The Patient Protection and Affordable Care Act (PPACA; Pub. L No. 11-148) was signed into law by President Barack Obama on March 23, 2010, and the Health Care Education Reconciliation Act of 2010 (RCA; Pub. L No. 111-152) was signed into law on March 30, 2010. Together, these acts set in motion a comprehensive reform of the nation’s health care system. Shared decision making is among delivery system reforms contained in the new Center for Medicare and Medicaid Innovation established by the law to test payment and service delivery models. The law also authorizes a Shared Decision Making Program to help beneficiaries–in collaboration with their health care providers–make more informed treatment decisions based on an understanding of available options, and each patient’s circumstances, beliefs and preferences.
Program to Facilitate Shared Decision Making
Under Sec. 3506, the Secretary of the Department of Health and Human Services (HHS) is required to establish a program that develops, tests and disseminates certificated patient decision aids. These educational tools help patients and caregivers better understand and communicate their preferences about reasonable treatment options.
Get the Facts about Sec. 3506
- This provision calls for the HHS to contract with an entity to develop independent standards for educational tools known as “patient decision aids” for preference-sensitive care.
- This provision requires the Secretary of the HHS, the CDC, the NIH and other agencies to establish a program to award grants or contracts to develop, update and produce patient decision aids for preference-sensitive conditions to assist in educating patients and others about the relative safety, effectiveness and cost of treatment. The program would be required to test materials to ensure they are balanced and evidence-based.
- The legislation includes a definition of patient decision aids and preference-sensitive care.
- This provision outlines general design requirements for patient decision aids, including that they:
- Be designed to engage patients, caregivers and authorized representatives in informed decision making with health care providers;
- Present up-to-date clinical evidence about the risks and benefits of treatment options in a form and manner that is age-appropriate and can be adapted for patients, caregivers and authorized representatives from a variety of cultural and educational backgrounds, thereby reflecting the varying needs of consumers and diverse levels of health literacy;
- Where appropriate, explain why there is a lack of evidence to support one treatment option over another; and,
- Address health care decisions across the age span, including those affecting vulnerable populations.
- Unfortunately, Sec. 3506 is one of many provisions of the ACA that were authorized, but not funded. Given the federal fiscal crisis, unfunded provisions are unlikely to be implemented at this time.
Accountable Care Organizations and Medicare Shared Savings Program
Under Sec. 3022, a new model of care known as “accountable care organizations” (ACOs) was established on January 1, 2012. These models will allow health care providers to better coordinate care for their patients in the Medicare program. In addition, ACOs will create incentives for health care providers who participate in these new models of care. The goal of an ACO is to improve care management and quality through integrated delivery of care, while reducing overall cost of care to the population through:
- Better coordination of care among primary care providers, specialists and hospitals
- Improved quality through coordination and enhanced performance measurement
- Providing incentives in the form of shared savings for providers and payers
Get the Facts about Sec. 3022
Medicare Shared Savings Program
The Centers for Medicare and Medicaid Services (CMS) within HHS created the Medicare Shared Savings Program to implement the ACO concept in the Medicare program.
- ACOs meeting eligibility requirements can share in savings achieved by reducing the costs of care to their assigned Medicare patients if the ACO meets quality performance standards developed by CMS.
- The Medicare Shared Savings Program Final Rule incorporates shared decision making into the requirements for ACO eligibility to participate in the program, as well as the quality measures used to determine whether an ACO may receive a portion of any shared savings.
- CMS divided quality measures into different domains, including Patient/Caregiver Experience. Among the specific measures in this domain is “CAHPS Shared Decision Making.”
- [Note that CMS acknowledged concerns raised by commentators in its proposed rule that CG-CAHPS and Hospital CAHPS (HCAHPS) do not include the desired shared decision making modules that are included in the draft Patient Centered Medical Home CAHPS (PCMH-CAHPS) and the Surgical CAHPS. Although not incorporated into the current program, CMS stated that "we may consider these modules, when available, in future rulemaking."]
