HHS proposes ‘modern’ approach to substance abuse privacy

HHS is proposing to update the Confidentiality of Alcohol and Drug Abuse Patient Records regulations to improve information exchange of the medical records of patients with substance abuse disorders. The proposals are designed to improve care coordination and modernize patient privacy protections by updating rules that were promulgated in 1975 and last updated in 1987. HHS believes that changes must be made to the confidentiality rules in order to permit patients seeking substance abuse treatment to participate effectively in new integrated health care models. The Proposed rule is set to publish in the Federal Register on February 9, 2016. HHS is accepting comments on its proposal through April 11, 2016.

Current protections

The Proposed rule acknowledges that the current laws and regulations governing substance abuse health record confidentiality were developed out of fears that the use of information regarding an individual’s substance abuse treatment in a criminal prosecution would deter individuals from seeking treatment. Under the current regulations, a federally assisted substance use disorder program can only release identifiable information related to substance use disorder diagnosis, treatment, or referral for treatment with the individual’s express consent.


The Proposed regulations are HHS’ attempt to revise 42 C.F.R. Part 2 to ensure patients can participate in newer integrated care models while ensuring that patients are not made more vulnerable through increased information sharing. HHS acknowledges the legitimate privacy concerns of patients seeking treatment for substance abuse. Some of the concerns noted by the Proposed rule include the potential for loss of employment, loss of housing, loss of child custody, discrimination by medical professionals and insurers, arrest, prosecution, and incarceration.

“This proposal will help patients with substance use disorders fully participate and benefit from a health care delivery system that’s better, smarter and healthier, while protecting their privacy,” said Secretary Burwell in a press release. “We are moving Medicare, and the health care system as a whole, toward new integrated care models that incentivize providers to coordinate and put the patient at the center of their care, and we are modernizing our rules to protect patients.”


The specific changes would facilitate electronic exchange of patient records by allowing patients to make a general designation in the “To Whom” section of their patient consent form. HHS believes that the change would facilitate the sharing of patient information within the health care system, while decreasing burdens on participants in integrated health care models. Under the proposal, entities named on a consent form that disclose information under a general designation must, upon request of the patient, provide the patient with a list of entities to which their information has been disclosed. The Proposed rule contemplates that such entities might include entities like Accountable Care Organizations and patient-centered medical homes.

Information on geographic variation of utilization and quality updated

As part of its efforts to support data-driven decision making efforts, the Office of Enterprise Data and Analytics (OEDA) within CMS updated the Geographic Variation Public Use File (GV PUF) in January 2016. The GV PUF is based primarily on information from CMS’ Chronic Conditions Data Warehouse (CCW), which contains 100 percent of Medicare claims for beneficiaries who are enrolled in the fee-for-service (FFS) program as well as enrollment and eligibility data. The January 2016 update to the GV PUF includes data for 2007-2014 and incorporates minor revisions to the CMS methodology.


The GV PUF is made up of 12 separate files with data designed to enable researchers and policymakers to evaluate geographic variation in the utilization and quality of health care services for the Medicare FFS population. The individual files are available from the CMS Web site and contain data on demographic, spending, utilization, and quality indicators at the state level (including the District of Columbia, Puerto Rico, and the Virgin Islands), the hospital referral region (HRR) level, and the county level. The GV PUF was originally posted in July 2011 and updated in July 2012, January 2013, May 2013, December 2013, February 2015, and September 2015.

The 12 files

The GV PUF has two files with state and county-level data, four files with only state-level data, and six files with HRR-level data. The files are presented in “Table” and “Report” formats. The “Table” files present indicators for all states, counties, or HRRs, and can be exported from Excel to another data analysis program for additional analysis. The corresponding “Report” files allow users to compare a specific state, county, or HRR to national Medicare benchmarks. The state- and HRR-level data are presented for beneficiaries under the age of 65, beneficiaries that are 65 or older, and all beneficiaries who regardless of age. The county-level data are only available for all beneficiaries.

Revisions to CMS methodology

The January 2016 update eliminated disease prevalence measures because CMS separately publishes this information in the Chronic Conditions Public Use File. OEDA produces this information to provide researchers and policymakers a better understanding of the burden of chronic conditions among beneficiaries and the implications for our health care system.

The update also made minor changes to the suppression methodology to ensure that all products from OEDA are consistent. Information is now suppressed for areas with fewer than 11 beneficiaries. Counter or secondary suppression is applied in cases where only one geographic area is suppressed for primary reasons, e.g. one county in a state has between 1 and 11 beneficiaries. In these cases, the geographic area with the next smallest count of Medicare FFS beneficiaries is suppressed as well. Also, if one sub-group (e.g. age group) is suppressed, then the other sub-group is suppressed.

Kusserow on Compliance: OIG issues favorable opinion related to patient assistance charitable foundation

The HHS Office of Inspector General (OIG) released Advisory Opinion 15-16 addressing a 501(c)(3) charitable foundation (the “Requestor”) that would seek donations from third parties (including drug manufacturers) and provide financial assistance to out-of-pocket patient expenses for outpatient prescription drugs. The Requestor would maintain two disease funds, one of which would provide assistance to patients with various types of cancer, and the other of which would provide assistance to patients with chronic kidney disease or iron deficiency anemia. The donors could earmark their donations for either fund but would have no control over the specific types of diseases each fund would apply to them.

