AAHIVM SIGN-ON LETTER AGAINST CHANGING
April 15, 2019
The Honorable Alex Azar
Secretary
Department of Health and Human Services
200 Independence Avenue, SW, Room 600E
Washington DC 20201
Mr. Russell Vought
Acting Director
Office of Management and Budget
725 17th Street NW
Washington, DC 20503
Dear Secretary Azar:
The undersigned clinical providers and pharmacists are writing to express our concern about recently proposed changes to the six protected classes in Medicare Part D that could lead to increased utilization management and reduced access to medicines for serious and life-threatening conditions.
Traditionally, Part D plans are required to cover all or substantially all medications in six classes and categories: antidepressants, antipsychotics, anticonvulsants, immunosuppressants, antiretrovirals, and antineoplastics. Given the conditions treated by these products, the “protected classes” policy protects some of the most vulnerable Medicare beneficiaries, including those suffering from conditions such as HIV, who we care for and treat on a daily basis. Access to the full range of treatment options is critical for successful management of patients with HIV, for both new, treatment naïve patients, as well as those who are stable on their anti-viral regimens.
CMS recently proposed exceptions to this policy that would allow insurers to use more aggressive utilization management for these classes of products, and even to exclude certain products from formulary altogether. As providers and pharmacists, we are deeply concerned about giving insurers the ability to exclude new generation products from formulary and thus denying patients access to the latest science. We are particularly concerned that the proposed rule would allow widespread use of prior authorization and step therapy for stable patients.
As providers and pharmacists, we know how difficult it can be to find a treatment in one of these six protected classes that works for a patient. Often a patient is only stable after a long period of trying different therapies to find one that is effective and has manageable or no side effects. In other cases, one medicine is appropriate due to a patient’s condition and comorbidities. A carve out for stable patients will not be sufficient as there are other clinical considerations that must be taken into account. Antiviral regimens are prescribed based on individual clinical and psychosocial factors that we determine during our assessments.
Further, the existence of the Part D exceptions and appeals process gives us little comfort. These processes are opaque and burdensome to providers and pharmacists, who should instead be focused on delivering clinical care. These processes create delays to treatment that are unacceptable to patients currently protected by the six-protected classes policy. Additionally, Medicare Payment Advisory Commission staff has stated that “CMS has found that several plan sponsors fail to comply with regulations” governing the exceptions and appeals process. In HIV, delaying and in some cases blocking patients’ access to tailored treatment is deleterious to not only the patients’ individual health, but also to the broader public health in terms of transmissibility of the virus.
For these reasons, we strongly oppose the Administration’s proposal to weaken the protected classes policy and urge this proposal to be withdrawn.
Sincerely,
David Aboulafia, MD, Virginia Mason Medical Center
