Iowa Health Cardiology, a physician specialty group with the Iowa Health system, has expanded its services to a clinic in Ankeny. A doctor currently sees patients one day every two weeks, but the cardiologists hope to eventually increase the services in Ankeny to weekly visits, he said. Future plans include offering cardiology services in Altoona and at Iowa Health's new hospital in West Des Moines, which is currently under construction.
Five years after President Bush announced plans for Americans' health records to go digital, only one in five doctors has converted from paper to electronic record keeping. But when Barack Obama takes over the White House, this could change. During his campaign for president, Obama promised a $50 billion investment to store patient records electronically and his economic stimulus package is expected to contain two years worth of funding. The money would be distributed to hospitals and doctors through grants and through higher reimbursement rates when serving Medicare patients. And for doctors who do not make the switch, Obama will propose lowering reimbursements from government-subsidized healthcare programs.
Hawaii doctors plan are starting online house calls in the nation's first large-scale program of its kind that some believe could be a groundbreaking step in healthcare. The service is being provided in Hawaii by Hawaii Medical Service Association under a licensing agreement with Boston-based American Well. It is available for a fee to all Hawaii residents, including the uninsured and non-HMSA members.
Georgia Gov. Sonny Perdue found quick opposition for his proposal to fund Medicaid and trauma care with new fees on hospitals and speeding motorists. Perdue has proposed a 1.6% fee on hospital revenues and health insurance plans to fill the state's $208 million hole in Medicaid this year, and to provide $60 million toward a statewide trauma network. Perdue told legislators he knew his plan would "not be universally acclaimed," but said the federal government created the problem.
Wyoming Valley Health Care System in Wilkes-Barre, PA, announced that the sagging economy is forcing it to lay off managers and other personnel. Seven managers and eight non-management staff are being cut, officials said. Twenty plant and facilities construction staff members are being temporarily laid off pending analysis of future building and construction needs, and 55 vacant positions aren't being filled.
TriStar Health System has told employees that it is delaying annual pay raises for 2009 and could eliminate them for the year if the economy doesn't improve. The subsidiary of Nashville-based HCA Inc. that operates its hospitals in Middle Tennessee also said that it has standardized pay practices across hopsitals in the markets that it serves.
Former Sen. Tom Daschle's confirmation as secretary of Health and Human Services has slowed as the Republican staff on the Senate Finance Committee staff examines his tax records and his association with an education-loan provider that is under committee scrutiny. Republican committee aides stressed they haven't determined there is a problem in any of their examinations, and said it was the complexity of the issues that is slowing the process instead of a suggestion of impropriety. GOP aides said they won't schedule a confirmation hearing until they have answered their questions, which means his nomination likely won't be considered by the Finance Committee before President-elect Barack Obama is sworn into office.
More than $100 billion worth of investment capital is pushing companies to embrace broad health reform principles, and the Interfaith Center for Corporate Responsibility said that it has filed 26 shareholder resolutions related to health reform for the coming proxy season. The group, a coalition of faith-based institutional investors, has been pushing this strategy for a while now.
Pharmaceutical and medical device manufacturers now have a clearer picture of when they can appropriately distribute valid scientific and medical information to healthcare providers about off-label or investigational uses of their products.
On January 12, the FDA finalized its Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices U.S. The guidance provides the agency's current thinking about the distribution of journal articles and reprints.
"It's good for the industry that they have some final guidance," says Erin Reilly Lewis, Esq., counsel with Baker and Daniels in Indianapolis. "A manufacturer, if called to the mat on it, can say, I looked at the final guidance you issued, FDA, and I believe I followed it for X, Y, and Z reasons."
Requirements in the guidance
According to the guidance, a scientific or medical journal article that is distributed should be:
Published by an organization with an editorial board that uses independent experts and has a public policy of full disclosure of any conflict of interest or biases
Peer-reviewed and published in accordance with the organization's peer-review procedures
Generally available in bookstores or other independent distribution channels
A scientific or medical reference publication that is distributed should not be:
Written, edited, excerpted, or published specifically for, or at the request of, a pharmaceutical or medical device manufacturer
Edited or significantly influenced by a pharmaceutical or medical device manufacturer or any individuals having a financial relationship with the manufacturer
In the form of a special supplement or publication funded in whole or in part by the manufacturer
In addition, articles must not be false or misleading or pose a significant risk to the public health, if relied upon.
