess, the three committee products will be combined into a single bill for consideration on the House floor.

For the latest developments on health system reform legislative activities and AMA advocacy efforts, please go to www.ama-assn.org/go/reform.

AMA SUPPORT FOR H.R. 3200

Answers to Frequently Asked Questions

Why is the AMA supporting H.R. 3200?

H.R. 3200 contains many elements that reflect AMA priorities for health system reform. This includes: expanding the availability of affordable health care coverage to the uninsured, increased support for prevention and wellness services, investments in the physician workforce, increased Medicare payments for primary care services without cutting payments for other services and, importantly, it represents medicine’s best hope for eliminating the current sustainable growth rate (SGR) formula for updating Medicare physician payments. The AMA will be working with members of the House of Representatives to improve the bill by seeking changes (e.g., adding medical liability reforms). Favorable action on a House bill is necessary to move the process to the end game negotiations that will determine the specifics of a final bill.

Why did AMA react so quickly?

The AMA has been reviewing and submitting detailed comments on draft proposals for several months, as well as engaging in substantive discussions with Congressional leaders and staff. There were a limited number of changes made in a draft of the bill that was released on June 19. So, we were able to complete an analysis of the 1,000+ page bill relatively quickly. Two of the three House committees completed their mark-up of the legislation last week so it was important to voice our views prior to votes in committee.

Does the AMA support all provisions of H.R. 3200?

As is typical with very large bills, it contains many provisions that we wholeheartedly support, others that concern us, and still other provisions that we want to see changed. We plan to continue our efforts to refine those elements that are inconsistent with our policy as the legislative process progresses. For example, during the process of committee consideration we have been supporting amendments to provide federal support to states that implement liability reforms and to preserve patient access to physician-owned hospitals. This is the beginning of a very lengthy process and we believe our support helps put us in a very favorable position to advocate for important changes when a House and Senate conference committee is appointed to craft a single bill for final passage.

Does the AMA support the public plan provisions included in H.R. 3200?

The public plan provisions in H.R. 3200 represent an improvement over previous draft proposals. The Senate is developing different approaches to a public plan. H.R. 3200 would require a public plan to be self-sustaining and not dependent on the federal treasury, and it would not require physicians to participate. It also does not affect the ability of physicians to engage in private contracting arrangements with patients. We believe that, as the legislative process continues, the details surrounding the public plan option will change considerably.

By supporting health reform legislation that includes a public plan, isn’t the AMA really endorsing socialized medicine?

It truly is regrettable that so many of the important goals we hope to achieve through health system reform have been overshadowed by a headline-grabbing debate over the prospects of creating a coverage option bearing the label “public plan,” without regard to the variety of forms such an option could take. The AMA continues to oppose nationalized medicine health insurance, and we continue to express opposition to elements of public plan proposals that we believe could lead us down the road to a single payer system or “socialized medicine.” However, we remain open to proposals that are consistent with our principles of pluralism, freedom of choice, freedom of physician practice, and universal access.

I have heard that as many at 120 million people will be enrolled in the new public option health plan. Is that true?

No. The nonpartisan Congressional Budget Office has estimated that the bill will ensure that 97% of the legal, non-elderly population will have health insurance. At most, 12 million people would be enrolled in the public plan, representing only about 4% of the entire population. Overall, 37 million uninsured Americans will have health insurance coverage who do not have it now.

Won't employers simply drop coverage?

Again, the non-partisan Congressional Budget Office estimates that from 2010 until 2019, the number of Americans with employer provided coverage will increase from 150 million to 162 million people. Additionally, for those Americans who purchase coverage through the Health Insurance Exchange, two-thirds (or 20 million people) will choose private plans. This means a significant increase in the number of American's insured by private insurance plans.

Does H.R. 3200 make private insurance illegal?

There have been some misleading press reports on this issue. The legislation does not make private insurance illegal. Rather, it regulates health insurance coverage and, except for some “grandfathered” existing policies, individual coverage could only be offered through the Health Insurance Exchange established by the bill. (The Health Insurance Exchange is a regulated market place for people to purchase private coverage that meets minimum criteria.) In fact, the legislation would make great strides in regulating insurers so that they treat patients and providers more fairly.

What about liability reform?

The AMA continues to believe that medical liability reform is essential to any health care cost containment strategy.

Is support for replacing the SGR weakening at the White House and in Congress?

