News and Updates for Healthcare Professionals

AHRQ’s EvidenceNow, an initiative that supports smaller primary care practices’ efforts to improve heart health, has found that participating practices regularly provide evidence-based care while recognizing the potential to improve on one or more of the heart health clinical services known as the ABCS: Aspirin use for high-risk individuals, Blood pressure control, Cholesterol management, and Smoking cessation counseling. EvidenceNOW provides support services typically not available to smaller primary care practices to help them improve the care they deliver. Baseline data from more than 1,000 primary care practices participating in EvidenceNOW indicate that while an average of more than 50 percent of patients are receiving each of the ABCS services, many practices have not yet reached the EvidenceNOW goal of 70 percent.

MarkVCID brings team science approach to small vessel disease biomarkers in the brain.

April 27th, 2016 executive notice by the US Department of Health and Human Services issued key provisions to the Medicare Access and Summary CHIP Reauthorization Act of 2015, (MACRA). MACRA replaced the 1997 Sustainable Growth Rate formula for determining Medicare reimbursement. MACRA provides a new approach in Medicare reimbursement based on value and quality care. MACRA legislation is guided by the Quality Payment Program, directing two paths for Medicare reimbursement: The Merit-based Incentive Payment System (MIPS), or the Advanced Alternative Payment Model (APM). Nurse Practitioners, require knowledge and information to prepare for MIPS and APM to begin January 1, 2017.

Heart disease is the leading cause of death for men and women in the United States. February is American Heart Month, a great time for health care providers to share the facts about heart health with their patients, especially those who may be at high risk of heart attacks.

AHRQ has fact sheets for primary care health professionals to help their high-risk patients adopt the ABCS of heart disease prevention: Aspirin use by high-risk individuals, control their Blood pressure, lower their Cholesterol, and quit Smoking.

To download these free materials go to: Aspirin Use, Control Blood Pressure, Lower Cholesterol, and Quit Smoking.

The tribal elder at Fort Berthold Reservation in western North Dakota had struggled with his diabetes for years. His blood glucose level was about twice what’s considered normal, his blood pressure was dangerously high, and he was overweight.

His health care provider talked to him about the need to address his diabetes and he was included in the tribal clinic’s diabetes registry, so they wouldn’t lose track of him. But he just didn’t take the steps necessary to manage his condition. Until one day, it apparently clicked.

Jared Eagle, Director of the Indian Health Service’s Special Diabetes Program for Indians (SPDI) at the reservation in New Town, said the man finally started taking advantage of the resources and care provided through the clinic. He started walking more; lost 20 to 30 pounds; and reduced his blood glucose and blood pressure levels.

“You can see him walking every day. He’s walking his dog every day, even in the winter,” Eagle said.

The story of this elder of the Mandan, Hidatsa and Arikara Nation (also known as the Three Affiliated Tribes) reflects the significant progress being made in Indian Country where Native Americans have a greater chance of having diabetes and kidney failure resulting from diabetes than any other U.S. racial or ethnic group, according to the Centers for Disease Control and Prevention. Nonetheless, the CDC also reported recently that kidney failure among Native Americans dropped by 54 percent between 1996 and 2013, the fastest rate for any racial or ethnic group in the U.S.

In January 2016, the Centers for Medicare & Medicaid Services issued a final rule reimbursing physicians and other providers for discussing advanced care planning with patients and their families. However, studies show that nearly two-thirds of physicians feel inadequately trained to engage in end-of-life counseling. A new issue brief from National Quality Partners (NQP) helps healthcare providers better navigate these conversations through the lens of six key preferences of high-quality, person-centered advanced illness care.

NQP’s Advanced Illness Care Action Team—which includes more than 25 patient advocates, physicians, hospital systems, and other stakeholders from the public and private sectors—identified purpose and connection, physical comfort, emotional and psychological well-being, family and caregiver support, financial security, and peaceful death and dying as key preferences of individuals with advanced illness. By placing individuals at the center as the guiding North Star of all healthcare decisions, this initiative calls on the nation to transform advanced illness care and to engage patients, families, and caregivers as true partners in care planning.

Download the issue brief now to explore these key preferences in depth, along with snapshots of organizations that have embraced one or more of these preferences. Register for NQP’s March 15 webinar to delve into case studies demonstrating how physicians, nursing homes, and home health agencies can integrate these preferences into existing quality efforts.

The Centers for Medicare & Medicaid Services (CMS) today finalized rules governing home health agencies that will improve the quality of health care services for Medicare and Medicaid patients and strengthen patients’ rights. These Medicare and Medicaid Conditions of Participation are the minimum health and safety standards a home health agency must meet in order to participate in the Medicare and Medicaid programs.

Home health care allows patients to receive needed health care services within the comfort and safety of their own homes. Patients receive coordinated services ranging from skilled nursing to physical therapy to medical social services, all under the direction of their physician. Currently, there are more than 5 million Medicare and Medicaid beneficiaries receiving home health care from nearly 12,600 Medicare and Medicaid-participating home health agencies nationwide.

“Our priority is to ensure that Medicare and Medicaid beneficiaries who receive health services at home get the highest level of patient-centered care from home health agencies,” said Kate Goodrich, MD, CMS Chief Medical Officer and Director of the Center for Clinical Standards and Quality for CMS. “Today’s announcement is the first update in many years to Medicare and Medicaid home health agency rules and reflects current best practices for in-home care, based on recommendations from stakeholders and medical evidence.”

These changes are an integral part of CMS’ overall effort to improve the quality of care furnished through the Medicare and Medicaid programs, while streamlining requirements for providers. The final rule includes:

• A comprehensive patient rights condition of participation that clearly enumerates the rights of home health agency patients and the steps that must be taken to assure those rights.
• An expanded comprehensive patient assessment requirement that focuses on all aspects of patient wellbeing.
• A requirement that assures that patients and caregivers have written information about upcoming visits, medication instructions, treatments administered, instructions for care that the patient and caregivers perform, and the name and contact information of a home health agency clinical manager.
• A requirement for an integrated communication system that ensures that patient needs are identified and addressed, care is coordinated among all disciplines, and that there is active communication between the home health agency and the patient’s physician(s).
• A requirement for a data-driven, agency-wide quality assessment and performance improvement (QAPI) program that continually evaluates and improves agency care for all patients at all times.
• A new infection prevention and control requirement that focuses on the use of standard infection control practices, and patient/caregiver education and teaching.
• A streamlined skilled professional services requirement that focuses on appropriate patient care activities and supervision across all disciplines.
• An expanded patient care coordination requirement that makes a licensed clinician responsible for all patient care services, such as coordinating referrals and assuring that plans of care meet each patient’s needs at all times.
• Revisions to simplify the organizational structure of home health agencies while continuing to allow parent agencies and their branches.
• New personnel qualifications for home health agency administrators and clinical managers.

Without ACA protections, more than half of non-elderly Americans could face discrimination in health care

Since the Affordable Care Act (ACA) became law, millions of Americans no longer face coverage denials, higher costs, or coverage carve outs because of their medical histories. A new analysis from the U.S. Department of Health and Human Services provides a first look at what happened to uninsured rates for Americans with pre-existing health conditions when the ACA’s major insurance market reforms took effect in 2014. It finds that, between 2010 and 2014, the share of Americans with pre-existing conditions who went without health insurance all year fell by 22 percent, meaning 3.6 million fewer people with pre-existing conditions went uninsured.

While data for individuals with pre-existing conditions are available only through 2014, the uninsured rate for all Americans has fallen by an additional 22 percent through mid-2016, and Americans with pre-existing conditions have likely seen similar additional gains.

“Today, thanks to Affordable Care Act protections, the uninsured rate is at its lowest level in history and millions of Americans with pre-existing conditions like asthma or cancer no longer have to worry about being denied coverage because of their medical history,” said HHS Secretary Sylvia M. Burwell. “This is clear and measurable progress, and we shouldn’t turn the clock back to a time when people were denied coverage.”

The new analysis estimates that 51 percent of non-elderly Americans, or 133 million people, have a pre-existing health condition under the definition insurers used for underwriting purposes before the ACA. Among the most common pre-existing conditions are: high blood pressure (46 million people); behavioral health disorders (45 million people); asthma or chronic lung disease (34 million people); heart conditions or heart disease (16 million people); diabetes (13 million people); and cancer (11 million people). Because the likelihood of having a pre-existing condition increases with age, the ACA’s protections are especially important to middle-aged and older Americans. Up to 84 percent of Americans between age 55 and 64, and up to 75 percent of Americans between age 45 and 54 have a pre-existing condition that could have been the basis for insurer discrimination prior to 2014.

