On March 23, 2020, the Centers for Medicare & Medicaid Services (CMS) announced that, effective immediately, it is temporarily postponing routine facility inspection and focusing on infection control and situations involving Immediate Jeopardy (where patient safety is placed in imminent danger). CMS is rolling out a new focused survey and inspection process to assess whether facilities are prepared for COVID-19, and has published a fact sheet describing the initiative. This will apply to inspections of all Medicare and Medicaid certified provider and supplier types across the country, such as long term care facilities (nursing homes), hospitals, and CLIA laboratories.
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Home Health Agencies
Massachusetts Issues New COVID-19 Guidance and Updates
Massachusetts government agencies have issued recent guidance and updates concerning the COVID-19 emergency. A summary is provided below.
Allowing Health Care Personnel with Potential Exposure to COVID-19 to Continue to Work
On March 19, the Massachusetts Department of Public Health issued the following Guidance for Health Care Personnel with Potential Exposure to Patients with COVID-19…
HHS Issues Section 1135 Waiver, and CMS Issues Blanket Waivers of Health Care Laws, in Response to Coronavirus (COVID-19) Emergency
Following the President’s proclamation on March 13 that the COVID-19 outbreak constitutes a national emergency, Secretary of the Department of Health and Human Services (HHS) Alex Azar issued a Waiver or Modification of Requirements Under Section 1135 of the Social Security Act (full text available here) that waives or modifies certain health care laws and regulations in connection with the COVID-19 pandemic. This “1135 Waiver” applies nationwide and took effect on March 15 at 6:00 p.m., but its applicability is retroactive to March 1, 2020. The 1135 Waiver applies for a period of 60 days (subject to extension by the Secretary for successive 60-day periods) or for the duration of the COVID-19 national emergency (if earlier), except the waiver of the HIPAA Privacy Rule described below applies for only 72 hours following a hospital’s implementation of its disaster protocol.
Continue Reading HHS Issues Section 1135 Waiver, and CMS Issues Blanket Waivers of Health Care Laws, in Response to Coronavirus (COVID-19) Emergency
New York DOH Proposed New Licensure Regulations for LHCSAs to be Effective April 1, 2020
The New York Department of Health (DOH) proposed amendments and additions to 10 NYCRR 765 that would amend application processes for Licensed Home Care Services Agencies (LHCSA). These regulatory changes stem from the 2018 NY State budget, which established a two-year moratorium on LHCSA applications and stipulated certain changes to licensure requirements. If finalized, the proposed regulations will create new public need and financial feasibility requirements for LHCSA applications, in addition to the existing character and competence requirement, and will change what constitutes an application amendment requiring the approval of the Public Health and Health Planning Council (PHHPC).
Continue Reading New York DOH Proposed New Licensure Regulations for LHCSAs to be Effective April 1, 2020
CMS Finalizes 2020 Home Health Agency Payment and Policy Changes
On October 31, 2019, the Centers for Medicare and Medicaid Services (CMS) finalized its 2020 payment and policy changes rule for Home Health Agencies (HHA Rule). The final rule is scheduled to be posted in the Federal Register on November 8, 2019 (see the since published rule), and allows for comments until December 30 in advance of its January 1, 2020, effective date. The HHA Rule makes changes to the Home Health Prospective Payment System (HH PPS), including the implementation of the Patient-Driven Groupings Model (PDGM), and makes other policy changes for home health agencies to the Home Health Value-Based Purchasing (HHVBP) Model and the Home Health Quality Reporting Program (HH QRP). These changes further the shift to a value-based payment system focusing on patient need over volume of care.
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CMS Passes Final Rule Reducing Regulations Burdensome on Health Care Providers
The Centers for Medicare and Medicaid Services (CMS) is moving forward with its Patients over Paperwork initiative, which was created in accordance with President Trump’s Executive Order directing federal agencies to reduce burdensome regulations in order to improve the patient and provider experience, and the health care system as a whole. On September 26, 2019, CMS passed the Omnibus Burden Reduction (Conditions of Participation) Final Rule (Final Rule), with the goal of removing CMS regulations that have become extraneous or burdensome on health care providers, allowing providers to increase and improve focus on patients. CMS estimates savings resulting from the Final Rule will be 4.4 million hours of time, and $800 million annually. The Final Rule was published on September 30, 2019, and goes into effect 60 days thereafter. Hospitals and Critical Access Hospitals (CAHs), however, have six months to implement antibiotic stewardship programs and CAHs have eighteen months to implement Quality Assessment and Performance Improvement (QAPI) programs.
Continue Reading CMS Passes Final Rule Reducing Regulations Burdensome on Health Care Providers
Connecticut Legislature Modifies Public Health Statutes
On July 9, 2019, Connecticut Governor Ned Lamont signed into law Public Act No. 19-118 “An Act Concerning the Department of Public Health’s Recommendations for Various Revisions to the Public Health Statutes” (PA 19-118). Certain relevant provisions of PA 19-118 are described below.
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Connecticut Enacts Budget that Includes Provisions Affecting Health Care Providers
Connecticut Governor Ned Lamont recently signed into law Public Act No. 19-117 (PA 19-117), which contains provisions affecting health care providers, including revisions to the hospital provider tax, a prohibition on non-compete agreements for home care workers and an expansion to Connecticut’s current surprise bill law. Highlights of PA 19-117, including the effective dates for each provision, are described below.
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Connecticut Legislature Modifies Statutes Relevant to Preventing and Treating Opioid Use Disorder
On July 9, 2019, Connecticut Governor Ned Lamont signed into law Public Act No. 19-191 “An Act Addressing Opioid Use” (PA 19-191). PA 19-191 makes various revisions to Connecticut’s opioid use prevention and treatment statutes, and also creates new legislation pertaining to opioid use prevention and treatment.
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Connecticut Legislature Permits Facilities to Administer Emergency Medication to Defendants Without Consent in Limited Circumstances
On July 1, 2019, Connecticut Governor Ned Lamont signed into law Public Act No. 19-99 “An Act Concerning the Recommendations of the Department of Mental Health and Addiction Services Regarding Emergency Medication” (PA 19-99). PA 19-99 went into effect on the same date.
Existing law provides for certain court procedures a facility must follow in order to provide treatment without informed consent for psychiatric disabilities to defendant patients in the custody of the Department of Mental Health and Addiction Services. A facility includes any inpatient or outpatient hospital, clinic or other facility for the diagnosis, observation or treatment of persons with psychiatric disabilities. For patients incapable of giving informed consent, the facility can petition the probate court for the appointment of a conservator with limited powers, who would have the specific authority to give or withhold informed consent to the administration of medication on behalf of the patient. For patients capable but unwilling to give informed consent, the facility can petition the probate court to authorize the treatment.
Continue Reading Connecticut Legislature Permits Facilities to Administer Emergency Medication to Defendants Without Consent in Limited Circumstances