In 2016, the Obama Administration issued a regulation implementing Section 1557 of the Affordable Care Act (ACA) (the 2016 Rule), which redefined sex discrimination to include termination of pregnancy and gender identity. Despite efforts by the U.S. Department of Health and Human Services (HHS) to repeal and revise certain provisions of the 2016 Rule through a new Rule, a NY Federal Court issued a preliminary injunction on August 17, 2020 against the new Rule from becoming effective.

Section 1557 of the ACA is a civil rights provision that prohibits discrimination on the basis of race, color, national origin, sex, age, or disability by providers that receive federal funding.

Notably, the 2016 Rule redefined discrimination “on the basis of sex” to include “discrimination on the basis of pregnancy, false pregnancy, termination of pregnancy, or recovery therefrom, childbirth or related medical conditions, sex stereotyping, and gender identity.” The 2016 Rule defines “Gender identity” as “one’s internal sense of gender, which may be male, female, neither, or a combination of male and female.”

Pursuant to a Press Release issued on June 12, 2020, HHS announced it had a finalized a rule (the 2020 Rule) that revised certain provisions of the 2016 Rule. Of note, the 2020 Rule returns “to the government’s interpretation of sex discrimination according to the plain meaning of the word “sex” as male or female and as determined by biology.” The 2020 Rule was to become effective as of August 18, 2020.

On August 17, 2020, the U.S. District Court for the Eastern District of New York issued a preliminary injunction staying the 2020 Rule’s repeal of the definition of “on the basis of sex”, in a case involving two transgender women who filed their suit in an effort to prevent implementation of the 2020 Rule. In the case (Asapansa-Johnson Walker v. Azar), the two women allege health care providers previously discriminated against them based on their transgender status.

In light of the above, health care providers should continue to take proactive steps to implement policies regarding discrimination on the basis of sex (including, but not limited to, gender identity sensitivity).  In addition, health care providers should educate and train physicians and staff on the importance of gender identity sensitivity and preventing discrimination in the workplace.

If you have any questions regarding the above, such as the implementation of effective protocols and policies to prevent workplace discrimination, please do not hesitate to contact us.

The U.S. Food and Drug Administration (FDA) issued a flurry of Press Releases and Alerts from mid-June through the end of July warning consumers and health care professionals not to use certain alcohol-based hand sanitizers due to the dangerous presence of methanol (or wood alcohol), a substance often used to create fuel and antifreeze that can be toxic when absorbed through the skin, and life-threatening when ingested.

The FDA has posted a do-not-use list of such dangerous hand sanitizer products, which is being updated regularly by the agency.  Note that in most cases, methanol does not appear on the product label. 

 Health care providers should frequently confirm that none of their sanitizers are on the list.

Last week, the FDA issued another Press Release regarding the Agency’s effort to prevent certain hand sanitizers from entering the U.S. by placing them on an import alert. In addition, the Press Release noted that the FDA is proactively working with manufacturers to recall products and is actively encouraging retailers to remove products from store shelves and online marketplaces. As part of these actions, the FDA has issued a warning letter to Eskbiochem S.A. de C.V. regarding the distribution of its products with undeclared methanol amounts, misleading claims (including incorrectly stating that the FDA approved these products) and improper manufacturing practices.

The FDA emphasized the importance of frequent hand washing with soap and water for at least 20 seconds and, if soap and water are not readily available, that the Centers for Disease Control and Prevention (CDC) recommends consumers use an alcohol-based hand sanitizer that contains at least 60 percent ethanol (also referred to as ethyl alcohol). The FDA further provided that no drugs, including hand sanitizers, are approved to prevent the spread of COVID-19.

On a related note, the scrutiny of hand sanitizer amid COVID-19 has been further highlighted by a newly filed suit in California federal court against hand sanitizer manufacturer, Vi-Jon Inc. The Complaint alleges that Vi-Jon Inc.’s claim “that its products can kill 99.99% of germs” is false, as there are a number of disease-causing microbes that the products are ineffective against.

