Advocacy Update

Read the Latest Issue of Advocacy Update

March 10, 2020

In This Issue:

CDC Urges Laboratories to Contact State Health Officials Before COVID-19 Testing

The Centers for Disease Control and Prevention (CDC) strongly encouraged clinical laboratories that are developing and implementing their own COVID-19 tests to contact their state public health department early in the process, even before receipt of any test orders or patient specimens.

The CAP is working with the CDC to monitor the outbreak and laboratory capacity to provide testing. The CAP will provide further updates as new information becomes available. Additional resources are also available from the American Medical Association.

The CDC issued this latest communication on March 4 following the February 29 Food and Drug Administration (FDA) guidance for laboratories to develop COVID-19 molecular diagnostic tests and begin using them prior to obtaining Emergency Use Authorization (EUA). By notifying state public health departments early, laboratories developing their own molecular diagnostic tests for COVID-19 will help ensure that there will be rapid reporting of information necessary to support case investigations, the CDC said. Early notification will also help state public health departments provide the capacity needed for confirmation of the initial testing results in support of the FDA guidance.

All state and local public health departments have laws that mandate reporting of diseases and conditions of public health significance, the CDC said. Any provider (laboratory or clinician) who fails to notify public health of COVID-19 test results or orders may be violating local or state public health laws or regulations.

Laboratories should be prepared to submit positive specimens (all or a subset) to public health for additional testing, the CDC said. Before discarding specimens, laboratories should contact the state health department to ensure the coordination of any additional public health specimen referral or testing. Electronic laboratory reporting of results via standard messaging for COVID-19 (positive, negative, inconclusive) is mandated by many state and local public health departments.

CMS Announces Additional Actions for Nursing Homes, Hospitals

On March 4, the Centers for Medicare & Medicaid Services (CMS) announced state survey agencies and accrediting organizations would focus their facility inspections exclusively on issues related to infection control and other serious health and safety threats, such as allegations of abuse, beginning with nursing homes and hospitals. This shift will allow inspectors to focus their energies on addressing the spread of COVID-19.

The CMS also issued Guidance for Infection Control and Prevention Concerning Coronavirus Disease (COVID-19): FAQs and Considerations for Patient Triage, Placement and Hospital Discharge and Guidance for Infection Control and Prevention of Coronavirus Disease 2019 (COVID-19) in nursing homes.

Coverage Update: CMS Creates New Codes to Bill for Coronavirus Tests

The CMS created new Healthcare Common Procedure Coding System (HCPCS) billing codes for laboratories to receive reimbursement for COVID-19 diagnostic tests.

Laboratories can bill HCPCS code U0001 for the CDC tests that diagnose SARS-CoV-2, the virus that causes coronavirus disease or COVID-19. The second HCPCS code U0002 allows laboratories to bill for non-CDC laboratory tests for SARS-CoV-2. On February 29, the FDA issued guidance for certain laboratories to develop their own validated COVID-19 diagnostic tests.

The CMS said Medicare claims processing systems would be able to accept these codes starting on April 1, 2020, for dates of service on or after February 4, 2020. Local Medicare Administrative Contractors (MACs) are responsible for developing the payment amount for claims they receive for these newly created HCPCS codes in their respective jurisdictions until Medicare establishes national payment rates. Laboratories may seek guidance from their MAC on payment for these tests prior to billing for them. As with other laboratory tests, there is generally no beneficiary cost-sharing under original Medicare.

Review a Medicare fact sheet and frequently asked questions with more information on coverage and payment related to COVID-19.

Private Insurers Vow to Cover COVID-19 Tests

On March 5, America’s Health Insurance Plans (AHIP) said it would cover “needed diagnostic testing when ordered by a physician. We will take action to ease network, referral, and prior authorization requirements and/or waive patient cost-sharing.”

Congress Adopts $8.3 Billion COVID-19 Spending Package, Includes Funding for Tests

To provide the government with greater resources to manage the COVID-19 outbreak, the Senate overwhelmingly passed a $8.3 billion spending bill on March 5, just a day after the House had also overwhelmingly voted for the legislation.

President Donald J. Trump signed the bill into law on March 6.

The Coronavirus Preparedness and Response Supplemental Appropriations Act provides:

  • More than $2 billion for the Biomedical Advanced Research and Development Authority to support advanced research and development of vaccines, therapeutics, and diagnostics
  • $826 million for the National Institutes of Health to support research and development for vaccines, therapeutics, and diagnostics
  • $300 million in contingency funds for procurement of vaccines, therapeutics, and diagnostics
  • $300 million for the government to purchase vaccines
  • $2.2 billion in public health funding for prevention, preparedness, and response, $950 million of which is to support state & local health agencies
  • Nearly $1 billion for medical supplies, health care preparedness, and medical surge capacity
  • $1.25 billion to address the coronavirus outbreak abroad

The law allows the Department of Health and Human Services to ensure that vaccines, therapeutics, and diagnostics developed with taxpayer funds be affordable to the commercial market and be available to the government at a fair and reasonable price.

New LDT Oversight Bill Includes Changes Advocated by the CAP

Following several months of negotiations with the CAP and key stakeholders, a group of bipartisan, bicameral lawmakers introduced legislation on March 5 to target the FDA review on certain laboratory-developed tests (LDTs).

