Finance Committee Invites Comments on Health Care Data Transparency

Senate Finance Committee Chairman Ron Wyden and Ranking Member Chuck Grassley are asking providers, patients, insurers, entrepreneurs, and other stakeholders for ideas on ways to improve the availability and utility of health care data, while protecting patient privacy. In particular, the Senators are requesting information on: the data sources that should be made more broadly available; the form such data should be conveyed; ways to reduce the unnecessary fragmentation of health care data; and reforms to overcome barriers that stand in the way of effective use of existing data sources. Comments will be accepted until August 12, 2014.

Congressional Hearings Examine Medicare Fraud, ACA, Digital Health, MedPAC Report, Brain Injuries

Recent Congressional hearings on health policy issues include the following:

Congressional Hearings this Week to Focus on Medicare Fraud, Telehealth

On Wednesday, April 30, 2014, the House Ways and Means Committee will focus on “Ideas to Improve Medicare Oversight to Reduce Waste, Fraud and Abuse." On May 1, the House Energy and Commerce Health Subcommittee is holding a hearing on “Telehealth to Digital Medicine: How 21st Century Technology Can Benefit Patients."

ONC Proposes Updated Electronic Health Record (EHR) Certification Criteria for 2015

The Office of the National Coordinator for Health Information Technology (ONC) is seeking comments on revisions to health information technology certification regulations for 2015. CMS is updating these criteria more frequently to provide more incremental regulatory changes, give stakeholders earlier information and greater opportunity for input, and respond more quickly to newer industry standards to enhance interoperability. ONC observes that its previous two to three-year regulatory cycle was “sub-optimal” because it “created cycles of significant peaks and valleys from a health IT development standpoint; resulted in missed opportunities to improve interoperability and programmatic alignment because of mismatched regulatory and standards balloting cycle timelines; and adversely affected EHR technology developers’ ability to strategically plan their development and product rollout processes due to uncertain regulatory timelines.” The proposed rule provides that the 2015 Edition EHR certification criteria would be voluntary; providers would not need to adopt this edition, and no EHR technology developer who has certified its EHR technology to the 2014 Edition would need to recertify to the 2015 Edition for users to participate in the Medicare and Medicaid EHR Incentive Programs. The proposed rule also includes revisions to the ONC HIT Certification Program intended to improve regulatory clarity, simplify certification of EHR Modules not used for achieving meaningful use; and discontinue the use of the “Complete EHR” certification concept. ONC will accept comments on proposed rule until April 28, 2014.

CMS Posts Final HIPAA Administrative Simplification Transaction Testing Checklists

CMS has released additional tools to help health plans, vendors, and providers prepare to demonstrate that they are compliant with Administrative Simplification Transaction Testing standards and operating rules and that they have completed end-to-end testing with their trading partners. Specifically, CMS has released payer, large provider, small provider, vendor-to-provider, and vendor-to-payer checklists to assist these segments as they perform multiple levels of testing, including end-to-end testing.

Omnibus Government Spending Signed to Fund HHS, Other Departments

President Obama has signed into law the Consolidated Appropriations Act of 2014, which provides $1.012 trillion in discretionary funding for the operations of the federal government through September 30, 2014. In addition to setting overall funding levels for HHS agencies, the law specifies funding for numerous HHS policies and initiatives, such as additional funding for program integrity effort involving the 340B drug pricing program and research on the impact of health information technology on patient safety, and reduced funding for the IPAB and certain other ACA activities. The agreement also includes directives for HHS to improve fraud and abuse efforts, including using the latest technology to ensure only valid beneficiaries and valid providers receive benefits (although on the other hand, the agreement raises concerns that the Recovery Audit Contractor program includes incentives “to take overly aggressive actions”). In addition, the agreement highlights more Congressional interest in more narrow HHS policies, such as objections to the criteria CMS uses to package drug costs under the hospital outpatient prospective payment system, and concerns that rural patients maintain access to needed health services if CMS proceeds with a proposal to remove critical access hospital status from certain facilities.

OIG Concludes OCR Slow to Enforce HIPAA Security Rule and Comply with Cybersecurity Requirements

The OIG has concluded that the HHS Office for Civil Rights (OCR) is not adequately overseeing and enforcing the HIPAA Security Rule. In short, the OIG found that OCR failed to provide for periodic audits, as mandated by HITECH, to ensure that covered entities were in compliance with the Security Rule, and instead continued to follow the complaint-driven approach to assess Security Rule compliance. OCR also failed to consistently follow its investigation procedures and maintain documentation needed to support key decisions made during investigations conducted in response to reported violations of the Security Rule. The report findings and recommendations are discussed in a posting on our Life Sciences Legal Update blog.