Today’s analysis confirms that the ACA’s insurance market reforms are having a major impact on coverage for Americans with pre-existing conditions. After passage of the Affordable Care Act, uninsured rates declined by almost 20 percent or more among non-elderly Americans with high blood pressure, behavioral health disorders, asthma or chronic lung disease, and osteoarthritis.

The analysis also sheds light on proposals that would restrict pre-existing condition protections to people who meet standards for continuous coverage, rather than protecting anyone who signs up during an annual open enrollment period. The analysis finds that tens of millions of people with pre-existing conditions go uninsured for at least short spells due to job changes, other life transitions, or periods of financial difficulty. In the two-year period beginning in 2013, almost one third of people (44 million) with pre-existing conditions went uninsured for at least one month.

The Affordable Care Act achieved dramatic improvements in coverage for people with pre-existing conditions through three fundamental reforms: first, requiring insurance companies to cover people with pre-existing conditions; second, providing financial assistance linked to premiums and income to help make coverage more affordable; and third, by requiring all Americans to get coverage if they can afford it. Prior to the Affordable Care Act, states that tried to protect people with pre-existing conditions without other measures such as financial assistance and an individual responsibility requirement saw premiums skyrocket as not enough healthy people entered the risk pool. Under the Affordable Care Act, the number of people in the individual market has grown, and most HealthCare.gov enrollees can select a plan for less than $75 per month in premiums.

We have made great progress in recent years on reforming our system into one that delivers better quality of care for patients and pays for care in a smarter way, including investing more in prevention and primary care.

Before 2010, there had been only modest efforts to improve care and reduce costs. Medicare – the country’s largest health care insurance program – was largely paying for health services based on volume – where providers were paid for every service they ordered or performed – which didn’t necessarily improve the health of beneficiaries or preserve the program for future generations. To improve our health care system, the largest payer of health care stepped up to partner with providers, doctors and other clinicians, states, private payers, consumers, and others to spur innovation. The market and people in communities across the nation have responded this initiative in extraordinary ways and delivered better care to patients.

This has been the mission of the Center for Medicare and Medicaid Innovation (CMS Innovation Center), to align incentives, partner with others to improve the health system, and implement best practices for coordinating patient care. Since opening its doors in late 2010, the CMS Innovation Center has worked tirelessly to enhance the quality of health care delivered while not increasing costs for Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) beneficiaries. The CMS Innovation Center takes locally-driven approaches – approaches from doctors and other health care partners providing care to patients every day – and gives them the platform to be tested through a collaborative process.

Today, based on the successful work of the CMS Innovation Center and countless public and private sector partners, we can now say that health care delivery system reform addressing both quality and cost has become part of the fabric of Medicare, Medicaid, and the health care sector nationwide. According to a new report to Congress prepared by the CMS Innovation Center:

• Over 30 new payment models have been launched over the past six years.
• Investments in electronic medical records and a data and analytics infrastructure are sparking a new set of innovative companies.
• The CMS Innovation Center’s portfolio of models has attracted participation from a broad array of health care providers, states, payers, and other partners. An estimated 18 million individuals, including CMS beneficiaries and individuals with private insurance included in multi-payer models, have been impacted by, have received care, or will soon be receiving care furnished by more than 207,000 health care providers participating in CMS Innovation Center payment and service delivery models and initiatives. These models are delivering care to people in every state across the nation.
• Medicare exceeded – earlier than predicted – the goal to tie more than 30 percent of fee-for-service payments by the end of 2016 through alternative payment models to quality and cost metrics. Medicare is on pace to reach 50 percent by the end of 2018.

The Innovation Center has partnered with Medicare, Medicaid, and private health plans in the commercial market on new models of care and innovation. And, a number of exciting initiatives will be coming to more beneficiaries over the next few years:

• The Medicare Diabetes Prevention Program expanded model, set to begin in 2018, will pay for services to prevent the onset of diabetes to all eligible Medicare beneficiaries, improving their health and that of the Medicare program both now and in the future. This is important because we estimate that Medicare spent $42 billion in 2016 on fee-for-service, non-dual eligible, over age 65 beneficiaries with diabetes.
• Three new payment models—the Acute Myocardial Infarction Model, the Coronary Artery Bypass Graft Model, and the Cardiac Rehabilitation Incentive Payment Model—will support clinicians in providing care to patients who receive treatment for heart attacks, heart surgery to bypass blocked coronary arteries, or cardiac rehabilitation.
  Through the Comprehensive Primary Care Plus Model, primary care doctors can care for their patients the way they think will deliver the best outcomes, and they’ll get paid for achieving results and improving care.
• One new payment model—the Surgical Hip and Femur Fracture Treatment Model—will support clinicians in providing care to patients who undergo surgery after a hip or femur fracture beyond hip replacement. In addition, we finalized updates to the Comprehensive Care for Joint Replacement Model, which began in April 2016.
• The Accountable Health Communities Model, beginning in 2017, will test whether increased awareness of and access to services addressing health-related social needs will impact total health care costs and improve health and quality of care for Medicare and Medicaid beneficiaries in selected communities. This model will address a critical gap between clinical care and community services in the current delivery system.
• Thirty-eight states and territories are engaged in the State Innovation Models initiative where they are testing their own best ideas to improve health, quality of care, and lower costs. Additionally, Vermont and Maryland have entered into global payment arrangements to improve care for the whole state’s population.
• And, already, investments in patient safety from the CMS Innovation Center, including through the Partnership for Patients, have contributed to an estimated 125,000 lives saved, over 3 million infections and adverse events avoided, and $28 billion in savings. We expect to see these numbers and savings continue to grow in the coming years.
• These exciting approaches are the result of careful design, thorough and rigorous evaluation, and close collaboration with patients, doctors, and other stakeholders to achieve real, measurable, and significant results in improving health and lowering spending. CMS conducts an independent evaluation of every CMS Innovation Center model and releases those findings publicly. These reports provide stakeholders with information on the impact of the model as a whole on health care expenditures and utilization, beneficiary and health care provider experiences with care, and, where feasible, health outcomes. The reports also often provide site-specific results.

Using the CMS Innovation Center to advance better, smarter health care has become even more important over time. Since the passage of the bipartisan Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), the CMS Innovation Center has been instrumental to its implementation. The Quality Payment Program, which implements provisions of MACRA, includes a five percent incentive payment for physicians and other clinicians sufficiently participating in Advanced Alternative Payment Models. The CMS Innovation Center is the mechanism to create new Advanced Alternative Payment Models in the future. In fact, the CMS Innovation Center has recently announced more than five new or re-opened opportunities for clinicians to join Advanced Alternative Payment Models. CMS expects 125,000 to 250,000 clinicians to be participating in Advanced Alternative Payment Models by 2018. The CMS Innovation Center looks forward to partnering with doctors, clinicians, patients, and others on new models.

The CMS Innovation Center continues to work on behalf of current and future Medicare, Medicaid, and CHIP beneficiaries. After more than six years, the health care system is objectively safer while making Medicare more financially secure for future generations. Such significant progress is possible because we have worked with Congress and stakeholders to listen, adapt, and advance proven ideas. Our work in developing and expanding new payment models will continue to be guided by the following core principles:

• Supporting innovative payment and service delivery models with strong potential to improve health care quality and lower costs.
• Engaging with and listening to consumers, providers, and other stakeholders allowing for open and transparent dialogue, including through the appropriate use of notice-and-comment rulemaking and ombudsmen.
• Evaluating results based on appropriately scoped and sized demonstrations and advancing best practices based on their impact on quality and cost.

Together we can continue to strive to achieve better care, healthier people, and smarter spending.

The CMS Innovation Center has released its third Report to Congress, as mandated by section 1115A(g) of the Social Security Act. It focuses on activities between October 1, 2014 and September 30, 2016, but also highlights a number of important activities started during that time period that were announced between September 30, 2016 and December 31, 2016. The CMS Innovation Center’s portfolio of models and initiatives has attracted participation from health care providers, states, payers, and other stakeholders in all 50 states, the District of Columbia, and Puerto Rico. During this period, the CMS Innovation Center has tested or announced 39 payment and service delivery models and initiatives authorized under section 1115A authority. To improve care and value, these model tests focus on reducing program expenditures while improving the quality of care.

