Saturday, May 24, 2014

Using mHealth to enhance population health management

The success of hospitals today requires innovative thinking, the ability to respond to new situations quickly and increasingly novel approaches to how they deliver quality patient care. Population health management is one of the key strategies required to thrive in this new world.
The goal of PHM, whether for a health system or an individual practice, is to keep patient populations as healthy as possible. Doing so reduces the need for expensive interventions such as emergency department visits and/or inpatient admissions. This not only lowers costs, but also redefines healthcare as ongoing, patient-centered and beyond just facility-based care.
A key component of PHM is patient engagement, or getting whole groups of individuals actively involved in and responsible for their care. Providing timely, relevant information that keeps patients aligned with their healthcare has been shown to reduce a hospital’s cost of unnecessary care by 30 percent. However, it requires physicians to rethink how they deliver information and the tools they use for proactively offering care. New enterprise communications technologies, when combined with clinical best practices, can help address the challenge of patient engagement by facilitating education, goal attainment and accountability while empowering providers with important information about each individual’s health status outside the clinical setting.
Achieving and maintaining optimal health involves more than medical care – it also encompasses the context of people’s lives, such as where they live and work, what they value and whether they have access to resources. Patients can face many challenges, including:
  • Transportation;
  • Mobility;
  • Language and health literacy;
  • Financial resources;
  • Readiness to change; and
  • Other social determinants of health, such as education, occupation and environment.
The first step to patient engagement begins with understanding the social, physical and individual barriers that can interfere with outcomes. Once these obstacles are understood, providers can leverage technologies such as improved direct communications and mHealth applications to deliver appropriate and targeted information, including care plans, based on an individual’s priorities, interests and unique situation to improve compliance and bring about behavioral change.
A patient's recollection of medical information at the point of care is limited. Whether due to age, stress, anxiety, lack of understanding of medical terminology or other factors, studies indicate that they immediately forget as much as 80 percent of what they are told at a doctor’s office. Moreover, what little they do remember is frequently incorrect. Therefore, communicating the right information in the right way – so that it’s timely, relevant and easily retrievable – is an important piece of the patient engagement puzzle. Mobile health tools offer several ways to help patients make the shift from passive observers to active users of resources that support self-management:
Automated communications
The most successful patient engagement programs rely on multichannel communication—strategies that provide information and feedback according to the participant’s preferred method of contact. This may include telephone, mail, e-mail or text messages. Automated messaging to all discharged hospital patients, for example, can be used to urge them to see their providers, fill their prescriptions, monitor potential complications or call the hospital if they have questions about their care plans. It can also remind them of appointments, alert them to the availability of test results or provide discharge notifications and instructions.
Educational materials
The traditional means of informing patients about their conditions, either by talking to them during a medical encounter or handing them a brochure, largely have proven ineffective.  This type of passive communication can be easily forgotten, lost or ignored. With the advent of mobile phones, however, has come a convenient and highly interactive way to push information to patients. Physicians can take advantage of this opportunity by sending out customized content, such as educational materials, tips, links and other information that the patient can use to make better healthcare decisions. Using communications platforms with a programmable rules engine enables physicians to engage patients around health, display health-related information at the right time and in the right context and reach patients with contextually relevant, motivating messages.
Physicians and healthcare facilities can use surveys to help them refine information-sharing techniques and uncover any additional needs within patient populations through assessments and other touch points. Post-visit questionnaires, for example, can make sure patients understand discharge instructions to greatly improve compliance, as well as return accurate, actionable data needed to improve satisfaction.
According to the Pew Research Center, more than 90 percent of American adults have a cellphone and are therefore equipped with a powerful tool for engagement and health tracking. Medicaid patient populations, which have been hard to reach using traditional communications techniques, are more accessible via cellphone. Across the board, mobile health devices make it easier for patients and providers to communicate, which is the first step in strengthening the provider relationship and keeping patients on track and accountable for their health. Mobile technology also gives patients a sense of control through shared decision-making and goal setting, and helps them to understand the importance of adhering to treatment plans. Perhaps most importantly, engaged patients express greater satisfaction with the care they’ve received.
These technologies not only better connect with patients but also improve provider engagement. They enable physicians to close gaps in care with secure, HIPAA-compliant communications. According to Marc Mitchell, a lecturer on global health at the Harvard School of Public Health, mHealth monitoring reduces the number of adverse events, shortens the length of inpatient stays and reduces hospital readmissions. Greater compliance can also help providers meet meaningful use measures and lead to better reimbursements. Furthermore, mobile technologies can help bring about additional financial savings by reducing waste. Automating routine, time-consuming tasks such as appointment reminders streamlines administrative workflows and conserves human resources. 
The healthcare industry is undergoing rapid, wholesale changes in the way it transacts business, administers care, reimburses physicians and approaches the patient. Mobile technologies play a vital role in helping providers meet the triple aim of improving care and enhancing the patient experience while lowering costs. By facilitating the delivery of medical care, these devices allow organizations to engage individual patients and efficiently manage the health of entire patient populations – thereby improving outcomes. In sum, they enable provider organizations to make the transition from fee-for-service to accountable care while enhancing financial and organizational sustainability.
Patrick Clarkin is vice president of engineering at HIT Application Solutions.

