We have been heartened by many of our client healthcare facilities and providers developing and offering up unique and creative solutions to address the surge of healthcare needs from the evolving COVID-19 outbreak. We have been working with our clients and the NYS Department of Health (DOH) to facilitate the necessary emergency approvals to implement these proposals in an expeditious manner. As you may know, the NYS Governor’s Executive Order 202.1 gave the DOH the authority to issue these emergency approvals (without a CON).

Different divisions or bureaus at DOH are handling these requests depending on the nature of the facility and the proposal.

If you wish to pursue such a proposal to create additional capacity for COVID-19, while our offices are closed, we are completely set up and are remotely available to help expedite your requests. These requests can include emergency approval for additional capacity or alternative sites for testing, triage, screening or treatment related to COVID-19 surge response. This may include construction or modification requests related to the use of alternative facilities, development of additional capacity or the repurposing of existing space.

Once again, we are proud to consider ourselves part of a healthcare community which has proven itself in this and other crises to be resilient and resourceful. We are here to play our part to help manage these challenging times.

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Should you have any questions, please contact the Garfunkel Wild attorney with whom you regularly work, or contact us at info@garfunkelwild.com. We have attorneys on call 24/7. If you call our main number, 516-393-2200, it will direct you to the on-call attorney. 

 

Garfunkel Wild Complimentary Webinar – Mayor de Blasio’s Emergency Executive Order

Tuesday, March 17, 2020

Speakers:  Andrew E. Blustein, James E. Dering, Stacey L. Gulick

Garfunkel Wild Vice Chairman Andrew E. Blustein and Partners James E. Dering and Stacey L. Gulick presented a webinar on “Mayor de Blasio’s Emergency Executive Order,” discussing Mayor de Blasio’s Emergency Executive Order requiring New York City Hospitals and ASCs to cease performing elective procedures.

Click Here to view webinar.

 

The number of confirmed cases of COVID-19 in the United States is increasing rapidly and health care providers need to be prepared.  Federal, state and local government agencies recommend that health care providers take various steps during their preparation efforts, including the following:

  • Review the organization’s Emergency Response Plan and be prepared to implement it
  • Contact the applicable trade association if encountering supply shortages
  • Implement Personal Protective Equipment (PPE) conservation strategies
  • Be prepared to implement communication plans with employees and patients
  • Consider tele-health and remote treatment options to keep individuals at home
  • Be prepared to isolate or address high risk patients
  • Understand when testing for the Novel Coronavirus is permissible (Note: there are limited testing options at this time and specific guidelines as to when tests can be requested)
  • Educate people on strategies to avoid Emergency Departments, which may become over-crowded
  • Identify essential staff and consider which staff can work remotely
  • Report confirmed cases or individuals who meet the criteria for persons under investigation (“PUI”)
  • Be prepared to address employee inquiries and concerns
  • In facilities, consider access and movement of visitors
  • Be familiar with Federal, State and local on-line resources. Here are a few:

https://www1.nyc.gov/site/doh/health/health-topics/coronavirus.page

https://www.nj.gov/health/cd/topics/ncov.shtml

https://portal.ct.gov/DPH/Public-Health-Preparedness/Main-Page/2019-Novel-Coronavirus

https://www.cdc.gov/coronavirus/2019-ncov/index.html

https://asprtracie.hhs.gov/MasterSearch?qt=coronavirus&limit=20&page=1&CurTab=0

https://www.health.ny.gov/diseases/communicable/coronavirus/

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As this situation unfolds, recommendations and requirements are being updated and changed at a rapid pace.  If you need any assistance in understanding or addressing these concerns, please contact the Garfunkel Wild attorney with whom you regularly work.

Click Here to download the Legal Alert.

 

 

On Thursday, February 6, 2020, the Public Health and Health Planning Council (“PHHPC”) voted to adopt the Department of Health’s (“DOH”) final amendments to the licensure requirements for Licensed Home Care Services Agencies (“LHCSA”) operating in New York State (the “Adopted Regulations”). These regulations will replace prior regulations and end the LHCSA application moratorium (the “Moratorium”) that went into effect on April 1, 2018 and is set to expire on March 31, 2020.