Today, the Centers for Medicare & Medicaid Services (CMS) announced the Medicare-Medicaid Accountable Care Organization (ACO) Model, a new initiative designed to improve the quality of care and lower costs for beneficiaries who are enrolled in both Medicare and Medicaid.

The Medicare-Medicaid ACO Model builds on the current Medicare Shared Savings Program and advances efforts to partner with states in transforming the health care delivery system.

“This model aims to provide improved care coordination for those enrolled in both Medicare and Medicaid, allowing providers to focus more on providing care for their patients rather than administrative work,” said Dr. Patrick Conway, CMS acting principal deputy administrator. “CMS continues to partner with and leverage the best ideas from states to transform our health care system to improve quality and care coordination. In the long run, this partnership will result in healthier people and smarter spending.”

In current Medicare ACO initiatives, beneficiaries who are Medicare-Medicaid enrollees may be attributed to ACOs. However, Medicare ACOs often do not have financial accountability for the Medicaid expenditures for those beneficiaries. The Medicare-Medicaid ACO Model will allow Medicare Shared Savings Program ACOs to take on accountability for the quality of care and both Medicare and Medicaid costs for Medicare-Medicaid enrollees.

CMS is accepting letters of intent from states that wish to work with CMS to design certain state-specific elements of the model. The Medicare-Medicaid ACO Model is open to all states and the District of Columbia that have a sufficient number of Medicare-Medicaid enrollees in fee-for-service Medicare and Medicaid. CMS will enter into participation agreements with up to six states with preference given to states with low Medicare ACO saturation. Once a state is approved to participate in the model, a request for application will be released to ACOs and health care providers in that state.

The Medicare Shared Savings Program and other ACO initiatives were created to change the incentives for how medical care is delivered and paid for in the United States, moving away from a system that rewards the quantity of services to one that rewards the quality of health outcomes. ACOs are groups of doctors, hospitals, and other health care providers who voluntarily come together to develop and execute a plan for a patient’s care and share information, putting the patient at the center of the health care delivery system.

The Affordable Care Act, through the creation of the Center for Medicare and Medicaid Innovation, allows for the testing of innovative payment and service delivery models, such as the Medicare-Medicaid ACO Model. Today’s announcement is part of the Administration’s broader strategy to improve the health care system by paying providers for what works, unlocking health care data, and finding new ways to coordinate and integrate care to improve quality.

In March 2016, the Administration announced that it met the ambitious goal – eleven months ahead of schedule – of tying an estimated 30 percent of Medicare payments to quality and value through alternative payment models by 2016. The Administration’s next goal is tying 50 percent of Medicare payments to alternative payment models by 2018. The Health Care Payment Learning and Action Network established in 2015 continues to align efforts between government, private sector payers, employers, providers, and consumers to broadly scale these efforts to achieve better care, smarter spending, and healthier people.

Today’s announcement is one in a series of Innovation Center initiatives that will expand opportunities for clinicians to participate in Advanced Alternative Payment Models under MACRA. Our work in developing and expanding new payment models will continue to be guided by the following core principles:

• Supporting innovative payment and service delivery models with strong potential to improve health care quality and lower costs.
• Engaging with and listening to consumers, providers, and other stakeholders allowing for open and transparent dialogue, including through the appropriate use of notice-and-comment rulemaking and ombudsmen.
• Evaluating results based on appropriately scoped and sized demonstrations and advancing best practices based on their impact on quality and cost.

We look forward to continuing to work with our many stakeholders to achieve better care for patients, better health for our communities, and lower costs through improvement for our health care system.

At the Centers for Medicare & Medicaid Services (CMS), we are working with numerous partners to transform our health care delivery system to one that delivers better health outcomes while spending dollars more wisely. In November of 2015, we updated the CMS Quality Strategy, incorporating the ongoing work to shift Medicare from paying for the number of services provided to paying for better outcomes for patients. We know that a key strategy to achieving better outcomes is to meaningfully engage patients as partners in decisions about their health care. Therefore, one of the six goals outlined in this strategy is: Strengthen person and family engagement as partners in care. Today, we are excited to announce the release of the CMS Person and Family Engagement Strategy, which we believe can lead to significant progress toward this important goal.

What does person and family engagement mean? We view this as patients and families being part of the health care team by working collaboratively with their doctor or other health care professional to be active partners when making decisions about their health.

Why is this important? Because consideration of the health, values, and goals of the individual in consultation with the entire health care team leads to an improved experience and better care. When people feel responsible for their own health and are partners with their providers in goal-setting and decision-making, they are much more likely to achieve their health care goals.

• If individuals feel their beliefs, desires, and culture are considered in their care, they are more likely to follow their care plan.
• If individuals are able to communicate effectively with their providers and have a prominent role in making health care decisions, they will receive better care, can more effectively manage their health, and may receive appropriate preventive care while relying less on emergency or urgent care[1].

The CMS Person and Family Engagement Strategy will serve as a guide for the implementation of person and family engagement principles and strategies throughout CMS programs. This strategy will expand the awareness and practice of person and family engagement by providing the following goals and objectives:

• Goal 1: Actively encourage person and family engagement along the continuum of care within the broader context of health and well-being in the communities in which people live.
• Goal 2: Promote tools and strategies that reflect person and/or family values and preferences and enable them to actively engage in directing and self-managing their care.
• Goal 3: Create an environment where persons and their families work in partnership with their health care providers to develop their health and wellness goals informed by sound evidence and aligned with their values and preferences.
• Goal 4: Develop meaningful measures and tools aimed at improving the experience and outcomes of care for persons, caregivers, and families. Also, identify person and family engagement best practices and techniques in the field that are ready for widespread scaling and national integration.

This Strategy emphasizes that person and family engagement goes beyond informed consent. It is about including the patients voice in policy and program planning. It is about proactive, effective communication and partnered decision-making with patients, families, and caregivers. It is about building a care relationship based on trust and inclusion of patients’ beliefs, values, preferences, and culture which can even lead to a reduction in health care disparities. Health care decision-making should not always be limited to the patient and provider. It is essential to include family members, care-givers, and close friends in the conversation about health when the patient desires inclusion of others. As delivery system reform efforts move the nation to focus on the quality of care and not the quantity of care received, person and family engagement is an essential part of a health care system that delivers high quality care, spends dollars more wisely, and improves the health of people in their communities.

[1] Epstein RM, Street RL, Jr. Patient-Centered Communication in Cancer Care: Promoting Healing and Reducing Suffering. National Cancer Institute, NIH Publication No. 07-6225. Bethesda, MD, 2007.

The Centers for Medicare & Medicaid Services is sharing a new Health Affairs article by Secretary Burwell outlining her vision for the future of health care. In it, she touts collaboration with stakeholders like you in advancing crucial Delivery System Reform efforts — including ongoing Center for Medicare and Medicaid Innovation initiatives.

To become a Qualified Clinical Data Registry (QCDR) or Qualified Registry for the Merit-based Incentive Payment System (MIPS) under the Quality Payment Program, you must self-nominate. The self-nomination period for vendors who wish to participate as a QCDR or a Qualified Registry in MIPS for the 2017 performance period opened November 15, 2016 and will close on January 15, 2017 at 5:00 p.m. Eastern Time (ET).

The Centers for Medicare & Medicaid Services (CMS) provides detailed instructions regarding how to obtain a JIRA account, and how to complete and submit a Quality Payment Program Self-Nomination Form.

Requirements to Self-Nominate

1. Participants: You must have at least 25 participants by January 1, 2017. These participants don’t need to be using the QCDR/Qualified Registry to report MIPS data to us, but they need to be submitting data to the QCDR/Qualified Registry for quality improvement.
2. Attestation Statement: You must provide a statement during the data submission period verifying that all data and results submitted to CMS are accurate and complete.
3. Data Submission: You must submit data via a CMS-specified secure method for data submission, such as a QRDA or XML file.
4. Data Validation Report: You must provide information on your process for data validation for both individual MIPS eligible clinicians and groups by submitting a data validation plan. Results of the executed data validation plan must be provided by May 31 of the year following the performance period.

