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The Food and Drug Administration (FDA) will not finalize its guidance document providing oversight of laboratory-developed tests (LDTs) at this time, the agency announced on November 18.

In 2014, the FDA issued its draft guidance document. The CAP opposed the initial draft as written and called for changes based on the CAP's longstanding principles for LDT oversight. Since 2009, the CAP advocated for a targeted, risk-based approach to oversight that ensures quality laboratory testing for patients, allows for innovation, and prevents undue burdens on laboratories.

Some members of Congress also have opposed the FDA's guidance document and sought to develop a legislative alternative. The CAP engaged with the House and Senate, as well as other key stakeholders, to advocate for its legislative proposal. The CAP's legislative proposal takes a balanced, risk-based approach that allows laboratories to provide accurate and reliable test results for clinicians and patients and relies on a public-private partnership utilizing the existing regulatory structures. To date, congressional committees have yet to reach consensus on legislation.

The FDA cited the recent presidential and congressional elections as a reason for not releasing its final LDT oversight guidance. "We have been working to develop a new oversight policy for laboratory developed tests, one that balances patient protection with continued access and innovation, and realize just how important it is that we continue to work with stakeholders, our new Administration, and Congress to get our approach right," the FDA said. "We plan to outline our view of an appropriate risk-based approach in the near future. It is our hope that such an approach will help guide continued discussions."

Following the FDA announcement, House Energy and Commerce Chair Fred Upton (R-MI) said his committee appreciated the agency's decision. "Diagnostics, regardless of whether they are developed in a lab or by a manufacturer, are critical to advancing precision medicine and raise complex policy issues the committee has been grappling with on a bipartisan basis," Rep. Upton said. "Working together, we are forging significant consensus among a number of patient groups, labs, and manufacturers around a 21st century approach uniquely designed with all diagnostic tests in mind from the outset. We look forward to discussing our efforts to date with additional stakeholders and completing our work next year."

The CAP will continue to engage on LDT oversight with the FDA, Congress and key stakeholders, including patient advocates, other physicians, laboratory organizations, and industry groups.

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Physicians who wish to dispute a Medicare Physician Quality Reporting System (PQRS) or Value-Based Modifier (VBM) penalty must request an informal review and appeal by a November 30 deadline.

For more information on the penalties, the CMS has published 2017 PQRS negative payment adjustment and value modifier informal review guides.

In September and October, individual physicians received letters regarding PQRS and VBM penalties for 2017 from the Medicare program.

Pathologists can confirm if they will be penalized in 2017 by accessing PQRS feedback reports for the 2015 program year. The reports include a payment adjustment assessment for next year. Physicians who did not satisfy quality reporting requirements in 2015 will face Medicare payment reductions of 2- 6% in 2017 depending on the size of the practice. To access reports from the CMS, physicians will need an Enterprise Identity Management (EIDM) account with the appropriate role established. The CMS published a guide for using the EIDM system. The feedback reports can be viewed through the PQRS Analysis and Payment webpage.

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Clinical laboratories will need to appoint two separate people to submit and certify lab payment data submitted to the new clinical laboratory fee schedule (CLFS) data collection system, which will be used to set Medicare payment rates for labs beginning in 2018. The CLFS payment reforms are required by the Protecting Access to Medicare Act (PAMA) of 2014.

The Centers for Medicare and Medicaid Services (CMS) detailed the steps that applicable labs need to take to register and to submit their payment data during a November 2 national provider call. First, laboratories will need to register through the Enterprise Identify Management System (EIDM); after that, they can request access to CMS’s specific data collection system for the CLFS, the Fee-for-Service Data Collection System (FFSDCS). Registration began November 14.

Each reporting laboratory must have two individuals register for the data collection system—laboratory, or someone designated by one of those individuals, to attest to the completeness and accuracy of the data.

Registration Steps

As the CMS concedes, the registration process detailed below is the most time consuming step for users of the FFSDCS.

  1. To register, log in to the CMS's Enterprise Portal at portal.cms.gov. Once there, if you do not have an EIDM account, you'll need to register for a CMS EIDM username and password, which is different from the CMS Enterprise User Administration (EUA) account.
  2. Select a role as either the CLFS data submitter or data certifier. You will be asked to go through a remote identity proofing process, which involves providing personal information and going through a "soft" credit check. The CMS indicates these security measures are needed due to the confidential laboratory data and personally identifiable information involved.
  3. Request access to the FFSDCS which entails selecting the CLFS submitter or certifier role. Approval of the request for the specific role may require up to 72 hours and if confirmed by email from the CMS portal and EIDM system.
  4. Once your registration is approved, you will be asked to register a multifactor authentication token device, a one-time user-only password is granted to establish the relationship between the CMS, the CLFS submitter and certifier. The code or "device" is valid for one week and is to be shared by the CLFS submitter with the CLFS certifier to complete certifier registration.
  5. You will go through a secondary registration process to supply your laboratory name, your reporting tax identification number, as well as any NPIs associated with this tax ID number and any CMS certification numbers.
  6. This information will be submitted to the PECOS repository for validation (make sure your PECOS is updated prior to the EIDM registration).

Role for the Data Submitter

Once the submitter has completed registration, the submitter will select one of two options for submitting data: file upload or manual entry. To use the file upload method, submitters will need to download a CSV file data template from the PAMA webpage. This is the best option of you have a large amount of data to submit. However, if you have a small amount of data to submit, the better option is likely manual entry.

For each test the submitter will need to fill in the HCPCS code, the payment rate, volume and National Provider Identifier. If an applicable laboratory has more than one payment rate for the same private payer for the same tests or more than one payment rate for different payers for the same tests, the reporting entity will report each such payment rate and volume for the tests. The system will accept duplicate HCPCS codes within your submission.

Next, the submitter will upload the data. The system will accept the submitter's file, pass it through validation rules largely to verify formatting such as appropriate number of digits and decimal point placement, and give the results of the submission. If any rows do not pass the validation rules, the submitter will be notified. The data will not be saved until all rows have passed validation.

Role for the Data Certifier

The data certifier must also go through the EIDM registration process as described above. Once registered, the certifier can review any data submitted by their organization. However, if any corrections are needed, those must be made by the data submitter. The certifier simply has the option to register and to review the data but not to modify the data.

Once the review is complete, the certifier will need to attest that they have certified all the data. Once the data are certified, that data is not accessible to the laboratory until the next reporting period.

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Following the Thanksgiving holiday, STATLINE will next appear in your email inbox on December 5. Please continue to check the CAP Twitter and Facebook accounts for updates from the CAP. And, if important news breaks before December 5, the CAP will send a STATLINE Special Alert to all members.

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