In-Depth: 12 HHS Funded Health Care Innovation Award Projects to Watch

On Thursday of this week, the HHS announced the twelve recipients of the second round of Health Care Innovation Awards program to test innovative models designed to deliver better care outcomes and lower costs. Twelve awards range in value from an expected $2 million to $18 million over a three-year period, with an average award size of $9 million. Each project will be monitored for measurable improvements in quality of care and savings generated.
Health Care Innovation Award Program Overview
The second round of the awards program will support public and private organizations that have a high likelihood of driving health care system transformation and delivering better outcomes. The four defined areas include:
  • Models that are designed to rapidly reduce Medicare, Medicaid, and/or CHIP costs in outpatient and/or post-acute settings.
  • Models that improve care for populations with specialized needs.
  • Models that test approaches for specific types of providers to transform their financial and clinical models.
  • Models that improve the health of populations – defined geographically (health of a community), clinically (health of those with specific diseases), or by socioeconomic class – through activities focused on engaging beneficiaries, prevention (for example, a diabetes prevention program or a hypertension prevention program), wellness, and comprehensive care that extend beyond the clinical service delivery setting.
An in-depth look at the awards are listed below: 

1. Altarum Institute

Project Title: “Reducing the Burden of Childhood Dental Disease”
Geographic Reach: Michigan
Estimated Funding Amount: $9,383,762
The Altarum Institute project will test a service delivery model with multiple components that involves direct work with primary care providers and dentists and the development and enhancement of supporting health information technology components. The model targets children enrolled in Medicaid or CHIP, ages 0 to 17.  Specific intervention activities include: 1) improving Identification of Children at high risk of dental disease by developing and deploying oral health risk screening tools, leveraging an existing statewide registry to document screenings and risk status, and delivering technical assistance/training to providers on the use of these tools in primary care and non-traditional settings; 2) linking to appropriate care providers through existing state and regional health information exchange infrastructure to establish electronic referral pathways between medical and dental providers, connecting dentists to the referral system, and monitoring the process, providing following-up on incomplete referrals; 3) promoting evidence-based preventive care by educating and preparing primary care providers and dentists to follow standards of care for preventive services such as fluoride varnish, sealants, and cleanings, providing outreach and education to families of high-risk children, coordinating with existing oral health promotion programs, and better aligning provider incentives to increase provision of preventive care; and 4) enabling care management and monitoring by developing and implementing a statewide dental quality monitoring system using recently validated American Dental Association measure sets.
2. American College of Cardiology Foundation
Project Title: “SMARTCare”
Geographic Reach: Florida, Wisconsin
Estimated Funding Amount: $15,871,245
The American College of Cardiology Foundation project will test the implementation of SMARTCare, which is a combination of clinical decision support, shared decision-making, patient engagement, and provider feedback tools designed to improve care for patients with stable ischemic heart disease. SMARTCare aims to achieve the following goals: 1) a reduction of imaging procedures not meeting appropriate use criteria, 2) a reduction in the percentage of percutaneous coronary interventions not meeting appropriate use criteria while achieving high levels of patient engagement and lower rates of complications, and 3) an increase in the percentage of stable ischemic heart disease patients with optimal risk factor modification. While many of these solutions have been studied and proven effective in isolation, this project will test them in combination.  The model will be tested at five sites in Wisconsin and five sites in Florida.
3. The Association of American Medical Colleges 
Project Title: “eConsults/eReferrals: Controlling Costs and Improving Quality at the Interface of Primary Care and Specialty Care”
Geographic Reach: California, Iowa, New Hampshire, Virginia, Wisconsin
Estimated Funding Amount: $7,125,770
The Association of American Medical Colleges project will test the scalability of an eConsult/eReferral model for implementation in five partner academic medical centers.  The eConsults model, developed by the University of California San Francisco (UCSF), is an electronic consultation and referral (eCR) platform for access to specialty input to address several well-documented gaps in primary care-specialty care communication and coordination and provide a foundation for non-face-to-face, asynchronous electronic consultation.  The proposed model has two components, both fully integrated into the Epic electronic health record.  The first being implementation of a standardized set of condition-specific referral templates across 12 medical specialties, with additional surgical specialties nearing completion. These templates, developed at UCSF and refined at each academic medical center by a consensus of primary care/specialist clinicians, provide immediate decision support to the primary care provider (appropriateness of referral, recommended pre-referral tests, etc.) and ensure that all necessary information is provided to the appropriate specialist. The second component of the model is the eConsult, an asynchronous exchange initiated by the primary care provider to seek guidance from the specialist, who is expected to respond in less than 72 hours. eConsults are completed in lieu of an in-person specialist visit, though the specialist can convert an eConsult to a referral if the situation warrants and the patients will still have the option to seek care with that specialist, if desired. The eConsult system integrates into current care-delivery practices and supports the work of both the primary care provider and the specialist involved in an eConsult exchange.
4. The Avera Virtual Care Center
