Policy and Medicine

HHS to Begin HIPAA Audits

Starting this month, healthcare organizations will be subject to audits by the Office of Civil Rights (OCR), evaluating their compliance with the HIPAA privacy and security rules and breach notification standards.

The American Recovery and Reinvestment Act of 2009, in Section 13411 of the HITECH Act, requires the Department of Health and Human Services (HHS) to provide for periodic audits to ensure covered entities and business associates are complying with the HIPAA Privacy and Security Rules and Breach Notification standards. 

To implement this mandate, OCR is piloting a program to perform up to 150 audits of covered entities to assess privacy and security compliance.   Audits conducted during the pilot phase will begin November 2011 and conclude by December 2012.  Auditors will conduct a site visit, interview key personnel, and record results in reports that will be shared with the organization and the OCR.

The audit program serves as a new part of OCR’s health information privacy and security compliance program.   OCR will use the audit program to assess HIPAA compliance efforts by a range of covered entities.  HHS asserted that, “audits present a new opportunity to examine mechanisms for compliance, identify best practices and discover risks and vulnerabilities that may not have come to light through OCR’s ongoing complaint investigations and compliance reviews.”  OCR will broadly share best practices gleaned through the audit process and guidance targeted to observed compliance challenges via this web site and other outreach portals.

The pilot audit program itself is a three-step process.  The first step entailed developing the audit protocols.  The second step is the initial audits beginning this month.  The results of the initial audits will inform how the rest of the audits will be conducted.  The last step will include conducting the full range of audits using revised protocol materials.  

Every covered entity and business associate is eligible for an audit.  Selections in the initial round will be designed to provide a broad assessment of a complex and diverse health care industry.  OCR is responsible for selection of the entities that will be audited.

OCR will audit as wide a range of types and sizes of covered entities as possible; covered individual and organizational providers of health services, health plans of all sizes and functions, and health care clearinghouses may all be considered for an audit.  OCR expects covered entities to provide the auditors their full cooperation and support and remind them of their cooperation obligations under the HIPAA Enforcement Rule.  Business Associates will be included in future audits.

The privacy and security performance audit process will include generally familiar audit mechanisms.  Entities selected for an audit will be informed by OCR of their selection and asked to provide documentation of their privacy and security compliance efforts. In this pilot phase, every audit will include a site visit and result in an audit report. During site visits, auditors will interview key personnel and observe processes and operations to help determine compliance.

Following the site visit, auditors will develop and share with the entity a draft report; audit reports generally describe how the audit was conducted, what the findings were and what actions the covered entity is taking in response to those findings. Prior to finalizing the report, the covered entity will have the opportunity to discuss concerns and describe corrective actions implemented to address concerns identified.

The final report submitted to OCR will incorporate the steps the entity has taken to resolve any compliance issues identified by the audit, as well as describe any best practices of the entity.

Audits are primarily a compliance improvement activity.  OCR will review the final reports, including the findings and actions taken by the audited entity to address findings.  The aggregated results of the audits will enable OCR to better understand compliance efforts with particular aspects of the HIPAA Rules.  Generally, OCR will use the audit reports to determine what types of technical assistance should be developed, and what types of corrective action are most effective.

Should an audit report indicate a serious compliance issue, OCR may initiate a compliance review to address the problem.  OCR will not post a listing of audited entities or the findings of an individual audit which clearly identifies the audited entity.

Government Targeting Pharmaceutical Executives with Renewed Enthusiasm

 
Over the past several years, we have seen an increasing focusing on litigation and prosecution of large pharmaceutical and medical device manufacturers ranging from off-label promotion, to fraud and abuse, and a number of other legal and regulatory issues. 

Many of these cases, in fact, almost all of them, have settled, largely because companies face the threat of debarment—the inability of a company to do business with the federal government (i.e. the Centers for Medicare and Medicaid).  These kinds of prosecutions of "responsible" officers trouble defense lawyers in the health sector because the threat can be career ending.

For example, last December, the U.S. District Court in Washington affirmed a federal health-care program exclusion of three Purdue Frederick Co. executives who had earlier pled guilty to misdemeanor violations of the food and drug laws associated with the misbranding of the drug OxyContin.

The Justice Department didn't allege that the three officers participated in or were even aware of the misbranding, but rather that they were "responsible" corporate officers at the time the conduct occurred.

"The exclusion of these individuals by HHS is unprecedented and unjust," said Andrew Good of Good & Cormier, the lawyer for one of the three executives. The exclusions have been appealed to the D.C. Circuit Court of Appeals, he added.

Additionally, a large portion of money contained in the American Recovery and Reinvestment Act, as well as the Affordable Care Act, went towards funding more attorneys and investigators at the Department of Justice and Department of Health and Human Services (HHS) to root out fraud, abuse and waste.  Over the past few years, these efforts have yielded billions of dollars and extremely large settlements, with virtually every company out there.  But the company money is not enough.

Consequently, a recent article from the Wall Street Journal noted that, the “U.S. authorities are now stepping up enforcement of a little-used law—the so-called "responsible corporate officer doctrine"—to hold executives personally and criminally responsible for corporate violations of U.S. food and drug laws.”

According to the article, “the development has triggered a new wave of worry among defense lawyers representing health-care executives.”

Congress authorized criminal sanctions against corporate officers in 1938 under the Food, Drug and Cosmetic Act.

The Supreme Court has since interpreted the law to allow prosecutions without evidence that executives knew a crime was committed—a lower standard than for other industries — because of the potential for health-care and food products to cause death and injury.

The doctrine is the prosecutors' "ticket around the need to prove criminal intent," says Michael W. Peregrine, a lawyer at McDermott Will & Emery LLP. "It puts the pistol to the head of the very senior executives." During the 1960s and 1970s, the government used the doctrine in a series of liability cases involving dirty food warehouses. But by the late 1980s, its use had declined.

Earlier this year, however, Marc Hermelin, the former chief executive of a Bridgeton, Mo., pharmaceutical maker, pleaded guilty to two misdemeanor violations of the food and drug laws as a "responsible corporate officer" in a case involving KV Pharmaceutical Co.'s production and distribution of two oversized morphine sulfate tablets.  A judge ordered Mr. Hermelin to pay a $1 million fine, forfeit $900,000 and serve a sentence of less than 30 days in jail.

Lawyers concerned about the revival of the so-called "corporate-officer responsibility doctrine" cite other recent health-sector cases, including one in Philadelphia involving medical-device maker Synthes Inc. and Norian Corp., a subsidiary.

