AHLAlerts: American Health Line’s Blog

The pieces argue: The actions of Democrats during the reform process reveal that they are concerned about how the majority of U.S. residents will vote in the upcoming midterm elections. Current reform proposals in Congress have “unhealthy” arrogance behind their creation.

Editorial

Washington Times: “President Obama and Democratic leaders say they are counting on a health care victory to buoy their electoral prospects in 2010,” but actions by Democrats suggest otherwise, the editorial states. The editorial continues that Democrats are not revealing “the content of the health bills until the last moment so that it would be difficult to read and discuss what was in them,” and it suggests that “they know they are in big trouble when Americans go to vote in November” (Washington Times, 12/31/09).

Opinion Pieces

• Thomas Sowell, National Review: “The only thing healthy about Congress’ health insurance legislation is the healthy skepticism about it shown by most of the public, as revealed by polls,” Sowell, senior fellow at the Hoover Institution, writes. According to Sowell, “What is most unhealthy about this legislation is the raw arrogance in the way it was conceived and passed” (Sowell, National Review, 12/29/09).
• Gene Lyons, Salon: “Democrats fear that the party is both providing inadequate coverage” under current reform legislation “and setting itself up for voter backlash,” columnist Lyons writes. However, he continues, “Retreat now is unthinkable” because the bills at least establish universal coverage “in principle” (Lyons, Salon, 12/24/09).
• John Fund, Wall Street Journal: Sen. Ben Nelson’s (D-Neb.) “fall in public esteem is a direct reaction to his having voted for the [Senate] health care bill (HR 3590) as part of a deal in which Nebraska was exempted from the costs of new federal Medicaid mandates,” columnist Fund writes. According to Fund, the bill “was already unpopular enough in Nebraska but became even more so when state residents discovered they would be saddled with it anyway, plus exposed to national ridicule over Nelson’s sweetheart deal” (Fund, Wall Street Journal, 12/30/09).
• Stuart Butler, Washington Times: “The right thing for the Democratic majority to do” in regard to health reform “would be to recognize that it is trying to go too far, too fast,” writes Butler, vice president of domestic policy studies at the Heritage Foundation. He continues, “This would be a good time to sharply pare back” overhaul legislation (Butler, Washington Times, 12/31/09).
• Jeffrey Schaler/Richard Vatz, Washington Times: “The vast majority of U.S. residents are unaware of most of what is included” in current reform legislation, and they “will be in for a big surprise concerning parity mental health care coverage, covering mental problems comparably to physical problems,” writes Schaler, a professor at American University, and Vatz, a professor at Towson University (Schaler/Vatz, Washington Times, 12/31/09).

– compiled by Matthew Wayt

Nine senators have asked Senate Majority Leader Harry Reid (D-Nev.) to include a provision in final health reform legislation that would ban drug patent settlements, in which a brand-name drugmaker pays a generic drugmaker to keep less costly generics off the market, Reuters reports. The provision is included in the House reform bill (HR 3962) but not the Senate version.

Drugmakers have an incentive to make the deals because a branded medicine loses up to 80% of its revenue once a less expensive generic floods the market, according to Reuters. The Federal Trade Commission estimated the deals cost U.S. residents $3.5 billion annually.

“These ‘pay for delay’ agreements between brand-name and generic drug companies deny consumers the benefits of generic drug competition,” the senators wrote in a letter to Reid dated Dec. 24. Democratic Sens. Byron Dorgan (N.D.), Al Franken (Minn.), Amy Klobuchar (Minn.), Herb Kohl (Wis.) and Jeanne Shaheen (N.H.) are among those who signed the letter (Reuters, 12/30).

– compiled by Ryan Holeywell

CMS officials on Wednesday released proposed regulations defining the “meaningful use” of electronic health records as part of a wider government effort to spur the adoption of health information technology to improve medical care and cut costs, Reuters reports. The regulations are included in the 2009 economic stimulus package, which provided about $19 billion in Medicare and Medicaid incentive payments to eligible health care providers who demonstrate meaningful use of health IT (Wutkowski/Heavey, Reuters, 12/30/09).

