No. 20-371
`
`IN THE
`Supreme Court of the United States
`
`_____________________________
`
`CARE ALTERNATIVES,
`
`Petitioner,
`
`v.
`
`UNITED STATES OF AMERICA; STATE OF NEW JERSEY
`EX. REL. VICTORIA DRUDING; BARBARA BAIN; LINDA
`COLEMAN; RONNI O’BRIEN,
`
`_____________________________
`
`Respondents.
`
`On Petition for a Writ of Certiorari to the
`United States Court of Appeals
`for the Third Circuit
`_____________________________
`
`BRIEF OF AMICI CURIAE HOSPICE, HEALTH
`CARE, AND PHYSICIAN ORGANIZATIONS
`IN SUPPORT OF PETITIONER
`_____________________________
`
`JODY L. RUDMAN
`HUSCH BLACKWELL LLP
`111 Congress Avenue
`Suite 1400
`Austin, TX 78701
`
`BRYAN K. NOWICKI
` Counsel of Record
`MEG S.L. PEKARSKE
`JOSEPH S. DIEDRICH
`HUSCH BLACKWELL LLP
`33 E. Main Street, Suite 300
`Madison, WI 53703
`(608) 255-4440
`bryan.nowicki
` @huschblackwell.com
`
`Counsel for Amici Curiae
`
`October 23, 2020
`
`
`
`IN THE
`Supreme Court of the United States
`
`_____________________________
`
`CARE ALTERNATIVES,
`
`Petitioner,
`
`v.
`
`UNITED STATES OF AMERICA; STATE OF NEW JERSEY
`EX. REL. VICTORIA DRUDING; BARBARA BAIN; LINDA
`COLEMAN; RONNI O’BRIEN,
`
`_____________________________
`
`Respondents.
`
`On Petition for a Writ of Certiorari to the
`United States Court of Appeals
`for the Third Circuit
`_____________________________
`
`BRIEF OF AMICI CURIAE HOSPICE, HEALTH
`CARE, AND PHYSICIAN ORGANIZATIONS
`IN SUPPORT OF PETITIONER
`_____________________________
`
`JODY L. RUDMAN
`HUSCH BLACKWELL LLP
`111 Congress Avenue
`Suite 1400
`Austin, TX 78701
`
`BRYAN K. NOWICKI
` Counsel of Record
`MEG S.L. PEKARSKE
`JOSEPH S. DIEDRICH
`HUSCH BLACKWELL LLP
`33 E. Main Street, Suite 300
`Madison, WI 53703
`(608) 255-4440
`bryan.nowicki
` @huschblackwell.com
`
`Counsel for Amici Curiae
`
`October 23, 2020
`
`
`
`
`
`i
`
`TABLE OF CONTENTS
`
`Page
`
`TABLE OF AUTHORITIES ...................................... iii
`
`INTEREST OF THE AMICI CURIAE ....................... 1
`
`SUMMARY OF THE ARGUMENT ............................ 4
`
`ARGUMENT................................................................ 7
`
`important and
`is an
`care
`I. Hospice
`increasingly used part of our health care
`system, as Congress and CMS have
`recognized. .............................................................. 7
`
`A. Hospice care improves quality of life for
`millions of Americans, most of whom are
`Medicare beneficiaries. ..................................... 8
`
`B. Congress and CMS have carefully
`designed the Medicare hospice benefit to
`account for the inherent uncertainty in
`predicting end of life. ...................................... 10
`
`C. Hospice care saves the Medicare system
`money. ............................................................. 14
`
`II. The decision below and the circuit split it
`creates will negatively affect hospice care
`and detrimentally limit patient access. .............. 17
`
`A. Contrary to statutory text and medical
`reality, the decision below enables
`improper second-guessing of hospice
`physicians’ clinical judgment. ........................ 17
`
`
`
`
`
`
`
`ii
`
`B. The decision below and the resulting
`circuit
`split
`threaten detrimental
`consequences
`for hospice providers,
`physicians, and patients. ................................ 20
`
`CONCLUSION .......................................................... 27
`
`
`
`
`
`
`
`
`
`
`iii
`
`TABLE OF AUTHORITIES
`
`
`
`Cases
`
`Caring Hearts Pers. Home Servs., Inc. v.