In 2009, federal prosecutors accused the two companies of running an unauthorized trial of a bone filler in spinal procedures. Three patients died, although prosecutors said they couldn't prove the Synthes product was the cause. The companies pleaded guilty and agreed to pay more than $23 million to settle with the government.

Four Synthes executives were accused of wrongdoing. Acknowledging that they were "responsible corporate officers," the employees each pleaded guilty in federal court to a misdemeanor associated with shipping the misbranded product, Norian XR, across state lines.

But prosecutors and defense lawyers are now fighting over what they can introduce in their arguments to the judge about sentencing, which could come as soon as this fall. Under current law, misdemeanor cases carry sentences for company executives of up to a year in prison and a maximum fine of $100,000 per count.

"If the government asks the court to impose jail time in this case, it will have a chilling effect on future 'responsible corporate officer' pleas," said Adam Hoffinger of Morrison & Foerster LLP, lead attorney for Thomas Higgins, a former Synthes division president, who is one of the defendants.

"You're going after defendants who by definition had no idea they [were] committing a violation," said Robert J. Becerra, a Miami-based lawyer who represented ChemNutra Inc., a Nevada pet-food company, and one of the two executives who pleaded guilty to a misdemeanor and got three years' probation in connection with the import of tainted wheat gluten that killed thousands of dogs and cats.

"There's more focus now on trying to identify whether it's a case where it's appropriate to charge corporate officials with wrongdoing," said John J. Pease, chief of the health-care fraud unit in the U.S. Attorney's Office in Philadelphia, which brought one of the recent prosecutions.

Ultimately, as the recent trend of going after company executives picks up, businesses will have to look closely at their practices.  A number of provisions contained in the Affordable Care Act, such as the Physician Payment Sunshine Act, along with the Foreign Corrupt Practices Act, and the increased scrutiny on fraud and abuse, all lead to heavier regulation of the health industry and greater oversight.  With the added threat of going after company executive’s, the need for compliance from the top down has never been greater.  Now that the government will be tracing every $10 that a company spends, and will know who that money goes to and for what, executives can be on the hook for anything considered to be a kickback or fraudulent claim.

Companies must begin changing their cultures now, before it is too late.  Training and education, as well as new policies adapting to the new regulatory culture are necessary.  To be able to continue doing business successfully today, the drug and medical device industry will need to focus on complying with federal rules, laws and regulations, otherwise the boardroom could soon be the jail cell.

HHS Secretary Sebelius: Improving Healthcare through Medical Innovation

 
Innovation in medicine and medical technology has led to tremendous achievements in American’s quality of life and health care. Over the past century, the life expectancy went from just over forty-seven years to nearly seventy-eight in 2006. “Diseases that had once been a death sentence were eradicated or cured. Conditions that had once been disabling were now manageable.”

As Kathleen Sebelius, Secretary of the Department of Health and Human Services (HHS) recently pointed out, “Many of these gains were made possible by the great leaps in biomedical science, from the discovery of insulin to the identification of effective therapies for HIV.” What she forgot to mention is that the pharmaceutical and medical device industry have overwhelmingly been responsible for this progress and improvements.

Consequently, in a recent article in the Journal of Health Affairs, Secretary Sebelius noted that America now has the chance to improve healthcare and medicine with even “bigger opportunities.” She pointed to “new treatments, such as cell-based therapies, which introduce new cells into body tissues to treat diseases such as diabetes, show great promise.” In addition, Secretary Sebelius championed “unlocking the human genome” as a way to “facilitate personalized treatments for diseases such as cancer, based on each person’s unique DNA.”

However, she recognized that gains from these breakthroughs “are not guaranteed.” Instead, she acknowledged that new “treatments and cures for cancer, Alzheimer’s disease, and HIV/AIDS will be made only if there is a robust pipeline that carries promising ideas forward from the microscope to the medicine chest.”

The only way to accomplish this robust pipeline according to the Secretary, “is with a new level of coordination among all of the partners in the research process.”

From Research To Final Product

Part of the problem why America is facing a challenge with discovering new drugs is that the “road from the research lab to an approved and marketable drug is a long one, and today there are many detours and obstacles along the way.” As Secretary Sebelius acknowledges, “despite billions of dollars invested every year in research and development, just twenty-one new drugs made it to market in 2008.”

She noted however that the Obama administration supports innovation and the potential of biomedical research, evidenced by the American Recovery and Reinvestment Act of 2009, which invested an additional $10.4 billion over two years in the National Institutes of Health (NIH), with the vast majority of those funds going directly to scientific research.

Despite this investment, Secretary Sebelius acknowledged that “more is needed than writing bigger checks” to enhance the drug pipeline.  She asserted that “resources must be invested so they will have the largest impact possible and will deliver greater numbers of cutting-edge drugs, therapies, and medical devices more quickly to the patients who need them the most.”

Stronger Public-Private Partnerships

To accomplish this kind of impact, Secretary Sebelius noted that the government has begun to “broaden its role from funding discovery to building innovative networks of all of the stakeholders in the development process.” Members of the networks include “foundations, such as the Bill & Melinda Gates Foundation, which are deploying funds to generate treatments and cures for diseases that disproportionately affect people in the world’s poorest countries; and patient advocacy groups, which can help collect patient blood, tissue, and other samples for basic research and connect their members with clinical trials.”

One such network is the Biomarkers Consortium, a public-private partnership that includes scientists from the National Cancer Institute, the Food and Drug Administration (FDA), major pharmaceutical companies, and nearly twenty major cancer research centers across the country. The consortium is now working on a clinical trial to improve the odds of survival for women with high-risk, fast-growing breast cancers.

Another example of partnership is the NIH Therapeutics for Rare and Neglected Diseases program, which links small companies or academic labs doing basic research on diseases such as sickle-cell disease and hookworm, with government researchers who can use high throughput screening and medicinal chemistry to move these discoveries closer to clinical trials.

The Cures Acceleration Network, which was enacted in the Affordable Care Act of 2010, is another example of private-public partnership.  It gives the NIH director the flexibility to fund a variety of innovative projects from the public, private, nonprofit, and academic sectors, with the goal of advancing research in areas where success is not a given but the payoff could be very high.

The Secretary also discussed how HHS will be forging stronger partnerships inside government, such as the NIH and FDA working together on translational efforts and developing standards for safety and effectiveness. However, the Secretary did not mention industry’s role in this partnership. It is crucial that industry has a seat at the table in discussing solutions and ideas for increasing the pipeline as well.

