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73 4 Accreditation, Regulation, and Agencies of Healthcare Quality Alex Brandon/AP/Associated Press Learning Objectives After reading this chapter, you should be able to do the following:

• Illustrate how healthcare policies, rules and regulations, and guidelines impact quality of care.

• Analyze the role of accreditors, including The Joint Commission, along with major steps in the accreditation of healthcare organizations.

• Evaluate the role of Leapfrog group on quality of healthcare and the methodology used to compute the hospital safety score.

• Analyze the structure and process of the National Committee for Quality Assurance (NCQA) accreditation for health plans.

• Assess the role of several government institutions on the quality of care. fin81226_04_c04_073-118.indd 73 10/30/14 7:41 PM What is Special Education? 1 iStockphoto/Thinkstock Pre-Test 1. You can use the terms disability and handicap interchangeably. T/F 2. The history of special education began in Europe. T/F 3. The first American legislation that protected students with disabilities was passed in the 1950s. T/F 4. All students with disabilities should be educated in special education classrooms. T/F 5. Special education law is constantly reinterpreted. T/F Answers can be found at the end of the chapter. Introduction Introduction At the turn of the 20th century, there were few federal regulations to protect the public from dangerous drugs. Many harmful products were freely sold, such as William Radam’s Microbe Killer and Benjamin Bye’s Soothing Balmy Oils to cure cancer. As is sometimes the case, trag - edy brought about the first real regulation to protect consumers health and safety. The Bio - logics Control Act was passed in 1902 after two incidents involving the deaths of children caused by contaminated vaccines. The law mandated producers in the U.S. to be licensed each year for the manufacture and sale of biologics such as antitoxins, serum, and vaccines to pre - vent future tragedies from reoccurring. That was followed by the Pure Food and Drugs Act in 1906, which prohibited interstate commerce in misbranded and adulterated foods, drinks, and drugs and mandated strict health safety and testing policies. The law was passed mainly in response to shocking public disclosures of unsanitary conditions in meat packing plants, as well as fears over poisonous preservatives and dyes in foods.

However, the 1906 law had its shortcomings and the government’s hands were tied when it came to preventing the sale of medicinal products that carried wild claims of health cures.

In 1910, the government stopped sales of a product called Dr. Johnson’s Mild Combination Treatment for Cancer, but the Supreme Court ruled in favor of the company because the prod - uct’s false claims were not within the scope of the Pure Food and Drugs Act (Meadows, 2006).

As a result, in 1912, Congress passed the Sherley Amendment, which prohibited labels on medicines that falsely advertised therapeutic benefits.

It was another tragedy, however, that would spur the passage of comprehensive legislation to protect the health and safety of consumers. In 1937, a Tennessee drug company launched a form of the new sulfa wonder drug that targeted pediatric patients, Elixir Sulfanilamide. How - ever, the formula in this untested product was a form of antifreeze and killed over 100 people, including many children (U.S. Food and Drug Administration, 2012a).

The public’s reaction affected policymakers and reshaped the drug provisions of the new law to prevent such an event from recurring. Franklin D. Roosevelt signed the Food, Drug, and Cosmetic Act (FD&C Act) on June 25, 1938 (FDA, 2012a). The main purpose of the FD&C Act was to assure that foods, drugs, and cosmetics are safe and effective. The law also created the U.S. Food and Drug Administration (FDA). It was the first law preventing the marketing of drugs that had not been thoroughly tested prior to their sale to the public, and it started a new system of drug regulation.

In 1962, the FDA Medical Officer, Frances O. Kelsey, kept the drug thalidomide off the U.S. mar - ket, which aroused public interest in drug regulation. Thalidomide had been marketed as a sleeping pill by a German firm, and was associated with the births of thousands of malformed babies in Western Europe. In the years before 1962, Senator Estes Kefauver had held hearings on drug costs, a lack of science on drug effectiveness, outrageous claims made on drug labels and in marketing, and the differences between well-controlled studies and the typical drug study. With the FD&C Act in effect because of thalidomide, Congress had the opportunity to make major changes.

In October 1962, Congress passed the Kefauver-Harris Drug Amendments to the FD&C Act. Before marketing a drug, firms now had to prove safety, as well as provide substantial fin81226_04_c04_073-118.indd 74 10/30/14 7:41 PM Introduction evidence of effectiveness for the product’s intended use, requiring data from well-controlled studies. Also, the 1962 amendments required that the FDA specifically approve the marketing application before the drug could be marketed, which was another major change. This moved the regulation of prescription drug advertising from the Federal Trade Commission to the FDA (Meadows, 2006).

Congress continues to update the legislative framework authorizing the work of the FDA. In 1990, the Safe Medical Devices Act required that healthcare facilities report events where a medical device potentially contributed to a patient death or serious injury (FDA, 2012b). In addition, companies that manufacture implantable devices that could cause serious harm or death by failure are required to monitor use of the devices for adverse patient events. In 1997, the Food and Drug Modernization Act included measures that would make device reviews more rapid, and it strengthened the FDA’s ability to regulate advertising for unapproved uses of medications and medical devices (FDA, 2012b).

The continuing evolution of the regulatory framework for the healthcare industry highlights the importance of understanding the various facets of health policy that impact organizations involved in the delivery of healthcare. Table 4.1 lists some key dates in the history of drug legislation.

Table 4.1: Key dates for actions to ensure drug safety Date Description 1848 Drug Importation Act passed by Congress to require U.S. Custom Service inspection to stop entry of adulterated drugs from overseas. 1862 President Abraham Lincoln appoints a chemist to serve in the new Department of Agriculture, which is the beginning of the Bureau of Chemistry, predecessor of the U.S. Food and Drug Adminis - tration (FDA). 1880 Peter Collier, the chief chemist, recommends passage of a national food and drug law based on his own investigations of food adulteration, but the bill is defeated and during the next 25 years more than 100 food and drug bills are introduced in Congress. 1902 The Biologics Control Act is passed, establishing government authority to regulate biological prod - ucts and ensure their safety. Until that time, biologics were not subject to federal oversight and lacked standards for quality, safety, purity, and potency. 1906 The federal Pure Food and Drugs Act is signed by President Theodore Roosevelt, prohibiting inter - state commerce in adulterated and misbranded food and drugs. 1912 Congress passes the Sherley Amendment, which prohibits labeling of medicines with false thera - peutic claims intended to defraud the purchaser. 1927 The Bureau of Chemistry is reorganized into two separate entities, with regulatory authority located in the Food, Drug, and Insecticide Administration—a name that is later shortened to Food and Drug Administration. 1938 The federal Food, Drug, and Cosmetic Act is signed by President Franklin D. Roosevelt, creating the FDA and regulations to assure that foods, drugs, and cosmetics are safe and effective. 1940 The FDA is transferred from the Department of Agriculture to the Federal Security Agency and the first commissioner of food and drugs is appointed. continued fin81226_04_c04_073-118.indd 75 10/30/14 7:41 PM Introduction Date Description 1941 The Insulin Amendment is passed, requiring the FDA to test and certify the purity and potency of this diabetes drug. 1951 The Durham-Humphrey Amendment is passed; it defines the kinds of drugs that cannot be safely used without medical supervision and restricts their sale to prescription by a licensed practitioner. 1962 The FDA keeps the drug thalidomide, a sleeping pill associated with the births of thousands of malformed babies in Western Europe, off the U.S. market. 1962 Congress passes the Kefauver-Harris Drug Amendments to the FD&C Act, to ensure drug efficacy and greater safety. For the first time, drug manufacturers are required to prove the safety and effectiveness of a drug before marketing it to the public. 1966 FDA contracts with the National Academy of Sciences/National Research Council to evaluate the effectiveness of 4,000 drugs approved on the basis of safety alone between 1938 and 1962. 1967 The Fair Packaging and Labeling Act requires all consumer products in interstate commerce to be honestly and informatively labeled and gives the FDA authority to enforce provisions on foods, drugs, cosmetics, and medical devices. 1968 The reorganization of federal health programs places the FDA in the Public Health Service. 1970 The FDA requires the first patient package insert, requiring oral contraceptives to contain infor - mation for the patient about specific risks and benefits of the medication. 1972 Over-the-Counter Drug Review is started to enhance the safety, effectiveness, and appropriate labeling of drugs sold without a prescription. The regulation of biologics, including serums, vac - cines, and blood products, is transferred to the FDA. 1976 Medical Device Amendments are passed to ensure safety and effectiveness of medical devices. 1977 Introduction of the Bioresearch Monitoring Program, an FDA initiative to ensure the quality and integrity of data submitted to FDA and provide for the protection of human subjects in clinical trials. 1988 The Food and Drug Administration Act of 1988 officially establishes the FDA as an agency of the Department of Health and Human Services with a Commissioner of Food and Drugs appointed by the President with the advice and consent of the Senate. 1990 The Safe Medical Devices Act is passed, requiring healthcare facilities report events where a medi - cal device potentially contributed to a patient death or serious injury. The act authorizes the FDA to order product recalls and other actions. 1997 Food and Drug Modernization Act passed, mandating the most wide-ranging reforms in agency practices since 1938, including measures to accelerate the review of medical devices, regulate advertising of unapproved uses of approved drugs and devices, and regulate health claims for foods. 1999 The FDA issues a final rule that mandates that all over-the-counter drug labels must contain data in a standardized format to provide patients with easy-to-find information, analogous to the nutri - tion facts label for foods. 2002 The FDA launches its current good manufacturing practice initiative and updates regulations to ensure quality manufacturing processes and products for animal and human drugs and biological medicines. Table 4.1: Key dates for actions to ensure drug safety (continued) fin81226_04_c04_073-118.indd 76 10/30/14 7:41 PM Section 4.1 Health Policies, Laws, and Regulations 4.1 Health Policies, Laws, and Regulations Chapter 4 aids in the understanding of the governing and regulatory agencies that support the promotion of quality. Governing agencies serve as an authority to reassure the public that particular organizational activities satisfy regulations and safety needs. These organizations can establish rules and regulations, and in some cases guidelines, to enforce laws typically developed through representation and due process. Regulatory agencies can aid in the defini - tion of quality, as it pertains to the benefits of the people they serve. In general, the healthcare industry and healthcare quality are regulated by policies, laws, rules and regulations, guide - lines, and best practices. The difference among them is their level of authority and purpose.

Health policies, rules, and regulations have a powerful effect on the quality of healthcare deliv - ered, and subsequently the health of individuals. For instance, the Institute of Medicine’s 2001 report, Crossing the Quality Chasm: A New Health System for the 21st Century , showed that the healthcare industry fails to meet expectations and frequently harms patients. The report rec - ommended a wholesale change of the healthcare system and provided specific directions for all healthcare players. To help change the American healthcare system, Congress created an “innovation fund” of $1 billion to redesign and renovate the healthcare system (IOM, 2001).

In order to revamp the healthcare system, the Agency for Healthcare Research and Qual - ity (AHRQ) identified about 15 common health conditions for which healthcare providers were to improve care (IOM, 2001). The U.S. Department of Health and Human Services (HHS) was given the authority to monitor quality improvements in (1) safety, (2) effectiveness, (3) responsiveness to patients, (4) timeliness, (5) efficiency, and (6) equity, and report to Congress annually. In addition, 10 new rules were proposed to improve the healthcare system (Longest, 2002). Specifically, these 10 rules to redesign and improve healthcare included: 1. Available care in many forms and at all times; 2. Standardized care for most common health problems with the capability of respond - ing to individual preferences; 3. Empowering patients with necessary information to encourage shared decision making; 4. Free and effective information flow between clinicians and patients; 5. Evidence-based decision making; 6. High priority on patient safety in the healthcare system; 7. Transparency in the system for informed decision making when selecting a health plan, hospital, physician, and alternative treatments; 8. Anticipating patient needs; 9. Eliminating waste and redundancies; and 10. Effective information exchange between physicians and institutions of the health - care system (IOM, 2001). By focusing on these goals, healthcare organizations can improve their systems and the care they provide.

Forms of Health Policies Health policies are authoritative decisions that come from the government in order to improve a certain outcome or control healthcare players’ actions (Longest, 2002). Health policies are more broadly known as public policies and are made through a dynamic public fin81226_04_c04_073-118.indd 77 10/30/14 7:41 PM Section 4.1 Health Policies, Laws, and Regulations policy making process. Most health policies pertain to healthcare quality and safety, financing of various government programs, and improving deficiencies in healthcare markets.