`Burwell,
` 824 F.3d 968 (10th Cir. 2016) ............................... 12
`
`Cmty. Health Ctr. v. Wilson-Coker,
` 311 F.3d 132 (2d Cir. 2002) .................................. 20
`
`Meyer v. Health Mgmt. Assocs., Inc.,
` 841 F. Supp. 2d 1262 (S.D. Fla. 2012) ................. 20
`
`Mississippi Band of Choctaw Indians v.
`Holyfield,
` 490 U.S. 30 (1989) ................................................. 20
`
`United States ex rel. Petratos v. Genentech
`Inc.,
` 855 F.3d 481 (3d Cir. 2017) .................................. 19
`
`United States v. AseraCare, Inc.,
` 938 F.3d 1278 (11th Cir. 2019) ..................... passim
`
`Vt. Agency of Nat. Res. v. U.S. ex rel. Stevens,
` 529 U.S. 765 (2000) ............................................... 22
`
`Statutory Authorities
`
`31 U.S.C. § 3732 ........................................................ 23
`
`42 U.S.C. § 1395f ............................................... passim
`
`42 U.S.C. § 1395pp .................................................... 12
`
`
`
`
`
`
`
`iv
`
`42 U.S.C. § 1395x .................................................. 4, 10
`
`Pub. L. 101-234 .......................................................... 11
`
`Pub. L. 105-33 ............................................................ 12
`
`Rules and Regulations
`
`42 C.F.R. § 409.44 ...................................................... 19
`
`42 C.F.R. § 412.3 ........................................................ 19
`
`42 C.F.R. § 418.202 .................................................... 15
`
`42 C.F.R. § 418.22 .......................................... 11, 13, 14
`
`42 C.F.R. § 418.302 .................................................... 14
`
`42 C.F.R. § 418.302 .................................................... 15
`
`42 C.F.R. § 418.308 .................................................... 15
`
`42 C.F.R. § 418.309 .................................................... 15
`
`42 C.F.R. § 418.3 ......................................................... 9
`
`55 Fed. Reg. 50831 (Dec. 11, 1990) ........................... 25
`
`59 Fed. Reg. 56116 (Nov. 10, 1994) .......................... 19
`
`70 Fed. Reg. 70532 (Nov. 22, 2005) .......................... 11
`
`73 Fed. Reg. 32088 (June 5, 2008) ............................ 13
`
`74 Fed. Reg. 39413 (Aug. 6, 2009) ...................... 13, 14
`
`75 Fed. Reg. 70372 (Nov. 17, 2010) .......................... 12
`
`
`
`
`
`
`
`v
`
`76 Fed. Reg. 47301 (Aug. 4, 2011) ............................ 14
`
`78 Fed. Reg. 48234 (Aug. 7, 2013) ...................... 12, 13
`
`79 Fed. Reg. 50451 (Aug. 22, 2014) .................... 12, 25
`
`83 Fed. Reg. 20934 (May 8, 2018) ............................. 15
`
`Legislative Materials
`
`142 Cong. Rec. S9582 (Aug. 2, 1996) .................. 12, 16
`
`Additional Authorities
`
`Abt Associates, Analysis of Medicare Pre-
`Hospice Spending and Hospice Utilization
`(2015), https://go.cms.gov/34l48ln. ........................ 16
`
`Am. Bar Ass’n, Deputy AG Rod Rosenstein to
`Speak at ABA Conference on Civil False
`Claims Act and Qui Tam Enforcement
`(June 6, 2018), https://bit.ly/34x7HXf ................... 22
`
`Amy S. Kelley et al., Hospice Enrollment
`Saves Money for Medicare and Improves
`Care Quality Across a Number of Different
`Lengths of Stay, 32 Health Affairs 552
`(2013) .................................................................. 8, 16
`
`Brian W. Powers et al., Cost Savings
`Associated with Expanded Hospice Use in
`Medicare, 18 J. Palliative Med. 400 (2015)........... 16
`
`
`
`
`
`
`
`vi
`
`Christopher W. Kerr et al., Cost Savings and
`Enhanced Hospice Enrollment with a
`Home-Based Palliative Care Program
`Implemented as a Hospice-Private Payer
`Partnership, 17 J. Palliative Med. 1328
`(2014) ...................................................................... 16
`
`CMS, Hospice Care Enhances Dignity And
`Peace As Life Nears Its End, CMS Pub.
