Health Law Advisor

HRSA’s “Audit Reporting Requirement Attestations” arrived in inboxes on Friday, March 22, 2024, and require a response by Friday, April 5, 2024.  The government is under pressure to show that the money distributed under the CARES Act and the American Rescue Plan was used responsibly.  These notices are frustrating and frightening, and a two-week turnaround may seem a bit callous, but the situation could certainly be worse—the government could have simply demanded a return of the funds.  If an organization expended more than $750,000 in a single fiscal year and does not comply ...

On December 6, 2023, Senate Budget Committee Ranking Member Chuck Grassley (R-Iowa) and Chair Sheldon Whitehouse (D.-R.I.) announced a new bipartisan investigation into private equity ownership in hospitals—just ahead of a new plan by the Biden-Harris Administration to crack down on anticompetitive practices in health care.

Under the Biden plan, announced December 7, the Department of Justice (DOJ), the Federal Trade Commission (FTC), and Department of Health and Human Services (HHS) will seek input on how private equity is affecting the health care of Americans and the ...

Beginning June 21, 2023, New York State (NYS) Public Health Law (PHL) Section 2830 requires hospitals and healthcare professionals to provide written notice to patients before the patient is charged a facility fee.

Overview of Hospital Billing

Billing by hospitals and certain medical facilities typically involves a combination of a facility fee and a professional fee. Facility fees account for the overhead costs of maintaining a hospital, or other health care facility, and refer to the payments for services provided by the hospital, or other health care facility, for either ...

It is axiomatic that New York State requires every Medicaid provider to have an “effective” compliance program.  New York Social Services Law § 363-d.  In July 2022, the New York State Office of the Medicaid Inspector General (“OMIG”) proposed extensive modifications to the regulatory requirements governing compliance programs for entities receiving “significant” Medicaid revenue (increased by these regulations from a threshold of $500,000 to $1 million).  These regulations were proposed to implement portions of the New York State 2020-2021 Budget Bill ...

New York recently enacted new legislation that will amend Article 45-A of the New York Public Health Law, entitled “Disclosure of Material Transactions”.  Although the legislation, as enacted, contains no description of legislative intent, the budget bill language originally proposed referenced concerns with the “proliferation of large physician practices being managed by entities that are investor-backed” (e.g., private equity platforms) and which are otherwise unregulated by the state outside of the licensure of the individual practitioners.

Effective August 1, 2023, the new legislation requires thirty (30) days advance notice to the New York State Department of Health (“Department”) of any “material transactions” involving “health care entities” that provide administrative or management services for physician practices, provider-sponsored organizations, health insurance plans, “or any other kind of health care facility, organization, or plan providing health care services. . . .”   

Throughout the course of the pandemic, the Health Resources and Services Administration (HRSA) distributed $178 billion in Provider Relief Funds (PRF) to hospitals and health care providers.  The Public Health Emergency has ended, and HRSA is now turning an eye to how the money was spent, and whether it was spent properly. 

PRF funds were distributed with nearly no-strings-attached; hospitals and providers had to simply agree to a few terms and conditions.  Yet a number of facilities and providers have received one of two types of letters from HRSA: (1) a Final Repayment Notice stating the money must be returned, or (2) a letter stating that HRSA will be conducting an audit.  

Revisions to Ohio’s Health Care Services rules have been in the works since last September, as part of the required five-year of review Ohio Administrative Code Chapter 3701-84 by the Ohio Department of Health (ODH). Without much publicity, the finalized rules became effective on May 15, 2023. 

“Health Care Services” include: (1) adult cardiac catheterization; (2) adult open heart surgery; (3) pediatric cardiac catheterization; (4) pediatric cardiovascular surgery; (5) pediatric intensive care; (6) a linear accelerator, cobalt radiation, or gamma knife service; (7) solid organ transplant services, and (8) blood and bone marrow transplant service. The revised Health Care Services rules make changes to nearly every regulation in Chapter 3701-84, many of a substantial nature. 

Of particular interest to Ohio hospitals, changes to the adult cardiac catheterization services requirements include:

In this episode of the Diagnosing Health Care Podcast:  A complex landscape of state laws overlays the direct access testing model, ranging from physician order requirements, such as telemedicine standards and the corporate practice of medicine doctrine, to specimen collection considerations, including how the varying options for collection could impact a model.

How do these factors combine to create a roadmap for companies navigating the direct access testing industry?

In this episode of the Diagnosing Health Care Podcast:  In the aftermath of the Dobbs v. Jackson Women’s Health Organization decision, important questions have emerged about the current legal and regulatory landscape surrounding patient access to drugs that have historically been used to induce abortions.

How can health care providers and pharmacies navigate these new restrictions?

On April 14, 2022, the Centers for Medicare & Medicaid Services (CMS) issued new guidance on the Independent Dispute Resolution (IDR) process, created under the No Surprises Act (NSA) to provide a mechanism for payers and providers to resolve disputes as to appropriate payment amounts for certain out-of-network claims. In addition, the Departments of Health and Human Services, Labor and the Treasury launched two online portals– one to host the IDR process for providers and payers and one to host the patient-provider dispute resolution process for self-pay and uninsured patients.

This new guidance replaces earlier instruction from the agency on how the IDR process would operate and what the independent arbitrator was required to consider. The prior guidance was withdrawn after a successful legal challenge to the interim final rule implementing the No Surprises Act provisions on the IDR process, specifically with respect to the weight to be given to the Qualifying Payment Amount (QPA). The QPA is essentially the payer’s median contracted rate for similar services. The QPA is used to calculate patient cost sharing and must be considered by the independent arbitrator in resolving a payment dispute between a payer and an out-of-network provider. Initially, regulators directed arbitrators to use the QPA as a baseline, and when choosing between the parties’ proposed payment offers to choose the amount closest to the QPA unless one of the parties submitted credible information demonstrating that the appropriate payment amount was materially different from QPA.

