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in the newsregulatoryUPDATESpecialty TiersAdvocacy groups representing patientswho rely on treatments for costly andchronic conditions are organizingin support of the Patients’ Access toTreatments Act (H.R. 4209) and thePart D Beneficiary Appeals Fairness Act(H.R. 3613). These bills are designed toaddress the emerging issue of “specialtytiers,” which require patients to paycoinsurance fees rather than co-pays forcertain therapies. Many of these therapiesare expensive biologic products andthe out-of-pocket expenses imposed byspecialty tiers create significant barriersto access for the individuals who relyon them. H.R. 4209, introduced byCongressman David McKinley (R-W. Va.,8 th Dis.) and Congresswoman Lois Capps(D-Calif., 23 rd Dis.), would restrict thepractice of specialty tiers inthe private insurance market.H.R. 3613, introduced byCongressman Hank Johnson(D-Ga., 4 th Dis.) and cosponsoredby 34 Democrats,would address specialty tiersin Medicare.Patient groups representingindividuals withhemophilia, primary immunedeficiencies, cancer andother conditions impacted byspecialty tiers are coming togetherthrough the Coalition for AccessibleTreatments (CAT). This coalition isprimarily interested in advancingH.R. 4209 and H.R. 3613 through thelegislative process towards the ultimategoal of having the bills passed into law.Advocates are presently working tocapitalize on opportunities to advancethe bills before the current Congressadjourns.Drug ShortagesAfter holding a number of hearingsand passing new regulations throughlegislation reauthorizing user fees forthe FDA, Congress continues to pursuethe issue of critical drug shortages.Just prior to the congressional recess,the Chair of the Commerce, Science,and Transportation Committee, SenatorJay Rockefeller (D-W.Va.), the Chair ofthe Health, Education, Labor and PensionsCommittee, Senator Tom Harkin (D-Iowa),and the Ranking Member of the HouseCommittee on Oversight and GovernmentReform, Congressman Elijah Cummings(D-Md., 7 th Dis.), have released a reportentitled, Shining Light on the “GrayMarket:” An Examination of WhyHospitals are Forced to Pay ExorbitantPrices for Prescription Drugs FacingCritical Shortages. The report detailscases of abuse, including practices bypharmacies that lead to exorbitant drugprices at the expense of hospitals.While Congress continues to investigatedrug shortages, the Administrationcontinues to search for innovativesolutions to address the issue. In thisregard, the Federal Trade Commissionreleased an advisory opinion. It foundthat a current plan to have generic manufacturersshare production informationfor drugs in shortage through a thirdparty is not likely to harm competition.The FDA will continue to work withstakeholders to implement the program,known as the Accelerated RecoveryInitiative (ARI), including determiningthe initial group of drugs that will beincluded in the program.12 InsideOut