Updates by Reed Smith on U.S. legislative & regulatory developments affecting the health care industry
The HHS Office of the National Coordinator for Health Information Technology (ONC) has proposed changes to the ONC Health IT Certification Program that are intended to “further enhance the safety, reliability, transparency, and accountability of certified health IT for users.” Notably, the proposed rule would:
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CMS is allowing eligible professionals, eligible hospitals, and critical access hospitals to apply for Medicare Electronic Health Record (EHR) Incentive Program hardship exceptions until July 1, 2016 to avoid adjustments to their Medicare payments in 2017. The hardship exception application form is posted on the CMS website.
The Senate Health, Education, Labor and Pensions (HELP) Committee has announced its plans to consider companion legislation to the House-approved “21st Century Cures Act,” which is intended to improve the drug and device development processes and expedite patient access to medical treatments. The Senate currently plans three sessions to consider components of its biomedical innovation…
On December 31, 2015, CMS published a request for information (RFI) seeking public comments on certification requirements for health information technology (HIT), including electronic health records (EHR) products used for reporting under certain CMS quality reporting programs. The RFI also invites feedback on how often CMS should require recertification, the number of clinical quality measures…
On December 18, 2015, President Obama signed into law the Consolidated Appropriations Act of 2015, which includes a wide range of government spending and tax provisions. As previously reported, the Act includes the following Medicare and Medicaid provisions:
Continue Reading President Obama Signs Spending/Tax Deal with Medicare and ACA Provisions
The HHS Office of the National Coordinator for Health Information Technology (ONC) has published a notice correcting errors and clarifying provisions of its October 16, 2015 rule that finalized the 2015 edition health information technology certification criteria and a new 2015 Edition Base Electronic Health Record (EHR) definition.
On December 8, 2015, CMS is hosting a call to discuss how the 2016 Medicare Physician Fee Schedule final rule impacts Medicare quality reporting programs. Specifically, the call will address changes to the Physician Quality Reporting System, the Electronic Health Record Incentive Program, the Comprehensive Primary Care initiative, the Value-Based Payment Modifier, the Medicare Shared…
The Centers for Medicare & Medicaid Services (CMS) has published a sweeping final rule with comment period that specifies the requirements that eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) must meet in order to qualify for Medicare and Medicaid electronic health record (EHR) incentive payments and avoid downward payment adjustments under the Medicare EHR Incentive Program. Notably, the rule establishes the requirements for Stage 3 of the program as optional in 2017 and required for all participants beginning in 2018.
Continue Reading CMS Adopts Changes to Medicare & Medicaid EHR Policies
The HHS Office of the National Coordinator for Health Information Technology (ONC) has released its final “Roadmap” to promote the secure exchange and use of electronic health information. The document, “Connecting Health and Care for the Nation: A Shared Nationwide Interoperability Roadmap Version 1.0,” describes policy and technical actions needed to meet ONC’s “vision…
The HHS Office of Inspector General (OIG) recently released a “Policy Reminder” on how “information blocking” — defined by HHS as knowingly and unreasonably interfering with the exchange or use of electronic health information — may affect protection under the regulatory electronic health records (EHR) safe harbor to the federal anti-kickback statute (AKS).
Continue Reading HHS OIG “Reminder” about Information Blocking & the Federal Anti-Kickback Statute
CMS is hosting several calls and webcasts in September and October 2015 on various Medicare quality programs, including the following:
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On July 31, 2015, the Centers for Medicare & Medicaid Services (CMS) released a major final rule to update the Medicare acute hospital inpatient prospective payment system (IPPS) and the long-term care hospital prospective payment system (LTCH PPS) for fiscal year (FY) 2016. The official version of the rule will be published in the Federal Register on August 17, 2015, and generally applies to discharges occurring on or after October 1, 2015. With regard to the IPPS, CMS projects that the rate and policy changes in the final rule will increase IPPS operating payments by approximately 0.4%, or about $378 million in FY 2016. The rule provide a 0.9% operating payment rate update for hospitals that submit quality data and are meaningful users of Electronic Health Records (EHR). This update reflects a 2.4% market basket update, adjusted by a -0.5 percentage point multi-factor productivity (MFP) cut and an additional -0.2 percentage point cut (as mandated by the Affordable Care Act, or ACA), with an additional -0.8 percentage point documentation and coding recoupment adjustment required by the American Taxpayer Relief Act of 2012.
