On November 15, 2019, the U.S. Department of Health and Human Services (HHS) Centers for Medicare and Medicaid Services (CMS) announced final regulations implementing greater price transparency requirements for hospitals. Issued on the heels of a Trump Administration Executive Order directing HHS to propose regulations on increased price transparency, the new regulations modify and finalize CMS’ earlier guidance implementing section 2718(e) of the Public Health Service Act, to further expand price transparency requirements for hospitals. (See our previous analysis of the Executive Order here.) Effective January 1, 2021, the …
Archives: Academic Medical Centers
Subscribe to Academic Medical Centers RSS FeedMassachusetts Board of Registration in Medicine Adds New Physician Credentials Verification Requirement for First Time Licensure
On October 11, 2019, the Massachusetts Board of Registration in Medicine (BORIM) announced a new requirement for initial physician licensure in the state. Effective January 1, 2020, all first-time applicants in Massachusetts will be required to also complete an application through the Federation Credentials Verification Service (FCVS). FRVS’s website indicates it is “a Lifetime Repository of Verified Core Credentials … that can be used for multiple state medical boards.” The new BORIM requirement will require first-time applicants to apply for a verified profile with FCVS that designates BORIM as …
Government Releases Proposed Rules on Physician Self-Referral Law (Stark Law), Anti-Kickback Statute and CMP Law; Significant Regulatory Changes Intended to Encourage Care Coordination and Value-Based Care
On October 9, 2019, the Department of Health and Human Services (HHS) released its long-awaited proposals (the Proposed Rules) to update regulatory exceptions and safe harbors, for the federal Physician Self-Referral Law (also known as the Stark Law), the Anti-Kickback Statute (AKS), and the beneficiary inducement Civil Monetary Penalties Law (CMP). The Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to update exceptions to the Physician Self-Referral Law (the PSR Rule), and the HHS Office of Inspector General (OIG) issued a proposed rule to update the …
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 …
Spurred by Opioid Crisis, Government Proposes Additional Changes to Substance Use Disorder Confidentiality Regulations to Facilitate Provision of Coordinated Care
On August 26, 2019, the Department of Health and Human Services Substance Abuse and Mental Health Services Administration (SAMHSA) published a notice of proposed rulemaking (NPRM) to “better align” its substance use disorder (SUD) confidentiality regulations at 42 C.F.R. Part 2 (Part 2) with the needs of providers and patients, and to “facilitate the provision of well-coordinated care” for individuals with SUD.…
D.C. Circuit Court of Appeals Allows HHS Rule that Includes Payments Received from Third Parties in DSH Payment Cap Calculation
On August 13, 2019, the D.C. Circuit Court of Appeals (the D.C. Circuit) issued an opinion in Children’s Hospital Association of Texas v. Azar (No. 18-5135), allowing the Department of Health and Human Services (HHS) to include payments from third parties, including Medicare and private insurers, in calculations of Disproportionate Share Hospital (DSH) payment caps. The D.C. Circuit had previously ruled against HHS’ implementation of its 2017 rule, which included third-party payments in the calculation of the hospital-specific caps on allowable DSH payments. …
Allscripts Announces $145 Million Preliminary Settlement with DOJ Related to an Investigation of Practice Fusion, a Recently Acquired EHR Company
In its second quarter Securities Exchange Commission (SEC) filing, Allscripts addressed its announced agreement in principle with the Department of Justice (DOJ) to resolve investigations into certain alleged practices of Practice Fusion, an electronic health records (EHR) vendor acquired by Allscripts in February 2018 for $100 million. Allscripts indicated the agreement is still subject to further negotiation and government approval, and would likely include additional non-monetary terms, including a deferred prosecution agreement, if a finalized settlement is reached.…
Connecticut Expands Minors’ Confidential Access to Treatment for HIV and AIDS, Adds Reporting Requirement
On July 1, 2019, Connecticut Governor Ned Lamont signed into law Public Act No. 19-109 “An Act Concerning The Prevention Of The Human Immunodeficiency Virus” (PA 19-109) which increases access to preventative and prophylactic human immunodeficiency virus (HIV) and acquired immune deficiency syndrome (AIDS) interventions for minor patients, and adds two exceptions to the confidentiality requirements for HIV/AIDS treatment of a minor patient. The Act is effective July 1, 2019.…
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 …
Connecticut Enacts Law to Increase Access to Epinephrine Auto Injectors
On June 13, 2019, Connecticut Governor Ned Lamont signed into law Public Act No. 19-19 “An Act Concerning Epinephrine Auto Injectors” (PA 19-19), which went into effect on the same date.
