State suspends clinical lab license fees for two years Governor Brown signed a bill (AB 658) on Sept. 28 that suspends the state's clinical laboratory license renewal fees for two years, 2018 and 2019. The bill is a result of an audit that found that the California Department of Public Health (CDPH) had collected millions more in laboratory fees than it had spent operating the Laboratory Field Services (LFS) branch. The fund’s current reserves exceed $22 million. Under existing state law, however, CDPH could not suspend or refund these fees. This bill only suspends renewal fees and will not apply to other fees like multiple site, personnel licensure, new lab or delinquency fees. Fees will be reinstated in 2020, but going forward CDPH will only be permitted to collect enough fees to operate its LFS branch, as spelled out in the current law. Labs in California—including physician operated labs—should see significant savings over the next few years as licensing fees paid to the state are lowered after the freeze. Did you know? Did you know that COLA Laboratory Accreditation is a California Medical Association (CMA) member benefit? COLA a physician-directed organization whose purpose is to promote excellence in laboratory medicine and patient care through a program of voluntary education, consultation and accreditation. This member benefit provides a 20 percent savings on COLA’s Laboratory Accreditation Program. COLA is approved by LFS under state law as well as the federal CLIA program. By enrolling, your one COLA survey every two years will meet both state and federal regulations. CMA members also receive free online support and a complimentary basic quality lab course and may be eligible for a discount on AAFP and ACP proficiency testing programs. Click here to learn more about COLA and to access the CMA member discount code. October 13, 2017 General Accreditation, Clinical Laboratories, State Legislation, State Legislative Advocacy 0 0 Comment Read More »
Assembly bill would temporarily suspend lab renewal fees The California Legislature is considering a bill (AB 658) that would temporarily suspend the state's clinical laboratory license renewal fees for two years, 2018 and 2019. The bill is a result of an audit that found that the California Department of Public Health (CDPH) had collected millions more in laboratory fees than it had spent operating the Laboratory Field Services (LFS) branch. The fund’s current reserves exceed $22 million. Under state law, however, CDPH cannot suspend or refund these fees. This proposed legislation will only suspend renewal fees and would not apply to other fees like multiple site, personnel licensure, new lab or delinquency fees. Fees would be reinstated in 2020, but going forward CDPH will only be permitted to collect enough fees to operate its LFS branch, as spelled out in the current law. If this bill becomes law, labs in California should see significant savings over the next few years as licensing fees paid to the state are lowered after the freeze. The bill passed the Assembly without objection and has passed the first Senate Committee. Did you know? Did you know that COLA Laboratory Accreditation is a California Medical Association (CMA) member benefit? COLA a physician-directed organization whose purpose is to promote excellence in laboratory medicine and patient care through a program of voluntary education, consultation and accreditation. This member benefit provides a 20 percent savings on COLA’s Laboratory Accreditation Program. COLA is approved by LFS under state law as well as the federal CLIA program. By enrolling, your one COLA survey every two years will meet both state and federal regulations. CMA members also receive free online support and a complimentary basic quality lab course and may be eligible for a discount on AAFP and ACP proficiency testing programs. Click here to learn more about COLA and to access the CMA member discount code. July 21, 2017 General Clinical Laboratories 0 0 Comment Read More »
CMS delays reporting deadline for physician labs The Centers for Medicare and Medicaid Services (CMS) has announced that it will delay the deadline for physician office-based laboratories to meet new reporting requirements. Qualified laboratories now have until May 30, 2017, to complete reporting of private payor payment data for clinical testing services, as required by the Protecting Access to Medicare Act (PAMA). Under PAMA, laboratories that meet revenue thresholds are required to report private payor payment rates and associated volumes for tests they perform that are paid on the Clinical Laboratory Fee Schedule (CLFS). CMS said it will use data collected to set new payment rates for these tests, a move that is expected to result in decreased reimbursement for these services. In an effort to preserve point-of-care testing and to stave off the decrease in rates, the American Medical Association (AMA) sent a letter requesting a one-year delay in the implementation of the new CLFS and that CMS work with the physician community to find an appropriate path forward that would preserve point-of-care testing in physician office-based laboratories. The California Medical Association supports AMA’s actions. More information on the announcement by CMS and the PAMA reporting requirements are available on the CMS website. April 19, 2017 General Centers for Medicare and Medicaid Services, Clinical Laboratories, CMS, Medicare, Regulatory Advocacy 0 0 Comment Read More »
United Healthcare extends clinical data submission deadline to Sept. 2 At the request of the California Medical Association (CMA), United Healthcare (UHC) has delayed the expansion of its Clinical Data Submission Protocol in California. Originally scheduled to take effect July 1, the expansion will now be pushed back until September 2. First introduced in 2015, the program originally targeted only Medicare benefit plans and required physicians to submit all laboratory test results for UHC Medicare patients. The expansion of the program will require practices to submit laboratory tests for all UHC Medicaid and commercial benefit plans. For more information about the protocol and requirements for submitting data to UHC, physicians should refer to the updated Clinical Data Submission Protocol Frequently Asked Questions and Methods of Clinical Data Exchange. While UHC lauds the sharing of clinical patient data as an opportunity to support quality and cost-effective patient care, CMA has expressed concerns about the administrative burden, impact on physician practices and proper notice to physicians. UHC has stated, however,that it will help practices establish the transmission method that works best with their current capabilities. For more information or to speak to the UHC clinical data team, contact the UHC Provider Call Center at (877) 842-3210 or your local Network Account Manager or Provider Advocate. July 14, 2016 General Medicare, United Healthcare, Clinical Laboratories 0 0 Comment Read More »
