FDA and CMS Form Task Force on LDT Quality Requirements

By: Jeffrey Shuren, M.D., J.D. and Patrick H. Conway, MD, MSc

Health care providers and their patients expect that laboratory tests used in clinical management of patients should be consistent and of high quality.

Under FDA’s Jeff Shuren, M.D., J.D.proposed framework for the oversight of laboratory developed tests (LDTs), outlined in draft guidance documents issued in October 2014, FDA would oversee the quality of these laboratory tests, along

—Jeff Shuren, M.D., J.D.side the Centers for Medicare and Medicaid Services (CMS), which regulate the laboratories themselves through the Clinical Laboratory Improvement Amendments (CLIA). We have heard stakeholder confusion about the roles of the two agencies in ensuring quality and concerns about potentially duplicative efforts. To coordinate efforts across the Department, FDA and CMS are establishing an interagency task force that will continue and expand on our collaboration related to the oversight of LDTs, which are tests intended for clinical use and designed, manufactured, and used within a single lab. The task force, comprised of leaders and subject matter experts from each agency, will work to address a range of issues, including those involving quality requirements for LDTs.

Patrick H. Conway, MD, MSc —Patrick H. Conway, MD, MScUnder the proposed LDT framework, FDA would phase in enforcement of premarket review requirements and the quality system regulation for some LDTs. FDA’s oversight of LDTs will assure that the tests are both analytically valid (able to accurately detect analytes) and clinically valid (able to measure or detect the clinical condition for which the test is intended). FDA is currently reviewing public comments on the draft guidances that it received through an open public docket and a two-day public meeting. In response to public comments, FDA may modify the proposed framework when we issue final guidance.

CMS, under CLIA, oversees the labs’ processes, rather than the tests they develop. CLIA and its implementing regulations include requirements for establishing and maintaining quality laboratory operations and ensuring the lab is staffed by qualified personnel. These laws do not require premarket review of tests or any evidence that a test is clinically valid.

When FDA’s proposed framework is implemented, both FDA and CMS will play a role in ensuring that LDTs are high quality—CMS through CLIA by continuing to focus on laboratory operations including the testing process and FDA by enforcing compliance with the agency’s quality systems regulation pertaining to the design and manufacture of the laboratory tests.

Although the roles of the agencies are different, FDA and CMS share an interest in ensuring effective and efficient oversight of LDTs so laboratories can offer tests to the American public with confidence that they are accurate and provide clinically meaningful information without unnecessary or duplicative agency oversight.

The goals of the FDA/CMS Task Force on LDT Quality Requirements include:

  • identifying areas of similarity between the FDA quality system regulation and requirements under CLIA;
  • working together to clarify responsibilities for laboratories that fall under the purview of both agencies; and
  • leveraging joint resources to avoid duplication and maximize efficiency.

The task force is currently exploring areas where collaboration may realize greater oversight efficiency and produce the greatest benefit to patients, providers, and laboratories. The task force understands stakeholders’ concerns about differences in terminology used by FDA and CMS. We intend to clarify the terms used so that labs may better understand what is expected of them.

Our new task force is committed to its stakeholders and intends to provide education and outreach, including an upcoming webinar series, to address additional needs that are identified during this collaboration. We welcome any feedback and encourage you to contact us at LDTFramework@fda.hhs.gov.

Jeffrey Shuren, M.D., J.D., is Director of FDA’s Center for Devices and Radiological Health

Patrick H. Conway, MD, MSc, is Acting Principal Deputy Administrator CMS Chief Medical Officer

This entry was posted in Drugs and tagged CLIA, Clinical Laboratory Improvement Amendments, CMS, disease, FDA, LDT, Medicaid, Medicare, medicine, patients, U.S. Food and Drug Administration by FDA Voice. Bookmark the permalink.

An Update for Consumers about Corrected 1095-As

By Kevin Counihan, Marketplace, Chief Executive Officer, Centers for Medicare & Medicaid Services

If you had coverage through the Health Insurance Marketplace last year, you may have benefited from advance payments of a tax credit to help make health coverage more affordable. By now, you should have received a statement in the mail from the Marketplace called a Form 1095-A. This statement includes important information you need in order to complete and file your tax return.

