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CMS grants Massachusetts Section 1135 Waiver, DPH issues Guidance regarding Determination of Need and Nurse Staffing Requirements, and MassHealth Issues Provider and Pharmacy Guidance

In this article, we highlight additional updates issued by state and federal government authorities for the health care community in Massachusetts related to COVID-19. This post addresses the Section 1135 waivers granted by the Centers for Medicare and Medicaid Services (CMS) related to MassHealth and CHIP, Massachusetts Department of Public Health (DPH) orders and guidance regarding Determination of Need and nurse staffing ratios, and MassHealth guidance for providers and pharmacies.

Massachusetts Section 1135 Waiver

On March 26, 2020, CMS issued a Section 1135 Waiver in response to the Massachusetts Executive Office of Health and Human Services’ request for waivers or modifications of certain provisions related to Medicaid, the Children’s Health Insurance Program (CHIP), and Medicare. Although not all requested waivers were addressed or granted, CMS states that it continues to work on the additional waiver or modification requests that are not currently reflected in the approval. CMS also clarifies that the granted waivers apply only to MassHealth and CHIP, as CMS has already issued blanket waivers for certain provisions related to Medicare. See our previous reporting of the blanket Medicare waivers here.

CMS granted the following waivers related to MassHealth and CHIP:

  • Temporarily suspending Medicaid fee-for-service prior authorization requirements.
  • Extending pre-existing authorizations for which a beneficiary has previously received prior authorization through the end of the public health emergency.
  • Suspending pre-admission screening and annual resident review (PASRR) level I and level II assessments for 30 days.
  • Modifying timeframes for state fair hearing requests and appeal timelines.
  • Temporary provider enrollment of providers enrolled in other State Medicaid Agencies (SMAs) and/or Medicare, and other waivers for providers not already enrolled in Medicare or another SMA.
  • Provision of Services in Alternative Settings.
  • State Plan Amendment Flexibilities: Submission Deadline, Public Notice, and Tribal Consultation.

The waivers are effective retroactively on March 1, 2020 and last for the duration of the public health emergency.

DPH Orders Regarding Determination of Need (DoN) Notice Requirements and Nurse Staffing Ratios 

DoN Notice Requirements

On March 24, 2020, DPH Commissioner Bharel issued an Order waiving Determination of Need (DoN) notice requirements in Massachusetts. The Order provides that a DoN notice will not be required for any person seeking approval for a Substantial Capital Expenditure, Substantial Change in Service, or Transfer of Site necessary to address COVID-19, as long as the person applying complies with DPH guidance. Guidance issued by DPH on March 24, 2020, provides that to be exempt from the DoN notice requirements, prior to commencing a Substantial Capital Expenditure, Substantial Change in Service, or Transfer of Site necessary to address COVID-19, a person seeking approval must provide a notification to DPH, signed under the pains and penalties of perjury by either the Chief Executive Officer or board chair, which must include:

  1. The identity of the Applicant and/or Health Care Facility;
  2. A description of the Proposed Project and why it is needed to address the COVID-19 emergency;
  3. The rationale for such service(s) or construction and how without issuance of a Notice of Determination of Need, the public health will be measurably harmed;
  4. An attestation that the facility, service or equipment is intended to be used for the management and treatment of the COVID-19 virus; and
  5. The location and projected costs of the Proposed Project

DPH will review the notices to ensure the proposals relate to the state of emergency. If they do, DPH will confirm the requestor may move ahead with the Substantial Capital Expenditure, Substantial Change in Service, or Transfer of Site. DPH clarifies, however, that for construction or changes in service that are not temporary in nature and will remain in place after the termination of the State of Emergency, DPH may, in its discretion, direct the facility to apply for a full Notice of Determination of Need, including all applicable Factors, on termination of the State of Emergency. The Order is effective for the duration of the Massachusetts state of emergency.