If you have any questions regarding the FDA’s do-not-use list or the use of sanitizers, please do not hesitate to contact us.  To subscribe to the Health Care Law Matters Blog, click here.

New guidance issued by the U.S. Department of Justice (DOJ) highlights the importance of updating corporate compliance programs to satisfy regulatory requirements.  The 2020 updates pick up where the 2019 guidance left off in addressing the evaluation metrics for compliance.  The key takeaway for 2020 is that companies are encouraged to update and improve compliance programs with the latest in technology, systems and training.

The three questions considered by the  DOJ in evaluating corporate compliance programs include:

  1. Whether the program is well-designed?
  2. Is the program being applied earnestly and in good faith?
  3. Does the corporation’s compliance program work in practice?

With respect to design, the DOJ focuses on the program’s thoroughness and risk assessment practices based on access to data on operations, as well as the incorporation of “lessons learned” both internally and within the company’s industry.  The 2020 Guidance also suggests that periodic audits should be used to test the effectiveness of the program.

A determination that the program is being applied earnestly and in good faith will require a culture of compliance at all levels of the organization with implementation by all tiers of management.  In addition to requiring that compliance personnel have sufficient access to data, an organization should also demonstrate consistency in its investigations and disciplinary actions.  According to the 2020 Guidance, whether a  compliance program can satisfy the ability to work “in practice” will largely depend on whether the program evolved in a manner that addresses existing and changing compliance risks over time.

To read more about the 2020 Corporate Compliance Guidance, see the article published by attorneys at Fox Rothschild here:  https://www.managedhealthcareexecutive.com/view/doj-issues-important-updates-to-evaluation-of-corporate-compliance-guidance

If you have any further questions regarding your practice’s or facility’s corporate compliance program, please contact us.  To subscribe to the Health Care Law Matters Blog, click here.

Physician working at desk with stethoscope

Dentists are now able to receive funds from the U.S. Department of Health and Human Services’ Provider Relief Fund, as a result of the American Dental Association’s advocacy.

In a press release dated July 17, 2020, the U.S. Department of Health and Human Services (HHS) extended the deadline to apply for the funds to August 3, 2020, “to ensure eligible Medicaid and CHIP programs, including dentists, have the opportunity to apply.” Eligible dental providers can now apply through the Enhanced Provider Relief Fund Payment Portal and receive reimbursement up to 2% of their annual reported patient revenue.

To be eligible, dental providers must not have received payment from the $50 billion in general distributions made to Medicare, Medicaid and CHIP providers, and must meet one of the following criteria:

  • Directly billed (or owns a subsidiary that has directly billed) a state Medicaid or Children’s Health Insurance Program (CHIP) program or a Medicaid managed care plan for healthcare-related services during the period of January 1, 2018 to December 31, 2019.
  • Directly billed (or owns a subsidiary that has directly billed) a health insurance company for oral healthcare-related services.
  • Be a licensed dental service provider who does not accept insurance and has directly billed (or owns a subsidiary that does not accept insurance and has directly billed) patients for oral healthcare-related services.

In addition, the dental provider must have either (i) filed a federal income tax return for fiscal years 2017, 2018, or 2019 or (ii) be an entity exempt from the requirement to file a federal income tax return and have no beneficial owner that is required to file a federal income tax return, such as a state-owned hospital or health clinic.

Finally, eligible providers must:

  • Have provided patient dental care after January 31, 2020;
  • Have not permanently ceased providing dental patient care, whether directly or through a subsidiary (pandemic closures excluded); and
  • If the applicant is an individual, he/she has gross receipts or sales from providing dental patient care reported on Form 1040, Schedule C, Line 1, excluding W-2 income reported as an employee.

The full instructions for the distribution for Medicaid, CHIP, and Dental Providers via the Enhanced Provider Relief Fund Payment Portal, and a list of additional required documentation is found here. A copy of the application form is found here.

