Category: Health Care

Late last week, Assemblymember Richard Gottfried introduced a bill in the New York Assembly to repeal the LHCSA RFO. The bill would repeal those portions of the New York Public Health Law that require authorization for a LHCSA to enroll and continue providing home care services that are paid for by Medicaid (including MLTC Medicaid). Assemblymember Gottfried’s bill explains that the bill was introduced because the LHCSA RFO would have “allow[ed] the Department of Health to arbitrarily limit the number of LHCSAs that may participate in Medicaid,” and that “[t]his arbitrary and extraneous contract limitation is bad health policy and morally objectionable.”

Just today, Senator Rachel May introduced a companion bill in the Senate that would repeal Section 3605-c of the Public Health Law, which is the provision of the law that establishes the LHCSA RFO.

It is not yet clear if these bills will become law, or whether they are merely symbolic gestures by two members of New York’s Legislature that have, traditionally, shown strong support for the home care industry with, albeit, limited success. Readers will recall that Assemblymember Gottfried had recently proposed the CDPAP RFO, round two, and his proposal was not successful. Similarly, readers will recall that Senator May was the proponent of raising the home care workers’ wages to more than $35,000 and that bill did not pass in the Legislature either.

It is expected that the two bills proposing the repeal of the LHCSA RFO will face significant pushback and opposition from SEIU 1199, which is vehemently fighting to consolidate the home care industry through the RFO. In a smaller industry, the union sees potential for easier unionization of home care workers. Thus, with such strong (expected) opposition to the repeal of the LHCSA RFO, it is not certain that these measures will become law. However, even if not ultimately successful, these bills will at least signal to the Department of Health that the Legislature is closely watching the Department’s moves with respect to licensed home care agencies.

We will report more on these bills as more information becomes available.

On Sunday, the DOH issued an advisory titled “Revised Protocols for Personnel in Healthcare and Other Direct Care Settings” that explains how covered entities must handle employees who have been exposed to a confirmed case of COVID-19 and are asymptomatic and certain travelers returning to New York. The Revised Protocols appear limited to these scenarios, and that the pre-existing DOH guidelines continue to apply to healthcare employees in other situations (e.g., where the employee has been exposed and is symptomatic).

The Revised Guidelines state that they apply to employees who are asymptomatic and who “have been in contact with (i.e., exposed to) a confirmed or suspected case of COVID-19 within the past 10 days.” For such employees, they may return to work “after a 10 day quarantine without testing if no symptoms have been reported during the quarantine period, providing the following conditions are met:”

1. Employee must continue daily symptom monitoring through Day 14;
2. Employee must be counseled to continue strict adherence to all recommended non-pharmaceutical interventions, including hand hygiene and the use of appropriate face coverings.
3. Employee must be advised that if any symptoms develop, they should immediately self-isolate and contact the local public health authority or their healthcare provider to report this change in clinical status and determine if they should seek testing.

With respect to employees who had traveled and return from a non-contiguous state or territory that is subject to a CDC Level 2 or higher COVID-19 risk assessment level, or for which the risk assessment level has not been designated by the CDC, then the healthcare personnel must adhere to the NYS November 3 travel guidance and seek diagnostic testing on Day 4.

In reference to paid sick leave for employees who are subject to the foregoing quarantine obligations, the Revised Guidelines state that such employees “may qualify for paid sick leave benefits, and their employers can provide them with a letter confirming this, which can be used to demonstrate eligibility for the benefit. However, New York employees will forgo their paid sick leave benefits from New York’s COVID-19 paid sick leave law if they engage in travel not directed by their employer to a country designated as having a Level 2 or higher health notice by the CDC or states other than those contiguous to New York from the time of return to New York until the end of the required period of quarantine or isolation.”

The guidance does not explain what type of proof employers may request to confirm that an employee has been “exposed to” a COVID positive case. The COVID paid sick leave law continues to state that employees must produce an order of a local department of health or a medical order directing them into quarantine in order to receive paid COVID sick leave. Further, nothing in the Revised Guidelines prohibits employers from seeing proof that an employee is required to quarantine for 10 days before being required to pay the employee for such quarantine.

It is not clear whether the Revised Protocols apply to CDPAP. The announcement did not list fiscal intermediary owners or administrators as one of the intended recipients of the Revised Protocols. We’re seeking further clarification on this question from the DOH.

On December 10, 2020, the U.S. Department of Health and Human Services (HHS), Office of Civil Rights (OCR) announced its proposal to make significant changes to the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. If adopted, the proposed rule would require covered entities to make substantial changes to their HIPAA policies and procedures and related workflows.