She also discussed a recommendation that NIH create a new center devoted to translational science that would generate new approaches for building bridges to link basic discovery research with the development of new therapeutics and clinical care. NIH is currently gathering input from the public and a broad range of stakeholders, and if all goes as planned, the new center will be established by October 1, 2011.

Conclusion

As Secretary Sebelius acknowledged, “some of the roadblocks that have held back the development of new medicines can be eliminated” by projects and partnerships with industry. Specifically, she recognized that “Public-private partnerships are needed to build new paradigms for drug development, not just when it’s time to manufacture and market a product, but from the beginning of the development process.”

Moving forward, policymakers must continue to include industry in regulatory discussions so that America can continue to develop a new generation of cures and treatments that could dramatically improve the lives of Americans and people around the world. By having “a broader conversation among stakeholders in government, academe, industry, and nonprofits about how everyone can do better,” America can fill its pipeline once again and create new jobs, revenue and medicine that will improve our health care system.  

National Prevention, Health Promotion and Public Health Council: Draft Recommendations Call for Comment

 
On June 10, 2010, the President signed an Executive Order creating the National Prevention, Health Promotion, and Public Health Council. On June 25, 2010, the Council ratified its first status report during a teleconference, and submitted its Annual Status Report  on July 1, 2010. 

An important component of the Affordable Care Act, the National Prevention, Health Promotion, and Public Health Council (National Prevention Council) brings together seventeen federal departments and agencies to plan and coordinate prevention efforts across the government and the nation through the development of the National Prevention and Health Promotion Strategy (National Prevention Strategy). 

Additionally, to provide guidance to the National Prevention Council, the President will establish an Advisory Group on prevention, health promotion, and integrative and public health composed of no more than 25 non-federal members. It is anticipated that the Advisory Group will be announced early in 2011. 

Members of the National Prevention Council include Department of Health and Human Services Secretary Kathleen Sebelius, Department of Veterans Affairs Secretary Eric Shinseki, and a number of other Secretaries and directors. The National Prevention Council, chaired by Surgeon General Regina Benjamin, is charged with providing coordination and leadership at the federal level and among all executive departments and agencies with respect to prevention, wellness and health promotion practices.

The Council is also responsible for making recommendations—with continual public input—to the President and the Congress concerning the nation’s most pressing health issues and on changes to federal policy that will promote health and achieve public health goals, including reducing tobacco use, sedentary behavior, and poor nutrition

Consequently, with input from the public and interested stakeholders, the National Prevention Council is charged with developing a National Prevention and Health Promotion Strategy (National Prevention Strategy) by March 23, 2011. The National Prevention Strategy seeks to shift the nation from a focus on sickness and disease to one based on wellness and prevention. It will present a vision, goals, recommendations and action items that public, private, nonprofit organizations and individuals can take to reduce preventable death, disease and disability in the United States.

The National Prevention Strategy brings together the many sectors that affect the health of Americans, including transportation, education, housing, and health. Implementation of the National Prevention Strategy must include the participation, coordination, leadership, and commitment of all parts of society, including public and private partners, in order to successfully improve the health of Americans.

A Draft Framework to guide the development of the National Prevention Strategy was made available for public comment from October 1 – December 5, 2010. Guided by this public input, the National Prevention Council has now developed a preliminary set of Draft Recommendations- overarching priorities with a focus on communities - that will greatly improve health and wellness in the United States. They have been posted online for public comment. Comments will be accepted until January 13, 2011.

The final National Prevention Strategy will also include specific actions that the federal government and others in the public, private, and non-profit sectors can take to achieve these priority Recommendations.  

The Recommendations and Action Items in the final National Prevention Strategy will be based on evidence-based interventions. It will also reflect the importance of tracking progress to ensure accountability. As National Prevention Council members and Designees receive public input, they will continue to refine the content and plan to release the final National Prevention Strategy in 2011.

National Prevention Strategy

Currently, chronic diseases and conditions account for at least 7 of every 10 deaths in the United States and for more than 75% percent of medical care expenditures. Many of these conditions are preventable. The National Prevention Strategy is designed to bring a focus on the prevention of disease and promotion of wellness to the forefront of efforts that will help lead to longer, healthier, and more productive lives for all Americans.

The National Prevention Strategy will also be aligned with the national health objectives set forth in Healthy People 2020, the First Lady’s Let’s Move! Campaign to combat the epidemic of childhood obesity, the National HIV/AIDS Strategy, the Department of Transportation’s Sustainable Communities, the Office of the National Drug Control Policy’s 2010 National Drug Control Strategy, and many others.

Additionally, four cross-cutting strategic directions, each containing specific recommendations, form the foundation for the National Prevention Strategy.

Healthy Physical, Social and Economic Environments: Create healthy physical, social and economic environments that encompass safe and healthy neighborhoods, worksites, schools, homes and public and green space. These environments should address physical (air, water, land, buildings and other structures) and economic (availably, affordability, fair market, opportunity) factors and social norms that promote health.

Eliminate Health Disparities: Eliminate health disparities experienced by populations (e.g., based on  race/ethnicity, gender, disability status, sexual orientation, socio-economic status, geography) in order to achieve  health equity. These disparities are exacerbated by poverty and inequities in employment, education, housing and others.

Prevention and Public Health Capacity: Build prevention capacity that supports state, Tribal, local, and Territorial efforts to promote health, prevent disability and disease and ensure preparedness for natural and man-made threats and emergencies.

Quality Clinical Preventive Services: Increase use of the most effective and highest impact/priority  evidence-based clinical preventive services and medications, such as the preventive use of aspirin; screening and  treatment for high blood pressure and cholesterol; cancer screening; screening and treatment for HIV, chronic viral  hepatitis, and STDs; and immunizations, among others.

These strategic directions are important in their own right and are applicable to each of the six targeted strategic directions, which include recommendations for:

• Tobacco-free living
• Reducing alcohol and drug abuse
• Healthy eating
• Active Living
• Injury-free living, and
• Mental and emotional wellbeing

Public comments on the Draft Recommendations can be submitted here until January 13, 2011.

 

FTC and Congress on Do Not Track Internet Proposed Rules

 

Last month, the outgoing House Committee on Energy and Commerce Subcommittee on Commerce, Trade, and Consumer Protection held a hearing entitled “Do-Not-Track Legislation:  Is Now the Right Time?” According to a briefing memo released by the Subcommittee, the purpose of the hearing was to examine the feasibility of establishing a mechanism that provides Internet users a simple and universal method to opt-out from having their online activity tracked by data-gathering firms (a.k.a. a “Do Not Track List”). 

