Health Law Advisor

Global hospital budgets, where hospitals receive a fixed amount of revenue for the upcoming year for a specific patient population (e.g., Medicare and/or Medicaid), are the opposite of fee for service reimbursement.

The Center for Medicare and Medicaid Services (CMS) and state Medicaid programs have taken interest in global hospital budgets and hospitals in impacted states will need to prepare.  This article summarizes two of these programs: the federal Advancing All-Payer Health Equity Approaches and Development (AHEAD) model and New York’s Health Equity Reform 1115 Medicaid Waiver.

Only a few days remain for stakeholders—which includes drug manufacturers, patients, health care providers, pharmacies and others—to take advantage of a rare opportunity to influence the statutory contours of the 340B Drug Pricing Program (the “340B Program” or the “Program”). Specifically, industry stakeholders have until April 1^st to submit comments to legislators regarding the Discussion Draft Explanatory Statement and Supplemental RFI (the “RFI”) of the “Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now ...

On Monday, February 26, 2024, BioMarin Pharmaceutical, Inc. (“BioMarin”) disclosed in its annual filing that the company recently received a subpoena from the U.S. Department of Justice (DOJ) requesting certain documents regarding BioMarin’s sponsored testing programs relating to two of its products, VIMIZIM and NAGLAZYME.[1] BioMarin also stated that the company “produced documents in response to the subpoena and are cooperating fully, but there is no assurance that such sponsored testing programs, or [BioMarin’s] other operations or programs, will not be ...

On July 1, 2024 the Center for Medicare and Medicaid Innovation (“CMMI”) will be inaugurating a new value-based payment model designed specifically to address the devastating impacts that a diagnosis of dementia^[1] or Alzheimer’s Disease[2] can have on a patient, their family, friends, and other caregivers who make up the patient’s circle of support. The Centers for Medicare and Medicaid Services (“CMS”) designed the Guiding an Improved Dementia Experience (“GUIDE”) model (the “Model”) for health care providers enrolled in Medicare Part B and that treat ...

Earlier this month, the Centers for Medicare & Medicaid Services (CMS) quietly added “Outreach Site/ Street” as an allowable place of service (POS) code for Medicare and Medicaid providers to use in claims submission for “street medicine” services provided. The “Outreach Site/ Street” POS code allows physicians to seek Medicare reimbursement of such medically necessary professional services when they are delivered in a “non-permanent location on the street or found environment, not described by any other POS code, where health professionals provide ...

On August 24, 2023, the U.S. District Court for the Eastern District of Texas issued an opinion and order in Texas Medical Association, et al. v. United States Department of Health and Human Services(“HHS”)(“TMA III”). TMA III challenged certain portions of the July 2021 No Surprises Act (“NSA”) interim final rules proposed by the U.S. Departments of Health and Human Services, Labor, and Treasury, along with the Office of Personnel Management (the “Departments”).  In a decision that significantly levels the field for providers, the District Court ruled in part ...

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 ...

On June 1, 2023, the U.S. Supreme Court unanimously settled a long-standing dispute over a subjective versus objective standard for scienter under the False Claims Act (FCA), holding that a defendant’s own subjective belief is relevant to scienter, rather than what an “objectively reasonable” person may have known or believed.

The case in question, U.S. ex rel. Schutte v. SuperValu Inc., consolidated from two lower court decisions, involved allegations that the defendants, two retail pharmacy chains, overcharged the government for prescription drugs in violation of ...

The federal government’s announcement that the COVID-19 public health emergency (“PHE”) declaration would end on May 11, 2023 marked the end of various federal mandates and benefits. The Centers for Disease Control’s authorizations to collect certain types of public health data expired, as did the requirement that insurance providers waive costs or provide free COVID-19 tests. However, the Biden Administration announced that COVID-19 hospital admissions, deaths, emergency department visits, test positivity and results of wastewater surveillance will continue to be reported, although the sources of some of this information will change.