Congressional Hearings Focus on HealthCare.gov Enrollment, Other Policy Issues

Congressional committees continue to focus on the experience of consumers and insurers since the HealthCare.gov insurance portal launched on October 1, along with potential issues related to the security of personal data transmitted through the site. For instance, House hearings this week include an Oversight and Government Reform Committee hearing on “ObamaCare Implementation: The Rollout of HealthCare.gov”; a Homeland Security Committee on “Cyber Side-Effects: How Secure is the Personal Information Entered into the Flawed Healthcare.gov?"; and an Energy and Commerce Committee hearing titled “Obamacare Implementation Problems: More than Just a Broken Website.” Next week, the Energy and Commerce Committee also will examine the security of the HealthCare.gov site

In other policy areas, on November 14, the House Small Business Committee is holding a hearing on “Self-Insurance and Health Benefits: An Affordable Option for Small Business.”  On November 15, the Energy and Commerce Subcommittee on Health will review the FDA’s implementation of the Food and Drug Administration Safety and Innovation Act, and on November 19 the panel will focus on federal regulation of mobile medical apps and other health software. 

Congressional Health Policy Hearings

Recent Congressional hearings on health policy issues include the following:

  • A House Energy and Commerce Health Subcommittee a hearing entitled “PPACA Pulse Check: Part 2,” focusing on ACA readiness and implementation issues (Part 1 of the hearing was on August 1, 2013). 
  • A House Homeland Security Cybersecurity Subcommittee hearing on “The Threat to Americans’ Personal Information: A Look into the Security and Reliability of the Health Exchange Data Hub.”
  • A Senate Health, Education, Labor and Pensions Committee hearing on the “Dental Crisis in America: The Need to Address Cost.” 

July Health Policy Hearings

Recent Congressional hearings have addressed the following health policy issues:

Health Policy Hearings

A number of recent Congressional hearings have focused on health policy issues, including the following:

CMS Call on Medicare and Medicaid EHR Incentive Programs and Certified EHR Technology (June 27)

On a June 27, 2013 call, CMS and the Office of the National Coordinator for Health Information Technology (ONC) will provide an overview of the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs, including the use of certified EHR technology to meet meaningful use.

HHS Update on HIT Activities

CMS and ONC have posted a fact sheet that details progress HHS has made in promoting the growth of health information technology since the enactment of the Health Information Technology for Economic and Clinical Health (HITECH). The fact sheet addresses, among other things, statistics on participation in the Electronic Health Record Incentive Programs and electronic prescribing and information on HHS plans to accelerate health information exchange development.

CMS Meeting on Billing and Coding with Electronic Health Records (May 3)

On May 3, 2013, CMS and the Office of the National Coordinator for Health Information Technology (ONC) are hosting a meeting to discuss electronic health records, the increase in code levels billed for some Medicare services, and appropriate coding in an increasingly-electronic environment. The meeting, which is aimed at providers, health information technology vendors, and other interested stakeholders, will address issues such as the impact of EHRs on high quality clinical care, provider efficiency and coding, and coding challenges and opportunities facing various groups, including hospitals and clinicians. Attendees may participate in person, via telephone, or web streaming.  Registration is required.

Congressional Health Policy Hearings

Recent Congressional hearings have addressed a number of health policy issues. For instance, the House Energy and Commerce Committee held a series of hearings on health information technologies, covering the Administration’s perspectives on innovation and regulation (including a discussion of the Administration’s policies on regulation of mobile medical apps), how innovation benefits patients, and “harnessing wireless innovation.” http://energycommerce.house.gov/press-release/three-day-hearing-series-produces-much-needed-certainty-patients-providers-and-innovators. Separately, a Health Subcommittee hearing focused on Medicare and Medicaid entitlement reform. In addition, the Senate Finance Committee held a hearing on health care delivery reform, focusing on the Center for Medicare and Medicaid Innovation efforts. 

HHS Invites Comments on Advancing Interoperability and Health Information Exchange

CMS and the Office of the National Coordinator for Health Information Technology (ONC) are seeking comments on a series of potential policies intended to accelerate electronic health information exchange (HIE) across providers. The notice identifies various gaps that the policies and programs are intended to address, such as low rates of electronic health record (EHR) adoption and HIE among post-acute and long-term care providers; low rates of EHR adoption and HIE across settings of care and providers (including ambulatory care, post-acute and long-term care, behavioral health, and lab providers); and low rates of consumer and patient engagement. The notice also includes specific questions for stakeholders, such as what changes in payment policy would have the most impact on the electronic exchange of health information (particularly among organizations that are market competitors); how policies should be developed to maximize the impact on care coordination and quality improvement; how CMS can leverage regulatory requirements for acceptable quality (such as conditions of participation for hospitals or requirements for skilled nursing facilities (SNFs) and home health) to support electronic, interoperable HIE; and how new authorities under the ACA for testing innovative payment and service delivery models can best accelerate standards- based electronic HIE across treating providers. Comments will be accepted until April 22, 2013. 