Resources

For additional assistance to help support you in the self-nomination process, please see the QCDR/ Qualified Registry fact sheets that are available under the Education and Tools tab of the Quality Payment Program website.

WASHINGTON, DC — FasterCures, a center of the Milken Institute, commends the U.S. Senate on today’s strong, bipartisan support of the 21st Century Cures Act (H.R. 34), which passed the Senate on a 94-5 vote, matching the U.S. House of Representatives’ vote of 392-26 on Nov. 30. The bill will now be sent to the White House. In last Saturday’s weekly address, President Barack Obama said that he would sign the bill into law as soon as it reaches his desk, enacting $4.8 billion of new funding for the National Institutes of Health (NIH) and $500 million for the Food and Drug Administration (FDA), as well as a comprehensive suite of policy provisions that will strengthen the entire biomedical innovation system.

“This landmark legislation will accelerate cures for many life-threatening diseases and help advance precision medicine,” said Michael Milken, chairman of the Milken Institute. “It assures patient-focused drug development, adds rigor to clinical trials, expands compassionate use of new drugs by dying patients, speeds the review of vaccines, addresses antibiotic resistance, responds to the opioid crisis and strengthens the nation’s research infrastructure.”

FasterCures has been honored to work with leaders in Congress, NIH and FDA throughout the bill’s journey. This is the culmination of more than two years of hard work and dedication by the bill’s bipartisan congressional champions and their staffs. House Energy and Commerce Committee Chairman Fred Upton and Representative Diana DeGette, with Ranking Member Frank Pallone, reached out to stakeholders throughout the medical research system to gather up the best ideas and translate them into legislation. Senate Health, Education, Labor and Pensions Chairman Lamar Alexander and Ranking Member Patty Murray also championed the effort and moved a set of bipartisan bills through their committee.

As the bill moved toward votes on the floors of both chambers, strong commitment from Speaker Paul Ryan, Majority Leader Kevin McCarthy and Democratic Leader Nancy Pelosi, in partnership with their Senate colleagues, Majority Leader Mitch McConnell and Democratic Leader Harry Reid, resulted in the overwhelmingly bipartisan votes we’ve seen in the past few days. Improving the biomedical innovation system is truly something that all can agree on.

“The time for medical research progress is now. We are so pleased that Congress seized this opportunity and united around this strong legislation,” said Margaret Anderson, executive director of FasterCures. “This act will invest in and strengthen the federal research system, which will support the United States’ long-standing tradition of scientific progress and hopefully spur advances for the many patients who are desperately waiting for effective treatments and cures.”

The 21st Century Cures legislation addresses the entire biomedical innovation system, and would support many of the recommendations from FasterCures’ Rx for Innovation project. Here are just a few examples from this comprehensive legislation:

• Enhances patient centricity in biomedical product development and regulatory approval.
• Bans efforts to block data sharing between health information systems, and provides the Department of Health and Human Services the authority to levy civil penalties against offenders.
• Reforms FDA hiring authorities to fill the agency’s vacancies by enabling it to compete more effectively with industry to hire and retain the best and brightest experts to review medical product applications.
• Expands the translational work done by the NIH’s National Center for Advancing Translational Sciences.
• Catalyzes innovation in clinical trials and regulatory approval, without diminishing FDA’s authority to determine what constitutes a safe and effective medical product.

The new funding for NIH will provide $1.5 billion for the Precision Medicine Initiative, $1.8 billion for the Beau Biden Cancer Moonshot and $1.5 billion for the Brain Research through Advancing Innovative Neurotechnologies® (BRAIN) Initiative. All of these initiatives have the potential to significantly advance our understanding of disease and identify opportunities for new therapies.

FasterCures looks forward to working with Congress, the Obama administration and the incoming Trump administration to help implement the 21st Century Cures Act, realizing its promise to support scientific breakthroughs, translate those discoveries into medical products and deliver those treatments and cures to the patients who need them. There are approximately 10,000 diseases and 500 treatments; even with today’s vote, we still have work to do.

AHRQ’s Role in Improving Care for Patients With Multiple Chronic Conditions

A new funding opportunity announcement from AHRQ solicits applications for research projects to develop, test and evaluate measures of shared decision making for research conducted in clinical settings. Shared decision making is a collaborative process in which patients and members of their clinical team make health care decisions that are informed by scientific evidence as well as patients’ values and preferences. Each project is expected to produce valid and reliable measures of shared decision making, along with instructions for implementing the measures, as well as documentation on the development, testing and evaluation of the measures. Maximum costs for each project are $500,000 per year and $1.5 million for entire project periods up to three years.

The U.S. Preventive Services Task Force released today a final recommendation statement on statin use for the primary prevention of cardiovascular disease in adults. The Task Force found that statin use is beneficial for some people ages 40 to 75 years who are at increased risk for cardiovascular disease, but did not find enough evidence to recommend for or against statin use for people older than age 75 years.
The final recommendation statement can also be found in the November 13, 2016 online issue of JAMA.

Earlier this year, Congress passed the Comprehensive Addiction and Recovery Act of 2016(CARA), but did not authorize funds for the policies it created. Shortly after that, the White House requested $920 million that would expand access to treatment in states as part of a larger effort to combat the opioid epidemic – Congress has not acted on that request.

Since passing CARA, Congressional Democrats have expressed concern surrounding the lack of funding to the policies the bill authorized. Senate Democrats, including Sen. Wyden, expressed frustration when only $7 million was provided in the legislation after efforts to produce an amendment that would deliver offsets to cover the full funding request.

On October 12, 2016, Senator Ron Wyden released a report that outlines the consequences of underfunding treatment for opioid addiction. According to Senator Wyden, “Congress’ approach to funding opioid addiction treatment is nothing short of legislative malpractice. There is bipartisan agreement that the opioid epidemic has to be confronted now. Yet, with dozens of Americans dying from an opioid overdose every day, Congress is breaking its promise to families around the country by not providing every resource available. The time for a ‘down payment’ has long passed.”

In his press release announcing the report, Senator Wyden referred to a study published by the Journal of American Medicine that showed nearly eighty percent of Americans suffering from opioid addiction are unable to access the treatment they need, especially in rural areas across the country.

Senator Wyden, who represents constituents in Oregon, stated,

“Sadly, Oregonians are no strangers to the human toll of drug use and addiction devastating families and communities. I’m extremely disheartened that Congress has closed up shop yet again without acting on its core promise to provide essential funding for proven opioid addiction treatment and prevention efforts. Until states receive real investments in these programs, Congress has failed its job. Families in Oregon and across the country deserve far better.”

Sen. Wyden’s report addresses two key challenges: (1) the lack of available treatment facilities and services across the country, and (2) the barriers patients face when treatment facilities or services are actually available. Additionally, the report details case studies in five states struggling with high rates of opioid addiction, including Wyden’s home state of Oregon, California, Ohio, Pennsylvania, and New Hampshire.

The report notes that “states are doing all they can to fight the epidemic, but as it stands now they do not have the money to build that capacity.” It then issues a call to action for Congress – “It is time for Congress to act. Every day Congress does not do so, another 78 people die waiting for someone to answer their call for help.”

According to Senator Wyden, if the requested funding were provided, it would help states like Oregon battle the opioid epidemic, by allowing them to establish additional treatment centers, to provide life-saving anti-overdose medication, and to train medical personnel to increase the number of those being treated.

The report includes appendices, which provide for a detailed breakdown of how much each state would receive under President Obama’s $920 million proposal; a justification of how the $920 million will be used, including eligible activities; and a summary of a Centers for Disease Control and Prevention (CDC) report, “Increases in Drug and Opioid Overdose Deaths – United States, 2000-2014”. At the end of the report is a lengthy list of footnotes, which provide additional reading for interested parties.

Pushing for additional federal money to go towards combating the opioid epidemic has been a top issue for Democrats in political office. When Congress comes back to work, and a new president elected, it is more likely than not this issue will rear its head once again.

The National Quality Forum (NQF) has endorsed measures in the areas of cancer, palliative and end-of-life care, perinatal and reproductive health, and person- and family-centered care.

Cancer

NQF has endorsed 15 measures related to cancer care. The measures focus on breast cancer screening, appropriate treatment of breast, colon and prostate cancer, hematology, and febrile neutropenia. In all, 18 measures were evaluated against NQF’s endorsement criteria. Thirteen of these measures received endorsement status and two received inactive endorsement with reserve status. Three of the 18 reviewed measures were newly submitted measures and 15 were maintenance measures. For a complete list of measures, see the Cancer 2015-2017 project page.

