U.S. Department of Labor: Implementation of Executive Order 13672 Prohibiting Discrimination Based on Sexual Orientation and Gender Identity by Federal Contractors

This final rule published by the U.S. Department of Labor implements Executive Order 13672 issued by President Barack Obama on July 21, 2014, which prohibits discrimination based on sexual orientation and based on gender identity by all federal contractors and subcontractors.

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That Executive Order 13672 amends Executive Order 11246 which prohibits discrimination based on race, color, religion, sex, and national origin by all federal contractors and subcontractors.  The original executive order also required all federal contractors to take affirmative measures to prevent the prohibited discrimination from occurring.  Executive Order 13672 includes a similar requirement on federal contractors to take affirmative measures to prevent discrimination based on sexual orientation and based on gender identity from occurring.

The rule applies to all contractors and subcontractors with the U.S. Department of Health and Human Services, and other federal departments and agencies involved in the provision of health care services.

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While this federal government executive action will prohibit employment discrimination against lesbian, gay, bisexual, and transgender employees working for federal contractors and subcontractors, 29 states still do not prohibit employment discrimination based on gender identity (states in lightest color and light green on map below) and 32 states still do not prohibit employment discrimination based on sexual orientation (states in lightest color on map below).  A federal bill, the Employment Non-Discrimination Act, has been pending in Congress since 1994 and was passed by the Senate in 2013 but did not advance to a floor vote in the House of Representatives, despite having 205 House members as co-sponsors.  The bill has yet to be re-introduced into the 114th Congress.

State Employment Discrimination Protections

 

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Centers for Medicare and Medicaid Services: Implementation of United States v. Windsor Decision

The Centers for Medicare and Medicaid Services (CMS) has published this ruling implementing the 2013 United States Supreme Court decision in United States v. Windsor declaring part of the so-called Defense of Marriage Act (DOMA) unconstitutional and requiring the federal government to recognize same-sex marriages.  This comprehensive CMS ruling now applies to all CMS programs, services, contractors, appeals, and other eligibility determinations, including Part A and Part B Medicare Administrative Contractors (MACs), Qualified Independent Contractors (QICs), the Provider Reimbursement Review Board, the Medicare Geographic Classification Review Board, and the Medicare Appeals Council and Administrative Law Judges (ALJs) who hear Medicare appeals.  Prior CMS directives had applied the Windsor decision to specific eligibility decisions but this ruling now applies the decision to all CMS eligibility decisions.  This CMS ruling is applies to all appeals pending on, initiated, or reopened in accordance with applicable rules after February 9, 2015, for entitlement and enrollment determinations made on or after June 26, 2013.

Consistent with prior interpretation and application of the Windsor decision by the Obama Administration, this ruling adopts a “celebration rule’’, which means that a same- sex marriage is recognized and treated as a lawful marriage (where marital status is relevant to a determination of entitlement) if the same-sex marriage was lawful where and when it occurred.  However, individuals in non-marital same-sex relationships (such as domestic partnerships or civil unions that are not marriages) are not considered married.

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National Center for Health Statistics: Use and Characteristics of Electronic Health Record Systems Among Office-based Physician Practices – United States, 2001-2013

This data brief from the National Center for Health Statistics reports on the use of electronic health records (EHRs) among office-based physician practices in the United States.  Among the key findings:

  • In 2013, 78% of office-based physicians used any type of electronic health record (EHR) system, up from 18% in 2001.
  • In 2013, 48% of office-based physicians reported having a system that met the criteria for a basic system, up from 11% in 2006. The percentage of physicians with basic systems by state ranged from 21% in New Jersey to 83% in North Dakota.
  • In 2013, 69% of office-based physicians reported that they intended to participate (i.e., they planned to apply or already had applied) in “meaningful use” incentives. About 13% of all office-based physicians reported that they both intended to participate in meaningful use incentives and had EHR systems with the capabilities to support 14 of the Stage 2 Core Set objectives for meaningful use.
  • From 2010 (the earliest year that trend data are available) to 2013, physician adoption of EHRs able to support various Stage 2 meaningful use objectives increased significantly.

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Food and Drug Administration: Draft Guidance on Low-Risk General Wellness Products

The Food and Drug Administration (FDA) has published this draft guidance for its regulation of low-risk general wellness products.  Public comments may be submitted at any time but are encouraged by April 20, 2015.  Online comments may be submitted to the general federal government regulatory comment website, and referencing Docket No. FDA–2014–N–1039.