The CAP is conducting a full analysis of the Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2020, which is sponsored by Sens. Richard Burr (R-NC) and Michael Bennet (D-CO) and Reps. Diana DeGette (D-CO) and Larry Bucshon (R-IN). An initial review of the bill indicated that the VALID Act had improved from previous versions and now includes changes explicitly requested by the CAP.

“As the leader in laboratory quality and improvement programs, the CAP remains committed to supporting a legislative plan for LDTs that focuses on protecting patients and providing access to reliable diagnostic tests under an oversight framework that minimizes administrative burdens for laboratories,” said CAP President Patrick Godbey, MD, FCAP, after the bill’s release. “Any new LDT oversight framework must leverage existing processes that are proven to ensure quality tests for patients while mitigating new costs for the implementation of added requirements. The CAP had provided its initial feedback to the bill’s sponsors and it is clear they are listening to stakeholder input. The CAP views the latest version of the VALID Act as another step in the right direction toward ensuring appropriate safeguards are in place for patients.”

“The CAP appreciates the changes from previous versions of the bill so that it now relies on current regulatory structures and directs the administration to ensure there is no duplication between CLIA and FDA requirements. We look forward to providing our comments as we meet with patients, the physician community, and members of Congress.”

While the latest draft is an improvement, the CAP is concerned that lawmakers included new terminology in the legislation. The CAP will examine these new additions and their relation to LDT oversight as it engages with members of Congress.

Virginia Passes Surprise Billing Legislation Championed by VSP, CAP

Following strong lobbying by pathologists and other physicians in Virginia, state lawmakers unanimously passed legislation backed by physicians to protect patients from surprise medical bills and ensure out-of-network care is reimbursed at reasonable rates.

If signed into law, Virginia would become the latest state to require its insurance department to evaluate health plans for hospital-based physician network adequacy, which has been a focus of the CAP’s advocacy to protect patients from surprise medical bills. Other states with network adequacy laws or regulations include California, Louisiana, New Hampshire, and Washington.

The issue of balance billing has been a sore subject in Virginia for years, with doctors and hospitals pitted against insurance companies who sought to cut payments to providers substantially. If signed into law, Senate Bill 172, which was supported by the Virginia Society for Pathology (VSP) and the CAP, would mandate that payers must compensate out-of-network providers at a “commercially reasonable rate” based on payments for the same or similar services provided in a similar geographic area. Payers would have 30 days to pay out-of-network bills, and physicians would have 30 days to dispute the initial offer or the payment.

If the two sides disagree on the amount, they have 30 days to negotiate an agreement. If that fails, either party can notify the State Corporation Commission, which is responsible for providing a list of approved arbitrators to settle the dispute.

Stopping Surprise Medical Bills

While the legislation would keep patients from receiving unexpected bills for care received out-of-network, lawmakers said the month-long negotiation process would discourage both parties from seeking further action. The measure mandates a “baseball-style” arbitration process, with both parties submitting their final offers without going through multiple series of offers and counter offers.

Among other key provisions included are:

  • The Department of Insurance must assess network adequacy of hospital-based physicians in health plans.
  • The data set used in the arbitration is to include All-Payer Claims Database (APCD) calculations.
  • Parties will be permitted to bundle claims for arbitration.
  • Health plans must disclose to out-of-network providers subject to the law.

The bill is expected to be signed into law. In 2019, Washington state enacted similar legislation to protect patients from surprise bills. The origins of that legislation had evolved from concepts proposed by the Washington State Society of Pathologists and the CAP.

Reminder: MIPS 2019 Data Submission Deadline is March 31

The data submission deadline for Merit-based Incentive Payment System (MIPS) eligible clinicians who participated in the 2019 performance period of the Quality Payment Program is just a few days away. Data can be submitted and updated any time until 8:00 PM EDT on March 31, 2020.

For quality measures reported via Medicare Part B claims that have been submitted throughout the 2019 performance period, you can sign in to to see your preliminary feedback on data processed to date. The CMS will update this feedback at the end of the submission period with claims processed by your Medicare Administrative Contractor within a 60-day run-out period.

If you submit your quality data, which is 85% of your MIPS score, via claims, be sure to attest to the Improvement Activities that will represent the other 15% of your MIPS score. You can do this through the CMS’ Quality Payment Program (QPP) website. Watch the CMS’ Manual Attestation of Improvement Activities video for further instructions.

How to Sign In to the Quality Payment Program Website

To sign in, pathologists can create an account on the QPP website. If you need help enrolling, please refer to the QPP Access User Guide. Note: Those who are not sure if they are eligible to participate in the QPP can check their final eligibility using the QPP Participation Status Lookup Tool. Clinicians and groups that are opt-in eligible will need to make an election before they can submit data.

Need help from the CAP

For answers to your MIPS questions, CAP members and their practice administrators can contact our experts by emailing,, or calling 800-323-4040 (select Option 3).

The Pathologists Quality Registry is now enrolling practices for 2020 MIPS reporting. To learn more, please complete the registry inquiry form to schedule a pre-enrollment call to determine if our registry is right for your practice.

Take the March Advocacy News Quiz

In its first week, over 50 CAP members have taken the March Advocacy news quiz. See how you compare against your fellow CAP members’ savvy advocacy knowledge. And then share your results on social media. Take the March news quiz today.