Health Law Advisor

In September 2024, a group of Washington, D.C., legislators introduced the Certificate of Need (CON) Improvement Act of 2024, B25-0948. If passed, the measure will reform the requirements and process for health establishments in the District to obtain CONs from D.C.’s State Health Planning and Development Agency (SHPDA).

Background

D.C.’s CON requirements were originally established in 1980 to ensure that access to health care services is available to all D.C. residents and to contain the costs of such health care services. D.C. regulators have more recently argued that D.C. was experiencing an overabundance of primary care providers, which has led regulators to apply the CON process in an overly broad manner to prevent a doctor on every block.^[1] The CON requirements have been applied in an inconsistent manner such that similarly situated providers may or may not have a CON depending on enforcement by regulators. Stakeholders within the D.C. community have contested the overly broad interpretation and enforcement of the CON law in D.C. and have argued that such interpretations are in fact creating provider shortages, increasing health care costs, and decreasing access to care.

In addition, the time and expense of complying with the CON requirements is enough of a barrier to potentially send independent physician practices across the border into Maryland and Virginia.^[2] Stakeholders have asserted that rather than decrease health care costs and increase access to care, the CON laws have had the opposite effect.

Lastly, the current requirements for institutional and physician providers to apply for a CON for even routine projects or activities is unnecessary and overly burdensome. For example, hospitals must wait months to a year following the CON process to get non-patient improvements like heating, ventilation, and air conditioning (HVAC). Furthermore, under the current interpretation by regulators, a physician group could subject itself to requiring a CON simply by hiring a non-owner physician or maintain a separate room to perform non-surgical procedures.

To honor the 34th anniversary of the Americans with Disabilities Act (ADA), on July 26, 2024, the U.S. Department of Justice (DOJ) signed a long-awaited final rule to improve access to medical diagnostic equipment (MDE) for people with disabilities (the “MDE Regulations”). Stressing that accessible MDE is essential for people with disabilities to have equal access to medical care and avoid poor health outcomes, the MDE Regulations, which were published by the Federal Register on August 9, 2024, amend Title II of the ADA (“Title II”) and apply to hospitals and health care clinics operated by state or local governments. The MDE Regulations create enforceable minimum standards for accessible design (as initially issued by the U.S. Access Board) covering MDE, including examination tables, weight scales, dental chairs, x-ray machines, mammography machines, and other radiological equipment commonly used for diagnostic purposes by health care professionals.

In full, the MDE Regulations and the accessibility standards they incorporate stand well in excess of 100 pages. To help our clients more readily understand what the MDE Regulations do and do not require, we are answering some of the most commonly asked questions here.

In this episode of the Diagnosing Health Care Podcast: Gender-affirming care has become the latest flashpoint in state legislatures and state and federal courts across the nation.

States are divided, with some passing laws that seek to restrict access to gender-affirming care and others aiming to protect access.

What is gender-affirming care? What risks does it pose to providers and patients? On this episode, Epstein Becker Green attorneys Jenny Nelson Carney, Lisa Pierce Reisz, and Erin Sutton dissect gender-affirming care: what it is, what it isn't, and what is at stake for everyone involved.

In this episode of the Diagnosing Health Care Podcast: Under the Biden administration, the Centers for Medicare & Medicaid Services published a health equity framework that drastically changed the playing field for health plans and other risk-bearing entities.

In the wake of these changes, how can health plans, accountable care organizations, and other similar stakeholders successfully create and administer social determinants of health interventions as a means to advance health equity?

On this episode, Epstein Becker Green attorneys Jackie Selby, Kevin Malone, and Marjorie Scher discuss the recent national focus on health equity, the actionable interventions behind the concept, and the responsibility of stakeholders in making care delivery more equitable.

On June 8, 2023, the New York City Council passed a bill focused on healthcare accountability, with the goal of increasing access to healthcare services for New Yorkers. Entitled the Healthcare Accountability & Consumer Protection Act (the “Act”), this legislation includes Introduction 844, which establishes an Office of Healthcare Accountability, whose work would allow patients to see through a website what they would be charged for procedures at hospitals throughout New York City. As part of the Act, this Office would also report on insurance and pharmaceutical pricing, as well as monitor the amount of money the City is spending on healthcare services. In addition, the Act includes Resolution 512, which calls on New York State to create an independent commission to oversee hospital pricing and to increase access to healthcare services. This local law, referred to as Local Law 78, was signed by Mayor Adams on June 23, 2023, and will be effective beginning on February 22, 2024.