Here are the most noteworthy aspects of the proposed regulations:

Increasing individuals’ access to PHI

The proposed rule would allow individuals inspecting their PHI to take notes or use other personal resources to view and capture images of such PHI. The proposed rule would also prohibit a covered healthcare provider from delaying an individual’s right to inspect PHI when the PHI is readily available at the point of care in conjunction with a healthcare appointment. A covered entity would not, however, have to allow individuals to connect personal devices to the covered entity’s information system.

The proposed rule would shorten the time frame within which a covered entity must respond to an individual’s request for access to the individual’s records from 30 days (with an option for a 30-day extension) to 15 days (with an option for a 15-day extension). Under the proposed rule, a covered entity may use an extension only if the covered entity has established written policies for prioritizing urgent or other high-priority access requests (especially those related to health and safety).

The proposed rule would prohibit such measures. Similarly, the proposed rule would prohibit a covered entity from imposing unreasonable identity verification requirement or other “unreasonable barriers or delay” in access to PHI.

Currently, the Privacy Rule requires covered entities to transmit a copy of PHI directly to another person designated by the individual when directed by the individual, provided that the request is in writing, is signed by the individual, and clearly identifies the designated person and where to send the copy of the PHI. The proposed rule would limit this right so that it applies only to electronic copies of PHI contained in an electronic health record (EHR), which could include PDF and other electronic formats that are accessible, usable and reasonable, such as .doc and .docx format. The proposed rule would require a covered healthcare provider to respond to such a request so long as the request is “clear, conspicuous, and specific”—replacing the current requirement that the request be in writing, signed by the individual, and clearly identify the designated person and where to send the copy of the PHI. The proposed rule would add a definition of EHR for the purpose of clarifying the scope of an individual’s right to direct an electronic copy of PHI in an EHR to a third party.
The proposed rule would also create a second mechanism (which is in addition to the treatment, payment and healthcare operations permitted disclosure) for a covered entity to obtain an electronic copy of PHI from another covered healthcare provider.

The proposed rule would require covered entities to inform individuals about their right to direct requested electronic copies of PHI in an EHR to designated third parties when a covered entity offers to provide a summary in lieu of the requested copies of PHI.

Changes Relating to Notices of Privacy Practices

The proposed rule would eliminate the requirement that covered entities that are direct treatment providers obtain an individual’s written acknowledgment of receipt of the covered entity’s Notice of Privacy Practices (NPP), and replace it with an individual right to discuss the NPP with a person designated by the covered entity whose name, phone number and email address must be listed in the header of the NPP. In addition, the proposed rule would modify the content requirements of the NPP to notify individuals of their rights with respect to accessing their PHI.

Modifying Fee Structure Based on Access Type

To increase an individual’s awareness of the cost of copies of PHI, and to make the access fee requirements more uniform, the proposed rule would require covered entities to provide advance notice of approximate fees for copies of PHI requested under the access right and with an individual’s valid authorization. In addition, the proposed rule would modify the access fee provisions to specify when a covered entity may charge fees when responding to an individual’s right to access request.

Clarifying the Scope of Permitted Disclosures for Care Coordination and Case Management

The proposed rule would amend the definition of healthcare operations in order to clarify that PHI may be shared with health plans involved in care coordination and care management. The proposed rule would also expressly permit covered entities to disclose PHI to social services agencies, community-based organizations, home- and community- based service providers, and other similar third parties that provide health-related services, to facilitate coordination of care and case management and wraparound support services for individuals. Under this provision, a health plan or a covered healthcare provider would only be permitted to disclose PHI without authorization to a third party that provides health-related services or other supportive services, such as food or housing.

Disclosures that are in the “Best interest” of the Individual

The proposed rule would replace the privacy standard that permits covered entities to make certain uses and disclosures of PHI based on their “professional judgment” with a standard permitting such uses or disclosures based on a covered entity’s good faith belief that the use or disclosure is in the best interests of the individual. The proposed standard would presume a covered entity’s good faith, and that presumption could only be overcome with evidence of bad faith. The circumstances in which the new standard would apply include the following:

1. Disclosure of an unemancipated minor’s PHI to parents or guardians who are not the minor’s personal representative if doing so is consistent with state or other applicable law.
2. Inclusion of an individual’s name in a facility directory and disclosure of the individual’s location and general condition when the individual is unable to agree or object.
3. Disclosure of relevant information to a person involved in an individual’s care or payment for care when the covered entity reasonably infers, based on a good faith belief, that the individual does not object.
4. Disclosure of relevant information about an individual to family members and other caregivers who are involved with the individual’s care or payment for care, or who require notification related to the individual, when the individual cannot agree to the disclosure because of absence, incapacity or emergency circumstances.
5. The proposed rule would also permit covered entities to disclose PHI to avert a threat to health or safety when a harm is “serious and reasonably foreseeable,” instead of the current stricter standard, which requires a “serious and imminent” threat to health or safety.

