Kusserow on Compliance: Changes in the Stark Law

Over the years, the Stark law has evolved considerably from regulatory requirements to use by the DOJ in enforcement of the False Claims Act. Unlike the Anti-Kickback Statute, which is enforced by the OIG, the Stark law is considered regulatory and under CMS jurisdiction. The Stark law was designed to prohibit doctors from referring Medicare patients to hospitals, labs, and colleagues with whom they have financial relationships, unless they fall under certain exceptions. Stark prevents hospitals from paying providers more when they meet certain quality measures, such as reducing hospital-acquired infections, while paying less to those who miss the goals. Providers have registered numerous concerns that the Stark Law is inhibiting their ability to participate in Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) reforms. The CMS Administrator, Verma, has acknowledged the difficulty of reconciling the Stark Law’s restrictions with the current shift to value based payment structures, noting that that the Stark Law “was developed a long time ago” with current payment systems and operations being different, requiring some changes in the rules. This is not the first time CMS has tried to move the easing of rules concerning the Stark law. In 2015, CMS published a Proposed rule relaxing aspects of the Stark law, including easing of some of the strict liability features of the law and the CMS burden in dealing with the interpretation of key terms, requirements, and other issues.  After reviewing an enormous amount of self-disclosures, CMS realized that a large part of its docket involved arrangements that may technically violate the statute but do not actually pose significant risks of abuse, thus necessitating some changes and clarifications.

Inter-Agency Group formed to focus on easing Stark Barriers

During a January, 2018 American Hospital Association webinar, the CMS Administrator announced plans to convene an inter-agency group consisting of CMS, the OIG, HHS General Counsel, and the DOJ to focus on how to minimize the regulatory barriers of the Stark law that began in 1989 and underwent expansion in the 1990s. Verma noted that the review is in line with CMS’s “Patients Over Paperwork” initiative, which is in accord with the President’s Executive Order that directs federal agencies to “cut the red tape” to reduce burdensome regulations.

Congress Acts

Regardless of the results of the inter-agency review, the fact remains that only so much can be done by regulatory policy changes. All real changes must be made in the law will necessarily have to come from Congress. The Bipartisan Budget Act of 2018 imposed changes on laws related to health care fraud and abuse. On one side they quadrupled fines and doubled potential prison time from five to ten years for violation of the Anti-Kickback Statute.  The Civil Monetary Penalties (CMP) law penalties were doubled. On the other side, Congress moved to reduce some of the burdens by codifying CMS regulatory guidance. Some specific relief involved expired leases and personal services contracts that, if otherwise compliant, will remain protected as long as the terms and conditions continue unchanged.


Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

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Copyright © 2017 Strategic Management Services, LLC. Published with permission.

CBO, JCT share methods for analyzing legislative proposals impacting health insurance coverage

The Congressional Budget Office (CBO) and the Joint Committee on Taxation (JCT) revealed in a recent report how they jointly analyze proposed legislation that would impact health insurance coverage for individuals younger than age 65, detailing how they develop analytic strategies, model a proposal’s effect, and finalize their analysis (CBO Report, February 2018).

Analytic strategy development

First, the CBO and JCT put together an analytic strategy. The agencies formally develop their strategy once the proposed legislation’s specifications become available, an official request for analysis has been made, and the CBO and JCT arrange the time to commence the analysis. However, the agencies also often work informally with Congressional staff during development of the proposal. The agencies begin by reviewing the policy specifications. The CBO and JCT consider how the proposed legislation would impact existing law and how the proposed legislation is different from earlier proposal drafts. The agencies work to verify that the Congressional staff’s intent is reflected in the language and then estimate the legislative effect by, namely, identifying how the proposal could affect health insurance coverage and the federal budget.

The CBO and JCT focus on the policy changes most likely to impact health insurance coverage or cost, ranging from the straight-forward to the more complex. Another key aspect the agencies consider is timing and what additional “administrative infrastructure” is necessary to bring about the changes of the proposed legislation—and how long it would take to do so. The timing element includes estimates of how other stakeholders (state governments, insurers, employers, etc.) would respond and how long it would take for them to implement the proposed changes. To help with their estimates, the agencies rely on past cases of legislative reform programs. Further, the agencies seek input from outside experts and existing evidence while maintaining the required confidentiality of a proposal.