In this episode of the Diagnosing Health Care Podcast:  The Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization one year ago overturned 50 years of legal precedent protecting the constitutional right to abortion in the United States, leaving the question of whether and how to regulate abortion to individual states.

What has happened since and what is to come?

Epstein Becker Green attorneys Amy Dow, Erin Sutton, and Jessika Tuazon examine how the Dobbs decision has impacted the legal landscape for patient access to abortion, discuss the challenges facing the health care industry, and explore how industries can manage their compliance efforts moving forward as the legal landscape continues to evolve.

In this episode of the Diagnosing Health Care Podcast:  On April 21, 2023, the U.S. Supreme Court ruled to preserve access to the prescription abortion drug mifepristone.

However, while the case continues in the U.S. Court of Appeals for the Fifth Circuit, the future of mifepristone—and the U.S. Food and Drug Administration’s authority to approve new drugs—will continue to be debated on appeal.

In this episode of the Diagnosing Health Care Podcast:  When analyzing the life cycle of any health care product, a key component to consider is how much the product will cost and who will pay for it.

What unique challenges do direct access tests (DATs) pose when it comes to reimbursement and related compliance requirements?

In this episode of the Diagnosing Health Care Podcast:  What are the various factors impacting stakeholders in the direct access testing industry?

By the end of this four-part series on direct access laboratory testing, listeners will have gained insight into how to navigate the complex regulatory and legal regimes that govern the process of making lab tests available directly to patients and understand the aspects that will dictate how their operations should be structured.

In this episode of the Diagnosing Health Care Podcast:   Changes are on the horizon for provisions of the Program of All-Inclusive Care for the Elderly (PACE) that haven’t been updated in over a decade.

What exactly is PACE and how will new proposed rule modifications affect PACE plans moving forward?

On this episode, hear from special guest Wendy Edwards, Director of Internal Operations at BluePeak Advisors.

On November 18, 2022, the Alliance Defending Freedom (“ADF”), a conservative legal group, filed a motion with the federal district court in the Northern District of Texas against the U.S. Food and Drug Administration (“FDA”) to withdraw approval of Mifepristone, an FDA-approved drug used to end pregnancies in the first trimester.[1]  While this case addresses access to a single product and was prompted by abortion opponents’ efforts to eliminate access to medication abortion, a loss for FDA in this case could have far broader implications.

The Joint Commission, one of the leading accrediting organizations of health care entities, recently announced significant updates to require that health care organizations invest in their health equity promotion infrastructure and The Joint Commission’s intention to acknowledge those organizations with more robust health equity initiatives and programs.

Effective January 1, 2023, The Joint Commission implemented new and revised standards for hospitals, ambulatory health care organizations, and behavioral health care organizations aimed at reducing health care disparities.

Most significantly, The Joint Commission added a new standard, LD.04.03.08, to the Leadership (LD) chapter. This standard provides: “Reducing health care disparities for the [organization’s] [patients] is a quality and safety priority.”[1] The new standard, which applies to all hospitals and certain ambulatory health care organizations and behavioral health care organizations, has the following six elements of performance:

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?

In this episode of the Diagnosing Health Care Podcast:  Following the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization, some states have banned abortion in all or most circumstances and many more have enacted new restrictions or enforced old ones.

In this episode of the Diagnosing Health Care Podcast, dive into the Biden Administration's first 100 days in office and the potential executive orders, regulations, and new legislation with noteworthy health care policy implications.

Epstein Becker Green attorneys Ted Kennedy, Philo Hall, and Paulina Grabczak discuss President Biden’s priorities, including his COVID-19 response plan, and examines which "midnight rules" put in place by the Trump Administration could be intercepted or retained.

The Diagnosing Health Care podcast series examines the business ...

Our colleagues Amy F. Lerman, Francesca R. Ozinal, and team have released the 2019 update to Epstein Becker Green’s Telemental Health Laws survey.