Project Title: “Avera Virtual Care Center: Improving Care & Reducing Costs for the Vulnerable Elderly Population”
Geographic Reach: Iowa, Minnesota, Nebraska, South Dakota
Estimated Funding Amount: $8,827,573
The Avera Virtual Care Center project will test the virtual wrapping of a set of comprehensive, resident-centered, geriatric care services around the long term care population. The project will operate in facilities located in South Dakota, Minnesota, Iowa and Nebraska. The three primary drivers of this project include: building the assessment capability and toolkits of the long term care team of care providers; providing long term care facility residents with routine and early access to appropriate goal-directed care; and improving management of care transitions. A Virtual Care Team will host INTERACT II training sessions and skill building workshops for long term care staff and will facilitate widespread implementation of INTERACT II tools and treatment algorithms to support earlier identification of urgent issues. The INTERACT II implementation will be further supported by high-quality care planning resources and training to promote alignment of resident care goals and treatment plans. To address the geriatric care access gap, the Virtual Care Team will offer daily rounds, comprehensive geriatric assessments and urgent care visits to address resident health needs in a timely manner. These services will be provided out of a centrally staffed telemedicine hub, spreading the expertise of one team over 30 long term care centers. To maximize safety and continuity across transitional points in care, the Virtual Care Center team will promote the adoption of standardized tools and processes.
5. The Children’s Home Society of Florida 
Project Title: “Improving child well-being through integrating care in a community school setting”
Geographic Reach: Florida
Estimated Funding Amount: $2,078,295
The Children’s Home Society of Florida project will implement a medical home for students, families, teachers and the community at the Wellness Cottage at Evans High School, which aims to reduce Emergency Department and inpatient utilization, increase sexually transmitted disease awareness, and address food insecurities and traumatic stress. Four community partners including Children’s Home Society of Florida (child welfare/behavioral health), the University of Central Florida, Orange County Public Schools and Central Florida Family Health Center will operate the Wellness Cottage, a hub for health, social, behavioral health, parental support, and after-school activities. The Central Florida Family Health Center will provide onsite primary care. Health risk assessments will inform health promotion activities. Student health ambassadors will promote healthy lifestyles. Community health workers will help parents remove barriers to care. The University of Central Florida will provide social work, nursing, and medical interns. Primary Health Maintenance Organizations will facilitate access to the clinic and assist in evaluating health costs. Programs and services targeting wellness will be available in the school and community. It is predicted that the services provided at Evans Wellness Cottage will improve both the physical health and behavioral health of students, staff, and adults living in the targeted area. The model is designed to create a safe environment where students can learn better health care seeking behaviors and personal health management. In addition, informal and formal connections will help facilitate the development of trust and establish critical lines of communication to improve access to care at the Evans Wellness Cottage.
6. Clifford W. Beers Guidance Clinic, Inc.
Project Title: “New Haven WrapAround”
Geographic Reach: Connecticut
Estimated Funding Amount: $9,739,427
The Clifford W. Beers Guidance Clinic, Inc. project will deliver evidence-based, culturally-appropriate integrated medical, behavioral health, and community-based services coordinated by a multidisciplinary Wraparound Team. Services include: 1) family engagement, recruitment, and education provided by trained community health workers in community-based settings; 2) multidisciplinary triage, screening, and assessment conducted by the Wraparound Team and including assessments of each family’s physical, behavioral, and psychosocial risks, needs, and strengths; 3) family-focused care plans developed with the family, family supports, and the Wraparound Team and used to guide care and interventions; 4) care coordination provided by a Wraparound Team and focused on coordinating the provision of appropriate care across multiple care settings, managing care transitions, reconciling and managing medications, and coordinating access to crisis support and wellness and social support services; and 5) wellness and social support services provided at the hubs and at community-based organizations to address chronic and toxic stress (e.g., smoking cessation, parenting courses, diabetes prevention, meditation). The model focuses on high-need families, addresses medical and behavioral health care needs, integrates services across multiple health care institutions, and addresses the “chronic and toxic stress” experienced by the target population families. This project integrates care for families and integrates care delivery across multiple health care and community-based institutions, which will reduce the fragmentation that currently puts families at risk for poor care, poor outcomes, and excessive costs.
7.  Four Seasons Compassion for Life 
Project Title: “Increasing patient and system value with community based palliative care”
Geographic Reach: North Carolina
Estimated Funding Amount: $9,596,123
The Four Seasons Compassion for Life project will test a new model for community-based palliative care (in conjunction with Duke University), which spans inpatient and outpatient settings. The model features interdisciplinary collaboration and the integration of palliative care into the health care system, continuity of care across transitions, and longitudinal, individualized support for patients and families. This expands upon a successful program in four Western North Carolina counties to include an additional ten counties.  With community-based palliative care, care coordination ensures clinical follow-up of patients as they transition across settings. Standardized assessments and data infrastructure facilitate quality monitoring/improvement and high-quality patient care leading to decreased hospital readmissions.
