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ACLA Applauds CMS for Removing Burdensome and Duplicative Medicare Advantage Compliance Training Requirements
(Washington, D.C.) – The American Clinical Laboratory Association (ACLA) today submitted comments to the Centers for Medicare & Medicaid Services (CMS) on the 2019 Medicare Program Proposed Rule, applauding the agency on its decision to remove first tier, downstream, related entities (FDRs), including laboratories, from Medicare Advantage (MA) compliance training requirements that are inapplicable, ineffective and burdensome.
“ACLA appreciates CMS’ proposal to address this issue, specifically acknowledging that the agency’s compliance training requirements under MA were not germane for some entities,” said Julie Khani, president of ACLA. “ACLA’s membership includes laboratories that have been subject to mandatory MA training that has been costly and duplicative of other training.”
ACLA comments to CMS Administrator Seema Verma on the Proposed Rule – Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program (“2019 Medicare Proposed Rule”) reiterate ACLA’s communication with the agency over the course of several years and note:
“ACLA members are committed to fostering a culture of compliance and to providing efficient and effective compliance training to their employees at least annually. As such, ACLA appreciates that CMS recognizes that implementation of the mandatory CMS-developed training, and the requirement that it be used by Medicare Advantage Organizations (MAO), has not achieved its intended goals or promoted effective administration of the MA program. ACLA strongly supports CMS’s proposal to delete the provisions from the Part C and D regulations that require the use of the CMS-developed training. ACLA also concurs that an MAO can ensure compliance with program requirements through routine monitoring and implementing corrective action when non-compliance is identified. As CMS acknowledged in the Proposed 2019 Medicare Rule, given the current MA climate and sophistication of the industry, the CMS training requirement is not the driver of performance improvements or FDR compliance with key CMS requirements. ACLA agrees and applauds CMS for proposing to remove the reference to FDRs in the compliance training requirements codified at §§ 422.503(b)(4)(vi)(C) and 423.504(b)(4)(vi)(C). Such a solution preserves the integrity and the spirit of MA compliance training while alleviating the unnecessary burden borne by FDRs under the current requirements.”
“The clinical lab community is committed to a culture of compliance and is supportive of training that fulfills statutory requirements and preserves the integrity of MA compliance training, but is not duplicative or irrelevant,” said Khani. “We strongly support finalizing the revisions in the 2019 Proposed Medicare Rule that address our concerns and make way for a meaningful yet less burdensome compliance training solution.”
To view ACLA’s comments in their entirety, click here.
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ACLA is a not-for-profit association representing the nation’s leading clinical and anatomic pathology laboratories, including national, regional, specialty, ESRD, hospital and nursing home laboratories. The clinical laboratory industry employs nearly 277,000 people directly and generates over 115,000 additional jobs in supplier industries. Clinical laboratories are at the forefront of personalized medicine, driving diagnostic innovation and contributing more than $100 billion to the nation’s economy.
ACLA Comments on Medicare Compliance Training Requirements Proposed Rule
CMS Ignored Congressional Intent in Implementing New Clinical Lab Payment System Under PAMA, ACLA Charges in Suit
(Washington, D.C.) – The government agency that runs the Medicare program failed to follow a congressional directive to implement a market-based laboratory payment system, thereby jeopardizing Medicare patients’ access to vital laboratory services, according to the American Clinical Laboratory Association (ACLA) in a lawsuit filed today against the Acting Secretary of the U.S. Department of Health and Human Services (HHS) in the U.S. District Court for the District of Columbia.
The lawsuit asserts that the Centers for Medicare & Medicaid Services (CMS), operating under the purview of HHS, ignored congressional intent and instituted a highly flawed data reporting process in advance of setting market rates under the Protecting Access to Medicare Act (PAMA). Contrary to Congress’s directives, the overwhelming majority of laboratories were prohibited from reporting private payer data. As a result, CMS failed to protect access to laboratory services for Medicare beneficiaries. This flawed process could cause serious financial harm to potentially thousands of hospital, independent and physician office laboratories, and make it harder for Medicare beneficiaries to get access to medical testing, particularly in remote rural areas and in nursing homes that depend on laboratory testing services.
“We have repeatedly advised CMS that there are significant, substantive deficiencies in the final rule, which fails to follow the specific commands of the PAMA statute,” said Julie Khani, president of ACLA. “Contrary to Congress’s intent, instead of reforming Medicare reimbursement rates to reflect the broad scope of the laboratory market, the Secretary’s final rule will disrupt the market and prevent beneficiaries from having access to the essential laboratory services they need.”
“CMS clearly disregarded and violated the statute’s specific, unambiguous directives requiring commercial rate information to be reported and collected from a broad, diverse group of market participants,” said Mark D. Polston, partner at King & Spalding, the law firm which will represent ACLA in the suit. Polston is a former Chief Litigation counsel for CMS, with decades of experience in Medicare reimbursement policy. “Instead, information was collected from less than one percent of U.S. laboratories. More than 99 percent of laboratories were prohibited from reporting their data.”