`60AB, Transmittal AB-03-040,
`https://bit.ly/2DB9JtY ............................................ 13
`
`CMS, Medicare Benefit Policy Manual, CMS
`Pub. 100-02, Ch. 9, § 10,
`https://go.cms.gov/3leRkDV ............................. 13, 15
`
`CMS, Medicare Claims Processing Manual,
`CMS Pub. 100-04, Ch. 11, § 30.1,
`https://go.cms.gov/33veboE .............................. 14, 15
`
`Correspondence from Nancy-Ann Min
`DeParle, HCFA Administrator (date-
`stamped Sept. 12, 2000) ........................................ 13
`
`David Hui, Prognostication of Survival in
`Patients with Advanced Cancer: Predicting
`the Unpredictable?, 22 Cancer Control 489,
`491 (2015) ......................................................... 10, 11
`
`Diane E. Meier, Increased Access to Palliative
`Care and Hospice Services: Opportunities to
`Improve Value in Health Care, 89 Milbank
`Q. 343 (2011) .......................................................... 11
`
`
`
`
`
`
`
`vii
`
`Donald H. Taylor Jr. et al., What Length of
`Hospice Use Maximizes Reduction in
`Medical Expenditures Near Death in the US
`Medicare Program?, 65 Social Science &
`Medicine 1466 (2007) ............................................. 16
`
`Isaac D. Buck, A Farewell to Falsity: Shifting
`Standards in Medicare Fraud Enforcement,
` 49 Seton Hall L. Rev. 1 (2018)................ 8, 9, 14, 22
`
`Jeffrey Clemens & Joshua D. Gottlieb, Do
`Physicians’ Financial Incentives Affect
`Medical Treatment and Patient Health?,
`104 Am. Econ. Rev. 1320 (2014) ............................ 24
`
`Melissa E. Najjar, When Medical Opinions,
`Judgments, and Conclusions Are “False”
`under the False Claims Act: Criminal and
`Civil Liability of Physicians Who Are
`Second-Guessed by the Government, 53
`Suffolk U. L. Rev. 137, 157 (2020) ............ 21, 25, 26
`
`Michael Frakes, Defensive Medicine and
`Obstetric Practices, 9 J. of Empirical Legal
`Studies 457 (2012) ................................................. 24
`
`Michael Frakes, The Impact of Medical
`Liability Standards on Regional Variations
`in Physician Behavior: Evidence from the
`Adoption of National-Standard Rules, 103
`Am. Econ. Rev. 257 (2013) ..................................... 24
`
`Michaelle Huckaby Lewis et al., The Locality
`Rule and the Physician’s Dilemma Local
`Medical Practices vs the National Standard
`of Care, 297 J. Am. Med. Ass’n 2633 (2007) ......... 26
`
`
`
`
`
`
`
`viii
`
`Nat’l Hospice & Palliative Care Organization,
`NHPCO Facts and Figures (Aug. 20, 2020),
`https://bit.ly/3gTXpmx ................................... passim
`
`Ronen Avraham & Max M. Schanzenbach,
`The Impact of Tort Reform on Intensity of
`Treatment: Evidence from Heart Patients,
`39 J. of Health Economics 273 (2015) ................... 24
`
`Ruth Kleinpell et al., Exploring the
`Association of Hospice Care on Patient
`Experience and Outcomes of Care, 9 BMJ
`Supportive & Palliative Care 13 (2019) .................. 8
`
`U.S. Dep’t of Justice, Fraud Statistics,
`https://bit.ly/3lMuCUM (2018) .............................. 22
`
`Ziad Obermeyer et al., Association Between
`the Medicare Hospice Benefit and Health
`Care Utilization and Costs for Patients with
`Poor-Prognosis Cancer, 312 J. Am. Med.
`Ass’n 1888 (2014) ................................................... 16
`
`
`
`
`
`
`
`
`
`1
`
`INTEREST OF THE AMICI CURIAE1
`
`The National Hospice and Palliative Care Or-
`ganization (NHPCO) is the oldest and largest
`membership organization in the country representing
`the entire spectrum of non-profit and for-profit hospice
`and palliative care programs and professionals in the
`United States. It represents over 4,000 hospice loca-
`tions and more than 60,000 hospice professionals, car-
`ing for the vast majority of the nation’s hospice
`patients. As such, it is committed to improving end-of-
`life care with the goal of creating an environment in
`which individuals and families facing serious illness,
`death, and grief will experience the best care that
`humankind can offer.
`
`The National Association for Home Care &
`Hospice (NAHC) is a not-for-profit trade association
`representing the interests of nearly 6,000 home- and
`community-based health care providers throughout the
`nation, including hospices, home health agencies, and
`home care companies. The hospice members include
`non-profit, proprietary, public, and government-based
`entities. Since its inception in 1982, NAHC has directly
`participated in legislative and regulatory matters
`involving the Medicare hospice benefit along with
`numerous matters before the courts.