8. Icahn School of Medicine at Mount Sinai 
Project Title: “Bundled Payment for Mobile Acute Care Team Services”
Geographic Reach: New York
Estimated Funding Amount: $9,619,517
The Icahn School of Medicine at Mount Sinai project will test Mobile Acute Care Team (MACT) Services, which will utilize the expertise of multiple providers and services already in existence in most parts of the United States but will transform their roles to address acute care needs in an outpatient setting. MACT is based on the hospital-at-home model, which has proven successful in a variety of settings.  MACT will treat patients requiring hospital admission for selected conditions at home. The core MACT team will involve physicians, nurse practitioners, registered nurses, social work, community paramedics, care coaches, physical therapy, occupational therapy and speech therapy, and home health aides. The core MACT team will provide essential ancillary services such as community-based radiology, lab services (including point of care testing), nursing services, durable medical equipment, pharmacy and infusion services, telemedicine, and interdisciplinary post-acute care services for 30 days after admission. After 30 days, the team will ensure a safe transition back to community providers and provide referrals to appropriate services.
9. New York City Health and Hospitals Corporation
Project Title: “ED Care Management Initiative: Preventing Avoidable ED/Inpatient Use”
Geographic Reach: New York
Estimated Funding Amount: $17,916,663
The New York City Health and Hospitals Corporation project will test an Emergency Department Care Management model, which expands and enhances a current successful pilot program. This model utilizes a multi-disciplinary team that will comprehensively assess patients who present in the emergency department for an ambulatory-care sensitive condition (ACSC), create a care plan that would avoid an unnecessary hospitalization, and provide ongoing support after discharge, including medication management, education, and linkages with primary care providers.  The program will operate in 6 hospitals.
10. North Shore-LIJ Health System, Inc.
Project Title: “Healthy Transitions in Late Stage Kidney Disease”
Geographic Reach: New York
Estimated Funding Amount: $2,453,742
The North Shore-LIJ Health System, Inc. project will implement the Healthy Transitions (HT) Program, which aims to improve late stage chronic kidney disease costs and outcomes. The model is based on a successful pilot and aims to integrate and coordinate aspects of chronic kidney disease care. The primary interventions center on improving patient education and preparation for renal replacement treatment, increasing home dialysis and preemptive transplantation, home safety, dietary counseling, depression screening, advanced directive counseling, detecting medication errors, identifying hospitalization risk and intervening to reduce risk. Nurse care managers will work in close collaboration with treating nephrologists. The HT chronic kidney disease informatics system creates a daily report with alerts that drives key care processes.
11. Regents of the University of California San Francisco
Project Title: “The UCSF and UNMC Dementia Care Ecosystem: Using Innovative Technologies to Personalize and Deliver Coordinated Dementia Care”
Geographic Reach: California, Nebraska
Estimated Funding Amount: $9,990,848
The Regents of the University of California San Francisco project will implement Care Ecosystem, an innovative clinical program that builds on the UCSF Memory and Aging Center’s 15-year history of offering high-quality dementia care, while incorporating the University of Nebraska Medical Center’s specialized expertise in functional monitoring and rural dementia care. Whereas most dementia care today is crisis-oriented and reactive, this model emphasizes continuous and personalized care. The target population is Medicare beneficiaries and persons dually eligible for Medicare and Medicaid.  By supporting family caregivers, keeping patients healthy, and helping them prepare together for advancing illness, this model aims to improve satisfaction with care, prevent emergency-related health care costs, and keep patients in the home longer. The primary point of contact for patients and families will be a Care Team Navigator (CTN) with 24/7 availability. An innovative “dashboard” with both CTN and patient portals will drive efficient and personalized communication between the CTN, care team, and the patient and family. The 4 modules of Care Ecosystem are as follows. The Caregiver Module will include educational forums and connect families with community resources. The Decision-Making Module will facilitate proactive medical, financial, and safety decisions. The Medication Module will track and reduce inappropriate medications or doses and trigger a pharmacist review when indicated. The Functional Monitoring module will use smartphones and sensors to rapidly detect and respond to changes in functional status, which is particularly important for patients living remotely, alone, or who are at-risk for acute declines.
12  Regents of the University of Michigan
Project Title: “Michigan Surgical and Health Optimization Program (MSHOP): A Multiplex Patient Risk Stratification and Intervention Program”
Geographic Reach: Michigan
Estimated Funding Amount: $6,389,850
The Regents of the University of Michigan project will implement the Michigan Surgical and Health Optimization Program (MSHOP), which focuses on- real-time risk stratification and peri-operative optimization for patients undergoing abdominal surgery. The model aims to improve surgical outcomes in two ways. (1) Real-time risk stratification aims to improve the appropriateness of surgery—in certain high-risk cases, patients and surgeons will avoid prohibitively high-risk surgical care, focusing on medical and palliative management. Further, real-time risk stratification can identify patients who would be good candidates for the peri-operative prehabilitation program. (2) This peri-operative program aims to enable patients to train for surgery, improving their physiology and mindset through an established outpatient program, leading to better outcomes and reduced costs by preventing complications and reducing length of stay.   Over the 3-year period MSHOP will be implemented in 40 Michigan hospitals.
The second and final batch for round two will be announced in the coming months.

