MSLaw Blog

Senior leaders from across the health care industry gathered at The Center Club in Baltimore for last week’s Hot Topics in Health Care program and reception, presented by the Miles & Stockbridge Health Care Group. The event brought together executives from hospitals, physician networks, insurers, digital health companies, regulatory bodies, financial institutions and advisory firms, and featured two fireside chats on key issues reshaping Maryland’s health care landscape, with networking receptions before and after. Molly Ferraioli moderated the first fireside chat,

Despite the numerous pivots in the Department of Justice's focus over the past year, one priority remains constant: identifying “waste, fraud, and abuse, including health care fraud and federal program and procurement fraud that harm the public fisc.” Indeed, the Criminal Division identified this as its No. 1 priority last year. Subsequently, DOJ announced the formation of a DOJ-HHS False Claims Act Working Group signaling a coordinated, cross-agency approach with the Department of Health and Human Services (HHS) to rooting

The U.S. Supreme Court agreed last week to permit the National Institutes of Health (NIH) to terminate hundreds of grants related to diversity, equity and inclusion (DEI) initiatives worth approximately $800 million. The order was issued in response to the government’s emergency request to stay a lower court injunction barring the termination of the grants. The Supreme Court held that suits challenging these terminations must be brought before the Court of Federal Claims (CFC) and that, conversely, the federal district

U.S. Attorney General Pam Bondi recently issued new guidance aimed at clarifying the current administration’s stance on the permissibility of diversity, equity and inclusion policies and procedures under federal anti-discrimination laws such as Title VII of the Civil Rights Act of 1964 and Title IX of the Education Amendments Act of 1972 – particularly among entities that receive federal funding, such as schools, universities, state and local governments, health care providers, nonprofits and other private employers. In its guidance, the Department

The Centers for Medicare and Medicaid Services (CMS) published its proposed 2026 Medicare Physician Fee Schedule on July 14. The agency’s announcement emphasized “significantly cutting spending waste, enhancing quality measures, and improving chronic disease management for people with Medicare.” While the fee schedule is still under review, and CMS is soliciting suggestions and public comment, health care providers should familiarize themselves with what CMS has proposed. Here are some key highlights. Enhancing Payment & Quality Measures: Revised Physician Payment Rates & Telehealth

The Department of Justice (DOJ) recently issued its annual Health Care Fraud Takedown results, announcing a record-breaking 324 defendants, including 96 doctors and licensed professionals, as well as more than $14.6 billion in intended loss. While the large figures grab attention, an analysis of the DOJ’s statements offers important insight for American health care professionals and companies: Despite various executive orders and policy changes with the new administration, the DOJ and other government agencies continue to focus significant resources on

The Maryland General Assembly’s 2025 legislative session concluded with a few impactful health care bills. The two bills below, signed into law by Gov. Wes Moore on Tuesday, represent significant steps in improving health care accessibility and affordability for Maryland residents. Lowering Prescription Drug Costs for All Marylanders Now Act This bill increases the authority of Maryland’s Prescription Drug Affordability Board. Created by the General Assembly in 2019, the board was the nation’s first independent body with authority to review affordability

Executives, general counsel and administrators of hospitals, physician groups, long-term care communities and other health care providers attended last week’s Hot Topics in Health Care Law seminar, presented by the Miles & Stockbridge Health Care Group. The event featured a panel discussion, moderated by Lisa Keenan and Molly Ferraioli, with three industry experts offering their thoughts on the rapidly evolving landscape of health care law: Cathy Hamel, president of Gilchrist Hospice, the largest provider of serious illness, hospice and palliative care

The short-term spending bill President Donald Trump signed into law last month included the extension of several telehealth waivers by entering a new termination date of Sept. 30 into the existing law. These waivers, called “flexibilities” by Congress, were first created in response to the COVID-19 public health emergency to allow Medicare beneficiaries to receive care by telehealth, mitigating the risk of the virus spreading. These flexibilities have been temporarily extended since the end of the federal emergency in 2023.