The Centers for Medicare & Medicaid Services (“CMS”) is using its annual rulemaking process to update the CMS payment system rules for fiscal year (“FY”) 2024 as a mechanism to advance health equity systematically across various CMS payment programs. Specifically, CMS is incorporating proposals to advance health equity in its proposed payment rules for inpatient hospitals and long-term care hospitals, skilled nursing facilities, inpatient psychiatric facilities, and hospices, and in the final rate announcement for the Medicare Part C and Part D programs for FY 2024. Significantly, in several instances, CMS is requesting comments, which opens the door for providers to share their input about relevant considerations. This CMS initiative is consistent with key components that were detailed in CMS’s “Framework for Health Equity,” the agency’s 10-year plan to “remedy systemic barriers to equity so that every one [CMS] serve[s] has a fair and just opportunity to attain their optimal health regardless of race, ethnicity, disability, sexual orientation, gender identity, socioeconomic status, geography, preferred language, or other factors that affect access to care and health outcomes.”[1] This post outlines the changes being proposed by CMS, as well as highlights opportunities where providers should consider preparing and submitting comments.

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.

As we previously reported, the Centers for Medicare and Medicaid Services’ (CMS) interim final rule (“the Rule”) requiring full COVID-19 vaccination for staff and others at Medicare- and Medicaid-certified providers and suppliers (i.e., the “vaccine mandate”) has been challenged in the U.S. District Courts for the Eastern District of Missouri (“the Missouri Court”) and the Western District of Louisiana, Monroe Division (“the Louisiana Court”).  As of the date of this writing, both Courts have granted preliminary injunctions placing the Rule on hold.

On November 29, 2021, the Missouri Court granted a preliminary injunction of the Rule, which applies to the coalition of ten states [1] that filed the challenge there. The following day, the Louisiana Court entered a similar injunction, which applies to the remaining forty states.

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.

Only a few days remain before the enforcement delay that the Centers for Medicare & Medicaid Services (CMS) exercised due to COVID-19 will end and the agency will require certain payors to publish a Patient Access application programming interface (“API”) and a Provider Directory API under the requirements of the CMS Interoperability and Patient Access Final Rule. Starting on July 1, 2021, all health plans that offer Medicare Advantage, Medicaid and Children’s Health Insurance Program (CHIP) and most Qualified Health Plans offered through the Federally-facilitated ...

The Illinois Coalition to Protect Telehealth, a coalition of more than thirty Illinois healthcare providers and patient advocates, announced its support for a bill that would, among other things, establish payment parity for telehealth services and permanently eliminate geographic and facility restrictions beyond the COVID-19 pandemic. Like many states, Illinois issued an executive order at the outset of the pandemic temporarily lifting longstanding barriers to consumer access to telehealth via commercial health plans and Medicaid.[1]  The executive order expanded the definition of telehealth services, loosened geographical restrictions on physician licensing requirements, and barred private insurers from charging copays and deductibles for in-network telehealth visits.

Now, House Bill 3498 seeks to make permanent some of those temporary waivers by aligning coverage and reimbursement for telehealth services with in-person care. If enacted, it would also establish that patients could no longer be required to use an exclusive panel of providers or professionals to receive telehealth services, nor would they be required to prove a hardship or access barrier in order to receive those services.  The bill does not include a provision that would permanently allow out-of-state physicians or health care providers to provide services in the state beyond the pandemic.[2]

In the Coalition’s announcement of support for this bill, it states that the use of telehealth over the last year has shown an increased adherence to patient care plans and improved chronic disease management.  “In recent surveys, over 70% of Illinois hospital respondents and 78% of community-based behavioral healthcare respondents reported that telehealth has helped drive a reduction in the rates at which patients missed appointments. Surveys of Illinois physicians, community health centers, and specialized mental health and substance use disorder treatment providers have also revealed similar dramatic reductions in missed appointments.”

The U.S. Supreme Court will consider whether the federal government can approve state programs that force Medicaid participants to work, go to school, or volunteer to get benefits. Both Arkansas and the Justice Department sought review of the issue. Epstein Becker Green attorney Clifford Barnes provides potential paths for the Biden administration to best position itself in the case.

The U.S. Supreme Court will hear oral argument in a case involving the authority of the Department of Health and Human Services to approve Medicaid work requirements programs in Arkansas and New Hampshire that were struck down by the U.S. Court of Appeals for the District of Columbia Circuit.

The high court has agreed to determine whether the HHS can allow states to impose work requirements in its Medicaid program even though all lower courts ruled against HHS’s approval of states’ Section 1115 work requirement waivers, based on the Trump administration’s refusal to consider the impact of the waivers on the core purpose of Medicaid—which is to increase health insurance coverage.