Audit says state lab oversight is duplicative, should be eliminated On September 10, the California Bureau of State Audits issued a report that said the California Department of Public Health's (CDPH) Laboratory Field Services should be eliminated because it duplicates a service provided by the Centers for Medicare and Medicaid Services (CMS). CMS regulates all human laboratory testing in the U.S. through the Clinical Laboratory Improvement Amendments system. In California, labs must also be licensed through the state's Laboratory Field Services. This dual regulatory system is a huge burden on physician-operated labs in our state, and the California Medical Association has for many years advocated for the elimination of this unnecessary and duplicative licensing system. In a letter to legislators and the governor, the auditors said the oversight provided by CDPH was “redundant and ineffective,” and that eliminating its laboratory oversight would save labs from unnecessary and duplicative fees and inspections. The audit also found that not only is the state's laboratory oversight unnecessary and duplicative, but it is also ineffective—only performing half of the required biennial inspections in 2013 and 2014; failing to investigate laboratory-related complaints; and without a process to ensure that it is aware, in a timely manner, when out-of-state labs that are licensed in California fail required proficiency testing. Read the Auditor’s report here. September 28, 2015 General Clinical Laboratories 0 0 Comment Read More »
Fraud alert: recognizing relationships that may trigger fraud and abuse concerns for physicians The laws regarding fraud, abuse and anti-kickback violations can be complicated and difficult for physicians to navigate. However, it is increasingly important that physicians be aware of relevant prohibitions to avoid being implicated in a potentially fraudulent scheme. The California Medical Association (CMA) has received reports that some clinical laboratories, especially those testing for cardiovascular markers, are offering physicians cash incentives for blood draws of Medicare patients. Accepting such incentives could put physicians afoul of laws governing fraud and abuse. Anti-kickback laws prohibit physicians from offering or receiving anything of value in exchange for referral of patients. Although a number of safe-harbor provisions exist to limit the breadth of this prohibition, it is strictly enforced. Additionally, self-referral laws prohibit physicians from referring their patients for specified goods or services to entities in which the physician or a member of the physician's immediate family has a financial interest. Again, although exceptions do exist, the law presumes there is an ethical dilemma whenever a physician refers a patient to an entity in which he or she has a financial interest. CMA offers informational materials to help physicians understand these complex laws and the potential consequences of partnerships or agreements they enter into. Physicians with questions about specific arrangements should contact an attorney or their professional liability carrier to navigate the complexities of the anti-kickback and referral prohibitions applicable to their unique situation. To learn more about fraud and abuse laws, see the chapter titled "Fraud and Abuse: Referral Issues" in CMA's online health law library. The health law library is free to members in CMA's online resource library at www.cmanet.org/cma-on-call. Nonmembers can purchase documents for $2 per page. Contact: CMA Legal Information Line, (800) 786-4262 or legalinfo@cmanet.org. February 18, 2015 General Fraud and Abuse, Self-Referral, Clinical Laboratories 0 0 Comment Read More »
HHS announces new rule that gives patients direct access to lab test results Patients will soon be able to obtain their medical test results directly from the laboratory, rather than having to request a copy from their physician's office, according to a new rule announced Monday by the U.S. Department of Health and Human Services (HHS). The rule is part of a broader effort to give Americans more control over their health care. It supersedes state law and will have particular significance in 13 states that currently prohibit labs from releasing test results directly to patients. Current California law allows the release of lab results to patients if providers give approval. Although under the Health Insurance Portability and Accountability Act (HIPAA), physicians and other covered entities were already required to provide patients with copies of their protected health information (PHI) upon request, many laboratories were exempt from this requirement. “The right to access personal health information is a cornerstone of the [HIPAA] Privacy Rule,” said HHS Secretary Kathleen Sebelius. “Information like lab results can empower patients to track their health progress, make decisions with their health care professionals and adhere to important treatment plans.” While patients can continue to get access to their lab tests from their physicians, under the new rule, labs will be required to provide patients copies, including electronic copies, of their lab test results within 30 days of a request. The new rule becomes takes effect 60 days after publication in the Federal Register, which is expected to happen Thursday. HIPAA-covered labs will have 180 days from the effective date of the rule to comply. The final rule amends the Clinical Laboratory Improvement Amendments (CLIA) of 1988. Before the revisions, CLIA stipulated that labs could release test results to only three types of individuals: the person authorized under state law to order or receive results, typically a physician; the person responsible for using the test results for treatment; and a referring lab that requested the test. The final rule is available for review at www.federalregister.gov. February 7, 2014 General Diagnostic Testing, HIPAA, HIPAA Privacy Rule, Clinical Laboratories 0 0 Comment Read More »