On April 7, 2022, the Centers for Medicare and Medicaid Services (CMS) issued guidance terminating numerous blanket waivers applicable to skilled nursing facilities (SNFs), inpatient hospices, intermediate care facilities for individuals with intellectual disabilities (ICF/IIDs), and end stage renal disease (ESRD) facilities.  The amount of blanket waivers ending is notable; while there have been terminations of waivers previously, these were usually limited to a single waiver.

CMS expressed concern “about how residents’ health and safety has been impacted by the regulations that have been waived, and the length of time for which they have been waived.” CMS reported that findings from onsite surveys at these facilities “revealed significant concerns with resident care that are unrelated to infection control.” Accordingly, CMS is acting to remove certain operational flexibilities not directly related to infection control.

In this episode of the Diagnosing Health Care Podcast:  This term, the Supreme Court of the United States is set to rule in a Medicare reimbursement case that has sparked a fresh look at the historical deference often granted to agencies and whether it should remain, be modified, or even be overruled.

Attorneys Stuart Gerson, Robert Wanerman, and Megan Robertson discuss why Chevron deference matters to health care industry stakeholders and what aspects of deference arguments should be in focus as these cases progress.

The Diagnosing Health Care podcast series examines the ...

On February 4, 2022, the Centers for Medicare and Medicaid Services (CMS) issued important updated guidance in a memo (QSO-21-08-NLTC) regarding how acute and continuing care facilities—including hospitals, ambulatory surgical centers, end-stage renal disease facilities, home health agencies, and hospices—manage infection control procedures in light of the COVID-19 public health emergency.

On September 30, 2021, the federal Departments of Treasury, Labor, and Health and Human Services issued “Requirements Related to Surprise Billing; Part II,” the second in a series of interim final regulations (the “Second NSA Rules”) implementing the No Surprises Act (“NSA”). This new federal law became effective for services on or after January 1, 2022.

In this episode of the Diagnosing Health Care Podcast:  The Biden administration has released a series of rules and guidance to implement the No Surprises Act, which went into effect on January 1. All providers and facilities must now provide a good faith estimate to uninsured and self-pay patients scheduling appointments for services or upon request.

In this episode of the Diagnosing Health Care Podcast:  The No Surprises Act (NSA) will go into effect on January 1, 2022. Since our last episode on the topic, the federal government has issued additional interim final rules and guidance to implement the NSA, including the second interim final rule. In addition to describing how the NSA interacts with the plan external review procedures, the second interim final rule describes the independent dispute resolution (IDR) process and how the IDR’s determination is made.

Attorneys Helaine Fingold, Lesley Yeung, and Alexis Boaz dive into how these changes impact entities subject to the NSA’s balance billing prohibitions.

From our Thought Leaders in Health Law video series:  Is your organization ready for the No Surprises Act (NSA)? The law goes into effect January 1, 2022, and contains a new federal ban on surprise billing as well as new disclosure requirements.

The NSA applies to certain payors, providers, facilities, and ancillary service entities that support patients who receive emergency services or other non-emergency services at certain facilities, such as hospitals, hospital outpatient departments, and ambulatory surgical centers.

On November 12, 2021, the Centers for Medicare and Medicaid Services (“CMS”) released final guidance confirming that hospitals can be co-located with other hospitals or healthcare providers.

CMS’ aim for the guidance is to balance flexibility in service provision for providers with ensuring patient confidence in CMS’ quality of care oversight functions.

The final guidance provides direction to state surveyors in the evaluation of a hospital’s compliance with the Medicare Conditions of Participation (“CoPs”) when it is sharing space or contracted staff through service arrangements with another co-located hospital or healthcare provider.  CMS also reiterated a key tenet of co-location arrangements: that each provider must independently meet its applicable CoPs, but, overall, the final guidance is less prescriptive than the draft guidance CMS released in May 2019, and in its wake raises new questions for providers.

In this episode of the Diagnosing Health Care Podcast:  We’re beginning to see how mergers and acquisitions in the hospital industry are being impacted by President Biden’s executive order promoting competition in the American economy. The Federal Trade Commission recently announced policy changes, and the Department of Justice has been asked to consider policy changes, that boards of directors and C-suite officers must take into account when weighing transactions.

Special guest Dr. Subramaniam (Subbu) Ramanarayanan, Managing Director at NERA Economic Consulting ...

As featured on the Diagnosing Health Care Podcast:  As 2021 nears a close, acute care hospitals and health systems are facing a host of financial, regulatory, and legislative challenges. In this special episode of Diagnosing Health Care, Rick Pollack, President and CEO of the American Hospital Association, and Epstein Becker Green’s Ted Kennedy, Jr., discuss the ways in which the industry is working with the Biden administration and Congress to shape policy around critical issues, such as surprise billing, coverage expansion, value-based care, and telehealth.

Rick ...

On June 21, 2021, Florida Governor Ron DeSantis signed into law a bill requiring genetic counselors to be licensed by the Florida Department of Health (“FLDOH”).  The new law, known as the Genetic Counseling Workforce Act (“GCWA”), became effective on July 1, 2021.  FLDOH has announced a 90 day enforcement moratorium to allow counselors time to become appropriately licensed in the State.  Florida now joins a growing number of states that regulate the work of genetic counselors.

The U.S. Department of Health and Human Services’ Office of Inspector General (“OIG”) recently issued Advisory Opinion No. 21-02, regarding a joint investment by a health system, a manager, and certain surgeons in an ambulatory surgery center (“ASC”) (the “Proposed Arrangement”). According to a national survey, most hospitals and health systems are planning to increase their investments in ASCs and anticipate converting hospital outpatient departments to ASCs. Many hospitals with ASCs operate the ASCs as physician joint ventures. As payors and patients continue to show interest in having outpatient procedures performed in ASCs, there is an expected trend to see an increase in investments and joint ventures in ASCs therefore making the Advisory Opinion particularly noteworthy.