The Department of Health has just released two Dear Administrator Letters (“DALs”) that will require home care agencies’ immediate attention. The first DAL discusses health assessments and immunization requirements for healthcare personnel, including PCAs and HHAs working for LHCSAs. It is available HERE. The second DAL discusses home care aide in-service requirements, and it is available HERE. These DALs do not appear applicable to CDPAP.

Annual Health Assessments and Immunizations

The annual health assessment for personnel of CHHAs, LHCSAs, LTHHCPs, and AIDS home care programs was suspended on April 10, 2020. As of October 14, that suspension is lifted and all personnel must obtain their annual health assessments by December 31, 2020.

In-Service

With respect to in-service, the DOH’s DAL nots that the DOH will exercise “enforcement discretion when surveying providers for compliance” with the 12-hour annual in-service requirements for home health aides, CHHAs, LTHHCPs, and AIDS home care programs. However, with respect to the 3-hour semi-annual in-service education requirements for PCAs, the DOH will exercise enforcement discretion “only where such semi-annual education was due between January and June 2020.” The Department will continue to exercise its discretion until the end of the “first full quarter following the declaration of the end of the State Disaster Emergency or expiration of Executive Order 202, whichever is sooner.” Nonetheless, in the DAL, the DOH is urging providers to have their aides complete both annual and semi-annual in-services as soon as practicable. The DAL emphasizes that:

“In-services can be conducted remotely or through other off-site methods. Online in-services may be used as a means of in-service completion provided it is under the supervision of an RN, includes an opportunity for questions and answers, and there is an evaluation that validates that learning took place. The online in-service training must also be pertinent to the aide’s job responsibilities. The agency should document remote in-service training in the agency’s personnel files and this documentation must be made available upon request for surveillance purposes.”

Orientation and Supervision

The DAL notes that CMS has waived the requirements at 42 CFR § 418.76(h)(2) for Hospice and 42 CFR § 484.80(h)(1)(iii) for Home Health Agencies, which require a registered nurse, or in the case of a Home Health Agency, a registered nurse or other appropriate skilled professional (physical therapist, occupational therapist, speech language pathologist), to make an annual onsite supervisory visit (direct observation) for each aide that provides services on behalf of the agency. The DAL notes that all postponed onsite assessments must be completed by these professionals no later than 60 days after the expiration of the public health emergency.

The DAL further notes that EO 202.5, issued on March 18, 2020 and extended by subsequent orders, permits CHHAs, LHCSAs, LTHHCPs, AIDS home care programs, and hospices serving individuals affected by the disaster emergency to conduct in-home supervision of HHAs and PCAs as soon as practicable after the initial service visit, or to permit in-person and in-home supervision to be conducted through indirect means, including by telephone or video communication. Note, the part of the DAL discussing PCA and HHA supervision requirements seems to contain a typographical error regarding the EO 202.5 expiration date. We are following up with the DOH to confirm that EO 202.5 is still in effect and that PCAs and HHAs can be supervised through indirect means, including telephone or video communication.

Opening Cases via Technology
The DAL reaffirms that LHCSAs, CHHAs, LTHHCPs, and AIDS home care cases may be opened using remote technology.

The fiscal intermediary PMPM battle continues, with New York State Department of Health filing a notice of appeal, signaling that it will seek to appeal the decision of an Albany County Supreme Court Judge that had ruled – only several weeks ago – that the PMPM reimbursement methodology for FIs was improperly promulgated by the Department and, thus, void.  In its notice of appeal, the State did not seek to expedite its appeal of the Court’s decision, meaning that it could be months before the case is actually reviewed and heard by the Appellate Division, Third Department.  In addition, the State did not seek a stay of the Court’s decision, which means that, until the Appellate Division, Third Department, rules otherwise, the Court’s decision invalidating PMPM stays in effect.  As the appeal is proceeding through the court system, the State could seek to re-issue the PMPM methodology through proper regulatory channels, or to amend New York law and how FIs are reimbursed through the upcoming legislative session.  There is no indication yet whether the State will do so.  However, given its options to effectuate a PMPM reimbursement system for FIs faster than through an appeal, it is surprising that the State has chosen to appeal the Court’s decision.