Unlike the narrow question considered by the lower courts, however, the court granted certiorari on a much broader issue. The question presented concerns the entire Section 1115 process and asks whether the HHS secretary has the power to establish additional purposes for Medicaid, beyond coverage.

Should the court rule that the HHS secretary does indeed possess this unbounded power, the entire Section 1115 landscape could shift, potentially allowing states to implement waivers like Arkansas, so long as they meet such additional purpose.

The case establishes an effective deadline for the Biden administration to take action to mitigate or eliminate the work requirements, in light of the administration’s commitment to expanding, rather than rolling back, Medicaid insurance coverage.

Our colleague Melissa L. Jampol of Epstein Becker Green has a new post on the Commercial Litigation Update blog that will be interest to our readers: “Opioids, Sober Homes and ‘Telefraud’: An Overview of the DOJ 2020 Healthcare Fraud Takedown.”

The following is an excerpt:

As we have previously reported, opioids have been a large focus of DOJ in the past few years in an attempt to stem the opioid epidemic through increased enforcement and this takedown is a continuation of those efforts. DOJ stated that the charges involved in the opioid-related takedown involved the ...

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.

On March 13, 2020, President Trump issued a proclamation that the novel coronavirus (“COVID-19”) outbreak in the United States constituted a national emergency. Following this proclamation, pursuant to section 1135(b) of the Social Security Act, the Secretary of the Department of Health and Human Services (“HHS”), Alex Azar, invoked his authority to waive or modify certain requirements of titles of the Act as a result of the consequences of the COVID-19 pandemic, to the extent necessary, as determined by the Centers for Medicare & Medicaid Services (“CMS”), to ensure that sufficient health care items and services are available to meet the needs of individuals enrolled in the Medicare, Medicaid, and Children’s Health Insurance Programs (“CHIP”). This authority took effect on March 15, 2020, with a retroactive effective date of March 1, 2020 and will terminate at the conclusion of the public health emergency period.[1] Pursuant to this authority, HHS announced a number of nationwide blanket waivers, including a waiver related to telehealth, in order for providers to respond to the COVID-19 public health emergency.[2]

Separate from and in addition to the blanket waivers, the Secretary’s authority under Section 1135 also allows CMS to grant Section 1135 waivers to states that request CMS to temporarily waive compliance with certain statutes and regulations for its Medicaid programs during the time of the public health emergency. So far, many states have requested these additional flexibilities in order to focus their resources on combatting the outbreak and providing the best possible care to Medicaid enrollees in their states. CMS has been rapidly approving these Section 1135 waiver requests, but it is important to recognize that not all state requests are created equal with respect to utilizing telehealth / telemedicine services during the public health emergency. Based on a review of the publicly available state request letters, it is clear that some states have prioritized use of telehealth in order to respond to COVID-19, while other states have not, or have not yet requested similar flexibilities related to provision of telehealth services. Examples of states that have prioritized greater use of telehealth include:

• California: The state requested flexibility for telehealth and virtual communications to make it easier for providers to care for people in their homes. Specifically, California requested flexibility to allow telehealth and virtual/telephonic communications for covered State plan benefits, such as behavioral health treatment services, and waiver of face-to-face encounter requirements for Federally Qualified Health Centers and Rural Health Clinics, among others. The state also sought reimbursement of virtual communication and e-consults for certain providers. CMS approved this waiver request on March 23, 2020.
• Illinois: The Illinois Department of Healthcare and Family Services waiver request, approved on March 23, 2020 by CMS, sought flexibility of documentation requirements, including the lack of documentation of consent for a telehealth consult. Like several other states, Illinois also requested CMS to allow providers to use non-HIPAA compliant telehealth modes from readily available platforms, such as Facetime, WhatsApp, Skype, etc., to facilitate a telehealth visit or check-in at the location of the patient, including the patient’s home.

While providers struggle to provide health care to their patients amid the coronavirus contagion concerns, recent regulatory and reimbursement changes will help ease the path to the provision of healthcare via telehealth.

On March 6, 2020, President Donald Trump signed into law an $8.3 billion emergency coronavirus disease 2019 (“COVID-19”) response funding package. In addition to providing funding for the development of treatments and public health funding for prevention, preparedness, and response, the bill authorizes the U.S. Secretary of Health and Human Services, Alex Azar (referred to herein as the “Secretary”), to waive Medicare restrictions on the provision of services via telehealth during this public health emergency.

