October 1, Honorable Kathleen Sebelius Secretary Department of Health and Human Services 200 Independence Avenue, SW Washington, D.C.

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1 October 1, 2012 Honorable Kathleen Sebelius Department of Health and Human Services 200 Independence Avenue, SW Washington, D.C Honorable Hilda L. Solis Department of Labor 200 Constitution Ave., NW Washington, D.C Honorable Timothy F. Geithner Department of the Treasury 1500 Pennsylvania Avenue, NW Washington, D.C Transmitted via Dear Secretaries Sebelius, Solis and Geithner, In July 2010, the Academy of Managed Care Pharmacy (AMCP) requested expedited clarification of requirements set forth by the Office of Consumer Information and Insurance Oversight (OCIIO) in the interim final rules for group health plans and health insurance issuers relating to coverage of preventive services under the Patient Protection and Affordable Care Act. In July 2011, the Academy sent an additional request to OCIIO, as no response resulted from the first letter. Two years have since passed, and no clarification has been issued even though this provision of the Accountable Care Act took effect for all employer-based insurance plans renewing on or after September 23, Lack of clarification with regard to fundamental regulations governing acceptable actions in this area has given rise to patients being afforded differing coverage of care and variation in implementation of the rule as well as placing those subject to the rule in an untenably vulnerable situation. We ask again for a rapid resolution of this situation.

2 As described in detail in the Academy s July 2010 letter to OCIIO (copy attached), the interim final regulations require that a group health plan and a health insurance issuer offering group or individual health insurance coverage provide benefits for and prohibit the imposition of cost-sharing requirements with respect to evidence-based items or services that have in effect a rating of A or B in the current recommendations of the United States Preventive Services Task Force (USPSTF) with respect to the individual involved. Four of the recommendations made by USPSTF relate to medications. None of the four recommendations are addressed in the interim final regulations. These recommendations are: Aspirin to prevent CVD: men The USPSTF recommends the use of aspirin for men age 45 to 79 years when the potential benefit due to a reduction in myocardial infarctions outweighs the potential harm due to an increase in gastrointestinal hemorrhage. Aspirin to prevent CVD: women The USPSTF recommends the use of aspirin for women age 55 to 79 years when the potential benefit of a reduction in ischemic strokes outweighs the potential harm of an increase in gastrointestinal hemorrhage. Supplementation with folic acid The USPSTF recommends that all women planning or capable of pregnancy take a daily supplement containing 0.4 to 0.8 mg (400 to 800 µg) of folic acid. Iron supplementation in children The USPSTF recommends routine iron supplementation for asymptomatic children aged 6 to 12 months who are at increased risk for iron deficiency anemia. The Academy and others have been in communication with the Center for Consumer Information and Insurance Oversight (CCIIO, formerly OCIIO) staff over the two years requesting clarification of the requirements. CCIIO staff has explained the need for a tri-agency committee of your Departments to resolve the situation. In the absence of the clarification that has been requested, we have been told unofficially that a good faith and reasonable interpretation of the regulations is acceptable to the government. Lacking more precise guidance, health plans have been forced to take action based on their individual interpretation of how future regulations might address issues such as coverage of the medications listed above and/or coverage for counseling related to those medications. The Academy has been informed by several directors of pharmacy at health plans that the plans legal counsel in some instances has indicated that the plan must cover the medications; in other instances, legal counsel has advised that the plan is not required to provide coverage for the medications. Ramifications of this imprecision have resulted in: Employees receiving different levels of benefits based on how health plans have interpreted the regulations. Disruption in the competitive health plan marketplace because health plans that interpret the regulation as requiring coverage of the medications find it necessary to charge higher premiums that those that interpret the regulation as requiring only counseling related to the medications. Health plans have been forced to spend valuable resources seeking legal opinion on what an appropriate course of action might be. Those interpretations have varied by counsel and can only be resolved by issuance of clarifying regulations that provide clear direction.