Continue Reading CMS Issues Final FY 2016 Medicare IPPS/LTCH Rule
The House of Representatives has taken action on a number of bills to modify certain Affordable Care Act (ACA) provisions, revise Medicare Advantage policies, and make other health policy changes.
On June 23, 2015, the House voted to approve H.R. 1190, a bill to repeal the Independent Payment Advisory Board (IPAB), by a vote of 244 to 154. The IPAB was established by the ACA to submit Medicare spending plans to Congress if projected spending growth exceeds specified targets. Under the ACA, future IPAB’s proposals would go into effect automatically unless Congress enacts alternative legislation achieving required savings levels. IPAB members have not been appointed, and the spending trigger for IPAB recommendations has not yet been reached. The Administration has expressed its opposition to the bill, noting that while the IPAB “is not projected to be needed now or for a number of years given recent exceptionally slow growth in health care costs, it could serve a valuable role should rapid growth in health costs return.”
This action follows House approval last week of H.R. 160, a bill to repeal the ACA medical device tax, applicable to sales in calendar quarters beginning after the date of enactment. The Administration also opposes enactment of this legislation on grounds that it would increase the deficit. In other action, the House also approved the following health policy bills last week:Continue Reading House Passes Bills to Repeal ACA Medical Device Tax and IPAB, Revise Medicare Advantage Policy
The HHS OIG has updated its FY 2015 Work Plan to reflect new and/or completed items since release of its Work Plan in October 2014. Of note, the OIG has announced its plans to conduct several new Medicare reviews addressing: intensity-modulated radiation therapy; hospital preparedness and response to high-risk infectious diseases; access to DME in…
A number of Congressional panels have held hearings this month on health policy issues, including the following:
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On April 30, 2015, the Centers for Medicare & Medicaid Services (CMS) is publishing its proposed rule to update the Medicare acute hospital inpatient prospective payment system (IPPS) and long-term care hospital (LTCH) prospective payment system (PPS) for fiscal year (FY) 2016. CMS will accept comments on the proposed rule until June 16, 2015. The final rule will be published by August 1, 2015, and generally will apply to discharges occurring on or after October 1, 2015.
With regard to the IPPS, CMS projects that the rate and policy changes in the proposed rule would increase IPPS operating payments by approximately 0.3%, or about $120 million in FY 2016. The proposed rule would provide for a 1.1% operating payment rate update for hospitals that submit quality data and are meaningful users of Electronic Health Records (EHR). This update reflects a 2.7% market basket update, adjusted by a -0.6 percentage point multi-factor productivity (MFP) cut and an additional -0.2 percentage point cut (as mandated by the Affordable Care Act, or ACA), with an additional -0.8 percentage point documentation and coding recoupment adjustment required by the American Taxpayer Relief Act of 2012.Continue Reading CMS Issues Proposed Rule to Update FY 2016 IPPS, LTCH PPS Rates, Policies
The Office of the National Coordinator for Health Information Technology (ONC) has released a revised Guide to Privacy and Security of Electronic Health Information. The guide is intended to help health care providers – especially those from smaller organizations – address federal health information privacy and security requirements in their practices. The new version…
CMS published a proposed rule on April 15, 2015 that would modify the Medicare and Medicaid Electronic Health Record (EHR) Incentive program to reduce complexity, simplify reporting requirements, and align Stage 1 and Stage 2 objectives and measures with Stage 3. Notably, CMS proposes to change the Medicare and Medicaid EHR Incentive Program reporting period…
On March 30, 2015, the Centers for Medicare & Medicaid Services (CMS) published its proposed rule on Stage 3 meaningful use criteria, which focus on the advanced use of Electronic Health Record (EHR) technology to promote improved outcomes for patients. The proposed rule would establish the requirements that eligible professionals (EPs), eligible hospitals, and critical …
The OIG has released its March 2015 “Compendium of Unimplemented Recommendations,” which highlights the OIG’s top 25 recommendations for cost savings and/or quality improvements in HHS programs, along with other significant unimplemented recommendations. High-priority recommendations address the following areas, among others:
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