“Every day, this industry provides laboratory services that are vital in preventing illness, diagnosing disease, and monitoring medical treatment,” said Curt Hanson, MD, ACLA Board Chair and Chief Medical Officer of Mayo Medical Laboratories. “This lawsuit reflects our obligation to those who are providing critical testing services, and to those millions of Americans who rely on the services our industry provides.”
ACLA continues to support modernizing the Clinical Laboratory Fee Schedule (CLFS) under PAMA, assuming the process would be based on the clear direction of Congress to establish a Medicare payment system based on the collection of private payor rates across the wide spectrum of the clinical laboratory community.
ACLA’s Khani stated: “From the beginning, ACLA has supported a fair and predictable market-based system that encourages innovation and recognizes the value of clinical laboratory testing in health care services for Medicare beneficiaries. It is reckless and damaging to Medicare beneficiaries for the Secretary to implement a payment system based on a specious data collection process that actually threatens the viability of some laboratories to continue operations and jeopardizes access to important lab tests.”
To view the complaint in its entirety, click here.
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ACLA is a not-for-profit association representing the nation’s leading clinical and anatomic pathology laboratories, including national, regional, specialty, hospital, ESRD and nursing home laboratories. The clinical laboratory industry employs nearly 277,000 people directly, and generates over 115,000 additional jobs in supplier industries. Clinical laboratories are at the forefront of personalized medicine, driving diagnostic innovation and contributing more than $100 billion to the nation’s economy.
ACLA to CMS: Overall Finalized Rates Still Fundamentally Flawed, Agency Must Halt Implementation
(Washington, D.C.) – The American Clinical Laboratory Association (ACLA) stepped up its call to the Centers for Medicare & Medicaid Services (CMS) to delay its flawed implementation of Congress’ efforts to modernize the Medicare clinical lab payment system and align payment rates with market prices in the Protecting Access to Medicare Act (PAMA). While ACLA acknowledged several modifications to the draft rates by CMS following the public comment period, the association repeated its concerns with the failure of the agency to include the broad laboratory market in data collection as required by PAMA.
“The final payment rates published today make clear CMS ignored Congress’s instructions to gather commercial price information from all sectors of the clinical laboratory market and base Medicare payment rates on that data, an objection ACLA and many other stakeholders have made since CMS first proposed its data collection methodology in 2015. CMS’ decision today to move forward with these rates is ill-advised, inconsistent with the statute and, most importantly, detrimental to patient care. Implementation of a modified Clinical Laboratory Fee Schedule (CLFS) that is inconsistent with PAMA must be delayed,” said Julie Khani, president of ACLA.
Khani reiterated ACLA’s grave concern that the data collected was grossly compromised because CMS excluded key market information which will result in cuts that go far beyond what Congress intended. “The final rates are based on insufficient and unrepresentative price information that does not accurately reflect the greater laboratory market. CMS has pressed forward with a flawed approach and produced a flawed outcome,” stated Khani.
From the outset, ACLA has advocated for a rational payment system that provides predictability, rewards innovation and maintains access to lab services for Medicare beneficiaries. To that end, the association recently joined 21 other stakeholders in a letter to CMS Administrator Seema Verma requesting “immediate action to address the significant deficiencies in its process to establish new clinical laboratory payment rates.” Additionally, ACLA submitted comments to CMS in response to the agency’s proposed market data reporting and collection requirements and the September 2017 announcement of the proposed payment rates that are based upon incomplete data.
“ACLA has worked diligently with the stakeholder community and CMS to get CLFS reform right,” said Khani. “Congress was clear that a market-based rate solution would best serve the lab community and patients in need of important test services. ACLA supported PAMA based on congressional intent. We strongly urge CMS to suspend its flawed implementation of PAMA until the process adheres to what Congress intended. We will advocate before all branches of government, including the courts if necessary, to ensure the best outcome for clinical laboratories and the Medicare beneficiaries we serve.”
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ACLA is a not-for-profit association representing the nation’s leading clinical and anatomic pathology laboratories, including national, regional, specialty, ESRD, hospital and nursing home laboratories. The clinical laboratory industry employs nearly 277,000 people directly and generates over 115,000 additional jobs in supplier industries. Clinical laboratories are at the forefront of personalized medicine, driving diagnostic innovation and contributing more than $100 billion to the nation’s economy.
ACLA Calls for Suspension of Flawed PAMA Rates in Comments to CMS
Association Cites CMS Failure to Implement CLFS Reform as Congress Intended, Says Proposed Rates Will Hurt Most Vulnerable Medicare Beneficiaries
(Washington, D.C.) – The American Clinical Laboratory Association (ACLA) today submitted comments to the Centers for Medicare and Medicaid Services (CMS) in response to the agency’s preliminary payment determinations for lab tests under the Protecting Access to Medicare Act (PAMA).