Palliative and End-of-Life Care

NQF has endorsed 23 measures related to palliative and end-of-life care. The measures focus on physical, spiritual, religious, existential, ethical, and legal aspects of care, as well as care of the patient at the end of life. In all, 24 measures were evaluated against NQF’s endorsement criteria and 23 received endorsement status. Eight of the 24 reviewed measures were newly submitted measures and 16 were maintenance measures. For a complete list of measures, see the Palliative and End-of-Life Care 2015-2016 project page.

Perinatal and Reproductive Health

NQF has endorsed 18 measures related to perinatal and reproductive health. The measures focus on treatment processes and outcomes for contraception, reproductive health, pregnancy and related complications, childbirth, and neonatal health. In all, 24 measures were evaluated against NQF’s endorsement criteria and 18 received endorsement status. Nine were newly submitted measures and 15 were maintenance measures. For a complete list of measures, see the Perinatal and Reproductive Health 2015-2016 project page.

Person- and Family-Centered Care

NQF has endorsed 13 measures related to person- and family-centered care. The measures focus on quality of life, functional status, experience of care, shared decision making, symptom/symptom burden, and communication. Twelve of the 13 measures that were evaluated against NQF’s endorsement criteria were newly submitted measures and one was a maintenance measure. For a complete list of measures, see the Person and Family Centered Care 2015-2017 project page.

Any party may appeal a decision to endorse a measure reviewed in these projects by submitting an appeal no later than November 25 at 6:00pm ET.

Appeals may be submitted through the NQF measure database. For an appeal to be considered, the notification must include information clearly demonstrating that the appellant has interests directly and materially affected by the NQF-endorsed recommendations and that the NQF decision has had (or will have) an adverse effect on those interests. All appeals are published on the relevant project pages on NQF’s website.

The recently announced changes to NQF’s measure endorsement procedures for decisions and appeals do not affect these projects.

Questions? Please contact project teams at cancerem@qualityforum.org, palliative@qualityforum.org, perinatal@qualityforum.org, pfcc@qualityforum.org.

Study addresses long-standing question for those with moderately low blood oxygen levels.
Newly published data from the Long-Term Oxygen Treatment Trial (LOTT) show that oxygen use is not beneficial for most people with chronic obstructive pulmonary disease (COPD) and moderately low levels of blood oxygen. It neither boosted their survival nor reduced hospital admissions for study participants. Previous research showed that long-term oxygen treatment improves survival in those with COPD and severely low levels of blood oxygen. However, a long-standing question remained whether a different group of COPD patients — those with moderately low levels of blood oxygen—also benefit. The study was funded by the National Heart, Lung, and Blood Institute (NHLBI) — a part of the National Institutes of Health—and the Centers for Medicare & Medicaid Services.

The study, the largest of its kind to evaluate the effectiveness of home oxygen in this group of patients, is published in the current online issue of the New England Journal of Medicine. The 738 patients enrolled in this study had COPD and moderately low levels of blood oxygen (in contrast to severely low blood oxygen levels) at rest or during exercise.

In the current study, patients with moderately low levels of blood oxygen are defined as those with a blood oxygen saturation (SpO2) between 89 and 93 percent at rest (moderate resting hypoxemia), or a SpO2 below 90 percent during the 6-minute walk test. Patients with severely low blood oxygen levels are defined as those with a SpO2 equal to or less than 88 percent at rest. This latter group was excluded from the LOTT study because prior studies showed that they benefit from long-term oxygen treatment. Blood oxygen saturation or SpO2 refers to the percentage of oxygen-saturated hemoglobin relative to total hemoglobin in the blood and is measured through a pulse oximeter. A pulse oximeter is a special probe that indirectly measures oxygen levels in the blood, often by attachment to the finger.

“These results provide insight into a long-standing question about oxygen use in patients with COPD and moderately low levels of blood oxygen. For the most part, this treatment did not improve or prolong life in study participants,” said James P. Kiley, Ph.D., director of NHLBI’s Division of Lung Diseases. “The findings also underscore the need for new treatments for COPD.”

Researchers say patients with any form of COPD should check with their doctors before making changes in their treatment plans. “We want to make it clear that LOTT was not designed to assess individual responses to oxygen treatment and that individual responses can vary. Each COPD patient should discuss their own personal situation with their healthcare provider,” said William C. Bailey, M.D., Professor Emeritus at the University of Alabama at Birmingham School of Medicine, and study Chair.

COPD, the third leading cause of death in the United States, is a progressive lung disease triggered primarily by cigarette smoking, although up to 20 percent of patients with COPD never smoked. Symptoms include shortness of breath, chronic coughing, and wheezing. The disease also causes low oxygen levels in the blood. About 15 million people have been diagnosed with COPD in the United States and another 10 million may be undiagnosed.

For decades, oxygen has been one of the main treatment tools for patients with COPD and low oxygen levels. It involves the use of metal tank cylinders containing oxygen or concentrators that extract oxygen from air; both systems deliver the gas through a nasal tube or mask.

The LOTT study is a randomized clinical trial to determine whether oxygen use could help COPD patients with moderately low levels of blood oxygen. The seven-year study, which included patients from 42 medical centers throughout the United States, began in 2009 and was completed in 2015.

In the study, half of the patients received long-term oxygen and the other half did not. The researchers found no significant differences between the two groups based on how long patients survived, and the amount of time leading to their first hospitalization. They also found no differences in other important benchmarks, such as the rates at which the patients were hospitalized or experienced worsening of COPD symptoms. Nor did researchers find statistically significant differences between the groups in quality of life, levels of depression or anxiety, lung function, or ability to walk for short periods.

Although no cure for COPD exists, there are a number of treatment options, including the use of bronchodilators and steroids, as well as pulmonary rehabilitation, surgery, and lung transplantation. Researchers worldwide are also studying new medications and exploring other approaches such as gene therapy. They continue to emphasize the importance of not smoking tobacco in preventing or slowing the progression of COPD.

About the National Heart, Lung, and Blood Institute (NHLBI): NHLBI, a part of the National Institutes of Health (NIH), plans, conducts, and supports research related to the causes, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases; and sleep disorders. The Institute also administers national health education campaigns on women and heart disease, healthy weight for children, and other topics. NHLBI press releases and other materials are available online at www.nhlbi.nih.gov.

About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

Findings give insight into designing safe and effective cannabinoid medications.
New research is providing a more detailed view into the structure of the human cannabinoid (CB1) receptor. These findings provide key insights into how natural and synthetic cannabinoids including tetrahydrocannabinol (THC)—a primary chemical in marijuana—bind at the CB1 receptor to produce their effects. The research was funded by the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health.

There is considerable interest in the possible therapeutic uses of marijuana and its constituent cannabinoid compounds. Molecules that target CB1 receptors may have promise in treating a variety of conditions such as pain, inflammation, obesity, nerve cell diseases, and substance use disorders. However, some synthetic cannabinoids such as K2 or Spice can produce severe and even deadly reactions, whereas other cannabinoids produce less serious side effects.

“Cannabinoids can produce very different outcomes, depending on how they bind to the CB1 receptor,” said NIDA Director Nora D. Volkow, M.D. “Understanding how these chemicals bind to the CB1 receptor will help guide the design of new medications and provide insight into the therapeutic promise of the body’s cannabinoid system.”

Researchers used a specific chemical, AM6538, to inactivate and crystallize the CB1 receptor. They then computed the three-dimensional structure of the CB1-AM6538 complex through crystallography, which determines molecular shape by measuring the angles and intensities of x-rays that are bounced off a crystal structure. Based upon prior evidence showing how specific cannabinoids attach to different chemical configurations, researchers were able to predict how these cannabinoids would fit into the three-dimensional CB1 model. The model was also used to calculate how long each cannabinoid bound to the CB1 receptor, thereby providing clues into mechanisms whereby some chemicals produce longer-lasting effects.

“We found that the CB1 receptor consists of multiple sub-pockets and channels,” said Alexandros Makriyannis, Ph.D., director of the Center for Drug Discovery, Northeastern University in Boston, and a co-author on the paper. “This complex structure will allow chemists to design diverse compounds that specifically target portions of the receptor to produce desired effects.”

