Thurgood Marshall, Hero of American Medicine.

One of the heroes in American history, Associate Supreme Court Justice Thurgood Marshall (1908-1993) sought legal remedies against racial discrimination in education and health care. As director of the Legal Defense Fund (LDF) of NAACP from 1940 to 1961, his success in integrating law schools in Texas led to the first black medical student admitted to a state medical school in the South. Representing doctors and dentists needing a facility to perform surgery, the LDF brought cases before the courts in North Carolina that moved the country toward justice in health care. His ultimate legal victory came in 1954, Brown v. Board of Education of Topeka, the decision that declared racial segregation in public schools unconstitutional. In 1964, the LDF under Jack Greenberg, Marshall's successor as director, won Simkins v. Moses H. Cone Memorial Hospital, a decision that held that hospitals accepting federal funds had to admit black patients. The two decisions laid the judicial foundation for the laws and administrative acts that changed America's racial history, the Civil Rights Act of 1964 and the Social Security Act Amendments of 1965 that established Medicare and Medicaid. His achievements came during the hottest period of the American civil rights movement of the 1950s and 1960s. Well past the middle of the twentieth century, black Americans were denied access to the full resources of American medicine, locked in a "separate-but-equal" system woefully inadequate in every respect. In abolishing segregation, Marshall initiated the long overdue remedy of the unjust legacies of slavery and Jim Crow.

The Economic Burden of Out-of-Pocket Expenses for Plastic Surgery Procedures.

BACKGROUND: Health insurance reimbursement structure has evolved, with patients becoming increasingly responsible for their health care costs through rising out-of-pocket expenses. High levels of cost sharing can lead to delays in access to care, influence treatment decisions, and cause financial distress for patients. METHODS: Patients undergoing the most common outpatient reconstructive plastic surgery operations were identified using Truven MarketScan databases from 2009 to 2017. Total cost of the surgery paid to the insurer and out-of-pocket expenses, including deductible, copayment, and coinsurance, were calculated. Multivariable generalized linear modeling with log link and gamma distribution was used to predict adjusted total and out-of-pocket expenses. All costs were inflation-adjusted to 2017 dollars. RESULTS: The authors evaluated 3,165,913 outpatient plastic and reconstructive surgical procedures between 2009 and 2017. From 2009 to 2017, total costs had a significant increase of 25 percent, and out-of-pocket expenses had a significant increase of 54 percent. Using generalized linear modeling, procedures performed in outpatient hospitals conferred an additional $1999 in total costs (95 percent CI, $1978 to $2020) and $259 in out-of-pocket expenses (95 percent CI, $254 to $264) compared with office procedures. Ambulatory surgical center procedures conferred an additional $1698 in total costs (95 percent CI, $1677 to $1718) and $279 in out-of-pocket expenses (95 percent CI, $273 to $285) compared with office procedures. CONCLUSIONS: For outpatient plastic surgery procedures, out-of-pocket expenses are increasing at a faster rate than total costs, which may have implications for access to care and timing of surgery. Providers should realize the increasing burden of out-of-pocket expenses and the effect of surgical location on patients' costs when possible.

Good Financial Practice and Clinical Research Coordinator Responsibilities.

OBJECTIVES: To describe clinical research billing pitfalls and good financial practices the research nurse coordinator can implement to decrease billing errors in clinical practice. DATA SOURCES: Government websites, published articles, and the author's expertise in national/international research studies. CONCLUSION: Clinical research billing is a risky business. It involves many steps in the process and requires good communication among all key stakeholders. The clinical research coordinator is the key team player to facilitate good financial practices for research billing. Creating and applying standards, cross-functional transparent communication, and effective processes across the organization can help to increase billing compliance and decreases billing risk to the organization. IMPLICATIONS FOR NURSING PRACTICE: The research billing process is a critical component of clinical research. However, billing in the process of generating evidence to inform clinical practice is not included in the core competencies in nursing curriculum. As such, in the real world many nurses grapple with taking on the new role of being a clinical research coordinator. Developing knowledge and understanding about the potential billing pitfalls and good financial practices can support clinical research nurses to decrease billing errors and exposure to risk.

Trends in smoking documentation rates in safety net clinics.