One piece of information included in your Marketplace tax statement is the premium amount for the “second lowest cost Silver” or benchmark plan in your area. This premium amount represents the benchmark plan we use to determine the amount of premium tax credit you were eligible to receive. In February, we notified about 800,000 tax filers, less than one percent of total tax filers, to expect an updated Marketplace tax statement because the original version they were issued listed an incorrect benchmark premium amount. At that time, Treasury announced that if you filed your taxes before learning that your Form 1095-A was incorrect because of this error, you will not need to file an amended return and the IRS will not pursue the collection of any additional taxes based on updated information in the corrected forms. You may still choose to file an amended tax return with your corrected form.

The vast majority of Marketplace consumers who needed an updated Marketplace tax statement now have access to their corrected form. If your form was affected, you can log into your HealthCare.gov account and download your updated form. Updated statements are also in the mail and should be arriving shortly, if you haven’t received it already. We’ll also call and email you to let you know your form is ready. If you’re concerned about the status of your updated form, contact the Marketplace Call Center at 1-800-318-2596.

As with any extensive data generation process – especially one that is being conducted for the first time – there are going to be issues that are a part of the normal course of business or other problems that are identified. For example, a consumer could have received a form with wrong coverage dates. This could occur if, for example, the Marketplace received updated information from your insurer after your form was generated. In other cases, the Marketplace encountered administrative issues relating to the quality of data used to populate the 1095-A form and it could have been generated with incorrect information or a form was unable to be generated. We are also aware of similar 1095-A issues in some State-based Marketplaces.

Today, the Department of the Treasury is expanding the relief it announced previously on February 24, which will mitigate any harm to tax filers. If you enrolled in Marketplace coverage, received an incorrect Form 1095-A, and filed your return based on that form, you do not need to file an amended tax return. The IRS will not pursue the collection of any additional taxes from you based on updated information in the corrected forms. This relief applies to tax filers who enrolled through the Federally-facilitated marketplace or a state-based marketplace.

As before, you still may choose to file an amended return. Treasury intends to provide additional information to help tax filers determine whether they would benefit from filing amended returns. You also may want to consult with you tax preparers to determine if you would benefit from amending. For more information on the Treasury announcement, see Treasury’s statement and consumer FAQs.

While Treasury expects that in the vast majority of cases the impact on a consumer’s tax refund or bill, if any, will be very small, we know that we have a responsibility to identify these issues quickly, understand the impact and reach out to you with the information you need. Issues that negatively impact your experience are not acceptable and we are focused on providing a smoother consumer experience. If you have not received your original or corrected form or have any questions about the information on your form, reach out to the Marketplace call center or your state Marketplace.

Our focus is on helping you understand the steps you need to take this tax season and providing you with the resources and assistance you may need. We’ve conducted extra quality assurance and are reviewing forms to make sure that when you receive your corrected form, it includes accurate information. We’re committed to listening and learning along the way so that we can improve our practices and the support we provide.

If you have questions or want to learn more visit www.HealthCare.gov/taxes. Representatives at the Marketplace Call Center are also standing by to answer your questions. The call center is open 24/7 at 1-800-318-2596.

Building on the Success of the ACO Model

By Patrick Conway, M.D., Deputy Administrator for Innovation and Quality and Chief Medical Officer, Centers for Medicare & Medicaid Services  

On March 10, the U.S. Department of Health and Human Services launched a new Accountable Care Organization (ACO) initiative from the Centers for Medicare & Medicaid Services (CMS) Innovation Center known as the Next Generation ACO Model. This model builds on the successes of earlier ACO models, such as the Pioneer ACO Model, and further enables innovation by providers to improve care for patients. Made possible by the Affordable Care Act, ACOs encourage quality improvement and care coordination to help improve our health care system. ACOs are a critical part of achieving the Department’s goals of delivery system reform nationally – aimed at better care, smarter spending and healthier people.

The Next Generation ACO Model is one of many innovative payment and care delivery models developed by the CMS Innovation Center. These models are designed to set clear, measurable goals and a timeline to move the Medicare program — and the health care system at large — toward paying providers based on the quality, rather than the quantity of care they provide to patients.

