From the Editor

New regulations defining how hospitals and eligible medical professionals can qualify for federal incentive payments for electronic health records (EHR) were unveiled at a press conference earlier today. Health & Human Services (HHS) Secretary Kathleen Sebelius was joined by members of the Centers for Medicare & Medicaid Services (CMS) and David Blumenthal, MD, national coordinator for information technology, to announce the CMS’ final ruling on the meaningful use requirements of EHR. The new regulations loosen some of the requirements presented in a preliminary rule issued last year by the CMS. The changes were based on more than 2,000 comments submitted to the CMS by healthcare professionals.

According to a statement released today by The American Medical Association, “The AMA and 95 state and specialty medical societies submitted formal complaints on an earlier draft of this rule and cautioned that proposed criteria for meaningful use was too aggressive and would prevent many physicians from participating. After thoroughly reviewing the final rule, the AMA will work to help educate physicians on the requirements for meaningful use and how they can incorporate them into their practices. As a first step, the AMA will be hosting a free webinar in the coming weeks.”

A summary overview of the meaningful use objectives is currently available on the New England Journal of Medicine website. Additional announcements made at today’s press conference included the establishment of a new EHR certification criteria to enhance the interoperability of EHR systems and assist users in meeting the criteria of meaningful use. Dr. Blumenthal also announced the formation of a network of regional centers to help medical professionals and facilities “become meaningful users.” In addition, the Office of Civil Rights released a notice of proposed rulemaking to increase privacy and security requirements that will be built into the meaningful use provisions. 

-Inga Hansen, editor

The United States Food & Drug Administration (FDA, fda.gov) is reaching out to healthcare providers in an effort to reduce misleading and inaccurate prescription drug claims made by sales representatives, local dinner programs and promotional speaker training sessions. The FDA has launched the Bad Ad program to increase the effectiveness of the FDA’s Division of Drug Marketing, Advertising and Communication (DDMAC)—charged with protecting the public health by assuring that prescription drug information is truthful, balanced and accurately communicated.
The outreach program is targeting healthcare professionals who prescribe medications and/or assist in the selection of prescription drugs for patients. In a letter to the healthcare industry the FDA notes that:

“DDMAC’s traditional regulatory activities for monitoring prescription drug promotion rely on review of industry promotional pieces submitted to FDA, complaints filed by the pharmaceutical industry, and field surveillance at large medical conventions. While these efforts are effective, FDA’s ability to monitor other promotional activities, which may occur in any number of settings, is limited.”

To kick off the program and increase awareness, The DDMAC will be exhibiting at major medical conferences starting this month. To report misleading drug claims or inappropriate promotional campaigns call 877.RX.DDMAC (877.793.3622) or email a summary of the incident to BadAd@fda.gov.
In addition to the Bad Ad program, the FDA has launched a web-based consumer educational campaign called EthicAd. 

-Inga Hansen, executive editor

Following the devastating earthquake that took place on January 12, citizens of Haiti remain in desperate need of humanitarian aid and medical care. In response to physician queries, the American Academy of Dermatology has released a list of organizations that are coordinating emergency relief and healthcare efforts for earthquake victims.

• Physicians who are willing to volunteer with federal and private sector response organizations can register with the American Medical Association Web Registry. The registry is supported by National Disaster Life Support (NDLS), an organization that coordinates deployment of physicians to areas affected by natural disasters.
• Haiti Clinic, a licensed nonprofit organization dedicated to medical care for the people of Cite Soleil, is seeking physician volunteers, antibiotics, wound care supplies and donations. Interested parties can contact president Neil Heskel, MD at nhesk@yahoo.com.
• The Center for Rural Development of Milot (CRUDEM), a city north of Haiti, is funding Hospital Sacre Couer. The hospital, which offers maternity services, HIV/AIDS prevention and a children’s nutrition centre for malnourished preschooler, is also a triage center for earthquake victims. They are in need of general surgeons, plastic surgeons and wound-care specialists. Contact Michael E. McCadden, MD, FAAD at mmccadden@sbcglobal.net.
• The LAMP for Haiti Foundation maintains a free medical clinic in one of the most impoverished areas of Haiti. The organization advocates for the respect and protection of basic human rights in the areas of greatest poverty. The LAMP provides basic health care, investigates allegations of human rights abuses, and provides educational and humanitarian aid. Contact Ellen Cunningham, MD, FAAD, at ecjmmd@hotmail.com.
• Konbit Sante Cap-Haitien Health Partnership is a Maine-based volunteer partnership dedicated to saving lives and improving health care in northern Haiti. Konbit Sante works with the Haitian Ministry of Health and Haitian colleagues.
• According to Health Volunteers Overseas, financial contributions to organizations that are based in Haiti and are delivering services, are urgently needed. A list of such organizations is available through InterAction. You can also make a contribution through Global Impact’s Haiti Earthquake Relief Fund. The funds will be dispensed to agencies providing assistance.

