Managed Care Archives - HEALTH & LIFE SCIENCES NEWS

Managed Care

CMS Issues FAQs to Aid Pharmacies in Preparing for Medicare Part B Coverage of PrEP Medications

by Gregory E. Fosheim, Monica Wallace, Emily Jane Cook and Jae Hyun Lee | Jun 26, 2024 | Hospitals & Health Systems, Life Sciences, Managed Care

As we previously advised, the Centers for Medicare & Medicaid Services (CMS) is preparing to issue a national coverage determination (NCD) for pre-exposure prophylaxis (PrEP) using antiretroviral drugs to prevent HIV under Medicare Part B. In response to questions from stakeholders, CMS released FAQs on June 25, 2024, to guide pharmacies through certain enrollment and billing intricacies.

Specifically, pharmacies are instructed that no new Medicare enrollment is needed if pharmacies are already enrolled in Medicare as a Part B pharmacy or a durable medical equipment, prosthetic, orthotics and supplies (DMEPOS) supplier. However, if the pharmacy is not currently enrolled in Medicare, they should consider enrolling as a Part B pharmacy rather than a DMEPOS supplier so that they are not subject to the supplier standards, accreditation and surety bond requirements.

CMS also provides pharmacies with appropriate ICD-10 CM diagnosis codes and J-codes to include with claims and instructs pharmacies that the date the drug is picked up or mailed should be entered as the date of service. Finally, recognizing that some pharmacies will fill orders for injectable PrEP to be administered by qualified practitioners, pharmacies may include a claim for the supplying fee along with a claim for the drug where appropriate. CMS anticipates that the final NCD will be posted and effective in late September 2024. The NCD is expected to be similar to the proposed NCD published on July 12, 2023.

HHS, DOL and Treasury Issue a Proposed Rule Increasing Federal IDR Fees

by Jamie Gelfman, Drew McCormick and Emily Curran | Oct 3, 2023 | Hospitals & Health Systems, Managed Care

On September 20, 2023, the US Departments of Health and Human Services (HHS), Labor (DOL) and the Treasury (collectively, the departments) issued a proposed rule related to the No Surprises Act’s (NSA’s) federal independent dispute resolution (IDR) process. The proposed rule would amend existing regulations to provide that the two fees associated with the IDR process—the administrative fee amount charged by the departments, and the ranges for the IDR entity fees for single and batched determinations—be established by the departments through notice and comment rulemaking. The proposed rule outlines the methodology for calculating the fees and proposes the fees/fee ranges for disputes initiated on or after January 1, 2024. The proposal comes in response to a court order in the recent Texas Medical Association (TMA IV) case, which requires the departments to establish such fees through formal rulemaking.

IN DEPTH

ADMINISTRATIVE FEE TO INCREASE TO $150

The NSA’s nonrefundable IDR administrative fee is paid by both parties to cover the cost of their participation in the IDR process. For 2022, the administrative fee was $50 per party. The fee was expected to remain the same for 2023. However, in December 2022, the departments issued revised guidance increasing the fee from $50 to $350 for 2023. Plaintiffs in TMA IV challenged the increase as being unlawfully issued via guidance. The US District Court for the Eastern District of Texas agreed and vacated the portion of the guidance that increased the fee.

In light of the court’s order, the [...]

Continue Reading

Five Questions with a Health Lawyer: Jeremy Earl

by McDermott Will & Emery | Dec 16, 2019 | Managed Care, Uncategorized

Jeremy Earl
Partner
Office: Washington, DC
Years at the Firm: 10

What is your favorite part about practicing healthcare law at McDermott?

My favorite part about practicing at McDermott is the challenging and constantly evolving nature of the work. Our clients put trust in us to advise them on their toughest legal questions and business challenges. I don’t take that trust lightly and it is exciting to come to work every day to meet and exceed the high expectations clients rightly have for us.

What is the biggest opportunity and greatest challenge facing clients in your area of focus today?

I represent managed care companies, which has traditionally meant health insurers and health maintenance organizations (HMOs). Due to legislative and competitive factors, healthcare financing and delivery is rapidly evolving and new models are being introduced to compete with traditional health insurers and HMOs. In 2012, Ezekiel Emanuel and Jeffrey Liebman boldly predicted in the New York Times that “[b]y 2020, the American health insurance industry will be extinct” and replaced by ACOs. That this has not happened is, at least in part, due to innovation by health insurers through such efforts as expanding value-based payment models.

