Medicaid and health care - 2020 supreme court preview

The Federal Nursing Home Reform Act (NHRA) defines and guarantees the legal rights of nursing facility residents, such as the right to be free of chemical restraints. The purpose of the NHRA

is to ensure that nursing facility residents receive high-quality care and are protected from physical, emotional, and social abuse and neglect. Nursing facilities must provide for

residents “in such a manner and in such an environment as will promote maintenance or enhancement of the quality of life of each resident.” Pub. L. No. 100-203, § 4211(b)(1)(A), 101 Stat.

1330, 1330-183 (1987). There is still an open question about whether nursing facility residents can sue under Section 1983 of the Civil Rights Act to enforce their NHRA rights. The Third and

Ninth Circuits have held they can. _Grammer v. John J. Kane Reg’l Ctrs._, 570 F.3d 520 (3d Cir. 2009); _Anderson v. Ghaly_, 930 F.3d 1066 (9th Cir. 2019). Section 1983 provides a private

right of action against state actors who have violated rights guaranteed by a federal statute. 42 U.S.C. § 1983. Without Section 1983,  residents cannot enforce their rights under the NHRA

and hold facilities accountable for harm. The Seventh Circuit is considering this issue for the first time in _Talevski v. Health & Hosp. Corp. of Marion Cty_. Notice of Appeal, No.

20-1664 (7th Cir. Apr. 22, 2020).  In that case, a nursing facility resident is suing a government-owned facility and others under the NHRA after they allegedly chemically restrained and

illegally discharged him. The district court dismissed the case, holding that a resident cannot use Section 1983 to challenge a violation of the NHRA. _Talevski v. Health & Hosp. Corp.

of Marion Cty._, No. 2:19 CV 13, 2020 WL 1472132 (N.D. Ind. Mar. 26, 2020). The resident appealed that decision to the Seventh Circuit. AARP and AARP Foundation filed an amicus brief in

support of the resident. This case is important to nursing facility residents because it will explore whether residents can require states and state entities to enforce the rights guaranteed

to them by the NHRA. Holding nursing facilities accountable allows residents to obtain redress for injuries and deters future misconduct. No matter the outcome, this case is likely to be

appealed to the Supreme Court. _PRESCRIPTION DRUGS_ Prescription drug prices continue to skyrocket each year, with the prices of brand name drugs increasing at an exorbitant rate. An AARP

study found that in 2018, retail prices for 267 widely used brand name prescription drugs increased by 5.8 percent, more than twice the rate of inflation. _See _Stephen W. Schondelmeyer

& Leigh Purvis, AARP Pub. Policy Inst., Brand Name Drug Prices Increase More than Twice as Fast as Inflation in 2018 (2019). These escalating drug prices disproportionately hurt older

adults. Many older adults, who average 4.5 brand name prescription medications each month, cannot afford them. _Id. _As a result, many risk their health by not filling their prescriptions or

by taking less than the prescribed dose. _See _Ashley Kirzinger, _Data Note: Prescription Drugs and Older Adults_, Kaiser Fam. Found. (Aug. 9, 2019). States and other stakeholders are

taking various actions to lower the price of drugs for consumers. The State of California enacted Assembly Bill 824, also known as the California Pay-For-Delay Bill, to combat the effect

that anticompetitive prescription drug agreements have on consumers. A.B. 824, Reg. Sess. (Cal. 2019). The law is the first-of-its-kind. Its specific targets are pay-for-delay agreements.

These are settlements where a brand name drug manufacturer agrees to settle a patent lawsuit by paying a generic drug company to delay entering the market. During the delay, the branded

manufacturer has a monopoly on the market and can charge consumers higher prices for the drug. As a result, consumers pay millions more for the brand name drug because they cannot access a

lower-cost generic. The California law creates a presumption that any transfer of value from a brand name drug manufacturer to a generic drug company settling patent infringement litigation,

combined with a delay of the generic drug’s entry into the market, has an anticompetitive effect. Shortly after its passage, generic drug lobbying group Association for Accessible Medicines

sued in federal district court to invalidate the California law and preliminarily enjoin its implementation and enforcement. In _Ass’n for Accessible Meds. v. Becerra_, No.

2:19-cv-02281-TLN-DB, 2019 WL 7370421 (E.D. Cal. Dec. 31, 2019), it alleged that, among other things, the law violates the dormant Commerce Clause of the U.S. Constitution by directly

regulating out-of-state conduct. A district court denied the injunction, and AAM appealed to the Ninth Circuit. Notice of Appeal, _Ass’n for Accessible Meds. v. Becerra_, No. 20-15014 (9th

Cir. Jan. 2, 2020). AARP and AARP Foundation submitted a brief explaining that the law is in the public interest because it ensures that consumers can access lower-cost generic drugs. Brief

for AARP & AARP Foundation, as Amici Curiae Supporting Defendant-Appellee, _Ass’n for Accessible Meds. v. Becerra_, No. 20-15014 (9th Cir. Mar. 5, 2020). The Ninth Circuit should issue

its decision before the end of 2020. In addition, continued litigation attacks are filed against the Patent Trial and Appeal Board (PTAB), which may affect drug pricing. The latest petition

in the Supreme Court claims that PTAB judges were unconstitutionally appointed. Petition for Writ of Certiorari, _Arthrex, Inc. v. Smith & Nephew, Inc._, 2020 WL 3805820 (U.S. June 30,

2020) (No. 19-1458). Congress created the PTAB to overturn improperly granted patents expeditiously. Limits on the Board’s authority can delay the invalidation of dubious patents, including

drug patents, which could ultimately increase consumer costs. As research for a coronavirus vaccine focuses on antibody research, pharmaceutical giants Amgen and Sanofi continue to litigate

about how narrowly patents involving antibodies must be claimed. _Amgen, Inc. v. Sanofi, _872 F.3d 1367 (Fed. Cir. 2017), _cert. denied_, 139 S. Ct. 787, 202 L. Ed. 2d 568 (2019). While the

patents at issue in the dispute involve cholesterol-lowering antibodies, many of the new drugs for cancer therapy and other immune immune-related diseases are antibody drugs. Amgen argues

that an entire genus of antibodies can be patented, whereas Sanofi maintains that inventors must narrow their patents to the specific antibodies that will be used in a drug, since a genus

can include millions of antibodies. _Id._ at 1377-1378. If drug companies are allowed to patent an entire genus of antibodies, drug costs may increase.