Proposal effect modeling

Second, the CBO and JCT undertake modelling the impact of the proposed legislation. Primarily, the agencies rely on CBO’s health insurance simulation model (HISIM), Medicaid enrollment and cost models, and JCT’s individual tax model. These models use data on health insurance coverage information for everyone younger than 65, Medicaid enrollment and expenditures, and detailed tax return information. The agencies also draw estimates based on information HISIM cannot project, namely, the behavior of states, employers, and insurers. These initial projections are incorporated as inputs into HISIM (state, employer, and individual enrollee behavior) or assessed outside HISIM (insurer behavior). CBO and JCT also use HISIM to estimate stakeholder responses to new coverage options. Medicaid enrollment and cost projections use HISIM estimates in addition to a more detailed Medicaid model and other methods. JCT usually provides estimates of proposed tax liability changes using its individual tax model.


Finally, both the CBO and JCT engage in rigorous review of their respective analysis results in order to ensure objectivity and proper analysis. Specifically, they examine results of one or more years out of the 10-year projection period to ensure that the analysis is being computed as intended and compare results against previous analyses. The agencies also inspect for programming errors or unexplained results. The CBO and JCT consider changes to the results if there were different critical inputs. The agencies prepare a formal written estimate and explanation thereof and, before releasing it to Congress and the public, agency staff carefully review the report.

Kusserow on Compliance: OIG summarizes investigative accomplishments from last three years

The OIG testified before the House Committee on Ways and Means and reported that in the last 3 fiscal years, its investigations have resulted in more than $10.8 billion in investigative receivables (dollars ordered or agreed to be paid to Government programs as a result of criminal, civil, or administrative judgments or settlements); 2,650 criminal actions; 2,211 civil actions; and 10,991 program exclusions. Much of this work involving the Medicare and Medicaid programs is funded by the Health Care Fraud and Abuse Control Program (HCFAC).  The HCFAC provides funding resources to the Department of Justice (DOJ), HHS, and OIG, which are often used collaboratively to fight health care fraud, waste, and abuse. Since its inception in 1997, the HCFAC has returned more than $31 billion to the Medicare trust fund.

The OIG is a lead participant in the DOJ led Medicare Fraud Strike Force, which combines the resources of Federal, state, and local law enforcement entities to fight health care fraud across the country. The Strike Force operates in nine geographic hot spots, including Miami, Florida; Los Angeles, California; Detroit, Michigan; southern Texas; Brooklyn, New York; southern Louisiana; Tampa, Florida; Chicago, Illinois; and Dallas, Texas. Strike Force teams are led by the DOJ, includes the FBI and the OIG, along with state and local law enforcement. In 2017 alone Strike Force teams accounted for over 2,000 criminal actions with about 3,000 indictments, and accounted for monetary results of around $3 billion. Since its inception in March 2007, the Strike Force has charged more than 3,000 defendants who collectively billed the Medicare program more than $10.8 billion.

The OIG also collaborates with state Medicaid Fraud Control Units (MFCUs) to detect and investigate fraud, waste, and abuse in state Medicaid programs, as well as private sector stakeholders to enhance the relevance and impact of its work to combat health care fraud, as demonstrated by its leadership in the Healthcare Fraud Prevention Partnership (HFPP) and collaboration with the National Health Care Anti-Fraud Association (NHCAA). The OIG strives to cultivate a culture of compliance in the health care industry through various educational efforts, such as Pharmacy Diversion Awareness Conferences, public outreach, and consumer education.


Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

Connect with Richard Kusserow on Google+ or LinkedIn.

Subscribe to the Kusserow on Compliance Newsletter

Copyright © 2017 Strategic Management Services, LLC. Published with permission.

Medicaid and CHIP are catching uncovered kids, the ACA helps

Due to high rates of Medicaid and Children’s Health Insurance Program (CHIP) coverage for young children, only 3.3 percent of children ages three and younger were uninsured in 2016. Coverage of both young children (age three and younger) and their parents increased under the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) in 2014 and 2015—a trend that continued in 2016. According to an Urban Institute report, young children and their families continued to rely on Medicaid and CHIP in 2016, with 48.5 percent of young children covered by Medicaid or CHIP. In comparison, only 42 percent of older children were covered by the programs.

Trends. Nearly half of young children and one-fifth of the parents of young children were covered by Medicaid and CHIP in 2015 as well. The high incidence of Medicaid and CHIP coverage is partly due to higher incidence of family characteristics among parents of younger children, including lower incomes, younger parents, and mixed immigration status.

Variance. Despite high overall levels of coverage, the prevalence of health insurance coverage for young children and their families continued to vary across state lines. Uninsurance rates were below 2 percent in 12 states but above 8 percent in three states—Alaska, Wyoming, and North Dakota. Additionally, the expansion of state Medicaid programs under the ACA continues to be a significant source of variation in state uninsurance levels for the parents of young children. For example, an estimated 8.7 percent of parents of young children in expansion states were uninsured in 2016, whereas 18 percent of parents of young children were uninsured in nonexpansion states.