Category: Administrative Law
Governor Charlie Baker of Massachusetts has recently issued an Order Expanding Access to Telehealth Services and to Protect Health Care Providers. The order, issued in March, is a public health response to the state’s state of emergency due to the Coronavirus or COVID-19 outbreak. Under the order, the Group Insurance Commission, all Commercial Health Insurers, Blue Cross and Blue Shield of Massachusetts, Inc. and health maintenance organizations regulated by the Division of Insurance are required to let all in-network providers deliver clinically appropriate, medically necessary covered services to their members via telehealth, and to mandate reimbursement for these services. The purpose behind the Order is to encourage the use of telehealth in the mainstream of health care provision, as a “legitimate way for clinicians to support and provide services to their patients.”
Blue Cross and Blue Shield of Massachusetts has recorded over half a million patient telehealth visits over a six-week span and that number is only increasing with time. In comparison, the average number of telehealth visits before the COVID-19 pandemic was 5,000. The demand for health care and medical advice without the requirement of an in-person appointment has soared in light of the outbreak that prevents or prohibits people from attending one due to social distancing guidelines. Prior to the crisis posed by the pandemic and before Governor Baker’s order, hospitals and doctors were disincentivized from offering telehealth visits because health insurers did not cover them or would offer a smaller pay as compared to in-person visits. By introducing payment parity between in-person visits and virtual ones, the order expands access to care as current Massachusetts law allows insurers to limit coverage of telehealth services to insurer-approved health care providers in a telemedicine network.
The arrival of the pandemic and state of emergency has pushed for a rapid expansion of the use of technology in the practice of health care. Many of the barriers to access of health care via telemedicine have shifted in a relatively short period of time. In addition to Governor Baker’s order for payment parity, for example, the Governor allowed health care providers outside Massachusetts to obtain emergency licenses to practice within the Commonwealth. Before this and other similar licensure waivers, licensure requirements usually demand that providers be licensed within the state that their patients reside. By waiving this requirement, providers can expand the network of care they are able to provide, and telehealth serves to eliminate the only other barrier–distance.
An additional movement towards lifting barriers to the implementation of telehealth services is the relaxation of Health Insurance Portability and Accountability Act of 1996 (HIPAA) noncompliance enforcements by Health and Human Services, with the caveat that providers engage in good faith provision of telehealth during the national health emergency posed by the COVID-19 pandemic. HIPAA rules require the protection of privacy and security of health information. The discretionary enforcement order allows health care providers to use any non-public facing audio or video communication products during the COVID-19 public health emergency. This movement attempts to strike a balance between providing access to care during a national health emergency and the privacy protections against the risk of information exposure that are expected by patients in their interactions with their health care providers.
Another response to the public health crisis has been issued by the United States Drug Enforcement Agency, notifying that practitioners can, in light of the state of emergency, prescribe controlled substances in the absence of an in-person patient encounter. Prior, the prescription of controlled substances via telehealth evaluation was prohibited entirely. Now, prescribers are allowed to write prescriptions so long as: (1) the prescription is issued for a legitimate medical purpose in the course of the practitioner’s usual professional practice; (2) the telemedicine communication is conducted in a real-time, two-way, audio-visual communication system; and (3) the practitioner is acting in accordance to state and federal law.
As of May 2020, the Commonwealth of Massachusetts has initiated a four-phase reopening plan, beginning with hospitals and community health centers. The East Boston Neighborhood Health Center, for example, has indicated that they have an extensive screening process for patients who head over for in-person appointments, including the use of phone-tracking technology to notify staff when the patient has entered the building in an attempt to streamline entrance to examination rooms. The continued need to introduce methods of facilitating social distancing within the hospitals and community health centers indicates that there will be a continued incentive for the provision of telehealth services. The East Boston Neighborhood Health Center reports that, in the first phase of reopening, they expect 25% of visits to be in-person, with 75% of visits to continue to be via telehealth services such as video chat or over the phone.
