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Quarterly Advocacy Update

Keeping you informed on policy issues affecting pathology and laboratory medicine.

Recap of the Latest Advocacy News from April-June 2022

In this Issue:

Pathologists Fight Future Medicare Cuts During the CAP’s Annual Hill Day

A record-breaking number of CAP members advocated to protect the value of pathology services while meeting with their federal legislators on May 3 during the CAP’s Hill Day. Hundreds of CAP members discussed how Congress can mitigate Medicare cuts, prepare for medical workforce shortages, and ensure funding for future pandemic preparedness. Read more

Senate HELP Committee Advances VALID Act to Senate Floor

The Senate Committee on Health, Education, Labor, and Pensions (HELP) on June 14 approved a package of bills to reauthorize existing Food & Drug Administration (FDA) user fees. It included new legislation (the VALID Act), which would authorize the FDA to regulate in vitro diagnostics (IVDs), including laboratory-developed tests. Read more

CAP Identifies Provisions it Supports and Wants Changed in Senate LDT Proposal

On May 17, the Senate HELP released the latest version of the Verifying Accurate Leading-edge IVCT Development (VALID) Act as part of the next user fee authorization bill for the FDA. The latest version of the VALID Act represented a positive step in the right direction on the oversight of laboratory-developed tests and captured several of the CAP’s long-held policy positions. Read more

CAP Joins in Call to Improve Diversity in Clinical Trials

The CAP joined 71 other organizations representing patients with chronic and acute health conditions to urge the Senate to take up critical provisions in the House Prescription Drug User Fee Act (PDUFA) reauthorization, which, if implemented, would improve diversity in clinical trials. Read more

CAP Praises Congress for Introduction of Legislation to Address Social Determinants of Health

The CAP applauded Congress for introducing the Health Equity and Accountability Act which includes policies to mitigate and eliminate the impact of social determinants of health, increase access to and the quality of health care for underserved communities, funds workforce diversity programs, and addresses the maternal health and mental health crises. Read more

CAP Urges CMS to Increase Pathology Residency Slots, Payments for CAR T-Cell, and Quality Measurements

In the proposed Hospital Inpatient Prospective Payment System regulation, the CAP asked the Centers for Medicare & Medicaid Services (CMS) to increase residence slots for pathology, monitor, and evaluate CAR T-cell therapies, and increase stratification of quality measures in hospital reporting programs. The CAP advocates fair payment for the value pathologists provides and reduced regulatory burdens on pathologists. Read more

Advocacy Win: CMS Retains Diagnostic Codes for Next Generation Sequencing

The CMS agreed to retain over 100 diagnostic (ICD-10) codes that they proposed to remove from the Next Generation Sequencing national coverage determination by July 1. Additionally, the Florida Medicare Administrative Contractor proposes to retire its local coverage policy for special stains. Read more

New CDC Center to Forecast Future Pandemics

On April 19, the White House held an event announcing the new Center for Forecasting and Outbreak Analytics under the Centers for Disease Control & Prevention (CDC). The new center, which the CAP supports, will provide forecasting for infectious diseases. The CAP had urged the federal government to centralize resources to counter the current pandemic and prepare for future ones, especially those elements concerning diagnostic testing. Read more

CMS Releases IDR Chart, Other No Surprises Act Resources

On April 12, the CMS released additional guidance on the No Surprises Act, including a chart for the Independent Resolution Process, FAQs surrounding the new surprise billing requirements, and requirements related to providing good faith estimates. The CAP had urged Congress to hold patients harmless from bills for out-of-network services provided at in-network hospitals or facilities and now engages with the administration on the implementation of the No Surprises Act. Read more

CAP Asks CLIAC to Consider Oversight for Nontraditional Laboratory Testing

With the significant increase in the number of nontraditional testing sites since the COVID pandemic, the CAP has urged the CMS to consider the optimal oversight for nontraditional testing sites and point of care testing. Regardless of where any of the test components are performed, laboratories should observe good laboratory practices throughout the total testing process. Read more

CAP Urges Quick Action on Additional COVID-19 Funding

The CAP, along with the members of the Cancer Leadership Council, urged congressional leaders to move quickly to approve additional resources for the nation’s COVID-19 response. Lawmakers in early April initially reached a deal for an additional $10 billion in COVID funding, well short of the $22.5 billion in emergency funds that President Joe Biden had requested. Read more

AMA, CAP Urge HHS to Extend COVID Physician Relief Reporting Period

The AMA, the CAP, and more than 30 medical professional organizations asked the Department of Health and Human Services (HHS) to extend its Provider Relief Fund (PRF) reporting period for 60 days. The CAP kept its members informed of the PRF resources and deadlines, but also understood that the HHS rules for reporting were challenging for physicians to meet. Read more

HHS Reopens Reporting for Provider Relief Funds, Answering Call from AMA, CAP

Due largely to efforts led by the American Medical Association (AMA), the CAP, and other organizations, the Health Resources and Services Administration (HRSA) reopened the reporting period for recipients of Period 1 Provider Relief Funds (PRF). Providers were supposed to have reported through a HRSA PRF portal by November 30, 2021, deadline, but many physician practices missed the deadline. Read more

CDC Announces Monkeypox Specimen Guidelines, PCR Test

The CDC released specimen collection guidelines and PCR test procedures for monkeypox virus. The CDC recommended that laboratories with suspected monkeypox virus specimens contact their state or territorial public health department (contact list) or the CDC Emergency Operations Center (EOC) at 770-488-7100 for guidance. Additionally, the CDC published a Real-Time PCR test procedure to detect non-variola orthopoxvirus. Read more

CDC Publishes Monkeypox Virus PCR Testing Procedure

On June 6, the CDC published a Real-Time PCR test procedure to detect the monkeypox virus. This assay is designed to detect the monkeypox virus and is intended for international partners and laboratories interested in pursuing a laboratory-developed test. This procedure includes sequence information for primer and probe development and cycling conditions. Read more

Advocacy Win: Kentucky Pathologists-CAP Amended Test Results Law Enacted

On April 8, Kentucky State House Bill 529 was enacted, without Gov. Andy Beshear’s signature, displacing the information blocking requirements of the federal 21st Century Cures Act for certain test results and pathology reports. The Kentucky Society of Pathology (KSP), the CAP, and the Kentucky Medical Association (KMA) successfully amended the legislation to address pathologist concerns with the initial bill. The CAP worked to safeguard pathologists and laboratories from federal legal risks under the Cures Act considered to be information blocking, resulting from delay in the release of diagnostic testing results to patients. Read more

Massachusetts Pathologists Oppose Scrapping Payment System in No Surprises Act

The Massachusetts Society of Pathologists (MSP) strongly opposed Senate Bill 2774 which establishes a default out-of-network commercial reimbursement rate for emergency and non-emergency services. The CAP worked closely with Congress to develop the bipartisan No Surprises Act and supports MSP in its efforts to oppose the proposed legislation. Read more

Advocacy Win: ASP-CAP Amended Pathologists’ Assistant Legislation Signed into Law

On March 29, Arizona Gov. Doug Ducey signed House Bill 2197 into law, which authorized pathologists’ assistants to assist with the performance of forensic autopsies under the direct supervision of licensed forensic pathologists. In coordination with the CAP, the Arizona Society of Pathologists and the National Association of Medical Examiners successfully worked to protect pathologists’ scope of practice in forensic pathology. Read more