Background

When individuals use the internet, details about their lives including age, gender, race zip code, income, marital status, health concerns, recent purchases, and other details that can be collected and packaged into profiles. As a result, a data-gathering industry with an increasing hunger for this information has grown, and over the past several years has sold this information so that companies can target consumers based on their tastes, needs, and even perceived desirability. What policymakers and some consumers are concerned about is that “many Americans don’t know that the details of their online lives are being gobbled up and used in this way, much less how to stop it in the event that such collection offends their expectations of privacy.”

Information about Internet users’ activity is instantaneously sold each day for the purpose of targeting ads to particular consumers (so-called “behaviorally targeted ads”). Spending on behaviorally targeted ads reached $925 million in 2009, and that figure is expected to reach $1.125 billion by the end of 2010. By 2014, spending on behaviorally targeted ads is projected to more than double to $2.6 billion.

In addition, those in the business of selling behaviorally targeted ads can generally command more for those ads than non-targeted ads. In 2009, advertising networks on average charged $1.98 per thousand displays of an untargeted ad, while they charged on average $4.12 per thousand displays of a behaviorally targeted ad.

However, the revenue that is generated by this type of advertising helps finance the free content that many Internet users have come to expect. In fact, “more than half of ad network revenue goes to publishers who host the [targeted] ads.” As a result, industry proponents have argued that regulation of this industry to protect consumers’ privacy could reduce the availability of free content on the Internet and the proliferation of more unwanted and irrelevant ads.

Current Laws and Regulations

No federal law specifically governs the online advertising industry or the practice of tracking internet consumers to deliver behaviorally target ads. Nor are there any federal laws that comprehensively govern the collection, use, and dissemination of consumer information across the board.  

Specific federal laws, however, do address certain categories of personal information or specific entities. For example, the Fair Credit Reporting Act (FCRA) governs consumer report information. Title V of the Gramm-Leach-Bliley Act addresses the sharing of certain nonpublic personally identifiable information by financial institutions, and rules promulgated pursuant to the Health Insurance Portability and Accountability Act apply to the privacy of medical records.

In addition, the FTC may bring actions for unfair or deceptive acts or practices under the FTC Act, which includes the authority to bring actions related to a company’s information collection and use.

Industry Regulations

While no specific law governs online advertising or internet consumer tracking, last October a coalition of media and marketing trade associations launched a self-regulatory program for the behavioral advertising industry. The voluntary initiative began by encouraging companies that track Internet users to display on or near behaviorally targeted ads a clickable “Advertising Option Icon.” Once fully implemented, the  icon will signal to Internet users that an ad was served based online tracking and provide an  avenue for consumers to get more information about the company’s data practices and to opt-out  from receiving behaviorally targeted ads served by some or all participating companies.

The program is based on the seven Self-Regulatory Principles for Online Behavioral Advertising that correspond with tenets proposed by the FTC in February 2009, and also address public education and industry accountability issues raised by the Commission.

Do Not Track

Despite the advertising industry’s attempt to regulate online advertising and tracking noted above, the FTC last month published a preliminary draft for protecting consumer privacy. According to their press release, the report proposes a framework to balance the privacy interests of consumers with innovation that relies on consumer information to develop beneficial new products and services. The proposed report also suggests implementation of a “Do Not Track” mechanism – likely a persistent setting on consumers’ browsers – so consumers can choose whether to allow the collection of data regarding their online searching and browsing activities. Among specific suggestions, the FTC staff recommended that:

Companies adopt a “privacy by design” approach by building privacy protections into their everyday business practice, including reasonable security for consumer data, limited collection and retention of such data, and reasonable procedures to promote data accuracy.

Consumers should be presented with simplified choice about collection and sharing of their data at the time and in the context in which they are making decisions. These would include a “Do Not Track” option.

Marketers should adopt measures to improve transparency of information practices, including consideration of standardized notices that allow the public to compare information practices of competing companies.

Consumers should have “reasonable access” to the data that companies maintain about them, particularly for non-consumer entities such as data brokers.

Stakeholders should undertake a broad effort to educate consumers about commercial data practices and the choices available to them.

FTC Chairman John Leibowitz noted in his prepared comments that the report “lays a foundation for industry innovation – while protecting consumers and their privacy.” In his statement, Mr. Leibowtiz asserted that “despite some good actors, self-regulation of privacy has not worked adequately and is not working adequately for Americans consumers.” As a result, he acknowledged that the FTC “will take action against companies that cross the line with consumer data and violate consumers’ privacy.” Additionally, his comments echoed the recommendations noted above. Specifically, Mr. Leibowitz asserted that companies should collect and retain data only if they have a legitimate business need.

He also specifically acknowledged the need for a Do Not Track mechanism with respect to third-party ads. For the FTC Chairman, the most “practical method would likely involve the placement of a persistent setting on the consumer’s browser, signaling the consumer’s choices about whether or not to be tracked.” He acknowledged that “Microsoft, Google, Mozilla, Apple and a coalition of other companies have already experimented with this method, and such an option would “serve as an easy, one-stop shop for consumers to express their choices, rather than on a company-by-company or industry-by-industry basis.”

In response to FTC’s preliminary report, Nancy Hill, President-CEO of the American Association of Advertising Agencies (4A’s) noted in a press release that there is “little understanding in the report of how complex a task it is to point such a vast, diverse and rapidly changing ecosystem in the same self-regulatory direction.” Ms. Hill pointed to the Self-Regulatory Program for Online Behavioral Advertising, devised by industry, through two years of hard work, and noted that it is just now becoming operational. She asserted that the “new system will provide a very strong case for self-regulation and consumer protection as the roll-out becomes 100% functional.”

Ms. Hill’s concerns were echoed by Dick O’Brien, head of the 4A’s Washington office, who noted that “At its worst, the FTC report could be read as an effort by regulators to push Congress into enacting stringent new laws that would restrict marketers’ interaction with consumers.” The press release acknowledged that the will provide reaction to the report to the FTC during the “comment period” which ends on January 31.

4A’s and other marketing groups are preparing responses to the FTC report, which can be submitted here and are due January 31, 2011. While O’Brien agreed that “online marketing must provide transparent, simple and consumer-friendly options,” he noted that groups “will be meeting with Members of Congress to let them know what the industry is doing already and what the new industry efforts will mean to consumers.”

