Adapting To FDA’s Proposal For Diagnosis Support Software

*This article was originally posted in Law360 on November 4, 2019

With the rise of artificial intelligence and machine learning, clinical decision support, or CDS, software presents a novel opportunity to analyze immensely large amounts of data for patterns or other information that may be relevant to a particular patient’s diagnosis or health care options. Continue Reading

Legislation Re-Introduced to Expand Access to Telehealth Under Medicare

A bipartisan group of senators introduced legislation on October 30th designed to expand Medicare beneficiaries’ access to telehealth services. The bill is called the Creating Opportunities Now for Necessary and Effective Care Technologies for Health Act of 2019 (hereinafter, the “CONNECT Act” or the “Act”). In order to understand what the Act seeks to accomplish, it is important to have a working understanding of Medicare’s current policies governing telehealth. A brief overview is provided below followed by a section by section summary of the Act. Continue Reading

Merger of Adventist-St. Joseph Rejected by the California Attorney General

On October 31, 2019, the California Department of Justice (“DOJ”) issued a denial letter rejecting a proposed merger between Adventist Health System/West and St. Joseph Health System. The parties had submitted notices to the DOJ requesting approval to form a joint operating company to manage the health systems’ nine health facilities in Northern California. According to the denial letter, the proposed transaction was rejected because the Attorney General concluded that it was not in the public interest due to concerns related to the potential for higher health costs and for reduced access and availability of health care services. Continue Reading

CMS’s Mandatory Radiation Oncology Payment Model: Negative Reactions in the Radiation Oncology Treatment Community

On July 10 2019, the Centers for Medicare & Medicaid Services (“CMS”) issued a Notice of Proposed Rulemaking (“NPR”) entitled, “Medicare Program; Specialty Care Models to Improve Quality of Care and Reduce Expenditures.” In the NPR, CMS proposes to implement two new mandatory specialty care payment models – one of which, the Radiation Oncology Model (“RO Model”), applies to selected radiation therapy (“RT”) services[1] as provided by physician group practices, hospital outpatient departments, and freestanding radiation therapy centers, all located within randomly selected geographic areas throughout the country.

Although the proposed RO Model is consistent with broader trends in the healthcare industry to cut healthcare costs and increase quality through the use of bundled and other alternative (i.e., not fee-for-service) payment methodologies, the RO Model has garnered its fair share of detractors within the RT community.

In this article, we will focus on the concerns of such detractors, including those voiced by proton therapy providers who consider the RO Model’s payment reductions – which apply to all RT providers regardless of the treatment modality at issue – as a CMS-intended financial hit against proton beam therapy. Proton beam therapy is a form of radiation treatment that the Medicare Payment Advisory Commission (“MedPAC”), in its “June 2018 Report to the Congress: Medicare and the Health Care Delivery System,” (the “MedPac Report”) once referred to as a “potentially low value” treatment modality and an example of why CMS should consider the development and implementation of new RT payment models to create, “incentives for organizations to reduce low-value services.” Continue Reading

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

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