“General wellness products” are defined by the FDA as products that (1) are intended for only general wellness use, and (2) present a very low risk to users’ safety.  General wellness products may include exercise equipment, audio recordings, video games, software programs and other products that are commonly, though not exclusively, available from retail establishments (including online retailers and distributors that offer software to be directly downloaded).

For this draft guidance, a general wellness product has “(1) an intended use that relates to a maintaining or encouraging a general state of health or a healthy activity, or (2) an intended use claim that associates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition)”.

The first types of products include products that involve claims about sustaining or offering general improvement to conditions and functions associated with a general state of health that do not make any reference to diseases or conditions, such as weight management, physical fitness, relaxation or stress management, mental acuity, self-esteem, sleep management, or sexual function.

The second type of products promote, track, and/or encourage choice(s), which, as part of a healthy lifestyle, may help to reduce the risk of certain chronic diseases or conditions, or promote, track, and/or encourage choice(s) which, as part of a healthy lifestyle, may help living well with certain chronic diseases or conditions.   The claim that the healthy lifestyle choice(s) may play an important role in health outcomes should be generally accepted; such associations are typically described in peer-reviewed scientific publications.

The guidance separates out products that have some inherent risks, because they are invasive; involve an intervention or technology that may pose a risk to a user’s safety if device controls are not applied, such as risks from lasers, radiation exposure, or implants; raise novel questions of usability; or raise questions of biocompatibility.

In contrast, a mobile application that plays music to “soothe and relax” an individual and to “manage stress”; or a mobile application that monitors and records daily energy expenditure and cardiovascular workout activities to “allow awareness of one’s exercise activities to improve or maintain good cardiovascular health”; or a mobile application that monitors and records food consumption to “manage dietary activity for weight management and alert the user, healthcare provider, or family member of unhealthy dietary activity” are low-risk general wellness products that would not be subject to FDA regulation.

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Here is the request for public comments published in the Federal Register:

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Food and Drug Administration: Draft Guidance on Medical Device Accessories

The Food and Drug Administration has published a draft guidance for its regulation of medical device accessories.  Public comments may be submitted at any time but are encouraged by April 20, 2015. Online comments may be submitted to the general federal government regulatory comment website, and referencing Docket No. FDA–2015–D–0025.

Under the Federal Food, Drug, and Comestic Act, a  “device” means “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is….intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease… ”

The guidance defines a “parent device” as “a finished device whose performance is supported, supplemented, and/or augmented by one or more accessories” and defines a “device accessory” as “a device that is intended to support, supplement, and/or augment the performance of one or more parent devices”.

Instead of always classifying a device accessory the same way as its parent device, this draft guidance proposes that there be specific classifications for new types of devices that may have independent uses separate from their parent devices.  The FDA would then make a specific risk analysis about the safety and effectiveness of the new type of accessory device.  This proposal has specific implications for emerging health information technologies that are intended to have diagnostic or treatment functions.

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Here is the request for comments published in the Federal Register:

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Office of National Coordinator for Health Information Technology: $28 Million Available to Support Interoperability

After publishing its draft Shared Nationwide Interoperability Roadmap for public comment last week, the Office of National Coordinator for Health Information Technology has announced a new funding opportunity of $28 million for ten to twelve grants to states, territories, and state-designated entities to advance the standardized, secure, and interoperable movement of health information across organizations, vendors, and geographic boundaries.  While based on the 2009 Health Information Technology for Economic and Clinical Health (HITECH) Act state health information exchange program, this new funding opportunity intends to support the exchange of health information among a broader set of health care providers, including those that are not participating in the HITECH Act electronic health record Medicare and Medicaid  incentive programs (such as long term care programs).  Today’s announcement did not provide specifics for application or award timelines.

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Patient-Centered Primary Care Collaborative: The Patient-Centered Medical Home’s Impact on Cost and Quality

The Patient-Centered Primary Care Collaborative (PCPPC) has published its 2015 edition of its annual review of the evidence for improving quality and reducing costs through patient-centered medical homes.  This report’s evidence comes from 14 peer-reviewed articles, 7 state program evaluations, and 7 health care industry reports.  The specific evidence of quality improvement and cost reduction remains strong.  Six of the peer-reviewed articles reported cost reductions and all seven of the state program evaluations reported cost reductions on at least one metric.  11 of the 28 articles and reports found improvement in quality outcomes.