Kenneth Ackerman, Pharmacist,Chain Pharmacy
Preyanka Aggarwal, MD, Baycare Medical Group
JenniferAldrich, MD, Temple University
Fernando Alemany, MD, Solo Practitioner
Carla Alexander, MD FAAHPM, University of Maryland Baltimore School of Medicine Institute of Human Virology
Jennifer Allard, CRNP, Community Health Care
Patrick Allen, Physician, University of Kansas – Wichita
Kevin Aloysius, Pharmacist, Legacy Community Health
Joel Ang, Physician, Q Street Medical Associates
Jonathan Angel, MD, JPS Family Medicine Residency Program
Jonathan Appelbaum, MD, Florida State University College of Medicine
Deena Athas, MD, Gundersen
Darla Bagwell, APRN, Midway Specialty Care Center
Aiman Bandali, Pharm.D., Hahnemann University Hospital
Elizabeth Barnes, Clinical Pharmacist, Atrium Health
MichaelBauguess, PA-C, Ampla
Brian Beesley, MD, Mount Carmel Medical Group
Hermeyone Bell, Nurse Practitioner, AAHIVS
Paul Benson, Osteopathic Physician, Be Well Medical Center
Leonard Berkowitz, MD, The Brooklyn Hospital Center
Levi Berkshire, MHAC Community Co-Chair, Michigan HIV AIDS Council
Marye Bernard, Family Nurse Practitioner, Adult Special Care Center
Stephen Bickel, MD, Medical Director, Flagler and Volusia County Health Departments
Ann Blancke, Pharmacist, AAHIVP
Philip Bolduc, MD, University of Massachusetts Medical School
WilliamBone, MD, Panama City Infectious Disease Associates
LindsayBoothby MD, AAHIVS, Sutter Family Medicine Residency Program
Xavier Brager, Pharmacist, Specialty Pharmacy
Robert Brandt Jr., MD, Boonshoft School of Medicine, Wright State University
EdwardBraun, Medical Director, Midtown Medical Center
Walter Brewer, Pharmacist, Walgreens Specialty
Jennifer Brody, Director, HIV Services, Boston Healthcare for the Homeless Program
Betsy Brown, MD, The Polyclinic
Tammie Bryant, Family Nurse Practitioner, Harris Health Systems
Gary Bucher, Medical Director, ADC Midwest
Delia Bullock, MD and Medical Director, FFACTS Clinic, UT Health San Antonio
Daniel Burns, Medical Case Manager, Lansing Area AIDS Network
Ramona Burress, PharmD, Sisters Working It Out
Stuart Burstin, MD, Director of Health Care Clinic, AHF
David Busch, MD, Infectious Diseases Associates Medical Group, Inc.
Jaehyun Byun MD, AAHIVS, Holyoke Health Center
Krista Caiola, RPh, Arrow Pharmacy
Vashonia Campbell, PharmD, Grady IDP
Megan Campbell, Pharmacist, Primary Healthcare
Aviva Cantor, PA, Callen Lorde
CharlesCarpenter, Professor of Medicine Emeritus, Brown University
Rosmery Castañeda, M.D., HIV medicine
Nicole Caton, Physician, University of Tennessee
ShivaunCelano, PharmD, Johns Hopkins
Ravi Challa, Pharmacist, Retail Pharmacy
Edmond Chang, Nurse Practitioner, Harbor-UCLA Medical Center
JenniferChang, Physician, Kaiser Permanente
Eric, Christoff, MD, Howard Brown Health
CarolynChu, Clinical Director, Associate Professor, UCSF, San Francisco Health Network Family Health Center
Kendrick Clack, Family Nurse Practitioner, Coastal Bend Wellness Foundation
Megan Clancy, MD, Megan Clancy MD LLC
Radu Clincea, MD, FDOH in Osceola County, Kissimmee, Florida
Jonathan Cohn, Infectious Disease Physician, Wayne State University Physician Group
Ronald Collazo, MD, PR CONCRA
Justin Cornett, Pharmacist, Greatland Infusion Pharmacy
Chad Crager, Nurse Practitioner, Dr. Steven M. Pounders
ThomasDeetz, MD, PAMF
Mary Dillard, Family Nurse Practitioner, ENT
Dena Dillon, PharmD, AAHIVP, University of Iowa HealthCare
Sonali Dinani, Pharm.D/ Specialty Pharmacy Manager, Walgreens Specialty