Building upon experiences from the Pioneer ACO Model and the Medicare Shared Savings Program, the Next Generation ACO Model offers a new opportunity in accountable care — one that sets more predictable financial targets, enables providers and beneficiaries greater opportunities to coordinate care, and aims to attain the highest quality of care.

ACOs in the Next Generation ACO Model will take on greater financial risk than those in current Medicare ACO initiatives, while also potentially sharing in a greater portion of savings. To support increased risk, ACOs will have a stable, predictable benchmark and flexible payment options that support ACO investments in care improvement infrastructure to provide high quality care to patients. These changes are responsive to feedback from external stakeholders.

The Next Generation ACO Model encourages greater coordination and closer care relationships between ACO providers/suppliers and beneficiaries by enhancing services that beneficiaries can receive from participating ACOs. ACOs will have a number of tools available to enhance the management of care for their beneficiaries. These include additional coverage of telehealth and post-discharge home services, coverage of skilled nursing care without prior hospitalization, and reward payments to beneficiaries for receiving care from ACOs.

This ACO model provides for greater engagement of beneficiaries, a more predictable, prospective financial model, and more tools to coordinate care for beneficiaries.

For more information on the Next Generation ACO Model, please visit the Next Generation ACO Model web page.

CMS announces release of 2015 Impact Assessment of Quality Measures Report

By Dr. Patrick Conway, CMS Deputy Administrator for Innovation and Quality and Chief Medical Officer

Today, CMS released the 2015 National Impact Assessment of Quality Measures Report (2015 Impact Report) (http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityMeasures/National-Impact-Assessment-of-the-Centers-for-Medicare-and-Medicaid-Services-CMS-Quality-Measures-Reports.html.). The 2015 Impact Report demonstrates that the nation has made clear progress in improving the healthcare delivery system to achieve the three aims of better care, smarter spending, and healthier people.

This report is a comprehensive assessment of quality measures used by CMS. It examines the effectiveness and impact of measurement and demonstrates our commitment to achieving optimal results from our quality measurement programs. The report summarizes key findings from CMS quality measurement efforts and recommended next steps to improve on these efforts.

Specifically, the report outlines the performance on quality measures over time and improvements achieved. Findings from the report include research on 25 CMS quality programs and hundreds of quality measures from 2006 to 2013 and builds on the prior 2012 Impact Assessment Report. Many of these measures are also included in incentive programs that link payment to quality performance.

The key findings of the 2015 Impact Report indicate that CMS is making a difference for the patients we serve. Highlights include: 

  • Quality measurement results demonstrate significant improvement. 95 percent of 119 publicly reported performance rates across seven quality reporting programs showed improvement during the study period (2006–2012). In addition, approximately 35 percent of the 119 measures were classified as high performing, meaning that performance rates exceeding 90 percent were achieved in each of the most recent three years for which data were available. 
  • Race and ethnicity disparities present in 2006 were less evident in 2012. Measure rates for Hispanics, Blacks and Asians showed the most improvement, and American Indian/Native Alaskans and Native Hawaiian/Pacific Islanders the least improvement. Transparency and monitoring of measures rates by race and ethnicity for all publicly reported measures and ensuring that disparities across programs, setting and demographic groups are eliminated, remain top priorities consistent with our CMS Quality Strategy. 
  • Provider performance on CMS measures related to heart and surgical care saved lives and averted infections. From 2006 to 2012, 7,000 to 10,000 lives were saved through improved performance on inpatient hospital heart failure process measures, and 4,000 to 7,000 infections were averted through improved performance on inpatient hospital surgical process measures. (A number of the measures are also included in the previously released patient safety results demonstrating from 2010 to 2013 a 17 percent reduction in patient harm, representing 1.3 million adverse events and infections avoided, approximately 50,000 lives saved, and an estimated $12 billion in cost savings.) 
  • CMS quality measures impact patients beyond the Medicare population. Over 40 percent of the measures used in CMS quality reporting programs include individuals whose healthcare is supported by Medicaid, and over 30 percent include individuals whose healthcare is supported by other payer sources. This demonstrates the public-private collaboration that CMS facilitates and hopes to expand. 
  • CMS quality measures support the aims of the National Quality Strategy (NQS) and CMS Quality Strategy. CMS quality measures reach a large majority of the top 20 high-impact Medicare conditions experienced by beneficiaries, with more measures directed at the six measure domains related to the NQS priorities, and better balance among those domains. Much of our data resulted from process measures; however, there is an increase in measures related to patient outcomes, patient experience of care, and cost and efficiency. CMS is moving increasingly toward these outcome measures across programs. 

