Title of Regulation: 12VAC30-50. Amount, Duration, and Scope of Medical and Remedial Care Services (amending 12VAC30-50-220).

Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: September 22, 2017.

Agency Contact: Emily McClellan, Regulatory Supervisor, Policy Division, Department of Medical Assistance Services, 600 East Broad Street, Suite 1300, Richmond, VA 23219, telephone (804) 371-4300, FAX (804) 786-1680, or email emily.mcclellan@dmas.virginia.gov.

Basis: Section 32.1-325 of the Code of Virginia grants the Board of Medical Assistance Services the authority to administer and amend the Plan for Medical Assistance, and § 32.1-324 of the Code of Virginia authorizes the Director of the Department of Medical Assistance Services (DMAS) to administer and amend the Plan for Medical Assistance according to the board's requirements. The Medicaid authority as established by § 1902(a) of the Social Security Act (42 USC § 1396a) provides governing authority for payments for services.

Item 306 OOOO of Chapter 780 of the 2016 Acts of Assembly directs DMAS to cover low-dose computed tomography (LDCT) lung cancer screenings for high-risk adults.

Purpose: At present, DMAS does not cover LDCT screening for adults as a preventive service. There is evidence that this policy puts adults at increased risk of developing advanced-stage lung cancer. This regulatory action will permit DMAS to cover LDCT screenings for at-risk adults, thereby enabling DMAS to help make further reductions in lung cancer morbidity and mortality. Additionally, DMAS would align itself with established federal recommendations that support LDCT screening.

These regulatory changes will improve the health, safety, and welfare of the affected Medicaid individuals by providing care coordination and well-person preventive services. Additionally, this regulation will provide Medicaid coverage of annual LDCT lung cancer screening as a preventive measure, in the absence of symptoms, for at-risk beneficiaries.

Substance: DMAS has determined that this regulatory action is needed to increase the potential to diagnose lung cancer at earlier stages and reduce incidences of advanced-stage lung cancer and to help reduce the costs associated with lung cancer. The U.S. Preventive Services Task Force (USPSTF), an independent panel of experts authorized by Congress to make recommendations about specific preventive services for patients with no signs or symptoms of disease, issued a statement in 2013 giving LDCT scans a grade of "B" and recommending that certain individuals get an LDCT scan every year. Criteria include individuals between the ages of 55 and 80 years who are current smokers, have quit smoking within the last 15 years, or have a history of smoking at least one pack of cigarettes per day for 30 or more years.

The proposed amendment to 12VAC30-50-220 aligns Medicaid coverage with the coverage provided by Medicare and commercial health plans to achieve consistency among the fee-for-service and the managed care organization programs and to bring DMAS in line with USPSTF recommendations by providing for LDCT scans for certain individuals.

Issues: USPSTF estimates that a minimum of 20,000 lives can be saved each year through these preventive screenings. Nineteen percent of adults in Virginia were current smokers over the last several years compared to the national average of 17%. Additionally, according to the Centers for Medicare and Medicaid Services, nationwide 37% of Medicaid insured individuals smoke with total Medicaid expenditures attributable to smoking of nearly $22 billion annually, representing 11% of all expenditures. According to a Quit Now report, approximately 25% of Medicaid insured individuals in Virginia were current smokers in 2015, a figure that has been as high as 27% in the past three fiscal years. DMAS currently covers LDCT for adults when it is deemed medically necessary (i.e., symptoms are present). As a result, lung cancer in the Medicaid population can go undetected until its third and fourth stages when treatment is most costly and morbidity is at its highest. Nationwide, only 16% of lung cancers are stage one (localized) at the time of diagnosis when the five-year survival rate is highest (nearly 55%), while 22% are stage two (having spread regionally) and 57% are stage three (having spread distantly). Tragically, the five-year survival rate is only 4.0% for stage three lung cancer and just over 27% for stage two.

In Virginia, there were 3,041 inpatient hospitalizations for lung cancer in 2012 (non-Medicaid as well as Medicaid) at a total cost of about $167 million. The average length of stay was 6.5 days, and the average cost per stay was $55,122.16. Moreover, because many studies only examine direct medical costs incurred during hospitalization, these figures underestimate the true economic consequences of undetected lung cancer.