In their request to OIG, the health system and the manager (“Requestors”) specifically inquired whether the Proposed Arrangement would constitute grounds for sanctions under the Federal Anti-Kickback statute (“AKS”). Based upon the facts provided in the request for the Advisory Opinion and a supplemental submission, the OIG reached the favorable conclusion that due to the low risk of fraud and abuse, the OIG would not impose sanctions on the health system or the manager in connection with the Proposed Arrangement.

The Proposed Arrangement

Under the Proposed Arrangement, the health system, five orthopedic surgeons, three neurosurgeons employed by the health system, and a manager, would invest in a new ASC. The health system would own 46 percent of the ASC, the surgeons would collectively own 46 percent of the ASC, and the manager would own 8 percent of the ASC. The manager certified that no physician has had, or would have, ownership in the manager that provides management and other services to the ASC. Furthermore, the ASC would operate in a medical facility owned by a real estate company jointly owned by the health system, the surgeons, and the manager. The ASC would enter into space and equipment leases as well as service arrangements with the health system and the real estate company.

OIG’s Analysis

Based on the following criteria, the OIG determined that the following safeguards in the Proposed Arrangement would mitigate the risk and that, as such, the OIG would not impose administrative sanctions in connection with the Proposed Arrangement:

Health System and Physician Investor Interest

(1) Although one or more of the neurosurgeons would fail to meet the Hospital-Physician ASC Safe Harbor Provision requirement that a physician investor derive at least one-third of his or her medical practice income for the previous fiscal year or previous 12-month period from the performance of ASC-qualified procedures, the health system certified that the neurosurgeons would use the ASC on a regular basis as part of their medical practices. Additionally, the health system certified that the surgeons would rarely refer patients to each other.

(2) The Proposed Arrangement would contain certain safeguards to reduce the risk that the health system would make or influence referrals to the ASC or the surgeons. For example, the health system certified that any compensation paid by the health system to affiliated physicians for services furnished would be consistent with fair market value and would not be related, directly or indirectly, to the volume or value of any referrals. In addition, the health system certified that it would refrain from any actions designed to require or encourage affiliated physicians to refer patients to the ASC or the surgeons and would not track referrals made to the ASC.

In December 2015, we wrote about the many failed health insurance co-ops created under the Affordable Care Act (“ACA”), and the impact of those failures on providers and other creditors, consumers, and taxpayers. At that time, co-ops across the country had more than one million enrollees. As of January 2021, there were roughly 120,000 enrollees in three remaining co-op plans. Nonprofit co-op insurers were intended to increase competition and provide less expensive coverage to consumers. However, low prices, lack of adequate government funding, restrictions on the use of ...

At the end of March, Florida joined the roster of states that have erected legal shields for health care providers against COVID-19-oriented liability claims. Concerned about uncertainty surrounding the emergency measures taken in response to COVID-19 and the effects that lawsuits could have on the economic recovery and the ability of health care providers to remain focused on serving the needs of their communities, the Florida Legislature passed CS/SB 72 on March 29, 2021.  Governor Ron DeSantis signed CS/SB 72 into law as Laws of Florida 2021-1.  This law creates two new statutory provisions - section 768.38 and section 768.381, Florida Statutes – effective on passage.

What Are the Liability Protections?

Section 768.381, Florida Statutes provides protection for health care providers regarding COVID-19-related claims, as follows:

• Complaints alleging claims subject to the law must be pled with particularity, or will be dismissed. This is a higher pleading standard than typically required for a civil complaint, and requires a greater degree of specificity.
• Plaintiffs must prove gross negligence or intentional misconduct. This is a higher standard than ordinary negligence or professional malpractice.
• Health care providers are provided with several affirmative defenses which, if proven, preclude liability. These defenses primarily relate to a provider’s substantial compliance with government-issued standards regarding COVID-19, infectious disease generally in the absence of standards specifically applicable to COVID-19 or the inability to comply with applicable standards in light of medical supply shortages.
• There is a one-year statute of limitations on COVID-19-related claims against health care providers, which is substantially shorter than that for simple and medical negligence claims. When this statute starts to run depends on whether the claim arises out of the transmission, diagnosis, or treatment of COVID-19, or from other circumstances such as a delayed or canceled procedure. Actions for COVID-19 related claims that accrued before the law’s effective date must commence within one year of the effective date.

This Diagnosing Health Care Podcast episode dives into the growth of physician practices accepting risk-based payments from health plans and examines why these practices are attractive to investors. Special guest Jason Madden, Managing Director at Accordion, and Epstein Becker Green attorneys Joshua Freemire, Jason Christ, and Tim Murphy, discuss the health regulatory considerations investors must assess when evaluating investment opportunities with physician practices accepting risk-based payments.

To supplement the issues discussed in this ...

Epstein Becker Green (“EBG”) has released Value-Based Payments: A Comprehensive State Survey.

EBG has researched, compiled, and analyzed state-specific content about the regulatory requirements involved in providers moving away from fee for service reimbursement (such as discounted fees and per diems) and towards value-based payment arrangements involving “downside” risk or insurance risk-sharing with insurers, HMOs, and other types of state-regulated health plans. Some types of risk-sharing arrangements include capitation, shared savings and losses ...

In an important win for healthcare providers, on July 17, 2020, the Third Circuit determined in a published opinion that an out-of-network provider’s direct claims against an insurer for breach of contract and promissory estoppel are not pre-empted by ERISA.  In Surgery Ctr., P.A. v. Aetna Life Ins. Co.^[1] In an issue of first impression, the Third Circuit addressed the question of what remedies are available to an out-of-network provider when an insurer initially agrees to pay for the provision of out-of-network services, and then breaches that agreement.