At the same time, the traditional roles of providers and health insurers are blurring and providers and risk-bearing intermediaries are introducing innovative ways to finance healthcare delivery that [...]

Continue Reading

Five Questions with a Health Lawyer: Kate McDonald

by McDermott Will & Emery | Jun 11, 2019 | Health M&A, Managed Care

Kate McDonald
Partner
Office: Washington, DC
Years at Firm: 6

What is your favorite part about practicing health care law at McDermott?

The health care regulatory work we do is cutting edge. From the largest health care companies to the smallest start-ups, our clients tend to be highly sophisticated and they come to us with high stakes questions that have no easy answers. We help clients navigate a complex web of health care regulations to implement innovative business models or bend the cost curve. The work I do is intellectually challenging and I love partnering with my crazy smart colleagues to solve problems. This is what keeps me coming back to work day after day.

What is the biggest opportunity and greatest challenge facing clients in your area of focus today?

There is so much innovation occurring in the health care market today, and in particular in the managed care industry. Health insurers are partnering with an increasingly diverse set of business partners in an effort to provide higher quality care more efficiently, while actually keeping people healthier and improving their experience in the health care system – both of which inure to the benefit of both health insurers and consumers. While health care payors are at a critical intersection and have a unique opportunity to influence changes in the system, figuring out the best [...]

Continue Reading

McDermott Named Health Practice Group of the Year by Law360

by McDermott Will & Emery | Feb 19, 2019 | Health M&A, Health Private Equity, Hospitals & Health Systems, Managed Care, Transition to Transformation

We greatly appreciate our readers continuing to turn to us for insight on the most critical legal, regulatory and transactional developments, and innovative collaborations transforming health care. Over the past year, McDermott’s Health practice made headlines for our work on several of the most high-profile collaborative transformations that took place in 2018: We were one of several law firms to advise CVS Health Corp. on its approximately $70 billion cash and stock purchase of health insurer Aetna Inc. McDermott also assisted Air Medical Group Holdings in its $2.44 billion acquisition of American Medical Response (AMR), a medical transportation company, from Envision Healthcare Corporation. It is because of our role in ground-breaking transactions like these that—for the fifth time in 10 years—McDermott was recognized by Law360 as the Health Practice Group of the Year.

We’re passionate about the results our clients are achieving and our role in helping them transform health care. We are equally passionate about what these results mean for the industry and health care consumers. Through our blogs, articles and health-focused events, we are committed to providing you with thought leadership that will help expand your field of vision as you navigate the rapidly changing health care landscape.

To read Law360’s profile of McDermott’s industry-leading health care practice, click here. McDermott was also named Practice Group of the Year in the Tax category. For more information about our approach to Collaborative Transformation, visit mwe.com/collaborativetransformation.

Pursuing Progress: Collaborative Transformation in Action

by McDermott Will & Emery | Dec 3, 2018 | Digital Health, Health M&A, Hospitals & Health Systems, International Health, Life Sciences, Managed Care, PPM/ASC

It’s the industry disruptors, the unusual partnerships, and the cross-border and cross-sector relationships that are driving Collaborative Transformation in the health care and life sciences organizations. But a Collaborative Transformation takes more than signing paperwork and shaking hands. A successful Collaborative Transformation takes cultural integration between non-traditional partners, incorporating new technologies into health care regulatory compliance structures, and so much more. At McDermott, we’ve recently had the opportunity to help our clients pursue their own Collaborative Transformations, and are proud to showcase their achievements.

Innate Pharma Expands its Collaboration with AstraZeneca

McDermott Will & Emery advised Innate Pharma, a French oncology-focused biotech company, in signing a multi-term agreement with AstraZeneca and MedImmune – AstraZeneca’s global biologics research and development arm. This agreement broadens the existing collaboration, aimed at accelerating the development of an oncology portfolio of each of the parties and to provide patients with more rapid access to new therapeutic options. This extended collaboration will permit Innate Pharma to develop and commercially strengthen its investment ability to develop its immuno-oncology portfolio (IO) and its R&D platform. For its part, AstraZeneca will enrich its IO portfolio with new clinical and preclinical programs. For more information on this collaboration, click here.

CVS + Aetna

McDermott is one of the firms that has advised CVS Health in connection with its $69 billion purchase of Aetna. The transaction, one of this year’s largest M&A deals, is expected to transform the US health care sector. For more information on [...]

