Published: October 25, 2013

Physician-Industry Relationships: The Heat Is On

Robert M. Portman, JD, and Johanna Michaels Kreisel, JD The AAO-HNS Ethics Committee strives to keep physicians apprised of ethical standards for physician-industry relationships. These standards have changed significantly in recent years. In the following article, healthcare attorneys Robert M. Portman, JD, MPP, and Johanna Michaels Kreisel, JD, review legal risks and cases to explore the current ethical landscape of physician/industry relationships. They also offer tips for physicians on how to safely navigate that landscape. It has never been more important for physicians to protect themselves; the best armor is knowledge. —Lauren S. Zaretsky, MD, Chair  for the Ethics Committee Physician–industry relationships have come under intense legal and political scrutiny recently. Congress, the Food and Drug Administration (FDA), the HHS Office of Inspector General (OIG), federal and state prosecutors, and state legislatures, among others, have directed laser-like focus on the propriety of these relationships and are insisting on greater transparency and compliance with strict standards. Here are the most significant legal risks and political pressures that physicians confront in their relationships with the industry and tips to mitigate them. Legal Risks Associated with Industry Relationships Physician–industry relationships trigger scrutiny by the OIG and federal prosecutors under the federal False Claims Act, the Medicare-Medicaid Anti-Kickback statute, and FDA regulations on the promotion of unapproved uses of approved drugs and devices (i.e., “off-label uses”). The False Claims Act prohibits the knowing submission of false claims to government.1 The statute defines “knowing submission” broadly to include “actual knowledge,” “deliberate ignorance,” or “reckless disregard.” Physicians who act as consultants, clinical investigators, or speakers for pharmaceutical or device manufacturers may unwittingly be implicated in a false claims suit if they participate in the promotion or submission of a false claim for reimbursement relating to the use of pharmaceuticals or medical devices. The anti-kickback statute imposes both civil and criminal penalties for knowingly or willfully receiving or offering remuneration in any form to induce or generate business under any federal healthcare program.2 The OIG Compliance Program Guidance for Pharmaceutical Manufacturers, issued in 2003, makes clear that the exchange of remuneration between physicians and healthcare products companies is fraught with peril for both sides.3 In the OIG’s words, “These activities have a high potential for fraud and abuse and historically have generated a substantial number of anti-kickback convictions…if the remuneration is intended to generate any federal healthcare business, it potentially violates the anti-kickback statute.”4 Because of the inherent risks in these arrangements, the OIG recommends that all financial relationships between healthcare products companies and physicians fit within one of the anti-kickback safe harbors, such as the safe harbor for personal services and management contracts5 or employees.6 If the conditions for a safe harbor are not met, the OIG will look at the following factors in determining whether an arrangement violates the anti-kickback statute: nature of the relationship, manner in which payment is determined, value of remuneration, the impact on federal program costs/utilization, and potential conflicts of interest. The OIG Guidance notes that the Code on Interactions with Healthcare Professionals, originally issued by the Pharmaceutical Research and Manufacturers of America (PhRMA) in July 2002, addresses the OIG’s concerns and “provides useful and practical advice for reviewing and structuring these relationships.”7 The code adopts rigorous guidelines to prevent improper compensation relationships between physicians and pharmaceutical manufacturers. At the same time, the code permits drug companies to make reasonable payments for bona fide physician consulting and other services. The OIG states that while the agency won’t treat compliance with the PhRMA code like a safe harbor, “it will substantially reduce the risk of fraud and abuse and help demonstrate a good faith effort to comply with the applicable federal healthcare program requirements.”8 Given this unusual deference to a private ethical code, physicians would be well-advised to familiarize themselves with the provisions of the PhRMA code, as well as the OIG guidance document. PhRMA published a revised code in January 2009.9 The most important changes for physicians include the prohibition on the distribution of noneducational items to healthcare professionals and new disclosure requirements for physician speakers and consultants. Physicians should not accept any items or gifts from manufacturers that are not related to health education or treatment, even if such items are of minimum value, including pens, mugs, and other noneducational gifts. A physician may accept educational items of less than $100 as long as such items do not have value to the physician outside of his or her professional responsibilities. Another significant change is the prohibition on most meals and entertainment. Meals associated with a discussion or presentation of information that has educational value must occur in the office or hospital setting. The code also requires healthcare providers who participate in formulary boards, or serve as speakers or consultants, to disclose any relevant interests. The Advanced Medical Technology Association (AdvaMed), the association for medical device manufacturers, has issued a similar Code of Ethics on Interactions with Healthcare Professionals and recently followed PhRMA’s lead in revising its guidelines.10 The most important changes include a prohibition on entertainment and noneducational gifts for healthcare providers and a requirement that companies adopt and certify compliance with the Code. Following AdvaMed and PhRMA, the Council of Medical Specialty Societies (CMSS) has developed the “Code of Interaction with Companies,”11 which outlines the standards governing the relationships between medical specialty societies and for-profit healthcare companies. While less focused on individual physician interactions, this code has some key provisions with implications for physicians in elected roles. For example, the code requires physicians in leadership positions within their societies to divest themselves of all direct financial relationships with companies while in office, and board members are required to disclose all financial and uncompensated relationships with for-profit companies. Physicians should be particularly cautious about engaging in relationships with pharmaceutical and device manufacturers to promote “off-label” uses of their products—i.e., the use of an FDA-approved drug or device for unapproved indications not stated in approved labeling. In recent years, individual physicians have been found criminally liable for their involvement in the off-label uses. The FDA approves (or clears) drugs and devices for specific uses or purposes (referred to as “indications”). Manufacturers may not market their drugs or devices for unapproved uses.  The FDA has developed rules on how information on off-label uses can be disseminated by industry and has issued guidance documents on this issue.12 Manufacturers may not promote off-label use but may provide information in response to unsolicited requests from physicians. The FDA recently published the Good Reprint Practices, which outlines allowable practices that do not constitute off-label promotion for the dissemination of literature related to off-label use.13 Under the FDA’s “practice of medicine” exception, the agency does not regulate a physician’s decision to use or prescribe an approved drug or device for another an unapproved use that the physician believes is appropriate in diagnosing or treating a patient. However, where physicians are acting on behalf of drug or device companies in communicating information about off-label uses of specific products, the agency will treat them as agents of the manufacturer subject to the same rules and penalties and not protected by the “practice of medicine” exception. Recent Enforcement Actions In recent years, the federal government has taken significant enforcement actions against improper promotion of off-label uses by companies such as Eli Lilly (Zyprexa),14 Pfizer (Bextra)15 and Cephalon (Gabitril and Provigil).16 The case of Peter Gleason, MD, highlights the potential risks for physicians who engage in promotional activities on behalf of manufacturers, or who promote off-label uses of drugs or devices in a manner that is inconsistent with FDA rules. Dr. Gleason was indicted in 2006 and charged with conspiracy to illegally market Xyrem, a prescription medication, for unapproved medical uses on behalf of the manufacturer Jazz Pharmaceuticals.17 Xyrem is also known as “GHB,” which has been used as a “date rape” drug. The FDA heavily restricts its distribution. Dr. Gleason received thousands of dollars (estimated at least $70,000 in 2004) from the manufacturer to speak to other physicians at seminars encouraging off-label use. He also advised physicians on how to secure reimbursement for off-label use of Xyrem. Initially, the government sought to persuade Dr. Gleason to testify against Jazz Pharmaceuticals. When he refused to do so, he was indicted. Later, the manufacturer decided to cooperate with the government in its case against Dr. Gleason and was never charged.18 Dr. Gleason pleaded guilty to one count of misdemeanor misbranding and was sentenced to one year probation.19 Physician–industry relationships have also been the subject of recent enforcement actions under the False Claims Act and the anti-kickback statute. Physicians can be implicated in these cases where they could be accused of “aiding” and “abetting” manufacturers in the promotion of drugs or devices in exchange for remuneration. For example, in a recent criminal action, Patrick Chan, MD, was sentenced to three years’ probation and a $25,000 criminal fine for soliciting and receiving kickbacks in exchange for promoting medical devices on behalf of Blackstone Medical of Springfield, a subsidiary of Orthofix International.20 Dr. Chan also paid $1.5 million in a corresponding civil false claims action. Other recent enforcement activities involve a combination of allegations under the False Claims Act, the anti-kickback statute, and FDA off-label use regulations. For instance, the Department of Justice intervened in a “whistleblower” suit where an individual (a former AstraZeneca employee) alleged that AstraZeneca violated the false claims and anti-kickback statutes by providing remuneration to physicians for speeches, research, and “ghost-writing” articles promoting the unapproved, off-label use of Seroquel and submitting these claims to the government.21 AstraZeneca paid a fine of $520 million and entered into a five-year corporate integrity agreement. The Department of Justice also recently announced a recovery of $600 million from Allergan Inc. to resolve charges that it violated the False Claims Act by illegally paying physicians to prescribe BOTOX Therapeutic for off-label use.22 Legislative Activity Congress and the states have also increased their scrutiny and regulation of physician-industry relationships. Consequently, as part of the recent health reform law, section 6002 of the Patient Protection and Affordable Care Act (PPACA), requires pharmaceutical, device, or medical supply manufacturers to submit transparency reports detailing gifts, compensation, entertainment, traveling fees, and ownership or investment interests provided to physicians or teaching hospitals for any item of value of more than $10 unless the aggregate value over the calendar year exceeds $100.23 Product samples are excluded from this requirement as long as they are intended for patient use. Manufacturers will be required to report the name of the recipient of the item, the amount of the transfer, and the description of the item. This information will be available online in a public searchable database that will include the recipient’s name, business address, and specialty. Manufacturers are also required to report physician ownership or investment interests held by a physician or family member. Manufacturers are required to begin collecting data on January 1, 2012, and the first annual report is due on March 31, 2013. The Secretary of Health and Human Services is obligated to issue guidance by October 1, 2011, to establish reporting procedures and plans for how the information will be made available to the public. Currently, seven states as well as the District of Columbia also regulate physician–industry interactions.24 Most notably, Massachusetts recently enacted comprehensive regulations requiring pharmaceutical and medical device manufacturers to disclose financial benefits and gifts to healthcare providers for any remuneration over $50.25 The law also prohibits companies from providing gifts and entertainment to physicians. Forewarned, Forearmed Because of the heightened scrutiny surrounding physician–industry relationships, physicians should be cautious when engaging in formal or informal relationships with pharmaceutical or medical device manufacturers. These relationships should adhere to the anti-kickback safe harbor provisions, the OIG guidance, and the PhRMA/AdvaMed codes of conduct. In forming a consulting or speaking engagement with a pharmaceutical or medical device manufacturer, physicians should avoid any involvement or actions in furthering off-label use of medical devices and pharmaceuticals that do not strictly comply with FDA rules. Failure to follow these guidelines creates tremendous risk for physicians, including possible civil and criminal liability, as well as personal and professional embarrassment. Robert M. Portman, JD, MPP, (1-202-872-6756; Rob.Portman@ppsv.com) and Johanna Michaels Kreisel are healthcare attorneys with the law firm of Powers, Pyles, Sutter & Verville, PC, in Washington, DC. Portman is also legal counsel for the American Academy of Otolaryngology—Head and Neck Surgery.  An earlier version of this article appeared in Administrative Eyecare, a publication of the American Society of Cataract and Refractive Surgery and the American Society of Ophthalmic Administrators. References 31 U.S.C. 3729(a) 42 U.S.C. § 1320a-7b(b) Department of Health and Human Services, Office of Inspector General, “OIG Compliance Program Guidance for Pharmaceutical Manufacturers,” 68 Fed. Reg. 23731 (2003) (available at www.oig.hhs.gov). See also Department of Health and Human Services, Office of Inspector General, OIG Compliance Program Guidance for Individual and Small Group Physician Practices, 65 Fed. Reg. 59434 (2000) (available at www.oig.hhs.gov). 68 Fed. Reg. 23737. 42 C.F.R. § 1001.952(d). 42 C.F.R. § 1001.952(i). The original PhRMA code is available at http://www.phrma.org/files/PhRMA%20Code.pdf. 68 Fed. Reg. 23737. The revised code is available at http://www.phrma.org/code_on_interactions_with_healthcare_professionals/ http://www.advamed.org/NR/rdonlyres/61D30455-F7E9-4081-B219-12D6CE347585/0/AdvaMedCodeofEthicsRevisedandRestatedEffective20090701.pdf. Council of Medical Specialty Societies, Code for Interactions with Companies, http://www.cmss.org/uploadedFiles/Site/CMSS_Policies/CMSS%20Code%20for%20Interactions%20with%20Companies%204-19-10.pdf. See 21 C.F.R. § 99.1; 99.405; 62 Fed. Reg. 64074 (Dec. 3, 1997) (Guidance on Industry-Supported Scientific and Educational Activities) available at www.fda.gov/cder/guidance/isse.htm. http://www.fda.gov/oc/op/goodreprint.html (Such practices include material that is published in a peer-review publication, not influenced or written for a manufacturer and disclosed conflicts of interest) (last visited on April 6, 2009). http://www.usdoj.gov/opa/pr/2009/January/09-civ-038.html (assessed $515 million criminal fine, the largest ever in a criminal or civil suit against an individual or corporation). http://op.bna.com/hl.nsf/id/lroi-7vqmea/$File/Pfizer%20settlement.pdf (paid total of $2.3 billion in criminal and civil fines for illegal marketing) http://www.usdoj.gov/usao/pae/News/Pr/2008/sep/cephalonrelease.pdf (agreed to criminal plea and $444 million fine). Alex Berenson, “Indictment of Doctor Tests Drug Marketing Rules,” New York Times, July 22, 2006, available at http://www.nytimes.com/2006/07/22/business/22drugdoc.html?ex=1179288000&en=53396c715fc51c9a&ei=5070. Id. 240 N.Y.L.J 33 (September 26, 2008); http://psychcrimereporter.wordpress.com/2010/03/30/psychiatrist-peter-c-gleason-sentenced-for-federal-crime-reprimanded-in-california-on-patient-recordkeeping-violations/ (last visited Jan. 27, 2011). http://littlerock.fbi.gov/dojpressrel/pressrel08/kickbacks040808.htm; see  Alice Dembner, Plea Bolsters Kickback Case against Mass. Medical Firm, Boston Globe, Jan. 4, 2008, http://www.boston.com/business/articles/2008/01/04/plea_bolsters_kickback_case_against_mass_medical_firm/ http://www.justice.gov/opa/pr/2010/April/10-civ-487.html. http://www.justice.gov/opa/pr/2010/September/10-civ-988.html Patient Protection and Affordable Care Act (“PPACA”), P.L. 111-148, 111th Congress § 6002, 42 U.S.C. 1320a-7h, http://www.gpo.gov/fdsys/pkg/PLAW-111publ148/pdf/PLAW-111publ148.pdf The seven states are California, Maine, Minnesota, Nevada, Vermont, West Virginia and Massachusetts. Massachusetts Department of Health http://www.mass.gov/?pageID=eohhs2pressrelease&L=4&L0=Home&L1=Government&L2=Departments+and+Divisions&L3=Department+of+Public+Health&sid=Eeohhs2&b=pressrelease&f=090311_tough_new_rules&csid=Eeohhs2.

