Tag Archives: congress

House Subcommittee Hearing Focuses on HRSA’s Oversight of 340B

by Blair Burnett, Policy Analyst, ACCC

U.S. CapitolThis week, the U.S. House of Representatives Subcommittee on Oversight and Investigations, of the Energy and Commerce Committee, chaired by Rep. Tim Murphy (R-PA), held a hearing titled, “Examining HRSA’s Oversight of the 340B Drug Pricing Program.” Health Resources and Services Administration (HRSA) is the agency within the U.S. Department of Health and Human Services that currently oversees the 340B Drug Pricing Program. The program’s inception in 1992 sought to provide discounted outpatient drugs to “covered entities” (DSH facilities, rural referral centers, freestanding cancer centers, non-profit hospitals, etc.) who provide a certain level of care to Medicaid and low-income Medicare patients, allowing covered entities to stretch scarce federal resources to provide affordable prescription drug coverage to all patients.

The hearing, convened on Tuesday, July 18, addressed how HRSA’s oversight can improve review of eligible healthcare facilities utilizing the program in the face of continued expansion of facilities that qualify. As of October 2016, there are 12,168 covered entities utilizing the 340B Drug Pricing Program, and this number has quadrupled since 2011. The hearing also sought to explore how HRSA can be more transparent with 340B Drug Pricing Program reporting, calling attention to gaps in current data collection efforts.

Witnesses who testified at the hearing included:

  • Krista M. Pedley, PharmD, MS, CDR, USPHS, Director, Office of Pharmacy Affairs, Health Resources and Services Administration, U.S. Department of Health and Human Services;
  • Debbie Draper, Director, Health Care, Government Accountability Office (GAO); and,
  • Erin Bliss, Assistant Inspector General, Office of Evaluation and Inspections, Office of Inspector General (OIG), U.S. Department of Health and Human Services.

Both the office of the GAO and HHS OIG have done significant work with the 340B Drug Pricing Program, and the witness testimony spoke to the recommendations both have made to HRSA. Both offices have also repeatedly reviewed HRSA’s regulatory capabilities with the 340B Drug Pricing Program and stated the need for more robust oversight. Based upon witness testimony and member questioning, key takeaways include:

  • Possible bipartisan legislation efforts that seek to grant HRSA more oversight of the 340B Drug Pricing Program.
  • Increased transparency from HRSA on 340B Drug Pricing Program costs and rules.
    Multiple members called for insight into how covered entities are utilizing any savings accrued from the 340B Drug Pricing Program. Within the current oversight from HRSA, there are no guidelines on how covered entities utilize or report 340B Drug Pricing Program savings.
  • Additional hearings to examine the 340B Drug Pricing Program within the subcommittee bringing in physicians and hospital executives to ask healthcare facilities how they are utilizing savings acquired from the 340B Drug Pricing Program.

Notably, this hearing convened shortly after the July 13 release of the Centers for Medicare & Medicaid Services (CMS) proposed 2018 Outpatient Prospective Payment System (OPPS) rule, which calls for a drastic reduction in Medicare Part B payments for outpatient drugs to all covered entities utilizing the 340B Drug Pricing Program from average sale price (ASP) plus 6 percent to ASP minus 22.5 percent in an effort to reign in the program. Rep. DeGette (D-CO), Rep. Schakowsky (D-IL), and Rep. Pallone (D-NJ) voiced concern over this proposal and called for bipartisan support to make meaningful reforms to the 340B Drug Pricing Program to ensure HRSA oversight is effective in aligning transparency as well as improved facility and overall data audits.

As policymakers continue to shine the light on the 340B program, over the next several weeks ACCC will continue to monitor efforts to reform the program and evaluate the impact the OPPS proposal will have on ACCC membership. Along with other stakeholders and coalition partners, we will be forcefully advocating for policies that are in the best interest of all community-based providers and their patients.


ACCC members can gain an in-depth understanding of how CMS’ proposed CY 2018 Medicare rules will impact oncology by participating in ACCC’s August 9 webinar, “CMS Proposed 2018 OPPS & PFS Rules: What You Need to Know.” Learn more [member log-in required].