The Equal Employment Opportunity Commission (EEOC) recently issued guidance to assist health care providers in addressing their patients’ needs for accommodation under the Pregnant Workers Fairness Act (PWFA). The PWFA requires employers with 15 or more employees to provide reasonable accommodations for employees with known limitations related to or arising out of pregnancy, childbirth and related medical conditions, unless the accommodation will cause the employer an undue hardship. The EEOC’s guidance is intended to aid health care providers in understanding

The Maryland Department of Health (MDH) released an updated policy manual at the end of September for the 2025 Conrad 30 Waiver Program application cycle, which opened Oct. 1. Changes include an online-only submission process, flexibility for the three-providers- per-practice-site limitation, and guidance regarding telehealth. The Conrad 30 program is one avenue for an immigrant physician to obtain a waiver of the two-year home residency requirement and help alleviate the physician shortage in the United States. (For an overview of the

As of Oct. 1, health care providers in Maryland must maintain patient medical records and laboratory and X-ray reports for at least seven years after the records and reports are created. The new law increases the record-retention requirement from five years. For a minor patient, records and reports must be maintained until the minor patient reaches the age of majority plus seven years, which for most patients will be when they are 25 years old. Health care providers, which include hospitals

The CMS Innovation Center (CMMI) continues to prepare for its next episode-based alternative payment model, the Transforming Episode Accountability Model, or TEAM for short. This five-year model will offer both incentive payments for meeting a pre-determined target price and downside risk to TEAM hospitals that exceed that target price. TEAM will be a mandatory program for almost 750 hospitals selected by CMMI in specific geographic areas, including Washington, D.C., northern Virginia, Connecticut, Vermont and the greater New York City/New Jersey area.

The Miles & Stockbridge Health Care Practice Group hosted its inaugural Hot Topics in Health Care Law seminar last month for clients from Maryland and beyond. Miles & Stockbridge health care lawyers kicked off the seminar with a year in review, which covered topics including recent appellate cases and legislation impacting health care, consolidation in the health care market, the current state of Medicare telehealth rules, website tracking technologies and HIPAA breaches and enforcement. The seminar finished with an engaging panel

Maryland health care employers and J-1 physicians who commit to serve the underserved in Maryland and who missed Conrad 30 waiver application deadline Dec. 1 are in luck: The Maryland Department of Health (MDH) has reopened its application period! Physicians who completed graduate medical education in J-1 status now have additional time to secure a clinical service waiver of the two-year home residence requirement to provide medical services in Maryland. MDH received fewer than 30 Conrad waiver applications prior to the

The Centers for Medicare & Medicaid Services (CMS) published a Request for Information (RFI) on July 18 regarding the design of a future, episode-based payment model on behalf of CMS’s Center for Medicare and Medicaid Innovation (the Innovation Center). Comments in response to the RFI should be submitted by Aug. 17 either online or by mail. The Innovation Center seeks information from the public to supplement its previous experience with other episode-based payment models, like the Bundled Payment for Care Improvement

Over the past three years, employers have grappled with how best to respond to various workplace issues caused by the COVID-19 pandemic. Many of the protocols employers put in place relied heavily upon guidance issued by the Centers for Disease Control, National Institutes of Health and other federal, state and local government authorities during the COVID-19 national emergency (NE) and public health emergency (PHE). Now that the Biden administration has announced its plan to officially end both the NE and PHE

The federal Provider Relief Fund (“PRF”) continues to render financial assistance to medical providers that offer diagnoses, testing or treatment of individuals with possible or actual cases of COVID-19. To date, the U.S. Department of Health and Human Services has distributed over $19 billion to help medical professionals prevent, prepare for, and respond to the coronavirus. PRF distributions are subject to certain terms and conditions, and reporting requirements if a specific distribution exceeded $10,000. Providers who fail to agree to

Maryland health care employers and J-1 physicians who commit to serve the underserved in Maryland and who missed the Dec. 1 J-1 Conrad 30 waiver application deadline are in luck: The Maryland Department of Health (MDH) has reopened its application period! Physicians who completed graduate medical education in J-1 status now have additional time to secure a clinical service waiver for the two-year home residence requirement to provide medical services in Maryland. MDH received 24 Conrad waiver applications prior to the