`
`
`1 All parties were timely notified and consented to the filing of this
`brief. Nobody other than amici authored this brief in any part or
`funded its preparation or filing.
`
`
`
`
`
`
`
`2
`
`The American Medical Association (AMA) is the
`largest professional association of physicians, resi-
`dents, and medical students in the United States. Ad-
`ditionally, through state and specialty medical societies
`and other physician groups seated in its House of Dele-
`gates, substantially all U.S. physicians, residents, and
`medical students are represented in the AMA’s policy-
`making process. The AMA was founded in 1847 to
`promote the science and art of medicine and the bet-
`terment of public health, and these remain its core
`purposes. AMA members practice in every state and in
`every medical specialty.
`
`The American Academy of Hospice and
`Palliative Medicine (AAHPM) is the professional
`organization for physicians specializing in hospice and
`palliative medicine. AAHPM’s more than 5,500
`members also include nurses and other health and
`spiritual care providers who are committed to
`improving the care and quality of life of patients with
`serious illness, as well as their families and caregivers.
`Since 1988, AAHPM has been dedicated to expanding
`access of patients and families to high-quality
`palliative and end-of-life care and advancing the disci-
`pline of hospice and palliative medicine through pro-
`fessional education and training, development of a
`specialist workforce, support for clinical practice
`standards, research, and public policy.
`
`The American Health Care Association (AHCA)
`is a nationwide association of long-term and post-acute
`care providers that provide essential care to approxi-
`mately one million individuals in over 14,000 not-for-
`
`
`
`
`
`
`
`3
`
`profit and proprietary member facilities. AHCA advo-
`cates to government, business leaders, and the general
`public for quality care and services for frail, elderly,
`and disabled Americans. AHCA is committed to devel-
`oping necessary and reasonable public policies that
`balance economic and regulatory principles to support
`quality care and quality of life.
`
`
`
`
`
`
`
`
`
`
`
`
`
`4
`
`SUMMARY OF THE ARGUMENT
`
`The Court should grant certiorari to honor Con-
`gress’s decision to defer to physicians’ clinical judg-
`ment, to resolve a circuit split threatening gross
`disparities in hospice care provision, and to ensure
`Medicare’s hospice benefit remains accessible to those
`who need it most. Left in place, the decision below and
`the circuit split it creates will inject retrospective sec-
`ond-guessing into the patient-physician relationship
`and arbitrarily restrict access to cost-effective end-of-
`life care—all without any foothold in statutory text.
`
`Hospice care, which has time and again been shown
`to improve patient quality of life while reducing overall
`Medicare spending, is a critical part of our health care
`system. Focusing on caring, not curing, hospice care
`involves an interdisciplinary team working together to
`manage pain and symptoms, deliver therapies and
`counseling, and provide support to patients and their
`families at the end of life.
`
`Both the number of individuals accessing hospice
`care and the number of hospice providers have contin-
`uously increased. Most hospice patients are Medicare
`beneficiaries. To be eligible for the Medicare hospice
`benefit, patients must be “terminally ill,” meaning they
`have a “medical prognosis” that their “life expectancy is
`6 months or
`less.” 42 U.S.C. §§ 1395f(a)(7),
`1395x(dd)(3)(A). Even for experienced hospice physi-
`cians, predicting life expectancy comes with inherent
`uncertainty and requires the exercise of clinical judg-
`ment.
`
`
`
`
`
`
`
`5
`
`To that end, Medicare pays for an individual’s hos-
`pice care when a hospice physician certifies “that the
`individual is terminally ill . . . based on the physician’s
`or medical director’s clinical judgment regarding the
`normal course of the individual’s illness . . . .” Id.
`§ 1395f(a)(7) (emphasis added). Congress carefully
`adopted this statutory framework, which squarely ba-
`ses the condition for payment on good-faith, reasonably
`supported clinical judgments of hospice physicians
`made at the time care is provided. The framework re-
`flects the medical reality that reasonable physicians
`can reach different terminality determinations, with
`neither being wrong. At the same time they have con-
`sistently affirmed the centrality of hospice physicians’
`clinical judgment, Congress and CMS have adopted
`complementary measures—such as a requirement to
`evaluate patients face-to-face—to reinforce best prac-
`tice. Congress has also created financial safeguards,
`including fixed rates and payment caps, to limit the
`government’s payment obligations. Hospice care, in
`fact, typically saves money as compared to convention-
`al per-service medical care.