The OIG concluded that the proposed arrangement would not violate the federal prohibition against inducements to patients with regard to the Civil Money Penalties (CMP) law or the Anti-Kickback Statute (AKS). The OIG cited the following characteristics of the arrangement that led it to its conclusions:

  • No donor, affiliate of any donor, physician, or health care provider would exert direct or indirect control over the Requestor or its program.
  • The Requestor is a nonprofit, tax-exempt charitable organization that operates with absolute, independent, and autonomous discretion as to the use of donor contributions.
  • The Requestor has no financial relationship with any physician or other health care provider that treats patients eligible to receive assistance from the Requestor.
  • Before applying for assistance, each patient already would have selected his or her health care providers, practitioners, or suppliers, and already would have a treatment regimen in place so that the existence of the program would not influence the selection of a provider.
  • The Requestor would not refer patients to, recommend, or arrange for the use of any particular practitioner, provider, supplier, drug, or insurance plan.
  • Donors would not receive any data that would facilitate a donor in correlating the amount or frequency of its donations with the amount or frequency of the use of its drugs or services.
  • No donor or affiliate of any donor would directly or indirectly influence the identification or delineation of the diseases covered by its two disease funds.
  • The determination of a patient’s qualification for assistance would be based solely on financial need, without considering the identity of the health care providers, practitioners, suppliers, drugs, or insurance plans; the identity of any referring party; or the identity of any donor.
  • The Requestor would assist all eligible, financially needy patients on a first-come, first-served basis to the extent funding is available.
  • The Requestor will permit donors to earmark donations for both of the disease funds, which generally should not significantly raise the risk of abuse.
  • Diseases covered by its disease funds: (i) would be defined in accordance with widely recognized clinical standards and in a manner that covers a broad spectrum of available drugs; and (ii) would not be defined by reference to specific symptoms, severity of symptoms, the method of administration of drugs, stages of a particular disease, type of drug treatment, or any other way of narrowing the definition of widely recognized disease states.

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 © 2016 Strategic Management Services, LLC. Published with permission.

Highlight on Virginia: Health Opportunity Index maps out disparities

An updated version of the Virginia Health Opportunity Index (HOI) allows consumers, policymakers, and providers to evaluate multiple social determinants of health as they impact different geographic areas of the Commonwealth. The Virginia Department of Health’s Office of Minority Health and Health Equity (VDH-OMHHE) originally developed the HOI to provide a picture of the social, economic, educational, demographic and environmental factors that impact community health. Since its inception, the HOI has been redesigned into a continuously updated source of information to help stakeholders engage with changing health data using a convenient, visual dashboard.

Dashboards and Indicators

The HOI website uses a number of interactive dashboards and maps to allow consumers, policy-makers, and providers to interactively examine the HOI data. With separate dashboards for counties, health districts, and legislative districts, the HOI interface is designed to allow scrutiny of the data at multiple different levels of detail. The HOI relies on 13 indicators, which were chosen to serve as the building blocks of the HOI. The indicators were selected for their influence upon health, stakeholder input, and the availability of data on those factors for all of the relevant geographical areas in Virginia.  The indicators are all focused on determining an individual’s opportunity to live a long and healthy life in a particular area.


The HOI dashboards synthesize the 13 indicators into four different profiles: the Community Environment Profile, the Consumer Opportunity Profile, the Economic Opportunity Profile, and the Wellness Disparity Profile. The Community Environment Profile is an indicator of social and natural measures, including air quality, population turnover, population density, and walkability, which refers to street connectivity and public transit accessibility. The Consumer Opportunity Profile measures the availability of consumer resources, including access to and the affordability of food, transportation, housing, and education. The Economic Opportunity Profile evaluates economic opportunity in individual communities by measuring employment accessibility, income inequality, and the number of individuals actively participating in the workforce. The Wellness Disparity Profile provides a measure of the disparate nature of access to health care services within in a community. The Wellness Disparity Profile indicates access by measuring the number of physicians in a community, the number of uninsured individuals. The Profile also more broadly considers whether community members have access to a primary care physician and the means to pay for care.


According to VDH-OMHHE,” the HOI is remarkably predictive of health outcomes.” The VDH-OMHHE believes that because the HOI explains the majority of life expectancy variation in Virginia’s Census Tracts, the HOI influence is comparable to that of the World Health Organization’s Social Determinants of Health (SDOH). In other words, Virginia believes that its HOI does as good of a job predicting health outcomes as the economic and social predictor of health used by the Centers for Disease Control and Prevention (CDC). The HOI is premised upon an understanding that place matters and, with appropriate spatial modeling, health care can be improved. The HOI provides a wealth of information. Now, stakeholders need to put that information to good use in order to start improving health across the state of Virginia.