Private sector health policies are also authoritative decisions made in the private sector by organizations such as The Joint Commission (TJC), a private accrediting body for health- related organizations, or by the National Committee for Quality Assurance (NCQA), a private organization that monitors the quality of care delivered by managed healthcare plans and decides what criteria to use to assess quality of care.

Health policies are classified into several categories. Policies that are formulated and approved by legislators at any level of government are known as laws . For instance, the Patient Protec - tion and Affordable Care Act, signed into law on March 23, 2010, by President Barack Obama, is a federal statute that authorizes the establishment of state insurance exchanges for individ - uals and families currently uninsured to purchase coverage at affordable rates. Laws enacted by state and local governments are also considered health policies. For instance, 13 states cur - rently have laws or regulations in place to address nurse staffing in hospitals, since the num - ber of nursing staff versus the number of patients they are assigned to care for is considered critical to the delivery of quality patient care. Those states are California, Connecticut, Illi - nois, Minnesota, Nevada, New Jersey, New York, Ohio, Oregon, Rhode Island, Texas, Vermont, and Washington.

Seven states require hospitals to have staffing committees that review staff - ing plans and policy. Five states require some type of disclosure and/or pub - lic reporting of staffing levels. Only one state, California, stipulates in law and regulations a required minimum nurse to patient ratio (one nurse for every five patients on medical surgical units and smaller ratios for more spe - cialized units where patients require more care) that must be maintained at all times (Tevington, 2011).

Rules and Regulations Rules and regulations are more detailed interpretations of healthcare laws and are cre - ated by the organizations and agencies responsible for implementing laws and policies in the executive branch of government (Longest, 2010). These organizations and agencies set expectations such as the frequency of reporting, the nature of data to be submitted, benefits and penalties, and the overall processes of implementing a law or policy. HHS, with its many agencies and departments, has the authority to create rules and regulations for all public healthcare policies. The Centers for Medicare & Medicaid Services (CMS), AHRQ, FDA, and National Institutes of Health (NIH) are the most commonly known agencies regulating the healthcare industry and healthcare quality in the United States. Catherine Yeulet/iStock/Thinkstock Because the California Nurses Association (CNA) filed a lawsuit in 2005 and won, the 1:5 nurse-patient ratio in medical surgical units has become mandated. fin81226_04_c04_073-118.indd 78 10/30/14 7:41 PM Section 4.1 Health Policies, Laws, and Regulations The Summary of Final Rule Provisions for Accountable Care Organizations under the Medicare Shared Savings Program is an excellent example of rules and regulations. This program rewards accountable care organizations (ACO) when they incur lower costs while meeting quality standards and satisfying patients and their health plans.

These rules were finalized on October 20, 2011, by CMS, an agency within HHS (CMS, 2011b).

CMS worked closely with several federal agencies to develop the Medicare Shared Savings Program to help doctors, hospitals, and other healthcare providers better coordinate care under ACOs.

The Affordable Care Act encourages doctors, hospitals, and healthcare providers to form net - works to coordinate patient care and become eligible for bonuses when they deliver that care more efficiently, thus reducing healthcare costs. An ACO is a group of these healthcare provid - ers who come together voluntarily to give coordinated care to their Medicare patients (CMS, 2013c). It brings together different components of care for patients, including primary care, specialists, hospitals, post-acute care, home healthcare agencies, and others. Therefore, an ACO may include physicians, as well as physician assistants, nurse practitioners, and clinical nurse specialists.

The goal of coordinated care is to ensure that patients, especially the chronically ill, receive quality care, while avoiding the duplication of services and preventing medical errors. When an ACO succeeds in delivering high quality of care and spending healthcare money wisely, it will share in the savings it achieves for the Medicare program. In essence, providers make more if they keep their patients healthy.

About 4 million Medicare beneficiaries are now in an ACO, and combined with the private sec - tor, more than 428 provider groups have signed up. An estimated 14% of the U.S. population is now being served by an ACO (Gold, 2014). Under the Affordable Care Act, each ACO has to manage the healthcare needs of a minimum of 5,000 Medicare beneficiaries for at least three years. ACOs are projected to save Medicare up to $940 million in their first four years (Gold, 2014). Medicare Shared Savings Program is one of several ACO programs offered by Medicare.

The final rule includes several provisions concerning the ACO, providers in the ACO, and the Medicare beneficiary. For instance, providers of the ACO are required to inform patients that they are participating in an ACO and are eligible for additional Medicare payments to improve the quality of care while lowering costs. In addition, Medicare beneficiaries are free to choose another provider in or out of the ACO and can move within the same ACO if they desire. The final rule requires that the patient’s medical records may be shared with the ACO to improve the coordination of care, but the patient is free to decline the data sharing arrangements.

Furthermore, the final rule calls for Medicare to assess the ACO’s quality and financial perfor - mance based on the population’s use of primary care services at the end of each year.

ACOs operate under a different premise aimed at saving healthcare dollars. In Medicare’s traditional fee-for-service payment systems, doctors and hospitals generally are paid for each test and procedure ordered for a patient. This can drive up costs by fiscally rewarding provid - ers for doing more for patients, even if it is not needed.

ACOs create an incentive to be more efficient by offering bonuses to providers who keep costs down. However, the government ensures that providers do not sacrifice the quality of patient fin81226_04_c04_073-118.indd 79 10/30/14 7:41 PM Section 4.1 Health Policies, Laws, and Regulations care by requiring that doctors and hospitals meet specific quality benchmarks, focusing on prevention and carefully managing patients with chronic diseases. Providers are paid more for keeping patients healthy and out of the hospital. ACOs encourage doctors and hospitals to reduce hospital stays, emergency room visits, specialists, and tests—all ways they make money in the current fee-for-service system—but not by sacrificing patient care to do so.

Operational Decisions and Guidelines Operational decisions and guidelines are similar to rules and regulations as they deter - mine the course of action of a particular situation or condition. However, the difference is that operational decisions and guidelines are documents of practical application, which have less authority than rules and much less authority than healthcare laws. CMS is the operating divi - sion of HHS that is responsible for oversight of the Medicare program and the federal portion of Medicaid and creates guidelines for its contractors.

Other agencies and organizations also create guidelines to help healthcare organizations.

Evidence-based research provides the basis for clinical practice guidelines and recommen - dations, many of them collected in a database called the National Guideline Clearinghouse (ht tp://w w w.guideline.gov ). An initiative of the Agency for Healthcare Research and Quality, the clearinghouse provides physicians and other healthcare professionals with guidelines, for instance, on how to best treat a disease or condition. For example, healthcare professionals can find recommendations for preventing and controlling the flu in children or guidelines on how to recognize, assess, and treat social anxiety disorder.

In another example, healthcare guidelines can help define the standards of quality care for people with Down syndrome. Guidelines recommend screening tests and include information about the types of medical conditions that individuals with Down syndrome are at risk for.

They include suggestions for early intervention, diet and exercise, and other issues people can face.

The Centers for Disease Control and Prevention also publishes guidelines for preventing healthcare-associated pneumonia, an acute respiratory infection that people can acquire in hospitals, ambulatory, and long-term care settings.

Best Practices A best practice is a method or technique that has consistently produced results superior to those achieved with other means. It is often used as a benchmark to which other organiza - tions can compare their own results. A best practice does not necessarily hold any level of authority, meaning that organizations are not bound to follow a best practice.

A best practice occurs in many contexts, and can apply to clinical guidelines for healthcare providers, application of health information technology, and business practices. While the phrase may be considered a “buzzword” in some organizations, it has positive implications regarding the improvement of quality in healthcare when best practices are applied in a dis - ciplined fashion.

Best or promising practices can help an organization solve problems. Why reinvent the wheel if someone has found an effective way to solve a problem? For instance, a health coalition was fin81226_04_c04_073-118.indd 80 10/30/14 7:41 PM Section 4.1 Health Policies, Laws, and Regulations concerned that a survey of families showed most elementary school children were spending much of their time watching TV and playing video games. They weren’t getting the exercise they needed, which could lead to heart and other health problems later in life.

The coalition looked for a solution and found that research has shown that introducing chil - dren to sports they can enjoy throughout their lifetime—biking, tennis, swimming, hiking, skiing—is one of the best ways to create a lifetime commitment to regular physical activity.

This was a best practice and the coalition went to work with local schools and officials to teach and promote these sports to children and ensure there were facilities in their community.

Healthcare organizations can also use best practices to help protect their computer systems.

For example, one best practice is to require staff members to use strong passwords and change them regularly. Passwords are the first line of defense in preventing unauthorized access to any computer, and strong passwords can help prevent someone who shouldn’t be looking at patient records from gaining access. Another best practice is to install and maintain antivirus software so attackers cannot compromise computers in a physician office through viruses that exploit computer vulnerabilities.

An example of a best practice can be found at the CMS website for Skilled Nursing Facili - ties (SNF) entering into arrangements with outside providers and suppliers for the SNF’s patients (CMS, 2013d). Initially, the SNF community raised concerns that the best practices called for SNFs to execute a formalized contract with each outside vendor or provider. As a result, six months later, CMS issued another instruction (CR 3592, transmittal 412) clarifying the nature of the relationship between a SNF and its supplier. New guidelines required the SNF to assume responsibility for the arranged services, and the payment for those services from the bundled payment the SNF receives from CMS (CMS, 2013d).

There are specific steps provided in these best practices to prevent any confusion related to payment for these services. CMS even provides various sample forms for SNFs to improve the communication with the supplier (clinic) and formalize the relationship. These guidelines and forms outline the specific course of action in each specific case (CMS, 2013d).

Because of the growing interest in best practices, especially in the area of high quality and value-based healthcare, CMS initiated the Best Practices Pilot Program (CMS, 2013e). On Sep - tember 10, 2012, CMS released a report that showed best practices from Medicare Advantage (MA) organizations and Part D sponsors or those companies providing Medicare prescription drug benefits to seniors.