`
`Contrary to statutory text and medical reality, the
`decision below disregards Congress’s decision to en-
`trust the terminality determination to hospice physi-
`cians’ clinical judgment. The Third Circuit concluded
`that a factfinder can second-guess a terminality deter-
`mination and find it “false” under the False Claims Act
`even if the hospice physician exercised clinical judg-
`ment as required by statute. According to the Third
`Circuit, differing post hoc opinions about whether a pa-
`tient was, in fact, terminally ill create a jury question
`
`
`
`
`
`
`
`6
`
`regarding falsity. This holding opens a square circuit
`split with the Eleventh Circuit’s recent decision on the
`same issue in United States v. AseraCare, Inc., 938
`F.3d 1278 (11th Cir. 2019). See Pet. for Writ of Cert.
`15–19.
`
`The decision below and the circuit split it creates
`will lead to detrimental consequences for hospices,
`physicians, and patients. To start, the decision will
`complicate compliance with the Medicare payment
`statute. For multistate hospice providers operating on
`both sides of the circuit split, setting consistent inter-
`nal policy may be nearly impossible. Knowing that tre-
`ble damages, statutory penalties, and reputational
`harm accompany False Claims Act liability, these pro-
`viders are more likely to craft reactionary organization-
`wide policies to comply with the Third Circuit’s errone-
`ous decision, extending legal error beyond its jurisdic-
`tional bounds.
`
`So too will the decision below negatively affect hos-
`pice physicians’ approaches to accepting patients and
`providing care. Fearing retrospective second-guessing
`of their clinical judgment, physicians may be reluctant
`to certify a patient as terminally ill unless the patient
`is nearly certain to die within six months. Other physi-
`cians, in turn, may hesitate to refer potential patients
`to hospice.
`
`As a result, the decision below will restrict patient
`access to important care. Not only does the decision
`threaten access in jurisdictions that follow its rule, but
`the circuit split also could cause inter-circuit dispari-
`ties. Even though Medicare sets a nationwide stand-
`
`
`
`
`
`
`
`7
`
`ard, similarly situated patients might experience dif-
`ferent access to care based solely on where they happen
`to live.
`
`As the average age of Americans increases and the
`demand for hospice care escalates, negative conse-
`quences flowing from the Third Circuit’s decision will
`only intensify. By threatening to limit the availability
`of the Medicare hospice benefit, the decision could de-
`prive millions of terminally ill individuals and their
`families of hospice care’s undisputed benefits. It will
`encourage reliance on other forms of care that cost the
`health care system—and the government—more mon-
`ey. And it will do all this in defiance of statutory text
`and without medical justification.
`
`ARGUMENT
`
`I. Hospice care is an important and increasingly
`used part of our health care system, as Con-
`gress and CMS have recognized.
`
`Improving quality of life while saving money, hos-
`pice offers compassionate end-of-life care for millions of
`Americans. Since the early 1980s, Medicare has paid
`for hospice care for terminally ill patients with a life
`expectancy of six months or less. Predicting life expec-
`tancy, however, comes with inherent uncertainty and
`requires the exercise of clinical judgment. For that rea-
`son, Congress has carefully tied Medicare payment to
`the reasonable, good-faith clinical judgment of hospice
`physicians actually treating Medicare beneficiaries. At
`the same time, Congress has structured the hospice
`payment model to save Medicare money.
`
`
`
`
`
`
`
`8
`
`A. Hospice care improves quality of life for
`millions of Americans, most of whom are
`Medicare beneficiaries.
`
`Every year, millions of Americans turn to hospice
`care. See, e.g., Nat’l Hospice & Palliative Care Organi-
`zation, NHPCO Facts and Figures, 6–11, 22 (Aug. 20,
`2020), https://bit.ly/3gTXpmx [hereinafter NHPCO];
`Isaac D. Buck, A Farewell to Falsity: Shifting Stand-
`ards in Medicare Fraud Enforcement, 49 Seton Hall L.