Available as a complimentary app for iPhone, iPad, and Android devices, the survey covers state telehealth laws, regulations, and policies within mental health.

For more about the survey findings, visit “Epstein Becker Green Finds Telehealth Services Are Increasingly Accessible to Mental Health Professionals Despite Legislative Barriers.”

Also see the "Telemental Health Laws: Overview" for more about the ...

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 ...

The Centers for Medicare & Medicaid Services (CMS) issued a final rule on November 1, 2018 that updates physician fee schedule (PFS) payments for calendar year (CY) 2019 and finalizes several policies. The final rule includes amendments to the regulations promulgated under Section 216 of the Protecting Access to Medicare Act of 2014 (“PAMA”) intended to increase the number of clinical laboratories that qualify as an “applicable laboratory” for reporting purposes; specifically (1) removal of payments received from Medicare Advantage (MA) Plans for determining ...

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 ...

Earlier this year, Florida Governor Rick Scott signed into law HB7099 and SPB7028 (collectively referred to as the “Bills”), ratifying emergency rules that require nursing homes and assisted living facilities to acquire alternative power sources- such as generators- and fuel in preparation of the upcoming hurricane season. See Rule 59A-4.1265 and Rule 58A-5.036. These rules were enacted after 14 residents died from heat-related illnesses and complications during Hurricane Irma last year when a Florida nursing home lost power to its air conditioning units for three days.

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 ...

The Health Care Compliance Association (HCCA) kicked off its 22^nd Annual Compliance Institute on Monday, April 16, 2018. During the opening remarks, Inspector General Daniel Levinson, of the Department of Health and Human Services (HHS) Office of Inspector General Office (OIG), announced the rollout of a new public resource to assist companies in ensuring compliance with Federal health care laws. The Compliance Resource Portal on the OIG’s website features:

• Toolkits
• Advisory opinions
• Provider Compliance Resource and Training
• Voluntary Compliance and Exclusions ...

Faced with the inability to repeal the Affordable Care Act (“ACA”) outright, the Trump Administration and Congress have taken actions to provide more health insurance options for Americans.  Thus far, the Administration announced that they would no longer make cost sharing reduction (“CSR”) payments to insurers on the Exchanges and extended the time period in which short-term, limited-duration insurance (“STLDI”) plans could be offered.  Meanwhile, Congress removed the individual mandate in the 2017 tax bill. The Administration asserts that these efforts are all ...

On February 20^th the Department of the Treasury, Department of Labor, and Department of Health and Human Services (together the “tri-agencies”) released a proposed rule which would alter how long short-term, limited-duration insurance (“STLDI”) plans could be offered. Under current rules the maximum duration that a STLDI plan can be offered is less than 3 months, if the proposed rule is enacted that period would be extended to less than 12 months.  The tri-agencies are accepting comments on the proposed rule until April 23^rd.

What are short-term, limited-duration health ...

On February 9, 2018, President Trump signed into law the Bipartisan Budget Act of 2018 (“BBA”). Among the most notable changes that will occur with the enactment of the BBA is the inclusion of certain provisions taken from the Creating High-Quality Results and Outcomes Necessary to Improve Chronic (“CHRONIC”) Care Act of 2017 bill (S.870) which the Senate passed in September 2017. Among other things, the CHRONIC Care provisions will have the effect of redefining new criteria for special-needs plans (“SNPs”), in particular the special-needs Medicare Advantage ...

The Centers for Medicare and Medicaid Services’ (“CMS”) recently announced its intent to expand what may be considered “supplemental benefits,” broadening the scope of items and services that could be offered to Medicare Advantage (“MA”) plan enrollees over and above the benefits covered under original Medicare. However, in articulating the standards for covering this broadened group of items and services, CMS proposed a new requirement that could greatly limit enrollees’ ability to access all types of supplemental benefits and increase the already ...

In the last couple of months, ballot initiatives have significantly affected health policy and the health industry as a whole. Constituents are becoming more involved in policy matters that have traditionally been left to elected officials in state legislatures. On January 25, 2018, Oregon held a special election for a ballot initiative that asked whether Oregonians would support funding the state Medicaid program by taxing health plans and hospitals. The ballot initiative passed with a margin of 62 percent of voters supporting the measure. The measure proposed a 1.5 percent ...