Subcommittee Hearing

The growing awareness about the pervasiveness and invasiveness of online tracking noted above has sparked renewed interest in creating a Do Not Track mechanism by privacy advocates. In light of all the recent developments and changes, outgoing Subcommittee Chairman Bobby Rush (D-IL) discussed at last month’s hearing HR 5777, the Best Practices Act, which he introduced back in July of 2010. The purpose of the bill is to foster transparency about the commercial use of personal information and provide consumers with choice about the collection, use, and disclosure of such information. The bill applies to both the online and offline contexts.

Although the bill outlines specific protections for consumers and gives the FTC certain responsibilities for reporting and enforcement, HR 5777 does not include a provision to establish a mechanism that provides consumers a simple and universal method to opt-out from having their online activity collected and used by the tracking industry. Privacy advocates first proposed a version of such a “Do Not Track List” in 2007.

Congressman Rush noted in his opening statement that through such a mechanism, consumers could advise would-be trackers unambiguously and persistently that they do not wish to be followed by digital snoopers and spies across web sites and their various fixed and mobile computing devices. Mr. Rush made comparisons of the Do-Not-Track Legislation to the Do-Not-Call Registry that the FTC had successfully implemented several years ago. Accordingly, Mr. Rush then went on to hear testimony from:

Daniel J. Weitzner, Associate Administrator for the Office of Policy Analysis and Development, Department of Commerce, National Telecommunications and Information Administration, Department of Commerce

David Vladeck, Director, Bureau of Consumer Protection, Federal Trade Commission

Susan Grant, Director of Consumer Protection, Consumer Federation of America

Joe Pasqua, Vice President of Research, Symantec Corporation

Joan Gillman, Executive Vice President and President, Media Sales, Time Warner Cable

Eben Moglen, Ph.D., Legal Advisor, Diaspora*, Professor of Law, Columbia University, Founding Director, Software Freedom Law Center

Daniel Castro, Senior Analyst, Information Technology and Innovation Foundation

Conclusion

With the comment period closing at the end of this month and with several consumer groups having already filing a complaint with the FTC over online marketing and behavioral advertising, Congress will likely have to address this issue during its new session. However, with Republicans in control of the House, it remains uncertain whether any legislation will move forward to create the Do Not Track mechanism necessary to carry out the recommendations in the FTC report.

The use of the internet is growing exponentially each day, and consumers are finding valuable information about healthcare, mental health, financial help, education, nutrition, and numerous other resources. Accordingly, as policymakers consider comments from consumer groups on both sides of the argument, Congress and the FTC should ensure that the proposed regulations do not create obstacles for consumers to learn about products and get valuable information because online advertising and marketing is an extremely important tool for both consumers and companies.

To submit comments:

https://ftcpublic.commentworks.com/ftc/consumerprivacyreport/

DOJ Targets Pharmaceutical Manufactures In Foreign Corrupt Practices Act Probe

 
According to a recent articles in the Financial Times and New York Times, the US Department of Justice (DOJ) and the Securities and Exchange Commission (SEC) has launched an investigation into international payments made by drugmakers for consulting, hospitality, licensing agreements, charity and clinical trials.

The article reports that “to date, companies including Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Merck & Co. and Pfizer say they have been contacted in connection with the probe.”

One source, an industry attorney familiar with the investigation, told the Financial Times that “the justice department is seeking to determine whether drugmakers have ignored local and federal anti-bribery laws.”

Of particular interest to the DOJ, according to the law firm Arnold & Porter, are “corrupt payments that may have influenced the reliability of data in clinical trials performed outside the US.”

This issue has been spotlighted because “a recent report by the US Department of Health and Human Services (HHS) found that 80 percent of marketing applications for drugs approved by the FDA included at least one foreign trial.” As a result, Arnold & Porter noted that “companies may find themselves facing critical legal issues if approval of products rested on the results of studies the [justice department] deems corrupt."

In addition to foreign trials, the article reported that the DOJ and SEC are interested in probing instances in which bribery may have occurred. A second industry lawyer involved in the matter told the Financial Times that because “global pharmaceutical companies operating in countries with state-run medical institutions frequently deal with government officials,” there is a large risk of bribery if companies don’t train and educate their people.

Prosecution around the Foreign Corrupt Practices Act, connecting physicians as “state” employees, is a growth area for the DOJ especially since the successful $500 million agreement SEC agreement reached in December 2008 from the German imaging and power supply company Seimans.

Consequently, sources to the Financial Times that the investigation is currently at a relatively early stage, but is considered a priority for the justice department.

 

Public Private Partnership on Health Data: Innovation in Action

 

The chief technology officer of Health and Human Services (HHS), Todd Park has been working closely with other government officials and the technology community to put community healthcare data into role that will act as a catalyst for innovation.  His efforts began through the Community Health Data Initiative, a major new public-private effort that aims to help Americans understand health and health care performance in their communities -- and to help spark and facilitate action to improve performance. 

The initiative is designed to catalyze the advent of a network of community health data suppliers (starting with HHS) and “data appliers” who utilize that data to create applications that (1) raise awareness of community health performance, (2) increase pressure on decision makers to improve performance, and (3) help facilitate and inform action to improve performance. Park was also recently interviewed about the initiative.

The program began by providing to the public a free Community Health Data Set, with a wealth of downloadable data on health care, health, and determinants of health. Then, working with that data, a growing array of technology companies, researchers, health advocates, employers, media, consumer advocates, marketers, providers, etc., sought to identify the uses of this data that would do the most to raise awareness of health performance, help motivate civic leaders and citizens to improve performance, and help improvers do the improving. 

In addition to the new initiative, Park joined HHS Secretary Kathleen Sebelius and White House CTO Aneesh Chopra for a Community Health Data Forum at the Institute of Medicine at the National Academy of Science. The purpose of the forum was to further ongoing efforts of innovators using community-level health data to empower individuals and communities to make informed choices about their health.

Prior to yesterday’s forum, the IOM and HHS hosted a small gathering in March of various stakeholders to catalyze the formation of the new Community Health Data Initiative, according to O’RileyRadar.

Consequently, Park and others saw amazing technology applications from Google, the National Association of Counties (NACO), GE, Bing, and Healthways. For example, Google's Fusion Tables, essentially an online database powered by Google, allowed users to examine data, combine it and share, giving users the ability to search through community health data, mash it up with maps and see which regions are, for instance, the "best places to have chest pain." Another use of the tables and dataset was for a Hospital Finder.