While some find telehealth services to be inconvenient, due to technological challenges and care that requires more physical examination than can be completed over the phone or by video calling, it seems likely that we will see a blended version of care into the future. Health care practitioners have indicated that, while telemedicine is not a complete substitution of physically seeing and examining patients, being able to speak with a patient in combination with access to the patient’s medical history goes a long way in being able to diagnose and treat health problems. There is a growing sense of certainty that the use of a technology-based health care experience will “become the new normal.”
The natural question is how the legal landscape will have to adjust in response to the shift as society reopens and the balance of the role of technology in a “new normal” becomes more urgent to strike. Many of the barriers to the expansion of telehealth have been rapidly eliminated as a temporary alleviation in direct response to the public health crisis posed by COVID-19. This indicates that the changes are ephemeral; however, with the uncertainty posed by the length of the pandemic and the resulting impact this will have on the use of technology in health care, it seems likely that some of these legal shifts will need to be modified, rather than entirely eliminated, moving forward.
The Waiting Game: Supreme Court’s Decision on the Lawfulness of the Deferred Action for Childhood Arrivals (DACA) Program
As May 2020 comes to an end, many eagerly await a Supreme Court decision that could affect the futures of thousands of DACA recipients and shape immigration policy as we know it. The Deferred Action for Childhood Arrivals (DACA) is the program that is currently under scrutiny; in particular the Supreme Court will be deciding on the following two issues: (1) “Whether or not the Trump administration’s decision to end DACA can be reviewed by the courts at all?” and (2) “Whether or not the Trump administration’s termination of DACA was lawful?” This program was first instituted under the Obama Administration as an executive action to do the following for qualified Dreamers who completed the process of a first-time or renewal application: (1) protection from deportation for a time period, and (2) work authorization for a set period of time.
During the Obama Administration, the DREAM Act of 2010 (H.R. 6497) was proposed and passed in the House but did not pass the Senate. The purpose, like its other variations, was intended to aid undocumented individuals by providing them a way to eventually reach legal status, because they were brought to the United States when they were children and have to live with a continued sense of uncertainty that attaches to being undocumented. In its stead, the Obama Administration designed a temporary solution, which came to be known as DACA, in which an individual could qualify by meeting a series of requirements (i.e. arriving in the United States before they turned sixteen years old).
This policy gave a lot of individuals hope, but everything changed with the arrival of the Trump Administration. The Trump Administration’s policies quickly took on an anti-immigration rhetoric, and his Administration rescinded the policy on the basis that it was illegal. Thereafter, lawsuits followed with Department of Homeland Security, et al., v. Regents of the University of California, et al. reaching the Supreme Court level.
Regarding the two issues laid out above, there are many ways the decision could go, but the one that would have the worst effect on DACA recipients would be the court siding on the Trump Administration’s side in saying that “DACA was an unconstitutional use of presidential power to begin with.” This could have a devastating impact on DACA recipients especially at a time when they find themselves in the midst of the COVID-19 global pandemic alongside the rest of the world.
For example, ABC News quotes a college student saying “As a DACA recipient, and everything going on with COVID-19 and as well with the Supreme Court ruling coming at any time -- It's been very stressful.” On top of college, she works with authorization under DACA, but COVID-19 has added other stressors as she finds herself as the only provider at home. Ending DACA at a time like this would end up being very challenging and harmful for individuals like these who are trying to stay afloat during this pandemic.
Nevertheless, as this country struggles to recover from this pandemic, the most interesting development has happened to this Supreme Court case showing how vital Dreamers and immigrants have been to making this country function smoothly despite the havoc wreaked by the virus. A CNN report discusses how: “A letter sent to the Supreme Court states approximately 27,000 Dreamers are health care workers -- including 200 medical students, physician assistants, and doctors -- some of whom are now on the front lines in hospitals across the country.” The Supreme Court agreed to take this brief into consideration, and it makes one wonder whether the timing of the decision during a pandemic and the supplemental brief will have any impact at all?