CMS Announces 90-Day Enforcement Discretion Period for HIPAA Eligibility & Claim Status Operating Rules

On January 2, 2013, CMS announced a 90-day “enforcement discretion period” with respect to operating rules mandated by the ACA for two transactions: eligibility for a health plan and health care claim status. Specifically, the CMS Office of E-Health Standards and Services (OESS) will not initiate enforcement action until March 31, 2013, with respect to HIPAA-covered entities (including health plans, health care providers, and clearinghouses, as applicable) that are not in compliance with the two operating rules published July 8, 2011. Notwithstanding OESS’s discretionary application of its enforcement authority, CMS emphasizes that the compliance date for using the operating rules remains January 1, 2013. Applicable HIPAA-covered entities that are ready to conduct transactions using the adopted operating rules should do so, and all applicable covered entities are encouraged to “expeditiously become compliant.” Moreover, while enforcement action will not be taken, OESS will accept complaints regarding compliance with the rules beginning January 1, 2013 and, if requested by OESS, covered entities that are the subject of complaints must produce evidence of either compliance or a good faith effort to become compliant during the 90-day period. 

ONC Seeks Comments on Health IT Patient Safety Action and Surveillance Plan

The HHS Office of the National Coordinator for Health Information Technology (ONC) is seeking comments on its draft “Health IT Patient Safety Action and Surveillance Plan,” a blueprint for using health information technology (IT) to make care safer and to continuously improve the safety of health IT. The draft plan offers a list of actions in three broad strategic areas: increasing the quantity and quality of data and knowledge about health IT safety; targeting resources and corrective actions to improve health IT safety and patient safety; and promote a culture of safety related to health IT. The plan, which addresses recommendations made in the 2011 Institute of Medicine Report, “Health IT and Patient Safety: Building Safer Systems for Better Care,” emphasizes shared responsibly among the government, industry, clinicians, patients, accrediting bodies, health IT developers, and other parties. Comments on the plan will be accepted until February 4, 2013.

CMS Call on Meaningful Use Stage 1 & 2 (Jan. 16)

CMS is hosting a national provider call on January 16, 2013 on Meaningful Use requirements under the Medicare and Medicaid Electronic Health Record Incentive Programs. The target audience is hospitals, critical access hospitals, and professionals eligible for incentives. Registration is required. 

OIG Highlights Vulnerabilities in CMS Oversight of the Medicare EHR Incentive Program

The Medicare electronic health record (EHR) incentive program is vulnerable to paying incentives to professionals and hospitals that do not fully meet meaningful use requirements due to gaps in CMS oversight, according to a recent OIG report. Based on a review of CMS’s oversight of self-reported meaningful use of certified EHR technology in 2011, the OIG found that CMS did not have strong prepayment or postpayment safeguards. The OIG also noted that CMS cannot use EHR reports to verify all self-reported meaningful use information because the Office of the National Coordinator for Health Information Technology (ONC) does not require certified EHR technology to be capable of producing reports for all measures. As a result of these findings, the OIG recommends that CMS: (1) obtain and review supporting documentation from selected professionals and hospitals prior to payment to verify self-reported information (although CMS argued that this would increase the burden on providers); and (2) issue more detailed guidance on documentation requirements (CMS agreed). The report also contained recommendations for ONC, including recommendations that the agency: (1) require that certified EHR technology be capable of producing reports for yes/no meaningful use measures where possible; and (2) improve the certification process for EHR technology to ensure accurate EHR reports (ONC concurred with both recommendations). For more information, see the full report, “Early Assessment Finds That CMS Faces Obstacles in Overseeing the Medicare EHR Incentive Program."