Bing presented a new app called Bing HealthMaps, available to use now, which allows users to search using geolocated data and add overlays for the incidence of health conditions, like Diabetes or obesity. Bing will also integrate Oodle classifieds with health data, enabling searches to load rentals, school ratings and layer on different conditions.

Another app presented was the Network of Care for Healthy Communities, a web-based portal that targets individuals and policy makers, and includes a service directory, library, links and legislative information.

GE launched Healthymagination.com in May of 2009, focusing on showing data to drive change such as the cost of getting sick. They also have an interactive health visualizer, and will be adding new apps that present more health data in aggregate, including community health rankings.

With companies lining up to help bring health information to patients and physicians, collaboration with industry will be essential.  As HHS and Park have already done, making data available to companies, and launching an interim CHDI website, (www.HHS.gov/open under the "Connect with data" button), will speed up new discoveries. Future improvements will be a new HHS Health Indicators Warehouse, launching in December 2010 that will have Medicare community-level indicators.

In addition to yesterday’s meeting, the Community Health Data Forum will kick off the Health 2.0 Developer Challenge (Health2challenge.org), which will extend through this fall. The Challenge will host a series of code-a-thons and team competitions to build apps based upon CHDI data over the next four months. Regional events will culminate in a final challenge during the fourth annual Health 2.0 Conference in San Francisco.

According to Mazi Abdolrasulnia, PhD of CE Outcomes LLC “access to this information will transforms needs assessment information and gives CME providers and supporters the information needed to target gaps in health delivery”.

With the potential for electronic health records, enhanced medical imaging, and numerous other data and quality measures, the technology industry will be best suited for finding the most efficient and effective ways to keep track of health care data. Demonstrating the important role industry plays in providing health data and information to agencies such as HHS, Park and the Community Health Data Initiative have acknowledged the important partnership industry plays in bringing better technology and innovation to the health care system.

Watch Launch Event  6-02-10

 

VA Proposes Restrictions on Access to Pharmaceutical Representatives

The Department of Veterans Affairs (VA) proposed to amend its regulations regarding access to VA facilities to control the promotion of drugs and drug-related supplies at VA facilities and the business relationships between VA staff and sales representatives promoting drugs and drug-related supplies.

 

As detailed in the Federal Register, the purposes of the proposed rule is to reduce or eliminate any potential for disruption in the patient care environment, manage activities and promotions at VA facilities, and provide sales representatives with a consistent standard of permissible business practice at VA facilities.

 

The VA proposed rule would amend 38 CFR part 1 to regulate access to VA medical facilities by sales representatives (including account managers and clinical liaisons) promoting drugs and drug-related supplies. The proposed rule would prescribe Department-wide rules that must be followed by the Veterans Integrated Service Network (VISN), which consists of 21 regions.

 

Education

 

The Chief of Pharmacy or other official must approve educational programs and materials presented or furnished by these sales representatives. Materials and programs must focus on clinician education as opposed to marketing of drugs and drug-related supplies. A summary of the program and all materials must be provided well in advance of the proposed date so that a program can be adequately reviewed. Programs and materials must conform to the following guidelines:

 

-    Industry sponsorship (of any kind) must be disclosed in the introductory remarks and in the announcement brochure;

 

-    Marketing activities cannot be conducted during an educational program;

 

-    Promotional materials are not to be placed in any patient care area;

 

-    They must not offer patients a chance to participate in manufacturer sponsored programs and/or require the furnishing of Protected Health Information.

 

-    Patient education materials must not contain the name or logo of the pharmaceutical manufacturer or be used for promotion of specific medications without permission from the VA Pharmacy Benefits Management Service;

 

-    Programs or materials regarding a new drug, drug-related supply, or a new therapeutic indication for a drug, which is already on the VANF but has not yet been reviewed by VA, must be clearly identified as such.

 

-    Programs or materials focusing primarily on non-VANF drugs or drug related supplies are discouraged and must be clearly identified as such.

 

Sales representative are also prohibited from giving any VA employee any item that exceeds the value permissible for acceptance under government ethical rules, including but not limited to:

 

-    Promotional materials;

-    Continuing education materials;

-    Textbooks; entertainment; and gratuities

 

Items may be donated to a medical center library or individual department for use by all employees, in accordance with local policies.

 

Rep Access

 

Sales representatives generally may not wait for scheduled appointments or make presentations in patient-care areas (e.g. patient/clinical exam rooms; nurse stations, etc.), but may briefly travel through them.

 

They must make appointments at the facilities they intend to visit. Local exceptions may apply ‘‘for operational reasons,’ such as a particular facility within a VISN does not have a physician with the required expertise about a particular drug to prescribe.

 

Promotion in VA medical facilities of VANF and non-VANF drugs or drug related supplies is permitted if:

 

-    The promotion is consistent with criteria-for-use;

-    The drug is not classified as non-promotable; and

-    The promotion is consistent with the proposed rule and with facility initiatives.

 

The promotion of non-VANF drugs or drug-related supplies without criteria-for-use, such as for new molecular entities or new indications for existing drugs, must be regulated at the local level in order to allow for different clinical approaches. The promotion of new molecular entities would be permitted, but may be reconsidered if the VANF committee reviews the drug and grants or denies VANF status.

 

The proposed rule emphasized that the VA allow medical professionals to become educated through the promotion of new molecular entities for the benefit of patients.

 

A list of individuals or departments that do not wish to be called-on by sales representatives can be created, and sales representatives must not attempt to make appointments with individuals or departments on the list. The list could be obtained at the local office of the Chief of Pharmacy Services.

 

A sales representative visiting a VA medical facility for a scheduled appointment cannot initiate requests for meetings with other VA staff; however, sales representatives may respond to requests initiated by VA staff during the visit.

 

The sales representative cannot use the public address (paging) system to locate any VA employee but, the electronic paging system (beepers) is permissible if specifically requested by the VA employee.

 

Samples

 

-   Drug samples and free drug-related supplies must be approved by the Director of a VA facility or other person delegated responsibility;

-   Information pertaining to the trial use of these drugs or drug-related supplies must be forwarded to the VISN Pharmacy Executive or VISN Formulary Committee;

-   Drug or supply samples may not be provided to VA staff for their personal use; and

-   Drugs or drug-related supplies donated for patient use must be delivered to the Office of the Chief of Pharmacy Services for proper storage, documentation and dispensing, and must not be labeled ‘‘sample,’’ ‘‘professional sample,’’ or similar words, unless VA grants an exception in the interests of patient care.