By covering LDCT screenings as a preventive service, DMAS can help reduce lung cancer morbidity and mortality in Virginia. The procedure is safe, with no adverse effects to the recipient.

To establish the population that would benefit from preventive LDCT screenings, DMAS begins with the at-risk age range of individuals from 55 to 80 years of age. Since Medicare coverage (which begins at age 65) includes this service as a preventive measure, we can shorten the range to 55 to 64 years of age. For the past three state fiscal years, Virginia's average monthly Medicaid enrollment in this age range was approximately 21,684.17 Next, given that nearly 25% of Medicaid beneficiaries are current smokers, we can assume the at-risk population to be roughly 5,421.

The primary advantages to the public, the Agency, and the Commonwealth from this regulatory package include enhanced service delivery to Medicaid beneficiaries, and greater consistency between Virginia regulations and established federal recommendations which support LDCT screening. There are no disadvantages to the public or the Commonwealth as a result of these regulatory changes.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. Pursuant to Chapter 780 of the 2016 Acts of Assembly, the Director (Director) of the Department of Medical Assistance Services (DMAS) proposes to provide Medicaid coverage of annual low-dose computed tomography (LDCT) lung cancer screening as a preventive measure, in the absence of symptoms, for at-risk beneficiaries.

Result of Analysis. The benefits likely exceed the costs for all proposed changes.

Estimated Economic Impact. Under the current regulation DMAS does not cover LDCT screening for adults as a preventive service under Medicaid. The Director proposes to specify that "Low-dose computed tomography lung cancer screening shall be covered annually for individuals between the ages of 55 years and 80 years who are current smokers, have quit smoking within the last 15 years, or have a history of smoking at least one pack of cigarettes per day for 30 or more years." Lung cancer is by far the leading cause of cancer deaths accounting for 26% of all cancer deaths nationwide.¹ Each year, more people die of lung cancer than of colon, breast, and prostate cancers combined.² Nationally, individuals with lung cancer have a five-year relative survival rate of 54% if cancer is diagnosed in its earliest (localized) stage.³ Unfortunately, most lung cancers have spread widely and are at an advanced stage by the time that they are first detected, making them very difficult to treat or cure. In Virginia, only 19% of lung cancers were diagnosed at the localized stage between 2007 and 2011.⁴

LDCT can be used to screen for those at high risk for lung cancer and help detect cancer earlier, thus lowering the risk of death. These screenings are safe for the patient, using lower amounts of radiation than a standard chest scan and not requiring the use of intravenous contrast dye.⁵ A large clinical trial conducted by the U.S. National Institutes of Health, National Cancer Institute (the National Lung Screening Trial) compared LDCT screenings to standard chest x-rays in people at high risk of lung cancer to ascertain if these scans could help lower the risk of dying from lung cancer. The researchers concluded that LDCT scans provided more detailed pictures than chest x-rays and are better at finding small abnormalities in the lungs.⁶ Additionally, certain cancer cells were detected at the earliest stage more frequently by LDCT screenings than by standard chest x-rays.⁷ The researchers also found that people who got LDCT had a 16% lower chance of dying from lung cancer than those who got chest x-rays.⁸

Thus to the extent that covering LDCT lung cancer screening as a preventive measure in the absence of symptoms for at-risk beneficiaries leads to increased use of early LDCT use, the proposal would likely somewhat increase lung cancer survival rates in the Commonwealth. The annual cost for covering the LDCT lung cancer screening has been estimated to be $118,650 annually.⁹ The benefits of likely increased survival rates would for most observers exceed the estimated costs.

Businesses and Entities Affected. The proposed amendment potentially affects health care facilities that provide lung cancer screenings and Medicaid recipients between the ages of 55 years and 80 years who are current smokers, have quit smoking within the last 15 years, or have a history of smoking at least one pack of cigarettes per day for 30 or more years.

Localities Particularly Affected. The proposed amendment does not disproportionately affect particular localities.

Projected Impact on Employment. The proposed amendment may have a positive impact on employment for technicians who conduct LDCT lung cancer screenings.

Effects on the Use and Value of Private Property. The proposed amendment does not significantly affect the use and value of private property.

Real Estate Development Costs. The proposed amendment does not affect real estate development costs.