- To be eligible to participate in the Shared Savings Program, the ACO must define, establish, implement and periodically update processes to promote patient engagement in a list of areas, including:
- Communication of clinical knowledge/evidence-based medicine to beneficiaries in a way that is understandable to them.
- Beneficiary engagement and shared decision making that takes into account the beneficiaries’ unique needs, preferences, values and priorities.
- [In the preamble discussion to the rule, CMS also specifically references used of decision support tools as one option for patient engagement. "We explained that measures for promoting patient engagement may include, but are not limited to, the use of decision support tools and shared decision making methods with which the patient can assess the merits of various treatment options in the context of his or her values and convictions."
Pioneer ACO Model
In addition to the Medicare Shared Savings Program, CMS has implemented ACOs through the Center for Medicare and Medicaid Innovation (CMMI) Pioneer ACO Model.
- In December 2011, CMS selected 32 ACOs that they see as leading organizations with extensive experience and capable of taking on more financial accountability.
- Shared decision making was an element in the process for selecting participating Pioneer ACOs. These Pioneer ACOs had to demonstrate patient centeredness capabilities, including "the ability to engage patients in shared decision making, taking into account patient preferences."
- In order to share in savings, Pioneer ACOs must meet the same quality measures as the Medicare Shared Savings Program, which includes the Patient/Caregiver Experience CAHPS Shared Decision Making measure.
Center for Medicare and Medicaid Innovation
Under Sec. 3021, the Center for Medicare and Medicaid Innovation (CMMI) was created within the Centers for Medicare and Medicaid Services (CMS). As part of this provision, CMMI was awarded $10 billion to test innovative payment and service delivery models to reduce program expenditures, while preserving or enhancing the quality of care.
Get the Facts about Sec. 3201
- Sec. 3021 states that models to be tested by CMMI may include models that “assist individuals in making informed health care choices by paying providers for services and suppliers for using patient decision support tools.” CMMI created the Pioneer ACO Model under this provision.
- In November 2011, CMMI announced the creation of the Health Care Innovation Challenge which would fund applicants who propose the most compelling new service delivery and payment models.
- CMMI expects to make awards ranging from $1 million to $30 million to each selected project to cover a three-year period of performance.
- The objectives of this initiative are:
- Engage a broad set of innovation partners to identify and test new care delivery and payment models that originate in the field, and produce better care, better health and reduce cost through improvement for identified target populations.
- Identify new models of workforce developments and deployment, and related training and education that support new models either directly or through new infrastructure activities.
- Support innovators who can rapidly deploy care improvement models (within six months of award) through new ventures or expansion of existing efforts to new populations of patients, in conjunction (where possible) with other public and private sector partners.
- CMMI expects that a variety of proposals could satisfy this model. In describing potential models in the campaign, CMMI states that “Examples of infrastructure support could include, but need not be limited to: … shared decision making systems.”
- The first round of applications was due January 27, 2012.
Patient Centered Outcomes Research Institute
Under Sec. 6301, the Patient Centered Outcomes Research Institute (PCORI) was established as an independent, non-profit organization responsible for setting priorities for national clinical comparative effectiveness research. In addition, PCORI is to enter into contracts to manage funding and conduct of such research.
Get the Facts about Sec. 6301
- PCORI will generate new evidence to assist patients, as well as clinicians, purchasers and policy makers, in making informed health care decisions.
- Research will be funded by the newly established Patient Centered Outcomes Research Trust Fund (PCORTF), which receives appropriations from private insurance-based taxes under the ACA.
- According to PCORI:
“Patient-centered outcomes research is designed to inform health care decisions by providing evidence on the effectiveness, benefits and harms of different treatment options for different patients. The evidence is generated from studies that compare drugs, medical devices, tests, surgeries or ways to deliver health care. This research recognizes that the patient’s voice should be heard in the health care decision making process. PCORI’s research will be responsive to the preferences, values and experiences of patients in making health care decisions and the impact diseases and conditions can have on daily life.”