This case arose because two patients—identified as J.L. and D.W.—required medical procedures that were not available in-network through Aetna. J.L. needed bilateral breast reconstruction surgery following a double mastectomy and D.W. required “facial reanimation surgery,” which the Third Circuit describes as “a niche procedure performed by only a handful of surgeons in the United States.” Neither J.L. nor DW had out-of-network coverage for these procedures. D.W.’s plan also contained an “anti-assignment” clause, which would have prevented D.W. from assigning his or her rights under the plan to the Plastic Surgery Center, P.A.

In a previous post, we discussed the appropriate use of the Provider Relief Funds authorized and appropriated by Congress under the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act, Public Health and Social Services Emergency Fund (“Relief Fund”) for healthcare providers and facilities. Within that post, we specifically discussed the limitation imposed on use of the Relief Funds for payment of salaries, a topic of great interest to many recipients. Under the Terms and Conditions, recipients are prohibited from using the funds for salaries in excess of the Senior Executive Service Executive Level II amount – an annual salary of $197,300 – or $16,441 a month. We noted that, although the Department of Health and Human Services (“HHS”) had not spoken to this requirement with respect to the Provider Relief Funds, HHS permits other HHS grant Recipients to pay individuals’ salaries in excess of the $197,300 limit with non-federal funds.[1] Also, HHS’ federal contract regulations similarly limit use of federal contract funds for salary costs to the Executive Level II amount, but allow for amounts in excess of that limit to be paid with non-federal funds.[2]

To address the COVID-19 public health emergency fiscal burdens, Congress authorized and appropriated the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act[1], Public Health and Social Services Emergency Fund (“Relief Fund”) for healthcare providers and facilities. The Department of Health and Human Services (“HHS”) has begun to distribute several tranches of the Relief Funds. All totaled, Congress provided $175 billion to the Public Health and Social Services Emergency Fund (“Relief Fund”) through the CARES Act and the Payroll Protection Program and Health Care Act.[2]

As of May 7, 2020, HHS identified $50 billion for general distribution to Medicare providers. HHS distributed to Medicare providers the Relief Fund’s initial $45 billion tranche in April 2020, and is distributing the Relief Fund’s second $20 billion tranche. Also, HHS allocated Relief Funds to: hospitals in COVID-19 high impact areas ($10 billion); rural providers ($10 billion); Indian Health Services ($400 million), and skilled nursing facilities, dentists, and providers that take solely Medicaid (unidentified amounts).[3]

One of the many relief efforts contained in the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”), signed into law on March 27^th, 2020, is a hiatus of sequestration as it applies to Medicare payments. Section 4408 of the CARES Act exempts Medicare from the effects of sequestration from May 1, 2020, through December 31, 2020.[1] It also postpones the sunset of sequestration as it applies to Medicare from the end of 2029 to the end of 2030.

As background, on January 2, 2013, “sequestration,” automatic spending cuts applicable to all categories of the Federal budget, went into effect. Sequestration included a 2.0% reduction in most Medicare spending, and as a result of its implementation, many providers experienced reductions in their reimbursement. In addition to traditional fee-for-service Medicare payments, some Medicare Advantage plans reduced reimbursement under their contracts with providers to reflect the effect of sequestration, effectively passing on to providers the reductions in premiums recovered by such plans due to sequestration. Even non-Medicare reimbursement was affected for many providers whose participation agreements with plans contained fee schedules based off of Medicare reimbursement.

While this suspension of sequestration is certainly good news for providers participating in traditional fee-for-service Medicare, and plans offering Medicare Advantage products, the effect the suspension will have on reimbursement for providers participating in Medicare Advantage or commercial lines of business which rely on Medicare rates is slightly less clear.

On April 10, 2020, the U.S. Department of Health and Human Services (“HHS”) provided additional details regarding its plan to provide billions in relief to providers in an effort to off-set healthcare-related expenses resulting from the Coronavirus (“COVID-19”) outbreak.

Passed into law on March 27, 2020, the Coronavirus Aid, Relief and Economic Security Act, also called the “CARES Act”, provided $100 billion in funding for the Public Health and Social Services Emergency Fund (the “Fund”). The Fund is a pre-existing resource overseen by the Office of Financial Planning & Analysis within HHS. The $100 billion added via the CARES Act was made available to qualifying healthcare providers to reimburse them for “health care related expenses or lost revenues that are attributable to [COVID-19]”. The CARES Act stipulated that the $100 billion would be made available to public entities, Medicare or Medicaid enrolled suppliers and providers and other entities as may be further specified in regulations or guidance, provided that any such provider must “provide diagnoses, testing or care for individuals with possible or actual cases of COVID-19”. Monies received from the Fund may not be used to cover expenses that have already been reimbursed through other sources or that other sources are obligated to reimburse. Little other detail regarding the funding or mechanism for disbursal was provided in the CARES Act itself.

In a new issuance on its website, found here, HHS provided additional details on the program. HHS noted that $30 billion out of the appropriated $100 billion will be distributed immediately via direct deposit, starting April 10, 2020. Further, HHS clarified that the money is “payment” and not a loan, and thus will not need to be repaid. The initial $30 billion tranche is being made available only to providers that received Medicare fee-for-service payments in 2019. The payments are being distributed according to the Taxpayer Identification Number (TIN) of the billing organization.

The ongoing pandemic caused by the novel coronavirus has upended the American health care system in many ways. One of the many effects of COVID-19 will likely be substantial disruption in value-based payment arrangements between health plans and providers. Though this is an issue that is not on the top of providers or payors minds as the health care system prepares to respond to the crisis, there are some simple steps that providers can take now to avoid issues in the future.