A useful fact sheet on eligibility for the distribution can be found here.

If you have any questions regarding Provider Relief Funds, including eligibility as a dental services provider, please do not hesitate to contact us.  To subscribe to the Fox Health Care Law Matters Blog, click here.

Widespread testing for the novel Coronavirus is generally recognized as an important tool in combating the spread of the virus. The World Health Organization is an advocate for broad testing, so as to better locate incidents of infection for purposes of isolation, caring, and tracking.

However, the cumulative cost for such testing is significant. In a study commissioned by the American Health Insurance Plans, it is estimated that the cost could range from $6 billion to $25 billion.  [See https://www.ahip.org/wp-content/uploads/AHIP-Wakely-COVID-19-Testing-Report.pdf.] The expenses are particularly high in the nursing home industry where states may have requirements for frequent staff and patient testing.  For example, in New York, nursing home staff are required to be tested twice a week and patients must be tested weekly.

The key question is who bears the burden for the costs of testing? Is it the consumer? Is it private insurance? Is it government? Or is it employers? During the early stage of the pandemic in the United States, on March 18, 2020, Congress passed the Families First Coronavirus Response Act (FFCRA). It was a time in which testing resources were scarce, and all segments of the health care community wanted to remove any financial barriers for testing for those individuals who were experiencing severe symptoms or were at serious risk of exposure to the virus. Accordingly, Section 6001 of the FFCRA, generally requires that group health plans and health insurers offering group or individual health insurance coverage provide benefits for certain services related to testing for the detection COVID-19 during the pandemic. Moreover, the FFCRA provides that plans and insurers must not impose any cost-sharing requirements, prior authorization, or any other medical management requirements with respect to such services.

In the subsequent months, as access to testing substantially expanded and more people are seeking testing, the commitment to free testing has been scaled back. Pursuant to guidance issued by the Trump Administration on April 11, 2020 and June 23, 2020 [see 2020 https://www.cms.gov/files/document/FFCRA-Part-42-FAQs.pdf and https://www.cms.gov/files/document/FFCRA-Part-43-FAQs.pdf], coverage for testing under the requirements of 6001 is triggered “when medically appropriate for the individual, as determined by the individual’s attending health care provider in accordance with current accepted medical standards of medical practice.”  The June guidance further stated that, “testing conducted to screen for general workplace health and safety (such as employee ‘return to work’ programs), for public health surveillance for SARS-Co-V-2, or for any other purpose not primarily intended for individualized diagnosis or treatment of COVID-19 or other health condition is beyond the scope of section 6001 of the FFCRA.”

However, the Centers for Disease Control and Prevention (CDC) states that testing is appropriate in the following five scenarios:

  1. Individuals with signs or symptoms consistent with COVID-19
  2. Asymptomatic individuals with recent known or suspected exposure to SARS-CoV-2 to control transmission
  3. Asymptomatic individuals without known or suspected exposure to SARS-CoV-2 for early identification in special settings
  4. Individuals being tested to determine resolution of infection
  5. Individuals being tested for purposes of public health surveillance for SARS-CoV-2

[see CDC Testing Guidance].

The money does not appear to support CDC recommendations.

While federal administrative guidance seeks to eliminate testing for certain purposes, the fundamental question is when is testing medically appropriate for the individual?  Currently, it is an interpretation and judgment call for the provider with potentially costly ramifications for the patients, insurance organizations and government.

If you have questions regarding how current legal requirements impact your practice’s or facility’s coverage of the cost of COVID testing, please contact us.   You may subscribe to the Fox Health Care Law Matters Blog here for updates.

Medical record requests by payors are commonplace for health care providers. Typically, these requests are received by a front desk employee who responds to the inquiry in short order.  Yet, not all requests should be treated the same.  When a request for documentation is propounded by the “Special Investigation Unit” (S.I.U.)  of an insurance company, special care should be exercised and provider involvement is required.