Older Entries

December 19, 2012 — GAO Examines Characteristics of Providers Receiving Medicaid EHR Incentive Payments

December 17, 2012 — Interim Rule Revises EHR Certification Criteria, Incentive Program Specifications

December 14, 2012 — PQRS and eRx Incentive Program National Provider Call (Dec. 18)

December 3, 2012 — OCR Issues Guidance on De-identifying Protected Health Information

November 29, 2012 — ONC Invites Comments on Stage 3 Meaningful Use Policy

November 12, 2012 — November Congressional Health Policy Hearings

October 31, 2012 — CMS Posts Specifications for Electronic Clinical Quality Measures (eCQMs)

October 16, 2012 — GAO Flags Concerns about Implantable Medical Device Information Security

September 6, 2012 — CMS Issues Final "Stage 2" Medicare/Medicaid Electronic Health Record (EHR) Incentive Program Rules, EHR Certification Standards

September 5, 2012 — HHS Adopts Unique Health Plan Identifier, Delays Implementation Date for ICD-10

September 5, 2012 — CMS Call: Stage 2 Requirements for the Medicare/Medicaid EHR Incentive Programs (Sept. 13)

August 16, 2012 — HHS Publishes Operating Rules for Health Care Electronic Funds Transfers (EFT) and Remittance Advice Transactions

July 19, 2012 — HIPAA Electronic Funds Transfer, Remittance Advance Standards

June 27, 2012 — Health IT Pilot Targets Prescription Drug Abuse

June 22, 2012 — CMS/ONC Call: Using Certified EHR Technology to Meet Meaningful Use (June 27)

June 18, 2012 — Version 5010 Enforcement Discretion Period Ends June 30, 2012

June 18, 2012 — CMS Launches New Data/Analytics Office

May 31, 2012 — ONC Invites Comments on Nationwide Health Information Network Governance

May 31, 2012 — CMS Releases Data on Medicare EHR Incentive Program Payment Recipients

May 29, 2012 — CMS Call on Medicare & Medicaid EHR Incentive Programs (June 7)

May 10, 2012 — New ONC Health IT Resources

April 23, 2012 — HHS Proposes Unique Health Plan Identifier, Delays Compliance Date for ICD-10

April 23, 2012 — Patient Safety Events: Common Formats for Reporting, Reporting Challenge Announced

April 23, 2012 — CMS Invites Feedback on Proposed 2014 Clinical Quality Measures

April 19, 2012 — Safeguarding Health Information: Building Assurance through HIPAA Security Conference (June 6 & 7)

March 26, 2012 — CMS Call on Medicare & Medicaid EHR Incentive Program Basics (March 29)

March 14, 2012 — Medicare Claims Must Use Version 5010 Format By April 1, 2012

March 10, 2012 — CMS Calls on Stage 2 Requirements for the Medicare and Medicaid EHR Incentive Programs (March 12 & 27)

February 28, 2012 — Stage 2 Electronic Health Record (EHR) Meaningful Use Proposed Rules Released

February 22, 2012 — Mobile Devices Roundtable: Safeguarding Health Information (March 16)

February 13, 2012 — HHS Health IT Challenge Targets Post-Discharge Care

February 8, 2012 — CMS Call: Medicare FFS Implementation of HIPAA Version 5010 and D.0 Transaction Standards (Feb. 16)

January 25, 2012 — HHS Rule on Adoption of Standards for Health Care Electronic Funds Transfers

November 29, 2011 — CMS Announces "Enforcement Discretion Period" for HIPAA Transaction Standards

November 29, 2011 — Revisions to Accreditor Process Under HIT Certification Program

November 14, 2011 — CMS Resources on Transitions to HIPAA 5010 Transaction Standards/ICD-10

September 29, 2011 — HHS Launches "Safe Transitions from Hospital to Home" Software Challenge

September 29, 2011 — Final Federal Health IT Strategic Plan

September 27, 2011 — CMS/ONC Care Innovations Summit (Jan. 26, 2012)

September 1, 2011 — CMS Issues Final Medicare E-Prescribing Incentive Program Rule

August 29, 2011 — CMS Call: EHR Incentive Programs Registration and Attestation for Eligible Professionals (Sept. 9)

August 16, 2011 — HHS ONC Seeks Comments on Health IT Metadata Standards

June 13, 2011 — June Congressional Hearings on Health Policy Issues

May 31, 2011 — Proposed Revisions to HIT Certification Program

May 31, 2011 — Congressional Hearings on Health Policy Issues

May 31, 2011 — OIG Reports on the Security of Electronic Patient Health Information

April 27, 2011 — HHS Extends Comment Deadline on Federal Health IT Strategic Plan to May 6, 2011

April 13, 2011 — Medicare EHR Attestation Begins April 18, 2011

March 29, 2011 — HHS ONC Seeks Comments on Federal Health IT Strategic Plan

March 7, 2011 — Inconsistencies in Electronic Prescribing Incentive Programs

February 14, 2011 — CMS Call on Eligible Professional Registration for the Medicaid EHR Incentive Program (Feb. 18).