Earlier this year, the Southeast Crescent Regional Commission (SCRC), a federal-state partnership to alleviate economic and poverty issues, opened a J-1 waiver program, accepting applications for physicians of all medical specialties and subspecialties for positions at sites in designated underserved areas across the southeastern United States. This program significantly increases access to medical care in all of Florida and parts of Alabama, Georgia, Mississippi, North Carolina, South Carolina, and Virginia. Selection for a waiver spot is the first step to securing

The Maryland Department of Health (MDH) recently released its July 2022 Maryland Conrad 30 (J-1 Visa Waiver) Program Policy and Procedures. This policy is effective October 1, 2022 for the 2023 fiscal year. The Conrad 30 (J-1 Visa Waiver) program allows qualified foreign medical graduate (FMG) physicians to apply for a waiver of the 2-year foreign residence requirement. Recipients of a Conrad waiver remain in the United States to provide essential healthcare services in underserved areas of the United States. The

On June 24, 2022, the U.S. Supreme Court decided Becerra v. Empire Health Foundation and resolved a split between the U.S. Courts of Appeal for the 6th, 9th and District of Columbia Circuits in favor of how the Department of Health and Human Services (“HHS”) determines disproportionate share hospital (“DSH”) payments. The Medicare program accounts for the costs incurred by hospitals that serve a higher proportion of low-income patients by making DSH payments to those hospitals. The Medicare program calculates the DSH payment

The federal False Claims Act results in a host of interesting relator claims. This one caught my eye. In United States of America v. Intermountain Healthcare, Inc., Case No. 2:20-cv-00372-TC-CMR (U.S. Dist. Ct. D. Utah 1/28/2022), the relator alleged that anesthesiologists participating in his medical group often spent time during surgeries playing on their phones or other personal electronic devices. Some allegedly watched football, others paid bills. Naturally, the relator alleged that the anesthesiologists were not paying attention to their

Medical providers often are left confused by the incredibly complex statutory and regulatory body of law implemented by the Centers for Medicare and Medicaid Services (CMS). Without further administrative guidance, providers are left to their own conclusions with regard to what CMS intended. Unfortunately, sometimes these decisions lead to expensive and time-consuming False Claims Act litigation brought by relators, who disagree with the provider’s interpretation. In a recent decision, the Fourth Circuit offers some well-deserved protection from False Claims Act actions

When can a data breach can get worse? When the process of notifying victims creates a second breach. Take the example of a cancer treatment center that recently paid $425,000 to settle allegations that included a faulty notification process following a breach. The story provides an important lesson. One Breach Leads to Another It began with a spear phishing attack. Employees at the facility fell victim to the attack and their email accounts were compromised. The result: protected health information and other

The Department of Justice (DOJ) recently overturned the prior administration’s limitations on the use of regulatory guidance in False Claims Act (FCA) litigation. Now, DOJ attorneys may rely on guidance documents “in any appropriate and lawful circumstances.” How should compliance programs respond to the resurgence of the regulators in the ongoing FCA wars? Background Former Attorney General Jeff Sessions initiated the limitation on the use of regulatory guidance in the prior administration with his Memo dated November 16, 2017. His mandate prohibited “Improper Guidance

J-1 exchange visitors who received graduate medical education or training in the U.S. are subject to the two-year foreign residence requirement under Section 212(e) of the Immigration and Nationality Act (INA).  This requirement means that, upon completion of medical training, the J-1 physician must return to his/her home country (or country of last permanent residence) for a period of at least two years in the aggregate before being eligible for certain nonimmigrant work visas, such as H-1B, or legal permanent

It’s no secret that the Health Insurance Portability and Accountability Act of 1996 (HIPAA) exists to protect the privacy of patients and their sensitive health information. However, understanding the importance of HIPAA compliance and the potential consequences of violations also can help protect the health care providers who care for them. With this in mind, we are pleased to share a recap of five key areas important for health care providers of all shapes and sizes. The HIPAA Security Rule places

