(Medicare Benefit Policy Manual)

Effective, January 1, 1998, 4102 of the Balanced Budget Act (BBA) of 1997 (P.L. 105-33) amended 1861(nn) of the Act (42 USC 1395X(nn)) to include coverage every 3 years for a screening Pap smear or more frequent coverage for women:   1.  At high risk for cervical or vaginal cancer; or  2.  Of childbearing age who have had a Pap smear during any of the preceding 3 years indicating the presence of cervical or vaginal cancer or other abnormality.   Effective July 1, 2001, the Consolidated Appropriations Act of 2001 (P.L. 106-554) modifies 1861(nn) to provide Medicare coverage for biennial screening Pap smears.  Specifications for frequency limitations are defined below.  For claims with dates of service from January 1, 1998, through June 30, 2001, screening Pap smears are covered when ordered and collected by a doctor of medicine or osteopathy (as defined in 1861(r)(1) of the Act), or other authorized practitioner (e.g., a certified nurse midwife, physician assistant, nurse practitioner, or clinical nurse specialist, who is authorized under State law to perform the examination) under one of the following conditions.  The beneficiary has not had a screening Pap smear test during the preceding 3 years (i.e., 35 months have passed following the month that the woman had the last covered Pap smear  ICD-9-CM code V76.2 or ICD -10 code Z112.4 is used to indicate special screening for malignant neoplasm, cervix); or  There is evidence (on the basis of her medical history or other findings) that she is of childbearing age and has had an examination that indicated the presence of cervical or vaginal cancer or other abnormalities during any of the preceding 3 years; and a t least 11 months have passed following the month that the last covered Pap smear was performed; or  She is at high risk of developing cervical or vaginal cancer  ICD-9-CM code V15.89, other specified personal history presenting hazards to health) or as applicable, ICD -10 code Z77.21, Z77.22, Z77.9, Z91.89, OR Z92.89 and at least 11 months have passed following the month that the last covered screening Pap smear was performed.  The high risk factors for cervical and vaginal cancer are:   Cervical Cancer High Risk Factors   Early onset of sexual activity (under 16 years of age);   Multiple sexual partners (five or more in a lifetime);  History of a sexually transmitted disease (including HIV infection); and   Fewer than three negative or any Pap smears within the previous 7 years.   Vaginal Cancer High Risk Factors   The DES (diethylstilbestrol) -  exposed daughters of women who took DES during pregnancy.   The term woman of childbearing age means a woman who is premenopausal, and has been determined by a physician, or qualified practitioner, to be of childbearing age, based on her medical history or other findings.  Payment is not made for a screening Pap smear for women at high risk or who qualify for coverage under the childbearing provision more frequently than once every 11 months after the month that the last screening Pap smear covered by Medicare was performed.   B.  For Claims with Dates of Service on or After July 1, 2001  When the beneficiary does not qualify for a more frequently performed screening Pap smear as noted in items 1 and 2 above, contractors pay for the screening Pap smear only after at least 23 months have passed following the month during which the beneficiary received her last covered screening Pap smear.  All other coverage and payment requirements remain the same.   See the Medicare Claims Processing Manual, Chapter 18, Preventive and Screening Services, for billing procedures.   280.5  Annual Wellness Visit (AWV) Providing Personalized Prevention Plan Services (PPPS)  (Rev. 170, Issued: 05- 10-13, Effective: 01 -01-12, Medicare Coverage of the Annual Wellness Visit (AWV); 01 -01-13- Medicare Coverage of Hepatitis B Vaccine, Implementation: 06 -10-13)  A.  General   Pursuant to section 4103 of the Affordable Care Act of 2010 (the ACA), the Centers for Medicare & Medicaid Services (CMS) amended section 42 CFR 411.15(a)(1) and 42 CFR 411.15(k)(15) (list of examples of routine physical examinations excluded from coverage), effective for services furnished on or after January 1, 2011.  This expanded coverage, as established at 42 CFR 410.15, is subject to certain eligibility and other limitations that allow payment for an annual wellness visit (AWV) providing personalized prevention plan services (PPPS), when performed by a health professional (as defined in this section), for an individual who is no longer within 12 months after the effective date of his/her first Medicare Part B coverage period, and has not received eithe r an initial preventive physical examination (IPPE) or an AWV within the past 12 months. Medicare coinsurance and Part B deductibles do not apply.  The AWV will include the establishment of, or update to, the individuals medical/family history, measurement of his/her height, weight, body- mass index (BMI) or waist circumference, and blood pressure (BP), with the goal of health promotion and disease detection and encouraging patients to obtain the screening and preventive services that may already be covered and paid for under Medicare Part B.  Definitions relative to the AWV are included below.   Coverage is available for an AWV that meets the following requirements:   1.  It is performed by a health professional; and,   2.  It is furnished to an eligible beneficiary who is no longer within 12 months after the effective date of his/her first Medicare Part B coverage period, and he/she has not received either an IPPE or an AWV providing PPPS within the past 12 months.  Sections 4103 and 4104 of the ACA also provide for a waiver of the Medicare coinsurance and Part B deductible requirements for an AWV effective for services furnished on or after January 1, 2011.   B.  Definitions Relative to the AWV:   Detection of any cognitive impairment:  The assessment of an individuals cognitive function by direct observation, with due consideration of information obtained by way of patient reports, concerns raised by family members, friends, caretakers, or others.  