OBJECTIVE: To assess the impact of provider incentive policy on smoking status documentation. DATA SOURCES: Primary data were extracted from structured electronic medical records (EMRs) from 15 community health centers (CHCs). STUDY DESIGN: This was an observational study of data from 2006 to 2013, assessing changes in documentation of smoking status over time. DATA EXTRACTION METHODS: We extracted structured EMR data for patients age 18 and older with at least one primary care visit. PRINCIPAL FINDINGS: Rates of documented smoking status rose from 30 percent in 2006 to 90 percent in 2013; the largest increase occurred from 2011 to 2012 following policy changes (21.3% [95% CI, 8.2%, 34.4%] from the overall trend). Rates varied by clinic and across patient subgroups. CONCLUSIONS: Documentation of smoking status improved markedly after introduction of new federal standards. Further improvement in documentation is still needed, especially for males, nonwhite patients, those using opioids, and HIV + patients. More research is needed to study whether changes in documentation lead to improvements in counseling, cessation, and patient outcomes.

The Financial Effect of Medicare Coverage Design and Safety Net Options for Cancer Care.

BACKGROUND: National spending on specialty medications accounted for approximately $193 billion in 2016. The coverage design for Medicare Parts B and D has shifted medication costs to patients, which may prohibit patients from starting or maintaining therapy due to affordability. As a result, patients have enrolled in safety net financial options, such as patient assistance and foundation programs. Safety net options may provide savings not otherwise realized by Medicare; however, they may have a negative financial effect on health systems and pharmaceutical manufacturers. OBJECTIVES: To (a) quantify financial savings to Medicare as a result of patient enrollment in patient assistance programs and (b) quantify the financial effect of safety net options for patients, manufacturers, and the academic medical center that participated in this study. METHODS: A single-center, nonrandomized, retrospective pilot study of Medicare beneficiaries was conducted. Patients who were prescribed hematology/oncology specialty medications and enrolled in safety net options between July 2015 and June 2017 were included. Investigators collected data related to fill history, drug cost, and prescription coverage. The primary outcome was the overall cost savings to Medicare as a result of patient enrollment in patient assistance programs. Secondary outcomes included total patient out-of-pocket savings as a result of foundation copayment support, financial effect on manufacturers as a result of patient assistance programs, and health system revenue impact as a result of safety net options. Descriptive statistics were used. RESULTS: This study included 114 patients. Medicare saved $5,083,816.83 over 2 years as a result of patient assistance programs. Eight foundations provided $240,350.04 in patient insurance copayments. Nine manufacturers provided 2,243 free drug doses, valued at $3,379,032.34. The participating medical center missed the opportunity for $6,481,543.55 in revenue due to patient assistance programs. CONCLUSIONS: The participating medical center's efforts to improve access to oncology care took considerable time and resources. These activities, as well as unreimbursed infusion services, were costs to the medical center that may not be recognized by Medicare. Manufacturers also supported patient access through their sponsored patient assistance programs. The use of these services and safety net options resulted in cost savings to Medicare and their beneficiaries. DISCLOSURES: No outside funding supported this study. The authors have nothing to disclose. Findings from this study were part of a podium research presentation at the Great Lakes Pharmacy Residency Conference; April 25, 2018; West Lafayette, IN.

Current Policy Challenges in Genomic Medicine.

BACKGROUND: Molecular genetic testing has raised a variety of policy issues, ranging from privacy to reimbursement. Recently, payment policies have become of paramount importance as Medicare implemented the first significant change to test pricing since 1984 and announced a broad national coverage policy for the use of next-generation sequencing (NGS) in cancer patients that contains significant restrictions. Regulatory and oversight concerns have been important topics for discussion as the US Food and Drug Administration (FDA), Congress, and stakeholders have focused on new approaches to regulation of laboratory-developed tests (LDTs). Patents on gene sequences and relationships between genetic variants and clinical phenotypes have been points of contention since the field's inception. Two Supreme Court cases invalidated patents on gene sequences and biological relationships, ushering in the era of NGS and precision medicine. However, a recent legislative proposal threatens to reverse these gains and restore gene patents as barriers to progress in genetic and genomic testing and the implementation of genomic medicine. CONTENT: This review discusses current issues in payment policy, laboratory oversight, and gene patenting and their potential impacts on genetic and genomic testing. SUMMARY: Coverage and reimbursement policies present serious challenges to genetic and genomic testing. The potential for FDA regulation of LDTs looms as a significant threat to diagnostic innovation, patient access, and the viability of molecular genetic testing laboratories. Changes in patent law could cause gene patents to reemerge as barriers to the advancement of genomic medicine.

What Physicians and Health Organizations Should Know About Mandated Imaging Appropriate Use Criteria.