“ACLA has consistently objected to the failure of CMS to implement the PAMA statute according to Congressional intent,” said Julie Khani, president of ACLA. “The proposed rates published by CMS are based on a deficient data collection process that excluded the majority of laboratories from participating, resulting in the submission of inaccurate and incomplete laboratory payment data. CMS must delay implementation of any new CLFS rates until it has collected data and calculated rates that accurately reflect all segments of the laboratory market, ensuring continued access to laboratory testing services for Medicare beneficiaries.”
The association has been consistent in stating its concerns with PAMA implementation, and recently joined 21 other stakeholders in a letter to CMS Administrator Verma requesting “immediate action to address the significant deficiencies in its process to establish new clinical laboratory payment rates.” At the core of the lab community’s objection is CMS’ sidestepping of congressional intent to establish fair market-based pricing based on the broad scope of the laboratory market.
“The proposed rates represent drastic pricing reductions far beyond those intended by Congress,” said Khani. “If finalized, these rates will create severe disruptions in access to laboratory services, particularly for the most vulnerable Medicare beneficiaries. It is critical that implementation of the draft payment rates is delayed, in order to achieve PAMA’s intent: a true market-based payment solution for laboratory services.”
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ACLA is a not-for-profit association representing the nation’s leading clinical and anatomic pathology laboratories, including national, regional, specialty, ESRD and nursing home laboratories. The clinical laboratory industry employ nearly 277,000 people directly, and generate over 115,000 additional jobs in supplier industries. Clinical laboratories are at the forefront of personalized medicine, driving diagnostic innovation and contributing more than $100 billion to the nation’s economy.
ACLA Comments on PAMA Preliminary Rates
Laboratory Market Stakeholders Call for Suspension of Draft PAMA Rates; Urge CMS to Take Immediate Action to Address Flawed Data Collection and Methodology
ACLA, NILA, AdvaMedDx and POCTA Issue Joint Release Echoing Stakeholder Letter to Administrator Verma
WASHINGTON, D.C. – Leading laboratory stakeholders in a joint letter to Centers for Medicare and Medicaid Services (CMS) Administrator Seema Verma today called on the agency to take immediate action to address the significant deficiencies in its process to establish new clinical laboratory payment rates. CMS recently issued drastically low draft payment rates for lab tests under the Protecting Access to Medicare Act (PAMA). Stakeholders pointed to serious flaws in the data collection process, which resulted in unreliable and unsustainable draft payment rates that will threaten the viability of lab services and Medicare beneficiary access to important tests.
“ACLA is deeply concerned that CMS has issued draft rates determined by a process that clearly did not adhere to congressional intent,” said Julie Khani, president of the American Clinical Laboratory Association (ACLA). “ACLA stands with other laboratory stakeholders in the call for suspension of PAMA draft payment rates until issues with data integrity and market exclusion are addressed.”
The letter, signed by 22 stakeholders, states:
The payment data collected by CMS for tests on the Clinical Laboratory Fee Schedule (CLFS) does not result in an accurate weighted median of private payer rates for most tests on the CLFS, as required by the Protecting Access to Medicare Act (PAMA). We believe the data used to set the proposed rates would not stand up to statistical validity review. The data sources used to determine the preliminary rates do not appear to reflect the various market segments, which CMS has the authority to consider in order to validate the data submitted. It is also clear from our review that the overly burdensome regulatory requirements resulted in the submission of inaccurate and incomplete laboratory payment data that is not reliable for use in its current form. As a stakeholder community, we have repeatedly pointed out to CMS, HHS, and Congress in formal comments and in meetings our concerns with the final PAMA regulation, including the serious limitations and skewed process the regulation created.”
Additionally, the groups stress that the CLFS rates will “now result in significant harm to the nation’s surveillance network for emergent public health issues, job losses across the United States, and significantly reduced access to clinical laboratory testing for Medicare beneficiaries, particularly those in rural geographic and post-acute care settings.”
“The HHS Office of the Inspector General previously stated in its evaluation of the regulation that it may lead to inaccurate Medicare payment rates for lab tests,” says Mark S. Birenbaum, Ph.D., NILA Administrator. “We see with the release of flawed payment data that the OIG was correct. NILA urges Congress to work with HHS to suspend any implementation of revised Medicare payment rates until they can resolve the regulatory issues that have prohibited the government from accurately assessing data from all segments of the laboratory market. The consequences of getting this wrong are too grave, threatening access to clinical laboratory testing relied on by physicians and seniors for medical diagnoses, treatment, and monitoring of care.”