Appropriate information
The guidance allows companies to distribute information in scientific or medical journal articles or reference publications that address scientifically sound clinical investigations including historically controlled studies, pharmacokinetic and pharmacodynamic studies, and meta-analyses that test a specific clinical hypothesis.
The FDA also clarifies the types of publications that are appropriate for distribution. According to the guidance, publications or articles that are not appropriate include:
Letters to the editor
Abstracts of a publication
Reports of Phase 1 trials in healthy subjects
Reference publications that contain little or no substantive discussion of the relevant investigation or data
"The FDA broke down the information into the types of reprints and articles and reference publications and then the manner in which that information should be disseminated," says Bruce Armon, Esq., vice-office managing partner for Saul Ewing's Philadelphia office. "The FDA provided some useful information. I think they have tried to provide some clarity in terms of how a company could follow this guidance document and continue its business operations."
Off-label promotion still prohibited
The new guidance does not permit companies to promote products for off-label uses, says Howard Dorfman, Esq., counsel for Ropes and Gray in New York.
"The guidance . . . poses very real requirements on the part of manufacturers in relation to the appropriate way they can disseminate valid and reliable scientific information that the medical profession requires in order to help healthcare providers to understand the most up-to-date state of medical knowledge relating to determining appropriate therapeutic options for their patients," Dorfman says.
Off-label promotion remains an area of focus for the Department of Justice (DOJ) and the Office of Inspector General. How the guidance will affect investigations into allegations of off-label marketing is unknown.
"At the moment, we really don't have a clear idea of how the Justice Department is going to view the final guidance with regard to investigations of alleged off-label promotion in the industry, even though the FDA Guidance does not relate to off-label promotional activities and is totally different," Dorfman says.
Companies have to look at internal processes and procedures to determine whether they are distributing legitimate scientific information or engaging in unlawful off-label promotion, Lewis says.
"I think they need to, if possible, step back and say, 'I need to make sure the information I am putting out there is permitted under the final guidance,'" Lewis says.
Financial disclosures
The guidance provides some increased transparency regarding financial relationships between authors and industry. Companies must disclose if any author associated with an article has a financial interest in the product or manufacturer discussed. In addition, companies must disclose the nature of the affiliation and the amount of the financial interest.
"It's really an effort to make sure that if somebody is an author, anyone who is reading and potentially relying on that author's findings has the ability to know what relationships that author may or may not have," Armon says.
Industry need for guidance
The final guidance helps fill the gap created when certain provisions of the Food and Drug Modernization Act (FDAMA) sunset in 2006. The FDA released a draft version of the guidance in February 2008.
For some period of time, the industry found itself in a state of limbo, says Dorfman. The guidance provides clear direction to them. Implementing the guidance in its final form will allow companies to "do the right thing" when disseminating information that is critical to healthcare providers.
Although the guidance does not carry the force of law, it represents the FDA's current thinking, says Armon.
"Certainly even though it is only guidance . . . companies would be well served by heeding the FDA's recommendations and reviewing and updating their company policies," Armon says.
The lack of guidance may have kept companies from distributing any reprints at all, notwithstanding the fact that the reprints were of the type covered in the guidance, Dorfman says. Until release of a guidance in final form, companies were cautious about distributing any information because they weren't sure about the FDA's position as to what information they were permitted to distribute and under what procedure. The guidance gives manufacturers an opportunity to evaluate whether they want to disseminate medical articles and also provides them with a clear idea of what they can and cannot distribute.
"There is a more defined line which manufacturers and companies can look at and figure out, 'how can I make this work for me and how can I make this work for my company,'" says Lewis.
This story first appeared as a breaking news item from the editors ofPharma Compliance Alert, a weekly e-newsletter from HCPro, Inc.