Quality measurement is a key lever that CMS uses to drive the transformation of the health care system in partnership with hospitals, clinicians, and patients. We will use the results from the 2015 Impact Report to refine our CMS quality measurement strategies, better understand the measures that have worked well, and guide the development and application of measures going forward. Important messages from this comprehensive report include: 

  1. Performance based on quality measures has improved, and the programs that include these measures support a healthier individual and a healthier nation; 
  2. New themes and actions to consider have emerged, which provide new insights for informed measure and program-specific decisions in the months ahead.

 We hope providers, private payers, and patient communities will use this report to understand which measures have worked well and which have had less of an impact on quality. Everyone receiving healthcare in our nation can benefit from CMS progress on quality measurement and the programs associated with these measures. We strive to achieve better care for our patients and families, better health in our communities, and smarter spending through quality improvement.

Physician Groups that demonstrate high quality care receive increases to their Medicare Payments

By Sean Cavanaugh, Deputy Administrator & Director, Center for Medicare & Patrick Conway, MD, Deputy Administrator for Innovation and Quality & CMS Chief Medical Officer

This week, CMS posted results from the implementation of the first year of the Value-based Payment Modifier (Value Modifier) : http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeedbackProgram/Downloads/2015-Value-Modifier-Results.pdf. Part of the Affordable Care Act, the Value Modifier rewards physicians and groups of physicians who provide high quality and cost effective care, while encouraging improvement for those who do not report quality measures or who don’t meet the mark. Based on their 2013 performance on quality and cost measures, nearly 7,000 physicians in 14 group practices across the country are receiving an increase in their Medicare payments in 2015.

Those group practices receiving increases fall into two categories:

  1. Groups that were determined to be providing high quality care and having average costs compared to national benchmarks. This comprises the majority of those receiving increases.
  2. Groups that were determined to be low cost and met the average quality performance compared to national benchmarks.

While groups that exceeded the program’s benchmarks in quality and cost efficiency receive an increase in physician payments under the Medicare Physician Fee Schedule, those who do not perform well or failed to meet quality reporting requirements are seeing a decrease to their Medicare payments in 2015. Most physician groups nationwide met the quality reporting requirements and their Medicare payments remain unchanged.

Physician groups getting an upward 2015 Value Modifier adjustment had, on average, lower (better) hospital readmissions rates—14.3 per 100 admissions—than the corresponding benchmark of 16.4 per 100 admissions. These groups also had on average lower hospital admissions rates for acute and chronic ambulatory care sensitive conditions.

Today’s news comes on the heels of Secretary Burwell’s recent announcement that HHS is setting measurable goals and a timeline to move Medicare toward paying providers based on the quality, rather than the quantity, of care they give to patients. The Value Modifier is just one of many programs currently underway geared toward providing better care, spending healthcare dollars more wisely, and having healthier people and communities through the Affordable Care Act. To achieve these aims, we are focused on three key areas: (1) improving the way providers are paid, (2) improving and innovating in care delivery, and (3) sharing information more broadly to providers, consumers, and others to support better decisions while maintaining privacy.

The Value Modifier is being phased in gradually. In 2015, the Value Modifier is being applied to groups with 100 or more eligible professionals. In 2015, these groups were also given the option of electing “quality-tiering,” which was voluntary for the first year of the Value Modifier. Quality-tiering determines the type of payment adjustment (upward, downward or neutral) and the amount of the adjustment based on performance on quality and cost measures. Those who did not elect quality-tiering are not subject to upward or downward adjustments in 2015 based on their performance. Physician groups and physicians can find information about their quality and cost performance in their Quality Resource and Use Reports that were made available last fall. Information on how to access the reports can be found here.