Despite the positive contributions of these and other essential individuals, there have been a lot of issues that have also surfaced reflecting further difficulties that Dreamers are enduring. An example of this is federal funding under CARES Act. The pandemic has had even more disastrous effects on particular communities, and though the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 was passed with a part of it designed to provide aid and federal dollars to help students, and yet the benefits are not available to everyone. DACA students could not qualify to receive money under this Act, and it was one of the reasons the Democrats reached out to Secretary DeVos to change the language but to no avail. The House has brought another bill to the forefront, the Heroes Act, which proposes many changes; one aspect of which directly seeks to overturn “Secretary DeVos’s decision to exclude DACA students from the emergency aid.”
This is a hopeful change, but the culmination of issues including the Supreme Court decision yet to be released, the uncertainty of COVID-19 on employment, health, and education, and a delay in passing the House bill paints a bleak picture.
Yet, at the end of the day, it is as Antonio Alarcon described it on CNN: “We’re hopeful that the Supreme Court will see the humanity of our stories and see the humanity of our families, because at the end of the day, this is a nation of immigrants.”
Pharmacy Benefit Managers (“PBMs”) are at the center of the discussion about the causes of high pharmaceutical prices and efforts to reduce the nations pharmaceutical spending. Currently over 80% of pharmaceuticals in the United States are purchased through PBMs. While PBMs were originally intended to reduce drug costs to consumers, they now face criticism for actually increasing drug prices. A 2016 study found $23billion of health care spending was directly attributable to PBMs. In order to reduce pharmaceutical spending in the United States, legislative efforts must aim to align the incentives of PBMs and their payer clients. One such effort would be to eliminate the rebate safe harbor.
PBMs are for-profit entities that broker deals in the pharmaceutical supply chain. PBMs are entitled to retain profits for the services they provide. However, the problematic practices of PBMs all have to do with the amount of profit they are able to retain. PBMs act as middlemen between payers, pharmaceutical manufacturers, and pharmaceutical retailers. PBMs use their payer client networks to create a large network that has more buying power in order to negotiate for lower prices from pharmaceutical manufacturers, usually in the form of rebates.
The rebate system is extremely controversial and receives a lot of criticism. It works like this: PBMs negotiate for lower drug prices for their health insurance payer clients by offering different types of placement on health plan formularies. Manufacturers agree to give rebates to the health plan for use of the drug based on where the drug is listed on the health plan formulary. When the drug is paid for by the health plan, the manufacture gives a discount to the plan in the form of a rebate. The rebate passes through the PBM to get to the plan, and the PBM often retains a portion of the rebate as part of the contract (“Some research has found that major PBMs can retain around 38-40 percent of rebate dollars collected from drug manufacturers”). The rebate that the PBMs negotiate is not a rebate that is given to the consumer directly at the pharmacy; the purported benefit of the rebate to the beneficiary is a decrease in premiums.
The central concern is that the reduction in price from the rebate is benefiting PBMs, drug manufactures and health plans, but not patients. Health plan beneficiaries often have deductibles and co-insurance payments, and the price they pay is not based off of the discounted price the insurer gets, but rather the list price of the drug (“many rebates do not flow through to consumers at the pharmacy counter as reductions in price. In these instances, beneficiaries experience out-of-pocket costs more closely related to the list price than the rebated amount during the deductible, coinsurance”). The rebate does not apply to the price that a beneficiary directly pays for a drug, it only applies when the health plan is covering the cost.
The rebate system is also harming patients by driving up the prices of drugs. The system creates perverse incentives for PBMs, where they are incentivized to include drugs with higher list prices on formularies. This is because the portion of the rebate that PBM retains is based off of the amount of savings, meaning that a higher priced drug generates a higher rebate. In addition to incentives placed on PBMs to select higher priced drugs, the system can also incentivize manufacturers to raise or keep list prices high. Logically, if PBMs are selecting the higher priced drugs in order to get larger rebates, drugs with lower list prices will not be selected for preferred placement on formularies. Lower list prices reduce the savings generated which results in removal from formulary. The nature of the rebate system means that rebates effectively function as kickbacks to PBMs.