Robert M. Portman, JDRobert M. Portman, JD

Robert M. Portman, JD,
and Johanna Michaels Kreisel, JD

The AAO-HNS Ethics Committee strives to keep physicians apprised of ethical standards for physician-industry relationships. These standards have changed significantly in recent years. In the following article, healthcare attorneys Robert M. Portman, JD, MPP, and Johanna Michaels Kreisel, JD, review legal risks and cases to explore the current ethical landscape of physician/industry relationships. They also offer tips for physicians on how to safely navigate that landscape. It has never been more important for physicians to protect themselves; the best armor is knowledge.
—Lauren S. Zaretsky, MD,
Chair  for the Ethics Committee

Physician–industry relationships have come under intense legal and political scrutiny recently. Congress, the Food and Drug Administration (FDA), the HHS Office of Inspector General (OIG), federal and state prosecutors, and state legislatures, among others, have directed laser-like focus on the propriety of these relationships and are insisting on greater transparency and compliance with strict standards. Here are the most significant legal risks and political pressures that physicians confront in their relationships with the industry and tips to mitigate them.

Johanna Michaels Kreisel, JDJohanna Michaels Kreisel, JD

Legal Risks Associated with Industry Relationships
Physician–industry relationships trigger scrutiny by the OIG and federal prosecutors under the federal False Claims Act, the Medicare-Medicaid Anti-Kickback statute, and FDA regulations on the promotion of unapproved uses of approved drugs and devices (i.e., “off-label uses”).

The False Claims Act prohibits the knowing submission of false claims to government.1 The statute defines “knowing submission” broadly to include “actual knowledge,” “deliberate ignorance,” or “reckless disregard.” Physicians who act as consultants, clinical investigators, or speakers for pharmaceutical or device manufacturers may unwittingly be implicated in a false claims suit if they participate in the promotion or submission of a false claim for reimbursement relating to the use of pharmaceuticals or medical devices.

The anti-kickback statute imposes both civil and criminal penalties for knowingly or willfully receiving or offering remuneration in any form to induce or generate business under any federal healthcare program.2

The OIG Compliance Program Guidance for Pharmaceutical Manufacturers, issued in 2003, makes clear that the exchange of remuneration between physicians and healthcare products companies is fraught with peril for both sides.3 In the OIG’s words, “These activities have a high potential for fraud and abuse and historically have generated a substantial number of anti-kickback convictions…if the remuneration is intended to generate any federal healthcare business, it potentially violates the anti-kickback statute.”4

Because of the inherent risks in these arrangements, the OIG recommends that all financial relationships between healthcare products companies and physicians fit within one of the anti-kickback safe harbors, such as the safe harbor for personal services and management contracts5 or employees.6 If the conditions for a safe harbor are not met, the OIG will look at the following factors in determining whether an arrangement violates the anti-kickback statute: nature of the relationship, manner in which payment is determined, value of remuneration, the impact on federal program costs/utilization, and potential conflicts of interest.

The OIG Guidance notes that the Code on Interactions with Healthcare Professionals, originally issued by the Pharmaceutical Research and Manufacturers of America (PhRMA) in July 2002, addresses the OIG’s concerns and “provides useful and practical advice for reviewing and structuring these relationships.”7 The code adopts rigorous guidelines to prevent improper compensation relationships between physicians and pharmaceutical manufacturers.

At the same time, the code permits drug companies to make reasonable payments for bona fide physician consulting and other services. The OIG states that while the agency won’t treat compliance with the PhRMA code like a safe harbor, “it will substantially reduce the risk of fraud and abuse and help demonstrate a good faith effort to comply with the applicable federal healthcare program requirements.”8 Given this unusual deference to a private ethical code, physicians would be well-advised to familiarize themselves with the provisions of the PhRMA code, as well as the OIG guidance document.

PhRMA published a revised code in January 2009.9 The most important changes for physicians include the prohibition on the distribution of noneducational items to healthcare professionals and new disclosure requirements for physician speakers and consultants. Physicians should not accept any items or gifts from manufacturers that are not related to health education or treatment, even if such items are of minimum value, including pens, mugs, and other noneducational gifts. A physician may accept educational items of less than $100 as long as such items do not have value to the physician outside of his or her professional responsibilities.

Another significant change is the prohibition on most meals and entertainment. Meals associated with a discussion or presentation of information that has educational value must occur in the office or hospital setting. The code also requires healthcare providers who participate in formulary boards, or serve as speakers or consultants, to disclose any relevant interests.

The Advanced Medical Technology Association (AdvaMed), the association for medical device manufacturers, has issued a similar Code of Ethics on Interactions with Healthcare Professionals and recently followed PhRMA’s lead in revising its guidelines.10 The most important changes include a prohibition on entertainment and noneducational gifts for healthcare providers and a requirement that companies adopt and certify compliance with the Code.

Following AdvaMed and PhRMA, the Council of Medical Specialty Societies (CMSS) has developed the “Code of Interaction with Companies,”11 which outlines the standards governing the relationships between medical specialty societies and for-profit healthcare companies. While less focused on individual physician interactions, this code has some key provisions with implications for physicians in elected roles. For example, the code requires physicians in leadership positions within their societies to divest themselves of all direct financial relationships with companies while in office, and board members are required to disclose all financial and uncompensated relationships with for-profit companies.

Physicians should be particularly cautious about engaging in relationships with pharmaceutical and device manufacturers to promote “off-label” uses of their products—i.e., the use of an FDA-approved drug or device for unapproved indications not stated in approved labeling. In recent years, individual physicians have been found criminally liable for their involvement in the off-label uses.

The FDA approves (or clears) drugs and devices for specific uses or purposes (referred to as “indications”). Manufacturers may not market their drugs or devices for unapproved uses.  The FDA has developed rules on how information on off-label uses can be disseminated by industry and has issued guidance documents on this issue.12 Manufacturers may not promote off-label use but may provide information in response to unsolicited requests from physicians. The FDA recently published the Good Reprint Practices, which outlines allowable practices that do not constitute off-label promotion for the dissemination of literature related to off-label use.13

Under the FDA’s “practice of medicine” exception, the agency does not regulate a physician’s decision to use or prescribe an approved drug or device for another an unapproved use that the physician believes is appropriate in diagnosing or treating a patient. However, where physicians are acting on behalf of drug or device companies in communicating information about off-label uses of specific products, the agency will treat them as agents of the manufacturer subject to the same rules and penalties and not protected by the “practice of medicine” exception.

Recent Enforcement Actions
In recent years, the federal government has taken significant enforcement actions against improper promotion of off-label uses by companies such as Eli Lilly (Zyprexa),14 Pfizer (Bextra)15 and Cephalon (Gabitril and Provigil).16 The case of Peter Gleason, MD, highlights the potential risks for physicians who engage in promotional activities on behalf of manufacturers, or who promote off-label uses of drugs or devices in a manner that is inconsistent with FDA rules.

Dr. Gleason was indicted in 2006 and charged with conspiracy to illegally market Xyrem, a prescription medication, for unapproved medical uses on behalf of the manufacturer Jazz Pharmaceuticals.17 Xyrem is also known as “GHB,” which has been used as a “date rape” drug. The FDA heavily restricts its distribution. Dr. Gleason received thousands of dollars (estimated at least $70,000 in 2004) from the manufacturer to speak to other physicians at seminars encouraging off-label use. He also advised physicians on how to secure reimbursement for off-label use of Xyrem. Initially, the government sought to persuade Dr. Gleason to testify against Jazz Pharmaceuticals. When he refused to do so, he was indicted. Later, the manufacturer decided to cooperate with the government in its case against Dr. Gleason and was never charged.18 Dr. Gleason pleaded guilty to one count of misdemeanor misbranding and was sentenced to one year probation.19

Physician–industry relationships have also been the subject of recent enforcement actions under the False Claims Act and the anti-kickback statute. Physicians can be implicated in these cases where they could be accused of “aiding” and “abetting” manufacturers in the promotion of drugs or devices in exchange for remuneration. For example, in a recent criminal action, Patrick Chan, MD, was sentenced to three years’ probation and a $25,000 criminal fine for soliciting and receiving kickbacks in exchange for promoting medical devices on behalf of Blackstone Medical of Springfield, a subsidiary of Orthofix International.20 Dr. Chan also paid $1.5 million in a corresponding civil false claims action.

Other recent enforcement activities involve a combination of allegations under the False Claims Act, the anti-kickback statute, and FDA off-label use regulations. For instance, the Department of Justice intervened in a “whistleblower” suit where an individual (a former AstraZeneca employee) alleged that AstraZeneca violated the false claims and anti-kickback statutes by providing remuneration to physicians for speeches, research, and “ghost-writing” articles promoting the unapproved, off-label use of Seroquel and submitting these claims to the government.21 AstraZeneca paid a fine of $520 million and entered into a five-year corporate integrity agreement. The Department of Justice also recently announced a recovery of $600 million from Allergan Inc. to resolve charges that it violated the False Claims Act by illegally paying physicians to prescribe BOTOX Therapeutic for off-label use.22

Legislative Activity
Congress and the states have also increased their scrutiny and regulation of physician-industry relationships. Consequently, as part of the recent health reform law, section 6002 of the Patient Protection and Affordable Care Act (PPACA), requires pharmaceutical, device, or medical supply manufacturers to submit transparency reports detailing gifts, compensation, entertainment, traveling fees, and ownership or investment interests provided to physicians or teaching hospitals for any item of value of more than $10 unless the aggregate value over the calendar year exceeds $100.23 Product samples are excluded from this requirement as long as they are intended for patient use. Manufacturers will be required to report the name of the recipient of the item, the amount of the transfer, and the description of the item. This information will be available online in a public searchable database that will include the recipient’s name, business address, and specialty. Manufacturers are also required to report physician ownership or investment interests held by a physician or family member. Manufacturers are required to begin collecting data on January 1, 2012, and the first annual report is due on March 31, 2013. The Secretary of Health and Human Services is obligated to issue guidance by October 1, 2011, to establish reporting procedures and plans for how the information will be made available to the public.

Currently, seven states as well as the District of Columbia also regulate physician–industry interactions.24 Most notably, Massachusetts recently enacted comprehensive regulations requiring pharmaceutical and medical device manufacturers to disclose financial benefits and gifts to healthcare providers for any remuneration over $50.25 The law also prohibits companies from providing gifts and entertainment to physicians.

Forewarned, Forearmed
Because of the heightened scrutiny surrounding physician–industry relationships, physicians should be cautious when engaging in formal or informal relationships with pharmaceutical or medical device manufacturers. These relationships should adhere to the anti-kickback safe harbor provisions, the OIG guidance, and the PhRMA/AdvaMed codes of conduct. In forming a consulting or speaking engagement with a pharmaceutical or medical device manufacturer, physicians should avoid any involvement or actions in furthering off-label use of medical devices and pharmaceuticals that do not strictly comply with FDA rules. Failure to follow these guidelines creates tremendous risk for physicians, including possible civil and criminal liability, as well as personal and professional embarrassment.