 

Food

 

All sales representatives who have business relationships with VA Clinical Services may not provide food items of any type or any value to VA staff (including volunteers and without compensation employees) or bring food items into VA medical facilities for use by non-VA staff (e.g., employees of affiliates) above the de minimis value set forth in the standards of ethical conduct for Federal employees.

 

Other Provisions

 

Sales representatives must ensure that all drugs or supplies are discussed, displayed and represented accurately, in accordance with FDA and VANF guidelines/restrictions.

 

Sales representatives are prohibited from marketing to medical, pharmacy, nursing and other health profession students (including residents). Exceptions may be permitted when approved by, and conducted in the presence of, their clinical staff member.

 

A sales representative is not allowed to attend a medical center conference where patient-specific material is discussed or presented.

 

Gifts of travel in support of VA staff official travel may be accepted by the Department subject to advance legal review.

 

Compliance

 

Any individual, or any company, that fails to comply can lose access to VA facilities, which may include suspension of a sales representative’s access privileges, or denying access to a company’s entire sales force.

 

The director of the VA Medical Center would make the determination if a violation occurred and if restriction to particular VA facilities is warranted, and would notify the sales representative or company of the violation and any proposed restrictions on access privileges before issuing any final order. The director would be required to provide notice to a company’s sales manager if the proposed action would result in a denial of access privileges for the company’s entire sales force. A company would have the right to a one-time appeal of the matter to the Under Secretary for Health.

 

Conclusion

 

As the notice acknowledged, pharmaceutical sales representatives have heavy interaction with local VA staff each year, and this interaction provides valuable information to physicians about how to treat patients and stay up to date with new treatments and advances. Since the VA noted that “in most cases, sales representatives are considerate of VA’s needs and mission, and do not behave inappropriately,” what is the need for this new policy?

It seems a little ironic that for over a year, the Obama Administration was saying the government would not take over health care. Clearly, the VA telling their doctors who they can meet with and where they can get information from is contrary to that notion.

 

With baby boomers—many of which are Veterans—retiring and numerous soldiers coming back from Iraq and Afghanistan, this policy is unpatriotic. The policy also restricts access to public institutions, which is likely unconstitutional. Our soldiers and Veterans deserve the best care and best access to treatments and medicines for the sacrifices they and their families have made. Since Congress does not cut industry support for these men and women when they are fighting to make us safer, the VA should not cut industry support at home as doctors try to make them healthier.

 

Comments must be received by VA on or before July 6, 2010.

 

For more information contact:

 

Louis E. Cobuzzi, PBM Services (119),

Veterans Health Administration,

Department of Veterans Affairs, 810

Vermont Avenue, NW., Washington, DC

20420; (202) 461–7362.

HHS OIG: Legal Issues Affecting Academic Medical Centers and Other Related Institutions

 

Late last month, Daniel R. Levinson, Inspector General of the Department of Health & Human Services, made remarks regarding conflicts of interest (COI) for a Keynote Address given at a Conference of the American Healthcare Lawyers Association. The conference was titled “Legal Issues Affecting Academic Medical Centers and Other Related Institutions.”

 

His focus was on “COIs and the challenging aspect of managing, reducing, and eliminating conflicts under the current regulatory framework and system where reliance is placed primarily on individuals, researchers, and institutions.” Mr. Levinson noted that the ongoing debate centers on what “extent to which government regulation should place oversight and verification responsibility on Federal agencies.”

 

Seemingly, while his ideas are not new, the fact that he addressed health care lawyers about how “subtle and often hard to detect” COIs are, is a bit concerning.  His speech uses hypothetical language about the nature of COIs, stating that “what may appear to be an appropriate arrangement between a researcher and a drug manufacturer may actually raise potential COI issues that could taint the results of a clinical trial.”

 

Such uncertainty should never be cause to go after scientists and doctors who are changing the way patients are treated and making them healthier, and it should especially not be given to lawyers whose livelihood depend on 50.1%--what it takes for a jury to determine a favorable verdict.

 

Mr. Levinson asserted that undetected COIs may expose people who volunteer in trials to unnecessary risk; deprive them of beneficial therapies; unsafe or ineffective drugs or devices may enter the US market; patients may receive inferior therapies when safer or more effective therapies are available; and the public may waste limited Medicare and Medicaid dollars to pay for this inappropriate treatment.

 

All of these concerns do not outweigh the clear benefit that industry has provided academics and researchers over the past few decades as evidenced by breakthroughs in heart disease, cancer, diabetes, HIV and numerous other chronic diseases.

 

Moreover, unsafe or ineffective drugs or devices will not ever enter the US market if FDA is doing their job, and patients will only be deprived of beneficial therapies or receive inferior ones if the relationship between industry and researchers is stigmatized more. And the money for better or brand name drugs is not wasting Medicare and Medicaid dollars because such medicine is paving the way for generations of generic brands that will eventually save the government money.

 

COI Regulation

 

Mr. Levinson’s brief history lesson of COIs talked about the early 2000s, when the NIH Director established a “Blue Ribbon Panel on COI policies to look at whether the COI policies for intramural research were sufficient to uphold agency standards and maintain public trust in NIH and its activities.

 

The Panel found an extremely complex set of rules governing COIs at NIH.” No wonder today there is so much of a debate or controversy around COI: no one knew then what to do, and now politicians and media are going about an individual crusade against doctors who simply make mistakes interpreting “extremely complex sets of rules.”

 

As a result, today’s politicians are having hearings on oversight to determine what information should be disclosed and who—individual, government or institution—should bear the responsibility for monitoring and managing potential COIs.

 

The 2010 Omnibus Appropriations Act, will also require the Secretary of HHS to amend Federal regulations to strengthen government and institutional oversight of financial conflicts of interest by May 1, 2010.

 

Such hearings and legislation have become standard practice as government employees like Levinson believe that the “relationships between the private sector and investigators have become more complex and that the collaborations may generate an increased potential of investigators to hold financial interests in multiple sources.”

 

Such complexity is cause for OIG to believe that “if not reported and appropriately managed, reduced, or eliminated, these relationships could introduce bias into the conduct of their research.”

 

Levinson told his crowd of lawyers that HHS has “recommended that NIH use its current authority to request further information about reported COIs where basic information about the COI is missing and, at the same time, revise the current regulation to require grantees to report certain details to NIH about their reported COIs.”