3 AMCP requests that the three Departments involved immediately provide clarification of the requirements contained in the interim final rules for group health plans and health insurance issuers relating to coverage of preventive services under the Patient Protection and Affordable Care Act as those requirements relate to medications. The Academy stands ready to assist in your efforts to resolve this untenable situation. If you have any questions, please contact me at (703) or at Sincerely, Edith A. Rosato, R.Ph., IOM Chief Executive Officer Attachment: AMCP letters - July 21, 2010; July 12, 2011 cc: Gary Cohen, Director, Center for Consumer Information and Insurance Oversight Phyllis C. Borzi, Assistant of Labor, Employee Benefits Security Administration J. Mark Iwry, Senior Advisor, Treasury Department

4 July12, 2011 Honorable Kathleen Sebelius Department of Health and Human Services 200 Independence Avenue, SW Washington, D.C Honorable Hilda L. Solis Department of Labor 200 Constitution Ave., NW Washington, D.C Honorable Timothy F. Geithner Department of the Treasury 1500 Pennsylvania Avenue, NW Washington, D.C Transmitted via Dear Secretaries Sebelius, Solis and Geithner, In July 2010, the Academy of Managed Care Pharmacy (AMCP) requested expedited clarification of requirements set forth by the Office of Consumer Information and Insurance Oversight (OCIIO) in the interim final rules for group health plans and health insurance issuers relating to coverage of preventive services under the Patient Protection and Affordable Care Act. It is now a year later and, despite numerous requests for guidance, no clarification has been issued even though this provision of the Accountable Care Act took effect for all employer-based insurance plans renewing on or after September 23, Lack of clarification with regard to fundamental regulations governing acceptable actions in this area has given rise to patients being afforded differing coverage of care and variation in implementation of the rule as well as placing those subject to the rule in an untenably vulnerable situation. The failure by the three Agencies to act on this issue is frustrating and arguably constitutes regulatory nonfeasance. The three departments have had an affirmative responsibility to address issues raised over the past year

5 by numerous affected parties (group health plans and health insurance issuers and those organizations representing them) and in failing to do so in a timely and responsible manner have put those parties at financial and legal risk. We ask for a rapid resolution of this situation. As described in detail in the Academy s July 2010 letter to OCIIO (copy attached), the interim final regulations require that a group health plan and a health insurance issuer offering group or individual health insurance coverage provide benefits for and prohibit the imposition of cost-sharing requirements with respect to evidence-based items or services that have in effect a rating of A or B in the current recommendations of the United States Preventive Services Task Force (USPSTF) with respect to the individual involved. Four of the recommendations made by USPSTF relate to medications. None of the four recommendations are addressed in the interim final regulations. These recommendations are: Aspirin to prevent CVD: men The USPSTF recommends the use of aspirin for men age 45 to 79 years when the potential benefit due to a reduction in myocardial infarctions outweighs the potential harm due to an increase in gastrointestinal hemorrhage. Aspirin to prevent CVD: women The USPSTF recommends the use of aspirin for women age 55 to 79 years when the potential benefit of a reduction in ischemic strokes outweighs the potential harm of an increase in gastrointestinal hemorrhage. Supplementation with folic acid The USPSTF recommends that all women planning or capable of pregnancy take a daily supplement containing 0.4 to 0.8 mg (400 to 800 µg) of folic acid. Iron supplementation in children The USPSTF recommends routine iron supplementation for asymptomatic children aged 6 to 12 months who are at increased risk for iron deficiency anemia. The Academy and others have been in communication with the Center for Consumer Information and Insurance Oversight (CCIIO, formerly OCIIO) staff on a regular basis over the past year requesting clarification of the requirements. CCIIO staff has explained the need for a tri-agency committee of your Departments to resolve the situation. We have been given to understand that the joint departmental committee has yet to address this issue. In the absence of the clarification that has been requested, we have been told unofficially that a good faith and reasonable interpretation of the regulations is acceptable to the government. Lacking more precise guidance, health plans have been forced to take action based on their individual interpretation of how future regulations might address issues such as coverage of the medications listed above and/or coverage for counseling related to those medications. The Academy has been informed by several directors of pharmacy at health plans that the plans legal counsel in some instances has indicated that the plan must cover the medications; in other instances, legal counsel has advised the plan is not required to provide coverage for the medications. Ramifications of this imprecision have resulted in: Employees receiving different levels of benefits based on how health plans have interpreted the regulations. Disruption in the competitive health plan marketplace because health plans that interpret the regulation as requiring coverage of the medications find it necessary to charge higher premiums that those that interpret the regulation as requiring only counseling related to the medications.