Robert M. Portman, JD, MPP, (1-202-872-6756; Rob.Portman@ppsv.com) and Johanna Michaels Kreisel are healthcare attorneys with the law firm of Powers, Pyles, Sutter & Verville, PC, in Washington, DC. Portman is also legal counsel for the American Academy of Otolaryngology—Head and Neck Surgery.  An earlier version of this article appeared in Administrative Eyecare, a publication of the American Society of Cataract and Refractive Surgery and the American Society of Ophthalmic Administrators.

References

  1. 31 U.S.C. 3729(a)
  2. 42 U.S.C. § 1320a-7b(b)
  3. Department of Health and Human Services, Office of Inspector General, “OIG Compliance Program Guidance for Pharmaceutical Manufacturers,” 68 Fed. Reg. 23731 (2003) (available at www.oig.hhs.gov). See also Department of Health and Human Services, Office of Inspector General, OIG Compliance Program Guidance for Individual and Small Group Physician Practices, 65 Fed. Reg. 59434 (2000) (available at www.oig.hhs.gov).
  4. 68 Fed. Reg. 23737.
  5. 42 C.F.R. § 1001.952(d).
  6. 42 C.F.R. § 1001.952(i).
  7. The original PhRMA code is available at http://www.phrma.org/files/PhRMA%20Code.pdf.
  8. 68 Fed. Reg. 23737.
  9. The revised code is available at http://www.phrma.org/code_on_interactions_with_healthcare_professionals/
  10. http://www.advamed.org/NR/rdonlyres/61D30455-F7E9-4081-B219-12D6CE347585/0/AdvaMedCodeofEthicsRevisedandRestatedEffective20090701.pdf.
  11. Council of Medical Specialty Societies, Code for Interactions with Companies, http://www.cmss.org/uploadedFiles/Site/CMSS_Policies/CMSS%20Code%20for%20Interactions%20with%20Companies%204-19-10.pdf.
  12. See 21 C.F.R. § 99.1; 99.405; 62 Fed. Reg. 64074 (Dec. 3, 1997) (Guidance on Industry-Supported Scientific and Educational Activities) available at www.fda.gov/cder/guidance/isse.htm.
  13. http://www.fda.gov/oc/op/goodreprint.html (Such practices include material that is published in a peer-review publication, not influenced or written for a manufacturer and disclosed conflicts of interest) (last visited on April 6, 2009).
  14. http://www.usdoj.gov/opa/pr/2009/January/09-civ-038.html (assessed $515 million criminal fine, the largest ever in a criminal or civil suit against an individual or corporation).
  15. http://op.bna.com/hl.nsf/id/lroi-7vqmea/$File/Pfizer%20settlement.pdf (paid total of $2.3 billion in criminal and civil fines for illegal marketing)
  16. http://www.usdoj.gov/usao/pae/News/Pr/2008/sep/cephalonrelease.pdf (agreed to criminal plea and $444 million fine).
  17. Alex Berenson, “Indictment of Doctor Tests Drug Marketing Rules,” New York Times, July 22, 2006, available at http://www.nytimes.com/2006/07/22/business/22drugdoc.html?ex=1179288000&en=53396c715fc51c9a&ei=5070.
  18. Id.
  19. 240 N.Y.L.J 33 (September 26, 2008); http://psychcrimereporter.wordpress.com/2010/03/30/psychiatrist-peter-c-gleason-sentenced-for-federal-crime-reprimanded-in-california-on-patient-recordkeeping-violations/ (last visited Jan. 27, 2011).
  20. http://littlerock.fbi.gov/dojpressrel/pressrel08/kickbacks040808.htm; see  Alice Dembner, Plea Bolsters Kickback Case against Mass. Medical Firm, Boston Globe, Jan. 4, 2008, http://www.boston.com/business/articles/2008/01/04/plea_bolsters_kickback_case_against_mass_medical_firm/
  21. http://www.justice.gov/opa/pr/2010/April/10-civ-487.html.
  22. http://www.justice.gov/opa/pr/2010/September/10-civ-988.html
  23. Patient Protection and Affordable Care Act (“PPACA”), P.L. 111-148, 111th Congress § 6002, 42 U.S.C. 1320a-7h, http://www.gpo.gov/fdsys/pkg/PLAW-111publ148/pdf/PLAW-111publ148.pdf
  24. The seven states are California, Maine, Minnesota, Nevada, Vermont, West Virginia and Massachusetts.
  25. Massachusetts Department of Health http://www.mass.gov/?pageID=eohhs2pressrelease&L=4&L0=Home&L1=Government&L2=Departments+and+Divisions&L3=Department+of+Public+Health&sid=Eeohhs2&b=pressrelease&f=090311_tough_new_rules&csid=Eeohhs2.
More from April 2011 - Vol. 30 No. 04
Dr. Mangus examines a child with a cleft lip while rounding with Dr. Netterville and Dr. Sinard.
Vanderbilt Mission to Malindi, Kenya
Brannon Mangus, MD Humanitarian Travel Grant Awardee Otolaryngology, Head and Neck Surgery; Vanderbilt UniversityFor 12 days in November 2010, a team from Vanderbilt University led by James L. Netterville, MD, and Robert J. Sinard, MD, worked at two hospitals in Malindi, on the coast of Kenya. This trip to Malindi, Kenya, was an experience I will take with me the rest of my life. I have been on mission trips before, but this was my first medical mission trip. For anyone considering a medical mission trip, I highly recommend going on one that is as organized as this one. Because of the impeccable planning and efficiency, we were able to focus on patient care while we were there. The host organization, the Caris Foundation, arranged our transportation, food, and lodging, allowing us to focus on patient care. We were there for 12 days. Our group was divided into two groups: one group of surgeons, anesthesiologists, and nurses worked at Tawfiq Hospital (the Muslim hospital) and another group worked at Malindi District Hospital (the Christian hospital). This allowed us to maximize the number of patients that we could treat. Each day began with seeing patients that the local doctors had “saved up” for us. Most of these patients were instructed to be NPO so that they could undergo surgery that day. There was a great variety of cases including thyroid masses, neck masses, parotid tumors, cleft lips and palates, mandibular tumors, scar revisions, chronic sinusitis, tonsillitis, OSA, chronic ear disease, and frontal sinus fractures. We completed 125 procedures. The number of cases we could care for in such short time and at such relatively low cost made the greatest impression on me. Many of the supplies that we used would have been discarded as waste in the U.S. With little to no red tape, we were able to maximize patient care. Unfortunately, the hospital conditions that the patients had to endure postoperatively were less than ideal. Many patients had to share a bed with another patient—most patients in the U.S. would call patient affairs if they had to share a semi-private room. These patients shared a bed with another patient in a large room with 50 other patients. To learn more about humanitarian travel grants, visit http://www.entnet.org/Community/public/Residents-and-Fellows.cfm or contact humanitarian@entnet.org.
Dr. Cheung-Phillips in the OR
Faith in Practice Mission to Antigua, Guatemala
Esther Cheung-Phillips, MD Humanitarian Travel Grant Awardee University of Texas, Houston In April 2010, thanks to a resident travel grant from the Humanitarian Efforts Committee, I joined a mission to Las Obras Sociales del Hermano Pedro Hospital and Orphanage in Antigua, Guatemala, sponsored by Faith in Practice and supervised by Becky McGraw-Wall, MD. This was an extremely rewarding and eye-opening trip. The patients and hospital personnel were so grateful and willing to help. It was an honor and a humbling experience to work among them. The country was stunning with its rich cultural background. I enjoyed our daily walks to and from the hospital along the cobblestone roads in this ancient city. The trip is perfect for anyone who is limited to shorter engagements. Faith in Practice is organized and efficient in sending teams and supplies to Guatemala. As a result, you can jump right in as a member of the team. The patient population is quite diverse and because the hospital and clinic have a steady supply of volunteers as well as its own Guatemalan physicians year-round, there is patient follow-up with some of the same teams. Knowing some Spanish was a definite plus. I am definitely considering a return visit. We saw a wide variety of cases ranging from facial plastics and reconstruction (cleft lip and palate, facial trauma, and burns,) to general ENT (facial and neck masses, myringotomy, and placement of tubes). We performed such operations as cleft lip and palate repair, nasal reconstruction and rhinoplasty, and excision of benign facial and neck masses. To learn more, contact escjordan@gmail.com. To donate equipment or medical supplies, call or email Faith in Practice at 1-713-484-5555 or donations@faithinpractice.org. Equipment needs include vital signs monitor (operating recovery room), automatic X-ray developer (dental clinic), wheelchairs (children’s and adult), physical therapy supplies and equipment, and operating room equipment such as scissors, toothed thumbs, and small retractors. If you wish to donate medical supplies, Faith in Practice could use spinal anesthesia trays, IV tubing and catheters, sterile gowns and gloves, masks, shoe covers, prep kits, shave kits, drapes, 4×4 and 2×2 gauze, lap sponges, and IV antibiotics. Dental supplies needed are prophy angles (disposable or sterilizable), patient bibs, amalgam pellets (one and two spills), amalgam squeeze clothes, forceps, elevators, burrs, surgical and polishing burrs, and articulating paper.
Performing microlaryngoscopy at Sabogal Hospital.
Teaching Mission in Lima, Peru
Elizabeth A. Guardiani, MD, Resident Humanitarian Travel Grant Awardee Georgetown University Hospital, Washington, DC Last November, I traveled to Lima, Peru, with Nazaneen N. Grant, MD, Craig H. Zalvan, MD, and Joseph F. Goodman, MD, for an educationally focused humanitarian mission.  In conjunction with Julio Perez-Lu, MD, we helped arrange a large course on laryngology and voice therapy.  The course consisted of lectures by several Peruvian physicians and voice therapists, Drs. Grant and Zalvan, and Silvia Rebelo Pinho, MD, from Brazil, as well as a workshop on flexible laryngosocopy, organized by Dr. Goodman and me. We were surprised to learn that most of the 20 Peruvian otolaryngologists who attended this workshop had performed fewer than five flexible laryngoscopies in their careers and generally felt uncomfortable with this skill.  As the Peruvian economy grows, flexible laryngoscopy is becoming more available, yet many physicians are not comfortable with its use. Each participant practiced on an anatomically correct mannequin as well as on each other. Dr. Goodman and I instructed the attendees on systemic examination of the upper airway and techniques to identify pathology.   After the attendees had a good understanding of normal anatomy and function, Dr. Zalvan directed a “Jeopardy” game of pathological laryngeal lesions to help participants recognize lesions in their own practice. In addition to the voice course, we spent time in the clinics and operating room at Hospital Alberto Sabogal Sologuren and Hospital Nacional Guillermo Almenara Irigoyen.  At Sabogal Hospital, we jointly discussed with the residents and attendings the complex laryngeal pathologies and options for management for patients they brought in.  We were again surprised that they actually had quite good technology, but lacked the confidence or experience to use it.  We helped them perform an awake laryngeal biopsy, using flexible laryngoscopy, a technique they claim will become part of their routine practice. We spent two full days in the operating room doing cases the local ENTs had pre-selected as difficult laryngology cases such as subglottic cysts, laryngeal papillomatosis, and laryngeal stenosis.  Again, we introduced them to new techniques such as sub-epithelial saline injection in the vocal fold to preserve the superficial lamina propria and apnea ventilation for posterior glottic lesions. I came away with a deep respect for the Peruvian otolaryngologists and their thirst for knowledge and new skills.  Resources we take for granted, such as access to multiple scientific journals and new textbooks, are prohibitively expensive for many.  I encourage anyone considering a similar trip to include education of local otolaryngologists as a key goal of their mission so that they may provide advanced care for their patients after the mission is complete. To learn more, contact lizguardiani@gmail.com.
CDMA Team Visits Valladolid, Yucatan, Mexico
Scott Sharp, MD Humanitarian Resident Travel Awardee, Duke University Medical Center I am a fifth-year otolaryngology resident at Duke.  In November 2010, I completed a medical mission to Valladolid, Mexico, sponsored by the Christian Medical and Dental Association (CMDA) and hosted by Ricardo Rodriguez, MD, of the Centro Medico San Lucas.  This life-changing experience was made possible by the AAO-HNSF Humanitarian Resident Travel Grant. Anesthesiologists, nurses, and logistics/support volunteers from all over the U.S. and Canada composed our 15-member team.  The otolaryngologists involved were team leader Christopher B. Perry, DO; David Hall, MD; Raymond R. Komray, MD; my faculty mentor Walter T. Lee, MD; William G. Sybesma, MD; and me. Valladolid is a city in the Yucatan, with a largely underserved Mayan population.   When we first arrived at the clinic, the waiting room was completely full, and hundreds more were lined up out the front door into the courtyard. Some people waited for hours.  Never once did I hear a complaint about the wait, only consistent and constant praises and “thank you’s.” Most of the operations performed were routine otolaryngic procedures, including sinus surgery, UPPP, tonsillectomy, tympanoplasty/mastoidectomy, nasal and ear foreign body removal, and septorhinoplasty. Highlights included excision of an inferior turbinate with fibrous dysplasia, several challenging chronic ear cases, and removal of a rhinolith the size of an egg. What I did not expect, however, was the way that my life was affected and changed. Taking care of patients who have nothing to give in return allows you the freedom and joy of practicing medicine solely because that is what you love to do. Writer and theologian Fredrick Buechner once said that one’s occupation should be “where your deepest gladness meets the world’s deepest needs.”  I have found that in otolaryngology, but never has it been clearer than during my time in Valladolid.  I certainly hope others can experience that same kind of fulfillment and joy by giving of their time and gifts in a medical mission.  I know that there are so many out there with so much to give, but trust me, you will be overwhelmed by how much more you receive in return. For more, contact scott.sharp@duke.edu.
Reviewing Temporal bone CT with residents prior to surgery, Chicalyo, Peru.
Global ENT Outreach Mission to Chiclayo and Lima, Peru
Felipe Santos, MD Humanitarian Travel Grant Awardee Awarded the Distinguished Human-itarian Award of the American Academy of Otolaryngology in 2009, the Global ENT Outreach (GEO) is a humanitarian outreach organization dedicated to teaching and training local physicians and medical staff in otologic surgical medicine. For a week in November, GEO founder Richard Wagner, MD, invited Kimberly Rutherford, MD, of the University of Connecticut and me to join him on a trip to Chiclayo and Lima, Peru. Our trip to Chiclayo included four mornings of surgery at the Almanzor Aguinaga Asenjo Hospital, a tertiary care center that serves the population of Chiclayo and smaller neighboring cities. We performed 12 surgeries with an emphasis on chronic otitis media. It was an opportunity to serve and teach the faculty, residents, and nursing staff. The practical experience was a complement to an organized three-day workshop that was held over three afternoons at the Universidad Nacional Pedro Ruiz Gallo School of Medicine. Dr. Wagner and I gave several lectures and presented videos on middle-ear anatomy, physiology, and pathology. The course was free of charge and held for medical students, residents and practicing physicians including otolaryngologists. The second half of our trip was spent in Lima, Peru, at the Divino Nino Jesus clinic. Together with the Universidad Nacional Mayor de San Marcos, GEO held its 7th annual temporal bone course. This hands-on training course included lectures on anatomy, physiology, pathology, diagnostic testing, and surgical techniques for residents and practicing otolaryngologists. The course was complemented by two mornings of OR observation including tympanoplasties and mastoidectomies. Working with Global ENT Outreach was an opportunity to be a part of a sustained presence that is committed to teach future generations of otolaryngologists in developing countries. By establishing workshops with hands-on experience, the needs of the local patient population and the local medical community could be served. It is our hope that through these efforts local physicians will continue a legacy of teaching otologic surgical medicine. To learn more, contact fsantos@hei.org.