What is a S.I.U. anyway?  Over the past two decades, campaigns have intensified to curb fraud and abuse in health care.  On the government side, False Claims prosecutions have markedly increased and in the private sector, insurance companies have created specific departments to combat fraud.  The S.I.U. is a department within an insurance company with a targeted focus on recovering payments from medical providers that appear to be the product of fraud.  Individuals employed by a S.I.U. include former law enforcement personnel, claims adjusters and fraud analysts, among others, who receive specific training and credentialing in fraud detection.  These investigators utilize data analytics and other methods to flag providers for claims that fall outside of the “normal range” for the type of health care provider under review.

S.I.U. “audits” or requests for information about the practice should be taken seriously and taken to the top of your organization.   In many cases, special investigators receive incentives from the insurance company for recovering payments from providers.  They often attempt to “strong arm” a resolution by threatening a fraud claim, which in a number of states includes the prospect of treble (triple) damages, punitive damages, and attorneys’ fees.  In some cases, medical records produced by the provider (or the absence thereof) will assist the fraud allegation.  In others, the records will assist in supporting a defense to the same.

Here are 5 tips for your practice:

  1. Instruct  staff that all audit requests should be forwarded to the owner of the practice and the provider whose records are being requested.
  2. If the audit is deemed routine (not S.I.U. generated), instruct staff to make a copy of the records requested and the cover letter that attaches the records so that you can memorialize exactly what was provided and when.
  3. If you receive a letter from the S.I.U., reach out to an attorney who has experience in dealing with the S.I.U. to assist you through the process.
  4. If an investigator from the S.I.U. appears at your office, ask for a business card and do not let him/her disrupt patient care.  You can call them later (or your attorney can).
  5. Do not provide access to your electronic records or files to anyone — including anyone employed by a payor.

If you have any questions regarding a medical records request from a payor, please do not hesitate to contact us.  To subscribe to the Health Care Law Matters Blog, please click here.

 

On July 1, 2020, the Pennsylvania Department of Health and Gov. Wolf issued a 14-day quarantine recommendation for any individual returning to PA from any of 19 states.  The Department expects to adjust the list from time to time to reflect the rise or decrease in COVID-19 cases in states around the country.

Health care practices and facilities should consider modifying their patient and employee COVID-19 policies to reflect this new guidance.  Similarly, if health care practices or facilities have implemented Patient Notice and Acknowledgment Forms, these should be updated to reflect the new guidance.  All patient and employee screening efforts should include a question regarding travel to or from these states in the prior 14-day period.

Individuals returning from travel to states on PA’s travel list should “stay in their quarantine location for the full 14 days and avoid interacting with anyone including those in their household.”   However, this is currently a recommendation from the Department, not a requirement.

If you have any questions regarding how this new guidance applies to your practice or facility, please do not hesitate to contact us.  To subscribe to the Health Care Law Matters Blog for updates, please click here.

***Update:  Eligible providers that participate in Medicaid and CHIP programs must electronically submit an application for Provider Relief Funds through the Provider Relief Fund Portal  by July 20, 2020. Note that such providers may select to use their gross revenues from patient care for CY 2017, or 2018 or 2019. The Instructions, Application and Terms and Conditions for Medicaid and CHIP Provider Relief Funds can be accessed here: Medicaid and CHIP Provider Relief Funds Instructions , Medicaid and CHIP Provider Relief Funds Application , Medicaid and CHIP Provider Relief Funds Terms and Conditions. 

In a Press Release issued Tuesday afternoon, the U.S. Department of Health and Human Services (HHS) announced they will distribute approximately $15 billion to eligible providers that participate in state Medicaid and Children’s Health Insurance Program (CHIP) programs that have not received a payment from the Public Health and Social Services Emergency Fund (Provider Relief Funds) and $10 billion in Provider Relief Funds to safety net hospitals that serve the nation’s most vulnerable citizens.

