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John M. Tilton is an associate in the Healthcare Practice Group in the firm's Century City office.

Telehealth services and providers have been in high demand as the world copes with the COVID-19 public health emergency.  Federal and state agencies have amended, and often loosened, regulations in an attempt to facilitate and expand access to telehealth.  However, the honeymoon phase of relaxed oversight may be coming to an end as the world adjusts to a new-normal.
Continue Reading The Honeymoon Phase Is Over: OIG to Audit COVID-19 Part B Telehealth Services

In response to the ongoing COVID-19 public health emergency (the “PHE”) first declared on March 13, 2020, the Centers for Medicare & Medicaid Services (“CMS”) issued blanket Section 1135 Waivers to expand, albeit on a temporary basis during the PHE, the range of healthcare professionals who can provide Medicare-covered telehealth services to include physical therapists, occupational therapists, speech language pathologists, and other non-physician practitioners.  (See also, CMS Fact Sheet, “Medicare Telemedicine Health Care Provider Fact Sheet” (March 17, 2020) and CMS’s “COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers” (December 1, 2020)).
Continue Reading The Other Shoe Drops: OIG To Audit COVID-19 Telehealth Home Health Services

On Thursday, April 16, 2020, the California Department of Managed Health Care (the “Department”) released an all plan letter (the “Letter”) regarding changes to the Department’s General Licensure Regulation (the “Regulation”) in light of the coronavirus (COVID-19) pandemic.  The Letter updated the Department’s previous guidance concerning the Regulation that was issued on June 13, 2019.  For further information, see our previous post regarding the Regulation here.  
Continue Reading The California Department of Managed Health Care Extends the Phase-In Period for the General Licensure Regulation

On April 16, 2020, the Trump Administration issued its “Opening Up America Again Guidelines” (the “OUAA Guidelines”) as a self-styled roadmap to the staged reopening of the American economy.

On Sunday, April 19, 2020, the Centers for Medicare & Medicaid Services (“CMS”) followed suit by issuing new guidance (the “Reopening Guidance”) designed to reintroduce the provision of non-essential surgeries and medical procedures by healthcare providers located in “Phase 1” states and/or regions.  Such non-elective procedures were previously put on hold at the state and local levels in accordance with prior CMS guidance dated March 18, 2020 (the “March Guidance”) in which CMS called for the delay of all elective surgeries, non-essential medical, surgical, and dental procedures during the COVID-19 state of emergency.
Continue Reading Elective and Non-Essential Medical Procedures: States React to Federal Recommendations and the Opening Up America Again Guidelines

On Tuesday, April 7, 2020, the California Department of Managed Health Care (the “DMHC”) released a guidance letter (the “Letter”) to all health care service plans regarding billing for and delivering telehealth services during the COVID-19 state of emergency.  The Letter provides  follow-up guidance to previous guidance the DMHC released on Wednesday, March 18, 2020 (the “Initial Guidance”).  The DMHC has also provided additional information regarding the most frequently asked telehealth questions it has received (the “FAQs”).
Continue Reading California Department of Managed Health Care Releases Additional Guidance on Telehealth Services

On Thursday, March 12, 2020, the California Department of Managed Health Care (the “Department”) released a guidance letter (the “Letter”) to all health care service plans regarding the coronavirus (COVID-19) pandemic. The Letter encourages plans to take certain steps to promote social distancing to decrease in-person visits during the delivery of health care services.  The Letter encourages plans to continue following these social distancing measures for the duration of the state of emergency proclaimed by Governor Newsom on March 4th.
Continue Reading California Health Plans Take Note: California Department of Managed Health Care issues All Plan Letter on Social Distancing and COVID-19

Background

On June 28, 2018, California’s new privacy bill A.B-375 was signed into law as the California Consumer Privacy Act of 2018 (“CCPA”). On October 10, 2019, the California Attorney General issued proposed regulations for implementing and interpreting the CCPA.[1] Effective on January 1, 2020, the CCPA will apply to all for-profit entities and businesses that:

  • Do business in California;
  • Collect the personal information (“PI”) of California residents, and
  • (a) Annually have gross revenues of $25 million or more; (b) derive half or more of their annual revenue from selling PI; or (c) transact in the PI of 50,000 or more consumers, households, or devices per year.[2]


Continue Reading The California Consumer Privacy Act of 2018: Why the Healthcare Sector Needs to Pay Attention (and Not Just in California)

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

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 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

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 California Department of Managed Health Care Opposes AB 1249

Where does my prescription come from? Has it been altered or diluted? Can I trust the label? With millions of prescriptions filled each year, quality control and security across the pharmaceutical supply chain seems like a herculean task. In an attempt to slay this proverbial hydra, the Food and Drug Administration (FDA) developed a new pilot program – the DSCSA Blockchain Interoperability Pilot (the “Blockchain Pilot”) – which aims to use blockchain to create a secure electronic, interoperable system that tracks and traces certain prescription drugs as they are distributed in the United States.
Continue Reading What’s in the Bottle? FDA Announces New Blockchain Pilot Program for Tracking Drug Distribution