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2011 Physician Quality Reporting System
The Center for Medicare and Medicaid (CMS) issued the 2011 Medicare Physician Fee Schedule Final Rule on November 29, 2010. The Final Rule made several changes to the Physician Quality Reporting System incentive program for 2011. The most visible change to the program is lowering of the reporting threshold to 50 percent from 80 percent, if reporting via the claims process. Registry reporting still requires reporting each measure 80 percent of the time on individual measures, due to registry reporting having a 90-percent success rate. The change in the claims process will improve PQRS success.  The name of the program has been updated to the Physician Quality Reporting System (PQRS); the program had previously been called the Physician Quality Reporting Initiative (PQRI). To participate in the program, professionals may report individual PQRS quality measures or group measures through one of these methods: To CMS on their Medicare Part B claims (claims-based reporting) To a qualified Physician Quality Reporting registry (registry-based reporting) Professionals who satisfy the reporting criteria will earn a Physician Quality Reporting incentive payment equal to 1 percent of their total Medicare Part B Physician Fee Schedule (PFS) charges, excluding drugs and biologics. The Affordable Care Act authorizes incentive payments through 2014. Physician Quality Reporting Incentive Payment through 2014 2011 1% 2012 0.5% 2013 0.5% 2014 0.5%   Beginning in 2015, the Affordable Care Act authorizes a penalty for eligible professionals who do not satisfactorily report quality measures. Eligible professionals who do not meet the reporting criteria in 2015 will be subject to a 1.5 percent reduction in their fees. The penalty for unsatisfactory reporting rises to 2 percent from 2016 onward. The PQRS does not require eligible professionals to register to participate in the program. A list of eligible professionals can be found on the CMS website at http://www.cms.gov/PQRI/Downloads/EligibleProfessionals.pdf. Physician Quality Reporting System Quality Measures The 2011 Physician Quality Reporting System includes 194 individual quality measures, an increase from the 179 quality measures used in 2010. There are seven otolaryngology specific measures. It is important that you review all of the measures to select those most frequently applied to your Medicare patients. You should also review them to make sure none of the measure specifications have changed if reporting on the same measures from 2010. It is also important to note that certain measures can only be reported using a CMS-approved registry. The measures listed below apply directly to otolaryngology, although there are non-specialty specific measures that may apply to your practice. MEASURES 91 Acute Otitis Externa (AOE): Topical Therapy 92 Acute Otitis Externa (AOE): Pain Assessment 93 Acute Otitis Externa (AOE): Systemic Antimicrobial Therapy – Avoidance of Inappropriate Use 94 Otitis Media with Effusion (OME): Diagnostic Evaluation – Assessment of Tympanic Membrane Mobility 188 Referral for Otologic Evaluation for Patients with Congenital or Traumatic Deformity of the Ear 189 Referral for Otologic Evaluation for Patients with History of Active Drainage from the Ear within the Previous 90 Days 190 Referral for Otologic Evaluation for Patients with a History of Sudden or Rapidly Progressive Hearing Loss   CMS has also established measure groups that pertain to a particular condition or have a common area of focus. Group measures have different specifications than the individual measures that make up the group. Currently, only the perioperative care measures group may be applicable to otolaryngologists. The perioperative care measures group includes the following measures: MEASURES GROUP 20 Perioperative Care: Timing of Antibiotic Prophylaxis – Ordering Physician 21 Perioperative Care: Selection of Prophylactic Antibiotic – First OR Second Generation Cephalosporin 22 Perioperative Care: Discontinuation of Prophylactic Antibiotics (Non-Cardiac Procedures) 23 Perioperative Care: Venous Thromboembolism (VTE) Prophylaxis (When Indicated in ALL Patients)   You can review the individual and group measures and their specifications on the CMS website. The 2011 Physician Quality Reporting System (Physician Quality Reporting) Measures List can be viewed at https://www.cms.gov/PQRI/15_MeasuresCodes.asp. Satisfactorily Reporting Quality Measures The 2011 incentive program has established criteria for satisfactorily reporting quality measures based on the reporting mechanism and the reporting period. The table below outlines the reporting criteria and reporting periods. TABLE 1. REPORTING CRITERIA AND PERIODS Reporting Mechanism & Period PQRS Measures Patient Threshold Claims-based Reporting  – 12-month period January 1, 2011 – December 31, 2011 Report 3 or more PQRS measures (Eligible professionals may report 1-2 measures if less than 3 apply to their practice) =50% of Medicare Part B FFS patients seen during the reporting period Claims-based Reporting – 6-month period July 1, 2011 – – December 31, 2011 Report 3 or more PQRS measures (Eligible professionals may report 1-2 measures if less than 3 apply to their practice) =50% of Medicare Part B FFS patients seen during the reporting period Registry-based Reporting – 12-month period January 1, 2011 – December 31, 2011 Report 3 or more PQRS measures (measures with a 0% performance rate will not be counted) =80% of Medicare Part B FFS patients seen during the reporting period Registry-based Reporting – 6-month period July 1, 2011 – – December 31, 2011 Report 3 or more PQRS measures (measures with a 0% performance rate will not be counted) =80% of Medicare Part B FFS patients seen during the reporting period   As the table highlights, eligible professionals, in most cases, are required to report at a minimum three quality measures within the selected reporting period in addition to meeting the patient threshold criteria. TABLE 2. GPRO II REPORTING REQUIREMENTS Group Size (Number of Eligible Professionals) Number of Measures Groups Required To Be Reported Minimum Number of Patients in Each Measures Group Number of Required Individual Measures To Report Percent of Medicare Part B Patients in Denominator for Satisfactory Reporting Individual Measures Via Claims Percent of Medicare  Part B Patients in Denominator for Satisfactory Reporting Individual Measures Via Registries Required Number of Unique Visits Where an Electronic Prescription Was Generated to Be a Successful Electronic Prescriber 2–10 1 35 3 50% 80% 75 11-25 1 50 3 50% 80% 225 26-50 2 50 4 50% 80% 475 51-100 3 60 5 50% 80% 925 101-199 4 100 6 50% 80% 1875   Group Practice Reporting CMS has expanded the group practice reporting option under the 2011 PQRS incentive program. A self-nomination is required for group practices to participate in both GPRO I and GPRO II. Due to the requirements of GPRO I, it is not applicable to otolaryngologists. GPRO II expanded group reporting to include groups with 2 – 199 members. Table 2 identifies the reporting requirements for GPRO II based on group size. At a minimum, GPRO II requires group practices to report on one measures group and three individual measures. (Individual measures may not be in the measures group report.) Further information on the group practice reporting option can be found on the CMS website: https://www.cms.gov/PQRI/22_Group_Practice_Reporting_Option.asp. Maintenance of Certification Program Incentive In 2011, physicians who satisfactorily meet the reporting requirements of the PQRS for a 12-month period, either as an individual or as a member of a group practice, may qualify for an additional 0.5 percent maintenance of certification incentive payment. Each individual specialty board must apply to CMS to obtain approval for a MOC program to meet this incentive. Next steps Here is a  list of recommendations to assist you in participating in the 2011 PQRS incentive program. Review the measures list for the 2011 PQRS incentive program; several new quality measures have been introduced while others have been retired. Having determined the measures that are applicable to your practice, review each measures specification. Determine which mechanism you will use to report measures. Clarify the reporting period you will participate in, 12-month (Jan. 1-Dec. 31) or 6-month (July 1-Dec. 31).
Gavin Setzen, MD, Chair, Imaging Committee
Imaging Committee: Health Policy and Quality Updates
Gavin Setzen, MD, Chair, Imaging Committee and Jenna Kappel, MPH, MA, Director, Health Policy and Staff Liaison, Imaging Committee The Academy’s Board of Directors approved the creation of a formal Imaging Committee structure beginning in 2011 for imaging policy and education issues. The Imaging Committee, formerly the CT Imaging workgroup, will continue to educate members on CT imaging policy and regulation. The Committee also will monitor and comment on government policy and regulation related to imaging, insurance carrier policy and coverage for imaging services.  As in the past, the Committee will continue to identify educational needs and recommended educational activities for the CT imaging practice area of otolaryngology. This service will help members achieve the necessary CME credits required for CT accreditation purposes. The Imaging Committee will continue to collaborate with other committees on imaging-related issues and provide feedback. With the current focus on imaging by payers (CMS and Commercial), the Academy has been seeking guidance from this group with increasing frequency, particularly with issues in the areas of health policy and quality. Examples of these activities included creating clinical scenarios for submission to the CMS Imaging Demonstration Project for sinus CT imaging, review of ACR Appropriateness Criteria for diagnostic imaging services, monitoring MedPAC and Congressional activities related to imaging services, and representing the Academy by advocating against inappropriate policies by National Imaging Associates (NIA) and Humana. The Academy and its membership also have a voice with the National Quality Forum (NQF) in Washington, DC, where Dr. Gavin Setzen, MD, sits on the NQF Imaging Steering Committee. Dr. Setzen’s leadership as President-Elect of Intersocietal Commission for Accreditation of Computed Tomography Laboratories (ICACTL) provides our Academy with a prominent role in the development and maintenance of CT accreditation standards, ensuring that its members are well-represented in this process. The formalization of the Imaging Committee will ensure continued member support regarding all imaging issues in the future, especially as it relates to health policy, safety, quality, reimbursement and other issues specific to providing imaging services to our patients. Persistence beats resistance The diligence and hard work of your Academy leaders, along with various committees, Academy members, practice administrators, and other stakeholders has paid off in several recent wins: NIA has agreed to recognize ICACTL accreditation for CT (and other) imaging as of February 14, 2011. NIA will accept all IAC division accreditations as of February 14, 2011. Essentially, anyone ICACTL approves after that date will be automatically accepted by NIA, and those who have an active ICACTL accreditation status prior to this date will have to reapply for NIA privileging but will be approved if the accreditation piece was the only thing holding them up. This is of major significance to our members, especially since ICACTL is currently the only organization that accredits cone-beam CT scanners (http://www.entnet.org/Practice/CMS-News.cfm; www.icactl.org, Humana’s coverage for Mini-CT Scans). In 2008, the Academy learned that although the Food and Drug Administration (FDA) had approved mini-CT scans for otolaryngology services, Humana would not cover the technology based on their policy because it was “experimental/investigational.” Over the next two years, representatives from the AAO-HNS, Health Policy leaders and staff, representatives of American Medical Association, members from Kentucky’s state and local medical associations, Association of Otolaryngology Administrators,  ICACTL, and Xoran Technologies,  engaged Humana Medical Directors in conference calls to discuss the policy and argue for appropriate coverage for mini-CT scans. In an October 2010 Academy comment letter to Humana, rationale based on evidence-based literature was provided (including our recently approved policy statement, Point of Care Imaging in Otolaryngology)  supporting safety, reduced costs, and convenience to patients that the device presented. Finally, in November 2010, a positive formal response was received and Humana stated it would reverse its negative coverage position for mini-CT scans for most uses by otolaryngologists based on medical necessity (http://www.entnet.org/Practice/News-and-Updates-from-Private-Payers.cfm). For more information on these and other imaging health policy issues, please contact Dr. Setzen at gavinsetzenmd@albanyentandallergy.com or Jenna Kappel at jkappel@entnet.org. Reminder: Mandatory CT accreditation deadline of January 1, 2012, is rapidly approaching. In order to comply with federal law, and to ensure reimbursement for CT imaging services, apply now for CT accreditation! www.icactl.org.
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Conforming Your Otolaryngology Documentation for ICD-10