Jeffery Dockery, MD, Family Medicine
Byron Doepker, MD, Kaiser Permanente
Ganesan Doraiswamy, Pharmacy Manager, State of Florida
Jill Douglas, NP, Stony Brook Medicine HIV Clinic
Staci Dufrene, PharmD, DOD
Angela Duncan, NP-C, AIDS Healthcare Foundation
Lauren Dunnet. Pharm D, North Texas Infectious Diseases Consultants
Nikesha Duplan, Nurse Practitioner, Queens Hospital Ctr
Elizabeth Egan, MHS, PA-C, AAHIVS, Whitman-Walker Health
YashicaEllis, Client Service Coordinator, Wellness Services
David English, MD, SFDPH/UCSF
J Yusuf Erskine, DO, NCMA
Farah Erzouki, Public Health Manager, ACCESS
Ashley Eschmann, PharmD, Walgreens Specialty Pharmacy
Helen Everett, Pharmacist, CVS Specialty Pharmacy
Kevin Farrow, Clinical Pharmacist, Penn State Milton S. Hershey Medical Center
Esther Fasanmi, Clinical Pharmacist, JPS Health Network
Michael Fingerhood, MD, Johns Hopkins University
ColleenFinnegan, Physician, Kaiser Permanente
Sharon Foster, MD, Adjunct Professor, JIB Medical, P.C
Laura Fredrickson, HIV AIDS Coordinator, Local Public Health
PrakashGanesh, MD, MPH, I-TECH, University of Washington
PatriciaGarton, APRN, Circle CARE Center
Stephen Geraci, MD, ETSU Physicians
Daniel Gillespie, Adult Nurse Practitioner, Brightpoint Health
Aregai Girmay, MD, Gaston Family Health Services
Shilo Godwin, PharmD, Walgreens
KathrynGoldman, MD, University of Connecticut/ Burgdorf Health Center
Leon Golson, Director of Prevention Programs, Unified HIV Health and Beyond
Mark Goodman, MD, Creighton University School of Medicine, American Academy of HIV Medicine
Brian Goodroad, DNP, APRN, CNP, AAHIVS, Nurse Practitioner, Hennepin Healthcare
RodneyGordon, Pharmacist in Charge, Great Land Infusion Pharmacy
SharonGrant, PharmD, AAHIVP
Meredith Greene, MD, San Francisco General Hospital, UCSF
Michael Greene, Dr. Nursing Practice, Riverside County., PHD
David Gysin, HIV Specialized Pharmacist, OptiMed Pharmacy
Philip Gyura, Director of Addiction Care and Behavioral Health Integration, Livio Healthcare Group
Beth Haire-Lewis, Early Intervention Specialist, CARES
Shannon Hammer, Pharmacist, AIDS Healthcare Foundation
Ari Hampton, Prevention Counselor, Detroit STD clinic
Les Harmon, Nurse Practitioner, Warren-Vance Community Health, Henderson, NC
Aiden Harrington, APN, CNM, AAHIVS, Howard Brown Health
Che Harris, MD, CIMS
Jean Haspel, APN, CompleteCare Health Network
Tassy Hayden, Dr, Southampton Healthcare, Inc
JoanneHayes, MPH, PA-C, Sinai Hospital/HIV Service
Ralph Hearn Jr.
Mark Hebert, Nurse Practitioner, Absolute Care Medical Center
Catherine, Herrington, MD, AIDS Healthcare Foundation
Lucas Hill, HIV Pharmacist Specialist, UC San Diego Owen Clinic
Jason Hindman, Medical Scientist, Gilead Sciences
Kimberly Holding, MD, MPH, AAHIVM, Broward health
Gail Hovorka, MD, Open Door Community Health Centers
BarbaraHuang, Clinical Pharmacist, University of Miami, Miller School of Medicine
Larry Huettl, Pharmacy Manager, Walgreens
Janice Hufnagle, Clinical Community Pharmacist, Wellspan Health
Naomi Huggins, EIS CoordinatorOLHSA, Pontiac, MI
Sherry Hytrek, Physician Assistant, Bickerstaff Family Center
Abel Irizarry, RPh, Health Department of Puerto Rico
Mahbubul Islam, Family Physician, Brightpointhealth.org
Seja Jackson, APRN, Trinity Health of New England/Burgdorf Health Center
Kumar Jairamdas, DNP, APRN, FNP-C, ENP-C, AAHIVS, Largo Medical Center
Jean James, Nurse Practitioner / HIV Specialist, MLK OPC