-Inga Hansen executive editor

According to the New York Times, the Federal government and more than two dozen states are seeking to reduce budget shortfalls by cracking down on employers who misclassify employees as independent contractors. Businesses that utilize the skills of independent contractors are not required to make Social Security, Medicare or unemployment tax payments. In addition, they do not withhold income taxes from these workers’ pay. According to the Times, President Obama’s 2010 budget “assumes the federal crackdown will yield $7 billion over 10 years” through stricter enforcement and tougher penalties for businesses that misclassify their workers. Don’t let it be you.

The Internal Revenue Service (IRS, irs.gov) offers the following guidelines to help business owners determine if their workers are legitimate independent contractors.

Behavioral control

Businesses have a right to direct and control how their employees perform their duties. A worker cannot be classified as an independent contractor if he is told:

• When and where to do the work
• What tools or equipment to use
• What workers to hire to assist with his work
• Where to purchase supplies and services
• What duties must be performed by a specified individual
• What order or sequence to follow when performing work

Financial control

Although both employees and independent contractors may provide some of their own tools and incur some unreimbursed expenses in the course of performing their job duties, a worker is more readily viewed as an independent contractor if he:

• has a significant investment in the tools and equipment used, and if he has significant unreimbursed expenses. Both of these factors result in a greater opportunity to lose money on a given job. The possibility of incurring a loss indicates the worker is an independent contractor.
• is free to seek out additional business opportunities. Independent contractors are free to advertise, maintain a visible business location and obtain work in their relevant markets.
• is paid a flat fee for the job. Although some professions can pay independent contractors on an hourly wage, guaranteeing a regular hourly or weekly wage amount tends to indicate an employee/employer relationship.

Length of Relationship

If a worker is brought on with the expectation that the relationship will continue indefinitely, as opposed to coming on for a specific project or time period, the worker is more likely to be viewed as an employee. Similarly, if a worker provides services that are a key aspect of the business, it is more likely that the business owner is directing or controlling that workers activities, which would also lead the IRS to conclude the worker is an employee, not an independent contractor.

For more information on drafting sound independent contractor agreements, see the March/April 2009 issue of MedEsthetics magazine (“Legal Issues,” page 10). You can access the free article through medestheticsmagazine.com, view past issues.

You can also view the full New York Times article at http://www.nytimes.com/2010/02/18/business/18workers.html.

-Inga Hansen, executive editor

For our readers in the New York City region: On Friday, February 12, 2010, at the Grand Ballroom at the Grand Hyatt Hotel, 42^nd Street, New York, more than 200 professionals from the spa and healing arts community, and the health and beauty industry of New York City metro area will be offering treatments to benefit UNICEF and the children of Haiti. This one-of-a-kind event will bolster the outstanding work that UNICEF has been doing in Haiti on behalf of children, many of whom have been injured and orphaned due to the January earthquakes and subsequent tremors. Participants in the open-to-the-public event can partake of an extensive array of special services ranging from massages, manicures, facials and makeovers to acupuncture, yoga, exercise and fitness. Also, there will be opportunities to participate in the Healing Arts For Haiti silent auction featuring spa treatments, gift items, gift certificates, and more. One hundred percent of the proceeds will benefit efforts to assist the Haitian community to rebuild. The event will take place from 12pm to 8pm.

“The Grand Hyatt Hotel has graciously donated its showplace for everyday New Yorkers to show their love on the weekend of Valentine’s Day for UNICEF and its stellar efforts in Haiti,” states Bruce Schoenberg, Co-Founder, Oasis Day Spa and Fundraising Chair, Healing Arts For Haiti. “Our efforts are all voluntary and the support has been tremendous. We are planning an event to send love and support in our own way – through healing techniques and positive energy.”  Along with The Grand Hyatt Hotel New York and Oasis Day Spa, additional supporting organizations and media partners include:  Swedish Institute, Spa Magazine, American Spa Magazine, Curiosity Works, Reed Exhibition, SpaFinder, Sheckys, Dermalogica, Savoy Professional Magazine, Matis Paris, MD Corrective Care, What’s Hot! and Day Spa Association.

For more information and to find out how you can help Healing Arts For Haiti, call 646.328.1620 or visit www.healingartsforhaiti.org; www.facebook.com/HealingArtsForHaiti or twitter.com/HealingHaiti.