Beginning in 2016, quality-tiering will automatically apply to all groups subject to the Value Modifier, which includes groups with at least 10 or more eligible professionals. In 2017, the Value Modifier will apply to all groups and to solo practitioners who are physicians. Although the Value Modifier currently only applies to physician payments, beginning in 2018, CMS will begin applying it to non-physician eligible professionals as well.

When it comes to improving the way providers are paid, we want to reward value and high-quality care, rather than volume. The Value Modifier reinforces our emphasis on quality, value and shared accountability, and recognizes and rewards those physician groups and physicians who meet those goals.

Successful ICD-10 Testing Shows Industry Ready to Take Next Step to Modernize Health Care

By Marilyn Tavenner, Administrator, Centers for Medicare and Medicaid Services

I am delighted to announce that CMS has recently successfully completed the first week of end-to-end testing of new ICD-10 coding.

The International Classification of Diseases, or ICD, is used to standardize codes for medical conditions and procedures. While most countries already use the 10th revision of these codes (or ICD-10), the United States has yet to adopt this convention. Since ICD-10 codes are more specific than ICD-9, doctors can capture much more information, meaning they can better understand important details about the patient’s health than with ICD-9-CM.

Approximately 660 providers and billing companies submitted nearly 15,000 test claims. This successful week of testing continues to put us on course for successful implementation of this important initiative that better reflects modern practice of medicine by Oct. 1, 2015.

Health care professionals use codes from the International Classification of Diseases—or ICD—to record their patients’ health conditions and document inpatient hospital procedures.

The U.S. is the last major industrialized nation to make the switch to ICD-10. The structure of ICD-9, which is more than 35 years old, limits the number of new codes that can be created, and many ICD-9 categories are full. ICD-10 provides room for code expansion, so providers can use codes more specific to patient diagnoses. [Fact sheet on ICD-10]

To promote the health care community’s smooth transition from ICD-9 to ICD-10, CMS is conducting a comprehensive program of testing. Because ICD codes are required on medical bills, we want health care providers to be confident they can submit Medicare claims and get paid as the nation switches to ICD-10.

To that end, Medicare recently tested ICD-10 claims processing with a variety of stakeholders including health care providers, billing agencies, and equipment suppliers. Overall, participants in the January 26 to February 3 testing were able to successfully submit ICD-10 claims and have them processed through our billing systems. To the extent that some claims were rejected, most didn’t meet the mark because of errors unrelated to ICD-9 or ICD-10.

Testing allows us to identify areas of improvement, and we will work with outside entities and stakeholders to improve those very small deficiencies identified. And we will continue to do testing, especially in those areas we identify as needing improvement.

We’ve also identified one point that’s caused some confusion in the health care community and beyond. So, we are communicating far and wide that everyone must use:

  • ICD-9 for services provided before the October 1 deadline
  • ICD-10 for services provided on or after October 1

That means ICD-10 can be used only for test purposes before October 1. And, only ICD-10 can be used for doctor’s visits and other services that happen on or after October 1. ICD-9 cannot be used to bill for services provided on or after October 1. This rule applies no matter when the claim is submitted, so claims submitted after October 1, 2015, for services provided before that date must use ICD-9 codes.

These rules and others around adopting ICD-10 apply to all health care providers, not just those who accept Medicare or Medicaid. So, like CMS, health insurance plans across the country are engaging in robust testing programs with doctors, hospitals, and other health care providers and suppliers. No major issues have emerged in the course of testing.

As the ICD-10 deadline draws near, I especially encourage medical practices and hospitals that bill Medicare to take advantage of testing opportunities. Beyond testing, CMS has undertaken an unprecedented level of outreach, training, and education to prepare the health care community for ICD-10. Our website cms.gov/ICD-10, offers many resources, including the Road to 10 tool, designed especially for small medical practices.

CMS is ready for ICD-10. And, thanks to our many partners—spanning providers, health plans, coders, clearinghouses, professional associations and vendor groups—the health care community at large will be ready for ICD-10 on October 1.

