James Caro, Chief Executive Officer, Ex Officio Board Member

Jim’s career has focused on improving patient outcomes through collaboration among advocacy organizations and the pharmaceutical industry. His senior management roles at the American Pharmacists Association and the American Society of Health System Pharmacists gave Jim the opportunity to lead pharmacists’ professional development and educational programs, as well as create and support the organizations’ public policy initiatives.

Then as Executive Director of Global Professional Affairs at Wyeth Pharmaceuticals, Jim had broad responsibilities across the product portfolio, supporting launches in internal medicine, oncology, transplant medicine, and vaccines. Immediately before joining Connect4Strategies, James was Senior Director in Sanofi’s Public Affairs Team responsible for the company’s engagement with professional and patient organizations across the oncology portfolio. He is a graduate of University of Maryland School of Pharmacy and Loyola University (MBA).

Saira Sultan, JD, Founder

Saira Sultan has represented corporate, nonprofit, and government interests in the legislative and regulatory health policy arena for more than 20 years in Washington, D.C. She has had repeated success in designing business solutions by identifying and creating advocacy opportunities and translating them into strategic legislative and regulatory results.

Saira brings a decade of experience working with market access, health outcomes, and commercial teams in pharmaceutical companies, including Pfizer and Sanofi. Saira is an experienced project management lead for large cross-functional efforts at Medtronic, Pfizer, Sanofi, and more.

Focusing in areas such as oncology, rare and extremely rare therapies, vaccines, and specialty products in sickle cell, pain, addiction, cell and gene therapy and more, Saira has worked extensively with CMS, FDA and Capitol Hill. Her insight and skill in working cross-functionally in a corporate environment, as well as with advocacy organizations and key trade associations serves her clients well. Saira's leadership at the Association of Community Cancer Centers (ACCC) allowed her to build strong relationships with the oncology community and gain insights into the evolution of oncology care. She continues to work closely with many oncology organizations, identifying emerging trends that have led to repeated success in tackling coverage, coding and payment of marketed and pipeline Part B and D products. The Government Affairs and Policy team at ACCC, under Saira's direction, raised significant revenue, improved the Association's profile, as she became a sought after speaker on oncology policy issues.

Complementing her 10 years in pharmaceuticals, Saira's time at Medtronic gives her an in-depth understanding of the unique needs of the device industry. Representing Medtronic at a time when CMS was completely revamping device reimbursement in hospital outpatient departments, gave her the opportunity to work closely with CMS and key stakeholders. Saira built a successful coalition of varied stakeholders that ensured reimbursement for Class III devices reflecting their value to patients.

Additionally, Saira brings House and Senate experience, including work on the Ways and Means Committee, and roles as senior legislative counsel for Senator Mike DeWine (R-OH) and Chief Counsel to one of the Senate Healthcare Subcommittees. She handled all healthcare issues under the Senate HELP Committee's jurisdiction, including extensive negotiations with FDA and industry on the Balanced Budget Act of 1997 and the first reauthorization of the Prescription Drug User Fee Act.   She spearheaded passage of the first Better Pharmaceuticals for Children.

Saira holds a JD from the University of Virginia in Charlottesville, VA. 

AFFORDABLE CARE ACT MEDICAID EXPANSION

Excerpt from the article…

Medicaid—a federal/state partnership with shared authority and financing—is a health insurance program for low-income individuals, children, their parents, the elderly and people with disabilities. Medicaid pays for health care for more than 74.5 million people nationally. Although participation is optional, all 50 states participate in the Medicaid program. However, eligibility for Medicaid benefits varies widely among the states - all states must meet federal minimum requirements, but they have options for expanding Medicaid beyond the minimum federal guidelines, the details are outlined here.

What’s Next for Medicaid expansion? States are considering the costs and benefits of expansion, and whether or not to pursue expansion through innovative Section 1115 waivers. Recent changes may affect enhanced federal financing for expansion populations, conditions for eligibility, and enrollment and renewal procedures.

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CVS announcement of cost-effective benchmarks puts ICER in the spotlight

Excerpt from the article:

By AMI GOPALAN

Last week’s announcement by CVS Health, which operates one of the country’s largest pharmacy benefit managers, is a harbinger of what may lie ahead for drug pricing and access in the United States.

In what it called an effort to nudge drug makers to reduce launch prices to a reasonable level, CVS said it would allow its Caremark clients — health plans, self-funded employer groups, and the like — to exclude drugs from their formularies (essentially a list of covered drugs) that don’t meet a benchmark of $100,000 per quality-adjusted life year in analyses by the independent Institute for Clinical and Economic Review (ICER). The initial focus will be on so-called me-too drugs, those where therapeutic alternatives exist, and exclude those the Food and Drug Administration deems as breakthrough drugs.

From the employer’s or insurer’s perspective, an ICER analysis indicating that a drug does not meet the quality-adjusted life year benchmark provides a transparent rationale for why certain products aren’t covered by the plan. From the patient’s perspective, it means that the drugs on the formulary are covered by their benefit, while they can get access to a drug that isn’t on the formulary only if they pay for it or go through an appeals and grievance process.

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