A recent report from the Government Accountability Office (GAO) published Jan. 10, 2020, calls on the Health Resources and Services Administration (HRSA) to improve processes to reasonably assure that participating non-governmental hospitals meet 340B Drug Pricing Program eligibility requirements.
The 340 Drug Pricing Program (340B Program) is administered by the U.S. Department of Health and Human Services' (HHS) Health Resources and Services Administration (HRSA). Under the 340B Program, certain hospitals and other qualified entities that care for many low-income and uninsured individuals receive discounted prices on outpatient drugs from drug manufacturers. About two-thirds of hospitals participating in the 340B Program (approximately 1,700) are non-governmental hospitals (i.e., private, nonprofit hospitals).
The GAO makes several recommendations for achieving greater oversight of hospital eligibility. Among these, the report recommends that HRSA:
HHS agreed with all of the GAO’s recommendations except the recommendation to implement a process to verify that all non-governmental hospitals have contracts in place. HHS says that HRSA does not have the resources to carry out the recommended verification process and it would over-burden the agency.
Read the full report.
Read GAO recommendations.
On Jan. 13, an updated guideline for estrogen and progesterone receptor (ER/PgR) testing in breast cancer was released jointly by the College of American Pathologists (CAP) and the American Society of Clinical Oncology (ASCO). The updated guideline reaffirms much of the original guidance and includes more specific recommendations for handling and reporting cases with low ER expression. The updated guideline was posted as online early release to the Archives of Pathology & Laboratory Medicine (Jan. 13, 2020, doi: 10.5858/arpa.2019-0904-SA).
A CAP press release highlights the following changes:
"Cases with 1-10% of cells staining for ER expression will now be reported as ER-low positive. Pathology reports for these cases should include a recommended comment that acknowledges the more limited data on endocrine responsiveness in this group. Also in such cases, pathologists should report the status of internal controls, with a special comment for specimens that lack internal positive controls."
The CAP press release also notes that the new guideline more clearly recommends that:
". . . ER be tested in cases of newly diagnosed DCIS (without invasion) to help estimate potential benefit of endocrine therapy to reduce the risk of a future breast cancer event. But, specifically, PgR testing in DCIS is optional."
Read the CAP press release.
Access the updated Estrogen and Progesterone Receptor Testing in Breast Cancer guideline.
The American Cancer Society’s annual report on U.S. cancer statistics, released Jan. 8, announced the greatest one-year decline in deaths from cancer since 1930. From 2016 to 2017, overall deaths from cancer dropped 2.2 percent. Between 1991 and 2017, the U.S. has seen the overall cancer death rate drop 29 percent.
In a statement, lead study author Rebecca Siegel, MPH, attributed the record drop to improved statistics related to lung cancer. While a decrease in smoking rates has contributed to the decline, Siegel also credited recent advances in lung cancer treatment for this year's record drop. These include surgical advances, improved diagnostic screening, as well as advances in radiation therapy and anticancer therapeutics.
The U.S. continues to see increases in new cases of certain cancers including cancers of the kidney, pancreas, liver, and oral cavity and pharynx (among non-Hispanic whites), and melanoma skin cancer.
Read the full report.
Read Facts & Figures 2020.
The proposed rule applies to drugs that meet FDA labeling standards and impose no risk to health and safety. The import rule excludes controlled substances, biological products and intravenous drugs. (FDA's Safe Importation Action Plan.)
Comments on the NPRM are being accepted for 75 days after publication in the Federal Register and comments on the draft guidance are being accepted for 60 days after publication in the Federal Register.
Read the HHS press release.
Read Importation of Prescription Drugs Proposed Rule.
Read new draft guidance for industry.