Small Businesses:

Definition. Pursuant to § 2.2-4007.04 of the Code of Virginia, small business is defined as "a business entity, including its affiliates, that (i) is independently owned and operated and (ii) employs fewer than 500 full-time employees or has gross annual sales of less than $6 million."

Costs and Other Effects. The proposed amendment does not significantly affect costs for small businesses.

Alternative Method that Minimizes Adverse Impact. The proposed amendment does not adversely affect small businesses.

Adverse Impacts:

Businesses. The proposed amendment does not adversely affect businesses.

Localities. The proposed amendment does not adversely affect localities.

Other Entities. The proposed amendment does not adversely affect other entities.

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¹ Source: U.S. National Institutes of Health, National Cancer Institute.

² Source: "Lung Cancer Prevention and Early Detection." American Cancer Society. Feb. 6, 2015.

³ Source: American Cancer Society. "Cancer Facts & Figures 2014."

⁴ Source: Virginia Cancer Registry. Based on combined 2007-2011 data. Incidence rates are age-adjusted to the 2000 U.S. standard population; Percent of Local Stage cancers reported using the Derived Summary Staging System.

⁵ Source: "Lung Cancer Prevention and Early Detection." American Cancer Society. Feb. 6, 2015.

⁶ Source: NIH, National Cancer Institute. National Lung Screening Trial, NLST Study Facts. Sep. 8, 2014.

⁷ Ibid.

⁸ Ibid.

⁹ The $118,650 figure is the amount listed in the state budget for this service.

Agency's Response to Economic Impact Analysis: The agency has reviewed the economic impact analysis prepared by the Department of Planning and Budget and raises no issues with this analysis.

Summary:

Item 306 OOOO of Chapter 780 of the 2016 Acts of Assembly, the 2016 Appropriation Act, directs the Department of Medical Assistance Services to cover low-dose computed tomography lung cancer screenings for high-risk adults. The proposed amendment conforms the regulation to this requirement.

12VAC30-50-220. Other diagnostic Diagnostic, screening, preventive, and rehabilitative services, i.e., other than those provided elsewhere in this plan.

A. Diagnostic services are provided but only when necessary to confirm a diagnosis.

B. Screening services.

1. Screening mammograms for the female recipient population aged 35 and over shall be covered, consistent with the guidelines published by the American Cancer Society.

2. Screening PSA (prostate specific antigen) and the related DRE (digital rectal examination) for males shall be covered, consistent with the guidelines published by the American Cancer Society.

3. Screening Pap smears shall be covered annually for females, consistent with the guidelines published by the American Cancer Society.

4. Screening services for colorectal cancer, specifically screening with an annual fecal occult blood test, flexible sigmoidoscopy or colonoscopy, or in appropriate circumstances radiologic imaging, in accordance with the most recently published recommendations established by the American College of Gastroenterology, in consultation with the American Cancer Society, for the ages, family histories, and frequencies referenced in such recommendations.

5. Low-dose computed tomography lung cancer screening shall be covered annually for individuals between the ages of 55 years and 80 years who are current smokers, have quit smoking within the last 15 years, or have a history of smoking at least one pack of cigarettes per day for 30 or more years.

C. Maternity length of stay and early discharge.

1. If the mother and newborn, or the newborn alone, are discharged earlier than 48 hours after the day of delivery, DMAS will cover one early discharge follow-up visit as recommended by the physicians in accordance with and as indicated by the "Guidelines for Perinatal Care," 4th Edition, August 1997, as developed by the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists. The mother and newborn, or the newborn alone if the mother has not been discharged, must meet the criteria for early discharge to be eligible for the early discharge follow-up visit. This early discharge follow-up visit does not affect or apply to any usual postpartum or well-baby care or any other covered care to which the mother or newborn is entitled; it is tied directly to an early discharge.

2. The early discharge follow-up visit must be provided as directed by a physician. The physician may coordinate with the provider of his choice to provide the early discharge follow-up visit, within the following limitations. Qualified providers are those hospitals, physicians, nurse midwives, nurse practitioners, federally qualified health clinics, rural health clinics, and health departments' clinics that are enrolled as Medicaid providers and are qualified by the appropriate state authority for delivery of the service. The staff providing the follow-up visit, at a minimum, must be a registered nurse having training and experience in maternal and child health. The visit must be provided within 48 hours of discharge.