PROVIDER RELIEF FUNDS FOR MEDICAID & CHIP PROVIDERS

HHS launched an enhanced Provider Relief Fund Payment Portal on Wednesday that allows eligible Medicaid and CHIP providers to report their annual patient revenue, which will be used as a factor in determining their Provider Relief Fund payment. The payment to each provider will be at least 2% of reported gross revenue from patient care and will be dependent in part on the number of Medicaid patients.

Clinicians that participate in state Medicaid and CHIP programs and/or Medicaid and CHIP managed care organizations who have not yet received Provider Relief Funds may submit their annual patient revenue information to the enhanced Provider Relief Fund Payment Portal to receive a distribution equal to at least 2% of reported gross revenues from patient care.

Examples of eligible providers, serving Medicaid/CHIP beneficiaries, include pediatricians, obstetrician-gynecologists, dentists, opioid treatment and behavioral health providers, assisted living facilities and other home and community-based services providers.

Note that to be eligible for this funding, health care providers must not have received payments from the $50 billion Provider Relief Funds general distribution and either have directly billed their state Medicaid/CHIP programs or Medicaid managed care plans for healthcare-related services between January 1, 2018, to May 31, 2020.

For additional details on the $50 billion Provider Relief Funds general distribution, see the following Fox Rothschild Alerts: Details Regarding $30 Billion Distribution to Health Care Providers and HHS Begins Second Provider Relief Fund Distribution, Congress Adds $75 Billion in New Aid.

$10 BILLION ALLOCATION FOR SAFETY NET HOSPITALS

HHS will automatically distribute, through direct deposit, $10 billion in Provider Relief Funds to hospitals that serve a disproportionate number of Medicaid patients or provide large amounts of uncompensated care. Qualifying hospitals will have:

  • A Medicare Disproportionate Payment Percentage (DPP) of 20.2 percent or greater;
  • Average Uncompensated Care per bed of $25,000 or more. For example, a hospital with 100 beds would need to provide $2,500,000 in Uncompensated Care in a year to meet this requirement; and
  • Profitability of 3 percent or less, as reported to the Centers for Medicaid and Medicare Services (CMS) in its most recently filed Cost Report.

*Note that Children’s Hospitals do not have to satisfy the uncompensated care per bed criteria to be considered a qualifying safety net hospital.

Qualifying hospital recipients will receive a minimum distribution of $5 million and a maximum distribution of $50 million.

If you have any questions regarding Provider Relief Funds, including eligibility as a Medicaid/CHIP provider or qualifying safety net hospital, please do not hesitate to contact us.

In the event of a national disaster or emergency under the Stafford Act or the National Emergencies Act and a Public Health Emergency Declaration by government officials, the Department of Health and Human Services (HHS) Secretary can temporarily waive certain Medicaid and Medicare criterion, which are commonly referred to as 1135 Waivers.  By way of example, 1135 Waivers or modifications include, but are not limited to:

  • Conditions of participation or other certifications requirements;
  • Program participation and similar requirements;
  • Licensing requirements;
  • Preapproval requirements;
  • Stark self-referral sanctions;
  • Performance deadlines; and
  • Limitations on payment for health care items and services to Medicare Advantage (MA) enrollees by non-network providers.  For additional information regarding 1135 waivers, please click here.

In response to the ever-evolving Novel Coronavirus 2019 (COVID-19) pandemic, the Centers for Medicare & Medicaid Service (CMS) and the Office of Medicare Hearings and Appeals (OMHA) modified their guidance on Medicare appeals for Fee for Service (FFS), Medicare Advantage (MA), and Part D participants.

Under new guidance, Medicare-approved bodies, such as Medicare Administrative Contractors (MACs), Qualified Independent Contractors (QICs), and Independent Review Entities (IRE), hearing appeals prior to the COVID-19 pandemic may now:

  • Allow extensions for filing appeals;
  • Waive requests for timeliness requirements for additional information to adjudicate appeals;
  • Allow appeal processing even with incomplete Appointment of Representation forms (however, any communication will only be sent to the beneficiary);
  • Process requests for appeals that do not meet the required elements using information outlined within the applicable appeals requirements; and
  • Utilize all flexibilities available in the appeal process so long as requests are made in good faith.