According to the 700-page plan, the proposed requirements for demonstrating meaningful use of health IT will be phased in over three stages between now and 2013. The criteria released on Wednesday mark the first stage, while the second stage is slated to be issued by the end of 2011. The third stage will be issued by the end of 2013, Government Health IT reports (Mosquera, Government Health IT, 12/30/09). “Such a phased approach encompasses reasonable criteria for meaningful use based on currently available technology capabilities and provider practice experience, and builds up to a more robust definition of meaningful use, based on anticipated technology and capabilities development,” the document states (Monegain, Healthcare IT News, 12/30/09).

The first stage of criteria will focus on gathering data electronically — which can be shared between providers and patients — and reporting the measures to the government, National Coordinator for Health IT David Blumenthal said during a briefing on Wednesday. The second stage of criteria will focus on structured information exchange and continuous quality improvement. Stage three will focus on decision support for “national high priority conditions” and population health, Blumenthal added (Simmons, HealthLeaders Media, 12/31/09).

Under the proposed rules, health care providers who use EHR technology for at least 80% of their medical instructions would be eligible for the incentive payments, according to the AP/New York Times. Providers also must give patients paper copies of their medical data and use computers to check for potential drug interactions. Hospitals would have to file at least 10% of their orders electronically to be eligible for incentive payments (AP/New York Times, 12/30/09).

ONC Releases Interim Final Regulation for Health IT

The Office of the National Coordinator for Health IT at HHS on Wednesday also issued an interim final rule outlining the technical standards and features that providers must implement in their EHR systems to comply with the standards and certification of meaningful use. Blumenthal said the criteria “are very specifically linked to the definition of meaningful use” outlined in CMS’ proposed regulations, adding, “This initial set of standards begins to define a common language to ensure accurate and secure health information exchange across different EHR systems.”

According to Government Health IT, the rule also explains:

• The standard formats for clinical summaries and prescriptions; and
• Standard terms to describe clinical problems, procedures, laboratory tests, medications and the secure transportation of the data online (Government Health IT, 12/30/09).

Both regulations will be published in the Federal Register on Jan. 13, 2010, with a 60-day comment period effective at that time, Health Data Management reports. The rule will become effective 30 days after publication (Goedert, Health Data Management, 12/30/09). The final rule on the EHR adoption standards will be issued sometime in 2010, according to Reuters (Reuters, 12/30/09).

– compiled by Santosh Rao

Thirteen Republican state attorneys general sent a letter on Wednesday to House Speaker Nancy Pelosi (D-Calif.) and Senate Majority Leader Harry Reid (D-Nev.) demanding that a deal to pay the cost of Medicaid expansion in Nebraska included in the Senate’s reform legislation (HR 3590) be rescinded or they would file suit, The Hill‘s “Blog Briefing Room” reports (Fabian, “Blog Briefing Room,” The Hill, 12/30/09).

In order to secure the support of Sen. Ben Nelson (D-Neb.), a provision was added to the Senate health reform bill granting Nebraska increased funding for the cost of the proposed Medicaid expansion. However, the state attorneys general in their letter alleged that the deal is illegal.

“We believe this provision is constitutionally flawed,” South Carolina Attorney General Henry McMaster (R) wrote. The letter was co-signed by the attorneys general from Alabama, Colorado, Florida, Idaho, Michigan, North Dakota, Pennsylvania, South Carolina, South Dakota, Texas, Utah, Virginia and Washington state (Kinnard, AP/San Francisco Chronicle, 12/31/09).

The letter continued, “As chief legal officers of our states we are contemplating a legal challenge to this provision and we ask you to take action to render this challenge unnecessary by striking the provision.” The letter also stated that the deal “violat[es] the most basic and universally held notions of what is fair and just,” as well as being “inconsistent with protections afforded by the United States Constitution against arbitrary legislation” (Isenstadt, Politico, 12/30/09).