Rhonda Buckholz, AAPC There will be many challenges to transitioning to ICD-10 across the realms of healthcare. Changes to forms, systems, coverages, and policies and procedures will all be a part of this transition. Practices need to embrace ICD-10 early in order to successfully implement ICD-10. One way practices can begin to prepare is by using documentation audits. The level of specificity required in ICD-10-CM may wreak havoc on your practice if providers are not documenting enough in the medical record. A documentation audit for ICD-10 purposes can be relatively simple if broken down into these steps. Run a practice management report of the most frequently used ICD-9-CM diagnosis codes being used in your practice today. Pull charts associated with those diagnosis reports. Start strategically with the most used codes first. These will be your highest impacts to the practice. Using the ICD-9-CM code, employ the General Equivalence Mappings (GEMS) to walk through what your ICD-10-CM codes will look like. This can be done very easily using the code translating tool found on the AAPC website (http://www.aapc.com/ICD-10/codes/index.aspx). Check your documentation to be sure it is specific enough to assign a code in ICD-10-CM. Educate, as necessary, to bring physicians up to speed and compliance. If you follow these simple steps, you should be able to determine your risk level for code assignment in ICD-10-CM. Between 40 percent and 45 percent of all provider notes are estimated to need some type of supplementing in order to assign an ICD-10-CM code. There are many facets to ICD-10-CM that providers have not been using in medical records consistently. Some of these are laterality, stages of healing, trimesters in pregnancy, and status of encounters. For example, “A patient presents for foreign body removal in the nose.” A quite common situation especially in pediatric offices and in ICD-9-CM, we had only one choice: 932 foreign body nose. In ICD-10-CM, choices will include: Was it in the nostril or the sinus cavity, and was it the initial encounter, subsequent, or a sequela? Suddenly our documentation needs to look like this: “Timmy is a 3-year old male who put a raisin in his nose about an hour ago. Mom was unsuccessful in removing it on her own.  Upon examination, raisin was easily grasped and removed via forceps from the left nostril.” The completed documentation gives us a full understanding of the nature of the encounter and from where the raisin was removed. Based on this information, we are able to assign all components of the code, which includes location and the initial encounter. Another example of necessary documentation is taking a look at the nicotine dependence codes found in ICD-10-CM. There are more than 20 choices for this. Is it dependence, abuse, or addiction? Is it complicated or uncomplicated, or a history of? Providers will need to become familiar with the code sets in order to make sure their documentation is compliant enough to assign a code. In otolaryngology, we will have the additional task of taking a full look at the new codes available. Often we have had to use unspecified codes in ICD-9-CM as there were not better selections available. In ICD-10-CM, there will be better choices for us. For example in ICD-9-CM, we had 380.10 for sensor neural hearing loss unspecified. In ICD-10-CM, we have seven code choice selections depending on laterality and involvement. Working on documentation is not an easy task. It will take many sessions and training to get the documentation in compliance. If you take it in stages, the task will be much more manageable. Start with four or five of the most frequently used codes, show the providers what additional documentation is necessary to assign a code, and then revisit those same codes over a series of months until you’ve noticed there are no more errors. Once those are finished, start introducing more documentation, but don’t forget to revisit the ones you have already worked on to make sure documentation is not reverting to the original mistakes. By using your own records, you are able to work on actually applying the codes. By taking small strategic steps over the next couple of years, you will be ready to go on October 1, 2013. Implementing ICD-10-CM will be no small task. Every aspect of healthcare will be touched in some part.
Update from the Physician Payment Policy Workgroup (3P)
Richard W. Waguespack, MD, Coordinator for Socioeconomic Affairs, and Michael Setzen, MD, Coordinator for Practice Affairs, Co-Chairs of 3P with Jenna Kappel, Director, Health Policy; Tricia Bardon, Assistant Director, Health Policy; Udo Kaja, Program Manager, Payer Advocacy The Physician Payment Policy Workgroup (3P), co-chaired by Richard Waguespack, MD, and Michael Setzen, MD, is the senior advisory body to Academy leadership and staff on issues related to socioeconomic advocacy, regulatory activity, coding or reimbursement, and practice services or management. 3P and the Health Policy staff have been busy this year with a continued high level of activity, e-mails and monthly calls. They are working diligently and tirelessly on behalf of all members. Below, we have highlighted some advocacy efforts. (For the latest health policy updates, visithttp://www.entnet.org/Practice/CMS-News.cfm.) Continued Advocacy Effort with United Healthcare (UHC)  After a January 18, 2011, conference call (http://tinyurl.com/4dhs38b) that leadership from AAO-HNS, ASPS, ARS, and AAFPRS had with Richard Justman, MD, the UHC National Medical Director, and other UHC officials, they agreed to revise their guideline on rhinoplasty, septoplasty, and repair of vestibular stenosis to align with current medical practice and reduce the burden it posed to patients and physicians. The revised policy (http://tinyurl.com/469f3n8) was effective from March 1, 2011. On February 17, we followed up with UHC (http://tinyurl.com/4bjsavt). On March 2, they responded indicating they would not make any further changes to the policy until February 2012 as their policy review cycle for 2011 has ended. UHC will only consider reviewing the policy before February 2012 if they determine that UHC medical directors are consistently misinterpreting sections of the policy and/or if it is causing undue burden to patients and physicians. The Academy and other specialty groups involved in this effort are disappointed with this response but will continue to monitor its effect on patients’ access to care. We are drafting an appeal template letter to assist you with septoplasty denials. If you received non-certifications because of this policy, please contact your local UHC medical director and copy healthpolicy@entnet.org on the request and outcome. For more information, visit http://www.entnet.org/Practice/News-and-Updates-from-Private-Payers.cfm. Coding for the Endoscopic Treatment of Zenker’s Diverticulum  At the annual meeting’s CPT/RUC Committee meeting, the consensus was to pursue a CPT code to capture the work of the endoscopic Zenker’s diverticulum surgery. 3P agreed and decided to request a new CPT code with the understanding that there is no specific code to report the endoscopic treatment of Zenker’s diverticulum. 3P was concerned about the potential erroneous billing of the procedure by using CPT code 43130 – Diverticulectomy of hypopharynx or esophagus, with or without myotomy; cervical approach, which was created to report the procedure when performed openly. Currently, the appropriate code to report the procedure when performed endoscopically is 43499 -Unlisted procedure, esophagus. (To review the Academy’s coding guidance on Zenker’s diverticulum, visit http://www.entnet.org/Practice/CPT4ENT-Zenkers.cfm). Because 3P determined that while some segments of the specialty are appropriately paid using the unlisted code, this poses significant reimbursement challenges for much of the general membership. Members of 3P, the CPT & Relative Value CMTE, and other interested parties deliberated on whether the Academy should request a new code for the endoscopic treatment of Zenker’s diverticulum.  As a result of these discussions, 3P decided to disseminate a survey, which was sent through The News (the Academy’s weekly electronic newsletter). After analyzing the results of the survey, 3P determined it was in members’ best interests not to request a new code for the endoscopic procedure at this time and recommended this position to Academy leadership. 3P is still analyzing the situation to ensure a well-balanced solution is obtained and will keep members updated. Revision of the Clinical Indicators The significant effort involved in updating more than two dozen Clinical Indicators was led by 3P members Bradley F. Marple, MD, Academy At-Large Director–Academic and Academy CPT Advisor, and Richard W. Waguespack, MD, who worked with Health Policy staff to prioritize review of the documents, initially published in 2000. In conjunction with 3P, members of the Rhinology and Paranasal Sinus, Pediatric Otolaryngology, Airway and Swallowing, Allergy, Asthma and Immunology, Equilibrium, and the Plastic and Reconstructive Surgery Committees are reviewing the Academy’s clinical indicators (initially published in 2000) on Allergy testing for Rhinitis, Adenoidectomy, Tonsillectomy/ Adenoidectomy/Adentonsillectomy, Caldwell Luc, Diagnostic Nasal Endoscopy, Endoscopic Sinus Surgery, Adult and Pediatric, Laryngoscopy or Nasopharyngoscopy, Neck Dissection, and Canalith Repositioning. Clinical Indicators for otolaryngology are suggestions (not rules) that serve as a checklist for practitioners and a quality care review tool for clinical departments.  Stay tuned for the finalized and updated clinical indicators, available in late Spring 2011 (http://www.entnet.org/Practice/CMS-News.cfm). Look for more information in the May issue of the Bulletin. 2011 Socioeconomic Survey Update Thank you to all of the Academy members who participated in the 2011 socioeconomic survey. Results will be displayed at the 2011 annual meeting in San Francisco, published in the November 2011 Bulletin, and provided on our website with previous socioeconomic surveys at http://www.entnet.org/Practice/members/socioeconomic.cfm.
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National Affinity Services Joins the AAO-HNS Academy Advantage Program
National Affinity Services (NAS), with more than 35 years of experience working with professional societies, is now an Academy Advantage Partner of the American Academy of Otolaryngology—Head and Neck Surgery (AAO-HNS). Through NAS, AAO-HNS members have access to insurance products, including: Auto Insurance Special member discounts could help you save on your auto insurance from MetLife Auto & Home®. Preferred Dentist Program Get help managing your oral health needs while reducing out-of-pocket expenses and providing the superior customer service and features you value. Short Term Disability Protect your income in the event you are unable to work due to a sickness or injury. Short Term Disability can help you meet expenses and maintain your standard of living. Long Term Care Available in all 50 states through Mass Mutual, you receive a special member discount of 10 percent and an additional 5 percent if you purchase life insurance. Medical Coverage Individual, Short Term and Group medical coverage is available through Assurant Health and Humana. International Health Individual and Group Coverage is available to meet your needs for both short stays overseas and extended work or vacations abroad  (underwritten by Sirius International, rated A by A.M. Best). For information, please go online to www.insnetwork.info/AAO. For a quote, please call Customer Care at 1-435-615-2054. For Auto/Home, please call 1-800-888-2308 for quick quotes.
aco
Accountable Care Organizations: Aligning Quality and Cost
Rahul K. Shah, MD, George Washington University School of Medicine, Children’s National Medical Center, Washington, DC If you have not heard about Accountable Care Organizations (ACOs), consider yourself fortunate.  Broadly speaking, ACOs are partnerships between hospitals and physicians (and other providers) to manage the clinical care of a specified population. We have seen a lot of information in the media recently regarding ACOs because they are a focus of recent legislation; The Affordable Care Act attempts to align patient, financial, and quality issues with outcomes. Within healthcare reform, ACOs are charged with “manag[ing] and coordinat[ing] care for Medicare fee-for-service beneficiaries.”1 There are financial implications in ACOs in that the shared savings are passed on to the ACOs and presumably to members of such. The discussion about ACOs has myriad points to consider: those of the patient, the payer, the physician, the community served by the physician, and the ACO organization/governance itself.  As there are several pertinent contentious issues, there is a plethora of literature on this topic in various forms of media.  There exist issues with the governance of ACOs as well as the concept that the ACO functions as a single governing unit. There are significant legal issues that ACOs must contend with, especially when they are attempting to collectively align interests; this runs into issues regarding anti-trust. Many organizations that are interested in becoming an ACO or joining an ACO may not have the proper legal, information technology, and leadership infrastructures to meet the required key competencies to be successful. You might ask, what is the need for ACOs?  The concept of ACOs is a response to the hypothesis that when all stakeholders have a vested financial interest in the long-term care of the patient, then not only will the care and quality improve, but there will be financial savings as well.  The end result of this organization is to improve the quality of care in a community and do this in an economically sensible paradigm.  However, we all practice in significantly different community populations, so great care will need to be taken to ensure that when comparing quality outcomes, we are comparing apples to apples. Despite the legislation and the discussions regarding the role of ACOs, there is not much discussion and literature devoted to the role of the surgical subspecialist in such an organization. For otolaryngologists, there exists considerable concern as we are a very small specialty that treats a significant volume of patients and disease burden. What is unclear is the question: Do all specialists need to be formal partners of the ACOs or can certain specialists be retained to deal with a specific disease burden for the population (e.g., cardiologist, endocrinologist)? Ultimately, this answer will most likely lie within which quality metrics are reported and the role that otolaryngologists play in those metrics. For example, I would surmise our role would be limited if the quality metrics are all on acute myocardial infarction outcomes; however otolaryngology would be central to the discussion if metrics such as quality of life post-treatment for upper aerodigestive tract cancers are those that are benchmarked.  As such, otolaryngologists may opt out of the ACOs, but the concern may be that if private payers all migrate to such a model, then the otolaryngologist would have an issue sustaining his practice. An additional problem for otolaryngologists is that many of our members are in small group practices, and not all are using the electronic medical record.  The successful creation of ACOs is predicated upon certain characteristics existing in practices.  If these practices do not have the relevant or necessary “hard-wiring,” they are inevitably not going to be able to compete within an ACO model. It is very hard to be dismissive of ACOs. The concept is alluring: to align all the stakeholders around the core objective of showing demonstrable gains in quality with cost savings and the potential to share in such savings.  However, the operation of such for surgical subspecialists is fraught with issues regarding governance, scope of practice, and economics.  It is much easier, potentially, within the primary care realm to make the business case for ACOs; however, many anticipate that for surgical specialties, it will be difficult. As ACOs evolve and if the legislation persists, otolaryngologists will be pressed to be a part of these new reimbursement and quality delivery mechanisms or will need to show that we can survive as pure consultants, outside of such a realm.  Many believe that one of the important factors will include the definitions of the quality outcomes that will be measured, our role in the treatment of these chronic disease states, as well as the eventual governance of ACOs.  Nevertheless, from patient safety and quality improvement perspectives, ACOs hold promise. However, there is much work and clarification to be accomplished prior to delivering on the hope. References Kastor JA. Accountable Care Organizations At Academic Medical Centers. NEJM February 3, 2011. We encourage members to write us with any topic of interest, and we will try to research and discuss the issue.  Members’ names are published only after they have been contacted directly by Academy staff and have given consent to the use of their names.  Please email the Academy at qualityimprovement@entnet.org to engage us in a patient safety and quality discussion that is pertinent to your practice.