No. Key House and Senate leaders as well as senior White House officials remain committed to enacting legislation this year that would erase the existing SGR debt and establish a new, more favorable payment structure for Medicare physician payments. It sometimes is confusing when policymakers discuss Congressional Budget Office scoring rules and legislative procedures.

Using past approaches, the “budget score” would be $239 billion for changing the SGR policy. This year, we gained the support of House, Senate and White House policymakers to erase the SGR debt and establish a new payment formula without have to identify budgetary offsets. The term of art is a “pay-go waiver.”

When Office of Management and Budget Director Peter Orszag talks about “removing the Medicare physician payment fix” he is referring to budget scoring estimates--not about jettisoning a change in the SGR policy from health system reform legislation. Key policymakers in the House, Senate and White House continue to support replacing the SGR through a pay-go waiver.

Does the bill expand scope of practice of non-physician practitioners?

The bill would establish a medical home pilot program under Medicare that would allow a nurse practitioner to lead a medical home “so long as…the nurse practitioner is acting consistently with State law.” State law requirements regarding physician supervision of nurse practitioners would continue to apply. While the AMA recognizes nurses as valuable members of the health care team, we do not support nurse practitioners practicing independently, without at least regular consultation with a physician. It is the AMA’s policy that a multidisciplinary health care team should be led by a physician who is in the best position to provide coordination of disciplines to assure delivery of high quality patient care.

Preparing for H1N1 and the upcoming flu season

As the President's advisor on Homeland Security, I am passing along the following message from Kathleen Sebelius, Secretary of Health and Human Services, Janet Napolitano, Secretary of Homeland Security, and Arne Duncan, Secretary of Education, who are leading the efforts to prepare our Nation for the coming flu season.

Fellow Americans,

This spring we were confronted with an outbreak of a troubling flu virus called 2009-H1N1. As the fall flu season approaches, it is critical that we reinvigorate our preparedness efforts across the country in order to mitigate the effects of this virus on our communities.

Today, we are holding an H1N1 Influenza Preparedness Summit in conjunction with the White House to discuss our Nation's preparedness. We are working together to monitor the spread of 2009-H1N1 and to prepare to initiate a voluntary fall vaccination program against the 2009-H1N1 flu virus, assuming we have a safe vaccine and do not see changes in the virus that would render the vaccine ineffective.

But the most critical steps to mitigating the effects of 2009-H1N1 won't take place in Washington — they will take place in your homes, schools and community businesses.

Taking precautions for this fall's flu season is a responsibility we all share. Visit Flu.gov to make sure you are ready and learn how you can help promote public awareness.

We are making every effort to have a safe and effective vaccine available for distribution as soon as possible, but our current estimate is that it won't be ready before mid-October. This makes individual prevention even more critical. Wash your hands regularly. Take the necessary precautions to stay healthy and if you do get sick, stay home from work or school.

We are doing everything possible to prepare for the fall flu season and encourage all Americans to do the same — this is a shared responsibility and now is the time to prepare. Please visit Flu.gov to learn what steps you can take to prepare and do your part to mitigate the effects of H1N1.

Take Care,
Kathleen, Janet and Arne

AMA ADVOCACY UPDATE - July 8, 2009

Please visit the AMA Web site for a pdf version of this and past advocacy updates.

Congress continues work on health system reform legislation
The three committees with health care jurisdiction in the U.S. House of Representatives-Ways and Means, Energy and Commerce, and Education and Labor-released a draft bill on June 19. The legislation calls for creating a national health insurance exchange, mandating coverage for individuals and employer contributions to coverage, creating a public option insurance plan, and resetting Medicare's flawed sustainable growth rate (SGR) formula to eliminate the accumulated debt that is undermining physician payments. The bill would set the 2010 Medicare fee schedule update at the Medicare Economic Index. Beginning in 2011, it would establish two new expenditure targets, one for primary care and preventive services, and a second for all other physician services. A revised House bill is expected to be introduced on July 9.

The three House committees held legislative hearings on the draft bill during the week of June 22. Members debated the proposed government health plan option, the proposed employer "pay or play" mandate, and the cost of reform. The House Committees plan to mark up a revised bill during the week of July 13, and floor consideration is expected to be complete prior to the August recess.