On December 14, the Federal Communications Commission (FCC) voted to remove regulations that prohibit providers from blocking websites or charging for high quality service to access specific content. Many worry that allowing telecommunications companies to favor certain businesses will cause problems within the health care industry. Specifically, concerns have risen about the effect of the ruling on the progress of telemedicine and the role it plays in access to care. Experts worry that a tiered system in which service providers can charge more for speed connectivity can be ...

There has been a growing trend of strategic joint ventures throughout the healthcare industry with the goal of enhancing expertise, accessing financial resources, gaining efficiencies, and improving performance in the changing environment. This includes, for example, hospital-hospital joint ventures, hospital-payor joint ventures, and hospital joint ventures with various ancillary providers (e.g., ambulatory surgery, imaging, home health, physical therapy, behavioral health, etc.). Extra precautions need to be taken in joint ventures between tax-exempt entities ...

In an Advisory Opinion dated October 20, 2017, to Crouse Health Hospital ("Crouse Hospital"), the Federal Trade Commission ("FTC") agreed that the Non-Profit Institutions Act ("NPIA") would protect the sale of discounted drugs from Crouse Hospital to the employees, retirees, and their dependents of an affiliated medical practice (Crouse Medical Practice, PLLC) ("Medical Practice") from antitrust liability under the Robinson-Patman Act.  Significantly, the FTC provided this advice despite the fact that the Medical Practice is a for-profit entity, and is not owned by Crouse ...

New rules issued on November 7, 2017 by FDA will make it easier for companies to offer certain types of genetic tests directly-to-consumers (DTC), without a health-care provider intermediary.

The first rule exempts "autosomal recessive carrier screening gene mutation detection systems" that are offered DTC from FDA premarket review.  FDA first proposed this exemption in 2015, on the same date as the agency issued a final order classifying these types of tests as Class II medical devices, in response to a request from 23andMe.  The 2015 final rule specified the conditions under which ...

On November 1, 2017, the Centers for Medicare & Medicaid Service ("CMS") released the Medicare Hospital Outpatient Prospective Payment System ("OPPS") final rule ("Final Rule"), finalizing a Medicare payment reduction from Average Sales Price ("ASP") + 6% to ASP - 22.5%, for 340B discounted drugs in the hospital outpatient setting, as was proposed in the OPPS proposed rule earlier this year. This payment reduction is effective January 1, 2018, and would primarily impact disproportionate share hospitals, rural referral centers, and non-rural sole community hospitals.

340B ...

The Medicare Payment Advisory Commission ("MedPAC") met in Washington, DC, on October 5-6, 2017. The purpose of this and other public meetings of MedPAC is for the commissioners to review the issues and challenges facing the Medicare program and then make policy recommendations to Congress. MedPAC issues these recommendations in two annual reports, one in March and another in June. MedPAC's meetings can provide valuable insight into the state of Medicare, the direction of the program moving forward, and the content of MedPAC's next report to Congress.

As thought leaders in health ...

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 ...

After July 1, 2017, optometrists and ophthalmologists ("Ophthalmic Providers") in Virginia will be able to practice through telehealth. Va. Code § 54.1-2400.01:2 permits Ophthalmic Providers to establish a bona fide provider-patient relationship "by an examination through face-to-face interactive, two-way, real-time communication" or through "store-and-forward technologies." Licensed Ophthalmic Providers may establish a provider-patient relationship so long as the provider conforms to the in-person standard of care.  To the extent that an Ophthalmic Provider ...

Recently, Judge Robert T. Conrad, Jr. of the United States District Court for the Western District of North Carolina (Charlotte Division), rejected efforts by The Charlotte- Mecklenberg Hospital Authority, doing business as the Carolinas Health Care System ("CHS"), to dismiss, at the pleadings stage, a complaint filed by the United States' Antitrust Division of the Department of Justice, and the State of North Carolina, asserting that CHS's anti-steering provisions in its payer contracts unreasonably restrain trade in violation of section 1 of the Sherman Act. Recognizing the ...