`Rev. 1, 11 (2018). Unlike conventional medicine, hos-
`pice care “focuses on caring, not curing.” NHPCO, su-
`pra, at 2. Studies have repeatedly shown that hospice
`care is associated with reduced symptom distress, im-
`proved patient experience, and high patient and family
`satisfaction. See Ruth Kleinpell et al., Exploring the
`Association of Hospice Care on Patient Experience and
`Outcomes of Care, 9 BMJ Supportive & Palliative Care
`13 (2019); Amy S. Kelley et al., Hospice Enrollment
`Saves Money for Medicare and Improves Care Quality
`Across a Number of Different Lengths of Stay, 32
`Health Affairs 552 (2013). Indeed, hospice care “greatly
`improve[s] the quality of care for patients and their
`families near the end of life.” Kelley, supra.
`
`Depending on a patient’s circumstances, hospice
`care can be delivered at the patient’s home, in a free-
`standing hospice facility, at an assisted living facility,
`at a nursing home or long-term care facility, or in a
`hospital. NHPCO, supra, at 2–3. Regardless of setting,
`hospice care is provided by an interdisciplinary team
`“consist[ing] of the patient’s personal physician, hos-
`pice physician or medical director, nurses, hospice
`
`
`
`
`
`
`
`9
`
`aides, social workers, bereavement counselors, clergy
`or other spiritual counselors, trained volunteers, and
`speech, physical, and occupational therapists, [as]
`needed.” Id. at 3. Working together, the hospice team
`provides a patient with virtually all needed care, from
`pain and symptom management, to psychosocial and
`spiritual counseling, and everything in between. See 42
`C.F.R. § 418.3. The length of time any particular pa-
`tient remains enrolled in hospice care can vary great-
`ly—from a few days, to a few weeks, to multiple
`months. See NHPCO, supra, at 12–14. Although pri-
`marily used by elderly individuals, hospice care is
`available to (and used by) all age groups. Id. at 9.
`
`With more and more individuals and their families
`accessing hospice for end-of-life care, the number of
`hospice organizations has also steadily increased. See
`Buck, supra, at 11. As of 2018, over 4,600 Medicare-
`certified hospice providers were operating—a 13.4% in-
`crease since 2014. NHPCO, supra, at 20. Hospice pro-
`viders vary in size, from fewer than 50 patients to over
`500 per day. See id.
`
`Finally, the vast majority of hospice patients are
`Medicare beneficiaries. In 2018, 1.55 million Medicare
`beneficiaries were enrolled in hospice care at some
`point during the year. Id. at 6. That same year, over
`50% of all Medicare decedents—those who died while
`on Medicare—were relying on hospice care at the end
`of their lives. Id. at 7. In 2001, that number was only
`19%. Buck, supra, at 11. These numbers highlight how
`Medicare beneficiaries are increasingly choosing to rely
`
`
`
`
`
`
`
`10
`
`on this important service to meet their health care
`needs at the end of life.
`
`B. Congress and CMS have carefully designed
`the Medicare hospice benefit to account for
`the inherent uncertainty in predicting end
`of life.
`
`The Medicare statute sets forth conditions for pay-
`ment of health care services. See 42 U.S.C. § 1395f(a).
`Under the subsection devoted to hospice care, Medicare
`pays if “the individual’s attending physician” and “the
`medical director” “certify in writing . . . that the indi-
`vidual is terminally ill . . . based on the physician’s or
`medical director’s clinical judgment regarding the
`normal course of the individual’s illness . . . .” Id.
`§ 1395f(a)(7).2 As a medical matter, hospice care is in-
`tended to provide “caring, not curing” treatment and
`comfort for terminally ill individuals. See NHPCO, su-
`pra, at 2. It thus makes sense that Medicare pays for
`hospice care only for patients who are “terminally ill,”
`42 U.S.C. § 1395f(a)(7), meaning they have a “medical
`prognosis” that their “life expectancy is 6 months or
`less,” id. § 1395x(dd)(3)(A).
`
`Yet “[b]ecause death is a probabilistic event, its ex-
`act timing cannot be predicted with certainty.” David
`Hui, Prognostication of Survival in Patients with Ad-
`
`2 For the first 90-day hospice benefit period, both the “attending
`physician” and “the medical director” or “physician member of the
`interdisciplinary group” must certify. 42 U.S.C. § 1395f(a)(7). For
`subsequent benefit periods, only the medical director or physician
`member of the interdisciplinary group must certify. Id.
`
`
`
`
`
`
`
`11
`
`vanced Cancer: Predicting the Unpredictable?, 22 Can-
`cer Control 489, 491 (2015); see United States v.
`AseraCare, Inc., 938 F.3d 1278, 1282 (11th Cir. 2019).