The Office of Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS) jointly published final rules that expand upon and modify regulatory safe harbors and exceptions to the Anti-Kickback Statute and the Ethics in Patient Referrals Act (the Stark law), respectively. This article will address each rule and focus on the exceptions and safe harbors applicable to value-based arrangements. Stark Law Final Rule: Value-Based Arrangements The Stark law prohibits physicians from referring patients to receive certain designated health services

Earlier this week, the Center for Medicare & Medicaid Services (CMS) revised its previous guidance concerning nursing home visits, and—in much welcome news to residents and their loved ones—is instructing nursing homes to allow indoor visits effective March 10, 2021. Because the population of nursing homes is particularly at risk for COVID-19 infection, CMS first severely restricted visits in long-term care settings on March 13, 2020, in the early stages of this pandemic. In guidance released in September 2020, CMS updated its

A medical device manufacturer learned what might seem an obvious lesson when it paid $18 million to settle a False Claims Act lawsuit brought by its former Compliance Officer: don’t ignore your compliance officer. The federal government received $15.21 million; state governments received $2.79 million; and the whistleblower received $2.65 million of the federal share. The company, Merit Medical Systems, Inc. (MMS), also must pay attorneys’ fees due to the whistleblower’s counsel and enter into a five-year Corporate Integrity Agreement with the

The Department of Justice recently announced the results of its 2020 National Health Care Fraud and Opioid Takedown. This annual DOJ tradition, aimed at targeting and arresting individuals for health care fraud abuse, resulted in the filing of criminal charges against more than 50 doctors and more than 20 health care executives. Prosecutions spanned the country, including more than 50 federal districts and 40 U.S. Attorney’s Offices. FY2020’s efforts represent “the largest amount of fraud ever charged by the department

A look at selected soon-to-be-reported decisions on various False Claims Act issues. This month we can glean three quick lessons: 1) A lesson for corporate executives: If you are the owner/CEO, don’t transfer company funds to your personal bank account, particularly if the funds represent Medicaid payments received from inappropriately submitted claims. A home health care company, with a single owner/CEO and six employees, allegedly submitted claims for reimbursement to the D.C. Medicaid program for services provided to patients without adequate documentation of

On August 3, 2020, a federal court in the Southern District of New York overturned key provisions of the Families First Coronavirus Response Act (FFCRA)—the federal law requiring certain employers to provide eligible employees with emergency paid sick leave (EPSL) and expanded family and medical leave (EFML) for specified reasons related to COVID-19—significantly broadening employee eligibility to receive emergency leave under the Act. The unexpected decision came in response to a challenge by the state of New York, which sought

Governor Larry Hogan, the Maryland Department of Health (MDH) and the state’s long-term care provider community continue to take aggressive steps to combat COVID-19 in nursing homes and other long-term care settings. Most recently, on April 29, 2020, Governor Hogan issued Executive Order Number 20-04-29-01, which amended and restated all previous orders for nursing homes and other senior facilities and imposed new strict compliance requirements. The MDH published a new accompanying Directive and Order further clarifying the requirements from the Governor’s Executive

On April 17, 2020, the Centers for Medicare and Medicaid Services (CMS) issued an MLN Matters Special Edition Article with additional guidance for rural health clinics (RHCs) and federally qualified health centers (FQHCs) during the COVID-19 public health emergency (COVID-19 PHE). The Coronavirus Aid, Relief, and Economic Security Act (CARES Act), which was signed into law on March 27, 2020, permits RHCs and FQHCs to furnish distant site telehealth services to Medicare beneficiaries during the COVID-19 PHE. Prior to the CARES

CMS continues to issue revised guidance to health care providers to assist them with dealing with the COVID-19 crisis, including blanket waivers of CMS’s conditions of participation (“CoPs”). New guidance published from CMS’s Center for Clinical Standards and Quality/Quality, Safety and Oversight Group expands these waivers to licensed independent freestanding emergency departments by allowing them to enroll as a Medicare/Medicaid-certified hospital and bill for both inpatient and outpatient services. Freestanding emergency departments (IFEDs) are state-licensed emergency departments that are unaffiliated with hospitals.