Our colleagues Joshua A. Stein and Frank C. Morris, Jr., at Epstein Becker Green have a post on the Health Employment And Labor blog that will be of interest to many of our readers: "The U.S. Access-Board Releases Long-Awaited Final Accessible Medical Diagnostic Equipment Standards."

Following is an excerpt:

As part of a flurry of activity in the final days of the Obama Administration, the U.S. the Architectural and Transportation Barriers Compliance Board (the "Access Board") has finally announced the release of its Accessibility Standards for Medical Diagnostic Equipment (the ...

On Monday, January 23^rd, Senators Bill Cassidy (R-LA) and Susan Collins (R-ME) introduced the Patient Freedom Act of 2017 ("PFA"), the first of what may be many Republican Affordable Care Act ("ACA") "replacement" alternatives. The PFA is notable for several reasons. It is the first replacement plan to be introduced in the 115^th Congress, it is sponsored by Senators who are considered comparatively moderate on health issues, and thus its content may represent an opportunity for compromise in the future, and, perhaps most interestingly, does not actually repeal the ACA. The ...

As the transition in Washington moves into high gear this month, it's not just the new Administration and Congress that are putting in place plans for policy and legislation; stakeholders are busy creating agendas, too.

Many stakeholder agendas will seek to affect how government addresses such prominent health care issues as the Affordable Care Act, Medicare entitlements, fraud-and-abuse policies, FDA user fees, and drug pricing. There will be a myriad of stakeholder ideas, cutting a variety of directions, all framed with an eye to the new political terrain.

But whatever policies ...

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 ...

Epstein Becker Green has just released the 50-State Survey of Telemental/Telebehavioral Health (2016), a groundbreaking, comprehensive survey on the laws, regulations, and regulatory policies impacting telemental health in all 50 states and the District of Columbia.

While other telehealth studies exist, this survey focuses solely on the remote delivery of behavioral health care.

Compiled by attorneys in Epstein Becker Green's Telehealth practice, the survey details the rapid growth of telemental health—mental health care delivered via interactive audio or video ...

Epstein Becker Green's Peter M. Panken and Frank C. Morris, Jr. have authored a post on the Hospitality Labor and Employment Law blog entitled, "Loose Lips Sink Ships: New Liabilities Under The Affordable Care Act."

Following is an excerpt:

The Affordable Care Act ("ACA") requires larger employers (50 or more full time equivalents) to offer "affordable" "minimum value" health care to employees working thirty (30) or more hours per week or face the possibility of significant penalties in some cases.  Thus the cost of staffing with part time employees may be far less than paying for ...

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 ...

Joshua A. Stein, a Member of the Firm in the Labor and Employment practice at Epstein Becker Green, has a Hospitality Labor and Employment Law blog post that will be of interest to many of our readers: "DOJ Further Delays Release of Highly Anticipated Proposed Website Accessibility Regulations for Public Accommodations."

Following is an excerpt:

For those who have been eagerly anticipating the release of the U.S. Department of Justice's proposed website accessibility regulations for public accommodations under Title III of the ADA (the "Public Accommodation Website ...

On March 24, 2015, the House of Representatives Energy and Commerce Health Subcommittee^[1] (the "Subcommittee") held a 340B Program hearing with testimony from the Deputy Administrator of Health Resources and Services Administration ("HRSA"), the Director of the Office of Pharmacy Affairs ("OPA") of HRSA,[2] the Director of Health Care of the Government Accountability Office ("GAO"), and Assistant Inspector General of the Office of Evaluation and Inspection of the U.S. Department of Health and Human Services ("HHS") Office of Inspector General ("OIG").

The purpose of the ...

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

In response to multiple requests, the Centers for Medicare and Medicaid Services ("CMS") have extended the deadline for comments on the proposed changes to the home health conditions of participation ("CoPs").  Home health providers and other interested stakeholders now have until 5:00 p.m. EST on January 7, 2015 to submit comments to CMS.

The proposed changes to the CoPs were published on October 9, 2014[1] and represent the most significant changes to the home health CoPs in seventeen years.  According to CMS, the new CoPs are intended to better reflect modern home health practice by ...