In the Senate, the Health, Education, Labor, and Pensions Committee is continuing its mark-up of health reform legislation this week, and the Finance Committee is expected to release details of its proposed legislation shortly. The two Senate committees plan to merge their proposals into a single bill for consideration on the Senate floor

2010 Medicare fee schedule proposed rule issued
Last week, the Centers for Medicare and Medicaid Services (CMS) released the 2010 Medicare physician payment schedule proposed rule, including a long-awaited announcement that the Obama Administration will change the definition of physician services under the SGR to exclude physician-administered drugs. The drug costs will be removed retroactive to the 1996/97 base year of the SGR formula, which will greatly lessen the forecast SGR cuts in future years. This action will substantially reduce the legislative cost of congressional proposals to reform physician payments and makes a permanent solution to the SGR morass much more feasible

CMS also used data that it purchased from a new practice expense survey sponsored by the AMA, 72 specialty societies and other health care professional organizations to revise the practice expense relative values. Specialty impacts resulting from proposed changes in relative values for practice expenses, physician work, and malpractice expenses range from +11 percent for ophthalmology to -19 percent for radiation oncology.

Other changes in the rule include a CMS proposal to eliminate Medicare coverage for consultations and redistribute the relative values to visits, revisions to the e-prescribing incentive program intended to simplify reporting requirements, and the addition of more measures and more measures groups for the Physician Quality Reporting Initiative (PQRI).

The proposed rule is scheduled for publication in the Federal Register on July 13, but is currently available online. Comments are due by August 31st.

Physician Consortium issues new COI policy
Last week, the AMA convened Physician Consortium for Performance Improvement (PCPI) issued a revised Conflict of Interest (COI) policy. The goal of the policy is to insure that PCPI decisions are made as objectively as possible, without improper bias or influence. Specifically, the revised policy does not allow anyone with a material interest to participate in measure development work groups, and also requests disclosure of conflicts from those commenting on measures. The strengthened PCPI COI policy is consistent with recent JAMA articles and an April IOM report discussing COI in medical research, education, and practice. To view the revised PCPI COI policy, please visit www.physicianconsortium.org.

AMA and specialties comment on FDA plans for opioids
On June 30, the AMA and 15 specialty societies submitted a joint comment letter to the Food and Drug Administration (FDA) on its plans for developing a risk evaluation and mitigation strategy or REMS for certain opioid drugs used to treat pain. The letter acknowledges the significant and growing public health danger posed by the misuse and diversion of these drugs and responds to questions raised by the FDA in a notice issued on April 20. It supports providing positive incentives to physicians to encourage education in pain management and increased support for mentoring programs such as the Physician Clinical Support System for Buprenorphine. The letter urges FDA to avoid elements of the REMS that could either hurt patient access to needed pain relief or lead to unintended consequences such as physicians opting out of managing chronic pain patients or shifts in prescribing from one type of pain medication, such as extended release opioids, to another, such as immediate release opioids or NSAIDs. The letter is available at:

New laws in Tennessee and Nevada regulate rental networks and mergers
The AMA campaign to regulate rental network contracting had another victory on June 23, 2009, when Tennessee Governor Phil Bredeson (D) signed Senate Bill (S.B.) 693, the "Preferred Provider Transparency Act." This law reflects many provisions of the AMA/National Conference of Insurance Legislators (NCOIL) model rental network act. Highlights of the new law include definitions of contracting parties; required registration with the Department of Insurance; original contract privity and termination requirements for contracting entity and downstream entities; limitations on third-party access; mandated transparency, notice and contact information of contracting parties; and clear penalties and enforcement provisions. Connecticut, Georgia, Utah and Vermont have had similar rental network victories this session, and bills were introduced with some still pending in Hawaii, Oregon, Rhode Island and Texas.

The campaign to protect competition in the health insurance market had a victory in Nevada this session, when Governor Jim Gibbons (R) signed Assembly Bill (A.B.) 248 on May 29, 2009. This bill strengthens current Nevada law by limiting the circumstances when a health insurer merger or acquisition can occur, mandating that the applicant have the burden of proving there are not any violations of competitive standards and allowing the Insurance Commissioner to consider new evidence when granting a merger, including the effect on the interests of the insurance-buying public.

The AMA's Advocacy Resource Center (ARC) has model bills and campaign toolkits on both of these campaigns. Contact Liz Schumacher for more information.