Nelson Defends Vote

Nelson on Wednesday defended his vote for the Senate health bill in a 30-second television advertisement broadcast during the Holiday Bowl football game, which featured the University of Nebraska, the New York Times reports. After having received harsh criticism for casting the decisive 60th vote for the legislation, Nelson described the bill as “a common sense approach” to health reform, emphasizing that it is “not run by the government.” According to the Times, despite having a conservative voting record, Nelson’s vote for the health reform bill made many “painfully aware” that he is the only Democrat serving in a statewide office (Davey, New York Times, 12/31/09).

– compiled by Julia Moss

The Progressive Change Campaign Committee is launching phone and advertising campaigns urging voters to ask Sens. Bernie Sanders (I-Vt.) and Russ Feingold (D-Wis.) to vote against any health reform legislation that does not include a public option, The Hill‘s “Blog Briefing Room” reports. In addition, the group is planning to deliver petitions to Sens. Sherrod Brown (D-Ohio) and Al Franken (D-Minn.).

PCCC is hoping the campaign, called “Be a Hero,” will prompt one of the four senators to withhold their support unless some form of a public option is included during Senate and House negotiations. PCCC co-founder Adam Green said, “Bernie Sanders can be a hero at this historic moment by declaring that any final bill must have a public option to win his support. That would change the entire calculus in House-Senate negotiations and force President Obama to finally fight back against [Sen.] Joseph Lieberman’s (I-Conn.) threats” not to support a health bill that contains a public plan (Zimmermann, “Blog Briefing Room,” The Hill, 12/30/09).

– compiled by Julia Moss

A federal program that would fund long-term care for the elderly and disabled is poised to make it into the final health care reform bill, even though the majority of the Senate opposes it, the Los Angeles Times reports.

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FDA often uses a flawed process for approving cardiovascular medical devices, which can be placed on the market based on weak studies open to bias, according to two recently published studies, the Wall Street Journal reports (Favole/Mundy, Wall Street Journal, 12/30/09).

A study published online Tuesday in the Journal of the American Medical Association by researchers at the University of California-San Francisco found that of 78 heart and blood-vessel device applications approved by FDA between January 2000 and December 2007, 65% were supported by only one study. The JAMA study also found that 27% of the studies were randomized and that 14% were blinded (Allen, Reuters, 12/29/09). The new study also found that many devices were approved based on small studies that consisted of about 300 participants.

A second study published in the American Journal of Therapeutics conducted by researchers from FDA and Boston’s Beth Israel Deaconess Medical Center found that about 40% of the research submitted by device makers lacked information on how safety should be measured, as well as important patient information that could have influenced the results (Johnson, AP/Washington Times, 12/30/09).

According to Jeffrey Shuren, acting director of FDA’s device division, the agency recognizes the weaknesses of the trials used to approve cardiovascular devices and “want[s] to be clear to manufacturers about what is expected of them” (Wall Street Journal, 12/30/09). He noted that “a randomized double-blind, placebo-controlled trial” is “the kind of study you would do in the case of drugs, but for medical devices that may not necessarily be either feasible or ethical” (Reuters, 12/29/09).

– compiled by Julia Moss

Govs. David Paterson (D-N.Y.) and Arnold Schwarzenegger (R-Calif.) have criticized the Senate health care bill (HR 3590) for its plan to expand Medicaid, saying it would create significant burdens for their states which already are in financial straits, Politico reports. The governors say the current bill penalizes states that already have expanded Medicaid coverage — which California and New York have done — by making them pay a disproportionately large share of the costs for expanding coverage in states that currently offer limited Medicaid programs.

Paterson said that New York, which already faces a $6.8 billion budget shortfall, would incur $1 billion in new costs under the proposal. In an opinion piece published in the Buffalo News on Dec. 25, Paterson wrote, “New York taxpayers are being used to pay for handouts to other states.” Similarly, New York City Mayor Michael Bloomberg (I) has called the Senate’s bill a “disgrace” and warned that it could cause several city health clinics to close if it is passed. In a letter to House Speaker Nancy Pelosi (D-Calif.), Schwarzenegger warned that reform legislation could add an additional $3 billion to $4 billion to California’s current $20.7 billion budget deficit.