On March 30, 2020, the Secretary of the Department of Health and Human Services (HHS) acted pursuant to the declared COVID-19 public health emergency and granted blanket waivers—effective March 1, 2020—of certain provisions of Section 1877(g) of the Social Security Act, otherwise known as the Physician Self-Referral (or “Stark”) Law. The Stark Law prohibits a physician from making referrals for certain designated health services payable by Medicare to an entity with which he or she (or an immediate family member) has

Governor Hogan, in conjunction with the Maryland State Department of Education (MSDE), has taken action to ensure that child care is available and free for essential personnel during the pandemic. Initially, Governor Hogan permitted MSDE to waive certain regulations so that child care centers would have capacity to accommodate children of emergency workers. However, last week, Governor Hogan and MSDE went further and ordered all child care centers to close unless the centers provide services to “essential persons.” The Executive

On March 22, 2020, the Centers for Medicare & Medicaid Services (CMS) implemented substantial administrative relief for clinicians, providers and facilities participating in Medicare quality reporting programs, including widely implemented programs like Medicare Shared Savings Program Accountable Care Organizations (ACOs) and the Merit-based Incentive Payment System (MIPS). These measures include extensions of deadlines and delays in reporting requirements for certain quality programs in order to alleviate the administrative burden on health care providers during the COVID-19 crisis. For example, CMS

On March 23, 2020, the Maryland Secretary of Health issued an Order and Directive (the “Directive”) that addresses a number of different health care issues for the prevention and control of COVID-19. One area addressed is the postponement of elective surgery. The Directive orders all Maryland licensed hospitals, ambulatory surgery centers and other licensed health care facilities to cease all elective and non-urgent medical procedures effective as of 5 p.m. on Tuesday, March 24, 2020, and to not permit any

As of March 18, 2020, Maryland regulators have temporarily suspended certain child care licensure requirements in order to expand access to child care for school-age children of “emergency personnel.”  The state has identified “emergency personnel” as employees who work in hospitals and first responders such as fire, police, doctors and nurses.  The State Superintendent of Schools for the Department of Education (the state agency responsible for licensing child care centers) took this action in response to the Executive Order issued

The Telehealth Services During Certain Emergency Periods Act of 2020 (the “Act”) is part of the larger bipartisan Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020.  The Act gives the Secretary of the Department of Health and Human Services (HHS) the authority to waive certain existing limitations on Medicare coverage and payment for telehealth services furnished to Medicare beneficiaries, making it easier for seniors to receive telehealth services from their homes and through the use of their smartphones. The Act

On March 13, 2020, President Trump declared a national state of emergency as a result of the coronavirus (COVID-19) outbreak.  Regardless of the intensity of the emergency from COVID-19 in a particular area, the President’s declaration allows the federal government, under Section 1135 of the Social Security Act, to waive many of the day-to-day requirements imposed on health care providers by Medicare, Medicaid and the Children’s Health Insurance Program. Additionally, health care providers now have an opportunity, either collectively or

CMS issued guidance on March 9, 2020, that allows hospitals to set up alternative screening sites on campus and at off-campus, hospital-controlled sites.  The guidance provides the following options:  Alternative Screening Sites On-Campus – The guidance states that the medical screening exam (MSE) that hospitals are required to provide to every patient that presents to the emergency department (ED) is not required to take place in the ED; hospitals may set up alternative sites on campus to perform the MSEs, including

The Centers for Medicare and Medicaid Services (CMS) recently issued guidance in response to questions from the hospital provider community concerning Coronavirus Disease (COVID-19).  CMS provides useful guidance on some of the more mundane, daily administrative aspects of care, while reminding hospitals that the Centers for Disease Control and Prevention (CDC) provides critical guidance for clinical decisions. Some key elements from CMS, as they relate to essential patient rights such as access to care, visitation, and discharge, include the following:  1.    Should COVID-19

While there are many unanswered questions about COVID-19, or coronavirus, one thing is very clear --- older people and those with pre-existing medical conditions are most vulnerable to infection and related adverse outcomes.  COVID-19 is presenting novel challenges for all segments of our society, but the response of long term care providers literally can be a matter of life and death because of the unique vulnerability of residents. In an effort to assist long term care providers, the Centers for Disease