Plugged Into Health @ Hinman Straub – October 1, 2018

Committee Meetings of the Public Health and Health Planning Council (“PHHPC”)

On Monday September 17, the Public Health and Health Planning Council (“PHHPC”) held a joint meeting of the Health Planning Committee and Establishment and Project Review Committee (“EPRC”). The purpose of the meeting was to serve as an educational session for the Public Health and Health Planning Council Committee members regarding the Department of Health’s existing regulatory framework and policies related to hospital governance models. A copy of meeting materials can be found here.

The discussion primarily focused on the relationships between “active” and “passive” parent and grandparent entities that currently make up hospital governance models in New York State. The Department indicated that a number of hospitals throughout the state have requested that the Department allow for a new “limited establishment” governance model whereby an active parent corporation would be permitted to infuse capital and share in the revenue of the child hospital’s operations, while the child hospital operator retains exclusive control over the day-to-day operations of the hospital. Under current policy, this practice is not feasible since an active parent entity must be co-established and share in all powers and liabilities of the hospital’s operations.

During the meeting, Committee members were receptive to a Departmental proposal to allow for “limited establishment” arrangements that allow an active parent entity to share liability for only a portion of the hospital’s operation, namely participation in revenue sharing and financial obligations. The Committees expressed a consensus that they would entertain applications for these types of models going forward. Since this meeting was a preliminary discussion, there was no final resolution adopted. The meeting concluded with Mr. Kraut requesting that the Department and Committee members consider information that they would like to see from applicants seeking this type of approval.

On July 19, the Public Health and Health Planning Council (“PHHPC”) Committee on Establishment and Project Review (“EPRC”) met in New York City. At the meeting, the EPRC considered a number of project applications, including two applications for hospital consolidation (Arnot Ogden Medical Center/St. Joseph’s Hospital & Samaritan Hospital/St. Mary’s Hospital). A copy of the agenda can be found here.

The EPRC, once again, considered two related applications to the full PHHPC with no recommendation. The applications (True North IV DC, LLC & True North V DC, LLC) for establishment/construction of dialysis services centers, which have come before the EPRC a number of times since March 22, 2018, would transfer a portion of ownership in each existing dialysis facility from DaVita Inc. to Northwell Health and a group of independent nephrologists.  Similar to past discussions of the applications, PHHPC members had reservations regarding the character and competence of DaVita Inc. and were unable to achieve enough votes to recommend approval.

All other applications on the EPRC agenda received a recommendation for approval with the exception of Northern New York ASC, LLC d/b/a Northern New York, which was deferred at the request of the Departments, and Brookhaven Home Care, LLC, which was withdrawn by the applicant.

The next PHHPC meeting is scheduled for Thursday, October 11, 2018 in NYC.

VBP Updates

VBP Bootcamp-Registration Now Available

The Department of Health has opened registration for the latest Value Based Payment (VBP) Bootcamp in Albany, New York on October 10, 2018. The VBP Bootcamp will be held in Empire State Plaza (1 Empire State Plaza, S. Mall Arterial, Albany, New York 12210), meeting rooms 2-4 from 8:30 a.m. to 3:00 p.m.

The VBP Bootcamp will focus on a deep dive into VBP fundamentals and key VBP principles.  The day will also feature a managed care organization and a healthcare provider who will present best practices and lessons learned based upon their own experience in negotiating a VBP contract. The afternoon session will consist of a mock-negotiation exercise that will give participants hands on experience in negotiating a mock ‘VBP contract’.

To register for the VBP Bootcamp, click here. Registration will stay open until Wednesday, October 3, or until event is sold out.

DFS to Hold Hearing on of Aetna Inc. by CVS Acquisition of Aetna Inc.

The Department of Financial Services (“DFS”) will be holding a hearing on the application by CVS Health Corporation and CVS Pharmacy, Inc. for approval of acquisition of control of Aetna Health Insurance Company of New York. The hearing will take place at 10:00 a.m. on October 18, 2018 at the offices of the Department of Financial Services, One State Street, 6th Floor Hearing Room, New York, NY 10004. The public hearing that is intended to provide an opportunity for stakeholders to comment on the acquisitions potential impacts on consumers and the insurance marketplace in NYS.

Interested parties may testify at the hearing or submit written comments to be included in the hearing record. Requests to testify and/or attend the hearing should be made 48 hours in advance of the hearing (by 10:00 a.m. on October 16, 2018) by email with the subject line “CVS-AETNA 2018 HEARING”. Written comments for the hearing record will be accepted both in advance and for up to five business days after the hearing.

DFS Superintendent Maria Vullo sent her own letter of caution to the Connecticut Insurance Department ahead of its October 4 hearing on the acquisition. The letter warned Connecticut that the transaction could result in increased prices for consumers due to reduced market competition for pharmacy benefit managers (“PBMs”) and Medicare Part D plans. She also warned that the transaction could also lead to significant data privacy and company debt concerns. The DFS has limited approval authority over the transaction specific to the change in control of Aetna’s New York insurance license.