I appreciate the tremendous efforts and achievements of health professionals as we work together to realize the benefits of ICD-10 and other advances toward the ultimate goal of improving the quality and affordability of health care for all Americans.


What Consumers Need to Know about Corrected Form 1095-As

Last year, millions of Americans used advance payments of tax credits to help lower the cost of their monthly health insurance premiums. Now that tax season is here, individuals and families enrolled in a health plan through the Marketplaces will need to provide some basic information about their health insurance when they file their tax returns.

If you signed up for coverage through the Marketplace last year, you should have received a statement in the mail in February from the Marketplace called a Form 1095-A. This statement includes important information you need in order to complete and file your tax return. One piece of information included in your 1095-A is the premium amount for the “second lowest cost Silver plan” in your area. This premium amount represents the benchmark plan we use to determine the amount of premium tax credit you were eligible to receive.

Your 1095-A form should have arrived in your mailbox in February. Most consumers can also download a copy of their 1095-A through their HealthCare.gov account. We have been urging consumers to check the information on their forms – such as the number of people in your household – for accuracy. People who find errors on their form can contact the Marketplace Call Center at 1-800-318-2596 to find out how to request a corrected form.

About 20 percent of the tax filers who had Federally-facilitated Marketplace coverage in 2014 and used tax credits to lower their premium costs – about 800,000 (< 1% of total tax filers) – will soon receive an updated Form 1095-A because the original version they were issued listed an incorrect benchmark plan premium amount. Based upon preliminary estimates, we understand that approximately 90-95% of these tax filers haven’t filed their tax return yet. We are advising them to wait until the first week of March when they receive their new form or go online for correct information before filing. For those who have filed their taxes — approximately 50,000 (< 0.05% of total tax filers) – the Treasury Department will provide additional information soon.

It’s important to note that this issue does not affect the majority of Marketplace consumers and only affects people who signed up through one of the 37 states using HealthCare.gov. About 80 percent of Marketplace consumers who received a 1095-A from the federal Marketplace do not have affected forms and should go ahead and file their annual tax return. Additionally, this issue does not mean that consumers received the incorrect amount of tax credit throughout the year. It’s also important to note that this does not affect the vast majority of tax filers who will just need to check a box on their tax return to indicate that they had health coverage in 2014 either through their employer, Medicare, Medicaid, veterans care, or other qualified health coverage programs. 

Our priority is to make sure people with affected forms are alerted to the issue and are made aware of the steps they need to take. If your form was affected, you will receive a phone call from the Marketplace by early March, in addition to letters and emails with additional information about the status of your form.

Marketplace consumers concerned about the status of their 1095-A forms should take the following actions:

  1. You can find out if you are affected by logging in to your account at HealthCare.gov. You will see a notice message that will let you know if your form was or was not affected.  A majority of tax filers with Marketplace coverage through HealthCare.gov that received a 1095-A– about 80 percent – will find that their form was not affected by this issue and will be able to file their taxes with their current form.
  2. Wait to file if your form was affected. It’s best to wait to file your tax return until you receive your corrected 1095-A Form from the Marketplaces.  New forms are being sent from the Marketplace beginning in early March. When your corrected form is ready, we’ll also send a message to your Marketplace account on HealthCare.gov.
  3. If you need to file now, use our tool. If you can’t wait, and want to find the correct amount of the second lowest cost Silver plan that applied to your household in 2014, you have 2 options: 1) You can use this tool to find that amount, or 2) You can call the Marketplace Call Center at 1-800-318-2596 (TTY: 1-855-889-4325) and they can help.

As soon as we discovered the error, we immediately began examining who was affected, how to communicate about the error, and how to make the corrections process as simple as possible for consumers. We are committed to making sure that consumers who need corrected forms are contacted with updates and will receive new forms quickly. We are focused on making sure that every Marketplace consumer understands how taxes and health care intersect and if they need to get a corrected form, the steps they need to take.

Consumers with questions or who want to learn more are encouraged to visit www.healthcare.gov/taxes.  Representatives at the Marketplace Call Center are also standing by to answer consumer questions. The call center is open 24/7 at 1-800-318-2596.


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