6 Health plans have been forced to spend valuable resources seeking legal opinion on what an appropriate course of action might be. Those interpretations have varied by counsel and can only be resolved by issuance of clarifying regulations that provide clear direction. AMCP requests that the three Departments involved immediately provide clarification of the requirements contained in the interim final rules for group health plans and health insurance issuers relating to coverage of preventive services under the Patient Protection and Affordable Care Act as those requirements relate to medications. The Academy stands ready to assist in your efforts to resolve this untenable situation. Sincerely, Judith A. Cahill Executive Director Attachment: AMCP letter to OCIIO (July 21, 2010) cc: Steve Larsen, Director, Center for Consumer Information and Insurance Oversight Phyllis C. Borzi, Assistant of Labor for the Employee Benefits Security Administration J. Mark Iwry, Senior Advisor, Treasury Department

7 July 21, 2010 Office of Consumer Information and Insurance Oversight Department of Health and Human Services Attention: OCIIO-9992-IFC P.O. Box 8016 Baltimore, MD Re: Docket No. OCIIO-9992-IFC The Academy of Managed Care Pharmacy (AMCP) is requesting expedited clarification of certain requirements set forth by the Office of Consumer Information and Insurance Oversight (OCIIO) in the interim final rules for group health plans and health insurance issuers relating to coverage of preventive services under the Patient Protection and Affordable Care Act published in the Federal Register on July 19, AMCP is a national professional association of pharmacists and other health care practitioners who serve society by the application of sound medication management principles and strategies to achieve positive patient outcomes. The Academy s 6,000 members develop and provide a diversified range of clinical, educational and business management services and strategies on behalf of the more than 200 million Americans covered by managed care pharmacy benefits. The interim final regulations require that a group health plan and a health insurance issuer offering group or individual health insurance coverage provide benefits for and prohibit the imposition of cost-sharing requirements with respect to evidence-based items or services that have in effect a rating of A or B in the current recommendations of the United States Preventive Services Task Force (USPSTF) with respect to the individual involved. The interim final regulations address the cost-sharing requirements when a recommended preventive service is offered during or separate from an office visit and include examples related to services. Four of the recommendations made by USPSTF relate to medications. None of the four recommendations are addressed in the interim final regulations. These recommendations are: Aspirin to prevent CVD: men The USPSTF recommends the use of aspirin for men age 45 to 79 years when the benefit due to a reduction 1

8 in myocardial infarctions outweighs the potential harm due to an increase in gastrointestinal hemorrhage. Aspirin to prevent CVD: women The USPSTF recommends the use of aspirin for women age 55 to 79 years when the potential benefit of a reduction in ischemic strokes outweighs the potential harm of an increase in gastrointestinal hemorrhage. Supplementation with folic acid The USPSTF recommends that all women planning or capable of pregnancy take a daily supplement containing 0.4 to 0.8 mg (400 to 800 µg) of folic acid. Iron supplementation in children The USPSTF recommends routine iron supplementation for asymptomatic children aged 6 to 12 months who are at increased risk for iron deficiency anemia. One of the above recommendations is indirectly referred to in the interim final regulations in a discussion of benefits that will result from the regulations: these interim final regulations require a group health plan and a health insurance issuer offering group or individual health insurance coverage to provide benefits for and prohibit the costimposition of cost-sharing requirements with respect to the following preventive health services: Evidence-based items or services that have in effect a rating of A or B in the current recommendations of the USPSTF (Task Force). While these guidelines will change over time, for the purposes on this impact analysis, the Departments utilized currently available guidelines, which include blood pressure and cholesterol screening, diabetes screening for hypertensive patients, various cancer and sexually transmitted infection screenings, and counseling related to aspirin use [emphasis added], tobacco cessation and other topics. 1 Because the only reference to any of the four recommendations related to medications indicates that the service to be covered is counseling related to the medication, it appears that counseling related to aspirin use, folic acid use or iron supplementation is the intent of the regulations. It does not appear that the regulation requires coverage of the medication itself by a group health plan with no cost-sharing. AMCP requests that OCIIO provide clarification of the requirements contained in the interim final rules for group health plans and health insurance issuers relating to coverage of preventive services under the Patient Protection and Affordable Care Act as those requirements relate to medications. In addition, the Academy requests the opportunity to meet with OCIIO staff to obtain clarification on the requirements of the regulation and asks that OCIIO issue a final rule with clarification of the above information before the implementation date. Pharmacy benefits are provided to group health plan members through an online claims payment process which requires significant lead time for adjudication system programming. A health plan would require clarification by September 1, 2010 to implement these changes for insured groups with a benefit year beginning on October 1, AMCP appreciates the opportunity to comment on this important issue. If you have any questions, please contact me at (703) or at jcahill@amcp.org. Sincerely, Judith A. Cahill Executive Director 1 Department of Health and Human Services, Interim Final Rules for Group Health Plans and Health Insurance Insurers Relating to Coverage of Preventive Services Under the Patient Protection and Affordable Care Act. Federal Register, Vol. 75, No. 137 (July 19, 2010), p (accessed July 20, 2010). 2