This legislation expands access to epinephrine, which can be lifesaving when treating anaphylactic allergic reactions. PA 19-19 permits “authorized entities” to acquire and maintain a supply of epinephrine cartridge injectors, subject to certain conditions. With a few exceptions, authorized entities are for-profit or nonprofit entities or organizations that employ at least one “person with training.” …
Supreme Court Rejects HHS Proposal that Could Have Significantly Lowered Certain Medicare DSH Payments to Hospitals
In a 7-1 decision released June 3, 2019, the U.S. Supreme Court vacated a proposal of the U.S. Department of Health and Human Services (HHS) that would have had the effect of significantly reducing Disproportionate Share Hospital (DSH) payments to thousands of hospitals for care furnished to low income patients in 2012.
In Azar v. Allina Health Services, Et Al., the Supreme Court held that HHS needed to comply with statutory notice and comment rulemaking procedures under the Social Security Act (Act) when making interpretive changes, because HHS sought …
OIG Approves of Free In-Home Follow-Up Care Program Targeting High Risk CHF and COPD Patients in Advisory Opinion
On March 6, 2019, the U.S. Department of Health & Human Services Office of Inspector General (OIG) issued a favorable advisory opinion that allows a nonprofit medical center (“Center”) to offer free, in-home follow-up care after a recent hospital admission for qualifying patients (the “In-Home Program”). In Advisory Opinion No. 19-03, the OIG concluded that although services furnished to qualifying patients under the In-Home Program would constitute remuneration to patients under the Anti-Kickback Statute (AKS) and the Civil Monetary Penalties law (CMP), the OIG would not impose sanctions on the …
2019 Physician Fee Schedule Rule Review: Supervision Requirements for Radiologist Assistants Reduced
In its 2019 Medicare Physician Fee Schedule Final Rule (PFS Rule), CMS finalized a regulatory change that updates supervision requirements for Registered Radiologist Assistants and Radiology Practitioner Assistants (collectively, RAs) to reduce the level of supervision necessary to perform diagnostic tests reimbursable by Medicare. Specifically, the PFS Rule revises 42 C.F.R. § 410.32(b) to provide that RAs may perform certain diagnostic tests that would otherwise require a personal level of supervision under direct supervision instead, to the extent permitted by state law and regulations.…
OIG Issues Favorable Advisory Opinion for Trust Donations to Public-Private Research Institute Affiliated with a Health System Having Ongoing Business Relationships with Trustee-Owned Long-Term Care Facilities
On November 6, 2018, the Office of Inspector General (OIG) of the Department of Health and Human Services published a favorable Advisory Opinion regarding a proposed arrangement comprised of substantial donations that were earmarked for biomedical research purposes, made by a charitable trust (“Trust”) to a public-private medical research institute (“Research Institute”). The Research Institute had been formed by a health care system (“Health Care System”) and a public university (“University”). In addition, one of the Trustees planned to make a separate, individual donation to the Research Institute, through the …
Laws Affecting Health Care Entities in Connecticut Take Effect October 1, 2018
On October 1, 2018, a number of new laws affecting health care entities in Connecticut became effective. Below please find a brief description of some of the newly-effective provisions, as well as links to our analyses of the changes.…
Congress Considering Legislation Aimed at Curbing Surprise Medical Bills
The United States Senate is currently considering bipartisan legislation that would establish statutory limits on the financial exposure of certain patients to so-called “surprise” medical bills. The proposed legislation would amend the federal Public Health Service Act (at 42 U.S.C. § 300gg-19a) to prohibit surprise balance billing of patients receiving health care services in the following three situations: (1) Emergency services provided by a nonparticipating (i.e., out of network) provider in a nonparticipating facility; (2) Non-Emergency services following an emergency service at a nonparticipating facility; and (3) Non-Emergency services performed …
CMS Revises Hospital Inpatient Admission Order Documentation Requirements
On August 17, 2018, the Centers for Medicare & Medicaid Services (CMS) published its Hospital Inpatient Prospective Payment Systems final rule for Fiscal Year 2019 (Final Rule). The Final Rule contains a number of important updates to Medicare Part A that take effect October 1, 2018.
Among other provisions in the Final Rule, CMS finalized its proposed update of the regulations that govern hospital admissions under Medicare Part A (42 C.F.R. § 412.3). Specifically, the Final Rule revises language in 42 C.F.R. § 412.3(a) to remove the current requirement that …
Medicare Proposes Revised Telehealth Services and Payments
The Centers for Medicare & Medicaid Services (CMS) recently published a Proposed Rule, primarily intended to modify certain Medicare payment policies. The Proposed Rule contains several provisions that address the growing use of telehealth. CMS noted that it had received many suggestions regarding the expansion of access to telehealth as well as appropriate pay for the same, in response to its call for comments in the CY 2018 Medicare physician fee schedule (PFS) proposed rule.…
CMS Announces Change to Student Documentation Requirement Intended to Reduce Burden on Teaching Physicians
On February 2, 2018, the Centers for Medicare & Medicaid Services (CMS) released Transmittal 3971 (Change Request 10412), which revises a section of the Medicare Claims Processing Manual (Manual), that provides guidance regarding billing for Evaluation and Management (E/M) services involving students. According to CMS, the Change Request is part of a broader goal to reduce the administrative burden on practitioners.…