`All hospice patients present with their own unique cir-
`cumstances and conditions that impact the overall pre-
`diction. Moreover, substantial portions of hospice
`patients die of dementia, respiratory diseases, and oth-
`er causes for which “the art and science of predicting
`prognosis” is particularly uncertain. Diane E. Meier,
`Increased Access to Palliative Care and Hospice Ser-
`vices: Opportunities to Improve Value in Health Care,
`89 Milbank Q. 343, 355 (2011); see NHPCO, supra, at
`11. This lack of certainty means physicians acting in
`good faith exercising clinical judgment can arrive at di-
`vergent predictions that are equally valid and support-
`able. See AseraCare, Inc., 938 F.3d at 1296–98.
`
`When crafting payment conditions for hospice care,
`Congress accounted for that inherent uncertainty. This
`is reflected in statutory text, which empowers the
`“physician’s clinical judgment” to “dictate[] eligibility”
`“as long as it represents a reasonable interpretation of
`the relevant medical records.” Id. at 1294; see 42 C.F.R.
`§ 418.22(b)(2).
`
`What the text lays bare, statutory and regulatory
`history reinforce. Congress had originally limited Med-
`icare beneficiaries to 210 days of covered hospice care.
`Recognizing the scientific uncertainty in predicting life
`expectancy, Congress repealed the 210-day limit in
`1989. See Pub. L. 101-234; 70 Fed. Reg. 70532, 70533
`(Nov. 22, 2005). Medicare now covers hospice care for
`
`
`
`
`
`
`
`12
`
`eligible beneficiaries for as long as they remain termi-
`nally ill.
`
`Then in 1997, to further reflect how predicting life
`expectancy “will never be an exact science,” 142 Cong.
`Rec. S9582 (Aug. 2, 1996) (statement of Sen. Breaux),
`Congress added a “sort of good faith defense” for pro-
`viders submitting claims, Caring Hearts Pers. Home
`Servs., Inc. v. Burwell, 824 F.3d 968, 970 (10th Cir.
`2016) (Gorsuch, J.); see 42 U.S.C. §§ 1395pp,
`1395pp(g)(2); Pub. L. 105-33, § 4447. Section 1395pp
`protects “providers who didn’t know and couldn’t have
`reasonably been expected to know that their services
`weren’t permissible when rendered” from “hav[ing] to
`repay the amounts they received from CMS.” Caring
`Hearts, 824 F.3d at 970. Subsection (g)(2) explicitly co-
`vers hospice claims based on terminality determina-
`tions. This “sort of good faith defense,” id., provides
`some financial protection for hospices, which must as-
`sume a significant financial burden for their patients
`based on an inherently inexact terminality determina-
`tion. Together with the 1989 repeal of the 210-day lim-
`it, this 1997 change underscores Congress’s deliberate
`choice to entrust the terminality determination to hos-
`pice physicians’ clinical judgment.
`
`So too does CMS’s “rulemaking commentary signal[]
`that well-founded clinical judgments . . . be granted
`deference.” AseraCare, Inc., 938 F.3d at 1295; see, e.g.,
`79 Fed. Reg. 50451, 50470 (Aug. 22, 2014); 78 Fed. Reg.
`48234, 48247 (Aug. 7, 2013); 75 Fed. Reg. 70372, 70448
`(Nov. 17, 2010). CMS, in fact, explicitly rejected a pro-
`posal to define certification requirements, thereby “re-
`
`
`
`
`
`
`
`13
`
`mov[ing] any implication that there are specific CMS
`clinical benchmarks in this rule that must be met in
`order to certify terminal illness.” 73 Fed. Reg. 32088,
`32138 (June 5, 2008).
`
`CMS also understands that a terminal prognosis is
`far from a guarantee of death within six months. Ra-
`ther, Medicare beneficiaries are hospice-eligible when
`their clinical status is “more likely than not to result in
`a life expectancy of six months or less.” 78 Fed. Reg.
`48234, 48247 (Aug. 7, 2013) (emphasis added). That a
`patient has the “good fortune to live longer than pre-
`dicted by a well-intentioned physician,” Correspond-
`ence
`from Nancy-Ann Min DeParle, HCFA
`Administrator (date-stamped Sept. 12, 2000), “is not
`cause to terminate benefits,” CMS, Medicare Benefit
`Policy Manual, CMS Pub. 100-02, Ch. 9, § 10,
`https://go.cms.gov/3leRkDV [hereinafter CMS, MBPM].