First it was in, then it was out, then it was back in again. Now, the proposed tax on cosmetic procedures has been removed from the healthcare reform bill currently in the Senate. The so-called “Botax” was pulled by Congress at the last minute and replaced with a 10% tax on indoor tanning services. President Obama has said that he expects a vote on the healthcare reform bill prior to Christmas, but Republicans have vowed to slow the process to hold off a final vote until next year. Depending how quickly (or slowly) things move at this point, it is possible that the tax could reappear prior to a final vote on the legislation. To stay up-to-date on all developments, you can sign up for alerts at Stop Cosmetic Tax (stopcosmetictax.org), a site founded by Allergan to fight the proposed tax. We will also keep you updated through our MedEsthetics blog and Facebook page.

-Inga Hansen, executive editor.

Allergan, in partnership with 22 medical and medical professional organizations, has launched the Stop Medical Taxes Coalition (stopcosmetictax.org) to oppose the Senate healthcare reform bill’s proposed 5% cosmetic procedure tax. Patients can email their concerns about the proposed tax to their senators through the site, which also includes a petition drive and a letter sent to senators by the coalition on November 30, 2009.

Allergan is also providing fliers that physicians can post in their offices to alert patients to the proposed tax. Opponents of the tax, including the American Society of Aesthetic Plastic Surgeons, argue that it unfairly burdens middle income, working women.

“Elective surgery taxes discriminate against women, given that 86% of cosmetic surgery patients are female, of which 91% are between the working ages of 19 and 64 years of age,” said Michael McGuire, MD, ASPS president. “Moreover, contrary to popular belief, cosmetic surgery is no longer an exclusive luxury afforded by the very wealthy, but rather a mainstream and reasonable option most common amongst the working middle class.”

In a 2005 American Society of Plastic Surgery survey of people planning to undergo cosmetic surgery, 60% of respondents reported an annual household income of $30,000-$90,000.

In 2004, the state of New Jersey passed a 6% tax on elective cosmetic procedures. Its shortcomings have been highlighted by many critics. Chicago-based facial plastic surgeon Steven Dayan, MD, FACS, notes that, “a similar bill was signed into law in New Jersey in 2004. However, it has fallen far short of its expectations. Having collected 59% less than what was projected and costing three to four dollars in government expense for every dollar collected, its failings have resulted in its repeal led by assembly member Joseph Cryan, the original sponsor. However, Governor Corzine vetoed the repeal, and the law remains in place.”

Though the Senate bill claims that the only procedures to be taxed are those that are “not necessary to ameliorate a deformity arising from, or directly related to, a congenital abnormality, a personal injury resulting from an accident or trauma, or a disfiguring disease,” the ASPS and ASAPS note that the line between “cosmetic” and “reconstructive” is thin and not always clear. State tax auditors would be charged with determining the medical necessity of procedures. In the case of New Jersey, lawsuits challenging the state’s determination of “cosmetic” versus “reconstructive” surgery are one of the factors that led to expenses that outweigh the taxes income.

-Inga Hansen, executive editor

Following the arrest of several medical professionals, the Physicians Coalition for Injectable Safety (PCIS) is urging physicians to avoid the use of and report solicitation of non-FDA approved injectables. According to the PCIS, as of August 2009 five physicians, one nurse and one practice manager from a New Jersey-based medical practice are facing fines and jail time for charges stemming from the use of non-FDA approved fillers purchased through an online pharmacy.
“Physicians fax machines and email accounts are filled with offers to buy offshore or unbranded, cheaper injectables,” said coalition leader Mark L. Jewell, MD of Eugene, Oregon. “Buying from such sources is not a naïve or innocuous act…It’s a dangerous act that can cause unexpected adverse events, and ultimately land the physician in prison.”
Warning signs of counterfeit products include:
• Misspelled brand names, unknown or unfamiliar names, or catchy marketing names
• Generic packaging that does not include serial and lot numbers for injectables that correspond to serial and lot numbers on the actual vials and syringes
• A lack of trademarks and identifying holograms
• Logos, type and packaging that are inconsistent with those of FDA-approved injectables
Physicians can visit the PCIS website at www.injectablesafety.org to review logos, packaging, brand names and other identifiers for approved products, as well as a list of all legal distributors for all currently FDA-approved injectable brands. If you have come across a suspicious product or supplier, information on reporting a suspected crime can be found on the FDA website at www.fda.gov/consumer/updates/oci072307.html.

Inga Hansen, executive editor

The California State Assembly has approved AB 1116, aka the “Donda West Law,” placing new restrictions on patients undergoing cosmetic surgery. The impetus of the bill was the untimely death of 58-year-old Donda West (mother of rapper Kanye West), who died in 2007 of complications related to existing coronary artery disease following cosmetic surgery. Assemblywoman Wilmer Amina Carter (D-Rialto) of the 62nd assembly district authored AB 1116, which requires that cosmetic facial surgery patients undergo a physical examination within 30 days of surgery. Following the physical examination, physicians must provide written clearance for surgery. The bill, which was opposed by the California Nurses Association, will now go to Governor Arnold Schwarzenegger.