Nurse Staffing Ratios

On March 24, 2020 DPH Commissioner Bharel issued an Order exempting hospitals from the nurse staffing requirements of M.G.L. c. 111, s. 231, which requires that all intensive care units must have a nurse to patient ratio of 1:1 or 1:2 depending on the stability of the patient as assessed by an acuity tool and by the staff nurses in the unit. Per the Order, all hospitals licensed by DPH are exempt from the acuity-assessed staffing and nurse-to-patient ratio requirements in intensive care units. Under the Order, hospitals must still ensure that staffing levels are adequate to meet patients’ needs, and that staff is trained and competent to meet patient needs. The Order is effective for the duration of the Massachusetts state of emergency.

MassHealth Bulletins

MassHealth has issued an all provider bulletin clarifying MassHealth’s Hospital-Determined Presumptive Eligibility (HPE) coverage and two pharmacy facts sheets making exceptions to refill and prior authorization (PA) requirements and chloroquine and hydroxychloroquine prescription practices.  These are described below.

MassHealth All Provider Bulletin 290

This MassHealth All Provider Bulletin 290 supersedes the earlier-issued Bulletin 288 describing the HPE process (see our earlier discussion of that bulletin here).  The bulletin largely restates the requirements of Bulletin 288 but also notes, among other things, “an individual may apply for HPE even if that individual (1) has received MassHealth benefits via HPE within the previous 12 months or (2) was enrolled in MassHealth Standard, MassHealth CommonHealth, MassHealth CarePlus, or MassHealth Family Assistance within the previous 12 months.”

MassHealth Pharmacy Facts Sheet 142

According to MassHealth Pharmacy Facts Sheet 142, MassHealth is:

  • allowing additional exceptions to the 30-day supply limitation described at 130 CMR 406.411(D) for behavioral health medications and schedule IV benzodiazepines and hypnotics to allow for 90-day supply dispensing;
  • removing PA requirements for
    • Aminoglycoside Agents—Inhaled
    • Antibiotics—Oral and Injectable
    • Antifungals—Oral and Injectable
    • Respiratory Agents—Oral and Inhaled
    • Sublocade;
  • extending existing PAs that are due to expire for 60 days;
  • allowing for clozapine refills if current lab results cannot be obtained; and
  • allowing for emergency overrides if a claim is rejected for lack of PA.

MassHealth Pharmacy Facts Sheet 143

MassHealth Pharmacy Facts Sheet 143 states that MassHealth is adopting new policies for prescribing and dispensing chloroquine and hydroxychloroquine. “Pharmacy claims for chloroquine and hydroxychloroquine should process without a new [PA] for individuals with existing prescriptions for lupus, malaria, or rheumatic conditions.” The Pharmacy Facts Sheet further provides that, for individuals who have or are suspected to have COVID-19, or new prescriptions for lupus, malaria, or rheumatic conditions, a PA process must occur before chloroquine or hydroxychloroquine can be dispensed. According to the Pharmacy Facts Sheet, “If a MassHealth member or Health Safety Net patient is approved for COVID-19, pharmacies must dispense up to a 14-day supply.  If a MassHealth member or HSN patient is approved for other diagnoses, pharmacies may dispense up to a 90-day supply if requested by the MassHealth member, HSN patient, or prescriber as long as sufficient quantity remains on the prescription to support the quantity being filled.”

This post was co-authored by Michael Lisitano, legal intern at Robinson+Cole. Michael is not yet admitted to practice law.

Copyright © 2020 Robinson & Cole LLP. All rights reserved.

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About this Author

Anna Gurevich Healthcare Attorney Robinson Cole Law Firm
Associate

Anna Gurevich advises hospitals, physician groups, community providers, and other health care entities on a variety of health law and general business issues. She is a member of the firm's Health Law Group. Her practice focuses on counseling health care providers in complex business arrangements and regulatory issues. Prior to joining Robinson+Cole, Anna worked at a health care law firm and a large academic medical center. 

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