Any iteration of value-based payments (“VBP”) is likely to be disrupted by COVID-19; be it shared savings, shared risk, or full risk arrangements. Quality targets and reporting deadlines are likely to be missed as providers move many routine and preventative services to telehealth services or suspend them entirely for the time being, as well as turn the bulk of their clinical focus to COVID-19. Under some VBP arrangements, providers may be ineligible for any savings due to their inability to meet “quality gates” (i.e., certain quality metric thresholds that must be met before any savings payments are made) in the current climate. Cost savings targets are likely to be missed or at least distorted as providers focus on building out their capabilities to address the pandemic. How will these sudden and substantial changes affect the parties participating in value-based arrangements?

CMS has already announced that it will amend its quality reporting requirements from the fourth quarter of 2019 through the end of the second quarter of 2020.[1] The announcement covers a variety of quality reporting requirements and payment programs with the stated purpose of alleviating reporting requirements and disregarding unrepresentative data created during the emergency. CMS has also stated that it intends to prorate any losses incurred by Medicare accountable care organizations (“ACOs”) in 2020 for the duration of the public health emergency (e.g., if the public health emergency lasts for six months, the annual losses an ACO incurs in 2020 would be halved). Many – including a bipartisan group of Senators – have argued that this approach is insufficient to truly address the pandemic-related costs incurred by ACOs.[1] CMS has also stated that it will disregard all costs associated with care related to COVID-19 when performing benchmark calculations.[2] States may make similar changes for VBP arrangements in Medicaid programs. How these government steps would flow down into VBP agreements between managed care plans and providers is not clear and requires analysis of the specific agreements.

As the coronavirus spreads throughout the country, hospitals and other health care providers are finding themselves inundated with patients. Those providers who are in-network with payors have and will likely continue to experience difficulty in complying with certain provisions of their contracts. For instance, as payors are also experiencing an unexpected influx of telephone traffic, the wait time for various approvals, including, but not limited to, pre-authorizations are being delayed.

Providers are often contractually obligated to obtain pre-authorizations for certain procedures and services prior to rendering the care. Due to the increased telephone traffic and increased wait times on the payor end, these providers are now faced with a dilemma. A process that as of two weeks ago only took a matter of ten to fifteen minutes now can take up to an hour or more. This creates a serious dilemma for those providers who need to render care to their patients and comply with their contractual obligations to payors.

The Senate has spoken to this issue via the Families First Act which prohibits cost sharing and imposing prior authorizations for COVID-19 related testing under Medicare, CHIP, and individual and small/large self-funded group plans. See Division F-Health Provisions, § 6001, Coverage of Testing for COVID-19. While some payors have recognized and acknowledged the difficulties posed by COVID-19 and have made exceptions to the standard requirements, those exceptions have been limited. For example, the Blue Cross Blue Shield Association has indicated that its network of 36 BCBS companies will waive prior authorizations for diagnostic tests and covered services that are medically necessary for members diagnosed with COVID-19. Similarly, Wellmark and Anthem, Inc., have waived prior authorizations for covered services related to COVID-19. While these limited pre-authorization waivers are a start, they do not resolve the dilemma faced by those providers treating patients who are not suffering from COVID-19.

Many physicians rely on publicly available reports to assess the safety of the devices they use on patients, but in some cases, these reports aren’t painting the full picture.  A recent Kaiser Health News (“KHN”) article raises serious questions about FDA’s practice of allowing a significant number of medical device injury and malfunction reports to stay out of the public eye.

Under FDA’s Medical Device Reporting (“MDR”) regulation (21 CFR part 803), device manufacturers, importers, and device user facilities (which include hospitals, ambulatory surgery ...

For the first time since 2008, the Advanced Medical Technology Association (“AdvaMed”) has updated its “Code of Ethics on Interactions with Health Care Professionals.”  These updates were announced on January 9, 2019 and will become effective on January 1, 2020.

AdvaMed’s goal in updating the Code was to address the evolving nature of interactions between the medical device industry and health care professionals (“HCPs”), bring existing examples up-to-date, and enhance user-friendliness.  Topics that were previously covered in multiple areas of the Code are now ...

Clinical laboratories need to review how they compensate sales personnel following the passage of the Eliminating Kickbacks in Recovery Act of 2018 (“EKRA”) (Section 8122 of the SUPPORT Act) which is effective as of October 24, 2018.  The SUPPORT Act is a combination of more than 70 bills aimed at fighting the opioid epidemic, with EKRA intended to address patient brokering in exchange for kickbacks of individuals with substance abuse disorders.  However, as written, EKRA is far more expansive.

EKRA adds an all payor (public and private) anti-kickback rule to the health care fraud ...

A dental practice and related dental management company have become the first two entities to make their way on to the newly created “High Risk – Heightened Scrutiny” list from the Office of Inspector General for the United States Department of Health and Human Services (the “OIG”).[1]

ImmediaDent of Indiana, LLC, a professional dental practice (“ImmediaDent”), and Samson Dental Partners, LLC, a dental management company which provides management and administrative services to ImmediaDent and other dental practices in Indiana, Kentucky and Ohio ...

In response to Republicans' failure to repeal the Affordable Care Act (ACA), the Trump Administration is using administrative action to modify the ACA and health insurance options for Americans. On October 12, 2017, President Trump signed an executive order that instructs various departments to consider regulations related to association health plans and short-term insurance. Shortly after, the Administration announced that they would no longer make cost sharing reduction (CSR) payments to insurers on the Exchanges.  Section 1402 of the ACA requires insurance companies to ...

Our colleague Robert F. Atlas, President of EBG Advisors, Inc., published an advisory that will be of interest to stakeholders in the health care industry: The After-Effects of Graham-Cassidy's Demise.

Following is an excerpt:

Taken together, the failure of the ACA repeal-and-replace effort (for now) bodes well for health care providers. The percentage of the population that's covered—and thus is less likely to represent uncompensated care for providers—will remain fairly high, notwithstanding some erosion if the individual market isn't bolstered.

