The AHA Reports Economic Benefits Associated with Increased Hospital Consolidation

The American Hospital Association (“AHA”) recently released a report that concludes that hospital acquisitions result in better care for patients at lowers costs. The study described in the report consisted of structured interviews with the leaders of about 20 hospital systems and an econometric analysis of hospital acquisitions. Continue Reading

INFORMATION BLOCKING AND THE RIGHT TO ACCESS INITIATIVE: Why Patients Struggle to Obtain their Medical Records and what the Office of Civil Rights Intends to Do About It

Access to healthcare information (or lack thereof) has always been touted as one of the key factors/necessities to realizing the promise of technology in the delivery of healthcare. Despite various legislative, judicial, patient and industry initiatives, access continues to be a challenge due to a variety of competitive practices and lack of capabilities. Consider the following events and whether they signal real progress:

  1. In a September 9, 2019 Press Release issued by the United States Department of Health & Human Services – Office of Civil Rights (“OCR”), the OCR announced that it had taken action against Bayfront Health St. Petersburg (“Bayfront”), an academic medical center in St. Petersburg, Florida, to enforce the Health Insurance Portability and Accountability Act (“HIPAA”) protections that guarantee every patient the right to receive copies of his/her medical records promptly and without being overcharged. The enforcement action against Bayfront (which includes the assessment of an $85,000 fine against Bayfront and the imposition of a “Resolution Agreement” between OCR and Bayfront) is notable as the OCR’s first enforcement action under the OCR’s “Right of Access Initiative” – a program designed to focus OCR resources on the enforcement of HIPAA’s right of access guarantees.
  2. On February 11, 2019, two offices of the US Department of Health and Human Services (“HHS”) — the Office of the National Coordinator for Health Information Technology (“ONC”) and the Centers for Medicare and Medicaid Services (“CMS”) – each released a proposed rule (ONC Proposed Rule; CMS Proposed Rule) (collectively, the “Proposed Rules”) aimed at enhancing the interoperability of electronic health record (“EHR”) systems and increasing patient access to electronic health information (“EHI”) as required by the 21st Century Cures Act.
  3. On September 23, 2019, seven major healthcare leadership groups, including the American Health Information Management Association (“AHIMA”) and the American Medical Association (AMA), sent a letter to Congress (the “AHIMA Letter”) critiquing the ONC Proposed Rule.

What is the link between the Bayfront case, the Proposed Rules, and the AHIMA letter? The link is commonly referred to as “Information Blocking.” Continue Reading

CMS and OIG Propose Regulatory Changes Impacting the Scope of the Stark Law and the Federal Health Care Program Anti-Kickback Statute

On October 9, 2019, the Department of Health and Human Services (“HHS”) Centers for Medicare and Medicaid Services (“CMS”) and Office of Inspector General (“OIG”) released proposed rules in conjunction with HHS’ “Regulatory Sprint to Coordinated Care.” The Regulatory Sprint to Coordinated Care “aims to remove potential regulatory barriers to care coordination and value-based care created by four key Federal health care laws and associated regulations: (1) the physician self-referral law [(“Stark Law”)]; (2) the anti-kickback statute [(“AKS”)]; the Health Insurance Portability and Accountability Act of 1996 [(“HIPAA”)]; and (4) the rules… related to opioid and substance use disorder treatment.” Continue Reading

California Expands Medicaid Telehealth Policy

The California Department of Health Care Services (“DHCS”) recently revised its Medi-Cal telehealth policy to allow providers increased flexibility in their use of telehealth as a modality for delivering medically necessary services to their patients. The policy is retroactively effective as of July 1, 2019, and fee-for-service providers must submit claims for services provided via telehealth according to the new policy. Updates to the telehealth policy include the following: Continue Reading

OIG to Audit Provision of Behavioral Health Services Through Tele-Health Under Medicaid Managed Care

In its recently updated Work Plan, the Office of the Inspector General (“OIG”) at the Department of Health & Human Services (HHS) announced that it will conduct an audit focusing on how selected state Medicaid agencies and Medicaid managed care organizations (“MCOs”) leverage telehealth to provide behavioral healthcare. Continue Reading

New Set Of Guidance From FDA Provides Clarity On Digital Health Policies, Machine Learning

On September 26, 2019, the US Food and Drug Administration (FDA) published six guidance documents clarifying its scope of authority and enforcement discretion policies in light of the 21st Century Cures Act (Cures Act). The long-awaited draft guidance on Clinical Decision Support (CDS) software sets forth FDA’s proposed approach to regulating CDS, including software that incorporates machine learning (ML) technology. Companies developing ML software for life science applications should consider reviewing FDA’s planned approach to inform their regulatory strategies. Continue Reading

Bipartisan Push To Repeal ACA’s Cadillac Tax

One of the most controversial taxes of the Affordable Care Act (ACA) is in danger of repeal. The tax colloquially known as the “Cadillac Tax” was supposed to take effect in 2018, but Congress has delayed it twice. With the tax now slated to take effect in 2022, opponents of the tax have taken the opportunity to attempt to repeal it for good. On July 17, 2019, the House of Representatives overwhelming voted, 419-6, to approve the Middle Class Health Benefits Tax Repeal Act of 2019, which would abolish the Cadillac Tax. A Senate companion bill with 61 co-sponsors, including 32 Republicans and 28 Democrats, shows that the bill is unlikely to encounter much resistance if it is brought to a vote. Continue Reading

FDA’s New Safety and Performance Based Pathway for Medical Devices Reflects a More Modern Approach to Finding Substantial Equivalence

On September 19, 2019, FDA issued a guidance document, “Safety and Performance Based Pathway,” describing an optional pathway for medical devices with well-understood safety and performance profiles. The guidance signals FDA’s willingness to implement a more modern approach under the arcane 510(k) premarket pathway. Continue Reading

D.C. District Court Vacates CMS Final Rule, Finds that CMS’ Lesser Reimbursement of Services Provided at Grandfathered Off-Campus Provider-Based Departments Was Improper

On September 17, 2019, the U.S. District Court for the District of Columbia ruled against the Centers for Medicare and Medicaid Services (“CMS”), vacating CMS’ 2018 Final OPPS Rule, which cut Medicare reimbursement rates for certain outpatient hospital services provided at certain off-campus provider-based departments (“PBDs”). Continue Reading

California Department of Managed Health Care Opposes AB 1249

On Monday, August 8th, the Deputy Director of Legislative Affairs of the Department of Managed Health Care (the “Department”) released a letter of opposition (the “Letter”) to Assembly Bill 1249 (“AB 1249”). The Letter was addressed to Brian Maienschein of the California State Assembly, who is the lead author of AB 1249. Continue Reading

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