The paper by Hua, et al., can be found at http://www.cell.com/cell/abstract/S0092-8674(16)31385-X

To learn more about NIH-supported research on marijuana and cannabinoids, go to: www.drugabuse.gov/drugs-abuse/marijuana/nih-research-marijuana-cannabinoids.

This study was funded in part by NIDA under grants DA009158 and DA023142.

About the National Institute on Drug Abuse (NIDA): The National Institute on Drug Abuse (NIDA) is a component of the National Institutes of Health, U.S. Department of Health and Human Services. NIDA supports most of the world’s research on the health aspects of drug use and addiction. The Institute carries out a large variety of programs to inform policy, improve practice, and advance addiction science. Fact sheets on the health effects of drugs and information on NIDA research and other activities can be found at www.drugabuse.gov, which is now compatible with your smartphone, iPad or tablet. To order publications in English or Spanish, call NIDA’s DrugPubs research dissemination center at 1-877-NIDA-NIH or 240-6450228 (TDD) or email requests to drugpubs@nida.nih.gov. NIDA’s media guide can be found at www.drugabuse.gov/publications/media-guide/dear-journalist. You can follow NIDA on Twitter and Facebook.

About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

By Dr. Patrick Conway, CMS Principal Deputy Administrator and Chief Medical Officer

Medicare’s investment in primary care shows progress

Today, the Centers for Medicare & Medicaid Services (CMS) announced the Comprehensive Primary Care (CPC) initiative’s second round of shared savings results, with nearly all practices (95 percent) meeting quality of care requirements and four out of seven regions sharing in savings with CMS. These results reflect the work of 481 practices that served over 376,000 Medicare beneficiaries and more than 2.7 million patients overall in 2015.

As the largest test of advanced primary care in U.S. history, CPC demonstrates the potential of primary care clinicians redesigning their practices to deliver better care to their patients, and provides clinicians support to innovate and deliver care in ways that better meet their patients’ needs and preferences.

During 2015, its second shared savings performance year, CPC generated a total of $57.7 million gross savings in Part A and Part B expenditures. These savings are essentially equivalent to the $58 million paid in care management fees to the practices. Four of the seven regions participating in CPC – the states of Arkansas, Colorado, and Oregon, and the Greater Tulsa region in Oklahoma – realized net savings (after accounting for the care management fees paid) and will share in those savings with CMS. Although three of the CPC regions had net losses, the savings generated in the other four regions covered those losses, such that care management fees across CPC were offset by reduced spending on Medicare Part A and Part B services. Further, more than half of participating CPC practices will receive a share of over $13 million in earned shared savings.

In addition to the gross Medicare savings, CPC practices showed positive quality, with lower than expected hospital admission and readmission rates, and favorable performance on patient experience measures. CPC practices’ performance on electronic Clinical Quality Measures (eCQMs) also exceeded national benchmarks, particularly on preventive health measures.

This is the first year CMS has included eCQM performance in Medicare shared savings determinations for CPC. eCQM reporting covering the entire practice population at the practice site level is critical to using health information technology as a tool to support care delivery transformation. eCQM data are recorded in the electronic health record in the routine course of clinical care, allowing practices to engage in real time quality improvement efforts that drive population health. As we move to a health care system that rewards value over volume, CPC practices are at the forefront of using eCQMs for quality improvement, measurement, and reporting.

Quality highlights from the 2015 shared savings performance year include:

• 97 percent of CPC practices successfully reported 9 eCQMs. For ten out of the eleven eCQMs in the CPC measure set, the majority of CPC practices who reported surpassed the median national performance.
• Nearly all (99 percent) practices reported higher levels of colorectal cancer screening and influenza immunization compared to national benchmarks. Additionally, 100 percent of practices who reported on screening for clinical depression surpassed national benchmarks.
• Compared to 2014, most regions maintained or improved their scores on hospital readmissions and admissions for chronic obstructive pulmonary disorder and congestive heart failure.
• Patients rated the care they receive from their CPC practitioners highly, particularly on how well practitioners supported them in taking care of their own health and the attention they paid to care from other providers.

The positive performance is a testament to the efforts CPC practices have made to provide truly “comprehensive primary care.”

CPC is a multi-payer partnership launched by the Center for Medicare and Medicaid Innovation (Innovation Center) in October 2012 to advance primary care by paying clinicians to deliver accessible, comprehensive, and coordinated care in seven regions across the country. CPC supports advanced primary care as the foundation of our health system. In addition to attending to patients’ acute, chronic, and preventive health care needs, primary care practices act as the quarterback of each patient’s health care team. CPC practices help patients navigate their care, communicate with specialists and hospitals, and ensure that patients with complex social and medical needs do not “fall through the cracks” of the health care system.

These results build on the first shared savings performance year in 2014. Gross savings nearly doubled from the first performance year to the second and practices in four regions were eligible to receive shared savings, compared to one region in 2014. Primary care transformation takes time, and it is especially encouraging that CPC practices maintained such positive quality of care results while also seeing gross Medicare savings in the 2015 performance year.

The experience in CPC has contributed to our continued efforts to support primary care going forward in the Innovation Center’s Comprehensive Primary Care Plus (CPC+), which will begin on January 1, 2017 and for which we recently announced the 14 selected regions and are currently reviewing practice applications. CMS anticipates that CPC+ could meet the criteria to qualify as an Advanced Alternative Payment Model (Advanced APM) under the recently finalized Quality Payment Program rule, which implements the Medicare Access and CHIP Reauthorization Act of 2015. A robust primary care system is essential to achieve better care, smarter spending, and healthier people. For this reason, CMS is committed to supporting primary care clinicians to deliver the best, most comprehensive primary care possible for their patients.

MACRA rule will accelerate health care system’s shift toward value

Today, the Department of Health & Human Services (HHS) finalized a landmark new payment system for Medicare clinicians that will continue the Administration’s progress in reforming how the health care system pays for care. The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) Quality Payment Program, which replaces the flawed Sustainable Growth Rate (SGR), will equip clinicians with the tools and flexibility to provide high-quality, patient-centered care. With clinicians as partners, the Administration is building a system that delivers better care, one in which clinicians work together and have a full understanding of patients’ needs, Medicare pays for what works and spends taxpayer money more wisely, and patients are in the center of their care, resulting in a healthier country.

HHS finalizes streamlined Medicare payment system that rewards clinicians for quality patient care MACRA rule will accelerate health care system’s shift toward value

Today, the Department of Health & Human Services (HHS) finalized a landmark new payment system for Medicare clinicians that will continue the Administration’s progress in reforming how the health care system pays for care. The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) Quality Payment Program, which replaces the flawed Sustainable Growth Rate (SGR), will equip clinicians with the tools and flexibility to provide high-quality, patient-centered care. With clinicians as partners, the Administration is building a system that delivers better care, one in which clinicians work together and have a full understanding of patients’ needs, Medicare pays for what works and spends taxpayer money more wisely, and patients are in the center of their care, resulting in a healthier country.

“Today, we’re proud to put into action Congress’s bipartisan vision of a Medicare program that rewards clinicians for delivering quality care to their patients,” said HHS Secretary Sylvia M. Burwell. “Designed with input from thousands of clinicians and patients across the country, the new Quality Payment Program will strengthen our health care system for patients, clinicians and the American taxpayer.”

With the Affordable Care Act, America has made important strides in helping more Americans than ever afford quality health insurance and access patient-centered care. The Affordable Care Act created important tools to put individuals at the center of their own care and unlock access to health care data for patients and their clinicians. Today’s announcement builds on this progress and make our health care system work better for everyone. With MACRA, Congress gave HHS the tools to keep improving how we pay for care, so clinicians can focus on the quality of care they give, not the quantity of services they provide; and to keep improving the way care is delivered, by encouraging better coordination and prioritizing wellness and prevention.

“It’s time to modernize the Medicare physician payment system to be more streamlined and effective at supporting high-quality patient care. To be successful, we must put patients and clinicians at the center of the Quality Payment Program,” said Andy Slavitt, Acting Administrator of the Centers for Medicare & Medicaid Services (CMS). “A critical feature of the program will be implementing these changes at a pace and with options that clinicians choose. Today’s policies are designed to get all eligible clinicians to participate in the program, so they are set up for successful care delivery as the program matures.”