New AMA resources help physicians understand risk assessment and adjustment models
Two new educational resources from the AMA are designed to help physicians understand health insurers' use of risk assessment and risk adjustment models and how they might affect the physician practice. "An introduction to risk assessment and risk adjustment models" defines the terms "risk assessment" and "risk adjustment" and provides overviews of the prominent risk assessment and risk adjustment models and their various uses, including profiling physicians and other health care professionals. Because numerous risk adjustment models have failed to predict valid practice efficiency rankings and/or health care expenditures, this resource concludes that risk adjustment systems that fail to accurately account for differences in the patient's health status and the related costs of care should not be used to profile individual physicians. Currently, we are unaware of any systems that take into account all of the risk factors that should be considered when using risk adjustment to determine costs of care. A second resource, "Terminology used in physician profiling" helps physicians assess information they receive about physician profiling programs by defining common profiling terms used in health insurers' physician profiling programs. Visit the AMA Web site to access these resources and many others on physician profiling.

Caring for the Health of the Community Means Caring for the Health of the Environment

Nancy J. Larson, RS

In fulfilling the obligation to care for their communities, hospitals and other health care facilities can have a negative impact on the environment. Over the past decade, the health care industry has come under the environmental microscope, and the daily work of treating patients has been discovered to be highly wasteful of natural and financial resources. In 1998, the U.S. Environmental Protection Agency (EPA), in partnership with the American Hospital Association and Health Care Without Harm, formed Hospitals for a Healthy Environment (H2E), to address some of the following major environmental concerns related to the health care sector.

• Medical-waste incinerators were the fourth largest source of mercury, a well-known persistent bioaccumulative and toxic substance. The National Academy of Sciences reported that, each year, 60,000 children may be born in the United States with neurological problems due to their mothers’ having eaten mercury-contaminated fish.
• The health care industry generated more than 2.4 million tons of waste per year, often incinerated or deposited in landfills.
• The health care industry was an excessive user of toxic cleaners, pesticides, and sterilants that can affect both patient health and safety.
• Medical-waste incinerators were a source of dioxins and other hazardous chemicals.

LEARNING OBJECTIVELearn about efforts of the last decade to mitigate the harmful impact of the health care industry on the environment.

Recognizing these environmental health concerns, hospitals across the country voluntarily established green teams, joined national voluntary organizations such as H2E, developed environmental policies to guide their purchasing practices, and set waste-reduction and toxic-elimination goals. Top management supports these policies, but physicians, surgical teams, nurses, and support staff make them work, exploring new ways to practice health care while minimizing its impact on the environment and ultimately the health of the community.

What are the environmental compliance obligations? Hospitals, like any business that produces waste as a part of its everyday work, are subject to a range of environmental regulations. These regulations may include:

• The Solid Waste Disposal Act and Resource Conservation and Recovery Act, which regulate the disposal of solid waste and hazardous waste.
• The Clean Air Act, which governs operation of onsite medical waste incinerators, as well as the venting of toxic chemicals such as ethylene oxide (a sterilant) into the atmosphere.
• The Clean Water Act, which covers discharge of wastewater that may contain high concentrations of chemicals.

Some hospitals have been motivated toward environmental awareness through voluntary policies, others through environmental compliance orders that have resulted from inspections by their state or regional environmental enforcement authority, like the EPA.

An example of the health care industry’s lack of awareness of its environmental regulatory obligation is documented by results of a hospital compliance-monitoring program published by the EPA’s Regional Office for New York, New Jersey, and Puerto Rico in August 2006. According to the summary data, the program completed 49 inspections and took enforcement actions at 36 facilities, noting that hospitals in the program had corrected 3,223 violations [1]. In the Midwest EPA Regional Office for Iowa, Kansas, Missouri, and Kansas, hazardous waste inspector Dedriel Newsome reported in October 2008 that the EPA and the states in that region had conducted about 55 inspections of hospitals in the preceding 5 years and had completed at least 35 enforcement compliance actions during that time [2]. Those inspections resulted in at least 35 formal compliance orders.

Both EPA regions reported that the most common violations at hospitals were related to hazardous waste; in the New York, New Jersey, and Puerto Rico region, 70 percent of the violations were hazardous-waste related. Failure to identify hazardous waste and improper hazardous waste-container management accounted for 56 percent of the Resource Conservation and Recovery Act violations cited in the 2006 program. These hazardous wastes typically involve spent solvents used in clinical and research labs; unused chemicals, drugs, and alcohols; respiratory machine media in the surgery and emergency departments; and acutely hazardous chemotherapy agents and other pharmaceuticals.

To assist the health care sector to better understand its compliance obligations, the EPA funded an online resource, the Healthcare Environmental Resource Center, that provides pollution-prevention and compliance-assistance information [3].

As a result of these compliance needs and heightened awareness, most hospitals now require staff who work in the lab and surgery to be trained in environmental compliance management for their areas. The hospital environmental health and compliance officers normally lead this program and act as a resource for regulatory and waste-management policies and questions.