Greater utilization of telehealth during the COVID-19 outbreak will reduce providers’ and patients’ exposure to the virus in health care facilities. Telehealth is especially useful for mild cases of illness that can be managed at the patient’s home, thereby decreasing the volume of individuals seeking care in facilities. To further facilitate the increased utilization of telehealth, the Centers for Disease Control’s interim guidance for healthcare facilities notes that healthcare providers can communicate with patients by telephone if formal telehealth systems are not available. This allows providers to have greater flexibility when telehealth technology providers lack the bandwidth to accommodate this increase in telehealth utilization or are otherwise unavailable.

On July 8, 2019, Anthony Camillo, owner of Allegiance Medical Laboratory and AMS Medical Laboratory, was sentenced to 30 months in prison by a federal judge in the Eastern District of Missouri. He was ordered to pay $3.4 million in restitution for violations of the anti-kickback statute, associated conspiracy charges, and illegal kickbacks related to various health care fraud schemes to defraud federal health care benefit programs. Those operating in the clinical laboratory testing space or referring specimens to such laboratories should know that what happened in this case is ...

The Centers for Medicare & Medicaid Services (“CMS”) has published a final rule that will expand access to telehealth services for Medicare Advantage (“MA”) plan enrollees.[1] CMS Administrator Seema Verma characterized the agency’s latest policymaking efforts as “a historic step in bringing innovative technology to Medicare beneficiaries” and a way for the agency to provide “greater flexibility to Medicare Advantage plans, [so] beneficiaries can receive more benefits, at lower costs and better quality.”[2]

Traditionally, MA plans have been limited to ...

Did you know that your zip code is a better predictor of your health than your genetic code? Public health experts – and your health insurance provider – have long known that the air you breath, the education you receive, your net worth, and even the music that you listen to are strong indicators of your overall health – and the possibility that you might need expensive medical procedures in the future. By some measures, up to 50% of your overall health is determined by social, economic, and environmental factors. As the movement to value-based payment continues in health care, there ...

Last month, the New York State Court of Appeals invalidated a state Department of Health (DOH) regulation that restricted certain health care providers contracting with the state from paying executives more than $199,000 annually, regardless of whether the funds came from the state or not. However, the Court upheld two other DOH regulations; one that limits providers from using public tax-payer money directly to pay executives in excess of $199,000 annually, and another that limits the amount of public funds used for administrative costs.

In January 2012, Governor Andrew Cuomo ...

The Medicare Payment Advisory Commission (“MedPAC”) held its monthly public meetings in Washington, D.C., on November 1-2, 2018. The purpose of this and other MedPAC public meetings is for the commissioners to analyze existing challenges and issues within the Medicare program and to provide future policy recommendations to Congress. MedPAC issues these recommendations in two annual reports, one in March and another in June. These meetings offer a comprehensive perspective on the current state of Medicare as well as future outlooks for the program.

As thought leaders in ...

On October 24, 2018, President Trump signed sweeping bipartisan legislation to combat the opioid epidemic. The Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, or the SUPPORT for Patients and Communities Act (“H.R. 6” or “the Law”), aims to “reduce access to the supply of opioids by expanding access to prevention, treatment, and recovery services.”[1] Congress has already appropriated $8.5 billion to implement this “landmark legislation” in 2018 and 2019.

In a series of Client Alerts, Epstein ...

The Medicare Payment Advisory Commission (“MedPAC”) met in Washington, D.C., on September 6-7, 2018. The purpose of this and other public meetings of MedPAC is for the commissioners to analyze existing challenges and issues within the Medicare program and to provide future policy recommendations to Congress. MedPAC issues these recommendations in two annual reports, one in March and another in June. These meetings offer a comprehensive perspective on the current state of Medicare as well as future outlooks for the program.

As thought leaders in healthcare law, Epstein ...

The Office of Inspector General (“OIG”) of the U.S. Department of Health and Human Services issued Advisory Opinion No. 18-03 in support of an arrangement where a federally qualified health center look-alike (the “Provider”) would donate free information technology-related equipment and services to a county health clinic (the “County Clinic”) to facilitate telemedicine encounters with the County Clinic’s patients (the “Proposed Arrangement”).  The OIG concluded that although the Proposed Arrangement could potentially generate prohibited ...