January 28, 2011 — HIT Extension Program Revisions

January 27, 2011 — February 2011 HHS HIT Panel Meetings

January 13, 2011 — Final Rule Establishes Electronic Health Record (EHR) Certification Programs

December 29, 2010 — HHS Semiannual Regulatory Agenda for FY 2011

December 29, 2010 — Electronic Health Record (EHR) Incentives Program Registration Opens Jan. 3, 2011

December 15, 2010 — HHS Announces Health Promotion/Disease Prevention Agenda

December 14, 2010 — HHS Seeks Comments on HIT Report

December 13, 2010 — HIT Quality Measures Workgroup Comment Opportunity

November 16, 2010 — Federal Funding, Guidance for Medicaid Eligibility Determination/Enrollment, HIT Activities

November 15, 2010 — ONC Conference on Personal Health Records

October 29, 2010 — Common Formats for Patient Safety Data Collection/Event Reporting

October 29, 2010 — NCI Seeks Information on Evidence-Based Informatics Resources

October 29, 2010 — ONC Governance Workgroup/Governance of Nationwide Health Information Network

October 27, 2010 — ONC Seeks Comments on Authentication of Provider Organizations (Due Oct. 29)

October 25, 2010 — HHS Meeting on HITECH Act Psychotherapy Notes/Testing Data Study (Nov. 18)

October 15, 2010 — HHS Issues Clarifications to Health IT Rules

September 30, 2010 — Congressional Hearings

September 30, 2010 — ONC Conference on Personal Health Records (Dec. 3, 2010)

August 31, 2010 — CMS Guidance on Federal Funding for Medicaid HIT Activities

August 31, 2010 — Office of the National Coordinator (ONC) Holds Informational Sessions on Meaningful Use

August 13, 2010 — Final Health Information Breach Notification Rule Withdrawn from OMB

August 13, 2010 — ONC Temporary Certification Program Test Tools and Test Procedures

July 29, 2010 — Medicare and Medicaid Electronic Health Record Incentive Program, Initial Standards Rules Finalized

July 29, 2010 — CMS Calls on Medicare/Medicaid EHR Incentive Programs (Aug. 10 - 12, 2010)

July 29, 2010 — Congressional Health Policy Hearings

July 28, 2010 — Meaningful Use Workgroup Public Hearings (July 29 & August 5, 2010)

July 21, 2010 — Upcoming House Energy and Commerce Hearing on HITECH Act (July 27)

July 20, 2010 — CMS Educational Call on HIT Certification, Medicare/Medicaid EHR Incentive Rules (July 22)

July 14, 2010 — Ways & Means Hearing on Incentives for Meaningful Use of Electronic Health Records (July 20)

July 12, 2010 — Temporary Certification Rule for Electronic Health Records Technology Finalized

July 12, 2010 — CMS Rule on E-Prescribing and the Medicare Prescription Drug Program

June 8, 2010 — Advance Primary Care (Medical Home) Demonstration

June 5, 2010 — CMS Call on "ICD-10 Implementation in a 5010 Environment" (June 15)

April 30, 2010 — HHS Semiannual Regulatory Agenda

April 29, 2010 — April 2010 Congressional Hearings

April 16, 2010 — New Law Extends Physician Fee Schedule Fix Through May

April 16, 2010 — HIT Policy Committee to Meet April 21

March 30, 2010 — HHS Conference on HIPAA Security

March 17, 2010 — House Approves Additional Short-Term Extension of Medicare Physician Fee Schedule Fix/Therapy Cap Exception Process

March 11, 2010 — ONC Issues Proposed Rule Establishing Health Information Technology Certification Programs

February 26, 2010 — Entities Reporting Breaches of Protected Health Information

February 26, 2010 — GAO Report on Electronic Personal Health Information Exchange

February 22, 2010 — CMS Teleconference on Medicare and Medicaid EHR Incentives (Feb. 23)

January 26, 2010 — HHS Resources on State Health IT Laws

January 13, 2010 — HIT Rules Released: HIT Standards and Definition of "Meaningful Use" and Criteria for Electronic Health Record Incentive Program

December 21, 2009 — Use of Technology by Laboratories a Focus of Meaningful Use for Ambulatory Providers

December 21, 2009 — HIT Meaningful Use Workgroup Approximates 2010 Timeline

December 4, 2009 — House Passes Small Business Health IT Financing Bill

December 4, 2009 — Restructuring of the Office of the National Coordinator for HIT