Stop by the ENT PAC Booth during Annual Meeting
Visit the ENT PAC Booth at the AAO-HNS Annual Meeting & OTO EXPO to learn more about how you can support the Academy’s legislative and political advocacy efforts on Capitol Hill.  ENT PAC, the political action committee of the AAO-HNS, financially supports incumbent members of Congress and viable candidates who support the specialty’s legislative priorities. Stop by the ENT PAC Booth to: Obtain information on becoming an ENT PAC donor in 2011; View the “Wall of Donors” display; Receive the latest updates on federal legislation affecting the specialty; Join the ENT Advocacy Network to receive timely updates on political and legislative issues affecting otolaryngology—head and neck surgery and a subscription to a biweekly e-Newsletter, The ENT Advocate; Register for the Key Contacts Network, a network of members dedicated to helping advance the AAO-HNS grassroots efforts by strengthening its personal legislative contacts; and Learn ways to advocate on behalf of the specialty. To recognize the generosity of our 2011 donors, an ENT PAC reception is scheduled for Sunday, September 11, 2011. AAO-HNS members who make donations at the ENT PAC Booth during the annual meeting are also invited to this exclusive event. Take a key step to being a leading advocate for the specialty – stop by the ENT PAC Booth. Contributions to ENT PAC are not deductible as charitable contributions for federal income tax purposes.  Contributions are voluntary, and all members of the American Academy of Otolaryngology—Head and Neck Surgery have the right to refuse to contribute without reprisal.  Federal law prohibits ENT PAC from accepting contributions from foreign nationals. By law, if your contributions are made using a personal check or credit card, ENT PAC may use your contribution only to support candidates in federal elections.  All corporate contributions to ENT PAC will be used for educational and administrative fees of ENT PAC, and other activities permissible under federal law. Federal law requires ENT PAC to use its best efforts to collect and report the name, mailing address, occupation, and the name of the employer of individuals whose contributions exceed $200 in a calendar year.  ENT PAC is a program of the AAO-HNS which is exempt from federal income tax under section 501 (c) (6) of the Internal Revenue Code.
Michael D. Seidman, MD (above), Chair, Board of Governors, and Brian J. Broker, MD, MBA
The Growing Fragmentation of Otolaryngology—Head and Neck Surgery
Are general otolaryngology practices being “cannibalized” by subspecialization? Is fellowship training for all an inevitable reality, or can we keep this from being divisive? Is there too much overlap between the services that subspecialists and generalists perform, and is it fragmenting the profession? These questions are an increasingly pervasive source of contention among all medical disciplines. Many will argue that subspecialization is an evolution that occurs in response to the ever-increasing growth in medical knowledge. It is estimated that 60 percent of residents feel the need to further their education by securing a fellowship. Does this create better doctors or allow those with additional training to secure market share and dilute the relevance of the general otolaryngologist? Subspecialists within otolaryngology typically perform services that are outside the confines of a general otolaryngology practice. Head and neck oncologists perform more difficult resections and reconstructions, neurotologists perform more complicated otologic and intracranial surgeries, and pediatric otolaryngologists perform airway procedures that require specialized training and experience. Yet there is often a degree of overlap between the services offered by these subspecialists and general otolaryngologists. These areas of overlap typically do not present a conflict between subspecialists and generalists because the major volume of the subspecialist care is not the same as the generalist. As a neurotologic surgeon, I would never ask a generalist colleague to stop doing tympanoplasties, mastoidectomies, or stapes surgery, when his or her outcomes are good. On the other hand, we would probably agree that a general otolaryngologist would not be inclined to perform vestibular schwannoma surgery, the fourth revision of frontal sinus disease, a free flap or laryngotracheoplasty on a 3-year-old. Competition for patients is a reality, not only between the generalist and specialists but also between competing generalist and subspecialty groups. Although no one in the AAO-HNS would argue that a fellowship-trained specialist is any more qualified than a general otolaryngologist to treat such problems as tonsillitis, chronic serous otitis media, sinusitis, or chronic suppurative otitis media, patient referral patterns cannot be mandated or legislated, and there may be a natural affinity for pediatricians and parents to gravitate toward pediatric subspecialists. We can argue that subspecialization is fragmenting medicine today, although I would suggest that this is a canard. In reality, it is market forces and local/regional referrals that create this chasm. There is a need for continued subspecialization within otolaryngology—HNS, but this evolution need not  herald the demise of the generalist. Rather, the existence of the one can strengthen the other. A study that evaluated quality and efficiency (Berry, et al1) concluded: “Specialist physicians should do less of what generalist physicians can do.” This study was based on the Institute of Medicine’s Quality Guidelines, which defines six aspects of care that should be maximized; safety, effectiveness, patient-centeredness, timeliness, efficiency, and equitability2. Given that effectiveness, patient-centeredness, and equitability are likely similar between care provided by a generalist and subspecialist for specific conditions, the differences arise in safety, timeliness, and efficiency. If subspecialists are routinely performing surgeries at a distance from their home institutions and without the ability to provide local emergency care, safety is compromised and care is better provided by a local generalist. It can be argued that because  subspecialists will invariably perform general otolaryngology procedures, and because waiting times are typically shorter to see a generalist, the care is also timelier.  Thus, perhaps for some conditions and situations, a general otolaryngologist is capable of delivering better quality than a subspecialist as defined by the Institute of Medicine’s goals. In other cases, the presence of a subspecialist in the geographic area may help the generalist offer care for more, and more complex, patients. A concern has been raised in one state; and although controversial, it appears that in some specific situations, subspecialists are performing a large volume of general otolaryngology procedures and, in essence, eroding the general otolaryngologist practice. This seems to be a significant problem where hospital administrators have created satellite locations to compete with general otolaryngology practices. But it is also concerning that surgery is being performed in some areas without local call coverage. There can be a point in which there is too much overlap between services provided by subspecialists and general otolaryngologists. To paraphrase, 3 our existing healthcare system was created considering patients with acute conditions that required immediate attention. This is not the case today and the majority of our patients have chronic conditions such as cardiovascular disease, diabetes, obesity, cancer, and chronic degenerative diseases. By the time our patients need a subspecialist, you could argue that conventional medicine has failed the patient. Thus across all areas of medicine there is an important role for both the generalist and subspecialist to collaborate in order to provide quality care to our patients. References Berry LL, Seiders K, Wilder SS. Innovations in access to care: a patient-centered approach. Ann Intern Med 2003;139:568 –74. Institute of Medicine. Crossing the quality chasm: a new health system for the 21st century. Washington, DC: National Academy Press; 2001. Henderson, J. Marcus Welby and the relentless growth of specialization. www.kevinmd.com/blog/2011/01
David R. Nielsen, MD, AAO-HNS/F EVP/CEO
Physician Payment Reform
By January 2012, the Secretary for Health and Human Services (HHS) will be required to report her recommendations for physician payment reform to Congress in compliance with the Patient Protection and Affordable Care Act (ACA). At a recent meeting of the Specialty Society CEO Coalition, more than two dozen CEOs of major national medical specialty societies shared the collective concerns of our members about some of the models being proposed for physician payment reform.  Although this column is too short to share every concern, your elected leaders and professional staff are sharing ideas and providing input on the following issues, among others. The ACA includes quality improvement provisions, but the value to our healthcare system is unproven. Specific concerns include: Requiring physicians to face future Medicare cuts/penalties if they don’t participate in the Physician Quality Reporting System (PQRS) before specialty-specific quality elements are developed, validated, and feasible. Developing a new budget-neutral payment modifier based on the relative quality and cost of care founded on an extensive composite of risk-adjusted measures of quality – although no such system now exists, nor is it possible to complete any time soon. Requiring HHS to publicly report individual physician quality and resource use prematurely (Physician Compare), while lacking reliable, risk-adjusted, valid, and feasible measures and systems for collecting and reporting clinical outcomes data. There are potential barriers to the widespread adoption of health information technology for the Electronic Health Record Incentive Program and Meaningful Use (MU), including the need for: Greater flexibility; More time to achieve MU; Lack of small physician practice representation on the Health IT Policy Committee; Adequate specialty-specific  integrated electronic health records and systems; Less burdensome reporting requirements; Funds and funding mechanisms; and Greater attention to operational issues. The volatility and instability of the current Medicare physician payment system (Sustainable Growth Rate or SGR formula) is threatening Medicare beneficiaries’ access to surgical care and making it difficult for physicians to effectively manage their practices. The flawed SGR formula must be repealed and replaced with a system that accurately reflects the natural increases in the costs of delivering high quality healthcare.  Continued threats of impending payment cuts, rising practice costs, and a lack of certainty going forward, make it difficult, if not impossible, for already financially challenged practices to continue to treat Medicare patients. Accountable Care Organizations (ACOs), bundled payments for defined episodes of care, and gainsharing are three mechanisms that are being examined and tested as possible means to encourage collaboration among physicians, hospitals, and other relevant providers by aligning incentives to improve the quality of care and lower costs. Among other things, we are specifically concerned that: Alternative payment systems may not have sufficient physician leadership or input, and may not be patient-centered or quality driven; Not all patients and physicians may be able to participate in these new structures; and Patients and physicians who cannot or choose not to participate, even for reasons beyond their control, may be unfairly penalized. Also, we continue to challenge the implementation of the Independent Payment Advisory Board (IPAB), an unelected, unaccountable body of individuals appointed solely by the President and charged with creating Medicare payment policy. By limiting Congressional authority and oversight, the IPAB essentially eliminates the transparency of hearings, debate, accountability, and the meaningful opportunity of stakeholder input. Fewer than half of the IPAB members can be healthcare providers, and none are permitted to be practicing physicians or be otherwise employed. It is doubtful that an appropriate perspective of practicing physicians and patients can be obtained, and we are concerned that this group would recommend additional payment cuts to physicians without this perspective or additional Congressional oversight. Your Academy professional staff and leaders continue to work for you by participating in the discussions with other physician organizations and federal government representatives regarding federal plans to implement sections of the PPACA that have the potential to affect you the most. By joining with other organizations and participating in these meetings held by federal agencies, we are working to ensure that CMS and health plans address and eliminate barriers to quality care, assure relevant and feasible reporting requirements, and fair payment policy. Please continue to read the weekly The News and check the AAO-HNS Practice and Advocacy webpage (http://www.entnet.org/practice/) for the most up-to-date information on these programs in preparation for implementation of payment reform over the next few years.
J. Regan Thomas, MD, AAO-HNS/F President
Regulatory Advocacy
