President Obama Signs Bill Expanding Meaningful Hardship Exemption Authority
Key Takeaway: Meaningful Use program participants will now have additional pathways to seek a hardship exemption for the 2015 program year resulting from the law signed by President Obama on December 28, 2015.
Why It Matters: One of Congress’ final acts before adjourning for 2015 was the passage of the Patient Access and Medicare Protection Act (S. 2425), which included narrowly-focused language to expand the authority of the Centers for Medicare and Medicaid Services (CMS) to issue hardship exemptions for the 2015 program year.
The legislation enables CMS to grant hardships not just on a case-by-case basis, but also to "categories" with the deadline of March 15, 2016, for eligible professionals (EP) and April 1, 2016, for eligible hospitals (EH), after which time CMS would still have the case-by-case authority to grant hardship exemptions until July 1, 2016.
CMS has not yet released the hardship exemption applications for the 2015 program year for EPs or EHs. CHIME staff will continue to work with CMS to disseminate resources and information concerning 2015 program year attestation and hardship exemptions as it becomes available.
Agency Seeks Input on Quality Reporting and CEHRT
Key Takeaway: CMS publishes RFI seeking feedback on quality reporting and CEHRT; CHIME schedules workgroup calls
Why it Matters: CMS recently released a Request for Information (RFI) seeking input on quality measure reporting and certified EHRs. Comments are due to the agency by February 1. The RFI focuses on numerous quality reporting programs including, but not limited to, the Hospital Inpatient Quality Reporting (IQR) Program and the Physician Quality Reporting System (PQRS). CMS is also seeking input on how often to require recertification, the number of clinical quality measures (CQMs) a certified Health IT Module should be required to certify to, and testing of certified Health IT Module(s).
Medical Devices and Cybersecurity Take Center Stage at FDA Workshop
Key Takeaway: FDA posts agenda for event on devices, cybersecurity
Why it Matters: The workshop, “Moving Forward: Collaborative Approaches to Medical Device Cybersecurity,” will span two days, January 20-21. The workshop will bring together diverse stakeholders to discuss complex challenges in medical device cybersecurity. The meeting will be held at the FDA campus in Silver Spring, MD, and will be webcast.
Office for Civil Rights Issues New HIPAA Guidance
Key Takeaway: The guidance addresses patient access to their protected health information (PHI)
Why it Matters: In an era of growing consumer and patient engagement, patient access to information is taking center stage. The Office for Civil Rights (OCR) released new guidance on the Health Insurance Portability and Accountability Act (HIPAA) requirements late last week. The guidance takes aim at clarifying patients’ rights to accessing their information under the law and associated rules. OCR posted a short blog detailing why they published this information noting, “Far too often individuals face obstacles to accessing their health information, even from entities required to comply with the HIPAA Privacy Rule. This must change.” They also indicated that this is just the first in a series of new guidance they plan on releasing. Specifically, the newly published guidance details general patient rights to accessing their information both on paper and electronically, processes for requesting access, form and format data must be shared, denial of access, denying access to patient information, timelines for providing access, as well as, a series of frequently asked questions associated with these topics.
Executive Order on Gun Violence Impacts HIPAA
Key Takeaway: HHS releases HIPAA rule on national background checks and White House releases executive action on gun violence
Why it Matters: HHS last week published a final rule modifying HIPAA to expressly permit certain covered entities to disclose to the National Instant Criminal Background Check System (NICS) the identities of individuals who are subject to a federal “mental health prohibitor” that disqualifies them from shipping, transporting, possessing, or receiving a firearm. Only covered entities with lawful authority to make the adjudications or commitment or that serve as repositories of information for NICS reporting purposes, are permitted to disclose the information needed for these purposes. The disclosure is restricted to limited demographic and certain other information needed for NICS purposes. The rule specifically prohibits the disclosure of diagnostic or clinical information, from medical records or other sources, and any mental health information beyond the indication that the individual is subject to the Federal mental health prohibitor.
The White House released a fact sheet shortly after the New Year on new executive actions to stem gun violence. “The Administration is proposing a new $500 million investment to increase access to mental health care. The Social Security Administration has indicated that it will begin the rulemaking process to include information in the background check system about beneficiaries who are prohibited from possessing a firearm for mental health reasons. The Department of Health and Human Services is finalizing a rule to remove unnecessary legal barriers preventing States from reporting relevant information about people prohibited from possessing a gun for specific mental health reasons,” according to the White House statement.
Important Meaningful Use Dates Looming
Key Takeaway: Key Meaningful Use and Quality Reporting dates
Why it Matters: There are a lot of important reporting deadlines approaching, we’ve listed many below so that you can stay on top the requirements.
- Attestation for 2015 Reporting Year: Attestation is open January 4 through February 29, for all eligible providers. For information about batch uploading go here.
- Reconsiderations: The deadline for eligible professionals to submit reconsideration forms for the 2016 payment adjustment, based on the 2014 EHR reporting period, is February 29, as is the deadline for CAHs to submit hardship applications for the 2015 payment adjustment, based on the 2015 EHR reporting period. For more info go here.
- Hardships: As noted above, Congress expanded CMS’ authority to grant hardship exemptions in a bulk or blanket fashion to those EPs that apply before March 15 and EHs before April 1, under “unforeseen circumstances.” CMS can still grant on a case-by-case basis until July 1. CHIME will share information on the hardship application as CMS makes it available.
2015 PQRS data submission timeframes:
- EHR Direct or Data Submission Vendor (QRDA I or III) - 1/1/16 - 2/29/16
- Qualified clinical data registries (QCDRs) (QRDA III) - 1/1/16 - 2/29/16
- Group practice reporting option (GPRO) Web Interface - 1/18/16 - 3/11/16
- Qualified registries (Registry XML) - 1/1/16 - 3/31/16
- QCDRs (QCDR XML) - 1/1/16 - 3/31/16
Self-Nomination for 2016 Qualified Registries and Qualified Clinical Data Registries (QCDRs)
Entities interested in becoming a PQRS qualified registry or QCDR for 2016 must submit a self-nomination to CMS. Self-nominations must be submitted electronically using a self-nomination form on JIRA prior to the 5:00 p.m. Eastern Time (ET) on January 31, 2016.
Regulators Bring Stakeholders Together Around Privacy
Key Takeaway: Federal Trade Commission event will look at new developments on the privacy front.
Why it Matters: The Federal Trade Commission will hold a conference on January 14, to bring together a diverse group of stakeholders, including whitehat researchers, academics, industry representatives, consumer advocates, and government regulators, to discuss the latest research and trends related to consumer privacy and data security. The FTC called for research to be presented at the conference. As consumers become more engaged with their health care, the proliferation of devices that engage patients with their health, and the requirement under Meaningful Use Stage 3 that mandates providers accept patient-generated data, the concerns around consumer privacy will mount. The event will be webcast for those unable to attend in person.
The agency also recently released a new report on big data – “Big Data: A Tool for Inclusion or Exclusion? Understanding the Issues.” The report stems from a 2014 workshop on the topic. “Big data can produce tremendous benefits for society, such as advances in medicine, education, health, and transportation, and in many instances, without using consumers’ personally identifiable information,” the agency noted. “Big data will continue to grow in importance, and it is undoubtedly improving the lives of underserved communities in areas such as education, health, local and state services, and employment. Our collective challenge is to make sure that big data analytics continue to provide benefits and opportunities to consumers while adhering to core consumer protection values and principles. For its part, the Commission will continue to monitor areas where big data practices could violate existing laws, including the FTC Act, the FCRA, and ECOA, and will bring enforcement actions where appropriate.”