PBMs are subject to a host of federal regulations due to the highly regulated nature of health care. The industry is affected by federal regulations because PBMs contract with the federal government to administer drug benefits for Medicare Part D and because they submit claims to federally funded programs, Medicaid and Medicare, on behalf of their clients. The Federal Anti-Kickback Statute (“AKS”) “prohibits offering, paying, soliciting or receiving anything of value to induce or reward referrals or generate federal health care program business.” 42 U.S.C § 1320a-7b(b) (2012). The AKS and subsequent regulations include voluntary safe harbors, which “describe various payment and business practices that, although they potentially implicate the federal anti-kickback statute, are not treated as offenses under the statute.” 42 C.F.R. §1001.952 (2018). The AKS has a mandatory discount safe harbor, meaning that the government will not prosecute for arrangements that fall within the discount safe harbor requirements. 42 U.S.C. § 1320a-7b(b) (2012). The discount safe harbor applies to PBMs because they use rebates to negotiate deals between drug manufactures and clients. These rebates fall within the definition of kickbacks under AKS because the PBM retains, as revenue, a portion of the rebates that it negotiates for each drug, and the amount they are paid is based on how much that drug is purchased using the rebate.
While these rebates are technically a violation of AKS, they do not currently put PBMs at risk for prosecution under the statute because the rebates are a form of discount, and, consequently, the discount safe harbor applies. In order to be protected by the safe harbor, PBM arrangements for rebates with manufacturers and clients must strictly comply with the requirements or else the PBM is in violation of AKS. 42 U.S.C. § 1320a-7b(b)(3)(A) (2012); 42 C.F.R. § 1001.952(h) (2018). This safe harbor, as presently understood, applies to prescription drug rebates paid by drug manufacturers to PBMs, Medicare Part D, and Medicaid managed care organizations, and thus protects the rebates from violation of the Anti-Kickback Statute.
On February 6, 2019, the HHS Office of the Inspector General (“OIG”) published a proposed rule to eliminate the AKS safe harbor applicable to PBMs. The proposed rule would have revised the discount safe harbor “to explicitly exclude from the definition of a discount eligible from safe harbor protection certain reductions in price or other remuneration from a manufacturer of prescription pharmaceutical products to plan sponsors under Medicare Part D, Medicaid managed care organizations ... or pharmacy benefit managers under contract with them.” This would have meant that the rebates from manufactures to PBMs would constitute kickbacks and put the PBMs at risk for AKS violation. The basis for the proposed rule was that the safe harbor is operating to decrease transparency and increase costs to consumers, instead of increasing transparency and lowering costs to consumers.
The proposed rule would have removed the incentive that PBMs have to negotiate for rebates on their own behalf instead of on behalf of the plans and their beneficiaries. Under the terms of the proposed rule, safe harbor protection would have still applied to discounts that the patient receives at point of sale. This protects the consumer interest by ensuring that they receive the discount directly, and allows PBMs to still use discounts as a negotiating tool for their clients. The proposed rule would have also granted safe harbor protection to PBM service fees, which would allow PBMs to continue to profit, at fair market value, from the services they provide.
The response to the proposed rule was, naturally, divided. Proponents of the proposed rule argued it would fulfill its intended purpose and lower the list prices of drugs to price that PBMs are currently negotiating for after rebates, and also lead to increased use of lower cost generics. That result is supported by analyses prepared by Milliman for HHS, which estimate that implementation of the proposed rule would lead to up to a ninety-eight billion dollar reduction in spending by federal programs over ten years. However, the PBM industry argued the rebates do not have the negative effects that HHS claim, and that there are no “viable alternatives to rebates, in light of drug manufacturers’ inability to offer up-front discounts under current antitrust case law.” Industry push-back also contended that the prohibition on rebates would lead to increased premiums because the use of rebates allows plans to lower premiums. Unfortunately, the Trump Administration sided with the industry perspective and reversed course and withdrew the proposed rule.
Eliminating the rebate discount safe harbor would have had a significant impact toward eliminating a major conflict of interest inherent in the PBM model. If the administration is not willing to put federal programs and beneficiaries ahead of industry, then Congress must enact legislation that achieves the result necessary to reign in excessive and unnecessary pharmaceutical drug spending.