Since the inauguration of President Trump, the Affordable Care Act (ACA) has taken quite a few significant jabs and blows. When Congress failed to repeal the ACA, Congress instead eliminated the individual mandate penalty through the GOP tax bill. The individual mandate penalty was one of the main pillars of the ACA because it effectively widened the pool of participants who buy health insurance in order to keep costs down. While removal of this penalty hit the ACA where it hurt, the true threat to the stability of the ACA arose when the Trump Administration announced that it would no ...

In March 2018, the Medicaid and CHIP Payment and Access Commission (MACPAC) made its 2018 report to Congress, which included the Commission’s evaluation of telehealth services provided through the Medicaid program. Chapter 2 of MACPAC’s report had a positive outlook on telehealth’s contribution toward better accessibility of health care services to underserved individuals as well as individuals with disabilities.

Unlike its larger counterpart, Medicare, federal policy has not placed many restrictions on state Medicaid programs in terms of adopting or designing ...

This is the 7th and final installment in the Medicare Secondary Payer Compliance series. All titles in this series can be viewed below. Subscribe to our blog to receive these future updates. Prior installments of this series can be accessed using the links provided.

• Medicare Secondary Payer Compliance: An Introduction (Part I)
• Medicare Secondary Payer Compliance: Conditional Payments (Part II)
• Medicare Secondary Payer Compliance: Group Health Plans (Part III)
• Medicare Secondary Payer Compliance: Non-Group Health Plans (NGHPs) (Part IV)
• Medicare Secondary Payer Compliance:

This is part 6 of 7 in the Medicare Secondary Payer Compliance series. All titles in this series can be viewed below. Subscribe to our blog to receive these future updates. Prior installments of this series can be accessed using the links provided.

• Medicare Secondary Payer Compliance: An Introduction (Part I)
• Medicare Secondary Payer Compliance: Conditional Payments (Part II)
• Medicare Secondary Payer Compliance: Group Health Plans (Part III)
• Medicare Secondary Payer Compliance: Non-Group Health Plans (NGHPs) (Part IV)
• Medicare Secondary Payer Compliance: Providers (Part V)

Over the past week, the White House administration (the “Administration”) has issued two documents addressing drug pricing. First, on February 9, 2018, the White House’s Council of Economic Advisers released a white paper titled “Reforming Biopharmaceutical Pricing at Home and Abroad” (the “White Paper”).  Second, on February 12, 2018, the Administration issued its 2019 Budget Proposal (“2019 Budget”).

Whereas the recommendations set forth in the White Paper are more conceptual or exploratory, the 2019 Budget purportedly reflects the ...

On January 16, 2018, the Department of Health and Human Services Office of Inspector General (OIG) published its most recent update to the agency’s “Work Plan.”  Of note to Durable Medical Equipment (DME) manufacturers, suppliers and prescribers, OIG signaled increased interest in the investigation of three specific off-the-shelf orthotic devices identified by the HCPCS codes:

• L0648—back bracing
• L0650—back bracing
• L1833—knee bracing

According to OIG, the government paid out $349 million for these braces in 2016, representing a 97% increase from just 2014.  OIG ...

Perspectives on Health Care and Life Sciences advisory by Bob Atlas, President of EBG Advisors, Inc. 

Following is an excerpt:

The U.S. Senate and House of Representatives have both passed their tax reform bills and will now confer toward creating a unified bill that both chambers can support, and that President Trump will sign. The two bills differ in some key respects, but their implications for health care are already rather clear. Some aspects of the legislation explicitly touch health care, while other effects would be indirect. Overall, it appears that most of the changes would ...

On March 15, 2017, the United States District Court for the Western District of Pennsylvania issued an opinion that sheds insight on how courts view the "writing" requirement of various exceptions under the federal physician self-referral law (or "Stark Law"). The ruling involved the FCA qui tam case, United States ex rel. Emanuele v. Medicor Assocs., No. 1:10-cv-245, 2017 U.S. Dist. LEXIS 36593 (W.D. Pa. Mar. 15, 2017), involving a cardiology practice (Medicor Associates, Inc.) and the Hamot Medical Center. The Court's detailed discussion of the Stark Law in its summary judgment ...