Today’s rule is informed by a months-long listening tour with nearly 100,000 attendees and nearly 4,000 public comments. A common theme in the input HHS received was the need for flexibility, simplicity, and support for small practices. And that’s what this final policy aims to provide. First, the new payment system creates two pathways. These paths let clinicians pick the right pace for them to participate in the transition from a fee-for-service health care system to one that uses alternative payment models that reward quality of care over quantity of services. Clinicians will choose between two options:

• The first path gives clinicians the opportunity to be paid more for better care and investments that support patients. It reduces existing requirements, while still emphasizing and rewarding quality care. In the first year, it also provides a flexible performance period, so that those who are ready can dive in immediately, but those who need more time can prepare for participation later in the year.
• The second path helps clinicians go further by participating in organizations that get paid primarily for keeping people healthy. For example, they could be part of an Accountable Care Organization where clinicians come together to coordinate high-quality care for the patients they serve. When they get better health results and reduce costs for the care of their patients, the clinicians receive a portion of the savings.

Evolving along with payment reform

CMS is building the Quality Payment Program to evolve along with the health care system. That’s why it facilitates participation in new payment models. The Affordable Care Act created the Center for Medicare and Medicaid Innovation (Innovation Center) to implement and scale the best ideas from the medical community to improve the quality of care for Medicare beneficiaries while lowering costs. Thanks to the Innovation Center’s work so far, Medicare has a plan for eligible beneficiaries to receive free diabetes prevention services, the quality of hip and knee replacements are being improved while lowering costs, and primary care clinicians are using flexibility to deliver the best outcomes with a payment system that rewards results. CMS intends to broaden opportunities for clinicians, including small practices and specialties, to participate in these kinds of initiatives. For example, a major opportunity being considered for 2018 will be the new Accountable Care Organization Track 1+ model that provides more flexibility for clinicians. CMS is also reviewing reopening some existing Advanced Alternative Payment Models for application to allow more clinicians to join these types of initiatives. In 2018, CMS expects about 25 percent of eligible clinicians will be a part of the second path of Advanced Alternative Payment Models.

Providing comprehensive support to clinicians

To further support small practices, MACRA provides $20 million each year for five years to train and educate Medicare clinicians in small practices of 15 clinicians or fewer and those working in underserved areas. Beginning December 2016, local, experienced organizations will offer free, on-the-ground, specialized help to small practices using this funding. In addition, Jean Moody-Williams, Registered Nurse and Deputy Director of the CMS Center for Clinical Standards and Quality (CCSQ), is leading an outreach effort to individual clinicians nationwide to help them prepare for the Quality Payment Program. In addition, CMS has launched a long-term initiative, led by Dr. Shantanu Agarwal, to improve the clinician experience with Medicare.

Today, we’re also launching a new Quality Payment Program website, which will explain the new program and help clinicians easily identify the measures most meaningful to their practice or specialty. There will also be a service center available by email and phone that will answer questions about the Quality Payment Program.

Continuing to listen

Today’s rule incorporates input received to date, but it is only the next step in an iterative process for implementing the new law. We are launching a new interactive website to help clinicians understand the program and successfully participate. We will continue to host listening and learning sessions throughout the country, and welcome additional feedback from patients, caregivers, clinicians, health care professionals, Congress and others on how to better achieve these goals. HHS looks forward to feedback on the final rule with comment period and will accept comments until 60 days after the final rule’s release date.

For more information about today’s rule, including a fact sheet, please visit: https://qualitypaymentprogram.cms.gov/education

Comments may be submitted electronically through our e-Regulation website at http://www.cms.gov/Regulations-and-Guidance/Regulations-and-Policies/eRulemaking/index.html?redirect=/eRulemaking

First step of the initiative is to reduce medical review for certain Advanced Alternative Payment Models.

Today, the Centers for Medicare & Medicaid Services (CMS) announced a new initiative to improve the clinician experience with the Medicare program. As we implement delivery system reforms from the Affordable Care Act and the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), this new long-term effort aims to reshape the physician experience by reviewing regulations and policies to minimize administrative tasks and seek other input to improve clinician satisfaction. The initiative will be led by senior physicians within CMS who will report to the Office of the Administrator.

“Physicians and their care teams are the most vital resource a patient has. As we implement the Quality Payment Program under MACRA, we cannot do it without making a sustained, long-term commitment to take a holistic view on the demands on the physician and clinician workforce,” said Andy Slavitt, CMS Acting Administrator. “The new initiative will launch a nationwide effort to work with the clinician community to improve Medicare regulations, policies, and interaction points to address issues and to help get physicians back to the most important thing they do – taking care of patients.”

Acting Administrator Andy Slavitt is appointing Dr. Shantanu Agrawal to lead the development of this function and implementation, which will cover documentation requirements and existing physician interactions with CMS, among other aspects of provider experiences. To ensure CMS is hearing from physicians on the ground, each of the ten CMS regional offices will oversee local meetings to take input from physician practices within the next six months and regular meetings thereafter. These local meetings will result in a report with targeted recommendations to the CMS Administrator in 2017. Three of CMS’s regional Chief Medical Officers – Dr. Barbara Connors in Philadelphia, Dr. Ashby Wolfe in San Francisco, and Dr. Richard Wild in Atlanta – have agreed to serve as regional champions of this initiative.

“CMS is turning a new page in assessing not only how to reward for quality, but also to reduce administrative hurdles,” said Dr. Agrawal. “I look forward to hearing about what steps we can take to make the practice of medicine in Medicare more efficient and rewarding.”

Launch of First Initiative: Medical Review Reduction

The first action is the launch of an 18-month pilot program to reduce medical review for certain physicians while continuing to protect program integrity. Under the program, providers practicing within specified Advanced Alternative Payment Models (APMs) will be relieved of some scrutiny under certain medical review programs. Advanced APMs were identified as a potential opportunity for this pilot because participating clinicians share financial risk with the Medicare program. Two-sided risk models provide powerful motivation to deliver care in the most efficient manner possible, greatly reducing the risk of improper billing of services. After the results of the pilot are analyzed, CMS will consider expansion along various dimensions including additional Advanced APMs, specialties, and provider types.

“Like all successful changes, we will begin with the basic steps and build over time,” said Dr. Ashby Wolfe, Region IX Chief Medical Officer. “Most importantly, we are excited to build on the listening and engagement process we began this year by creating more opportunities for physicians to interact with CMS, especially through our regional offices.”

The dedicated team of clinicians participating in Medicare serve over 55 million of the country’s seniors and individuals with disabilities. Through this new initiative, CMS is focused on supporting and empowering those clinicians through a flexible, modern Medicare program informed by clinician expertise and experience.

NIH today announced awards to add four regional medical center groups to the national network of health care provider organizations that will implement the PMI Cohort Program.

Strategic plan will complement and enhance ongoing research efforts across NIH on diseases and conditions affected by nutrition.

The Centers for Medicare & Medicaid Services (CMS) Center for Medicare and Medicaid Innovation is announcing refinements to the design of the second year of the Medicare Advantage Value-Based Insurance Design (MA-VBID) model. The MA-VBID model is an opportunity for Medicare Advantage plans (MA plans), including Medicare Advantage plans offering Part D benefits (MA-PD plans), to offer clinically nuanced benefit packages aimed at improving quality of care while also reducing costs.

In the second year of the model, beginning January 1, 2018, CMS will: open the model test to new applicants; conduct the model test in three new states – Alabama, Michigan, and Texas; add rheumatoid arthritis and dementia to the clinical categories for which participants may offer benefits; make adjustments to existing clinical categories; and change the minimum enrollment size for some MA and MA-PD plan participants.

Value-Based Insurance Design (VBID) generally refers to health insurers’ efforts to structure enrollee cost sharing and other health plan design elements to encourage enrollees to use high-value clinical services – those that have the greatest potential to positively impact enrollee health. VBID approaches are increasingly used in the commercial market, and evidence suggests that the inclusion of clinically-nuanced VBID elements in health insurance benefit design may be an effective tool to improve the quality of care while reducing its cost for Medicare Advantage enrollees with chronic diseases. As part of the “better care, smarter spending, healthier people” approach to improving health care delivery, CMS will test VBID in Medicare Advantage and measure whether structuring patient cost sharing and other health plan design elements encourages enrollees to use health care services in a way that improved their health and reduces costs.

The MA-VBID model will begin January 1, 2017 and run for five years. CMS expects to release a Request for Applications for the second year of the model test in the fall of 2016, and will accept proposals from MA and MA-PD plans to offer VBID benefits in 2018.