Medicare Program; Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs

 A Rule by the Centers for Medicare & Medicaid Services on 05/23/2014

Summary of the Major Provisions

1. Modifying the Agent/Broker Requirements, Specifically Agent/Broker Compensation

The former regulatory compensation structure was comprised of a 6-year cycle that ended December 31, 2013. Under that structure, MA organizations and Part D sponsors provided an initial compensation payment to independent agents for new enrollees (Year 1), and paid a renewal rate (equal to 50 percent of the initial year compensation) for Years 2 through 6. MA organizations and Part D sponsors had the option to pay the 50 percent renewal rate for CY2014 (year 1). This compensation structure proved to be complicated to implement and monitor, and also created an incentive for agents to move beneficiaries as long as the fair market value (FMV) continued to increase each year. To resolve these issues, we proposed to revise the compensation structure. Under our proposal, MA organizations and Part D sponsors would continue to have the discretion to decide, on an annual basis, whether or not to use independent agents. Also, for new enrollments, MA organizations and Part D sponsors could determine what their initial rate would be, up to the CMS designated FMV amount. For renewals in Year 2 and subsequent years, with no end date, the MA organization or Part D sponsor could pay up to 35 percent of the current FMV amount for that year. We believed that revising the existing compensationstructure to allow MA organizations or Part D sponsors to pay up to 35 percent of the FMV for year 2 and subsequent years was appropriate based on a couple of factors. First, we believed that a 2 tiered payment system (that is, initial and renewal) would be significantly less complicated than a 3-tiered system (that is, initial, 50 percent renewal for years 2 through 6, and 25 percent residual for years 7 and subsequent years), and would reduce administrative burden and confusion for plan sponsors. Second, our analysis determined that 35 percent was the renewal compensation level at which the present value of overall payments under a 2-tiered system would be relatively equal to the present value of overall payments under a 3-tiered system (taking into account the estimated life expectancy for several beneficiary age cohorts). In addition to revising the agent and broker compensation structures, we proposed to amend the training and testing requirements as well as setting limits on referral fees ($100) for agents and brokers.
We received more than 140 comments from agents, health plans, and trade associations opposing the 35 percent renewal rate, and instead suggesting that CMS maintain the 50 percent renewal rate. A number of commenters expressed concerns that the proposed reduction in compensation would represent a significant decrease from the current compensation limit, and a rate set at 50 percent of FMV would be in line with industry standard. They noted that the higher compensation amount would be particularly important for stand-alone prescription drug plans, as 35 percent would be insufficient to cover an agent's costs associated with the renewal transaction and could discourage agents from assisting in the annual evaluation of a Medicare beneficiary's options. Commenters also stated that, compared to current practice, the proposed 35 percent renewal rate is a reduction since a number of MA plans began offering a renewal rate of 50 percent for 10 years or more at the end of the 6-year cycle (2013). The majority of commenters also stated that agents play an important role in educating beneficiaries about Medicare and the proposed reduction in the renewal rate could reduce the level and quality of services provided to beneficiaries, thereby resulting in less information sharing and poorer plan choices by beneficiaries. Many commenters also stated that agents spend a significant amount of time in training, preparing, and educating beneficiaries and that the compensation is already low relative to the hours spent. Some commenters also expressed concern that the lower compensation rate would discourage new agents from entering the MA market. Many agents stated they would have to stop selling MA products and instead sell other more profitable products. No plans strongly supported the 35 percent renewal rate. Therefore, we are modifying the compensation renewal rate from up to 35 percent to up to 50 percent. These changes will be applicable for enrollments effective January 2015. Because the proposed rate is similar to previous regulatory requirements, present CMS guidance, and industry practice, we believe this implementation timeframe is reasonable and appropriate. We are not finalizing the proposed changes to agent and broker training and testing at this time. We are finalizing limits on referral fees for agents as proposed.