As you may recall, a DC Circuit panel held that the Affordable Care Act makes federal premium tax credits available to taxpayers only in States where the State has established an exchange – which is what the ACA literally provides. On the same day, the Fourth Circuit issued a contrary decision in King v. Burwell, accepting the government's argument that where HHS sets up an exchange in a State, that is a State exchange. The same argument is being made by the appellant (the government lost in District Court) in Oklahoma ex rel. Scott Pruitt v. Burwell, which is pending before the 10th ...

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 ...

Epstein Becker Green and EBG Advisors, as part of their Thought Leaders in Population Health Speaker Series, will host a complimentary webinar in July on emerging trends in population health. The webinar—What Role Do Patient Engagement Strategies Play in Promoting Population Health?—will examine different approaches to target, engage, and modify individual behaviors to lead a healthier lifestyle. Key thought leaders in population health will share examples of ways to engage high-risk and chronically ill groups so as to achieve meaningful clinical and financial ...

By Gretchen Harders and Michelle Capezza

On May 8, 2013, the Employee Benefits Security Administration of the Department of Labor (the “DOL”) issued Technical Release 2013-02 (the “Release”) providing important guidance under the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (the “Affordable Care Act”) with regard to the requirement that employers provide notices to their employees of the existence of the Health Insurance Marketplace, generally referred to previously as the Exchange. These ...

Our colleagues at Epstein Becker Green have issued a client alert: "Federally Facilitated Exchanges Are Almost Ready," by Linda V. Tiano.

Following is an excerpt:

On March 1, 2013, the Center for Consumer Information and Insurance Oversight ("CCIIO") and the Centers for Medicare & Medicaid Services ("CMS") released lengthy and detailed draft guidance regarding the federally facilitated exchanges ("FFEs") that will operate in the 26 states that have chosen not to establish their own exchange or partner with CMS. Although the guidance was issued in draft form, CCIIO and CMS allowed ...

Our Epstein Becker Green colleagues Jane L. Kuesel, Jackie Selby, and Linda V. Tiano have released a client alert titled "New York Issues 'Invitation to Participate in the New York Health Benefit Exchange,' Clarifying Application Process and State Requirements."

The alert describes a number of the more significant requirements by New York on applicants that want to become eligible for certification as a Qualified Health Plan and to participate in the New York Exchange, as well as applicable time frames and processes.

Following is an excerpt:

The New York Department of Health’s ...

by Brandon C. Ge

In the months leading up to Election Day 2012, the pace of health reform implementation slowed considerably as the Obama administration held off on releasing regulations to avoid pre-election controversy. With the 2012 elections now in the books, health reform has scored two major victories: the re-election of President Barack Obama and the preservation of a Democratic majority in the Senate. Although the Affordable Care Act (ACA) is now safe from repeal, implementation still faces hurdles, such as state resistance, the fiscal cliff, and pending lawsuits ...

In addition to the work that states are doing (or purposefully not doing) to implement State Health Insurance Exchanges for operation in 2014, states have also been given the task of choosing a benchmark plan for purposes of defining the essential health benefits (“EHB”), a minimum package of benefits that must be offered by all insurance policies sold in the small group and individual markets beginning in 2014. 

Section 1302(b) of the Affordable Care Act directs the Secretary of Health and Human Services (the “Secretary”) to define the EHB. The scope of the EHB must equal the ...

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 ...

Back in 1996, the Federal Trade Commission and Department of Justice, in providing antitrust guidance for multi-provider networks, considered financial integration and clinical integration as separate pathways for such networks to avoid per se violations of the antitrust laws and, instead, to be treated under the rule of reason, allowing for an assessment of their procompetitive vs. anticompetitive effects. With 65 organizations now participating in Medicare shared savings initiatives, including the 27 Medicare Shared Savings Program participants announced on April 10 ...

By Stuart M. Gerson

The three days of arguments about the constitutionality of the Patient Protection and Affordable Care Act are complete. The Justices of the Supreme Court of the United States have conducted their post-argument conference and are now turning their attention to the drafting and the discussions that will lead to a majority opinion and, likely, several dissents and concurrences. The Court's decision should be issued before the end of June. Health care companies and employers, like the rest of the population, await the ultimate decision. However, there are several ...

by Lynn Shapiro Snyder and Lesley R. Yeung

On December 16, 2011, the Center for Consumer Information and Insurance Oversight ("CCIIO") within the Centers for Medicare & Medicaid Services ("CMS") released a "bulletin" to provide information and solicit comments on the regulatory approach that the Department of Health and Human Services plans to propose to define essential health benefits ("EHB") under section 1302 of the Affordable Care Act. The "bulletin" provides information to stakeholders (i.e., consumers, states, employers, and health insurance issuers) about what ...