The letter cites revisions to the PAMA regulation that must be addressed before stakeholders can support implementation. Specific concerns include data integrity, market representation of all segments of the laboratory market including national independent, community and rural independent, hospital outreach, and physician office laboratories, and the validation of data collection by CMS.
AdvaMedDx Executive Director Andrew Fish noted, “For many tests, the Medicare reimbursement cuts now projected to take place under the PAMA are dramatically deeper than Congress originally envisioned, which could imperil patient access to important diagnostic tests.” Fish continued, “It appears that this is due in significant measure to serious flaws in the lab-reported data CMS used to calculate the new payment rates, which do not accurately reflect the private market. CMS should suspend implementation of new rates under PAMA until stakeholders can be assured that they fairly reflect the full diagnostics marketplace and are consistent with Congressional expectations when PAMA was enacted.”
Signers to the letter to Administrator Verma include: AdvaMedDx, American Academy of Family Physicians, American Association of Bioanalysts, American Association for Clinical Chemistry, American Clinical Laboratory Association, American Hospital Association, American Medical Association, American Medical Technologists, American Society for Clinical Laboratory Science, American Society for Clinical Pathology, American Society for Microbiology, Association of American Medical Colleges, Association of Public Health Laboratories, Clinical Laboratory Management Association, COLA, College of American Pathologists, Medical Group Management Association, National Association for the Support of Long Term Care, National Independent Laboratory Association, New York State Clinical Laboratory Association, New York State Society of Pathologists and Point of Care Testing Association.
CMS’ period for comment on the proposed draft PAMA rates ends October 23rd.
To view the letter, click here.
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Leading Laboratory Stakeholders Letter to Centers for Medicare and Medicaid Services (CMS) Administrator Seema Verma
ACLA Unveils New Economic Analysis that Underscores Clinical Laboratory Industry’s Contribution to National, State, Local Jobs and Tax Base
Proposed Medicare Cuts to Clinical Lab Services May Cause Lab Closures, Job Losses, and Reduce Patient Access
(Washington, D.C.) – The American Clinical Laboratory Association (ACLA) announced a new analysis today that shows clinical laboratories contribute $100 billion in overall economic output to the US economy. ACLA cautioned that proposed Medicare cuts to lab tests by the Centers for Medicare and Medicaid Services (CMS) could trigger job losses, lab closures, and threaten beneficiary access to critical lab services.
“The new economic analysis shows the clinical laboratory sector is a strong industry that delivers jobs, economic growth, and patient care nationwide,” said Julie Khani, president of ACLA. “The analysis further shows that the clinical laboratory industry operates in all types of communities, including those that are medically underserved and in rural areas. The clinical laboratory industry is well-suited to continue to serve these communities’ patients, including Medicare beneficiaries and those whom lack mobility due to poor health or other circumstances.”
“Unfortunately, it is this broad patient access to lab services that is now threatened by ill-advised proposed payment rate policies put forth by CMS. These proposed rates will devastate many of our members and create severe disruptions in access to laboratory services, particularly for the most vulnerable Medicare beneficiaries.”
The Medicare cuts, proposed as part of the Protecting Access to Medicare Act of 2014 (PAMA), will not only serve as a detriment to patients but threaten the very jobs the clinical lab industry provides.
Khani emphasized, “This is the highest priority for ACLA. We will pursue all options to ensure that PAMA is implemented in accordance with congressional intent and in a manner that protects Medicare beneficiary access to a broad range of providers for laboratory services.”
The Economic Impact of Clinical Laboratories Study, sponsored by ACLA, is a first-time analysis of the economic contributions of the clinical laboratory industry for the country, states, and congressional districts. For the United States alone, the clinical laboratory industry:
- Provides more than $40 billion in wages.
- Employs or is responsible for more than 622,000 direct and indirect jobs.
- Pays more than $13 billion in taxes.
- Generates more than $100 billion in overall economic output.
An estimated 37,000 representative laboratories were included in The Economic Impact of Clinical Laboratories Study. The analysis measures the combined economic impact of medical testing laboratories including those operated by independent firms, hospitals, physician offices, in- and outpatient medical facilities, pharmacies and various other medical sites that are defined as complex testing facilities under the Clinical Laboratory Improvement Amendments (CLIA) as maintained by CMS.
“Clinical laboratory innovation is responsible for ushering in an era of personalized medicine that has transformed health care and led to more precise diagnoses and treatments,” said Khani. “In communities across America, clinical laboratories make vital contributions to our economy and the lives of patients every day.”
To view the entire report, click here.
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ACLA, a not-for-profit association representing the nation’s leading national, regional and esoteric clinical laboratories on key issues of common concern, including federal and state government reimbursement and regulatory policies. Clinical laboratories are at the forefront of personalized medicine, driving diagnostic innovation and contributing more than $100 billion to the nation’s economy.