Table 4.2 reveals seven major operational areas with best practice guidelines that include (1) prescription drug formulary administration which requires electronic medical record and E-prescribing, (2) Part D and (3) Part C Coverage determinations, appeals, and griev - ances, (4) compliance program effectiveness, (5) agent/broker oversight, (6) Part C and Part D enrollment and disenrollment, and (7) Part D late enrollment penalty. These best practices for MA plans explain desired norms by CMS and should encourage MA plans to continuously improve their business practices in order to satisfy Medicare beneficiaries. Table 4.2 also provides a summary of findings from MA plan audits, and the most common mistakes that should help the plans to improve their practices and the quality of care Medicare beneficia - ries receive from these health plans. fin81226_04_c04_073-118.indd 81 10/30/14 7:41 PM Section 4.1 Health Policies, Laws, and Regulations Table 4.2: Best practices and common findings from CMS 2012 program audits No Operational areas Best practices Common findings 1 Prescription drug formulary administration 1. E-prescribing: Electronic medical record (EMR) systems enhance informed decision- making on appropriate medications, featuring a clear information transfer, educa - tional messaging to prescribers regarding preferred medication options and the best overall value for members, and the pharmacist involvement. 2. The same transition process for new and existing members, identifying the presence of ex - isting medications accounting for dosing adjustments as well as the presence of prescriptions that were extended. 3. Updating prior authorizations (PAs) efficiently, featuring a re - port of all PAs in the system to notify prescribers to extend the PAs’ duration when necessary, and a renewal letter together with an updated PA form to be sent out to prescribers prior to the end of the year. 4. Effective communication among the beneficiary, sponsor, pharmacy, and the pharmacy benefit manager (PBM), includ - ing routine review of rejected claim reports and directing calls about medications from customer service to experi - enced staff in the pharmacy department. 5. Formulary inclusion and alterations reduces errors at the point of service and ensures beneficiaries’ access to their medications. 1. Unapproved system edits, including unapproved quantity limits, unapproved prior autho - rization edits and inappropri - ate maximum cost edits. 2. Transition fills were denied due to utilization management restrictions, including failure to provide formulary medica - tions, failure to pay an eligible transition claim, and failure to properly administer the CMS- approved formulary. continued fin81226_04_c04_073-118.indd 82 10/30/14 7:41 PM Section 4.1 Health Policies, Laws, and Regulations No Operational areas Best practices Common findings 2 Part D coverage determinations, appeals, and grievances 1. Ensuring timeliness in spon - sors’ decision making by track - ing and overseeing their cover - age determinations, appeals, and grievances. Enhancing accurate and timely drug dis - tribution by notifying pharma - cies of coverage determination and appeal decisions within an hour of a decision. 2. Providing complete and de - tailed documentation by utiliz - ing detailed and clear letters and reports, as well as utilizing a cross-functional, internal database. 3. Developing effective communi - cation, including implementing policies to take responsibility for grievances, repeated at - tempts to contact prescribers for additional information, “5 point of contact” method to re - quest coverage determination and appeal information. 4. Implementing EMRs to develop more accurate and timely clini - cal decision making. 1. Noncompliance with adjudica - tion timeframes and processing. 2. Noncompliance with notifica - tion requirements. 3. Improper classification and processing of requests. 4. Noncompliance in handling Part D grievances. 3 Part C organiza - tion determina - tions, appeals, and grievances 1. Routinely processing pre- service request prior to dead - lines to reduce reconsidera - tions and appeals. 2. Implementing EMRs to improve operational efficiency, increase access to clinical information and enhance safety. 3. Implementing effective pro - vider outreach to collect clini - cal documentation quickly and completely. 4. Communicating effectively with beneficiaries through phone calls, open communication process that provides direct contact with the sponsor’s management staff, appoint - ment of representation forms, and customized grievance letters. 1. Inaccurate and unclear in the communication of coverage decisions 2. Noncompliance with adjudica - tion timeframes and processing 3. Misclassifying organization determinations, appeals, and grievances Table 4.2: Best practices and common findings from CMS 2012 program audits (continued) continued fin81226_04_c04_073-118.indd 83 10/30/14 7:41 PM Section 4.1 Health Policies, Laws, and Regulations No Operational areas Best practices Common findings 4 Compliance pro - gram effectiveness 1. Tracking and monitoring systems help detect excluded providers, monitor compliance, assess contractor risks, track the status of corrective action plans and Medicare Prescrip - tion Drug Integrity Contractor referrals, assign measures such as priority levels, metrics, scor - ings, and produce reports. 2. Collecting and sharing data to identify abnormal relationships and aberrant patterns indicating fraud, waste, and abuse (FWA). 3. Developing staff through train - ing and providing resources of information and policies such as a user-friendly intranet site, FWA website, and a Code of Conduct (COC) with links to supporting policies. 4. Hotline for FWA calls staffed with pharmacy-certified Cus - tomer Service Representatives. 1. Failure to implement training and education among staff 2. Lack of an effective system for monitoring, auditing, or identi - fying compliance risks 3. Lack of procedures for fully investigating, reporting, and timely remediation of compli - ance and potential FWA issues 5 Agent/Broker oversight 1. Providing mandatory trainings to agents and brokers of plans with the passing score of 85% or higher. 2. Enhancing Outbound Enroll - ment Verification (OEV) Proce - dures by sending OEV letters to all beneficiaries, reviewing OEV calls related to providing correct information in a timely manner, and utilizing check - lists, spreadsheets, and other tracking mechanisms. 3. Maintaining the most current information through an agent/ broker advisory board and/or quarterly broker meetings. 4. Appropriately and timely managing complaints through investigations and providing appropriate actions. 1. Failure to meet the require - ments for OEV calls 2. Failure to implement complete investigations of complaints Table 4.2: Best practices and common findings from CMS 2012 program audits (continued) continued fin81226_04_c04_073-118.indd 84 10/30/14 7:41 PM Section 4.1 Health Policies, Laws, and Regulations No Operational areas Best practices Common findings 6 Part C and Part D enrollment and disenrollment 1. Reviewing the status of enroll - ments with missing informa - tion on a daily basis. 2. Appropriately using resources, including regular meetings between customer service and Medicare enrollment depart - ment, cross-training staff, strong system providing up-to- date information. 3. Maintaining communication with beneficiaries regarding their plan and benefits to en - sure their understanding. 1. Failure to properly process en - rollment/disenrollment denials and incomplete enrollment request 2. Failure to timely process enroll - ment/disenrollment requests 7 Part D Late Enroll - ment Penalty (LEP) 1. Developing and implementing systems to help organizations process Part D LEPs through streaming, tracking, and moni - toring sponsor activities. 2. Ensuring decision-making within four days or less. 3. Multiple attempts to obtain beneficiaries’ responses to the creditable coverage attestation form, including sending re - minder of the last day to attest. 1. Noncompliance with regard to complete and effective com - munication with beneficiaries about Late Enrollment Penalty concerns Source: Centers for Medicare & Medicaid Services (CMS). (2013). Best practices guidelines . Retrieved from http://www.cms.gov /Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/BestPractices.html Judicial Decisions Judicial decisions , or decisions of U.S. courts, are another form of health policies. In some cases, laws, rules and regulations, and operational decisions are unclear, and clarification is needed. In the case of a dispute, the judicial system provides clear interpretation of health policy and makes a final decision in the implementation of the laws and regulations. A recent example is the Supreme Court’s ruling on the Affordable Care Act (ACA) to uphold the penalty imposed on individuals who do not obtain healthcare coverage. The 5–4 decision ruled that the individual mandate is constitutional and within the powers of the government, treating it as a “tax” ( National Federation of Independent Business v. Sebelius , 2012). Table 4.2: Best practices and common findings from CMS 2012 program audits (continued) fin81226_04_c04_073-118.indd 85 10/30/14 7:41 PM Section 4.2 Accreditation and The Joint Commission (TJC) 4.2 Accreditation and The Joint Commission (TJC) Creating a high quality environment for patients and staff is a common goal among healthcare organizations. The foundation of healthcare is rooted in providing effective and efficient ser - vices to the community and satisfying patient needs. Since the early 1900s, there has been an emphasis on creating the ideal environment to foster quality care.

As standards came to form, unbiased outside organizations began acting to ensure that estab - lished standards were being met and to provide accreditation for the organization. Accredita - tion is a voluntary process undertaken by a healthcare provider, program, system, or insti - tution to demonstrate its commitment with standards designed by the accrediting agency (“Accreditation,” 2005). By achieving accreditation with an organization approved or granted “deemed status” by CMS, the healthcare organization is presumed to be in compliance with applicable regulations (CMS, n.d.b).

Often accreditors, such as The Joint Commission, also offer certification, which is voluntary but exists as a mark of distinction for a particular program of the hospital (or other entity).

Programs within an organization that become certified are used for the purposes of market differentiation. A hospital can promote its program to treat asthma, diabetes, or heart failure based on its certification status.

The accreditation process holds practitioners, administrators, and staff to a higher standard to continuously improve the quality of services and promote their organizations as leaders in the healthcare community. Accreditation is also tied to reimbursement. For instance, The Joint Commission certifies a healthcare organization has met the Conditions of Participation or the regulations required for reimbursement under the federal Medicare program. Most states also recognize Joint Commission accreditation as a condition of licensure and receiving Medicaid reimbursement.

There are a number of organizations that accredit hospitals and other healthcare organiza - tions. The Joint Commission is the United States’ first accreditation agency for quality assur - ance, and remains the largest agency in the country for setting quality standards in healthcare.

While it is the oldest, the Joint Commission is not the only organization approved to accredit hospitals. As mentioned in Chapter 3, CMS has granted “deemed status” to three other organi - zations to accredit acute care hospitals: Det Norske Veritas Healthcare, Inc. (DNV), the Health - care Facilities Accreditation Program (HFAP), and the Center for Improvement in Healthcare Quality (CIHQ). Questions to Consider 1. How can laws and regulations improve the quality of healthcare? How can a recent healthcare policy like the ACA affect patient care? Give an example. 2. Healthcare policies are heavily used in the healthcare industry and the source of these rules and regulations is the government. Do you think government regulations are pushing healthcare organizations to improve quality of care? Explain your reasoning. fin81226_04_c04_073-118.indd 86 10/30/14 7:41 PM Section 4.2 Accreditation and The Joint Commission (TJC) There are also organizations that accredit other types of healthcare organizations, such as ambulatory care organizations or managed care organizations. Accreditation and certifi - cation are considered by many as a mark of excellence and therefore can have a financial benefit for organizations. Accreditation can carry the added benefit of cost effectiveness and profitability.

The Joint Commission itself points out that accreditation can provide a competitive edge in the marketplace (The Joint Commission, 2014). It can provide a marketing advantage in a competitive environment and improve the ability of an organization to secure new busi - ness. If a patient is looking for a surgery center to have a cosmetic procedure and has several choices in the area, he or she may choose the center that’s been accredited.

Accreditation may also reduce liability insurance costs. By enhancing risk management efforts, accreditation may improve access to and reduce the cost of liability insurance cover - age (The Joint Commission, 2014). Accreditation has a third potential benefit. It is recognized by insurers and other third parties. In some markets, it is a prerequisite to being eligible for insurance reimbursement and to participate in managed care plans or contract bidding (The Joint Commission, 2014).

In short, organizations that have been accredited or had programs certified can use that in their marketing to attract new patients. They can also leverage their scores to get higher reimbursement based on fee schedules from insurance companies and even quality for pay- for-performance incentives. Higher quality of care also translates into fewer medical errors and what can be expensive lawsuits against an organization. So there is a financial benefit to the investment of time and resources necessary to achieve accreditation or certification. CQI programs are key in the process. Because it is the largest accreditor of healthcare organiza - tions in the United States, we will take a closer look at The Joint Commission’s accreditation process. The other accrediting organizations follow a similar survey or inspection process to ensure healthcare organizations are in compliance with their standards or requirements.

A Closer Look at The Joint Commission The Joint Commission is a private, non-profit organization that promotes quality standards for healthcare delivery. It was established in 1951 as an accreditation organization. Today, it provides nationally recognized accreditation and certification for over 20,000 hospitals and healthcare organizations across the United States. Along with accrediting acute care hos - pitals, it offers accreditation programs for nursing care centers, laboratory services, ambu - latory healthcare, behavioral healthcare, critical access hospitals, and home care agencies.

Accredited organizations can also earn certification for programs devoted to chronic diseases and conditions, such as asthma, diabetes, and heart failure.

The Gold Seal of Approval TM is the marker awarded by The Joint Commission to accredited organizations. These organizations may display the Gold Seal of Approval as internationally recognized proof of their commitment to quality and high-level performance. This seal rep - resents the ability to meet strict continuous quality standards and performance measures.

Every organization that applies for the Gold Seal of Approval must participate in an onsite inspection from The Joint Commission every three years (The Joint Commission, 2013c). fin81226_04_c04_073-118.indd 87 10/30/14 7:41 PM Section 4.2 Accreditation and The Joint Commission (TJC) While Joint Commission accreditation is a voluntary process, many states associate a particu - lar organization’s licensure requirement with participation in The Joint Commission’s accred - itation. Additionally, third party payers may connect their reimbursement rates for various services and procedures to whether the healthcare organization has the Gold Seal of Approval.

Thus noncompliance with Joint Commission standards can result in being denied accredita - tion, and payers, such as Medicare, may refuse to pay for care provided to their patients.

Health organizations seek Joint Commission accreditation in order to maintain medical reim - bursements and to remain attractive to patients. Table 4.3 shows the various accreditation programs The Joint Commission provides.

Table 4.3: Number of accredited organizations by The Joint Commission No. Accreditation programs Healthcare facilities Average number of accredited organizations* 1 Ambulatory care accreditation Freestanding ambulatory care organizations that provide surgical, medical/dental, and diagnostic/therapeutic services 1,900 2 Behavioral healthcare accreditation Behavioral healthcare organi - zations that provide services for chemical dependency, mental health, intellectual, and developmental disabilities 2,000 3 Critical access hospital (CAH) accreditation Critical access hospitals that maintain less than 25 total beds and hospitalize patients no more than 96 hours 362 4 Home care accreditation Organizations that provide services of home health, personal care and/or support, home medical equipment, hos - pice, and pharmacy 5,600 5 Hospital accreditation Hospitals including general, children’s, long term acute, psychiatric, rehabilitation, and specialty facilities 4,067 6 Laboratory accreditation Organizations that provide laboratory services 1,700 7 Nursing and rehabilitation center accreditation Nursing and rehabilitation centers Not available *Numbers can vary from year to year because organizations can lose accreditation or be placed on probation.