2. Drug Categories or Classes of Clinical Concern

We are not finalizing any new criteria and will maintain the existing six protected classes.

3. Improving Payment Accuracy—Implementing Overpayment Provisions of Section 1128J(d) of the Social Security Act (§§ 422.326 and 423.360)

These proposed regulatory provisions codify the Affordable Care Act requirement establishing section 1128J(d) of the Act that MA organizations and Part D sponsors report and return identified Medicare overpayments.
We proposed to adopt the statutory definition of overpayment for both Part C and Part D, which means any funds that an MA organization or Part D sponsor has received or retained under Title XVIII of the Act to which the MA organization or Part D sponsor, after applicable reconciliation, is not entitled under such title. To reflect the unique structure of Part C and Part D payments to plan sponsors, we also propose to define two terms included in the statutory definition of overpayments: “funds” and “applicable reconciliation.” We proposed to define funds as payments an MA organization or Part D sponsor has received that are based on data that these organizations submitted to CMS for payment purposes. For Part C we proposed that applicable reconciliation occurs on the annual final risk adjustment data submission deadline. For Part D, we proposed that applicable reconciliation occurs on the date that is the later of either the annual deadline for submitting prescription drug event (PDE) data for the annual Part D payment reconciliations referred to in § 423.343(c) and (d) or the annual deadline for submitting DIR data.
In addition, we proposed to state in regulation that an MA organization or Part D sponsor has identified an overpayment if it has actual knowledge of the existence of the overpayment or acts in reckless disregard or deliberate ignorance of the existence of the overpayment. An MA organization or Part D sponsor must report and return any identified overpayment it received no later than 60 days after the date on which it identified it received an overpayment. The MA organization or Part D sponsor must notify CMS, using a notification process determined by CMS, of the amount and reason for the overpayment. Finally, we proposed a look-back period with an exception for overpayments resulting from fraud, whereby MA organizations and Part D sponsors would be held accountable for reporting overpayments within the 6 most recent completed payment years for which the applicable reconciliation has been completed.
We received approximately 30 comments from organizations and individuals. Generally, commenters supported establishing separate applicable reconciliation dates for Part C and Part D. Many commenters questioned when the 60-day period for reporting and returning begins, and what activities constitute reporting and returning an overpayment to CMS, including questions about estimating an amount of overpayment. A number of commenters also requested to clarify the standards for “identifying” an overpayment, including questions about the meaning of reasonable diligence. Finally, a few commenters recommended that we impose the same limitation on the look-back period for all overpayments, even those relating to fraud.
We are finalizing the provisions at §§ 422.326 and 423.360, with the following modifications. First, we add at the end of paragraph § 422.326(d) the phrase “unless otherwise directed by CMS for the purpose of § 422.311.” Also, to increase clarity we revise §§ 422.326(c) and 423.360(c) regarding identified overpayments. Finally, we strike the following sentence in the proposed paragraphs on the 6-year look-back period: “Overpayments resulting from fraud are not subject to this limitation of the lookback period.”