The Appropriate Use Criteria Program, enacted by the Centers for Medicare & Medicaid Services in response to the Protecting Access to Medicare Act of 2014 (PAMA), aims to reduce inappropriate and unnecessary imaging by mandating use of clinical decision support (CDS) by all providers who order advanced imaging examinations (magnetic resonance imaging; computed tomography; and nuclear medicine studies, including positron emission tomography). Beginning 1 January 2020, documentation of an interaction with a certified CDS system using approved appropriate use criteria will be required on all Medicare claims for advanced imaging in all emergency department patients and outpatients as a prerequisite for payment. The Appropriate Use Criteria Program will initially cover 8 priority clinical areas, including several (such as headache and low back pain) commonly encountered by internal medicine providers. All providers and organizations that order and provide advanced imaging must understand program requirements and their options for compliance strategies. Substantial resources and planning will be needed to comply with PAMA regulations and avoid unintended negative consequences on workflow and payments. However, robust evidence supporting the desired outcome of reducing inappropriate use of advanced imaging is lacking.

Reframing Medicare Physician Payment Policy for 2019: A Look at Proposed Policy.

On July 12, 2018, the Centers for Medicare and Medicaid Services (CMS) released the proposed 2019 Medicare physician fee schedule and quality payment program, combining these 2 rules for the first time. This occurred in a milieu of changing regulations that have been challenging for interventional pain management specialists. The Affordable Care Act (ACA) continuous to be amended by multiple administrative changes. This July 12th rule proposes substantial payment changes for evaluation and management (E&M) services, with documentation requirements, and blending of Level II to V CPT codes for E&M into a single payment. In addition, various changes in the quality payment program with liberalization of some metrics have been published. Recognizing that there are differing impacts based on specialty and practice type, as a whole interventional pain management specialists would likely see favorable reimbursement trends for E&M services as a result of this proposal. Moreover, in comparison with recent CMS final ruling, this proposed rule has relatively limited changes in procedural reimbursement performed in a facility or in-office setting.CMS, in the new rule, has proposed an overhaul of the E&M documentation and coding system ostensibly to reduce the amount of time physicians are required to spend inputting information into patients' records. The new proposed rule blends Level II to V codes for E&M services into a single payment of $93 for office outpatient visits for established patients and $135 for new patient visits. This will also have an effect with blended payments for services provided in hospital outpatients. CMS also has provided additional codes to increase the reimbursement when prolonged services are provided with total reimbursement coming to Level V payments. Interventional pain management-centered care has been identified as a specialty with complexity inherent to E&M associated with these services. Among the procedural payments, there exist significant discrepancies for the services performed in hospitals, ambulatory surgery centers (ASCs), and offices. A particularly egregious example is peripheral neurolytic blocks, which is reimbursed at 1,800% higher in hospital outpatient department (HOPD) settings as compared with procedures done in the office. The majority of hospital based procedures have faced relatively small cuts as compared with office based practice. The only significant change noted is for spinal cord stimulator implant leads when performed in office setting with 19.2% increase. However, epidural codes, which have been initiated with a lower payment, continue to face small reductions for physician portion.This review describes the effects of the proposed policy on interventional pain management reimbursement for E&M services, procedural services by physicians and procedures performed in office settings. KEY WORDS: Physician payment policy, physician fee schedule, Medicare, Merit-Based Incentive Payment System, interventional pain management, regulatory tsunami, Medicare Access and CHIP Reauthorization Act of 2015.

Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2019 Rates; Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs (Promoting Interoperability Programs) Requirements for Eligible Hospitals, Critical Access Hospitals, and Eligible Professionals; Medicare Cost Reporting Requirements; and Physician Certification and Recertification of Claims. Final rule.

We are revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2019. Some of these changes implement certain statutory provisions contained in the 21st Century Cures Act and the Bipartisan Budget Act of 2018, and other legislation. We also are making changes relating to Medicare graduate medical education (GME) affiliation agreements for new urban teaching hospitals. In addition, we are providing the market basket update that will apply to the rate-of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis, subject to these limits for FY 2019. We are updating the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs) for FY 2019. In addition, we are establishing new requirements or revising existing requirements for quality reporting by specific Medicare providers (acute care hospitals, PPS-exempt cancer hospitals, and LTCHs). We also are establishing new requirements or revising existing requirements for eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) participating in the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs (now referred to as the Promoting Interoperability Programs). In addition, we are finalizing modifications to the requirements that apply to States operating Medicaid Promoting Interoperability Programs. We are updating policies for the Hospital Value-Based Purchasing (VBP) Program, the Hospital Readmissions Reduction Program, and the Hospital-Acquired Condition (HAC) Reduction Program. We also are making changes relating to the required supporting documentation for an acceptable Medicare cost report submission and the supporting information for physician certification and recertification of claims.