Lessons for pharmaceutical manufacturers in provider APMs

Pharmaceutical manufacturers are facing increasing pressure over prices and value. The advantages of pharmaceutical alternative payment models (APMs) may be increasingly attractive to both pharmaceutical manufacturers and insurers. But pharmaceutical APMs are more nuanced and resource-intensive than traditional fee-for-service contracts that pharmaceutical manufacturers negotiate with payers.

Whether pharmaceutical APMs succeed or fail will depend on finding solutions to operational and logistical challenges, some of which are unique to the pharmaceutical industry.

Patient attribution is integral to any APM. In pharmaceutical APMs, patient attribution equates to adherence to a particular medication because patients cannot be expected to benefit from a product they do not use. But adherence metrics are imperfect, and the best way to calculate patient adherence differs by medication. There is also often inaccurate information in claims databases, an issue that plagues provider APMs but could be an even bigger challenge for pharmaceutical APMs.

Pharmaceutical APM targets based on real-world experience can be judged by comparing the targets to historical data. By contrast, clinical trial endpoints may not be well-defined in administrative data, so these should be used only after careful testing with real-world data. Otherwise, the real-world outcomes could be far from those expected.

Although sampling is not a common component of pharmaceutical business operations, measurements based on samples could be crucial for some pharmaceutical APMs, especially when it is impractical to obtain full population data.

Managing APM risk requires real-world data analytics to quantify the financial impact of outcomes. Although pharmaceutical manufacturers have expertise in data analytics for clinical trials and outcome research, successfully managing pharmaceutical APMs requires expertise in different quantitative skills—risk/actuarial analytics.

In this article, Milliman’s Maggie Alston and Bruce Pyenson discuss in more detail the valuable lessons for pharmaceutical manufacturers in provider APMs.

Mid-year 2018 financial results for composite of medical professional liability specialty writers

In this article, Milliman’s Eric Wunder and Brad Parker summarize some key financial results for a composite of medical professional liability specialty writers through the second quarter of 2018. The 12-year decline in direct written premium finally reversed course in the first quarter of 2018 and second quarter premium levels have followed suit. The composite brought in $102 million (3.6%) more premium through six months than through the first six months of 2017. This is the largest year-over-year increase in written premium since December 2005.

This article was originally published in the September 2018 issue of Medical Liability Monitor.

Are preference-sensitive surgical procedures a significant cost contributor for Medicare?

Medical conditions with more than one treatment option are termed preference-sensitive conditions. For many preference-sensitive conditions, surgery is one of several treatment options, and in some instances, several types of surgical procedures are available to treat a single condition. Surgical procedures for the subset of preference-sensitive conditions with surgery among their treatment options are termed preference-sensitive surgical procedures (PSSPs).

Variation in rates of surgery for preference-sensitive conditions commonly reflects a lack of strong clinical evidence or an unresolved debate about the efficacy of treatments. For example, greater disagreement among surgeons about the effectiveness of a procedure increases the likelihood of its geographic variation.

There is no industry standard definition or list of PSSPs, and no comprehensive list of PSSPs has been published. In addition, the contribution of PSSPs to total population costs has not been previously reported. However, shared decision-making (SDM) provides patients with a review of conservative and invasive treatment options. Its greatest impact is expected to be on the treatment of preference-sensitive conditions, including the use of PSSPs. Studies demonstrate the potential for the wider adoption of SDM to reduce healthcare costs because as many as 20% of patients who participate in SDM choose less invasive surgical options and more conservative treatment than do patients who do not use decision aids.

In this paper, Milliman’s Kate Fitch, Carol Bazell, and Sumudu Dehipawala focus on 15 PSSPs that may be performed to treat certain preference-sensitive conditions that have surgical treatment options. Their interest is in quantifying the incidence and cost of PSSPs for the Medicare Fee-for-Service population and identifying areas of spending that may provide opportunities for reducing medically unnecessary utilization.

Two proposed rules open up opportunities for care coordination through telehealth

Over the summer, the Centers for Medicare and Medicaid Services (CMS) issued two proposed rules that will create mechanisms for some providers to receive payment for telehealth as well as other non-face-to-face and care coordination services using telecommunications technologies. Together, the changes proposed in the calendar year 2019 Medicare Physician Fee Schedule (PFS) and the Medicare Shared Savings Program (MSSP) proposed rules have the potential to enable new interactions that strengthen care access and coordination for a much broader set of patients.