4. Risk Adjustment Data Requirements

We proposed several amendments to § 422.310 to strengthen existing regulations related to the accuracy ofrisk adjustment data, including: (1) A requirement that medical record reviews, if used, be designed to determine the accuracy of diagnoses submitted under §§ 422.308(c)(1) and 422.310(g)(2); (2) a revision in the deadlines for submission of risk adjustment data; and (3) a limitation on the type and purpose of late data submissions. We also proposed a restructuring of subparagraph (g)(2) as part of the revisions. We received approximately 25 comments from organizations and individuals regarding these proposals; many of the comments were concerned and critical of the proposals, highlighting vagueness and the potential for operational instability. For reasons discussed in more detail below in section III.B.2 of the preamble, we are not finalizing the proposed amendment regarding the scope of medical reviews and we are not finalizing at this time the proposal to change the date for final risk adjustment data submission. We are finalizing as proposed the restructuring of §§ 422.310(g)(2) and the 422.310(g)(2)(ii) provision to prohibit submission of diagnoses for additional payment after the final risk adjustment data submission deadline.

C. Summary of Costs and Benefits

Table 2—Summary of Costs and Benefits Back to Top
Provision descriptionTotal costsTransfers
Modifying the agent/broker requirements, specifically agent/broker compensationN/AN/A
Improving Payment AccuracyN/AN/A
Eligibility of Enrollment for Incarcerated IndividualsWe estimate that this change could save the MA program up to $27 million in 2015, increasing to $103 million in 2024 (total of $650 million over this period), and could save the Part D program (includes the Part D portion of MA PD plans) up to $46 million in 2015, increasing to $153 million in 2024 (total of $965 million over this period).