Source: The Joint Commission. (2013). Quality Check ®. http://w w w.qualit ycheck.org/qualit yreport.aspx?hcoid=7239 . Reprinted by permission of The Joint Commission.

Today, The Joint Commission accredits over 4,067 hospitals, but that is not its largest pro - gram. Because there are many more home health agencies than hospitals in the United States, that is the largest accreditation program, with Joint Commission accrediting 5,600 agencies in 2012 (The Joint Commission, 2013f ). fin81226_04_c04_073-118.indd 88 10/30/14 7:41 PM Section 4.2 Accreditation and The Joint Commission (TJC) Accreditation A hospital must undergo an onsite survey by a Joint Commission survey team at least every three years. The goal is to investigate how the organization is compliant with Joint Commis - sion standards, which are developed with input from various healthcare experts, profession - als, and government agencies, including CMS. During the onsite survey, the tracer methodol - ogy , combined with other survey techniques, is used to identify areas of non-compliance. The tracer methodology allows surveyors to evaluate the organization’s systems of providing care and services by using a patient’s record as a roadmap, moving through areas that individual experienced. This focuses squarely on the quality of care provided in the organization. While the survey team previously spent their efforts poring over thick binders of policies and pro - cedures, now they study the patient’s experience in the healthcare organization. They want to see that not only an organization has a policy, but they follow it.

At the start of a survey, members of the survey team will choose a number of patient records and follow those patients through the entire healthcare process. The patients that surveyors choose may have riskier conditions or represent areas where more errors were reported.

For example, if a hospital has a high volume of elderly patients, a surveyor may select older patients’ records and ask questions about how the organization prevents falls, which is a high-risk area for the elderly.

The surveyors trace patient care from admission through each applicable department to dis - charge, while asking staff members across various disciplines questions about that patient’s care. For example, for a patient who underwent knee replacement surgery at a hospital, they might ask surgical staff, “How did you verify this was the correct surgical site?” If surveyors review the progress of an emergency room patient who went to surgery and then to the medi - cal surgical unit, they might ask a floor nurse, “What are you doing to make sure patient com - plications don’t happen?” Surveyors will talk to the staff members who cared for the patient, view the health record, and observe the care the person received.

Surveyors may ask to see corresponding human resources or credentials files to verify that staff have the proper competencies and privileges to perform procedures. If a patient received sedation, surveyors may check to see that a physician has the right credentials to administer that sedation and nursing staff have certification in Advanced Cardiac Life Support if the hos - pital requires it.

If there’s something unusual in a patient’s health record, a surveyor will look further to ensure that the practice made sense and staff provided consistent care. Surveyors will ask for poli - cies related to an issue they examine. If they find a problem with a patient’s care, they can select the charts of similar patients to see whether it is an isolated incident or whether the problem represents a pattern of care.

Once the onsite survey is completed, a comprehensive review is conducted by staff at The Joint Commission’s central office to derive the hospital’s final summary of survey findings report, indicating which processes must improve to meet the accreditor’s standards. The organiza - tion must submit an Evidence of Standards Compliance (ESC) to prove its full compliance. The accreditation decision is only made after The Joint Commission’s approval of the organiza - tion’s ESC. There are four levels of accreditation: (1) accreditation with full standards compli - ance, (2) conditional accreditation, (3) provisional accreditation, and (4) preliminary denial of accreditation. The organization’s accreditation decision is publicly available on the “Quality Check” website: www.qualitycheck.org (The Joint Commission, 2013a). fin81226_04_c04_073-118.indd 89 10/30/14 7:41 PM Section 4.2 Accreditation and The Joint Commission (TJC) Certification Joint Commission accredited organizations can also earn certification for specific programs under these sections: disease-specific care, advance disease-specific care, advanced certifica - tion for palliative care programs, and healthcare staffing services. While accreditation is the Joint Commission’s recognition of the overall quality and safety of the entire organization, cer - tification demonstrates the organization’s commitment to excellence in specific clinical care services or programs. For example, under the disease-specific care certification programs, an eligible organization can be certified for its joint replacement programs, wound care, and spinal surgery programs. Two levels of certification exist: (1) core and (2) advanced, in which the advanced certification meets clinically specific requirements and higher expectations.

The Joint Commission’s certification decisions follow the same process as that of accredita - tion. An onsite comprehensive review is conducted using the tracer methodology to assess the organization’s standards compliance. For instance, in the Disease-Specific Care Certifica - tion program, surveyors evaluate the organization’s performance in disease-specific services and assess the following three key components: • Compliance with 28 national consensus-based national standards, including pro - gram management, clinical information management, delivering or facilitating care, supporting self-management, measuring and improving performance; • Integration of clinical practice guidelines within the program to effectively manage and optimize care; and • Collection and analysis of performance measure data in the program is utilized to drive improvement activities. Certification to an organization is awarded for two years once the Joint Commission approves its ESC submission and Measures of Success (if required).

After one year, the organization is required to review its performance improvement activities and attest to its continued compliance with the stan - dards (The Joint Commission, 2013b).

The Joint Commission Quality Report The Joint Commission plays an important role in efforts to improve transparency in healthcare and help consumers make well-informed decisions.

Its Quality Report provides summary information about the quality and safety of a healthcare organi - zation, and its benchmark with similar accredited organizations as well as the national average. Two key areas covered in this report are National Patient Safety Goals (NPSG) and National Quality Improve - ment Goals (NQIG).

National Patient Safety Goals (NPSG) are a series of specific actions recommended by a panel of national experts to prevent medical errors such as iStock/Thinkstock National Patient Safety Goals (NPSG) are a series of specific actions recommended by a panel of national experts to prevent medical errors, such as surgery on the wrong body part. fin81226_04_c04_073-118.indd 90 10/30/14 7:41 PM Section 4.2 Accreditation and The Joint Commission (TJC) patient misidentification, miscommunication among caregivers, surgery on the wrong body part, healthcare-associated infections, medication mix-ups, and risk of patient harm result - ing from falls. The survey team accesses an organization’s compliance with NPSGs during the accreditation process. In order to receive a “check” on a particular goal, the organization must meet the requirements for that goal or implement an acceptable alternative. Otherwise, the “minus” symbol represents the organization’s failure to meet that particular goal. The symbol “N/A” means that particular goal is not applicable for that organization (The Joint Commission, 2011). For example, Table 4.4 demonstrates selected 2011 NPSGs together with the requirements and the implementation of those goals at Rush-Copley Medical Center, in Aurora, Illinois.

Table 4.4: Selected 2011 National Patient Safety Goals, Rush-Copley Medical Center, Illinois Safety goals Organizations should Implemented Improve the accuracy of patient identification Use two patient identifiers ✓ Eliminate transfusion errors ✓ Improve the effectiveness of communica - tion among caregivers Timely reporting of critical tests and critical results ✓ Improve the safety of using medications Label medications ✓ Reduce harm from anticoagulation therapy ✓ Reduce the risk of healthcare-associated infections Meet hand hygiene guidelines ✓ Prevent multi-drug resistant organism infections ✓ Prevent central-line associated blood stream infections ✓ Prevent surgical site infections ✓ Source: The Joint Commission. (2013). Quality Check ®. Retrieved from http://www.qualitycheck.org/qualityreport.aspx ?hcoid=7239 . Reprinted by permission of The Joint Commission. National Quality Improvement Goals (NQIG) are desirable goals for effectively treat - ing patients with specifically identified conditions such as children’s asthma, heart attack, heart failure, pneumonia, pregnancy and related conditions, and surgical care improvement.

Patients with these conditions comprise a large portion of the total number of patients in hospitals every year, so the potential savings from improving quality of care and preventing medical problems could be substantial. Hospitals are required to submit NQIG results on a quarterly basis. Each measure in NQIG is calculated as the number of times the hospital met the criteria divided by the number of opportunities or eligible patients at the hospital during the year. fin81226_04_c04_073-118.indd 91 10/30/14 7:41 PM Section 4.2 Accreditation and The Joint Commission (TJC) Based on an organization’s submitted results, 95% confidence intervals of the organization’s expected care are constructed in order to compare with the national or state average relative to a given measure or a given set of measures. The organization is assigned a “star” or achieve - ment of optimal results of 100%. The organization is assigned a “plus,” a “check,” or a “minus” if its confidence interval respectively is above, overlaps, or is below the target range/value.

Scores of the top 10% of all Joint Commission nationwide and statewide hospitals for a given measure are also given for reference purposes (The Joint Commission, 2011).

Table 4.5 demonstrates Rush-Copley Medical Center’s NQIG results for selected measures under the Center’s heart attack care measure set. The complete quality information is avail - able in The Joint Commission Quality Report.

Table 4.5: Selected National Quality Improvement Goals, January 2012– December 2012, Rush-Copley Medical Center, Illinois Compared to other JC accredited organizations Measure area Explanation Nation - wide State - wide Heart attack care This category of evidence-based measures assesses the overall quality of care provided to heart attack patients ✚ ✚ Compared to other JC accredited organizations Nationwide Statewide Measure Explanation Hospital results Top 10% scored at least: Average rate: Top 10% scored at least: Average rate: ACE inhibi - tor or ARB for LVSD This measure reports what percent of heart attack patients having problems with heart pumping were prescribed medicine to improve the heart’s ability to pump blood. (Not displayed due to insuf - ficient number of patients for comparison purposes).

96% of 26 eli - gible patients 100% 98% 100% 98% continued fin81226_04_c04_073-118.indd 92 10/30/14 7:41 PM Section 4.2 Accreditation and The Joint Commission (TJC) Aspirin at arrival This measure reports what percent of heart attack patients received aspirin within 24 hours before or after they arrived at the hospital. ✚ 98% of 194 eligible patients 100% 99% 100% 99% Aspirin pre - scribed at discharge This measure reports what percent of heart attack patients received aspirin prescription when being discharged from the hospital. ★ 100% of 175 eligible patients 100% 99% 100% 99% Source: The Joint Commission. (2013). Quality Check ®. Retrieved from http://w w w.qualit ycheck.org/qualit yreport .aspx?hcoid=7239 . Reprinted by permission of The Joint Commission. As part of its efforts to improve healthcare safety, The Joint Commission also focuses on what it calls sentinel events. It defines a sentinel event as an unexpected occurrence involving death or serious physical or psychological injury or the risk of it happening. The Joint Commission uses the word “sentinel” because these events signal the need for immediate investigation by the healthcare organization and response. Examples of sentinel events include patient sui - cides, the unanticipated death of a full-term infant, surgery on the wrong patient or wrong site, or a rape within a facility. The Joint Commission encourages healthcare organizations to report sentinel events and keeps track of those statistics. It also expects accredited orga - nizations to respond to all sentinel events, by conducting a root cause analysis to determine why the event occurred, developing an action plan to implement improvements to reduce the risk, implementing the improvements, and monitoring their effectiveness. The accreditor also issues what it calls “Sentinel Event Alerts” to bring attention to issues, such as preventing accidents and injuries in the MRI suite or calling for the hospital to address “alarm fatigue,” wherein staff are so conditioned to the sound of alarms they ignore them or become desen - sitized to them.

Many healthcare organizations focus their continuous quality improvement efforts around the prevention of these sentinel events, such as incorporating practices to prevent wrong site surgeries or eliminating unsafe injection practices.

Table 4.5: Selected National Quality Improvement Goals, January 2012– December 2012, Rush-Copley Medical Center, Illinois (continued) Compared to other JC accredited organizations Nationwide Statewide Measure Explanation Hospital results Top 10% scored at least: Average rate: Top 10% scored at least: Average rate: fin81226_04_c04_073-118.indd 93 10/30/14 7:41 PM Section 4.3 Hospital Safety Score and the Leapfrog Group Web Field Trip In 2011, the Joint Commission listed hospitals that were top performers in adhering to evidence-based care practices for the first time. A brief news report for BSN Headline News (http://www.youtube.com/watch?v=2cPaPcDNFnw ) explains the commission’s assessment approach and the guidelines applied, spotlighting Bon Secours Community Hospital in Port Jervis, New York, which was ranked as one of the top performing hospitals. Watch the video up to minute 2:09. The Joint Commission has added these programs in recent years to help ensure that health - care organizations are providing good care to patients and looking at ways to improve that care. Questions to Consider 1. The Joint Commission serves as a regulatory agency for quality assurance. Do you think Joint Commission accreditation assures the safety of a patient at each hospital and pre- vents medical errors? Explain your reasoning. 2. Accreditation and certification are two important services of The Joint Commission.