Legislation enacted in April 2019 amended Section 3-110 of the New York State Election Law to now entitle all employees to leave with pay during working hours for purposes of voting in certain elections. This amendment expanded existing law which required time off from work only if the employee did not have sufficient time during non-working hours within which to vote. The law applies to primary and general elections, as well as special elections called by the governor. It does not apply to school district elections. The law covers employees who are scheduled to work on a qualifying election day, and, based on guidance from the New York State Board of Elections, appears to apply to election day only, and not to early voting periods. It does not appear that employers may compel employees to use available paid leave accruals in conjunction with this leave.

The components of the new election leave entitlement are as follows:

• Only registered voters are entitled to this leave.
• The leave is to be used solely for purposes of voting in a primary, special or general election.
• The employee is entitled to paid leave for up to three hours, at the beginning or end of the employee’s work shift as either designated by the employer or mutually agreed.
• An employee must provide notice to the employer no less than two working days prior to the day of the election if the employee wishes to use this election leave.

In addition, employers have a notice obligation that must be satisfied by no later than Tuesday, October 22, 2019 for the upcoming general election. The notice obligation requires employers to post a required notice “conspicuously in the place of work where it can be seen as employees come or go to their place of work.” The notice must be kept posted until the close of the polls on election day, and must set forth the above-referenced provisions of Section 3-110. The New York State Board of Elections website provides a model notice for this purpose. Although the model notice notably says that employees must notify employers two days prior to the election if they wish to use this election leave entitlement, the actual requirement is that the employees provide such notice no later than two working days prior to election day. If you are using the model notice to satisfy your notice obligation, the reference to working days should be included with regard to the employee notice.

There are a number of open questions regarding the implementation of this new election leave law. For instance, inasmuch as the law specifically is applicable solely to employees who are “registered voters,” and solely for purposes of permitting such employees paid time off to “enable him or her to vote,” may an employer ask an employee for proof of voter registration prior to approving leave, or ask the employee for proof that the employee actually voted? The law itself is silent on these questions. However, the New York State Civil Service Department issued a bulletin stating (without any citation to legal authority) that employers “may not require proof of voter registration or proof that an employee actually voted [emphasis in original].” In any event, voter registration, and whether a registered voter voted in a primary or general election, are matters of public record, and it is not necessary for employers to obtain confirmation directly from employees. Indeed, doing so may lead to a claim that the employer is trying to intimidate or deter employees from exercising their right to vote under Section 3-110. However, employers may wish to consider notifying employees in the posted notice or otherwise that the election leave entitlement is available solely to registered voters for purposes of enabling such employees to vote, and that any employee who uses the election leave benefit who is not a registered voter and/or who does not actually vote in conjunction with such leave may be subject to administrative or disciplinary actions. Of course, any such approach by an employer may have legal consequences, including with regard to collective bargaining obligations, so employers should carefully evaluate this implementation issue and consider whether to consult with legal counsel.

A further question is the extent to which employers may establish an expectation that employees will take only so much of the three hour maximum leave period reasonably necessary to actually vote. Again, the law is clear that the leave entitlement is for “up to three hours” of paid leave, and solely for the purpose of enabling the employee to vote. Accordingly, the expectation of how much leave is reasonably necessary for an employee who has a voting location within a few blocks of the workplace may be very different than the expectation with regard to an employee who has a voting location that is a considerable distance from the workplace. Employers may wish to consider reminding employees of this standard, and may also wish to request that employees provide as much advanced notice as is practical, but in no case less than the two working days advance notice that is required. Further, employers should consider being explicit in the posted notice as to whom or by what procedure employees should provide such notice.

Employers should also consider how to exercise the right to designate whether qualified employees will take election leave at the beginning or end of the work shift (employers appear to have authority to address this on an employee-by-employee basis). For instance, designating employees to take election leave at the start of their work shift may allow the employer to more safely implement its expectation that the employee will only use so much of the three hour maximum leave as is necessary to vote. Trying to do so with regard to employees who are approved for election leave at the end of their working shift risks unexpected traffic delays, polling place delays, etc., which may not actually allow an employee to vote prior to the conclusion of the employee’s work shift.

In addition to the above considerations, employers are encouraged to modify their workplace policies to recognize the election leave entitlement and address some or all of the implementation issues identified above.  Employees with supervisory responsibilities should also be trained to handle and process requests from employees who wish to vote in upcoming elections. Lastly, employers should specifically plan for the impact that employee use of election leave may have on staffing levels and employer operations.