Barack Obama will be sworn in on Jan. 20 as the United States' 44th president and the first African-American to hold the nation's highest office. Regardless of political leanings, Americans should take a justifiably proud moment to mark this truly historic occasion.
But when the hoopla dies down and the nation's business is taken up, we must also remember that Obama didn't get elected because of his race. He got elected because for nearly two years he ran a near-flawless presidential campaign that most voters felt better addressed their anxieties in these rough economic times. And judging by his comments on the campaign trail, and by the people he's picked for key Cabinet posts, I believe that the Obama presidency will be a boon for rural health. Here's why:
First, on the campaign trail, no other candidate came close to matching Obama's understanding of rural healthcare issues coupled with a detailed action plan. The nonpartisan National Rural Health Association says Obama was the only presidential candidate who took the time and effort to respond to its questionnaire about rural healthcare.
If you put 100 rural hospital CEOs in a room and asked them to come up with a list of rural healthcare priorities, it'd look a lot like what Obama has proposed. He has called for: universal health coverage; helping small businesses afford health coverage; promoting fairness in Medicare and Medicaid reimbursements; expanding community clinics; bringing more physicians, nurses, and other healthcare providers into rural areas (What good is coverage if you don't have access?); improving care for rural veterans; and investing in massive IT upgrades and telemedicine for rural hospitals.
"We are very optimistic," says Maggie Elehwany, vice president and chief lobbyist for the NRHA, the Washington, DC-based umbrella group for several rural healthcare advocacy groups. "We know he has a whole lot on a very big plate, but we have been so pleased at his willingness from the get-go to be engaged not only during the campaign but also with the transition team. For a guy from Chicago, he gets it. You have to give him props for being able to communicate those concerns."
Of course, a campaign promise doesn't guarantee anything. But the fact that Obama shows that he at least understands the issues surrounding rural health speaks volumes. It also allows Elehwany and other rural healthcare advocates to hold him accountable. He can't plead ignorance.
Second, the high-profile selection of former South Dakota Sen. Tom Daschle as Obama's secretary of Health and Human Services— the first major post-election announcement from the president-elect--clearly indicates that expanding healthcare coverage and overhauling the nation's healthcare delivery system is a priority. Daschle spent eight years in the House and another 18 years in the Senate and knows how Washington works. He is both a leading advocate for rural healthcare and a consummate Beltway insider, and his first Senate confirmation hearing as HHS Secretary-nominee was a love fest with old colleagues.
Even though conflict is guaranteed in the coming months, right now Daschle is saying all the right things about forging bipartisan solutions. Republicans on the Senate Finance Committee this week are expected to press him on any attempts to expand government-funded healthcare programs.
"Obama knows the game is going to be played in the Senate, and he picked someone like Sen. Daschle who understands what works," Elehwany says. "We've worked with Sen. Daschle for years and he is someone who gets it. He understands that just giving people coverage doesn't equate to access. Access is the No. 1 problem in rural America."
Third, fears that this recession could sink into a full-blown depression or hobble the economy for a decade or more –- like the economic malaise that hit Japan in the 1980s and 1990s -- mean that Obama will not be constrained by deficits. Obama has already outlined an $850 billion recovery package and he's indicated that he will spend freely to bolster the economy. One area that the president-elect has targeted for investment is healthcare.
"We'll create hundreds of thousands of jobs by improving healthcare -- transitioning to a nationwide system of computerized medical records that won't just save money, but save lives by preventing deadly medical errors," Obama said this week. As part of his efforts to mend the nation's infrastructure, there will also be federal money available for capital improvements, building or expanding existing hospitals and healthcare clinics.
This column is not a pep rally for Obama. So far, it's been mostly talk. But if you're an advocate for rural healthcare, it's hard not to be encouraged by what the president-elect has said. Rural healthcare is on his agenda. He recognizes the issues. He's got a plan. He's on record.
Now, it's our job, as rural healthcare advocates, to make sure he delivers on those promises.
John Commins is the human resources and community and rural hospitals editor withHealthLeaders Media. He can be reached atjcommins@healthleadersmedia.com.
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