APHL’s Policy Program promotes the work of governmental public health laboratories by advocating for a sustainable laboratory network and voicing the impact of federal regulatory rules on public health laboratories.
Regulatory Response Activities
FDA Re-classification of HIV/HCV Diagnostics
CMS Requesting Information for CLIA Update
HHS Notice of Proposed Rulemaking to update the federal policies that protect human subjects in federally funded research
Laboratory Developed Tests
FDA Policy Guidance on Oversight of Laboratory Developed Tests
Semantic Interoperability of Laboratory Data
Promoting Semantic Interoperability of Laboratory Data Public Workshop
Pandemic Influenza Preparedness Framework
Antimicrobial Resistance Rapid, Point-of-Care Diagnostic Test Challenge
Request for Comment: Antimicrobial Resistance Rapid, Point-of-Care Diagnostic Test Challenge
CMS Reimbursement Rates
APHL joined organizations in the laboratory community to raise concerns of the integrity of the data CMS collected when determining accurate weighted median of private payer rates for tests on the Clinical Laboratory Fee Schedule (CLFS). The letters urge Seema Verma, Administrator of CMS, to involve all stakeholders when calculating and establishing pricing.
APHL led a group of governmental public health organizations in a letter to Congress to oppose the cuts to the Clinical Laboratory Fee Schedule (CLFS) that are set to take place in January 2018. ASTHO, NACCHO, CSTE, AMCHP, NASTAD and NCSD joined APHL in calling on Congress to immediately suspend the implementation of the new CLFS rates which cut testing of public health importance up to 35-40%.
APHL joined 24 public health organizations on a letter urging the leadership of the House and Senate Labor, HHS, Education and Related Agencies appropriations subcommittees to provide adequate fiscal year 2018 funding for the activities of the CDC National Center for Environmental Health.
APHL joined over 2,000 organizations on a letter to Congress and the president urging them to work together to protect federal funding for nondefense programs, like those under the department of Health and Human Services. President Trump has proposed cutting that spending by $54 billion.
Repeal of Prevention and Public Health Fund
APHL sent letters to Senate leadership stating to continue provide funding for critical public health programs that are currently funded from the Prevention and Public Health Fund (PPHF), a component of the Affordable Care Act (ACA).
Newborn Screening Funding
APHL sent letters to leadership of Labor-HHS appropriations urging them to increase federal spending on newborn screening. to enable programmatic improvements that include assisting states in implementation of newly added disorders.
- Letter to Labor-HHS Appropriations
Eight US Senators sent a letter to the leadership of the Labor-HHS appropriations subcommittee urging them to increase federal spending on newborn screening to $50 million annually to enable programmatic improvements that include assisting states in the implementation of newly added disorders. This is the first time Senators have organized a request on this issue and APHL worked closely with Senator Gillibrand's office, who spearheaded the effort, on the structure of this letter to the subcommittee.
Sign-on Letter, April 2017
Sign-on Letter, March 2017
APHL joined on two letters to congressional leadership urging continued federal funding for Zika response activities.
APHL joined 16 laboratory organizations on a letter to the leadership of the Labor-HHS appropriations committee urging them to continue funding CDC's efforts on harmonizing laboratory test results.
CSTE-APHL: CDC Epidemiology and Laboratory Programs, March 2017
APHL has joined with CSTE to urge the leadership of the Congressional appropriations committees to provide appropriate funding for CDC surveillance and detection activities, with a focus on workforce efforts.
APHL joined over 350 public health and health organizations on a letter to the president expressing unequivocal support for the safety of vaccines. Robust vaccination programs are critical to improvements in the public's health.
Multiplex Nucleic Acid Amplification Test, 2017