The report estimates that since 2009, the number of initiatives and patients served by patient-centered medical homes has quadrupled and the number of states implementing patient-centered medical home-based transformation has doubled.

The report also includes commentaries on integrating services outside a patient-centered medical home; provide additional financial support to primary care to help control the total cost of care; developing the primary care health professions workforce; engaging patients, consumers, and the public; and embracing the potential of technology to support patient-centered medical homes.

You need to register with an email address on the PCPCC website to download the report.

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Office of National Coordinator for Health Information Technology: Draft Shared Nationwide Interoperability Roadmap

The Office of National Coordinator for Health Information Technology (ONC) has released this draft Connecting Health and Care for the Nation: A Shared Nationwide Interoperability Roadmap for public comment.  The draft Roadmap builds on its vision paper, Connecting Health and Care for the Nation: A 10-Year Vision to Achieve an Interoperable Health IT Infrastructure, issued in June 2014.   The draft identifies the following core set of building blocks that are needed to achieve interoperability:

  1. Core technical standards and functions;
  2. Certification to support adoption and optimization of health IT products and services;
  3. Privacy and security protections for health information;
  4. Supportive business, clinical, cultural, and regulatory environments; and
  5. Rules of engagement and governance.

According to the draft Roadmap, as a first step, ONC will identify the best available technical standards for core interoperability functions, working through its Standards Committee.

Public comments on the draft may be submitted online to ONC by April 3, 2015.

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ONC also released an infographic that highlights the 3 year, 6 year, and 10 year goals in the draft roadmap.

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Office of National Coordinator for Health Information Technology: Vision and Draft Roadmap for Nationwide Interoperability

In June 2014, the Office of National Coordinator for Health Information Technology published this “vision” for nationwide interoperability of health information technology over the next ten years.  The vision paper is still very general (more “guiding principles”, with very broad 3-year, 6-year, and 10-year goals) and does not have the type of specificity of actions, priorities, and milestones called for in the March 2014 General Accountability Office (GAO) report, or the focus on supporting application program interfaces (APIs) called for in the April 2014 JASON report.  The “strategy” in the vision paper is still very general, described as “building blocks for a nationwide interoperable health information infrastructure”:

  • Core technical standards and functions
  • Certification to support adoption and optimization of health IT products and services
  • Privacy and security protections for health information
  • Supportive business, clinical, cultural, and regulatory environments
  • Rules of engagement and governance

Link to Original Source

At the October 2014 ONC Policy Committee, ONC staff presented on what will become a draft “Roadmap for Nationwide Interoperability”.   The initial ideas presented by ONC do contain the types of specific actions and milestones called for in the GAO report. The initial ideas do incorporate an AP-based strategy, but are more aligned with the joint ONC JASON task force recommendations than the JASON report recommendations.

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The Roadmap is expected to be published for public comment in January 2015, with finalization by March 2015.

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Office of National Coordinator for Health IT Policy and Standards Committees: Response to JASON Report

After the publication of the JASON report, the Policy Committee and the Standards Committee of the Office of National Coordinator for Health Information Technology convened a task force to respond to the report.  In October 2014, this joint task force published its response.  The task force fundamentally agreed with the JASON report that an application program interface (API)-based strategy for interoperability is needed, and that Meaningful Use Stage 3 requirements should have an increased focus on interoperability. However, the task force disagreed with the JASON report about the degree of progress that has currently been made towards interoperability, and highlighted policy, legal, governance, and business issues with adopting an API-based strategy. The task force also noted that the JASON report recommends a top-down regulatory approach (while failing to identify the regulatory authority to mandate such an approach), while the task force still supports a market demand approach (where the current market demand for interoperability is still weak).

The task force made specific recommendations to ONC and CMS to begin to implement a modified API-based strategy, working within existing committees and regulatory processes, including Meaningful Use Stage 3 requirements. The task force described this strategy as “coordinated architecture [i.e., the JASON report’s call for a national API-based strategy] that loosely couples market-based data sharing networks” (i.e, existing health information exchanges).

The specific recommendation that caught the most attention and discussion by the members of ONC Policy and Standards Committee was “the potential need for delay or staggering of MU Stage 3 incentives, to account for the time needed to standardize and then implement the Core Data Services of the Public API.”  After discussion, this wording was amended to recommend that “CMS and ONC should consider mechanisms to accommodate an accelerated process for a feasible initial public API specification.”

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