SGR Bill Heads to Senate—Contact Your Senators Today!

U.S. Capitol By Leah Ralph, Manager, Provider Economics and Public Policy, ACCC

On March 26, by a vote of 392-37 the U.S. House of Representatives overwhelmingly passed H.R. 2, the Medicare Access and CHIP Reauthorization Act of 2015, legislation to permanently repeal and replace Medicare’s sustainable growth rate (SGR) formula for physician reimbursement. Read a summary of the legislation here.

Rep. Michael C. Burgess, MD, (R-Texas), the bill’s primary sponsor, said in a statement, “This is the work of a collaborative body. . . .It is time to end the SGR. Let us never speak of this issue again.”

On March 25, the White House expressed support for the bill.

The Senate is expected to vote on the bill March 27, before Congress recesses for two weeks.

ACCC urges members to contact your Senators and ask them to support a permanent repeal of the SGR. As an expert in cancer care, they need to hear from you!

Protecting Patient Access: Taking It to the Hill

By Sydney Abbott, JD, Manager, Provider Economics and Public Policy, ACCC

U.S. Capitol We’re on the countdown to ACCC’s Capitol Hill Day on March 31. ACCC members who join us will be visiting with congressional staff to speak out on major concerns affecting oncology care. Those on the front lines of cancer care can deliver a powerful, clear message on issues affecting cancer patients and providers. Patient access to care—in particular to anti-cancer medications—is a cross-cutting concern.

Where Things Stand in Congress—Two Bills

Many health insurance plans cover IV chemotherapy, injected anti-cancer medications, and oral anti-cancer drugs differently, causing patients to pay far more out-of-pocket for oral drugs than for IV chemotherapy or injected medications. With the ever rising cost of healthcare, insurers employ various methods to keep costs down, including increasingly shifting the cost of prescription drugs to patients. To help patients afford the life-saving medications they need, Congress has introduced two complementary—if not somewhat confusing—pieces  of legislation: HR 1801 and companion bill S 1879 to lower the cost of prescription oral chemotherapy drugs, and HR 460, to limit cost-sharing requirements for prescription drugs on specialty tiers. Both bills aim to protect cancer patients in different ways.

Here’s a quick side-by-side comparison of the legislation. For ACCC members joining us for Capitol Hill Day, this snapshot can help you prepare for conversations with congressional staff.

Oral Parity (HR  1801/S 1879)

  • Legislation would require insurers to provide coverage for orally administered anti-cancer medication under terms no less favorable than for medication administered intravenously. Insurers may not create parity by raising rates for IV infusions.
  • Focus is on cost-sharing across prescription drug coverage and office visit coverage for anti-cancer medications only.
  • Requirements: A physician must deem the treatment to be medically necessary for treating cancer, and the treatment must be clinically appropriate in terms of type, frequency, and duration.
  • Types of insurance affected: Group  and individual private plans and self-insured group plans regulated by ERISA that cover oral and IV-infused anti-cancer medications.

Specialty Tier (HR  460)

  • Legislation would limit cost-sharing requirements applicable to prescription drugs in a specialty tier to the dollar amount of such requirements applicable to prescription drugs in a non-preferred tier.
  • Focus is on cost-sharing in prescription drug coverage plans and formularies for any specialty-tier drug covered by the plan.
  • Requirements: A health plan that provides coverage for prescription drugs using a cost-sharing structure shall not impose cost-sharing requirements applicable to prescription drugs in a specialty drug tier that exceed the dollar amount of cost sharing for drugs in a non-preferred brand tier.
  • Types of insurance affected: Group and individual private plans that cover prescription drugs and use a formulary or other tiered cost-sharing structure. Bill language is unclear as to whether ERISA plans are affected.

Both bills help protect patient access to affordable prescription drugs. However, because oral parity legislation already has 67 co-sponsors in the House and a companion bill in the Senate, this will most likely move through Congress first. Therefore, ACCC will be advocating for oral parity (HR 1801/S 1879) in both chambers on Hill Day. In addition, we will be talking to our representatives about SGR reform, elimination of cancer drugs from the 2% Medicare sequester, and elimination of the prompt pay discount. Learn more about Hill Day 2014 and register today.