JenniferJanelle,MD, University of Florida College of Medicine
Sherry Jansen, PharmD,NuCara Pharmacy
Marc Johnson, MD, KDMC HIV Clinic
Bethsheba Johnson, NP, AAHIVM
MichaelJonas, Medical Case Manager, Unified HIV Health and Beyond
MonicaJones, DNP, FNP-BC, GA Carmichael Family Health Center
MarionJordan, Physician Assistant, Santa Cruz County Health Services
Daniel Jude, Clinical Pharmacist, North Memorial Health
Kristin Juelson, Nurse Practitioner, Housing Works
Margaret Keller, Professor of Pediatrics, David Geffen School of Medicine
Matin Khan, MD, AAHIVS, Govt. of Jharkhand Health Services, India
Jamie Kimbrell, PharmD, Atrium Health
Terrie Kirk, PharmD, Legacy Community Health
Natan Kraitman, MD, USF
Sheyam Ladwa, Pharmacist, Ambulatory Care
Adam Lake, Medical Director, Physician,LG/Penn Medicine – Comprehensive Care
Melisa Laurits-Stocek, Physician Assistant, Kaiser Permanente
Jolie LeBlanc, Assistant Professor, LSU Health Sciences Center
Sharon Lee, MD, Family Health Care
Daniel Lee, MD, UCSD Owen Clinic
Christian Lee Rodriguez, Physician, Kaiser Permanente
Jason Leider, MD, Jacobi Medical Center
Ralph Liporace, MD, Dartmouth Hitchcock
Guanzhong Lo, Pharmacist, Borrego Health
Alvaro Lopez, M.D., ID Consultants, PC
Anna Lowell, DO, MPH, AAHIVS,Family Physician, MCR Health Services
WarrenMagnus, DO, AHF-Las Vegas
Cindy Magrini, Pharmacist, AHN
Kasongo Marcel, Physician, Center of Excellence
ShaunaMarkes-Wilson, Pharmacy Supervisor, Walgreens
Susan Marshall, MD, Susan Marshall, MD PC
Paige Martin, Nursing Student, University of Pennsylvania School of Nursing
Erin McCaffrey Crespo, APRN, AIDS Healthcare Foundation
Hope McGratty, PA-C, ID Management Group
Deborah McMahon, MD, UPMC Presbyterian
David McNamara, M.D., Gundersen Health System
Kate McNamer, Social Worker, Infectious Disease
- Sharon Meador, M.D., ARcare
Ivan Melendez-Rivera, Medical Director, Centro Ararat, Inc
Erin Metcalf, PA-C, Medical Group of the Carolinas Infectious Disease
Sarah Michienzi, Clinical Pharmacist / Assistant Professor, University of Illinois at Chicago College of Pharmacy
Sylvia Miller Wiley, MSN, ANP, AAHIVS, IU Health LifeCare
Alex Mills, PharmD, AAHIVP, The University of Mississippi School of Pharmacy
Michael P. Modzelewski, PharmD, New London Specialty Pharmacy
RobbieMoore, HARC
Richard Moore II, MD, Rural Health Group
Robert Murayama-Greenbaum, MD, The Institute for Family Health
Brett Murdy, RPH, Community Pharmacy
John Narro, M.D./Medical Director, HIV Center of Excellence Knox County Health Department, Knoxville
Scott Nass, Program Director, Family Medicine Residency Program, Eisenhower Health
Lisa Navracruz, MD, FAAFP, AAHIVS, Care Alliance, Case Western Reserve University
Gary Newman, RPh, BCGP Consultant Pharmacist
Dan Nguyen, MD, PGY3University of Texas Dell Medical School
Nilda Nieves, MD, Health Department of Puerto Rico
Ifeoma Nwofor, Nurse Practitioner, Care4U
Randi O’brien, Nutrition Consultant, RDN, APNH
Parthenia Oliver, FNP, AAHIVM
Linda Ording-Bauer, Nurse Practitioner, Stony Brook University Medicine
Ray Ownby, Professor, Nova Southeastern University
Mark Paris, MD MPH FACS AAHIVS, Mark Paris MD PA
Deborrah Paris, Director of Operations, Treatment Outreach Program
David Parks, MD/ Primary Practicing Physician, President, Private Practice, CentralWest Healthcare and Associate Professor of Clinical Medicine, Washington University School of Medicine in St. Louis
Sam Parmar, Pharmacist, NASP
Kush Patel, MD,MD DO Associates Inc.
