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APPLIED POLICY INSIGHT
We trust modern medicine to be evidence-based: grounded in the most current and reliable research available.

But sometimes medicine gets it wrong, and clinicians engage in unproven, ineffective, expensive, and even harmful practices. Worse, these practices can become entrenched as standard protocols.

From cardiac care to pain management, the medical community has more than once committed itself to the wrong course, sometimes with deadly consequences.
Thirty-five states and the District of Columbia currently have some form of certificate of need (CON) requirement under which specified healthcare organizations—including hospitals, outpatient facilities, and long-term care facilities—must secure approval from a state regulatory agency before undertaking major capital expenditures or program expansions.

Depending on each state’s CON program, hospitals looking to add beds, increase their physical footprint, or purchase equipment may not be able to until they can demonstrate the need to a certifying authority. CONs may also be required for mergers or acquisitions.

Proponents credit CON programs with improving quality of care and access to care, but critics fault them for stifling competition and growth.
The Medicaid and CHIP Payment and Access Commission (MACPAC) held a virtual public meeting on March 2.

The meeting included sessions on additional analyses of potential recommendation for countercyclical disproportionate share hospital allotments and updates on unwinding the continuous coverage requirements and other flexibilities. 
The Durable Medical Equipment Medicare Administrative Contractors (DME MACs) have announced a policy change expanding coverage for continuous glucose monitors (CGMs). The decision, which the Centers for Medicare & Medicaid Services (CMS) hopes will decrease health disparities in the diabetes community, is expected to improve health outcomes for many Medicare beneficiaries with diabetes, while reducing Medicare spending for the treatment of diabetes-related complications. 

When Applied Policy first reported on the proposed expansion in November, it was expected to extend coverage to persons using insulin at least once a day (compared to the existing threshold of three times daily) or to those with a history of problematic hypoglycemia. However, as adopted, the policy does not include language specifying a minimum daily dosing frequency, but uses the term, “The beneficiary is insulin-treated.” As a result, the coverage expansion is larger than had been anticipated. 

Medicare beneficiaries with CGMs will still be required to meet with their treating practitioner in person or by telehealth every six months to assess adherence with their CGM regimen and treatment plan.

The DME MACs' decision comes after diabetes stakeholders, including the Diabetes Technology Access Coalition, endocrinologists, and Applied Policy employed the latest diabetes research, clinical evidence, and practice to quantify the value of an expansion of CGM coverage for Medicare beneficiaries.

The policy change’s effective date of April 16 has important implications. Under the COVID-19 Public Health Emergency (PHE), CMS waived enforcement of clinical indications for CGMs. As a result, many beneficiaries who would not qualify for a CGM under the current coverage guidelines have received the devices in the last three years. The expansion of CGM coverage before the end of the PHE on May 11 will allow at least some of these beneficiaries to qualify under the new criteria and prevent beneficiaries from being taken off therapy. 

Applied Policy is proud to have contributed to this change through development and submission of a policy recommendation which outlined a pathway to promote health equity in diabetes care and management that can reduce federal spending for diabetes-related complications.
The Medicare Payment Advisory Commission (MedPAC) held a virtual public meeting on March 2 and 3.

The meeting included sessions on:

  • Reforming Medicare’s wage index systems;
  • Addressing the high prices of drugs covered under Medicare Part B;
  • Mandated report: Evaluation of a prototype design for a post-acute care prospective payment system;
  • Favorable selection and future directions for Medicare Advantage payment policy; and
  • Aligning fee-for-service payment rates across ambulatory settings.
In what it described as part of “ongoing efforts to increase access to care and to reduce unnecessary administrative burdens for stakeholders,” The Centers for Medicare & Medicaid Services (CMS) discontinued the use of Certificates of Medical Necessity (CMNs) and Durable Medical Equipment (DME) Information Forms (DIFs) for claims with dates of service on or after January 1, 2023.

The change stemmed from CMS’s relaxation of coverage requirements for home oxygen therapy in 2021, which included dropping the CMN for these claims.

Given that CMNs and DIFs can represent an administrative burden, it is not surprising that the reaction to their elimination has been largely positive.

But not everyone is satisfied. Some wonder how the change will impact claims processing. And the Council for Quality Respiratory Care (CQRC), a coalition of home oxygen therapy providers and manufacturing companies, argues that the change does not go far enough towards ensuring that patient access to supplemental oxygen supplies is not restricted.
On our calendars
Under review/On the docket
Applied Policy is paying particular attention to the following rules under review at the Office of Management and Budget:

  • OSHA: Occupational Exposure to COVID-19 in Healthcare Settings
  • Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; the Long-Term Care Hospital Prospective Payment System; and FY 2024 Rates (CMS-1785)
  • FY 2024 Hospice Wage Index, Payment Rate Update, and Quality Reporting Requirements (CMS-1787)
  • FY 2024 Inpatient Psychiatric Facilities Prospective Payment System Rate and Quality Reporting Updates (CMS-1783)
  • FY 2024 Skilled Nursing Facility (SNFs) Prospective Payment System and Consolidated Billing and Updates to the Value-Based Purchasing and Quality Reporting Programs
  • Contract Year 2024 Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Medicare Cost Plan Programs, Medicare Overpayment Provisions of the Affordable Care Act, and PACE

See all rules under OMB review here.
From the headlines
Insight Joke of the Month for March
What do you get when you cross
a four-leaf clover with poison ivy?
March's Book Recommendation:
Malignant,
How Bad Policy and Bad Evidence
Harm People with Cancer
Author Vinayak K. Prasad describes Malignant as "a book about how the actions of human beings—our policies, our standards of evidence and our drug regulation—incentivize the pursuit of marginal or unproven therapies at lofty and unsustainable prices.” 

A hematologist-oncologist and self-proclaimed skeptic, Prasad has earned a reputation as a crusader for evidence-based medicine, and Malignant builds upon the arguments he and Adam S. Cifu, M.D. began in their groundbreaking text, Ending Medical Reversal.

The Lancet described Malignant as "punchy and persuasive," and, in his examination of topics from academic medicine to regulatory agencies, Prasad rarely holds back.

Published by Johns Hopkins University Press, Malignant can be read for free through Project Muse and is also available as an audio book.
Applied Policy, L.L.C., is a health policy and reimbursement consulting firm strategically located minutes from Washington, D.C.