Reimbursement Archives - HEALTH & LIFE SCIENCES NEWS

Reimbursement

CMS Sneaks 340B Billing Proposals into Medicare Physician Fee Schedule: What 340B Stakeholders Need to Know

by Emily Jane Cook | Jul 23, 2024 | 340B, Reimbursement

On July 10, the Centers for Medicare & Medicaid Services (CMS) released the 2025 Medicare Physician Fee Schedule (MPFS) proposed rule, which includes proposals related to identification of Medicare Part B and Part D claims for 340B drugs in order to exclude them from inflation-related Medicare drug rebates established under the Inflation Reduction Act. Because MPFS is not often on the radar for 340B stakeholders, we want to make sure that folks are aware of the 340B-related provisions in the proposed rule and the deadline for submitting comments. We have excerpted the relevant pages of the MPFS proposed rule for ease of reference (the entire proposed rule is well over 2,000 pages and available here. The proposed rules are generally consistent with guidance materials previously released by CMS.

As described in more detail below, the CMS proposals would eventually require claims-level information reporting to exclude Medicare Part D 340B claims and use claim modifiers to exclude Part B claims. ALL 340B-covered entities are now expected to report claim-line modifiers for separately payable Medicare Part B drugs under guidance that was effective January 1, 2024.

Comments are due on September 9, 2024. We note that in light of the recent US Supreme Court decision in the Loper Bright case and the end of the Chevron doctrine, 340B stakeholders should consider submitting comments (both in support of the proposals and with alternatives that CMS should implement). Legal challenges to whatever rules CMS ultimately implements should be expected, and the [...]

Continue Reading

Advancing Primary Care in Washington, DC, in 2021

by McDermott Will & Emery | Nov 19, 2020 | Digital Health, Reimbursement

Guest post by Mara McDermott, Vice President at McDermott+Consulting.

With the 2020 election almost in the rearview mirror, clinicians and policymakers alike are turning their attention to the 2021 agenda. For primary care providers, 2021 will hopefully bring COVID-19 recovery and response efforts, additional opportunities to pursue value-based payment arrangements, and ongoing deployment of telehealth and virtual technology.

The 2020 presidential election is expected to bring about a change in administration. However, the “blue wave” Democratic sweep projected by some pundits and pollsters failed to materialize. Instead, in Washington, DC, we will have a closely divided US Senate, with the final balance of power to be determined by two run-off races in Georgia. The US House of Representatives will remain in Democratic control, but by a smaller margin. The narrow margins in the House and Senate will likely constrain the extent to which Democrats are able to advance progressive policy changes. Instead, both sides of the political aisle in Congress are likely to focus on bipartisan areas of agreement. For primary care clinicians, this environment may be encouraging, as members of both parties share goals around protecting and advancing primary care across the country.

COVID-19 Response

When the new Congress begins and President-Elect Biden is inaugurated in January 2021, COVID-19 relief is expected to be at the top of the agenda. Expect President-elect Biden and the incoming Congress to pursue economic and public health relief. Clinicians across the country who have faced depressed revenue as [...]

Continue Reading

Proactive Due Diligence Considerations for Life Sciences Dealmakers

by McDermott Will & Emery | Jul 3, 2019 | Digital Health, FDA, Life Sciences, Life Sciences Private Equity, Reimbursement

In today’s competitive and fast-paced life sciences dealmaking environment, buyers and investors are often unable to spend as much time on due diligence as they might like. Market players are often highly focused on the science itself and, as a result, may pay less attention to issues such as supply chain, intellectual property components and reimbursement. However, addressing these topics at the due diligence stage is critical—they can cause a deal to unravel if left unexamined, regardless of the strength of the science.

Due diligence standards and considerations vary significantly across life sciences subsectors— pharma, medical devices, digital health and AI are each governed by unique regulatory structures and operate in very different deal landscapes. Buyers and investors are well advised to consider end-game issues such as reimbursement options, protection for valuable IP and pathways to commercialization early in the planning process. Framing the areas of diligence focus around the value drivers of their target deal model and key contract elements requiring verification will allow buyers to leverage their diligence findings into an informed, forward-thinking action plan.