Beyond compliance—successful toxics and natural-resource management. Many hospitals have gone beyond compliance and set goals to reduce and manage their wastes and natural resources more efficiently. In fact, most have virtually eliminated use of mercury-containing devices in patient-care areas, and nearly 200 facilities have been recognized with a Making Medicine Mercury-Free award given out by the H2E program through 2006, and now by Practice Greenhealth. Practice Greenhealth continues the work begun by the H2E program and has become the primary membership and networking organization for health care institutions committed to sustainable, eco-friendly practices. Members include hospitals, health care systems, businesses, and others engaged in the “greening” of health care to improve the health of patients, staff, and the environment [4].

Physicians as part of the solution. Hospitals do not participate in these programs solely to be good environmental stewards—they can often save money at the same time. One Minnesota surgeon’s green efforts have saved his facility $2,000 and 80 pounds of waste annually [5]. Dr. Rafel Andrade saw that waste could be reduced and implemented a program that eliminated needless, redundant supplies from surgical picks, switched to reusable gowns, promoted prudent use of sterile saline solutions, and minimized surgical prep waste. Several hospitals in Kansas have documented 40 to 70 percent reductions in the volume of their red-bag wastes, simply by educating staff about the written policy that defines what should and should not go into the red bags [6].

Nationally, Veteran’s Administration Hospitals have adopted Green Environmental Management Systems (GEMS), a set of policies designed to prioritize, integrate, and address compliance and pollution-prevention opportunities at their facilities nationwide. It considers a balance between environment and economics and uses a 9-step approach to environmental management [7]. Many hospitals have followed with their own version of GEMS.

According to Energy Star for Healthcare, a national program that supports hospital energy conservation, health care organizations spend more than $8.3 billion on energy each year to meet patient needs. Every dollar a nonprofit health care organization saves on energy is equivalent to $20 in new revenues for hospitals or $10 for medical offices. Just a 5 percent reduction in energy costs in for-profit hospitals, medical offices, and nursing homes can boost earnings a penny per share. One Wichita, Kansas, hospital has used Kansas State University engineering interns to benchmark and identify energy-conservation opportunities. In the summer of 2008, it documented more than 3 million kWh conserved with a related savings of $350,000 [8]. The hospital recently detailed a plan to expand the program that may result in a savings of up to $6 million—money that will be put back into patient care.

You see it every day, and if you look for it at your hospital, it’s there—excessive waste of our natural resources and raw materials. Our medical profession stands by an oath to “First do no harm.” Physicians must use available tools, ask about the hospital policies, and be part of the “green” solution for the financial and environmental health of each facility and community.

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References

1. EPA. Healthcare environmental compliance pitfalls. 2007. http://www.sbeap.org/past_workshops/HHE_2007/Main/ Compliance_for_Hospitals.ppt. Accessed May 1, 2009.
2. Newsome D. What to expect when EPA shows up. Routine RCRA inspections, common violations, and enforcement follow-up. 2008. http://www.iowadnr.gov/waste/p2/files/08h2e_rcra.pdf. Accessed May 1, 2009.
3. Healthcare Environmental Resource Center. Pollution prevention and compliance assistance information for the healthcare industry. http://www.hercenter.org. Accessed May 1, 2009.
4. Practice Greenhealth. Knowledge & resources. http://www.practicegreenhealth.org/educate. Accessed May 1, 2009.
5. University of Minnesota. Minnesota technical assistance program. http://www.mntap.umn.edu/health/142.html. Accessed May 1, 2009.
6. Kansas Small Business Environmental Assistance Program. Kansas hospitals for a healthy environment. 2003. http://www.sbeap.org/publications/KS_hospital_factsheet.pdf. Accessed May 1, 2009.
7. Kulas B. The federal electronics challenge and the VA GEMS program. http://federalelectronicschallenge.net/resources/docs/va_gems.pdf. Accessed May 1, 2009.
8. Kansas State University Pollution Prevention Institute. Energy conservation for small business. http://www.sbeap.org/publications/energy/?section=Energy&name=GHG. Accessed May 1, 2009.

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Nancy J. Larson, RS, is the director of the K-State Pollution Prevention Institute and the Kansas Small Business Environmental Assistance Program. She has more than 20 years’ experience in the environmental and public health arena and previously worked as a nurse.

Related in VM

Medicine’s Role in Mitigating the Effects of Climate Change, June 2009

Educating Patients as Medicine Goes Green, June 2009