DFS Issues Circular Letters Reminding Insurers of SUD Requirements

Last week, the Department of Financial Services (“DFS”) issued two circular letters reminding health insurance plans of their obligations with respect to coverage of services to treat SUD and advising Plans that DFS will be reviewing Plans’ compliance with SUD treatment requirements on Market Conduct Exams.

Circular Letter No. 12 (2018) reminds plans that, in addition to cost, plans should take into consideration the safety and effectiveness of drugs in determining tier placement of drugs on their formularies. DFS goes on to state that in reviewing the safety of either an opioid or non-opioid drug used for pain management, plans should consider the addictive or non-addictive qualities of the drug under review.

Circular Letter No. 13 (2018) advises plans of the law that took effect earlier this year restricting Plans from conducting preauthorization and concurrent review of outpatient substance use disorder (“SUD”) services received at OASAS-certified facilities. It also clarifies that this law applies to medication-assisted treatment (“MAT”) received on an outpatient basis from an OASAS-certified facility. It also addresses utilization review and preauthorization for outpatient SUD services received from non OASAS-certified providers.

Medicaid Managed Care Advisory Review Panel (“MMCARP”)

MMCARP met on September 28, to receive program updates from the Department of Health (“DOH”). The updates are largely duplicative of updates previously provided at the monthly Medicaid Managed Care Policy and Planning meetings. However, DOH provided the following new information:

• Mainstream Medicaid Managed Care Applications—three managed long-term care plans (“MLTCPs”), Partners Health Plan, Hamaspik, and iCircle Care, have submitted mainstream Medicaid managed care plan applications in preparation to become specialized plans for individuals with intellectual and development disabilities when the application is released in 2019.
• MLTCPs Closing—Guildnet is closing its MLTCP effective January 1. DOH is working to extend continuity of care protections for Guildnet members who switched MLTCPs before receiving DOH-approved notice of the closure. United Healthcare is closing its MLTCP in upstate counties effective February 1 but will remain in New York County.

Medicaid Drug Cap Webinar

On September 17, the Department of Health held an update webinar on the SFY 2018-19 Medicaid Drug Cap.

The purpose of the update was to officially announce that the State Division of Budget and the Department of Health (DOH) have determined that drug expenditures for SFY 2018-19 are projected to exceed the Medicaid Drug Cap by $75 million State share. According to DOH, this is driven by an 11.5% year-over-year increase in managed care and FFS state share pharmacy spend, of which 9.7% is attributable to MMC.

As a result, last week specific drug manufacturers were notified that the State is seeking $119 million in additional supplemental rebates to address the shortfall. If the State does not receive the $119 million it is seeking, the drugs will be referred to the DOH Drug Utilization Review Board (DURB) for review and recommendation of a target supplemental rebate amount.  However, it is worth noting that for the SFY 2017-18 cap, the State realized $75 million of the $119 million savings by reducing mainstream MMC, HARP, and HIV SNP premiums for the six-month period October 2017-March 2018. This action was based on DOH and its actuary (Mercer) determining that such savings were possible due to “new lower cost Hepatitis C agents” available on the market. Thus, the savings to stay under the cap may not necessarily come from additional supplemental rebates from drug manufacturers alone.

Advance Care Planning RFI

The Department of Health has published a Request for Information (“RFI”) to gather input for any necessary changes to ensure the Medical Orders for Life Sustaining Treatment (“MOLST”), Nonhospital Do Not Resuscitate, and Health Care Proxy forms are used appropriately and are understandable to the general public. The Department would also like to know how the Department can support advance care planning conversations. The RFI seeks recommendations for language changes, educational materials, information on barriers to having the conversation, and any data organizations may be collecting on this process.

Comments and recommendations should be sent to [email protected] no later than November 16, 2018.  For more information on this initiative, click here.

Supreme Court Holds that the “13 Hour Rule” Regulation for live-in Home Care Attendants Should Not Have Been an “Emergency” Regulation

On September 26, 2018, a state Supreme Court judge ruled invalid a NYS Department of Labor (“DOL”) Emergency Regulation that temporarily codified its “13-Hour Standard.”  The basis for the ruling is that the Regulation did not qualify as an “Emergency” and, therefore, should have been promulgated through the more lengthy regulatory process.

The DOL now has 30 days to decide whether to appeal the case and, if so, enforcement of the order is stayed while the appeal is pending.  In the meantime, the DOL has proposed a permanent regulation that is substantially similar, and if adopted, would restore the “13 Hour Standard.”

DOH Publishes Fiscal Intermediary Advertising Guidance

The Department of Health has issued guidance to Consumer Directed Personal Assistance Services (“CDPAS”) Fiscal Intermediaries (“FIs”) regarding the review and approval of FI advertising.

The 2018-19 state budget included a provision that prohibits FIs from publishing any advertisement that is false or misleading and requires FIs to obtain approval by the Department of any advertisement prior to dissemination.