According to Politico, the governors’ criticisms “are notable because they are distinct from the opposition to the health care bill voiced by many Republican governors,” because both Paterson and Schwarzenegger generally support President Obama’s domestic agenda and neither has opposed Democrats’ health reform efforts. A majority of New York’s congressional delegation supports Paterson’s stance and has asked congressional leaders to solve the Medicaid financing inequities, Politico reports. A spokesperson for Pelosi said the Speaker intends to address Schwarzenegger’s concerns in ongoing negotiations to merge the Senate with the House reform bill (HR 3962) (Isenstadt, Politico, 12/29/09).

– compiled by Zach Swiss

FDA is developing guidelines to set stronger scientific standards for human test data submitted by medical device makers when seeking approval for their products, Jeffrey Shuren, acting director of the Center for Devices and Radiological Health, said Monday, the New York Times reports. Shuren said that the agency likely will urge device makers to take steps like measuring the success of clinical trials using more clearly defined targets, as well as urging device makers to track patients involved in clinical trials more closely to determine if targets are met.

Shuren’s announcement was made before the Tuesday release of two studies that found inadequacies in some FDA-accepted clinical trials from 2000 to 2007. The trials involved the approval of high-risk cardiovascular devices, such as coronary stents, implanted defibrillators and pacemakers.

In recent years, policymakers, researchers and patient advocates have criticized FDA’s standards for approving medical devices, an issue that has become particularly significant because of a U.S. Supreme Court decision that shields high-risk medical device makers from patient lawsuits if their products are FDA-approved, the Times reports. Shuren said that one of the two new studies found enough issues with the quality of data submitted for clinical trials to justify the policy changes. “It is not acceptable, and that is the reason we are making the changes in the program we are making,” he said (Meier, New York Times, 12/30/09).

– compiled by Brittany Hackett

The pieces argue: Democrats should leverage their majority in Congress to quickly pass health reform. Democratic leaders should use the House bill (HR 3962) as the base for final reform legislation because it includes stronger preventive measures. President Obama deserves praise for his efforts on advancing reform legislation.

Editorial

“Reforming this country’s broken health care system is an urgent and essential task,” a New York Times editorial states, adding, “The need is clear and the political timing is right with the Democrats controlling the White House, the Senate and the House.” The editorial continues, “If this chance is squandered and Republicans gain seats, as expected, in the midterm elections, it could be a decade or more before reformers have another opportunity.” The editorial concludes, “Americans shouldn’t have to wait any longer” (New York Times, 12/30/09).

Opinion Pieces

• Bill Osborne, San Diego Union-Tribune: If lawmakers charged with merging the House and Senate (HR 3590) health reform bills “are truly serious about cutting the cost of health care in America, they should focus harder on preventing disease in the first place,” Union-Tribune staff writer Osborne writes. Osborne continues, “Neither version of reform goes as far as it ought to in the cause of prevention” but the House bill dedicates more funding to preventive medicine (Osborne, San Diego Union-Tribune, 12/29/09).
• DeWayne Wickham, USA Today: “By threatening to join a GOP filibuster” against the Senate bill, Sen. Joseph Lieberman (I-Conn.) “forced Democrats to strip first a public option and then a Medicare buy-in compromise from the … bill, provisions many experts and activists consider essential to effective reform,” columnist Wickham writes. He adds that as a “Democrat of convenience,” Lieberman “succeeded” in “a masterful act of treachery” to retain “a position of trust among the very people he betrayed.” Wickham concludes, “Joe Lieberman is unmatched in his ability to persuade those he betrays to treat him as a friend — instead of the enemy he really is” (Wickham, USA Today, 12/29/09).
• Robert Dallek, Wall Street Journal: President Obama “has carried off something of a minor miracle” in getting health reform legislation so close to final passage, Dallek, an author and presidential historian, writes. Unlike the reform efforts by past presidents, Dallek writes that President Obama “had a much higher mountain climb” to pass health reform despite Democratic majorities in both the House and Senate. Obama also has had to deal with two wars abroad and other significant domestic issues, he notes (Dallek, Wall Street Journal, 12/29/09).

– compiled by Santosh Rao