The OMHA remains open and hearings/appeals continue to move forward as scheduled.  Unless expressly told otherwise by the adjudicating body, appellants should proceed to appear for scheduled hearings and conferences via teleconference.

Providers should expect less Medicare Parts C, D, and PACE audits, which ultimately could lead to an appeal.  In conjunction with the appeals guidance waivers, CMS modified its scheduled program audits by focusing on noncompliance leading to serious risks or complaints alleging infection control concerns.  For more information on audits,  please click here.

Please note that Section 1135 Waivers are temporal in nature.  The Secretary may extend 1135 Waivers at his discretion.  Lastly, 1135 Waivers pertain only to federal requirements, which means applicable state regulations still apply.  If you have any questions regarding the Medicare appeals and/or auditing processes, please contact us.

On June 1, 2020 CMS published QSO-20-31-All. It is effective immediately and provides in part as follows:

(1) States will need to perform focused infection control surveys (FICS) of 100% of the certified nursing homes in their State by July 31, 2020 or lose access to certain federal funding.

  • CMS and CDC are tracking the surveys done to date. Currently approximately 54% of the nation’s nursing homes have gone through a FICS. The state totals range from 11% surveyed (West Virginia) to 100% surveyed (Colorado, Nevada, North Dakota, Wyoming).

(2) States can submit a corrective action plan with a strategy of how they will complete FICS for all nursing homes within 30 days avoid reduction of access to federal funds.

(3) State must conduct FICS pursuant to the following specific timeframes after a report of actual or suspected COVID-19 cases in a nursing home:

  • By July 1, perform on-site surveys of nursing homes which have:
    • had cumulative positive COVID-19 cases equal to 10% of their bed capacity; or
    • had cumulative confirmed positive COVID-19 cases PLUS suspected COVID-19 cases at 20% of their bed capacity; or
    • had ten or more deaths reported due to COVID-19.
  • Within 3-5 business days of identification perform on-site surveys of any nursing home:
    • with 3 or more new COVID-19 suspected and confirmed cases within a week time period; or
    • 1 confirmed resident case in a facility that was previously COVID-free.
  • Beginning in FY 2021, perform annual FICS of 20% of nursing homes dependent on State’s discretion or additional data that identifies nursing homes and community risks.

(4) Specific penalties are to be imposed when there are identified infection control deficiencies. The penalties vary based on a nursing home’s past history and the severity of the deficiency.  Penalties/Enforcement remedies range from:

  • Directed Plan of Correction, Discretionary Denial of Payment for New Admission (DPNA) with 45 days to demonstrate compliance for nursing homes with no infection control deficiencies in the last year and a current level D or E deficiency, to
  • Directed Plan of Correction, Discretionary DPNA with 30 days to demonstrate compliance and at least a $20,000 per instance CMP, for nursing homes with 2 or more infection control deficiencies in the past year and a current Level F deficiency, to
  • Directed Plan of Correction with Discretionary DPNA with 15 days to demonstrate compliance and the imposition of the highest CMP permitted utilizing the CMP analytic tool for nursing homes with a current immediate jeopardy level (J, K, L)  deficiency.

(5) Starting In August 2020, State Survey Agency Priorities may be influenced by recommendations from the Coronavirus Commission for Safety and Quality in Nursing Homes.

(6) Quality Improvement Organizations are being deployed to provide technical assistance to 3,000 low performing nursing homes.

The guidance states that it will cease to be in effect when there is no longer a Public Health Emergency due to COVID-19. The guidance’s reference  to Focused Infection Control Surveys in FY 2021, indicates that CMS anticipates the Public Health Emergency continuing for many more months.