Last week’s guidance establishes a definition of advertising, distinguishes between permitted and impermissible advertising activities, and describes the submission and review process, along with appeal procedures. Advertising materials intended to be used on or after November 1, 2018 must be submitted to DOH for review. Advertising materials used prior to November 1, 2018 are not required to be submitted to DOH for review, but may be voluntarily submitted until December 31, 2018 for an “FI Advertising Amnesty.”

DOH Issues Nursing Home DAL on Nursing Home Discharge Requirements

The Department of Health has issued a “Dear Administrator Letter” (DAL NH 18-05 Nursing Home Discharge Requirements) to remind nursing home administrators of their obligation to uphold the Olmstead decision by ensuring that all residents who express a desire to return to the community are provided the opportunity and assistance by the facility to allow the resident to live in the most integrated and least restrictive setting possible. The DAL encourages all facilities to review their current and training materials to ensure compliance with the Olmstead decision.

The DAL restates a number of State and Federal requirements related to resident admission, transfer, and discharge practices that facilities must meet. Among these requirements, the DAL particularly highlights the implications of question Q0500 in the Minimum Data Set (MDS), which identifies residents who wish to return to the community. The Department encourages facilities to review the HHS document Guidance and Resources for Long Term Care Facilities: Using the Minimum Data Set to Facilitate Opportunities to Live in the Most Integrated Setting for information on MDS Q0500. Additional information requiring the facilities’ obligations in completion of the MDS can be found here .

Health Home Update

Health Home Measure Specifications and Reporting Manual

The 2018 Health Home Measure Specification and Reporting Manual is now available on the Health Home Performance Management webpage, located under Quality and Process Measures.  The manual identifies the quality measures, annual improvement targets, performance goals and reporting requirements for the Health Home Program.

Health Home Serving Adults Operations Biweekly Webinar –Member Disenrollment from the Health Home Program policy, Segment End Date Reason Codes and MAPP 2.7 Release updates

During its October 3, 2018 Health Home Serving Adults Operations Biweekly Webinar, the Department of Health will review the recently released Health Home policy, Member Disenrollment From the Health Home Program (HH0007).  The Department will also discuss changes being made to Segment End Date Reason Codes, including those directly tied to member disenrollment, and will provide an overview of the upcoming MAPP Health Home Tracking System 2.7 release scheduled for October 31, 2018.

Join the webinar by clicking here.

Regulatory Updates

Education Department

Advanced Home Health Aides

The NYS Education Department recently issued a notice of continued emergency rulemaking to implement the Advanced Home Health Aide (“AHHA”) legislation passed and signed in 2016.  The regulations define AHHA related terms, establish criteria for RN supervision of AHHAs, establish criteria for AHHA certification, establish criteria for AHHA training programs, and establish AHHA training and competency requirements.  The Education Department intends to adopt these regulations as a permanent rule, having previously published a notice of proposed rulemaking in the June 27, 2018 edition of the NYS Register.

The emergency rule as of effective on September 7, 2018 and expire on November 5, 2018.

These emergency regulations complement the proposed regulations that were advanced by the Department of Health in the May 30, 2018 edition of the NYS Register.  It is important to note that during its September 17 meeting, the NYS Board of Regents approved these proposed regulations following the public comment period.  In its response to public comments, the Education Department appears to interpret the regulations to allow Licensed Home Care Services Agencies (“LHCSAs”) providing services to Assisted Living Program (“ALP”) residents to use AHHAs.  The Department of Health has not yet opined on whether or not they concur with this interpretation.

Legislative Spotlight

Now that the 2018 Legislative session has adjourned, bills that have passed both houses of the Legislature will be delivered to the Governor in “batches” over the next several months.  Once a bill has been delivered to the Governor, he has 10 days (excluding Sundays) to either sign the bill into law or veto the bill.

The following bill was recently delivered to the Governor.

• 10938 Gunther/S.8632 Ortt: This bill would amend the Geriatric Service Demonstration Program to add Mental Health‐Home Care collaboration for the purpose of coordination, integration and improved access of health and mental health services for individuals with co‐occurring mental health and physical health needs.  The Governor must act on the bill by midnight on Monday October 1.

Upcoming Calendar

Wednesday, October 3, 2018	Commissioner’s Medical Grand Rounds: Integration of Primary Care and Behavioral Health 8:00 a.m. to 10:00 a.m. Forchheimer First Floor Lecture Hall 105 – Albert Einstein College of Medicine, 1300 Morris Park Avenue (Belfer 115), Bronx, NY
Friday, October 5, 2018	Continuing Care Retirement Communities (CCRC) Council Regulatory and Framework Improvement Committee 10:00 a.m. – 12:00 p.m. New York State Department of Health, Main Conference Room, 875 Central Avenue, Albany
Tuesday, October 9, 2018	State Health Innovation Plan Council 10:30 a.m. to 2:30 p.m.
Thursday, October 11, 2018	Public Health and Health Planning Council 9:30 a.m. New York State Department of Health Offices at 90 Church Street, 4th Floor, Rooms 4A and 4B, NYC