On December 31, 2016, the U.S. District Court for the Northern District of Texas issued a nationwide preliminary injunction that prohibits the U.S. Department of Health and Human Services (HHS) from enforcing certain provisions of its regulations implementing Section 1557 of the Affordable Care Act that prohibit discrimination on the basis of gender identity or termination of pregnancy. This ruling, in Franciscan Alliance v. Burwell (Case No. 7:16-cv-00108-O), a case filed by the Franciscan Alliance (a Catholic hospital system), a Catholic medical group, a Christian medical ...

On December 31, 2016, the U.S. District Court for the Northern District of Texas issued a nationwide preliminary injunction that prohibits the U.S. Department of Health and Human Services (HHS) from enforcing certain provisions of its regulations implementing Section 1557 of the Affordable Care Act that prohibit discrimination on the basis of gender identity or termination of pregnancy. This ruling, in Franciscan Alliance v. Burwell (Case No. 7:16-cv-00108-O), a case filed by the Franciscan Alliance (a Catholic hospital system), a Catholic medical group, a Christian medical ...

On Monday, June 27, 2016, the U.S. Supreme Court declined to review a D.C. Circuit Court of Appeals decision upholding the new U.S. Department of Labor’s (DOL) requirement that home care providers pay the federal minimum wage and overtime to home care workers.  As we previously discussed, on August 21, 2015, the D.C. Circuit in Home Care Association of America v. Weil affirmed the validity of the Home Care Final Rule, which eliminated a long-existing prior regulation and barred third-party employers from claiming minimum wage and overtime exemptions for home care workers.

The U.S ...

[caption id="attachment_2451" align="alignright" width="113"] Maxine Neuhauser[/caption]

In conjunction with unveiling its Final Overtime Rule, the DOL announced a Time Limited Non-Enforcement Policy (“Policy”) for providers of Medicaid-funded services for individuals with intellectual or developmental disabilities in residential homes and facilities with 15 or fewer beds. Under the Policy, from December 1, 2016, to March 17, 2019, the DOL will not enforce the updated salary threshold of $913 per week for this subset of employers.

The Policy applies only to DOL ...

As you all know, the subject of telehealth reimbursement continues to vex the community. For example, Medicare lags far behind.  According to the Center for Telehealth and eHealth Law, Medicare reimbursed approximately $14 million total under its telehealth benefit for 2014.  This represents less than .0025 percent of the total Medicare reimbursed for services that year.  Medicaid is something of a mixed bag with the vast majority of states providing some coverage for telehealth, but many lagging in coverage and reimbursement for store-and-forward services and remote patient ...

2016 is poised to be a major year in network adequacy developments across public and private insurance markets.  Changes are ahead in the Medicare and Medicaid managed care programs, the Exchange markets and the state-regulated group and individual markets, including state-run Exchanges.  The developing standards and enforcement will vary significantly across these markets.

Through 2014 and 2015, major news stories discussed concerns over the growing use of narrow provider networks by issuers on the Affordable Care Act's insurance exchanges ("Exchanges").  Others reported on ...

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 ...

As many of you know, reimbursement for telehealth services is a mixed bag.  On the one hand, private payers generally seem ahead of the curve.  Many leading private insurers reimburse for telehealth.  Generally these coverage policies provide reimbursement for telehealth services when they involve the use of real-time interactive audio, video, or other electronic media for diagnosis and consultation.  Just as significantly, more than half the states and the District of Columbia have passed telehealth parity statutes which require health insurers to provide coverage for services ...

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 ...

Who knew?!  Buried among more than 1,000 pages of a new final rule with comment period on payments to physicians, released on October 31, 2014, the Centers for Medicare & Medicaid Services (“CMS”) finally has given telehealth providers a glimpse of its plans to expand reimbursement for telehealth services provided to Medicare beneficiaries. 

The final rule includes a provision that would cover remote chronic care management using a new current procedural terminology (“CPT”) code, 99490 (with a monthly unadjusted, non-facility fee of $42.60).  This new CPT code can be ...

By Clifford E. Barnes and Marshall E. Jackson, Jr.

Recent enforcements in home health fraud have highlighted the need for home health companies of every state to engage the State Medicaid payment agency in pro-active affirmative discussion to work together to identify issues related to fraud and abuse.  Such discussions will provide home health companies further insight regarding compliance with federal and state fraud and abuse laws. That being said, recent enforcement actions have shown that home health companies may be liable under fraud and abuse laws, despite efforts to ...