In its first year, CMS will test the model in seven states: Arizona, Indiana, Iowa, Massachusetts, Oregon, Pennsylvania, and Tennessee. Beginning January 1, 2018, CMS will also test the model in Alabama, Michigan, and Texas. These states have been selected in order to be generally representative of the national Medicare Advantage market, including urban and rural areas, areas with both high and low average Medicare expenditures, areas with high and low prevalence of Low-Income Subsidies, and areas with varying levels of penetration of and competition within Medicare Advantage. Test states have also been selected based on the availability of appropriate paired comparison areas for the purposes of evaluation. Eligible MA plans in these states, upon CMS approval, may offer varied plan benefit designs for enrollees who fall into certain clinical categories identified and defined by CMS. Benefit design changes made through this model may reduce cost sharing and/or offer additional services to targeted enrollees; however, targeted enrollees can never receive fewer benefits or be charged higher cost sharing than other MA enrollees in their plan as a result of the model.

Background

The existing Medicare Advantage “uniformity” requirement generally requires that an MA plan’s benefits and cost sharing be the same for all plan enrollees. Because of this, clinically-nuanced VBID approaches have generally not been incorporated into MA or MA-PD plans.

The model will test the hypothesis that giving MA plans flexibility to offer supplemental benefits or reduced cost sharing to targeted groups of enrollees with CMS-specified chronic conditions in order to encourage the use of services that are of highest value to them, will lead to higher-quality and more cost-efficient care. The increase in high-quality, cost-efficient care is expected to improve beneficiary health, reduce utilization of avoidable high-cost care, and reduce overall costs for plans, beneficiaries, and the Medicare program. The model is also intended to improve outcomes and reduce costs by encouraging targeted enrollees to obtain care from high-value providers and by providing new supplemental benefits specifically tailored to targeted enrollees’ clinical needs.

The MA-VBID model is authorized under Section 1115A of the Social Security Act (added by section 3021 of the Affordable Care Act) (42 U.S.C. § 1315a), which authorizes the Center for Medicare and Medicaid Innovation to test innovative health care payment and service delivery models that have the potential to reduce Medicare, Medicaid, and Children’s Health Insurance Program expenditures while preserving or enhancing the quality of beneficiaries’ care. CMS will test this model in the Medicare program through a limited waiver of the Medicare Advantage and Part D uniformity requirements.

Description

The MA-VBID model supports improved health outcomes and health care cost savings or cost neutrality through the use of structured patient cost sharing and other health plan design elements that encourage enrollees to use high-value clinical services. The MA-VBID model will provide flexibility for MA and MA-PD plans accepted into the model to develop clinically-nuanced benefit designs for enrollee populations that fall within certain clinical categories.

The conditions are:

• Diabetes
• Chronic Obstructive Pulmonary Disease (COPD)
• Congestive Heart Failure (CHF)
• Patient with Past Stroke
• Hypertension
• Coronary Artery Disease
• Mood disorders
• Rheumatoid Arthritis (starting in 2018)
• Dementia (starting in 2018)

In addition to developing interventions targeted at all enrollees in one or more of the above categories, participating MA plans will have the flexibility to identify specific combinations of the listed chronic conditions for one or more “multiple co-morbidities” groups and establish tailored VBID interventions for each group. Participating MA plans are required to provide VBID benefits to all VBID-eligible enrollees in the selected group. Participating MA plans selecting the Mood Disorders group will also have additional flexibility to focus on specific conditions within that group.

For each of the selected enrollee groups, participating plans may select one or more plan design modifications from a menu of four general approaches. Within each approach, plans have flexibility on how (and to what extent) to implement that approach. Plans may vary their proposed interventions from one target population to another, and from one participating plan to another. CMS will also consider proposals for related variants of these interventions offered to targeted groups of enrollees, such as supplemental benefits conditional on participation in a disease management program.

The four approaches are:

1. Reduced Cost Sharing for High-Value Services

Plans can choose to reduce or eliminate cost sharing for items or services, including covered Part D drugs, that they have identified as high-value for a given target population. Participating plans have flexibility to choose which items or services are eligible for cost-sharing reductions; however, these services must be clearly identified and defined in advance, and cost-sharing reductions must be available to all enrollees within the target population.

Examples of interventions within this category include eliminating co-pays for eye exams for diabetics and eliminating co-pays for angiotensin converting enzyme inhibitors for enrollees who have previously experienced an acute myocardial infarction.

2. Reduced Cost Sharing for High-Value Providers

Plans can choose to reduce or eliminate cost sharing when providers that the plan has identified as high-value treat targeted enrollees. Plans may identify high-value providers based on their quality and not solely based on cost, across all Medicare provider types, including physicians/practices, hospitals, skilled-nursing facilities, home health agencies, ambulatory surgical centers, etc.

Examples of interventions within this category include reducing cost sharing for diabetics who see a physician who has historically achieved strong results in controlling patients’ HbA1c levels and eliminating cost sharing for heart disease patients who elect to receive non-emergency surgeries at high-performing cardiac centers.

3. Reduced Cost Sharing for Enrollees Participating in Disease Management or Related Programs

Participating plans can reduce cost sharing for an item or service, including covered Part D drugs, for enrollees who choose to participate in a plan-sponsored disease management or similar program. This could include an enhanced disease management program, offered by the plan as a supplemental benefit, or it could refer to specific activities that are offered or recommended as part of a plan’s basic care coordination activities. Plans using this approach can condition enrollee eligibility for cost-sharing reductions on meeting certain participation milestones. For instance, a plan may require that enrollees meet with a case manager at regular intervals in order to qualify. However, plans cannot make cost-sharing reductions conditional on achieving any specific clinical goals (e.g., a plan cannot condition cost-sharing reductions on enrollees achieving certain thresholds in HbA1c levels or body-mass index).

Examples of interventions within this category include elimination of primary care co-pays for diabetes patients who meet regularly with a case manager and reduction of drug co-pays for patients with heart disease who regularly monitor and report their blood pressure.

4. Coverage of Additional Supplemental Benefits

Under this approach, participating plans can make coverage for specific supplemental benefits available only to targeted populations. Such benefits may include any service currently permitted under existing Medicare Advantage rules for supplemental benefits.

Examples of interventions within this category include physician consultations via real-time interactive audio and video technologies for diabetics, or supplemental tobacco cessation assistance for enrollees with COPD.

Eligible Applicants and Application Process for 2018

The MA-VBID model test is open to all qualifying MA and MA-PD plans in the test states that submit acceptable programmatic proposals to CMS. Only certain MA and MA-PD plan types are eligible and certain restrictions apply to multi-state plans.

CMS will generally restrict the model test to plans with a minimum enrollment in the test states of 2,000 enrollees. However, beginning in 2018, a MA organization participating in the model test with at least one plan with enrollment over 2,000 enrollees may have additional Plan Benefit Packages (PBPs) participate with a minimum enrollee requirement of 500 enrollees; an additional plan benefit package using this lower enrollment requirement may be from that MA organization or other organizations with the same parent organization. CMS may also grant an exception upon request.

Additionally, plans must meet minimum quality thresholds, including: being rated by CMS at three stars or higher, not consistently low-performing, not an outlier in the CMS past performance analysis, not under sanction, and able to pass a program integrity screening.

The plan must have been offered in at least three annual coordinated election (open enrollment) periods prior to the open enrollment period for the year for which the plan is applying to participate. There is no cap on the total number of participating plans.

CMS will accept applications for the second year of the MA-VBID model via a Request for Applications (RFA), to be released shortly. Once released, application materials will be available at: http://innovation.cms.gov/initiatives/VBID.

More information

More information about the MA-VBID model test can be found in the model’s announcements and other documents, available at http://innovation.cms.gov/initiatives/VBID. The announcement includes instructions for providing CMS with feedback on this model test’s design.

By: Mary K. Wakefield, Ph.D., RN, HHS Acting Deputy Secretary

One of the first actions President Obama took after taking office was to direct federal agencies to find new ways to increase transparency, collaboration and public engagement. Since then, one of our top priorities at HHS has been to make our Department more open and accountable to the people we serve.

With the publication of our fourth HHS Open Government Plan, we’re building on our past performance in making government more transparent to the public and engaging in new ways of collaborating and partnering with our stakeholders.