II. BackgroundBack to Top

A. General Overview and Regulatory History

The Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33) created a new “Part C” in the Medicare statute (sections 1851 through 1859 of the Social Security Act (the Act)) which established what is now known as the Medicare Advantage (MA) program. The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173), enacted on December 8, 2003, added a new “Part D” to the Medicare statute (sections 1860D-1 through 42 of the Act) entitled the Medicare Prescription Drug Benefit Program (PDP), and made significant changes to the existing Part C program, which it named the Medicare Advantage (MA) Program. The MMA directed that important aspects of the Part D program be similar to, and coordinated with, regulations for the MA program. Generally, the provisions enacted in the MMA took effect January 1, 2006. The final rules implementing the MMA for the MA and Part D prescription drug programs appeared in the Federal Register on January 28, 2005 (70 FR 4588 through 4741 and 70 FR 4194 through 4585, respectively).
Since the inception of both Parts C and D, we have periodically revised our regulations either to implement statutory directives or to incorporate knowledge obtained through experience with both programs. For instance, in the September 18, 2008 and January 12, 2009 Federal Register (73 FR 54226 and 74 FR 1494, respectively), we issued Part C and D regulations to implement provisions in the Medicare Improvement for Patients and Providers Act (MIPPA) (Pub. L. 110-275). We promulgated a separate interim final rule in January 16, 2009 (74 FR 2881) to address MIPPA provisions related to Part D plan formularies. In the final rule that appeared in the April 15, 2010 Federal Register (75 FR 19678), we made changes to the Part C and D regulations which strengthened various program participation and exit requirements; strengthened beneficiary protections; ensured that plan offerings to beneficiaries included meaningful differences; improved plan payment rules and processes; improved data collection for oversight and quality assessment; implemented new policies; and clarified existing program policy.
In a final rule that appeared in the April 15, 2011 Federal Register (76 FR 21432), we continued our process of implementing improvements in policy consistent with those included in the April 2010 final rule, and also implemented changes to the Part C and Part D programs made by recent legislative changes. The Patient Protection and Affordable Care Act (Pub. L. 111-148) was enacted on March 23, 2010, as passed by the Senate on December 24, 2009, and the House on March 21, 2010. The Health Care and Education Reconciliation Act (Pub. L. 111-152), which was enacted on March 30, 2010, modified a number of Medicare provisions in Pub. L. 111-148 and added several new provisions. The Patient Protection and Affordable Care Act (Pub. L. 111-148) and the Health Care and Education Reconciliation Act (Pub. L. 111-152) are collectively referred to as the Affordable Care Act. The Affordable Care Act included significant reforms to both the private health insurance industry and the Medicare and Medicaid programs. Provisions in the Affordable Care Act concerning the Part C and D programs largely focused on beneficiary protections, MA payments, and simplification of MA and Part D program processes. These provisions affected implementation of our policies regarding beneficiary cost-sharing, assessing bids for meaningful differences, and ensuring that cost-sharing structures in a plan are transparent to beneficiaries and not excessive. In the April 2011 final rule, we revised regulations on a variety of issues based on the Affordable Care Act and our experience in administering the MA and Part D programs. The rule covered areas such as marketing, including agent/broker training; payments to MA organizations based on quality ratings; standards for determining if organizations are fiscally sound; low income subsidy policy under the Part D program; payment rules for non-contract health care providers; extending current network adequacy standards to Medicare medical savings account (MSA) plans that employ a network of providers; establishing limits on out-of-pocket expenses for MA enrollees; and several revisions to the special needs plan requirements, including changes concerning SNP approvals.
In a final rule that appeared in the April 12, 2012 Federal Register (77 FR 22072 through 22175), we made several changes to the Part C and Part Dprograms required by statute, including the Affordable Care Act, as well as made improvements to both programs through modifications reflecting experience we have obtained administering the Part C and Part D programs. Key provisions of that final rule implemented changes closing the Part D coverage gap, or “donut hole,” for Medicare beneficiaries who do not already receive low-income subsidies from us by establishing the Medicare Coverage Gap Discount Program. We also included provisions providing new benefit flexibility for fully-integrated dual eligible special needs plans, clarifying coverage of durable medical equipment, and combatting possible fraudulent activity by requiring Part D sponsors to include an active and valid prescriber National Provider Identifier on prescription drug event records.

B. Issuance of a Notice of Proposed Rulemaking

In the proposed rule titled “Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs,” which appeared in the January 10, 2014Federal Register (79 FR 1918), we proposed to revise the Medicare Advantage (MA) program (Part C) regulations and prescription drug benefit program (Part D) regulations to implement statutory requirements; strengthen beneficiary protections; exclude plans that perform poorly; improve program efficiencies; and clarify program requirements. The proposed rule also included several provisions designed to improve payment accuracy.

C. Public Comments Received in Response to the CY 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs Proposed Rule

We received approximately 7,600 timely pieces of correspondence containing multiple comments on the CY 2014 proposed rule. While we are finalizing several of the provisions from the proposed rule, there are a number of provisions from the proposed rule (for example, enrollment eligibility criteria for individuals not lawfully present in the United States) that we intend to address later and a few which we do not intend to finalize. We also note that some of the public comments were outside of the scope of the proposed rule. These out-of-scope public comments are not addressed in this final rule. Summaries of the public comments that are within the scope of the proposed rule and our responses to those public comments are set forth in the various sections of this final rule under the appropriate heading. However, we note that in this final rule we are not addressing comments received with respect to the provisions of the proposed rule that we are not finalizing at this time. Rather, we will address them at a later time, in a subsequent rulemaking document, as appropriate.