Similarly, insurers ...

The U.S. Department of Health and Human Services, Office of Inspector General ("OIG"), has made pursuing fraud in the personal care services ("PCS") sector a top priority, including making it a focus of their FY2017 workplan.

Last week, OIG released a report, Medicaid Fraud Control Units Fiscal Year 2016 Annual Report,  which set forth the number and type of investigations and prosecutions conducted nationwide by the Medicaid Fraud Control Units ("MFCUs") during FY 2016.  Overall, the MFCUs reported 1,564 convictions, over one-third of which involved PCS attendants; fraud cases ...

On April 14, 2017, CMS issued the FY 2018 Medicare Hospital IPPS Proposed Rule that includes numerous proposed changes.   However, there is a very small provision in this proposed rule that organizations may not be aware of …. especially those that are not hospitals and who normally would not look at the Hospital IPPS rule.

Within the rule, there is a section proposing to revise the application and re-application process for Accrediting Organizations so as to require them to post provider/supplier survey reports and plans of corrections on their website.   Although the survey results ...

As many pundits speculate regarding the future of the Yates Memo[1] in a Trump administration, on Wednesday, November 30, 2016, Department of Justice ("DOJ") Deputy Attorney General, Sally Q. Yates, provided her first comments since the election.  The namesake of the well-known, "Yates Memo," Yates spoke at the 33^rd Annual International Conference on Foreign Corrupt Practices Act in Washington, D.C. and provided her perspective on the future of DOJ's current focus on individual misconduct.

Yates, who has served at the DOJ for over twenty-seven years, stated that while the DOJ has ...

If your organization has missed an opportunity to participate in the voluntary Medicare Bundled Payments for Care Initiatives and/or the mandatory CJR program, CMS' Centers for Medicare and Medicaid Innovation has issued a proposed rule introducing three new mandatory Episode Payment Models (EPMs) and a Cardiac Rehabilitation incentive payment model intended to be tested with a broad scope of hospitals which may not have otherwise participated in innovative payment model testing.

In the proposed rule issued August 2, 2016, CMS introduced EPMs for Acute Myocardial infarction ...

On July 7, 2016, the Centers for Medicare and Medicaid Services ("CMS") imposed several administrative penalties on Theranos, a clinical laboratory company that proposed to revolutionize the clinical laboratory business by performing multiple blood tests using a few drops of blood drawn from a finger rather than from a traditional blood draw that relies on needles and tubes. However, after inspecting the laboratory, CMS concluded that the company failed to comply with federal law and regulations governing clinical laboratories and it posed an immediate jeopardy to patient ...

In its Fiscal Year 2017 Private Insurance Legislative Proposals, President Obama's Budget contains a provision seeking to "eliminate surprise out-of-network healthcare charges for privately insured patients." Described as an attempt to "promote transparency on price, cost, and billing for consumers," this measure requires hospitals and physicians to collaborate so that patients receiving treatment at in‐network facilities do not face unexpected charges from out‐of‐network practitioners. This provision could have far-reaching effects, potentially impacting ...

We recently wrote about the many failures of health insurance co-ops created under the Affordable Care Act ("ACA"), and the impact of those failures on providers and other creditors, consumers, and taxpayers.

As we described, nonprofit co-op insurers were intended to increase competition and provide less expensive coverage to consumers; however, low prices, lack of adequate government funding, restrictions on the use of federal loans for marketing, and low risk corridor payments from the Centers for Medicare & Medicaid Services created financial challenges for these ...

The top story on Employment Law This Week is the unfolding Zika virus crisis.

For the fourth time in history, the World Health Organization has declared a global public health emergency, following the spread of the Zika virus throughout Latin America and the Caribbean. The disease can have harmful effects on fetuses, and the CDC has warned against travel for pregnant women and their partners. The Zika crisis has important implications for employers. Workers who travel for their jobs may request accommodations, and employers should make them aware of the risks if they aren't ...

On Monday, the World Health Organization ("WHO") declared the rise in birth defects linked to the Zika virus outbreak a public health emergency, marking only the fourth time that the WHO has made such a declaration. This announcement by the WHO underscores the seriousness of the Zika virus outbreak and, hopefully, will pave way for a coordinated and well-funded global response to this serious public health problem that may include intensified mosquito control efforts, expedited creation of a more rigorous diagnostic test to detect the virus, and development of a preventive ...

Hospital-physician practice acquisitions represent a large segment of the very active healthcare mergers and acquisitions market, which will likely continue in 2016.[1]  In New York, an acquiring hospital often forms a new professional corporation owned by one or more hospital-based physicians to acquire the business and operations of a group physician practice in an asset purchase. The acquiring hospital will be able to exercise a level of management and control over the new professional corporation, often referred to as a "captive PC", through a contractual arrangement with ...

On December 14, 2015, the U.S. District Court for the Western District of Texas denied the Texas Medical Board's ("TMB") motion to dismiss an antitrust lawsuit brought by Teladoc, one of the nation's largest providers of telehealth services.[1]  Teladoc sued the TMB in April 2015, challenging a rule requiring a face-to-face visit before a physician can issue a prescription to a patient.  Following two recent Supreme Court cases stringently applying the state action doctrine, this case demonstrates the latest of the continued trend where state-sanctioned boards of market ...

House Republican leaders introduced legislation on Monday, finalizing a two-year budget agreement between Congressional leaders and the White House. This legislation is currently being considered and may be up for a vote as early as Wednesday on the bipartisan budget deal.

Hospitals should note the language in Section 603 (which is on pages 35-39 of the draft bill) codifies the definition of a "provider-based off-campus hospital outpatient department" (PBD HOPD) as a location that is not on the main campus of a hospital and is located more 250 yards from the main campus.  The section ...