How are these two key services related? Do you think one is more important or effective than the other? Discuss. 3. Visit The Joint Commission website ( w w w.qualit ycheck.org ) and find healthcare facili- ties certified for cancer care within 50 miles of your home. Compare and contrast the information for these facilities. Where would you seek care? Why? 4.3 Hospital Safety Score and the Leapfrog Group In response to employers’ demands to assess and compare healthcare quality of health plans and other providers, in November 2000, a group of large companies launched the Leapfrog Group as an independent organization to measure and recognize institutions in the health - care industry. This national non-profit organization mobilizes the purchasing power of its members to improve regulations related to the quality and value of healthcare providers and change healthcare delivery (Leapfrog, 2013b).

Due to the lack of public quality reporting, it is difficult for patients, payers, and health plans to differentiate among healthcare providers and delivery organizations. Which hospital, for instance, has been able to reduce central-line infections in its intensive care unit (ICU) or uses a computerized physician order entry system to reduce medication errors?

To address this information gap, the Leapfrog Group consulted with leading medical experts and developed programs focusing on quality in the healthcare industry. First, they promote transparency by publishing the results of a hospital quality survey that assesses standardized quality measures of over 1,300 hospitals across the nation. Second, they promote incentives fin81226_04_c04_073-118.indd 94 10/30/14 7:41 PM Section 4.3 Hospital Safety Score and the Leapfrog Group and rewards to high-performing hospitals. By the same token, Leapfrog gathers information related to hospitals’ processes to improve patient care through surveys and reports survey results on Leapfrog’s website (Leapfrog, 2013d).

Leapfrog Hospital Survey The Leapfrog survey initiative was launched in 2001 to encourage all U.S. hospitals to volun - tarily submit their progress in meeting Leapfrog’s recommended quality and safety practices that are endorsed by the National Quality Forum (NQF) by completing an online survey (Leapfrog, 2013c). The NQF is a non-profit organization that enhances healthcare transfor - mation by reviewing, endorsing, and recommending use of standardized healthcare perfor - mance measures.

After receiving a hospital’s submitted survey, Leapfrog conducts an intensive review to assess quantitative responses with empirically driven, normative data quality standards. If any potential error in reporting arises, Leapfrog investigates these concerns and requests the hospital update its responses; otherwise, its survey may be subject to decertification (Leap - frog, 2013f ). Through the survey data, Leapfrog rates hospitals and posts the results on its website ( ht tp://w w w.leapfroggroup.org/cp ). High-performing hospitals receive recognition as “Top Hospital,” which is considered a gold standard for measuring and reporting hospitals’ performance. To receive this recognition, hospitals must willingly submit data proving their consistent efforts to provide high quality care to their patients (Leapfrog, 2013g).

Hospital performance is rated on five major areas proven to reduce preventable medical mistakes: (1) General Information or Overall Patient Safety Measures, (2) Maternity Care, (3) High Risk Surgeries, (4) Hospital-Acquired Conditions, and (5) Resource Use. A hospital’s overall scores under each section of the survey are publicly displayed as filled bars in one of the following five categories (Leapfrog, 2013a): • Fully meets standards (4 filled bars): The hospital is in the top performance category. • Substantial progress (3 filled bars): The hospital is above the median but not in the top performance category. • Some progress (2 filled bars): The hospital is below the median, but not in the low - est performance category. • Willing to report (1 filled bar): The hospital is in the lowest performance category. • Decline to respond (0 filled bar): The hospital did not respond to this section of the survey. Potential patients may use this information to ensure that they will receive good quality care at a particular hospital. For instance, a pregnant woman with complications might use the report to check a hospital’s score related to high-risk deliveries or a heart patient might check to see which hospital has a high score when it comes to a high-risk procedure such as an aor - tic valve replacement.

Table 4.6 summarizes the 2012 Massachusetts General Hospital (MGH) quality measures based on the Leapfrog survey. MGH has successfully satisfied almost all of Leapfrog’s stan - dards in general measures and maternity care. However, it made little progress in the area of hospital-acquired conditions and resource use, and declined to respond on performance measures related to high-risk surgeries. As a result, it was assigned a safety score of “B.” fin81226_04_c04_073-118.indd 95 10/30/14 7:41 PM Section 4.3 Hospital Safety Score and the Leapfrog Group Table 4.6: Massachusetts General Hospital Quality Measures, Leapfrog Hospital Survey 2012 Ratings Declined to respond* Fully meets standards ( ) Sub - stantial progress ( ) Some progress ( ) Willing - ness to report ( ) Overall patient safety measures Prevent medication errors (use of CPOE) Appropriate ICU staffing Steps to avoid harm (Safe Practice Score) Managing serious errors Safety-focused scheduling X Maternity care Rate of early elective deliveries Rate of episiotomy Maternity care standard precautions High-risk deliveries X High-risk surgeries Aortic valve replacement X Abdominal aortic aneu - rysm repair X Pancreatic resection X Esophagectomy resection X Hospital-acquired conditions Reduce central-line infec - tions in ICUs Reduce urinary catheter infections in ICUs Reduce hospital-acquired pressure ulcers Reduce hospital-acquired injuries continued fin81226_04_c04_073-118.indd 96 10/30/14 7:41 PM Section 4.3 Hospital Safety Score and the Leapfrog Group Ratings Declined to respond* Fully meets standards ( ) Sub - stantial progress ( ) Some progress ( ) Willing - ness to report ( ) Resource use Length of stay for common acute conditions Readmissions for common acute conditions Hospital safety score B *For those hospitals that choose not to respond to a request to complete the survey, the publicly reported survey results read: “Declined to Respond.” Source: Leapfrog. (2013). Leapfrog hospital survey results. Retrieved from http://w w w.leapfroggroup.org/cp?frmbmd=cp _listings&find_by=city&city=boston&state=MA . Copyright © Leapfrog Group. Reprinted by permission. Hospital Safety Score Hospital safety score is a separate initiative that Leapfrog launched in 2012, offering hospi - tals a letter grade rating their efforts to protect patients from injuries, accidents, and medi - cal errors. This score empowers patients and purchasers to make informed decisions on the safety of hospital care. Leapfrog sought guidance from the Leapfrog Blue Ribbon Expert Panel consisting of nine members who are national patient safety experts. This panel selected mea - sures and developed a scoring methodology.

There are 28 measures included in the score, ranging from practicing good hand hygiene to prevent infections to preventing pressure ulcers. The measures are placed into two domains:

(1) process/structural measures and (2) outcome measures. (Those domains are described in the Donabedian model of care, where measures are categorized into structure, process, and outcome.) Process/structural measures represent the hospital’s compliance with best practices in patient care, and a higher score is always better. In contrast, outcome measures represent the incidence of adverse events for patients, so a lower score is always better. Scores above the mean reflect better than average performance (Austin et al., 2013).

The safety rating is calculated using data from the Leapfrog Hospital Survey, CMS, and the American Hospital Association (AHA) and assigned to over 2,600 American hospitals twice annually. The scores are available on the Hospital Safety Score website ( www.HospitalSafety Score.org ), where consumers can search for hospitals by state, city, or zip code. The score reflects not only the hospital’s letter score but also a breakdown of numeric scores on mea - sures such as infection prevention, patient information, teamwork building, and skill build - ing. Scores of the worst, the best, and the average performing hospitals are also available for comparison purposes. In 2012, of 2,652 general hospitals that joined in the program, 729 Table 4.6: Massachusetts General Hospital Quality Measures, Leapfrog Hospital Survey 2012 (continued) fin81226_04_c04_073-118.indd 97 10/30/14 7:41 PM Section 4.4 Health Plan Accreditation and NCQA earned an A, 679 earned a B, and 1,243 earned a C or below, proving a large number hospitals still fall short on safety measures (Leapfrog, 2012b). Web Field Trip 4.4 Health Plan Accreditation and NCQA The NCQA is a not-for-profit organization, like the Joint Commission, dedicated to improving the healthcare quality of healthcare organizations. It was founded in 1979 by the American Managed Care and Review Association and the Group Health Association of America. In 1990, the NCQA became its own entity. Since then, it has become a principal organization in bring - ing awareness to the importance of continuous quality improvement throughout the health - care industry. It is the industry leader in accrediting managed healthcare plans, particularly managed care organizations (MCO)—primarily health maintenance organizations (HMOs).

The NCQA has begun widening its scope and focusing on preferred provider organizations (PPO) and other forms of managed care.

The NCQA has created programs to make quality improvement methods more accessible and achievable. The well-known method is Measure, Analyze, Improve, Repeat. The NCQA uses this method to create quality and performance measures to apply across the healthcare sys - tem. Currently, it has established over 60 standards that must be met to achieve the Seal of Approval. These standards are intended to help reduce costs and encourage improvements in performance and consumer education. To assist healthcare organizations in measuring their quality and performance, the NCQA developed the Healthcare Effectiveness Data and Infor - mation Set (HEDIS), which has been widely adopted in the managed care industry. Questions to Consider 1. The Leapfrog Group reports the results of its survey of hospitals at http://w w w.leap froggroup.org/cp , and the hospital safety scores at www.HospitalSafetyScore.org . Which information would be more valuable to hospital administrators? Which informa- tion is more valuable for patients and insurance companies? Why? 2. Leapfrog hospital safety scores use structure/process and outcome measures but emphasize certain measures more than others. Why are certain measures more impor - tant for this quality indicator than others? Explain your reasoning. 3. Compare the Leapfrog quality indicators and hospital safety score measures to Joint Commission accreditation. Are these two quality organizations complementary or com- petitive in hospital quality work? Are there any overlapping sections? Web Field Trip Chicago Business Today reporter Danny Ecker ( https://w w w.youtube.com/watch?v=lUVRa 9GypK0 ) discusses the results of a 2012 safety survey that rated hospitals around Illinois. The survey, based on patient care outcomes and safety initiatives, identified several Chicago-area hospitals that fell short of local standards, including some teaching hospitals. fin81226_04_c04_073-118.indd 98 10/30/14 7:41 PM Section 4.4 Health Plan Accreditation and NCQA Similar to the Joint Commission, organizations seek NCQA accreditation to remain attractive to consumers. It, too, establishes a level of performance and accomplishment that improves employee morale, patient confidence, and an overall sense of organizational well-being.

In order to drive improvement through the healthcare system, NCQA has established a variety of accreditation programs for health plans, individual physicians, medical groups, and other provider organizations, in which they are required to meet regulatory requirements and the NCQA standardized measures. Table 4.7 lists all NCQA accreditation programs for healthcare organizations nationwide. Particularly, NCQA is nominated by HHS to be an accrediting entity for qualified health plans participating in the Health Insurance Exchange Marketplaces. NCQA Health Plan Accreditation is considered to be the industry’s gold standard that helps health plans demonstrate commitment to quality and accountability. NCQA Health Plan Accredita - tion contains all the key elements required by federal law and regulations (NCQA, 2013f ).

Table 4.7: NCQA accreditation programs No. Accreditation programs Healthcare providers 1 Health plan accreditation (HPA) All types of health plans 2 Disease management (DM) accreditation Health plans or health plan contracting organi - zations that offer comprehensive DM programs with services to patients, practitioners or both 3 Case management (CM) accreditation Health plans or health plan contracting orga - nizations that apply case management in their healthcare services 4 Wellness & Health promotion (WHP) accreditation Health plans or wellness vendors that provide full-service wellness programs 5 New health plans (NHP) accreditation New health plans that are under three years old 6 Accountable care organization (ACO) accreditation Accountable care organizations 7 Managed behavioral healthcare organization (MBHO) accreditation Organizations that provide services for chemi - cal dependency, mental health/ intellectual and developmental disabilities Source: NCQA. (2013). Accreditation programs . Retrieved from http://www.ncqa.org/Programs/Accreditation.aspx . Copyright © NCQA. Reprinted by permission NCQA uses the same standards and process to evaluate all types of health plans, whether they are an HMO, MCO, point of service (POS), or PPO (NCQA, 2013c). While the Health Plan Report Card previously listed three types of NCQA accreditation—health plan accreditation, MCO accreditation, and PPO accreditation—NCQA has discontinued its distinct MCO and PPO accreditation programs in favor of a single, consolidated accreditation program that uses a common set of standards and guidelines for all plans. The Health Plan Accreditation Program now applies to HMO, MCO, POS, and PPO plans.