`CMS has thus assured physicians that “[t]here is no
`risk” in “certifying an individual for hospice care that”
`the physician honestly “believes to be terminally ill.”
`CMS, Hospice Care Enhances Dignity And Peace As
`Life Nears Its End, CMS Pub. 60AB, Transmittal AB-
`03-040, https://bit.ly/2DB9JtY (emphasis added).
`
`As Congress and CMS have emphasized the central-
`ity of clinical judgment, they have also adopted com-
`plementary measures to fortify hospice physician
`accountability. In 2009, CMS mandated that physi-
`cians include an attested “narrative explanation of the
`clinical findings that supports a life expectancy of 6
`months or less” as part of a patient’s certification. 42
`C.F.R. § 418.22(b)(3); see 74 Fed. Reg. 39413 (Aug. 6,
`
`
`
`
`
`
`
`14
`
`2009). This narrative “must reflect the patient’s indi-
`vidual clinical circumstances and cannot contain check
`boxes or standard language used for all patients.” Id.
`§ 418.22(b)(3)(iv). Then in 2011, Congress and CMS be-
`gan requiring hospice physicians (or employed hospice
`nurse practitioners) to have face-to-face encounters
`with patients anticipated to reach their third hospice
`benefit period. 42 U.S.C. § 1395f(a)(7)(D)(i); 42 C.F.R.
`§ 418.22(b)(4). Information from these face-to-face en-
`counters is then shared with the relevant practitioner
`before certification.
`
`C. Hospice care saves the Medicare system
`money.
`
`To be sure, hospice care has been a “quickly growing
`piece of the Medicare budget.” Buck, supra, at 10. In
`2018, patients collectively received 114 million days of
`Medicare-paid hospice care. NHPCO, supra, at 12, 18.
`At $19.2 billion dollars, this expenditure represented a
`7.2% increase over the prior year. Id. Per hospice pa-
`tient, Medicare spent $12,200 on average. Id. at 18.
`
`Yet at the same time, hospice care saves the health
`care system—and hence, the government—money. By
`its very structure, the Medicare hospice payment mod-
`el makes sure hospices take responsibility for virtually
`all end-of-life care, while providing overall cost-savings
`to the Medicare trust. See 76 Fed. Reg. 47301, 47302
`(Aug. 4, 2011). To start, Medicare pays hospice provid-
`ers an all-inclusive per-diem rate. 42 C.F.R. § 418.302.
`Payment is made at one of four predetermined rates for
`each day that a Medicare beneficiary is under the care
`of a hospice. 42 C.F.R. § 418.302; CMS, Medicare
`
`
`
`
`
`
`
`15
`
`Claims Processing Manual, CMS Pub. 100-04, Ch. 11,
`§ 30.1, https://go.cms.gov/33veboE. The per-diem pay-
`ment covers all hospice-care services, including skilled
`nursing services, physicians’ administrative services,
`medical social services, physical and occupational ther-
`apy, home health aide, counseling, on-call services,
`medical equipment, and prescription drugs—all de-
`pending on the individual needs of the patient. Id.
`§ 418.202; see also 83 Fed. Reg. 20934, 20948 (May 8,
`2018).
`
`Two payment caps further limit the government’s
`obligations. These caps limit the amount and cost of
`care that any individual hospice agency provides in a
`single year. See 42 C.F.R. §§ 418.302(f), 418.308,
`418.309; see also CMS, MBPM, supra, Ch. 9, § 90. One
`cap limits the number of days of inpatient care an
`agency may provide to not more than 20 percent of its
`total patient care days. 42 C.F.R. § 418.302(f). The oth-
`er cap sets an aggregate dollar limit on the average
`annual payment per beneficiary a hospice provider can
`receive. Id. § 418.309. This aggregate cap limits the to-
`tal payments that any individual hospice can receive in
`a cap year to an allowable amount based on an annual
`per-beneficiary cap amount and the number of benefi-
`ciaries served. Id. § 418.309; see also CMS, MBPM, su-
`pra, Ch. 9, § 90. Providers exceeding the cap must
`repay the excess. 42 C.F.R. § 418.308(d). Together,
`these caps protect the government against paying hos-
`pices above a certain dollar amount.
`
`Hospice care also saves the government money as
`compared to conventional, per-service care. See, e.g.,
`
`
`
`
`
`
`
`16
`
`Abt Associates, Analysis of Medicare Pre-Hospice
`Spending
`and Hospice Utilization
`(2015),
`https://go.cms.gov/34l48ln
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