Care Coordination

In the U.S., orphan diseases are conditions impacting fewer than 200,000 people. There are more than 7,000 of these rare conditions affecting an estimated 30 million Americans — and more than 300 million people globally — and new diseases continue to be discovered. Most of them are inherited conditions caused by gene mutations, but some can be caused by environmental factors. These diseases may be serious and even life-threatening, and about half of them affect children.

Before the Orphan Drug Act was passed in 1983, not much research was done into treatments for rare diseases. But that law created financial incentives for pharmaceutical manufacturers, and since then, hundreds of orphan drugs have been developed. As of early 2020, the FDA had approved therapies for more than 800 rare diseases.

The notion of value-based care certainly is not a new one. But the concept of what it involves within the health care system and how it can be measured is undergoing a shift, asserted two industry experts. Life sciences companies in particular have an important role to play to ensure that quality and equity in health care are truly achieved.

A value-based care approach “is not centered around a certain payment model or a certain program demonstration,” maintained Taylor Musser, associate principal in the healthcare transformation practice at Avalere Health. Rather, it’s focused on ways to improve the quality of care, she told attendees at a recent webinar sponsored by Avalere. Such an approach will “encompass what care could be delivered by a provider or health system or the care that is coordinated by health plans. And some of the quality objectives” include “are we getting the clinical outcomes we want, are we improving people’s general quality of life and what they experience day to day, [and do] the services or processes of care…align with clinical practice guidelines, for example? We know there are gaps there.” She stated that “avoiding inappropriate or low-value services…is still a concern in our health care systems.”

Most non-pediatric office-based physicians accepted new patients, with similar shares accepting new Medicare (89%) and privately insured patients (91%), according to a Kaiser Family Foundation analysis based on the 2019 National Electronic Health Records Survey. A smaller share of primary care physicians accepted new patients with Medicare or private insurance than physicians in other medical or surgical specialties. Across the nation, the share of physicians accepting new Medicare patients ranged from 95% in Iowa, Minnesota and Pennsylvania to 76% in the District of Columbia, similar to the range across states for privately insured patients. As of March 2022, only 1% of non-pediatric physicians formally opted out of the Medicare program, with psychiatrists accounting for 42% of these physicians opting out.

With the costs of treating cancer patients rising ever higher, payers and providers are increasingly turning to third-party pathways — or treatment protocols designed to provide the optimal therapy regimens — to improve outcomes and reduce excess costs. But not all pathways are created equal, and it’s crucial for oncology drug manufacturers to understand their nuances if they want to ensure their therapies are able to reach the most patients.

Those are the main takeaways from a recent “Meet the Expert” webinar from MMIT, AIS Health’s parent company. “It’s really key to get optimal placement of a brand on a pathway to ensure that patients can have access to these lifesaving therapies,” said Yana Faykina, senior consultant, advisory services at MMIT.

Humana Inc. has become the latest insurer to increase its investment in building de novo primary care clinics, perhaps finding that while building is more effective than buying, opening clinics on a broad scale is a costlier proposition than first thought.

The insurer on May 16 said it had established a second joint venture with Welsh, Carson, Anderson & Stowe (WCAS) to further expand its value-based, senior-focused primary care clinics. (Hg Capital Partners and WCAS share control of MMIT, the parent of AIS Health.) The deal will provide up to $1.2 billion of additional capital for the development of approximately 100 new payer-agnostic clinics operated by Humana subsidiary CenterWell between 2023 and 2025. The expansion follows an earlier agreement that is currently deploying up to $800 million of capital to open 67 clinics by early 2023 and support ongoing operations, Humana added. WCAS will have majority ownership of the joint venture, while Humana will have a minority stake.

State Medicaid programs now have the option of applying to CMS to expand postpartum coverage for parents who have just given birth to 12 months, up from the default 60 days of coverage. Medicaid MCOs in states that have opted into the expanded coverage tell AIS Health, a division of MMIT, that they are taking steps to get ready for the new coverage and anticipate better outcomes for both new parents and new children as a result of the program.