A health plan’s accreditation score is determined based on a combination of its adherence to NCQA’s standards and its performance in HEDIS and Consumer Assessment of Healthcare Providers and System (CAHPS) measures. It is the only accreditation program that requires HEDIS and CAHPS in scoring (NCQA, 2013h). In addition, NCQA also proves its continuous fin81226_04_c04_073-118.indd 99 10/30/14 7:41 PM Section 4.4 Health Plan Accreditation and NCQA efforts to encourage high performance by providing equal weight to standards and perfor - mance measures, starting in the NCQA Health Plan Accreditation 2013 (NCQA, 2013a).

The Social Security Act requires states that operate Medicaid managed care programs to pro - vide for an external, independent review of their managed care organizations. States may contract with an independent entity called an external quality review organization (EQRO) to conduct the review of their Medicaid managed care programs. Most states then use the results of the EQRO reviews, sometimes requiring their managed care plans to make changes based on EQRO reports. Examples include changing the way plans document and conduct performance improvement projects and how they meet state standards for members’ access to care.

Federal regulations require that EQROs include three mandatory activities: validation of per - formance improvement projects required by the state and undertaken in the preceding year, validation of plan performance measures, and a review to determine the plan’s compliance with state standards for access to care, structure and operations, and quality measures and improvement.

NCQA Standards Through surveys conducted by a team of trained healthcare experts with extensive quality improvement and managed care backgrounds, a health plan’s structure and process are eval - uated against NCQA’s standards, which consist of the following categories (NCQA, 2013h): • Quality management and improvement: continuous improvement of quality of care and services, members’ access to care services, and specific plan programs available for chronically ill members. • Utilization management: fairness, consistency, and promptness in making decisions about medical necessity for care services, evidence-based clinical guidelines, clinical staff usage in decision making, and appeal process available for members. • Credentialing: investigation of physicians joining the plan’s network, and ongoing evaluation of its physicians. • Members’ rights and responsibilities: informing members of how to get care and use the plan’s services, process to respond to members’ concerns and complaints, and protection of members’ personal information. • Member connections: distribution of important information to members, wellness and prevention promotion to the plans’ members. Plans are also measured on a set of measures referred to as HEDIS.

HEDIS Measures HEDIS is a NCQA registered trademark that makes plans’ performance comparable through a set of precise clinical performance measures. Being a critical part of the NCQA accredita - tion process, HEDIS measures the plan’s performance in clinical care areas, including preven - tive services such as immunizations, screenings, prenatal care, and smoking cessation; acute illness treatment; and chronic illness management, including diabetes, asthma, depression, high cholesterol, and high blood pressure (NCQA, 2013h). fin81226_04_c04_073-118.indd 100 10/30/14 7:41 PM Section 4.4 Health Plan Accreditation and NCQA CAHPS Measures CAHPS is the AHRQ’s registered trademark that assesses consumers’ experience with health - care (Agency for Healthcare Research and Quality, 2013). CAHPS provides NCQA accredita - tion with insight into members’ satisfaction with services provided by a health plan or by physicians in the health plan’s network; scores measure factors such as getting care quickly, getting needed care, customer services, rating of health plan, rating of all healthcare, rating of personal doctor, rating of specialist seen most often, how well doctors communicate, and claim processing (NCQA, 2013h).

A health plan’s accreditation status is publicly reported on the NCQA Report Card website, which is divided into five categories of performance. Accreditation, HEDIS, and CAHPS scores are combined into a final score and allocated for each category under the form of star ratings (NCQA, 2013c). These five areas are: • Staying healthy: activities that help members maintain good health and avoid illness, such as providing doctors with guidelines to deliver preventive services and provid - ing members with appropriate tests and screenings. • Getting better: activities that help patients recover from illness, such as the plan’s evaluation of new procedures and drugs, patients’ access to the most current care, and advice from doctors in the plan’s network to help patients quit smoking. • Living with illness: activities that help patients manage chronic illness, such as pro - grams designed for specific chronic conditions (e.g., asthma or eye exams). • Access and service: health plan members’ access to needed care and good service, such as a sufficient number of physicians serving patients, how members reporting problems received needed care, and how the plan follows up on grievances. • Qualified providers: efforts to ensure providers are licensed to practice medicine and achieve patient satisfaction, such as checking sanctions or lawsuits among phy - sicians in the plan’s network and rating doctors and nurses. After the NCQA’s Review Oversight Committee analyzes the data, the plan may be assigned an accreditation status as follows, which is made publicly available on the NCQA Report Card (NCQA, 2013h). • Excellent: Organizations meet or exceed rigorous requirements for consumer pro - tection and quality improvement, having HEDIS results in the highest range of the national performance. • Commendable: Organizations meet rigorous requirements for consumer protection and quality improvement. • Accredited: Organizations meet basic requirements for consumer protection and quality improvement. These organizations are required to take further action to achieve a higher accreditation status. • Provisional: Organizations meet basic requirements for consumer protection and quality improvement. These organizations are required to take significant action to achieve a higher accreditation status. • Denied: Organizations fail to meet NCQA requirements. Table 4.8 demonstrates NCQA accreditation ratings for two health plans in Pennsylvania. The plans are assigned stars under each category of five core areas, based on their performance fin81226_04_c04_073-118.indd 101 10/30/14 7:41 PM Section 4.4 Health Plan Accreditation and NCQA against NCQA standards and measures. The highest rate is “excellent,” with four stars. The lowest rate is “denied,” with no stars.

Table 4.8: NCQA accreditation ratings for Aetna Health Inc. & Cigna Health and Life Insurance Company Plan name Aetna Health Inc. Cigna Health and Life Insurance Company Plan type Commercial Commercial Accredited product HMO/POS Combined PPO Accreditation type Health plan accreditation Health plan accreditation Access and services ★★★ ★★★★ Qualified providers ★★★ ★★★ Staying healthy ★★ ★★ Getting better ★ ★★ Living with illness ★★ ★★ Overall accreditation status Commendable Commendable Note: Updated as of August 31, 2013.

Source: NCQA. (2013). Health plan accreditation . Retrieved from http://www.ncqa.org/Programs/Accreditation/HealthPlan H P. a s p x . Copyright © NCQA. Reprinted by permission These measures are a means to judge how well health plans are performing.

NCQA Accreditation Methodology Health plans are divided into three categories for ranking: private plans, plans for Medicare beneficiaries, and HMOs for Medicaid beneficiaries. Each plan is ranked by its overall score, which is calculated on a scale of 1 to 100, based on a set of quality measures of performance.

Each individual measure in the set is scored and standardized using an assigned weight rang - ing from 1/4 to 1 point.

NCQA accreditation standards , the measures required during the accreditation process, account for 15% of the overall score. The standards score is calculated by the following formula: Actual standards score/Possible standards score × 15 fin81226_04_c04_073-118.indd 102 10/30/14 7:41 PM Section 4.4 Health Plan Accreditation and NCQA For example, if a new health plan has a NCQA Accreditation standards score of 75 out of 100 standards points, the points it receives in ranking score for NCQA Accreditation is (75/100) × 15 = 11.25. However, points for NCQA accreditation are not displayed in the public ranking report.

Consumer satisfaction measures account for 25% of the overall score. These consist of indi - vidual measures related to patients’ experiences with the plan, physicians in the plan’s net - work, and the plan’s customer service. These measures are provided from the CAHPS survey measurement set. In the public ranking report, these measures are displayed in the customer satisfaction category.

Clinical measures account for 60% of the overall score. These are part of HEDIS measures, measuring the proportion of eligible members who received appropriate preventive or treat - ment services to meet their conditions. In the public ranking report, a health plan’s clini - cal measures are displayed under two subcategories: prevention measures and treatment measures.

The health plan rankings are available on the NCQA Health Insurance Plan Rankings website (http://healthplanrankings.ncqa.org/ ), where health plans are presented from highest to lowest based on their overall scores. The report also displays health plans’ ratings of subcat - egories: customer satisfaction, prevention, and treatment based on a 1 to 5 scale. The detailed report of each health plan is publicly available as well. Each subcategory and individual mea - sure receives ratings on a scale of 1 to 5, based on confidence intervals on the difference between plan rates and a measure’s mean. • A plan receives a 5 if it is significantly higher than the mean and in the top decile of plans. • A plan receives a 4 if it is significantly higher than the mean and in the top third but not in the top percent of plans. • A plan receives a 3 if it does not fall into any of these groups. • A plan receives a 2 if it is significantly lower than the mean and in the bottom third of plans, but not in the bottom 10%. • A plan receives a 1 if it is significantly lower than the mean and in the bottom 10% of plans (NCQA, 2013g). Table 4.9 reports the top 10 health plans nationwide from 2013–2014, displayed with the overall score, and the 1–5 scaled rating for three subcategories: consumer satisfaction, pre - vention, and treatment measures. Harvard Pilgrim Health Care received the highest scores in all three categories and is ranked number one. Kaiser Foundation Health Plan of the North - west and Blue Cross and Blue Shield of Massachusetts are ranked a close second and third, respectively. For the top 10 health plans in the nation, the NCQA total scores are extremely close, ranging from 90.0 to 88.8, a difference of 1.2 points. fin81226_04_c04_073-118.indd 103 10/30/14 7:41 PM Section 4.4 Health Plan Accreditation and NCQA Table 4.9: Top 10 NCQA health insurance plans 2013–2014 Rank Plan name States Type Score NCQA accredi - tation Con - sumer satis - faction Preven - tion Treat - ment 1 Harvard Pilgrim Health Care ME, MA HMO 90.0 Ye s 5 5 5 2 Kaiser Foun - dation Health Plan of the Northwest OR, WA HMO 89.8 Ye s 4 5 5 3 Blue Cross and Blue Shield of Massachusetts HMO Blue MA HMO 89.6 Ye s 5 5 5 4 Harvard Pilgrim Health Care MA PPO 89.4 Ye s 5 5 5 5 Harvard Pilgrim Insurance MA PPO 89.4 Ye s 5 5 5 6 Tufts Associ - ated Health Maintenance Organization MA HMO 89.2 Ye s 4 5 5 7 Kaiser Foun - dation Health Plan of North - ern California CA HMO 89.1 Ye s 3 5 5 8 Tufts Benefit Administra - tions MA, RI PPO 89.0 Ye s 5 5 5 9 Harvard Pilgrim Health Care of New England NH HMO 88.9 Ye s 5 5 5 10 Kaiser Foun - dation Health Plan of Ohio OH HMO 88.8 Ye s 5 5 5 Source: NCQA. (2013). Health insurance plan rankings 2013–2014—detailed report . Retrieved from http://healthplanrankings .ncqa.org/HprPlandetails.aspx?id=56 . Copyright © NCQA. Reprinted by permission It is important to examine the subcategories of three major criteria: (1) consumer satisfac - tion, (2) prevention, and (3) treatment, which are used to compute total scores of health plans. Interestingly, Blue Cross and Blue Shield of Massachusetts received a five in all three categories, but still ranked behind Kaiser Foundation of Health Plan of the Northwest, which received four for consumer satisfaction. This is because of the greater health plan total score fin81226_04_c04_073-118.indd 104 10/30/14 7:41 PM Section 4.4 Health Plan Accreditation and NCQA of Kaiser Foundation. Table 4.10 shows the scores of the top health plan, Harvard Pilgrim Health Care. Consumer satisfaction includes 12 subcategories, ranging from getting care eas - ily to handling claims and customer service. The prevention category has 21 subcategories, while treatment has the most, with 32 subcategories.