By Constance Wilkinson, Alan Arville, and David Gibbons

The U.S. Department of Health and Human Services ("HHS") Office of Inspector General ("OIG") released a Report [1] on February 5th based on in-depth interviews with a sample of thirty 340B Covered Entities – half were disproportionate share hospitals ("DSH") and half were community health centers ("CH") – and eight contract pharmacy administrators to gain a better understanding of how contract pharmacy arrangements operate under the 340B Drug Discount Program, codified as Section 340B of the Public Health Service Act ...

During and after a recent presentation regarding telehealth before a health care executive group, we were inundated with the following question:  Why should a hospital provide telehealth services when often times it will not get paid for those services?  It is, on its face, a great question.  After all, few of us would want to provide services we know will not be reimbursed.  But, in many ways, the question misses the boat.  While a hospital may not be paid directly for providing telehealth services, it nevertheless could significantly benefit in a number of ways that prove just as valuable ...

As telehealth continues to grow, there are a number of legal, regulatory, and operational issues that threaten to stall its progress.  We have tackled many of these issues in previous blog posts.  But no obstacle looms larger than the issue of payment.  How can providers get consistently and appropriately reimbursed by payers for use of telehealth?  Absent a clear answer, telehealth will likely find it difficult to fulfill its great promise—at least in the United States.  Other countries are pulling ahead.  Here is a look at the current reimbursement landscape facing providers and what ...

by Lynn Shapiro Snyder and Shawn M. Gilman

Speculation abounds with respect to the decision that states will make on the issue of whether to expand Medicaid coverage under the Affordable Care Act, now that the Supreme Court of the United States has made the option to abstain a meaningful one. This health reform alert highlights some key factors that may influence a state's decision on whether to implement such an expansion.

Read the full alert here

Danielle Steele, a Summer Associate (not admitted to the practice of law) in Epstein Becker Green's Washington, DC, office, contributed ...

 A significant yet little-noticed trend is underway. And its effects could be far-reaching.  A growing number of states are enacting so-called telehealth parity statutes. These laws generally require health insurers to pay for services provided via telehealth the same way they would for services provided in-person. Almost a third of all states have enacted these statutes, and I predict more states will be jumping on the bandwagon. Telehealth is indeed going mainstream.

Maryland became one of the latest states to jump on the bandwagon when the state’s governor signed a telehealth ...

It should be an easy matter for an employer to determine which federal laws apply to it.  Not so, however, given the way in which the Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) administers and enforces the federal affirmative action laws (Executive Order 11246, the Rehabilitation Act, and the Vietnam Era Veterans Readjustment Assistance Act).

In the last sixteen months, OFCCP has (a) issued an expansive and controversial new “Directive 293,” asserting broad and deep jurisdiction over health care providers who participate in TRICARE, FEHBP ...

RECENT PRESS COVERAGE

Rock Center with Brian Williams recently featured a story about hospitals that were "overwhelmed by ‘permanent residents.’" The focus of the piece was individuals whose need for acute care in a hospital had long since been addressed, but who have no insurance or other way to pay for the long-term care they do need, in a nursing home or rehabilitation facility, or in their own home. Without a safe place to which discharge is available for these patients, hospitals must continue to provide for their care.

 One of the individuals profiled by the piece, and many ...

by Pamela D. Tyner, Amy Lerman, and Lesley R. Yeung

The Recovery Audit Contractor (“RAC”) program is a national program aimed at identifying Medicare program overpayments and underpayments through a review of individual Medicare claims by contractors paid on a contingency fee basis. Over the next year, the RAC program will expand its reach beyond the current focus on fee-for-service payments under Medicare Parts A and B to include Medicare Part C (Medicare Advantage) and Part D (Prescription Drug Benefit) as well as state Medicaid programs. As Medicaid RAC programs get ...

by Kathleen A. Peterson, Benjamin S. Martin, Wendy C. Goldstein, and Constance A. Wilkinson

This issue of Implementing Health & Insurance Reform summarizes and discusses some issues raised by the proposed rule ("Proposed Rule") that the Centers for Medicare & Medicaid Services ("CMS") published on February 2, 2012, to implement changes to the Medicaid Drug Rebate Program ("MDRP") and to reimbursement limits for outpatient drugs covered by Medicaid.

In Part 1, we discuss proposals relating to the MDRP that would change the manner in which pharmaceutical manufacturers calculate ...