Continue Reading

Collaborative Transformation: Shaping the Future of Health Care, Together

by McDermott Will & Emery | Oct 19, 2018 | Digital Health, Health M&A, Hospitals & Health Systems, International Health, Life Sciences, Managed Care, PPM/ASC

As the health care and life sciences fields experience ever-increasing levels of disruption, diverse entities across the industry are teaming up to embrace and foster innovation. These new pairings are shaping the future of health care, as organizations come together to tackle the industry’s most pressing issues with redoubled agility and pooled resources.

In an environment of change and uncertainty, this trend of Collaborative Transformation is yielding improved financial outcomes, increased operational efficiencies, and a fresh infusion of diverse talent and perspectives—all of which result in enhanced quality of care.

This is where the McDermott Health and Life Sciences team comes in. As a top-ranked US health law practice and a leader in life sciences with decades of experience advising the leading players in US and cross-border health and life sciences, we have the skill, market insight and ingenuity to partner with you wherever your innovation takes you. Whether you are forming innovative alliances across borders and industries, creating or implementing groundbreaking technologies and services, or restructuring investments to position your organization at the cutting edge of the market, our team can work alongside yours to achieve excellence.

Click here to learn more about McDermott Health, our recent work executing collaborative transformations on behalf of our clients and how we can help your organization form innovative business relationships.

ONC Expected to Release Proposed Information Blocking Rule Soon

by Daniel F. Gottlieb, James A. Cannatti III and Karen S. Sealander | Oct 17, 2018 | Digital Health, Fraud & Abuse, Hospitals & Health Systems, Life Sciences, Managed Care, Post-Acute Care, PPM/ASC

It has now been one month since the US Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) sent its proposed information blocking rule to the Office of Management and Budget (OMB) for required review.

We expect OMB to approve the much-anticipated proposed rule and ONC to release it soon with the usual opportunity for public comment. While we wait, there are some things that health information technology developers, health information exchanges, health information networks and health care providers who may be subject to the information blocking prohibition and enforcement actions can do to prepare for the upcoming comment period. But before we get to comments, let’s remind ourselves about how we got to this point.

By way of background, Congress asked ONC to produce a report describing the extent of information blocking and a strategy to address it. ONC submitted that report to Congress in 2015 (the 2015 Report) noting, among other things, enforcement authority gaps and indicating that successful information blocking prevention strategies would likely require congressional intervention. In the 21st Century Cures Act, which became law in 2016, Congress granted the HHS Office of Inspector General investigative and enforcement authorities for prohibited information blocking conduct. The Cures Act defined information blocking as a practice that “except as required by law or specified by the Secretary…, is likely to interfere with, prevent, or materially discourage access, exchange, or [...]

Continue Reading

Medicare Hearings and Appeals: Litigation, New Initiatives, and Opportunities to Exit the Backlog

by McDermott Will & Emery | Jun 14, 2018 | Fraud & Abuse, Health Controversies, Managed Care

Providers continue to face a massive Medicare appeals backlog before the Office of Medicare Hearing and Appeals (OMHA). Pending appeals number in the hundreds of thousands and the current average processing time for an appeal is over three years, with newly filed appeals likely to reach closer to five. While OMHA and Medicare reimbursement appeals face endemic issues, new developments and alternative programs may present strategic opportunities for providers and chip away at the backlog.

Regulatory changes from the U.S. Department of Health and Human Services (HHS) have come into play and are designed to provide clarity, reduce delays, and streamline the appeal process. For example, HHS has recently revamped the OMHA case processing manual, “deputized” OMHA attorney adjudicators, and determined that some decisions from the Departmental Appeals Board (the appellate level above OMHA) will now be precedential.

Additionally, OMHA and the Centers for Medicare & Medicaid Services (CMS) have initiated new programs that provide alternatives to the traditional appeals procedure with the goal of reducing the backlog. These include 1) the OMHA Settlement Conference Facilitation alternative dispute resolution process; 2) the Statistical Sampling Initiative; 3) CMS’s Low Volume Appeals settlement options, and 4) CMS’s Formal Telephone Discussion Demonstration for Durable Medical Equipment providers. Further, recent Federal Circuit court cases, including American Hospital Association, et al v. Thomas Price, may significantly impact the Medicare appeals process.

During the AHLA Annual Meeting on Monday, June 25, McDermott lawyer and former OMHA attorney advisor, Nicholas Alarif, and Amanda Axeen, the [...]

Continue Reading

BLOG EDITORS

STAY CONNECTED

TOPICS

ARCHIVES

RECENT POSTS