In March, otolaryngologists, other surgeons, and BOG members, assembled in Washington, DC, to advocate for a legislative policy platform that will help us to deliver quality patient care. As was true last year and is equally true this year, due to the continuing dialogue about the Affordable Care Act (ACA) and healthcare reform, our specialty had an opportunity to be heard on Capitol Hill, and we took it. Our members joined with 17 other societies under the Joint Surgical Advocacy Conference banner to be at the table and be heard. Now, it is time to address the other type of advocacy that our members require: the advocacy for health policy and issues related to the business of medicine. Legislators make the laws, but it is in the implementation of those laws where practical practice parameters are set. It is in these opportunities that member leaders with member support become the real entities at the table. A few individuals even become known among agencies for their persistence and devotion to the specialty and to the delivery of quality patient care. I would like to draw your attention to just how your Academy serves in the policy and regulatory arena: The Academy has the leading experts on coding and health policy issues relating to otolaryngology. Your professional staff and leaders have decades of experience in the field, are well-respected by national organizations (i.e., AMA) and federal agencies (i.e., CMS), and they work to maintain the Academy’s reputation while serving you. Although you may receive information about otolaryngology coding and health policy from other resources, I want to assure you that the Academy is your expert source of information on the latest issues that are crucial to your practice. You will certainly see this clearly in the updates each month in this publication, in items that you receive from our newsletter, in the latest AAO-HNS newsletter The News, and from member alerts especially for you such as on the RUC representation. Issues currently in process include the physician supervision issue. Your Academy reaches out to expert representatives within the Academy to gather information. When a coding or health policy issue arises and there are differences of opinions among members about how to move forward, your professional staff and leaders are making sure to take the time and effort to research the issue and gather data and information from a broad range of members who represent many different interests including the Board of Governors and the subspecialty societies. You can see that clearly reflected in this issue in the update of the 3P group about Zenker’s Diverticulum. Also I point out our collaboration with subspecialty societies to influence United Health Care’s guideline on septoplasty and turbinate resection. Together we have a better chance to gain momentum with national payers to improve coverage for important procedures benefiting and changing the lives of our patients. Advocating for membership as a whole. Your Academy professional staff and leaders are advocating for the membership as a whole. While they try to respond to your requests and concerns from your individual or group practices as quickly as possible, please keep in mind that they make decisions on priority efforts and how to move forward on controversial socioeconomic issues in a way that is most appropriate in the world of coding and health policy. This issue brims with policy information; there are several articles of primary importance to your practice. Use your member log-in at  http://www.entnet.org/practice/ to have immediate information on regulatory and socioeconomic advocacy; the Business of Medicine; coding; quality and safety; and access to guidelines and clinical indicators (more about these in upcoming issues).  And remember, unlike legislative calls for action, regulatory and health policy issues benefit most from your day-to-day practice data. You can engage best by supporting member leaders when they ask for this data.  When you share reimbursement problems with the Academy staff, using the process and systems they have outlined (see page 40), you can advocate from your office and benefit the specialty and your patients. You will no doubt hear that some national medical groups may be willing to compromise important issues, like the Independent Payment Advisory Board (IPAB), in order to “keep a seat at the table.” However, the Academy remains strong in the face of such key harmful issues, and we feel our strength of conviction will serve both our members and their patients best. The complex environment of medicine requires more of each of us than it did yesterday. Sometimes that requires that we are heard in legislative venues for quality care. Sometimes that requires that we develop an understanding of the complex issues that bring about the best result for patient care.  Your understanding and support make that difference.
AAO-HNS Foundation Education Activities
Maintenance of Certification: The ABOto and AAO-HNSF both strive to support diplomates in preparing for the MOC exam. Although the Academy cannot “teach to the test,” we have taken steps to ensure that the Foundation’s educational offerings are aligned with the body of knowledge upon which the test is based. Education Committees were realigned in 2007 to mirror ABO’s MOC specialty areas. Education Tracks for all AAO-HNSF materials are tagged with ABO’s MOC specialty areas. The Annual Academic Bowl at the Annual Meeting provides a competitive self-assessment opportunity. The 2009 Academic Bowl questions are available in quiz format in AcademyU. As the first diplomates go through the process, we are learning more about how to best support members preparing for MOC. Bookmark the MOC page (http://www.entnet.org/EducationAndResearch/Maintenance-of-Certification.cfm) for the latest information, including a webcast of the ABO and AAO-HNSF Miniseminar on MOC and Lifelong Learning from the 2010 Annual Meeting. NEW THIS YEAR: Academy members have access to six complimentary webcasts from the 2010 Annual Meeting & OTO EXPO. Additional webcasts are available for purchase. http://www.entnet.org/conferencesandevents/ AcademyU®: Academy members have complimentary 24/7 access to more than 100 CME activities developed by Academy members for Academy members. Activate your subscription today and make the best use of this member benefit. AAO-HNSF Annual Meeting & OTO EXPO will take place in September 11-14, 2011, in San Francisco. Registration opens May 2. Millennium Society Members have first access beginning April 18. Home Study Course is a subscription self-instruction/assessment program providing awareness of currently acceptable methods of diagnosis and treatment as well as new developments in the field. Registration opens in mid-May. Patient of the Month is a subscription program presenting patient scenarios in a branched learning format in which the physician uses his or her knowledge and clinical management skills to manage the presented otolaryngology—head and neck surgery patient case. Coding & Reimbursement Workshops offered on the weekend throughout the year teach physicians, administrators, practice managers, and billing supervisors how to code correctly, use the appeal process effectively, learn risk reduction strategies, and how to organize your practice. Journal Manuscript Review, our newest learning activity, provides CME credit for high-quality reviews of scientific manuscripts submitted to our top-ranked scientific journal, Otolaryngology—Head and Neck Surgery. CME for Journal Readers is in development in conjunction with the Journal’s transition to a new publisher.
Otolaryngology Historical Society: Call for Abstracts
Marc D. Eisen, MD The Otolaryngology Historical Society aims to provide a forum for the discussion, presentation, and preservation of the history of all aspects of otolaryngology.  The Society welcomes otolaryngologists from all over the world and all stages of training and practice, as well as individuals in related fields. The Society holds an annual event in conjunction with the AAO-HNSF Annual Meeting & OTO EXPO.  This event offers an informal social gathering for all members, guests, and those interested.  The program includes select presentations on historical topics. Topics presented in the past include the history of cochlear implantation, contributions of Julius Lempert, and the development of otolaryngology in Ireland. The Society encourages submitting your abstract related to the history of otolaryngology to clincoln@entnet.org by May 26. Abstracts should be no longer than 300 words.  Presentations are 20 minutes long, which includes a five-minute question-and-comment period. The Society’s review board will select the best abstracts for presentation based on originality, applicability, and historical content.
Guest Countries for 2011 Meeting
At the International Reception during the September 2010 annual meeting in Boston, MA, Academy President J. Regan Thomas, MD, announced his selections to honor five guest countries for the San Francisco meeting in 2011. Those countries are Australia, France, Germany, Japan, and Switzerland. In addition to receiving a $100 guest discount, delegates from those countries will be recognized at the Opening Ceremony and at the International Dessert Reception. To learn more, contact clincoln@entnet.org.
Committee Schedule
FRIDAY, September 9, 2011 Program Advisory Committee 2 PM 4 PM AAO-HNS/F Executive Committee** 5 PM 7 PM SATURDAY, September 10, 2011 Board of Governors Legislative Representatives Committee 8 AM 9:30 AM AAO-HNS/F Board of Directors Meeting 8 AM 3 PM Board of Governors Leaders Training Session 9:40 AM 11:10 AM Board of Governors Development/Fundraising Task Force Meeting 11:20 AM NOON Board of Governors Lunch NOON 12:45 PM Board of Governors Socioeconomic and Grassroots Committee 1 PM 2:45 PM Leadership Development Program 4 PM 5:30 PM Education Steering Committee 4 PM 6 PM AAO-HNS/F Business Meeting 4:30 PM 5 PM SUNDAY, September 11, 2011 Patient Safety and Quality Improvement Committee 6:30 AM 7:30 AM Skull Base Surgery Committee 6:30 AM 7:30 AM Medical Informatics Committee 10 AM 11 AM Infectious Disease Committee 10 AM 11 AM Ethics Committee 10 AM 11:30 AM History and Archives Committee 10 AM 11 AM Board of Directors Orientation 10 AM NOON International Otolaryngology Committee 11 AM NOON Panamerican Committee 12:30 PM 1:30 PM Facial Plastic & Reconstructive Surgery Education Committee 12:30 PM 1:30 PM Pediatric Otolaryngology Committee 1:30 PM 2:30 PM Humanitarian Efforts Committee 1:30 PM 2:30 PM Rhinology & Allergy Education Committee 2 PM 3 PM ENT PAC Board of Advisors** 2 PM 4 PM Finance & Investment Subcommittee of the E & F** 2:30 PM 3:30 PM Implantable Hearing Devices Subcommittee 3 PM 4 PM General Otolaryngology Education Committee 3 PM 4 PM Humanitarian Efforts Committee – Open Forum 3:30 PM 5:30 PM Board of Governors Executive Committee ** 4 PM 6 PM Plastic & Reconstructive Surgery Committee 4:30 PM 5:30 PM Head & Neck Surgery and Oncology Committee 4:30 PM 5:30 PM Sleep Disorders Committee 4:30 PM 6 PM MONDAY, September 12, 2011 Voice Committee 6:30 AM 8 AM Physician Resources Committee 7 AM 8 AM Head & Neck Surgery Education Committee 7:30 AM 8:30 AM CORE Study Section 8 AM 9 AM Hearing Committee 8 AM 9 AM CPT and Relative Value Committee 8 AM 10 AM Otology & Neurotology Education Committee 9 AM 10 AM Media and Public Relations Committee 9 AM 10:30 AM Physician Payment Policy Workgroup 10 AM 11:30 AM Pediatric Otolaryngology Education Committee 10:30 AM 11:30 AM Section for Women in Otolaryngology GA/Luncheon 11 AM 2 PM Complementary/Integrative Medicine 12:30 PM 1:30 PM Journal Editorial Board Meeting 12:30 PM 2:30 PM Airway and Swallowing Committee 1 PM 2 PM Allergy, Asthma and Immunology Committee 1 PM 2 PM CORE Otolaryngology & Practice Management Education Committee 1:30 PM 2:30 PM Outcomes Research and EBM Subcommittee 2 PM 3 PM Section for Residents and Fellows General Assembly 2:30 PM 4:30 PM Hearing and Equilibrium Steering Committee 3 PM 4 PM Laryngology & Bronchesophagology Education Committee 3 PM 4 PM Program Advisory Committee 3 PM 4 PM Treatment Modalities Steering Committee 3:30 PM 4:30 PM Equilibrium Committee 4 PM 5 PM International Steering Committee 4:30 PM 5:30 PM Microvascular Committee 4:30 PM 5:30 PM Board of Governors General Assembly 5 PM 7 PM TUESDAY, September 13, 2011 Endocrine Surgery Committee 6:30 AM 8 AM Rhinology and Paranasal Sinus Committee 7 AM 8 AM Geriatric Otolaryngology Committee 7 AM 8 AM Women in Otolaryngology Governing Council Meeting 7 AM 8:30 AM Imaging Committee 8 AM 9 AM Certificate Program for Otolaryngology Personnel 8:30 AM 9:30 AM Credentials and Membership 9 AM 10 AM Instruction Course Advisory Committee 10:30 AM 11:30 AM Young Physicians Committee 10:30 AM NOON Research Steering Committee NOON 1:30 PM Diversity Committee 12:30 PM 1:30 PM Member Relations Steering Committee 2 PM 3 PM Medical Devices and Drugs Committee 2 PM 3 PM Patient Groups Steering Committee 3 PM 4 PM Section for Residents & Fellows Transition Meeting 3 PM 4 PM Science and Educational Committee 3:30 PM 4:30 PM Laryngology & Sleep Steering Committee 4 PM 5 PM Head and Neck Steering Committee 4:30 PM 5:30 PM Rhinology, Allergy, Immunology and Infectious Disease Steering Committee 4:30 PM 5:30 PM WEDNESDAY, September 14, 2011 AAO-HNS/F Executive Committee** 7:30 AM 9:30 AM **By invitation Committee schedules are subject to change. Please visit www.entnet.org/annual_meeting for the most up-to-date schedule.
Open to All Members: Health Policy Educational Sessions
The annual meeting promises another round of excellent educational opportunities and resources. Be on the lookout for information on the dates and times for the following: At the CPT/RUC Education Session, you will learn about the AMA’s Current Procedural Terminology (CPT) and Specialty Society/Relative Value Update Committee (RUC) processes. You will also learn why it is so crucial for you to fill out the RUC surveys in order for your Academy representatives to advocate for appropriate values at the AMA meetings. At the informational and educational Medicare Contractor Advisory Committee (CAC) Session, you will learn about the importance of getting involved in local meetings held in your area, the role of your local CAC, and the impact of local policies on your practice, as well as how providers can avoid and prepare for any potential audits by the Recovery Audit contractors. 3P Miniseminar on Academy Advocacy for Physician Payment and New Strategies: As declining reimbursement over many years continues to threaten the viability of physician practices across specialties and practice settings, this seminar will provide updates on the efforts of our Academy to advocate for fair reimbursement for our members in increasingly challenging public and private payer environments. ICD-9-CM to ICD-10-CM Transition Miniseminar: There will be a miniseminar covering the required October 1, 2013, transition from ICD-9-CM to ICD 10 for all U.S. healthcare providers. During this session, the speaker will provide an overview of the ICD-10 transition, identify and crosswalk groups of ICD-9 codes that pertain to otolaryngology—head and neck surgery, and much more.
Where to Find Annual Meeting Information
This Bulletin   Gear up for Annual Meeting & OTO EXPO Pages 20 to 31 Late April  www.entnet.org The Official Meeting Website opens May Bulletin In the issue: Coordinators Message Registration and Housing information Millennium Society Recognition at Annual Meeting Social Media and Networking at the Meeting Supplement: The Preliminary Program June and July Bulletins Meeting Updates and Registration Information August Bulletin  Meeting Updates and Registration Information The OTO EXPO Featured August Journal Supplement  The Official Abstract Program
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The Changing Face of Foundation Education