On September 28, 2015, the Centers for Medicare & Medicaid Services ("CMS") issued a request for information ("RFI") seeking comments on two key components of the physician payment reform provisions included in the Medicare Access and CHIP Reauthorization Act of 2015 ("MACRA"), the law enacted on April 16, 2015, repealing the sustainable growth rate formula used to update payment rates under the Medicare Physician Fee Schedule.  The RFI was originally open for a 30-comment period.  However, CMS has announced that it is extending the comment period for an additional 15 days.  Comments ...

On Wednesday, October 14, 2015, the U.S. District Court for the District of Columbia (the "Court"), Judge Rudolph Contreras, vacated the Health Resources and Services Administration's ("HRSA") interpretive rule on Orphan Drugs ("the Interpretative Rule") as "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law."^[1]  As a result of the ruling, pharmaceutical manufacturers are not required to provide 340B discounts to certain types of covered entities for Orphan Drugs, even when the drugs are prescribed for uses other than to treat the rare ...

In January 2015, CMS announced that it was considering developing voluntary clinical templates to help physicians adequately document their encounters with Medicare patients who receive home health services.[1] CMS initially proposed a sample paper template progress note and suggested clinical template elements for an electronic progress note. CMS hosted three Special Open Door Forums to solicit feedback on the proposed templates from physicians, home health agencies, and other interested stakeholders to provide feedback on the proposed templates.

On August 12, 2015, CMS ...

On March 31, 2015, the Supreme Court of the United States decided Armstrong v. Exceptional Child Center, Inc. The Court handed down a hodgepodge of opinions but, in the end, five Justices concurred in the judgment that the Constitution's Supremacy Clause does not confer a private right of action, and that Medicaid providers, therefore, cannot sue for an injunction requiring compliance with the reimbursement laws.  This ruling will adversely affect at least those health care companies that have contemplated suing on the basis that the reimbursement they are getting is less than what ...

Epstein Becker Green's recent issue of its Take 5 newsletter focuses on the 25^th Anniversary of the ADA and recent developments and future trends under Title III of the ADA.

1. Website Accessibility
2. Accessible Point-of-Sale Devices and Other Touchscreen Technology
3. Movie Theater Captioning & Audio (Narrative) Description
4. The Availability of Sign Language Interpreters at Health Care Facilities
5. "Drive By" Design/Construction Lawsuits

CMS announced on February 13  (and to be published in a Federal Register notice this week) that despite the general guideline that final rules be issued within 3 years of a proposed or interim final rule, CMS will be taking an additional year to finalize the "Medicare Program; Reporting and Returning of Overpayments" final rule.   In February 2012 (see EBG's February 22, 2012 Client Alert), CMS issued a proposed rule on the requirements under the ACA to report and return overpayments within 60 days to the Medicare program for providers and suppliers of services under Parts A and B.  CMS ...

In the most recent updates to the Medicare Home Health Prospective Payment System,[1] CMS made significant changes to the face-to-face encounter documentation requirements by eliminating the physician narrative requirement for most home health services for care episodes beginning on or after January 1, 2015.[2] In making this change, CMS stated that the medical records of the certifying physician or the acute/post-acute care facility (if a patient in that setting was directly admitted to home health) must contain sufficient documentation to support the physician's ...

By Arthur J. Fried.

In what is being called an historic announcement, Department of Health and Human Services Secretary Sylvia Mathews Burwell announced on Monday the setting of clear goals and timeframes for moving Medicare from volume to value payments.  The stated goals are to tie 30% of all Medicare provider payments to quality and cost of care by 2016, moving to 50% by 2018.   Nearly all fee-for-service payments will be aligned with quality and value – 85% by 2016 and 90% in 2018.  This transformation will be achieved by the expansion of mechanisms already in use – Accountable Care ...

Our colleaguesEmily E. Bajcsi, Clifford E. Barnes, Marshall E. Jackson Jr., and Serra J. Schlanger recently published a client alert on legislative and regulatory efforts impacting the hospice and home health industries:

• President Obama signed the Improving Medicare Post-Acute Care Transformation Act of 2014 ("the IMPACT Act") into law;
• The Centers for Medicare and Medicaid ("CMS") published the Medicare Home Health Prospective Payment System final rule for calendar year 2015 ("Final Rule"); and
• CMS published proposed changes to the home health conditions of participation ...

The 2014 outbreak of the Ebola Virus Disease ("Ebola") is the largest in history and continues to affect multiple countries in West Africa. Although reports of new Ebola cases in the U.S. – potential or confirmed – have slowed down in recent weeks, the Centers for Disease Control and Prevention ("CDC") and its various domestic and international partners continue their efforts to prevent further transmission of Ebola in the U.S. as well as abroad. Earlier this week, in fact, the CDC released two new pieces of guidance regarding treatment of Ebola that will be of particular interest ...

On November 13, 2014, CMS published the 2015 Medicare Physician Fee Schedule ("MPFS") finalizing the following changes to the Sunshine Open Payments regulations.  The MPFS:

1. Deleted  the provision exempting certain payments to CME providers from the reporting requirements;
2. Added  three new forms of payment designations;
3. Made  the reporting of the marketed name of a covered device no longer optional; and
4. Deleted the definition of covered device.

These changes will be effective January 1, 2016, with reports to CMS in 2017.

(A summary of the final Open Payment regulations can be accessed ...

WHEN: November 17, 2014

TIME:    2:00pm – 3:30pm EST

To register for this webinar, please click here.

Please join us for a complimentary webinar addressing the professional and business challenges encountered by health care providers dealing with Ebola and other infectious diseases. This webinar will offer a clinical overview as well as a review of the guidelines which offer protocols for addressing concerns over Ebola and similar diseases, the health regulatory and risk management issues providers might consider in developing a response strategy, and the resulting labor and ...