Reimbursement. When evaluating a potential life sciences transaction, it is never too early to start thinking about reimbursement. Due diligence should take into account the commercialization channel for the product and include engagement with data sources on alternative therapies and their reimbursement. If the product in view is entering an existing market, conversations with reimbursement specialists can help a buyer determine the best path to reimbursement. A product that is opening a new [...]

Continue Reading

Five Questions with a Health Lawyer: Karen Owen Gibbs

by McDermott Will & Emery | Feb 28, 2019 | Reimbursement

Karen Owen Gibbs
Partner, McDermott Will & Emery
Office: Chicago
Years at the Firm: 5

What is your favorite part of practicing health care law?

US health care law is interesting, fast-changing and relevant to virtually every person in the United States. As the health care space changes to incorporate new technologies and adjusts to meet patient expectations, I work with my clients on a range of issues that were not on the radar 10 or even five years ago. For example, I do a lot of work in the pharmaceutical industry, including facilitating collaborations between traditional pharma companies and new players, helping clients address reimbursement challenges resulting from the transition to value-based care, and helping providers navigate the opioid crisis. It’s an exciting time to help clients bring new and better care to patients.

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

The challenge and the opportunity are closely related. Many clients are seeking to maximize opportunities within today’s rapidly evolving regulatory and reimbursement climate. Current health care policy is highly focused on delivering better care to more people at a lower cost. Our clients are looking for opportunities to deliver on that challenge. That can include collaborating with partners from outside the health care industry such as [...]

Continue Reading

Bills Ban Gag Clauses in Pharmacy Contracts

by Judith Wethall and Karen Owen Gibbs | Oct 18, 2018 | FDA, Hospitals & Health Systems, Reimbursement

On October 10, 2018 President Trump signed two bills that ban “gag clauses” in pharmacy contracts. Congress passed the two bills—one for Medicare prescription drug plans (“Know the Lowest Price Act”) that will go into effect in January 2020, and another for commercial employer-based and individual policies (“Patient Right to Know Drug Prices Act”) effective immediately—by almost unanimous vote in September 2018.

While many states have already prohibited the use of these clauses, this is the first such action on a federal level.

Gag clauses are sometimes found in contracts between pharmacies and insurance companies, pharmacy benefit managers or group health plans and bar pharmacists from telling customers that they could save money by paying cash for their prescriptions rather than using their health insurance. If pharmacists violate the gag rule, they risk penalties and/or contract termination. Under the new legislation, pharmacists are not required to tell patients about the lower cost option, but they also cannot be contractually prohibited from engaging in the cost conversation.

The legislation is consistent with the position of the Centers for Medicare & Medicaid Services (CMS), which, in May of this year, issued guidance stating that “gag clauses” are unacceptable in the Medicare Part D program.

Three Environmental Factors Impacting the PPM Industry and Getting Deals Done

by Jerry J. Sokol | Jul 10, 2018 | Health Antitrust, Health M&A, Health Private Equity, PPM/ASC, Reimbursement

The PPM industry is by no means immune to the ebbs and flows of a traditional marketplace. Since the consolidation bubble burst in the 1990s, PPMs have gone from practically extinct to a once-again substantial component of the health care delivery system. But with greater influence comes more pressure to respond, and adapting to today’s complex operating environment requires those in the PPM industry to ensure they are building the foundational structure needed to help practices adapt to external factors and achieve long-term success.

Here are three defining aspects of today’s complex PPM environment, as well as several important considerations to help navigate environmental uncertainties and create a better patient experience.

Physician satisfaction and expectations are changing: As millennial doctors enter the workforce, they’re driving a sea change in terms of job expectations. With better work-life balance as a top priority, many young physicians are looking to be employees rather than employers, joining an existing practice instead of starting their own. Therefore, communicating what a PPM has to offer in terms of long-term incentives, rather than short-term profit margins, will be crucial to drawing in younger doctors and building a foundation that will last into the future.
Reimbursement strategies are evolving: Payer models and expectations continue to shift. Patients are being folded into a system that’s evolving from fee-for-service to value-based reimbursement models. As of now, the federal government is the biggest source of health care reimbursements in the country, but how legislative changes to reimbursement frameworks will impact [...]

Continue Reading