Education & Quality Integration Timeline 2090 Screen 10/2006 Guidelines Development Task Force formed to direct guideline development activities of the Foundation. 10/2007 Education committee structure realigned focus from products to clinical practice area. 12/2007  Specialty Society Summit convened to identify opportunities to increase collaboration across otolaryngology–head and neck surgery. 11/2008  Research and Quality business units combined to lead the measuring of clinical outcomes, linking them to specific therapies using proper mechanisms to measure actual physician performance. 10/2008 Education and Meetings business units combined to integrate the planning and management of live, online, and enduring education, to ensure the integrity of CME activities and independence from commercial interests in CME planning. 10/2008 Annual Meeting Work Group convened to address otolaryngology specialty collaboration in education planning and delivery. 10/2008 Abstract/speaker management system and administrative program management redesigned to improve review and disclosure capabilities and ensure adaptability for future change. 12/2008 Science & Education Committee charge strengthened and Senior Director of Education & Meetings established as liaison to improve integration among education, research, quality, guideline development and scholarly publishing. 12/2008 Research Advisory Board formed to direct research activities of the Foundation and ensure development of supporting educational interventions. 6/2009 Research Officer Position created supporting the Senior Director of Research & Quality’s increased focus on patient safety and quality and development of guidelines, manuscripts, data registries in collaboration with Education & Meetings. 3/2010 Coordinator for Education role reviewed and revised to strengthen oversight of all Academy and Foundation education. 3/2011 Coordinator for Annual Meeting Scientific Program and Instruction Course Program begins. Providing the definitive knowledge base of the specialty is a key aspiration within the AAO-HNS mission to empower otolaryngologists to provide the best patient care.  The 2010-2011 strategic goal for education is: Use the ACCME self-assessment to develop data-driven recommendations for remapping our education activities. This year of assessment is part of the continuous improvement of education that began when the AAO-HNS Foundation was established by the Academy in 1978 to advance the art, science, and ethical practice of otolaryngology—head and neck surgery through education, research, and lifelong learning. All AAO-HNS/F education activities are planned and delivered by the Foundation, an independent accredited entity of the Academy since the Accreditation Council for Continuing Medical Education (ACCME)’s inception. “The Academy is in the process of applying for reaccreditation with the ACCME. This exhaustive undertaking confirmed some things that we suspected we could improve upon and has given us new ideas and new direction to continue our evolution,” says Mark K. Wax, MD, Coordinator for Education. “The reaccreditation has also confirmed how much we do very well as an organization.” All accredited providers face challenges in improving the knowledge, competency, and performance of their learners and their patient outcomes. The Foundation is no exception in prioritizing resources toward a seemingly unlimited need to provide education, support, and resources to empower otolaryngologists—head and neck surgeons to provide the best patient care. The assessment includes a scan of the rapidly changing physician education and healthcare environment. The Foundation leadership communicates regularly with the ABO regarding Maintenance of Certification and resident education. The Specialty Society Advisory Council regularly discusses collaboration on education activities across the specialty. “The assessment and improvement of our education program requires a look at every part of our CME Mission: Purpose, Content, Target Audience, Activity Types, and Expected Results,” reports Sonya Malekzadeh, MD, Education Coordinator-Elect. “We need to provide all learners with the education they need in a format that suits their learning goals and lifestyle. The education activities in the future will build upon the current program, but they may look very different from the activities we have today.” Integrating Education and Research & Quality The AAO-HNS/F 2003-2006 Strategic Plan set the course to increase otolaryngologist—head and neck surgery participation in sponsored clinical and evidence-based research, support clinical indicators with evidence, and expand size and scope of evidence-based medicine efforts through the National Center for the Promotion of Research in Otolaryngology (NCPRO). The 2006-2009 Strategic Plan established quality, research, knowledge, and education as linked strategic issues. The AAO-HNS/F began to collaborate with specialty societies and strategic partners that share our vision and values to provide the knowledge base that supports physician and patient education for the specialty and to have an optimal level of evidence to demonstrate and measure the quality care our members provide. The Foundation embraced the shift toward the measurement of changes in physician behavior and patient outcomes based on actual data, with quality and CME working together to fully integrate and continue to improve our research, quality and education. Internal and external collaboration have increased in support of the continuing evolution of the CME program in line with the ACCME’s evolving standards for CME quality and the changing practice of medicine. The strong foundation established in quality, research, and education and their full integration will ensure that all otolaryngologists can incorporate evidence and guidelines into their practice and receive feedback and assessment of their own patient care. Documenting Improvements in Patient Care “We are seeing evidence of change in patient care as a result of the significant organizational commitment to move from knowledge-based CME to education which changes learners’ competence, performance, or patient outcomes,” according to David R. Nielsen, MD, AAO-HNSF EVP/CEO. “You have no doubt noticed the changes in Foundation education evaluations since we began to document changes in practice. You will continue to see more of this – including requests for follow-up behavioral assessments after you return to practice. This data is required by the ACCME, but also extremely valuable to the education and meeting planning committees to adapt and improve both the activities and the evaluation methods. The responses have been overwhelming, as you can see from the 2010 annual meeting results.” In 2010, 61 percent of Annual Meeting Miniseminar participants agreed that participation in this session “will change (affect) the way I practice medicine” (4,705 out of 7,684 responses). When asked to describe the changes, participants provided a list of 2,929 examples. The top 50 words from the free-form responses are presented in scale according to their frequency of repetition in the nearly 3,000 documented changes in practice: This representation shows that the practice changes are focused primarily on patients, and perhaps either making their patients better, or on providing patients with better treatment, practice, techniques, and surgery. When asked to explain why they would not make a change in practice, 1,133 free-form responses were provided. The top-50 words from these responses are presented in a word cloud with their size representing the frequency of occurrence. The responses suggest that participants who do not anticipate a change in practice found already practice as presented, reinforced their practice, or received an update on current information rather than a need to change practice. In 2010, 72 percent of Annual Meeting Instruction Course participants agreed that participation in this Course “will change (affect) the way I practice medicine” (7,311 out of 2,807 responses). When asked to describe the changes, participants provided a list of 4,904 free-form comments. The top-10 words from these responses were: patients, better, practice, surgery, techniques, treatment, understanding, consider, approach, and change. When asked to explain why they would not make a change in practice, 1,294 free-form responses were provided. The top  four words from these responses were already, practice, course, and current. The data suggests that course participants who do not anticipate a change in practice report that they reinforced, confirmed their current practice, perhaps are already practicing what was presented in the course and found nothing about current practice to change. Data from learners confirms the value of physician education in empowering otolaryngologists to provide the best patient care. The assessment of education links the Academy’s culture of continuous improvement to its envisioned future in which otolaryngologist—head and neck surgeons are empowered and accountable for their personal performance and the welfare of their patients. “One barrier we never face is any faltering in the intent, commitment, or the strategic support of education by our leadership and membership. Otolaryngologists—head and neck surgeons own the Academy and Foundation,” says Dr. Nielsen. “The members’ hands-on involvement and pride in the specialty ensure that the Academy and Foundation will always push to provide the best education.”
Attendees at the 2010 Annual Meeting view poster presentations.
Gear Up for the Annual Meeting & OTO EXPO
M. Steele Brown, special to the Bulletin It’s getting to be that time again. Early registration and housing opens for the American Academy of Otolaryngology—Head and Neck Surgery Foundation’s 2011 Annual Meeting & OTO EXPO on May 2, so it’s time to start thinking about your trip. The world’s largest gathering of otolaryngologists, this year’s meeting will be held September 11-14, at the Moscone Center in San Francisco. The event, which is expected to bring together 9,000+ attendees and more than 300 exhibiting companies, will educate otolaryngologist—head and neck surgeons about the newest leading-edge tools and techniques, present ground-breaking discoveries, and provide an opportunity to renew old friendships and meet new colleagues. Ready for Registration  At present, the Academy is gearing up for the early meeting registration push. Meeting registration and the 2011 Annual Meeting & OTO EXPO Preliminary Program, will be available with the May edition of the Bulletin.  The best way to register is online at www.entnet.org/annual_meeting or call the registration line at 1-866-212-0683 or 1-972-349-5970. Building the Program With Miniseminar and Instruction Course proposal qualifiers already selected — the notifications for oral and poster Scientific Program Abstracts are set to be mailed in May. Although the AAO-HNSF isn’t quite ready to drop the green curtain on the preliminary program for the 2011 San Francisco event, members should expect the same high-quality meeting they’ve experienced year to year. The 2010 program in Boston featured approximately 76 miniseminars, 250 oral presentations, 400 poster presentations, and 342 instruction courses, which represented a more than double-digit increase in every category compared to the 2009 meeting in San Diego. Like its predecessor, the San Francisco program promises to be integrated across all areas of the specialty, including the newest discoveries in basic and translational science, as well as the latest trends in clinical research and practice. The Academy will again make CME stations available in the convention center, which will give attendees the opportunity to evaluate a course immediately after attending it. CME credits earned will be included in the official transcript sent to physicians in January. A Certificate of Attendance will also be available for printing at certain points in the convention center. Networking The Academy will continue to offer opportunities to attendees whose goal it is to find a new job, employee, or research partner. A list of available events and networking locations will be made available at the Moscone Center. The popular alumni events also will be on tap, allowing former colleagues to rekindle their professional relationships and catch up with old friends. The Millennium Society Appreciation Lounge will be open for business in San Francisco. Eligible visitors may take advantage of the business services available in the lounge, which include telephones, fax machines and computers for checking email and browsing the Internet. Millennium Society members can get help with course registrations and the submission of CME evaluations, as well as information about local events and meeting activities. The Academy will continue to offer an online itinerary planner in San Francisco, complete with a downloadable appointment scheduler. This application includes all education and scientific programming, social functions, and committee and other special meetings taking place at the 2011 Annual Meeting & OTO EXPO. As one satisfied attendee indicated, the Annual Meeting & OTO EXPO “inspires one to continue providing excellent care because of the universal bond between all otolaryngologists, which can be seen and felt when we all gather together.” Golden Locale The location of this year’s meeting is second to none. Known by many different names – “The Golden Gate City,” “The City by the Bay,” and “Everybody’s Favorite City” to name a few – San Francisco offers scenic beauty, cultural attractions, diverse communities, and world-class cuisine. Measuring 49 square miles, the 12th-largest U.S. city is dotted with landmarks like the Golden Gate Bridge, cable cars, Alcatraz, and the largest Chinatown in the United States. A stroll of the city’s streets can lead to Union Square, the Italian-flavored North Beach, Fisherman’s Wharf, the Castro district, Japantown, and the Mission District, with intriguing neighborhoods to explore at every turn. If you’re planning on walking, make sure to pack good shoes and the right clothing. San Francisco has some major hills and unique weather. While the rest of the country is starting to cool down, many consider fall to be the best time of year for weather in San Francisco, with warm, sunny days and mild, clear nights. It can, at times, get hot in September, so if you’re planning to walk, check the forecast and pack appropriately. Rainfall at this time of year is rare, and, for the most part, the ever-present fog has cleared, so this is one of the best times to visit San Francisco. Views of the Pacific Ocean and San Francisco Bay create a romantic mood in this European-influenced city. The city has a colorful past, growing from a small village to a major city nearly overnight as a result of the 1849 Gold Rush. The writers of the beat generation — Jack Kerouac and Alan Ginsberg are two good examples of the hippies of the Summer of Love in the late 1960s, and the large international population have all contributed to making San Francisco the fascinating place it is today. The city is home to world-class theater, opera, symphony, and ballet companies and often boasts premieres of Broadway-bound plays and culture-changing performing arts. San Francisco is also widely regarded as one of America’s best dining cities. The diverse cultural influences, proximity to the freshest ingredients, and competitive creativity of the many and varied chefs, results in an array of unforgettable dining experiences. San Francisco also offers first-class hotels and ultra-chic boutique hotels.  The Academy has negotiated excellent hotel rates and has made the reservation process seamless when you book your hotel after registering for the meeting.  Go online to register for the meeting at www.entnet.org/annual_meeting, and make your hotel reservation at the same time. If you want to get out of the city, you might try hiking or mountain biking through Mount Tamalpais across the Golden Gate in Marin County or  a tour of the vineyards in Napa Valley. If you’re planning an extended stay in the area, there’s surfing just south in Santa Cruz or the beautiful scenery to be had a few hours north in Lake Tahoe. For more information on registration, hotels, events, activities, and transportation in San Francisco, visit www.entnet.org/annual_meeting.