Epstein Becker Green is pleased to announce that Valerie Butera, an accomplished Occupational Safety & Health (OSHA) lawyer, has joined as a Member of the Firm based in the firm's Washington, D.C., office.  Valerie is OSHA 30 certified and has substantial training and experience in process safety management (PSM). Valerie represents clients from numerous industries, including health care and life sciences and focuses on OSHA and other workplace safety and health issues.   For more information, click here.

The Ebola virus disease ("Ebola") has become a worldwide threat, which, among many other effects, has forced employers to think about how to protect their employees. Employers also must consider how Ebola might impact employment policies and procedures, including, but not limited to, those addressing attendance, leaves of absence, discipline, and medical testing.

Employers are generally tasked with maintaining safe and productive workplaces for their employees, and the Ebola scare has brought many challenges in this regard. In particular, employers' desire to maintain safe ...

In response to the ongoing threat of the Ebola Virus Disease ("EVD" or "Ebola") and the increased risk of individuals traveling from the affected countries to the United States, The Joint Commission recently launched an Ebola Preparedness Resources portal on its website.  The portal contains information addressing various safety actions for health care providers to consider, such as ensuring that all staff and clinicians who may come in contact with Ebola patients are educated and trained on Ebola guidance, re-evaluating infection control plans to ensure proper guidelines ...

Epstein Becker Green and EBG Advisors, as part of the Thought Leaders in Population Health Speaker Series, will host a complimentary webinar titled Moving to an Integrated Population Health Management Model. This session will highlight several approaches to help manage populations to promote better clinical outcomes, more cost savings and enhanced patient satisfaction.

The webinar, scheduled for October 30, 2014 at 12:00 p.m. ET, will be led by Sarika Aggarwal, MD, Senior Vice President and Chief Medical Officer of Fallon Community Health Plan, and Julie O'Brien, RN, BSN, MS ...

Our colleagues at Epstein Becker Green released a client alert: "Medicare's Proposed Home Health Rule for 2015: CMS Suggests Only Limited Relief to the Face-to-Face Encounter Documentation Requirements but Continued Compliance Burdens on Home Health Agencies," by Emily E. Bajcsi and Serra J. Schlanger.

Following is an excerpt:

On July 7, 2014, the Centers for Medicare & Medicaid Services ("CMS") published proposed changes to the Medicare Home Health Prospective Payment System ("HH PPS") for calendar year 2015 ("Proposed Rule"). The Proposed Rule would update the HH PPS payment ...

The Office of the Inspector General ("OIG") of the U.S. Department of Health and Human Services ("HHS") is soliciting comments, recommendations, and other suggestions on the non-binding criteria used by OIG in assessing whether to impose a permissive exclusion, which were first published in 1997 (https://oig.hhs.gov/authorities/docs/2014/2014-16222.pdf).  The OIG's permissive exclusion criteria currently are organized into four general categories, including: (1) the circumstances and seriousness of the underlying misconduct; (2) the defendant's response to the ...

Our colleagues at Epstein Becker Green released a client alert: "DC Circuit Strongly Reaffirms the Applicability of the Attorney-Client Privilege to Internal Compliance Investigations," by George B. Breen, Jonah D. Retzinger, Marshall E. Jackson Jr., and Stuart M. Gerson.

Following is an excerpt:

Especially in the District of Columbia Circuit, the home base for many fraud cases in which the government is opposed to health care providers and defense contractors, there had been considerable doubt that the attorney-client privilege attached to internal compliance ...

Post-Acute Care in Transition:  Tackling the Legal/Regulatory Transformation of the Industry

Health Care Entities and the ADA:  Part 2 – Complex Issues in the Reasonable Accommodation of Patients, Residents & Guests with Disabilities

Wednesday, July 16, 2014, at 12:00 PM - 1:00 PM (EDT)

Presenters:
Andrea R. Calem, Epstein Becker Green
Frank C. Morris, Jr., Epstein Becker Green

In part two of the webinar series, Epstein Becker Green attorneys explain the laws, regulations, enforcement considerations and hot-button issues relating to the accommodation of individuals with ...

By Lori A. Medley

A recent decision from the United States Court of Appeals for the Seventh Circuit held that collection or "dunning" letters sent after a debt has become time-barred by the applicable statute of limitations violate the Fair Debt Collection Practices Act, 15 U.S.C. § 1692 et seq. ("FDCPA"), unless the dunning letters advise the debtor that the debt is no longer legally enforceable pursuant to the applicable statute of limitations.

In the consolidated appeals of McMahon v. LVNV Funding, LLC and Delgado v. Capital Management Services, Nos. 12-3504 & 13-2030, the Seventh ...

Our colleagues at Epstein Becker Green have issued a client alert: "HIPAA Omnibus Rule's Impact on Notices of Privacy Practices," by Patricia M. Wagner, Brandon C. Ge, and Alaap B. Shah.

Following is an excerpt:

This health reform alert summarizes the key changes to the Notice of Privacy Practices ("NPP") requirements in the revised Health Insurance Portability and Accountability Act ("HIPAA") regulations (the "Omnibus Rule") as well as what covered entities need to do to be compliant. Because many covered entities may have modified their NPPs based on the Notice of Proposed ...

Our colleagues at Epstein Becker Green have issued a client alert: "U.S. Supreme Court Opinion Addresses Availability of State-Action Antitrust Immunity," by Patricia M. Wagner, Ross K. Friedberg, and Daniel C. Fundakowski.

Following is an excerpt:

On February 19, 2013, in FTC v. Phoebe Putney Health System, Inc., a case that highlights vigorous enforcement activities by the Federal Trade Commission (“FTC”) in the health care arena, the Supreme Court of the United States issued a unanimous opinion (“Opinion”) that overturned a ruling by the U.S. Court of Appeals for the ...