The term “telehealth” is often used to broadly refer to the use of telecommunication technologies to furnish healthcare services. However, Medicare telehealth services specifically refer to a set of Part B-covered services specified under section 1834(m) of the Social Security Act. By law, Medicare fee-for-service (FFS) telehealth services under the PFS are currently subject to the following conditions:

• Provided using real-time, interactive audio and video
• Geographic restrictions on originating site (beneficiary location)
• Setting restrictions on distant site (provider location)
• Provider restrictions (and possibly further limitations due to state licensure laws)
• Limitations on type of visits

Waivers of Medicare telehealth rules are currently available under specific CMS’ Center for Medicare and Medicaid Innovation models. For example, under the existing Next Generation ACO Model, CMS has waived the geographic and originating site requirements for Medicare telehealth services. In addition, beginning in 2018, the Next Generation ACO Telehealth Waiver was expanded to include asynchronous telehealth services for teledermatology and teleophthalmology, which provides physician payment for the receipt and analysis of remote, asynchronous images for dermatologic and/or ophthalmologic evaluation.

MSSP ACOs do not currently have such flexibility because no telehealth waivers are available to them. However, under the MSSP proposed rule, for 2020, CMS proposes changes for telehealth services provided by ACOs that take on two-sided risk. Specifically, CMS proposes to expand ACOs’ use of telehealth by removing the geographic and originating site restrictions on these services. This means that ACOs will be able to provide telehealth services to beneficiaries in their homes as well as for beneficiaries obtaining care in Metropolitan Statistical Areas.

In addition, under the PFS proposed rule, CMS proposes to provide separate payment for new non-face-to-face services, virtual check-in visits, chronic care remote physiologic monitoring, interprofessional consultation, and remote professional evaluation of patient-transmitted information.

In this paper, Milliman’s Susan Philip, Carol Bazell, and Laurie Lingefelt describe these changes in greater detail and also discuss the possible implications for providers and MSSP ACOs in particular.

Regulatory roundup

More healthcare-related regulatory news for plan sponsors, including links to detailed information.

Medicare Parts A and B cost-of-living-adjustments for 2019 published
The Centers for Medicare & Medicaid Services (CMS) has issued the cost-of-living adjustments applicable to components in the Medicare program for 2019.

To view the rates, click here.

Bills prohibiting pharmacy “gag” clauses signed into law
President Donald Trump signed the Patient Right to Know Drug Prices Act and the Know the Lowest Price Act of 2018 into law. The first law prohibits health insurers and pharmacy benefit managers from limiting pharmacies’ ability to discuss cheaper drug options with consumers. These “gag” clauses prevent pharmacists from telling group health plan enrollees, and individual drug plan enrollees, if the retail price of a drug would be cheaper than the enrollees’ co-pay amounts.

This second law prohibits a prescription drug plan under Medicare or Medicare Advantage from restricting a pharmacy from informing an enrollee of any difference between the price, copayment, or coinsurance of a drug under the plan and a lower price of the drug without health-insurance coverage.

HHS releases annual civil monetary penalties inflation adjustment
The Department of Health and Human Services is updating its regulations to reflect required annual inflation-related increases to the civil monetary penalties in its regulations, pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015.

For more information, click here.

Understanding APM financial settlements

While alternative payment models (APMs) have increased in popularity over recent years, they can be difficult to implement because of their operational dependence on payment systems designed for fee-for-service (FFS) reimbursement. In addition, moving away from a FFS reimbursement construct can cause underreporting of detailed services. As a result, many APMs undergo financial settlements, meaning payments flow as normal during model performance periods and are retrospectively reconciled to a target price or benchmark after the fact.

APM financial settlement data offer providers opportunities to validate financial calculations, understand methodology, and enhance patient management. Providers can also gain perspective on other revenue drivers such as patient retention.

In this paper, Milliman consultants explore APM reimbursement methodologies through the lens of the Centers for Medicare and Medicaid Services Oncology Care Model as an illustrative case study.