 

Similar recommendations were made in the agency’s report on FDA’s oversight of clinical investigators’ financial interests, even though it was “found that only 42 percent of marketing applications were missing financial information.”

 

Mr. Levinson acknowledged that such recommendations were necessary based on a few examples (although totally unrelated to CME) of recent enforcement actions related to COIs in medical education. He even stated directly in his speech that “these cases did not involve AMCs,” but he felt that “AMCs could learn important lessons from these examples in terms of ensuring the integrity of educational sessions they host, responsible partnerships with co-hosts or industry funding sources, and appropriate behaviors and industry relationships for medical staff serving as faculty or filling the audience for educational events.” He used examples of drug companies who resolved charges relating to off-label promotion, no where near an accredited CME course or program.

 

Conclusion

 

Since Mr. Levinson himself noted that “the nature and amount of information that should be reported and disclosed, and where responsibility should be placed for reviewing and verifying the information, remains a constant subject of debate,” more research and discussion is needed before attempting to implement recommendations within the life-sciences community and the Federal Government.

 

As he also indicated, because “the vast majority of physicians and scientists are ethical and honest and committed to the welfare of their patients,” approaching new ways to manage COIs should carefully consider the “special role academic medical centers (AMCs) play in health care.”

 

Mr. Levinson specifically indicated that AMCs are “responsible for educating and training the next generation of physicians, nurses, and other types of health care workers; advancing clinical care for the sickest patients; and advancing basic science in pre-clinical research and participate in clinical trials to develop new technology.” With such a crucial role in making our health care system function, Mr. Levinson needs to consider where AMCs would be with industry support today and where funding would come from without it.

 

Accordingly, Mr. Levinson is certainly right that more “research on COIs and COI policies can provide a stronger evidence base for policy design and implementation.”

Until such research and evidence is found, we encourage him to follow his own words and engage “physicians, researchers, and medical institutions in developing conflict of interest policies and consensus standards” instead of distracting researchers from creating the next generation of treatments. 

Cardiologists Sue HHS to Prevent Medicare Cuts

If the public was wondering just exactly how health care reform is going to impact their doctors and physicians, a recent article in USA Today explains how one group of specialist’s has had enough.

 

On Monday, “heart specialists filed suit against Secretary of Health and Human Services Kathleen Sebelius in an effort to stave off steep Medicare fee cuts for routine office-based procedures such as nuclear stress tests and echocardiograms. The lawsuit, filed in U.S. District Court for the Southern District of Florida, charges that the government's planned cutbacks will deal a major blow to medical care in the USA, forcing thousands of cardiologists to shutter their offices, sell diagnostic equipment and work for hospitals, which charge more for the same procedures.”

Although “the issues raised in the lawsuit are not related to the health reform legislation being hammered out on Capitol Hill,  the dispute offers a revealing case study of the impact of payment reform on one specialty — cardiologists — and, ultimately, their patients.”

Considering the fact that heart disease is America’s biggest killer, this lawsuit should open the eyes of many Americans who think health care reform is going to bring better care and more access to citizens. Dealing with health related issues such as heart disease and other heart problems such as high cholesterol are extremely complex and complicated areas of medicine that require extensive and ongoing training. With all of the constant breakthroughs in pharmaceutical and medical devices to help patients with heart problems, cardiologists need more money, not less to stay up to date on new ways to save lives—literally hundreds of thousands.  A previous article in USA Today in fact showed that when it comes to cardiac care, More is better for Medicare patients.

According to Jack Lewin, CEO of the American College of Cardiology (ACC), which represents 90% of the roughly 40,000 heart specialists in the USA, Congress and HHS have “basically killed the private practice of cardiology." The slow decline of the private practice of cardiology “illustrates the vulnerability of the heart doctors, who over the past few decades have invested heavily in nuclear scanners and other costly tools of their trade only to discover that they may be too expensive to operate in an era of increasing restraint on medical costs.”

Lewin and other heart specialists met with Sebelius on December 8, 2009, and explained their concerns.

The problem now is that doctors are being punished for taking part in a system that “has long rewarded doctors for investing in technology,” according to Victor Fuchs, a professor of health economics at Stanford University. Mr. Fuchs believes that instead of reducing reimbursement rates for cardiologists, Congress needs to create “a reimbursement system that brings about a more rational use of these devices and a more rational investment in them."

As of January 1, 2010, medicare's new fee schedule cuts reimbursements for nuclear scans by about 40% according to the ACC. They also noted that fees for echocardiograms and other tests will shrink by about a third, with those cuts phased in over four years. On top of those cuts, in March, doctors also face an additional 21% cut due to an adjustment in the formula that limits the growth of Medicare spending for doctors' fees.

In an attempt to justify such cuts, Jonathan Blum, director of the government's Center for Medicare Management, said that “the agency is bound by law not to increase spending when making reimbursement decisions each year.”

Consequently, in order to not increase spending, the agency has to reduce payments to cardiologists in order to pay “the internists and family physicians — to boost payment rates for long "undervalued" primary care services.” Trying to bolster such a claim, Mr. Blum cited a “survey” that showed “cardiologists could absorb the payment cuts.” The heart specialists asserted in their lawsuit that this “was flawed and unrepresentative of their real costs.”

These cuts will especially impact heart attack patients in rural areas according to George Moutsatsos, a managing partner in Cardiology Consultants of Delaware, a group of 32 heart specialists that serves half of the heart patients in the state. He acknowledged that “the money doctors make for providing imaging services helps compensate them for their round-the-clock availability to treat heart attacks with balloon angioplasty.” Such compensation is critical in rural areas where cardiologists get “very little money to do the work,” areas where his group was going to “consider cutting.”

Scott Smith, a cardiologist who works in rural Silver City, N.M., added that because "The closest cardiologist to him was 150 miles away,” all of these cuts will “make it impossible for him to break even seeing 40 patients a day.”

With hundreds of thousands of baby boomers on the verge of retirement and being added into the Medicare system, along with millions more who are likely to enter our system through health care reform, can we really afford to be losing the private practice of cardiology? How can we pay cardiologists less when the advances we have seen over the past few decades have led to longer survival rates for heart attacks, more heart procedures, earlier detection of heart disease, and better recovery for heart patients?

 

Politicians and bureaucrats need to take a different approach at paying for medical care from physicians, especially specialists. The highly technical field of cardiology is rapidly changing and advances everyday are making this practice area critical for making patients healthier and live longer. In light of this lawsuit, hopefully discussions will begin on ways to continue giving cardiologist the payments they deserve.