Table 4.10: NCQA health insurance plan rankings 2013–2014: Detailed report for Harvard Pilgrim Health Care Measures Score Measures Score Measures Score Consumer satisfaction 5 Prevention 5 Treatment 5 Getting care 3 Children and adolescents 5 Asthma 2 Getting care easily 3 Well-child visits, infants 5 Medicate asthma appropriately 3 Getting care quickly 3 Well-child visits, ages 3–6 5 Medication compliance 75% 1 Satisfaction with physicians 5 Well-child visits, ages 7–11 5 Diabetes 5 How well doctors communicate 3 Adolescent well- care visits 5 Blood pressure control (140/80) 4 Rating personal doctor 5 Early immunizations 4 Blood pressure control (140/90) 4 Rating specialists 5 Adolescent immunizations 4 Retinal eye exams 5 Rating care received 5 BMI percentile assessment 5 Glucose testing 4 Satisfaction with health plan services 3 Nutrition counseling 5 Glucose control 4 Handling claims 3 Physical activity counseling 5 LDL cholesterol screening 5 Rating health plan 5 Women’s reproduc - tive health 5 LDL cholesterol control 5 Customer service 3 Timeliness of pre - natal checkup 5 Monitoring kidney disease 5 Postpartum care 5 Heart Disease 5 Cancer screening 5 Beta blocker after heart attack 5 Breast cancer screening 5 Controlling high blood pressure 5 Cervical cancer screening 5 LDL cholesterol screening 5 Colorectal cancer screening 5 LDL cholesterol control 5 continued fin81226_04_c04_073-118.indd 105 10/30/14 7:41 PM Section 4.4 Health Plan Accreditation and NCQA Measures Score Measures Score Measures Score Other preventive services 5 Mental and behavior health 5 Adult BMI assessment 5 Depression—adhering to medication for 12 weeks 4 Chlamydia screening 5 Depression—adhering to medication for 6 months 3 Flu shots for adult 5 Follow-up after hospital - ization for mental illness 5 Alcohol or drug depen - dence treatment initiated 4 Alcohol or drug depen - dence treated for 30 days 4 Follow-up after ADHD diagnosis 5 Continued follow-up after ADHD diagnosis 5 Other treatment measures Use of aspirin 3 Appropriate antibiotic use, adults with acute bronchitis 5 Appropriate testing and care, children with pharyngitis 5 Medication for rheuma - toid arthritis 4 Monitoring key long-term medication 4 Steroid after hospitaliza - tion for acute COPD 4 Bronchodilator after hospitalization for acute COPD 3 Testing for COPD 4 Appropriate antibiotic use, children with URI 5 Appropriate use of imag - ing studies for low back pain 4 Source: NCQA. (2013). Health insurance plan rankings 2013–2014—summary report . Retrieved from http://healthplanrankings .ncqa.org/default.aspx . Copyright © NCQA. Reprinted by permission Table 4.10: NCQA health insurance plan rankings 2013–2014: Detailed report for Harvard Pilgrim Health Care (continued) fin81226_04_c04_073-118.indd 106 10/30/14 7:41 PM Section 4.5 Government Institutions for Healthcare Quality The rankings allow consumers to compare their health plan with others across the country based on the same standard measures.

4.5 Government Institutions for Healthcare Quality Creating a high quality environment for patients and staff is not only a common goal among hospitals and other healthcare organizations but also for the government. Although organiza - tions such as The Joint Commission or NCQA regulate the industry and continuously improve the quality of care and safety of patients, the federal and state government departments also play an important role in this shared goal. These government organizations include HHS and various divisions, CMS, and State Department of Insurance or Managed Care.

Department of Health and Human Services The Department of Health and Human Services (HHS) is a depart - ment of the U.S. government charged with protecting the health of all Ameri - cans and ensuring that healthcare deliv - ery is equitable. HHS is responsible for healthcare insurance (i.e., Medicare), public health programs, social service programs, and healthcare research.

The HHS website ( http://www.hhs . g o v/a b o u t ) provides an overview of the department and various divisions.

HHS has a “family of agencies,” which include: Questions to Consider 1. What are the three main sections of NCQA health plan accreditation? Explain. Do you think the NCQA emphasizes certain sections of its accreditation over others? Why or why not? 2. Visit the NCQA website ( ht tp://reportcard.ncqa.org/plan/external/PlanRatings.aspx# ) and obtain a list of health plans offered in your state. Choose at least five plans and com - pare them. Identify the accreditation status of each plan, such as commendable or provi - sional, and determine why. © James Lawler Duggan/Reuters/Corbis The Department of Health and Human Services is an agency that was established to administer health- related services, particularly to communities that are unable to seek services themselves. fin81226_04_c04_073-118.indd 107 10/30/14 7:41 PM Section 4.5 Government Institutions for Healthcare Quality • The Office of the Secretary Staff Divisions (StaffDivs): This is the supervising division that oversees all programs and operations, • 10 regional offices: Each regional office covers a portion of the United States and works closely with state and local governments in those areas to deliver and moni - tor programs. • 11 operating divisions (Opdivs): These implement programs and conduct research.

These divisions include:

1. Administration for Children and Families (ACF): This agency promotes the eco - nomic and social well-being of families, children, individuals, and communities through programs as well as incentives and resources. 2. Administration for Community Living (ACL): This agency promotes the indepen - dence, well-being, and health of older adults with disabilities, their families, and caregivers. 3. Agency for Healthcare Research and Quality (AHRQ): This agency promotes health and well-being by improving the quality, safety, efficiency, and effective - ness of the healthcare system. 4. Centers for Disease Control and Prevention (CDC): This agency is responsible for the nation’s health security by conducting critical science and providing important health information to prevent and control health threats. 5. Centers for Medicare and Medicaid (CMS): This agency administers the Medi - care program, Medicaid program, State Children’s Health Insurance Program (SCHIP), and various healthcare standards (which will be discussed in more detail in the next section). 6. Food and Drug Administration (FDA): This agency promotes public health and protects consumers by managing providers’ compliance of FDA-regulated prod - ucts and controlling the associated risks. 7. Health Resources and Services Administration (HRSA): This agency increases access to healthcare services for uninsured, isolated, or medically vulnerable people. 8. Indian Health Service (IHS): This agency provides healthcare to Native Ameri - can and Alaskan Native peoples. 9. National Institutes of Health (NIH): A national medical research agency respon - sible for researching critical knowledge about the nature and behavior of living systems and applying the knowledge to improve human health, lengthen life, and reduce illness and disability. 10. National Cancer Institute (NCI): This agency is responsible for cancer research, training, and supporting the national network of cancer centers. 11. Substance Abuse and Mental Health Services Administration (SAMHSA): This agency reduces the impact of substance abuse and mental illness on the nation’s communities. Through the various divisions, HHS provides many important programs and services. In addi - tion to critical health programs and services, HHS plays a key role in advancing scientific knowledge and the evidence behind healthcare services and delivery by providing research funding, or grants, in these areas. HHS is also a principal agency for collection of national and state health data, used by many organizations to assess quality and performance. The next section provides an overview of CMS, which is one of the 11 operating divisions within HHS. fin81226_04_c04_073-118.indd 108 10/30/14 7:41 PM Section 4.5 Government Institutions for Healthcare Quality The Center for Medicare & Medicaid Services (CMS) The Center for Medicare & Medicaid Services (CMS) was previously known as the Health Care Financing Administration and is one of the 11 operating divisions of HHS. CMS is respon - sible for the Medicare program, the federal portion of the Medicaid Program, the State Chil - dren’s Health Insurance Program, and related quality improvement standards. The Medicare program provides health insurance coverage for all citizens 65 or older and the Medicaid program provides health insurance coverage to any citizen with a serious disability. Medicare and Medicaid provide coverage for about one in every four Americans (U.S. Department of Health and Human Services, 2014).

The Medicare health and drug plan quality and performance ratings measure Medicare health plans’ and drug plans’ performances and publicly reveal the results at the Medicare website (ht tp://w w w.medicare.gov ). In order to assess the quality of care in organizations serving Medicare patients, CMS uses a 5-star rating scale that assigns a plan’s overall rating based on a single summary score. Through these ratings, consumers can compare plans’ quality and performance in addition to costs and coverage (CMS, 2013a).

Medicare Advance (MA) plans’ and Prescription Drug (PD) plans’ ratings are calculated based on domains consisting of more than 50 measures. Each base level measure ratings are scored on a 5-star scale. Then, similar measures are grouped under each domain that is also assigned a star rating. The overall rating summarizes all measures and is assigned one to five stars.

Five-star rating is the highest level of quality, demonstrating “excellent” (CMS, 2013b). Plans providing both health and drug benefits are rated based on all nine domains.

Medicare health plans’ performance is based on the following domains: 1. Staying healthy: screenings, vaccines, and tests to help members stay healthy 2. Managing chronic (long-term) conditions: sufficient and appropriate tests and treat - ments for members with identified conditions 3. Member satisfaction with the plan 4. Member complaints and appeals 5. Health plan customer service Medicare drug plans’ performance is based on the following domains: 1. Drug plan customer service 2. Member complaints and Medicare audit findings 3. Member satisfaction with the plan 4. Patient safety and drug pricing Beginning in 2001, CMS created some new quality initiatives. One example is the Physician Quality Reporting System (PQRS), which provides incentive payments and adjustments to payments to encourage healthcare providers to report quality measures. After reporting, pro - viders receive feedback including a comparison of their performance on specific measures against their peers. Providers who satisfactorily submit required quality measures data earn an incentive payment of 0.5% of their total Medicare Part B fee-for-service allowed charges for covered services provided during the same reporting period. fin81226_04_c04_073-118.indd 109 10/30/14 7:41 PM Section 4.5 Government Institutions for Healthcare Quality Beginning in 2015, a payment adjustment will be applied to providers who did not satisfacto - rily submit required quality measures for covered medical services provided during the 2013 PQRS program year. They will be paid 1.5% less than the Medicare fee-for-service amount for services provided in 2015 (CMS, 2013f ).

Department of Insurance and Managed Healthcare State governments have a unit to manage the activities of insurance companies conducting business in their state, which is called the department of insurance . Chief insurance regula - tors from each state department of insurance make up the National Association of Insurance Commissioners (NAIC). NAIC is the organization through which chief insurance regulators collectively work to establish standards, best practices, and conduct regulatory oversight.

NAIC also works closely with policyholders and insurance companies to resolve disputes and protect insurance consumer interests (NAIC, 2013).

Some of NAIC’s main goals include educating consumers by helping patients evaluate their options on major types of insurance, including health, life, auto, and home, and providing guidance on laws/regulation by implementing a new law or determining if amendments might be needed for a law already in place.

Some states have expanded their departments of insurance to include additional divisions.

For example, California has a Department of Managed Health Care (DMHC), which was spe - cifically formed to manage HMOs, and is one of a kind. It is known for being an active con - sumer rights organization, as it assists patients and families in deciding which health plan will best serve their family. The DMHC also oversees all other HMOs in California to ensure quality service is provided and health plans meet the needs of their communities. In 2012, the DMHC reported that over 21 million Californians are enrolled in managed care health plans.

(Department of Managed Health Care, 2012a).

Health organizations file their health plans with the DMHC to remain transparent with busi - ness practices and to ensure compliance with various DMHC regulations and policies. In addi - tion, if members or applicants for health plans need to file a complaint on an organization, they can notify the DMHC for assistance. For instance, if a prospective applicant feels that health insurance coverage was denied due to an unfair business practice, a complaint can be filed with the DMHC, which will then investigate the issue.

The DMHC publishes an annual report regarding complaints it received during the year, including the independent medical review (IMR) summary report and the complaint sum - mary report. The IMR summary report reveals each health plan’s enrollment, the number and types of IMRs resolved for each health plan, and of IMRs per 10,000 enrollees, the number of IMRs in which the review organization upheld the health plan’s denial, the number of IMRs in which the review organization overturned the denial, as well as the number of IMRs reversed or withdrawn by the health plan during the reporting year. Tables 4.11 and 4.12 demonstrate, respectively, a part of the IMR summary report and the complaint summary report of plans having enrollment over 400,000. fin81226_04_c04_073-118.indd 110 10/30/14 7:41 PM Section 4.5 Government Institutions for Healthcare Quality Table 4.11: 2012 independent medical review results by health plan California Department of Managed Health Care Type of IMR Medical necessity Plan type and name Enrollment Total IMRs resolved IMRs per 10,000 Total IMRs Upheld by IMR % Over - turned by IMR % Reversed by plan % Full services—Enrollment over 400,000 Anthem Blue Cross 3,019,437 501 1.66 275 100 36.4 110 40.0 65 23.6 Blue Shield of California 1,643,269 319 1.94 228 104 45.6 81 35.5 43 18.9 Health Net of California Inc.

1,213,260 114 0.94 81 33 40.7 35 43.2 13 16.0 IEHP (Inland Empire Health Plan) 561,557 22 0.39 22 10 45.5 9 40.9 3 13.6 Kaiser Permanente 6,134,219 317 0.52 291 83 28.5 107 36.8 101 34.7 L.A. Care Health Plan 1,007,789 11 0.11 10 4 40.0 3 30.0 3 30.0 UnitedHealthcare of California 498,948 65 1.30 54 23 42.6 24 44.4 7 13.0 Subtotal 14,078,479 1,349 0.96 961 357 37.1 369 38.4 235 24.5 Source: DMHC. (2012).

