April 15, 2019

The Honorable Alex Azar


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.


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

  1. 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.