Under the Adopted Regulations, in addition to the existing requirement of undergoing a character and competence review, a LHCSA applicant will now be required to include in its application: (i) a demonstration of public need for additional LHCSA providers or services in a given planning area, i.e., county; and (ii) provide proof of financial resources and feasibility to operate the entity.  Failure on either one of these grounds will result in a denial of the application.   Furthermore, the Adopted Regulations provide that DOH’s determination to approve or deny an application may be made solely on the threshold matter of establishing a public need.  If DOH determines that such a need does exist, the application will then be subjected to financial feasibility and character and competence reviews.

Applicants Are Now Required to Demonstrate Public Need

The demonstrated public need requirement is a holdover from the Moratorium, which required proof that a need existed that was not being addressed by currently registered LHCSAs operating within a county.  However, while the Moratorium established a rebuttable presumption that adequate access to care existed if there are two or more LHCSAs already approved in the applicant’s proposed county, the Adopted Regulations expand that rebuttable presumption to five or more LHCSAs actively operating in a county as of April 1, 2020.

Under the Adopted Regulations, DOH will consider the following factors when determining whether there is a need for additional LHCSA services in a given area:

  • demographics and/or health status of the residents in the planning area;
  • documented evidence of patients who experience a long waiting time for placement;
  • number and capacity of currently operating LHCSAs;
  • quality of services provided by existing agencies;
  • availability and accessibility of the workforce;
  • personnel and resources dedicated to adding and training additional members of the workforce;
  • cultural competency of existing agencies; and
  • subpopulations requiring specialty services.

The Adopted Regulations explicitly state that LHCSAs seeking initial certification will only be approved as meeting a demonstrated public need if the LHCSA agrees to serve population groups in a county that has difficulty gaining access to appropriate LHCSA care due to minority status, age, medical history, case complexity, payment source, or geographic location.

LHCSAs affiliated with an Assisted Living Program (ALP), Program of All-Inclusive Care for the Elderly (PACE), Nurse Family Partnership (NFP), or Continuing Care Retirement Community (CCRC) are not required to submit to a public need review unless that agency intends to serve patients outside its licensed program.  Additionally, an application based on a change of ownership in an actively licensed LHCSA with at least 25 patients will not be subject to the public need requirement.

LHCSA Applicants Must Demonstrate Financial Feasibility

DOH’s review of a LHCSA applicant’s financial feasibility will be based upon (i) an examination of the sources of available working capital, with a minimum requirement of at least two months estimated operating expenses; (ii) the application passing a reasonableness test with respect to the financial capability of the LHCSA for start-up funding; and (iii) projections indicating that the LHCSA’s revenues, including but not limited to operating revenue, will be equal to or greater than projected expenditures over time.

New Circumstances Added Impacting The Need to Amend a LHCSA Application.

The Adopted Regulations expand the definition of what would be considered a circumstance requiring an amendment to an application prior to approval. Previously, a LHCSA applicant would need to amend its application if there was a change in the types of services the applicant would provide or if there was a change in the individuals being considered by PHHPC as part of the LHCSA applicant’s character and competence review.  Now, under the Adopted Regulations, an application is required to be amended when there has been (i) a significant change in the individuals being considered by PHHPC; (ii) any significant change in the LHCSA’s proposed patient capacity; (iii) any change in the LHCSA’s proposed service area; and/or (iv) any significant change to the LHCSA’s proposed annual operating budget.  Failure on the part of a LHCSA to disclose any of these circumstances prior to DOH issuing a license will be considered sufficient grounds for the revocation, limitation or annulment of DOH’s approval.

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If you have any questions regarding this Alert, please contact the Garfunkel Wild attorney with whom you regularly work.

Click Here to download the Legal Alert.

 

As most of you are aware, all 2019 HIPAA security breaches affecting less than 500 individuals must be reported by covered entities (e.g., providers and health plans) to the Federal Department of Health and Human Services, Office of Civil Rights (“OCR”) prior to February 28, 2020.   If you have not already submitted this information, you may do so by clicking on this link and following the instructions to make the electronic report:  https://ocrportal.hhs.gov/ocr/breach/wizard_breach.jsf?faces-redirect=true

Twist from the New York Attorney General

This year, in New York, the annual HIPAA breach notification requirement comes with a twist.  New York covered entities must now also report all HIPAA breaches to the New York Attorney General within five (5) days of making the report to the OCR.   Reports can be made using the on-line form found at this link:  https://formsnym.ag.ny.gov/OAGOnlineSubmissionForm/faces/OAGSBHome

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If you have any questions regarding this Alert, please contact the Garfunkel Wild attorney with whom you regularly work.

Click Here to download the Legal Alert.