2012 independent medical review and complaint results . Retrieved from http://w w w.hmohelp.ca.gov/ aboutTheDMHC/gen/gen_depreport.aspx fin81226_04_c04_073-118.indd 111 10/30/14 7:41 PM Section 4.5 Government Institutions for Healthcare Quality Table 4.12: 2012 Complaint results by category and health plan California Department of Managed Health Care Access Benefits/ coverage Claims/ financial Plan type and name Complaints resolved % of complaint resolved Enrollment Complaints per 10,000 Count Per 10,000 Count Per 10,000 Count Per 10,000 Full services—Enrollment over 400,000 Anthem Blue Cross 778 24.0 3,019,437 2.58 16 0.05 257 0.85 400 1.32 Blue Shield of California 672 20.8 1,643,269 4.09 20 0.12 316 1.92 257 1.56 CalOptima 2 0.1 418,323 0.05 0 0.00 2 0.05 0 0.00 Health Net of Califor - nia Inc. 224 6.9 1,213,260 1.85 8 0.07 110 0.91 68 0.56 IEHP (Inland Empire Health Plan) 11 0.3 561,557 0.20 2 0.04 7 0.12 0 0.00 Kaiser Permanente 1,390 42.9 6,134,219 2.27 53 0.09 333 0.54 304 0.050 L.A. Care Health Plan 20 0.6 1,007,789 0.20 6 0.06 5 0.05 2 0.02 UnitedHealthcare of California 141 4.4 498,948 2.83 1 0.02 97 1.94 24 0.48 Total full services 3,238 100.0 14,496,802 2.23 106 0.07 1,127 0.78 1,055 0.73 Source: DMHC. (2012).

2012 independent medical review and complaint results . Retrieved from http://w w w.hmohelp.ca.gov/aboutTheDMHC/gen/gen_depreport.aspx fin81226_04_c04_073-118.indd 112 10/30/14 7:41 PM Summary & Resources With so many people receiving their healthcare coverage through the federal Medicare and Medicaid programs, it is critical that government agencies are also focused on improving the quality of care for patients covered by these programs.

Summary & Resources Chapter Summary This chapter provided an overview of the organizations and agencies that play key roles in shaping and defining the quality of healthcare in the United States. Examples include third party, non-profit organizations, such as the Joint Commission and LeapFrog, as well as government-based agencies, such as HHS. These regulatory agencies provide part of the incentive and guidance with which healthcare systems and healthcare providers address quality improvement.

Mini Case Study A Computerized Physician Order Entry (CPOE) is a system that allows physicians to order prescriptions, diagnostic tests, and procedures and provides them with decision making Questions to Consider 1. Is the role of government agencies different from the role of private, non-profit quality agencies? Explain. Do government agencies regulate more than others? If so, why? If not, why not? 2. The CMS has an active role in the government’s quality efforts and its website, www .cms.gov , has many programs dedicated to this purpose. Visit the CMS website, identify two healthcare quality programs, and compare these two programs to those of the state governments or private non-profit agencies. What differences do you observe in the way these programs enforce their agenda? 3. Go to the CMS website, locate the Hospital Compare page ( http://www.medicare.gov /hospitalcompare/search.html ) and identify the number of hospitals in your area. Select three hospitals and compare them on the basis of patient survey results. Are the patient satisfaction survey results similar to those of The Joint Commission or Leap - frog? In what respect? Web Field Trip One goal of the Office of the Patient Advocate is to help healthcare consumers access the ser - vices for which they are eligible. Using sample scenarios, this video ( https://w w w.youtube .com/watch?v=SsXmIMBs18c ) gives a brief look into how this organization can assist consumers. fin81226_04_c04_073-118.indd 113 10/30/14 7:41 PM Summary & Resources support at the time they use it. Its integration with patient data and information allows for orders to be checked for potential concerns and issues. Because CPOE has the potential to improve communication between various health providers and increase efficiencies, several hospitals in a large metropolitan area have adopted its use. However, various large-group employers have begun to question whether these systems contribute to the increasing healthcare costs without necessarily improving outcomes (i.e., lower medication errors).

As a result, Leapfrog began to include a “CPOE Standard” to assess quality and effectiveness of CPOEs. To meet Leapfrog’s CPOE Standard, hospitals had to assure that at least 75% of medication orders were made via a system with prescribing-error prevention software and prove that the CPOE system could alert physicians to at least 50% of prescribing errors.

Leapfrog analyzed data from 214 hospitals in the area, including 187 hospitals that com - pleted an adult CPOE test and 37 hospitals that completed a pediatric test. There were 10 hospitals that completed both tests, which resulted in 224 total CPOE tests and 10,407 total medication orders processed through the CPOE systems of the large metropolitan area.

Tables 4.13 and 4.14 present the evaluation results.

Table 4.13: Results of adult and pediatric medication orders Hospital type Number of CPOE Rx orders processed % of CPOE Rx orders that did not result in appropriate warning Adult hospitals (n = 187) 8,706 51.0% Pediatric hospitals (n = 203) 1,701 40.1% Table 4.14: Results of adult and pediatric potentially fatal orders Hospital type Number of CPOE potentially fatal orders processed % of CPOE potentially fatal orders that did not result in appropriate warning Adult hospitals (n = 187) 311 32.8% Pediatric hospitals (n = 203) 62 33.9% Discussion Questions 1. Based on the results of the Adult & Pediatric Medication Orders, do the hospitals of the large metropolitan areas meet the Leapfrog CPOE Standard? Why or why not?

What do these results mean for the large-group employers, hospitals, and consumers? 2. Based on the results of the Adult & Pediatric Potentially Fatal Orders, should the hos - pitals of the large metropolitan areas be concerned? Why or why not? What do these results mean for the large-group employers, hospitals, and consumers? 3. As a result of the study, Leapfrog made recommendations based on the CPOE find - ings. While the federal government had invested in technology as part of the “mean - ingful use” definition, it was believed that there is also a need for the private market to invest in the monitoring of all technology uses in healthcare. Furthermore, the results of such monitoring efforts should be shared amongst one another in order fin81226_04_c04_073-118.indd 114 10/30/14 7:41 PM Summary & Resources best practice A method or technique that has consistently produced results superior to those achieved with other means.

Center for Medicare & Medicaid Services (CMS) An agency responsible for admin - istering the Medicare program, Medicaid program, State Children’s Health Insurance Program (SCHIP), and various healthcare standards.

clinical measures Measures that are related to clinical performance.

Department of Health and Human Ser - vices (HHS) An agency established to administer health-related services, particu - larly to communities that are unable to seek services themselves.

department of insurance A unit of the state government that manages the activities of insurance companies conducting business in their state.

health policies Authoritative decisions that come from the government in order to improve a certain outcome or control health - care players’ actions.

hospital safety score Score resulting from a survey conducted by the Leapfrog Group as its initiative to enhance the safety of hos - pital care.

The Joint Commission (TJC) A non-profit organization that serves as a regulatory agency for quality assurance. judicial decisions A final decision made by the courts in cases in which laws and other regulations are unclear and clarification or interpretation is needed.

laws Policies that are formulated and approved by legislators that are codified in the statutory language of specific pieces of enacted legislation.

Medicare Shared Savings Program A program that rewards ACOs when they incur lower costs while meeting quality standards and satisfying patients and their health plans.

National Patient Safety Goals (NPSG) A series of specific actions recommended by a panel of national experts to prevent medi - cal errors, such as patient misidentification, miscommunication among caregivers, and surgery on the wrong body part.

National Quality Forum (NQF) A non- profit organization that enhances healthcare transformation by reviewing, endorsing, and recommending use of standardized health - care performance measures.

National Quality Improvement Goals (NQIG) Desirable goals for effectively treating patients with specifically identified conditions, such as children’s asthma, heart attack, heart failure, pneumonia, pregnancy and related conditions, and surgical care improvement. to be transparent about best practices, so the adoption of such technological uses would be implemented at various healthcare organizations. What advantage does collaboration have with the improvement of health technologies, specifically CPOE systems? 4. In the world of technology, consumers and businesses often want systems that are “plug-and-play.” However, given the world of healthcare, how is it that these tech - nological systems are not so plug-and-play friendly? How do regulations, policies, operational decisions, and guidelines influence the use of these technologies? Key Terms fin81226_04_c04_073-118.indd 115 10/30/14 7:41 PM Summary & Resources NCQA accreditation standards Measures that are required by NCQA during its accred - itation process.

operational decisions and guide - lines Documents of practical application, which have less authority than rules and much less than healthcare laws. rules and regulations More detailed interpretations of healthcare laws, which are made in the executive branch of government by the organizations and agencies respon - sible for implementing laws and policies.

tracer methodology A methodology that allows Joint Commission surveyors to evalu - ate the organization’s systems of providing care and services by using a patient’s record as a roadmap, moving through areas that individual experienced. Critical Thinking Questions 1. Why do healthcare providers want to obtain various accreditations from different accrediting bodies? Why spend so much time and effort to obtain accreditations and certifications? Please explain. 2. Discuss the pros and cons of reporting to different accrediting bodies and govern - ment agencies. Are there different standards and measures used by these accrediting organizations? Why? 3. What are some ways to incentivize healthcare organizations and providers to report and improve their performance measures? Which ones are working better than oth - ers? Give an example. 4. What is the role of the Internet and multimedia in quality improvement efforts? In the absence of the Internet, how do you think accrediting bodies and government agencies would report their findings? Explain. 5. Over the years, there has been a shift in quality improvement to emphasize patient experience and patient-centered care. Why have patients become so important in measuring quality of care? 6. Has NCQA accreditation improved the quality of care provided by health plans since the 1980s? Why? What are the incentives in the NCQA accreditation that make it so attractive to health plans? 7. What is the role of HEDIS and CAHPS in quality improvement? How did healthcare providers adopt HEDIS and CAHPS over the years? Why? Suggested Websites • Agency for Healthcare Research and Quality:

ht tp://w w w.ahrq.gov/ This agency (part of the U.S. Department of Health and Human Services) provides information for patients and healthcare professionals regarding quality and costs of care. • CMS, Hospital Compare:

ht tp://w w w.medicare.gov/hospitalcompare/search.html A searchable public source of quality metrics from facilities that treat Medicare patients. Different hospitals can be compared based on specific quality metrics. fin81226_04_c04_073-118.indd 116 10/30/14 7:41 PM Summary & Resources • CMS, Medicare.gov:

ht tp://w w w.medicare.gov The main website for Medicare. • CMS, Medicare Plan Finder:

w w w.medicare.gov/find-a-plan A website that enables Medicare beneficiaries to find a managed care plan (Medi - care Advantage) if they want to opt for Medicare managed care instead of traditional Medicare coverage. • Food and Drug Administration:

ht tp://w w w.fda.gov/ The main website for the U.S. Food and Drug Administration. Provides links to infor - mation about medications, food, devices, and other products regulated by the FDA.

Information targeted to patients/consumers and healthcare professionals. • Leapfrog Group:

ht tp://w w w.leapfroggroup.org/ The main website for Leapfrog Group. • Leapfrog Group, Hospital Survey Results:

ht tp://w w w.leapfroggroup.org/cp Website with a searchable database containing Leapfrog survey results for individ - ual hospitals. • Leapfrog Group, Hospital Safety Scores:

w w w.HospitalSafet yScore.org Website with a searchable database containing overall safety scores for individual hospitals. • National Committee for Quality Assurance (NCQA):

ht tp://w w w.ncqa.org/ This website contains resources for clinicians, consumers, employers, and health plans regarding quality of care. • The Joint Commission:

ht tp://w w w.jointcommission.org/ The main website of the primary organization that accredits hospitals and also pro - vides certification for specific clinical care programs, such as joint replacements, at individual healthcare facilities. • The Joint Commission, Quality Check ®: www.qualitycheck.org This website provides a searchable database of accreditation status for hospitals, as well as information regarding certification status of special programs at hospitals. fin81226_04_c04_073-118.indd 117 10/30/14 7:41 PM fin81226_04_c04_073-118.indd 118 10/30/14 7:41 PM