Strong Start for Mothers and Newborns II First Annual Evaluation Report

By Patrick Conway, MD, Acting Principal Deputy Administrator of CMS

Today, we at the Centers for Medicare & Medicaid Services (CMS) are pleased to announce preliminary findings from the first annual evaluation report for Strong Start for Mothers and Newborns (Strong Start) strategy II cooperative agreements.  Strong Start is a federal initiative geared toward testing innovative approaches to improve maternal and infant health outcomes in low-income families. The work of the Partnership for Patients and the first strategy of Strong Start contributed to decreasing early elective deliveries 64.5 percent nationwide between 2010 and 2013, which may improve birth outcomes and increase numbers of healthy newborns. The second strategy seeks to build on this success by using innovative approaches to prenatal care for Medicaid and CHIP participants to promote maternal and infant health and to reduce preterm birth and low birth weight infants. Today’s preliminary results show the positive potential of strategy II to contribute to these goals.

We created the Strong Start initiative to leverage work conducted by the Partnership for Patients and decades of research that reiterate the health and financial risks associated with a lack of accessible, quality prenatal care available to Medicaid and Children’s Health Insurance Program (CHIP) beneficiaries. This research consistently shows that infants born preterm (before 37 completed weeks of gestation) have higher mortality risks and may endure a lifetime of developmental and health problems. In addition to having enormous medical needs, children born preterm often require early intervention services and special education and may have conditions that affect their productivity through adulthood.

To address this care need, we partnered with 27 organizations with 213 provider sites in 30 states, Washington, D.C., and Puerto Rico. The three year program tests evidence-based approached to reducing the rate of preterm births through three approaches:

  • Group Care – Group prenatal care that incorporates peer-to-peer support in a facilitated setting for three components: health assessment, education and support.
  • Birth Centers – Comprehensive prenatal care facilitated by midwives and teams of health professionals, including peer counselors and doulas.
  • Maternity Care Homes – Enhanced prenatal care at traditional prenatal sites with enhanced continuity of care and expanded access to care coordination, education, and other services.

Preliminary results from the first year evaluation indicate that Strong Start participants have

  • lower rates of cesarean than national averages,
  • higher rates of breastfeeding than national averages, and
  • overall lower rates of preterm birth than national averages.

The CMS evaluation indicates that when beginning the program, Strong Start participants had high levels of emotional and psychosocial needs such as food insecurity, chronic unemployment, unstable housing, lack of reliable transportation, unmet dental and behavioral health needs and low knowledge about self-care, nutrition, and healthy pregnancy. Preliminary results indicate that a common element among the three prenatal care models is an emphasis on relationship-centered care, including providing education on pregnancy, preterm risks, and self-care and connecting participants to community resources.

The initiative’s enhanced programs are designed to meet the specific emotional and psychosocial needs of their local populations. Strong Start participants expressed overwhelming satisfaction with their prenatal care, with nearly 90% of participants stating that they were either very satisfied or extremely satisfied with their care.

Although many awardees and provider sites faced common implementation challenges such as enrolling participants and integrating enhanced services into existing models, they also shared common promising practices. These included

  • strategies to promote engaged relationships with providers and staff,
  • adapting programs to the needs of the target population, and
  • developing skilled and resourceful staff.

Results should be interpreted cautiously as awardees were in various stages of implementation during the first year.  Comparisons with national averages are descriptive only and are not controlled for important factors such as risk profiles or demographics.  We cannot yet be certain that results are a direct result of Strong Start or if these outcomes are similar to those found in these particular care approaches prior to the initiative.  Annual evaluations of the second and third years of operations are likely to indicate more definitive findings as more comprehensive data becomes available for analysis.

Much work remains to be done to reduce the risk of significant complications for women and infants.  As a practicing pediatrician, I know the importance of this work and its impact on patients and families.  We remain committed to working together to improve health delivery, health outcomes, and cost of quality care for low-income pregnant women and their newborns.

Proposed Rules Include Commitment to Better Care, Smarter Spending, and Healthier Medicare Beneficiaries as well as Implement the IMPACT Act

By: Patrick Conway and Sean Cavanaugh

In January, Secretary Burwell announced a new vision for the Medicare program, including clear goals and a timeline for shifting Medicare payments increasingly from volume to value.  Through this vision, we crystalized the work we have been pursuing across the agency into real, measurable goals.

Over the past few weeks, CMS began the annual process of updating the payment rates and policies that apply to providers who furnish care to Medicare fee-for-service beneficiaries. So far this month, we released proposed updates for hospital inpatient care, skilled nursing facilities, hospice providers, and a few others.

Through these updates, we’re proposing important updates that reflect how we want the Medicare program to help build a health care system that delivers better care, spends our health care dollars more wisely, and results in healthier people. For example:

  • Potentially Expanding Bundled Payments for Care Improvement – Through the CMS Innovation Center, CMS has been testing some promising new payment arrangements in an initiative called Bundled Payments for Care Improvement. In the proposed hospital inpatient prospective payment system (IPPS) rule, CMS is looking for public comment on issues we should consider if the initiative is expanded.
  • Updating the Hospital Value-Based Purchasing Program – At CMS, we’re always looking for opportunities to improve or sharpen our initiatives. CMS is proposing in the FY 2016 IPPS/LTCH proposed rule to expand the quality measures used in this program to assess hospital performance.
  • Introducing Value-Based Purchasing to Skilled Nursing Facilities – The proposed rule for Skilled Nursing Facility payments lays the groundwork for implementation of a new Value-Based Purchasing program, authorized by the Protecting Access to Medicare Act of 2014 (PAMA) (Pub. L. 113–93), which will tie some portion of payments made to skilled nursing facilities to performance on a hospital readmission measure.

Implementation of the IMPACT Act

Several of the payment rules propose quality measurement requirements that implement the first stage of the Improving Medicare Post-Acute Care Transformation Act of 2014 (IMPACT Act). Enacted on October 6, 2014, the IMPACT Act requires the Secretary to collect standardized patient assessment data and data on quality, resource use, and other measures from four types of post-acute care providers: home health agencies, inpatient rehabilitation facilities, skilled nursing facilities and long term care hospitals. The IMPACT Act also requires the reporting of quality measures and resource use measures in specific domains.

In the recently published rules, CMS has proposed to adopt the following cross-cutting quality measures for three of these four settings: (1) new or worsening pressure ulcers; (2) falls with major injury; and (3) having an admission and discharge functional assessment with a care plan that addresses function.

Seeking Comments

As with all work we do through rulemaking, we are looking for input from stakeholders and the rest of the public. We use those comments to make our final rules better, and make sure we’re on track.

The Secretary has put forward an exciting vision for the future of the Medicare program.  We’re looking forward to finding new ways to put the beneficiary experience first, and to make that vision a reality.


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.


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