Expansion of the DMEPOS Competitive Bidding Program; Legislative Inquiry Related to Fraud and Abuse Enforcement Actions; and Automated Pre-Enrollment Provider Screening

by George B. Breen, Amy F. Lerman, Emily E. Bajcsi, Deepa B. Selvam

In order to be prepared for upcoming changes and to respond to new initiatives, providers and suppliers participating in Medicare must be aware of recent Congressional activity that would hold the federal government accountable for its intended enforcement efforts designed to curb health care fraud, waste, and abuse, as well as an effort by the ...

by Lynn Shapiro Snyder and Lesley R. Yeung

The Early Retiree Reinsurance Program (“ERRP”) was created by the Patient Protection and Affordable Care Act to provide financial assistance to employers, unions, and state and local governments to help them maintain health insurance coverage for early retirees age 55 and older. A report published by the Department of Health and Human Services on March 2, 2011, states that almost 5,500 plan sponsors have been approved to participate in the ERRP and that $535 million in ERRP reimbursement payments have been made to date. It is important ...

by George B. Breen, Carrie Valiant, Emily E. Bajcsi, Anjali N.C. Downs, and Amy F. Lerman

On February 2, 2011, the Centers for Medicare and Medicaid Services ("CMS") published new rules ("Final Rule") authorized by the Affordable Care Act ("ACA") creating a vigorous screening process for new and existing Medicare, Medicaid and the Children's Health Insurance Program ("CHIP") providers and suppliers; giving CMS authority to temporarily stop enrollment of new providers and suppliers; expanding the ability of CMS and States to temporarily suspend payments to providers and ...

by Shawn Gilman and Frank C. Morris, Jr.

A little-noticed provision of the Patient Protection and Affordable Care Act (PPACA) will significantly impact both health care manufacturers and providers.  The provision amends the Rehabilitation Act of 1973 to require regulations by March 23, 2012, mandating that all medical diagnostic equipment and health care provider locations be able to accommodate the needs of individuals with disabilities.  This requirement would mean a redesign of both diagnostic equipment and locations for patient interactions to assure that individuals ...

Now that we have sweeping new health care legislation, the Patient Protection and Affordable Care Act ("the Act"), let's look at the rollout of the accountable care provisions--i.e., those changes to the payment and delivery system that hold the most long-term promise of improving quality and cost-efficiency. They are discussed in my most recent article: "The Timeline for Accountable Care: The Rollout of the Payment and Delivery Reform Provisions in the Patient Protection and Affordable Care Act and the Implications for Accountable Care Organizations," published last week in ...

In my most recent article in the series I have been writing for the BNA's Health Law Reporter on payment and delivery system reform, accountable care organizations and bundled payments, I comment on where things are now that federal reform has stalled. The article, titled "Payment and Delivery System Reform: It's Only a Matter of Time," argues that changes in payment and delivery are on the horizon regardless of the pace of federal reform and that providers (and payers as well) should continue their efforts toward accountable care to meet the cost and quality challenges that ...

Thursday's White House Forum on Health Reform brought together people who have a stake in our health care system with people who have the ability to change it. Prior to his inauguration, President Obama called on Americans to hold community discussions about health care. More than 9,000 Americans signed up to host discussions in all 50 states and more than 30,000 Americans attended these discussions. These community groups submitted reports to the White House that detailed their concerns about the health care system and their suggestions for reform. At the Forum, several of these ...

Much of the work of the Commonwealth Fund and others seems to presume that payors are a necessary intermediary and should be the entities doling out population prepayment (aka capitation before it was a nasty word). However, it need not work out that way – particularly with House Dems’ concern that Medicare Advantage was profiteering.

It would be a small step for the new public plan likely to be created to make “population prepayments” directly to integrated health systems particularly because the covered lives under such a plan are likely to have the benefit of public ...