Maternal mortality rates in the United States are disturbingly high compared to other developed countries — in 2018, 17 women per 100,000 live births died, compared to three in the Netherlands, Norway and New Zealand, per the Commonwealth Fund — and the U.S. is the only developed country to see that rate increase in recent years. Most of those deaths were preventable.

About a quarter of the practitioners in Medicaid managed care organization networks provide more than three-quarters of the services used by members, according to an article published by researchers affiliated with Yale and Cornell Universities in the journal Health Affairs this month. Experts say that this concentration of care likely limits access to care for members, and health plans need to do more to make sure their networks aren’t made up of so-called “ghost providers.”

The article, which analyzed claims and enrollment data from Kansas, Louisiana, Michigan and Tennessee during 2015-17, found that care delivery is highly concentrated in both primary care and specialists. However, the authors caution that their study of the states “might not generalize nationally” and only studied four specialties.

Pharma manufacturers depend on contracts with PBMs — and, increasingly, their group purchasing organizations (GPOs) — to ensure favorable formulary positioning with PBMs’ health plan and employer clients. But as those contracts have grown more complex and less transparent, drugmakers may be at risk of losing significant amounts of money, according to some industry experts.

Revenue leakage — unintended revenue loss because of process inefficiencies — can be a huge financial drain on pharma manufacturers. It also may potentially result in compliance risks with the Anti-Kickback Statute and its discount safe harbor protections, “so it always has to be clearly defined as to what the rebate or any monies between pharma and the PBM being exchanged; there has to be a reason,” explains Stephanie Seadler, vice president of Trade Relations at EmsanaRx.

CMS’s stance has long been that manufacturer-provided assistance given to patients is excluded from best price and average manufacturer price (AMP) calculation for prescription drugs. However, the rise of copayment accumulators and maximizers — and health insurers’ subsequent taking of this assistance rather than allowing it to count toward patients’ deductibles and out-of-pocket maximums — have caused the agency to rethink its position. A rule slated to take effect at the beginning of 2023 would reverse that longtime approach, potentially resulting in increased patient out-of-pocket costs for drugs and pharma companies being on the hook for ensuring they know exactly where their assistance is going, industry experts tell AIS Health, a division of MMIT.

The Medicaid rebate rule allows state Medicaid programs to get the same discounts on drug prices that manufacturers offer commercial plans purchasing prescription drugs. Manufacturers pay rebates to Medicaid programs that are calculated based on drugmakers’ best price, which is the lowest price the manufacturer gives to most providers of health care services or items, including hospitals, HMOs and MCOs — but not patients. It includes any price adjustments, such as discounts and rebates, but not manufacturer-provided assistance to patients.

CMS’s stance has long been that manufacturer-provided assistance given to patients is excluded from Best Price and average manufacturer price (AMP) calculation for prescription drugs. However, the rise of copayment accumulators and maximizers and health insurers’ subsequent taking of this assistance rather than allowing it to count toward patients’ deductibles and out-of-pocket maximums have caused the agency to rethink its position. A rule slated to take effect at the beginning of 2023 would reverse that longtime approach, potentially resulting in increased patient out-of-pocket costs for drugs and pharma companies being on the hook for ensuring they know exactly where their assistance is going, industry experts tell AIS Health, a division of MMIT.

The Medicaid rebate rule allows state Medicaid programs to get the same discounts on drug prices that manufacturers offer commercial plans purchasing prescription drugs. Manufacturers pay rebates to Medicaid programs that are calculated based on drugmakers’ Best Price, which is the lowest price the manufacturer gives to most providers of health care services or items, including hospitals, HMOs and MCOs — but not patients. It includes any price adjustments, such as discounts and rebates, but not manufacturer-provided assistance to patients.