Ingrid Pearson, Director of Nursing and CPNP, Pediatrics
Sarah Perloff, DO, Einstein Medical Center Philadelphia
Russell Perry, MD FAAFP, Associate Chairman Family Medicine, Bronx Cares
Rachel Picone, DNP, Berkshire Internists
RogerioPinto, Professor, MHAC
LynettePosorske, MD, Montgomery Infectious Disease Associates
Tonia Poteat, PhD, MPH, PA-C, UNC
David PrelutskyMedical Director, Southampton Healthcare
RichardPresnell, MD, Medical Associates Plus
Wiily Quesada, Counselor
Steve Rademacher, MD,Consultants in Infectious Diseases
RobertRasa, R.Ph., CVS
Ola Reffell, Pharmacy, Arrowhead Healthmart Pharmacy
Dalilah Restrepo, Attending physician, AIDS Healthcare Foundation
Katina Richmond, Clinical Pharmacist, Retail Pharmacy
CelesteRodriguez, MD
Max Romano, MD, MPH, Johns Hopkins Bloomberg School of Public Health and MedStar Franklin Square Medical Center
David Rubin, Medical Director, Circle Care Center
Margaret Russell, Resident Physician, Erie Family Health Centers
Dr. Ralph Rynes, MD
Neal Rzepkowski, MD
Akpevweoghene Sagua,Pharmacist, LTC
Laura Salazar, MD, Hoag Medical Group
Alicia Salgado, RN/BSN, Fitchburg Gardens
Carol Salisbury, NP, Ingham County Health Dept.
WilliamSalzer, MD, University of Missouri-Columbia School of Medicine
Mindy Sampson, Infectious Disease Fellow, University of South Florida
Rachel Samuelson, MD, Anchorage Neighborhood Health Center
Edie Saville, Nurse Practitioner, FHCSD
Eileen Scarinci, DNP, NJCRI
Cyndy Schalter-Salsido, First Response Coordinator, Advocacy
Sarah Schmalzle, MD, University of Maryland THRIVE program (HIV Clinic)
James Scott, Associate Dean, Western University of Health Sciences
Stephanie Scott, Pharmacy Manager, Community Pharmacy (Retail)
Erika Shea, CRNP, PHMC
David Shepp, MD, Northwell Health
Kimberly Sherard, Nurse Practitioner, St Hope Foundation
Michelle Sherman, President, MichRx Pharmacist Consultation Services, Inc.
Gary Sinclair, PrismHealth NTX
Andrew Sitzmann, MD, OhioHealth Physician Group
David Snell, Council Member, MHAC
Marcia Sokol-Anderson, Professor of Medicine, St. Louis University
RichardSolero, MD, Infectious Diseases- HIV Specialist
Mark Speier, HIV Nurse Clinician, Family Healthcare
Natalie Spicyn, Chief of Internal Medicine, Park West Health System
Gary Spinner, HIV Specialist, Southwest Community Health Center
Alanna Steaple, NP, AAHIVM
Carl Stein, Physician Assistant, SPMF
Aileen Steiner, FNP, AAHIVM
Lars Stephenson, RN, Lincoln Community Health Center
Rob Striker, Physician, UW health
Gabrielle Surick, MD, AAHIVM
Michael Swarner, RPh., AAHIVPSpecialty Pharmacy
ShirleySwenson, Nurse Practitioner, Evergreen Medical Services
Gabriel G. Szego, MD, FACP FASN
Rebecca Thal, NP-C
Danny Toub, MD, Santa Rosa Community Health
David Trauber, Physician, Interfaith Medical Center
Martin Van Dort, Dr., Williamsport Hospital
Heather Vaquera, Public Health Social Worker, Washtenaw County Health Department
Carlos A. Vazquez-Santiago, Physician, American Care, Inc.
Emanuel Vergis, MD, One Medical
WilliamWade, Physician, Family Medicine and Counseling
Henry Webster, Pharmacy Manager, Walgreens
Louis Weiss, Professor of Medicine and Pathology, Albert Einstein College of Medicine
Monique Welbeck, DNP, CHCR
Sarah Williams, APRN, Care program
Sarah Wood MD, MSHP, AAHIVS, Children’s Hospital of Philadelphia
Kristin Yakubovich, PharmD, Walgreens
Caleb Youngblood, Physician Assistant, Be Well Medical Center
David Yurdin, Physician Assistant/Clinical Director, The Project of Primary Health Care, Inc.