Open Payments: Data review and dispute underway for physicians – log in today

By Shantanu Agrawal, M.D., CMS Deputy Administrator for Program Integrity

In its second year, the Open Payments program continues to promote transparency and accountability in health care by providing consumers with information about financial relationships between drug and medical device manufacturers and physicians and teaching hospitals. The data posted has been viewed nearly 6 million times and we’re pleased with the continuing engagement of stakeholders on this important transparency initiative.

All data for payments made in 2014 has been submitted by the drug and medical device manufacturers who are reporting the information. CMS is encouraging physicians and representatives of teaching hospitals to register in Open Payments now. Instructions and quick tips for registration are available here. While companies that are submitting payment records to CMS attest to the accuracy of the data, the continued success of the program relies on voluntary participation by physicians and teaching hospitals. This is the only opportunity for doctors and teaching hospitals to review the data submitted by manufacturers and group purchasing organizations (GPOs) before it is included in the public database on June 30, 2015.

CMS acknowledges the benefits of collaboration among physicians, teaching hospitals and drug and device manufacturers in the design and delivery of many life-saving drugs and devices. Open Payments has given patients a tool to become more involved and informed health care consumers by discussing these relationships with their physicians.

Last year, 26,000 physicians registered in the system and lodged over 12,500 disputes. In contrast, we published information about 4.45 million payments made to at least 366,000 physicians or teaching hospitals that were valued at $3.7 billion. I expect that the data reported this year will be on scale with the number and value of payments reported last year. For physicians, the only way for each of you to confirm that the data reported about you is correct is to register and review your payments before the review period ends.

To learn more about the program, visit today.

Physician Quality Reporting Programs Strategic Vision

By Patrick Conway, MD, Principal Deputy Administrator and Chief Medical Officer

As CMS releases statistics on the 2015 PQRS payment adjustment for the first time to the public, we are also announcing the publication of the Physician Quality Reporting Programs Strategic Vision (or “Strategic Vision”). This Strategic Vision, (, describes a long-term vision for CMS quality measurement for physicians and professionals and public reporting programs, and how they can be optimized and aligned to support better decision-making from doctors, consumers, and every part of the health care system. The physician quality programs support our vision of a health system that achieves better care, smarter spending, and healthier people. These programs support incentives to providers, encourage improvements in care delivery, and deliver information to consumers.

There are five principles we believe will ensure that  quality measurement and public reporting play a critical role in improving the healthcare delivered to millions of Americans:

  • Input from patients, caregivers, and healthcare professionals will guide the programs.
  • Feedback and data drives rapid cycle quality improvement.
  • Public reporting provides meaningful, transparent, and actionable information.
  • Quality reporting programs rely on an aligned measure portfolio.
  • Quality reporting and value-based purchasing program policies are aligned.

CMS relies heavily on quality measurement and public reporting to facilitate the delivery of high quality care. This Strategic Vision articulates how we will build upon our successful physician quality reporting programs to reach a future-state where quality measurement and public reporting are optimized to help achieve the CMS Quality Strategy’s goals and objectives, and therefore contribute to improved healthcare quality across the nation, including better care, smarter spending, and healthier people.

The Strategic Vision evolved out of our desire to plan for the future in how we administerthe Physician Quality Reporting System (PQRS), Physician Feedback/Value-Based Payment Modifier Program, and other physician quality reporting programs. With passage of HR2, key components of these physician programs will serve as the foundation for the Merit-based Incentive Payment System. The Strategic Vision describes in concrete terms how we will advance the goals and objectives for quality improvement outlined in the CMS Quality Strategy through these quality measurement and reporting programs.

These quality measurements and public reporting goals and initiatives encourage stakeholder engagement; reduce participation burden for healthcare professionals; and support meaningful public reporting. Our long-term vision for physician quality reporting programs and the improvement of these programs challenges us to continue striving for excellence in healthcare quality over the next several years.

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

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 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 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) ( 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) : 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.


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