Eligible beneficiary:  An individual who is no longer within 12 months after the effective date of his/her first Medicare Part B coverage period and who has not received either an IPPE or an AWV providing PPPS within the past 12 months.  Establishment of, or an update to, the individuals medical/family history:   At a minimum, the collection and documentation of the following:   a.  Past medical and surgical history, including experiences with illnesses, hospital stays, operations, allergies, injuries, and treatments.  b.  Use or exposure to medications and supplements, including calcium and vitamins.   c.  Medical events in the beneficiarys parents and any siblings and children, including diseases that may be hereditary or place the individual at increased risk.  First AWV providing PPPS :  The provision of the following services to an eligible beneficiary by a health professional that include, and take into account the results of, a health risk assessment as those terms are defined in this section:   a.  Review (and administration if needed) of a health risk assessment (as defined in this section).   b.  Establishment of an individuals medical/family history.   c.  Establishment of a list of current providers and suppliers that are regularly involved in providing medical care to the individual.  d.  Measurement of an individuals height, weight, BMI (or waist circumference, if appropriate), BP, and other routine measurements as deemed appropriate, based on the beneficiarys medical/family history.  e.  Detection of any cognitive impairment that the individual may have as defined in this section.   f.  Review of the individuals potential (risk factors) for depression, including current or past experiences with depression or other mood disorders, based on the use of an appropriate screening instrument for persons without a current diagnosis of depres sion, which the health professional may select from various available standardized screening tests designed for this purpose and recognized by national medical professional organizations.  g.  Review of the individuals functional ability and level of safety based on direct observation, or the use of appropriate screening questions or a screening questionnaire, which the health professional may select from various available screening questions or standardized questionnaires designed for this purpose and recognized by national professional medical organizations.  h.  Establishment of the following:   (1)  A written screening schedule for the individual, such as a checklist for the next 5 to 10 years, as appropriate, based on recommendations of the United States Preventive Services Task Force (USPSTF) and the Advisory Committee on Immunization Practices  (ACIP), and the individuals health risk assessment (as that term is defined in this section), the individuals health status, screening history, and age -appropriate preventive services covered by Medicare.   (2)  A list of risk factors and conditions for which primary, secondary, or tertiary interventions are recommended or are underway for the individual, including any mental health conditions or any such risk factors or conditions that have been identified t hrough an IPPE, and a list of treatment options and their associated risks and benefits.   i.  Furnishing of personalized health advice to the individual and a referral, as appropriate, to health education or preventive counseling services or programs aimed at reducing identified risk factors and improving self -management, or community -based lif estyle interventions to reduce health risks and promote self -management and wellness, including weight loss, physical activity, smoking cessation, fall prevention, and nutrition.  j.  Any other element determined appropriate through the National Coverage Determination (NCD) process.   Health professional:   a.  A physician who is a doctor of medicine or osteopathy (as defined in section 1861(r)(1) of the Social Security Act (the Act); or,  b.  A physician assistant, nurse practitioner, or clinical nurse specialist (as defined in section 1861(aa)(5) of the Act); or,   c.  A medical professional (including a health educator, registered dietitian, or nutrition professional or other licensed practitioner) or a team of such medical professionals, working under the direct supervision (as defined in 42CFR 410.32(b)(3)(ii)) of a phy sician as defined in this section.  Health Risk Assessment means, for the purposes of the annual wellness visit, an evaluation tool that meets the following criteria:   a.  collects self -reported information about the beneficiary.   b.  can be administered independently by the beneficiary or administered by a health professional prior to or as part of the AWV encounter.   c.  is appropriately tailored to and takes into account the communication needs of underserved populations, persons with limited English proficiency, and persons with health literacy needs.   d.  takes no more than 20 minutes to complete.  e.  addresses, at a minimum, the following topics:   1.  demographic data, including but not limited to age, gender, race, and ethnicity.   2.  self assessment of health status, frailty, and physical functioning.  3.  psychosocial risks, including but not limited to, depression/life satisfaction, stress, anger, loneliness/social isolation, pain, and fatigue.   4.  Behavioral risks, including but not limited to, tobacco use, physical activity, nutrition and oral health, alcohol consumption, sexual health, motor vehicle safety (seat belt use), and home safety.   5.  Activities of daily living (ADLs), including but not limited to, dressing, feeding, toileting, grooming, physical ambulation (including balance/risk of falls), and bathing.   6.  Instrumental activities of daily living (IADLs), including but not limited to, shopping, food preparation, using the telephone, housekeeping, laundry, mode of transportation, responsibility for own medications, and ability to handle finances.   Review of the individuals functional ability and level of safety:  At a minimum, includes assessment of the following topics:   a.  Hearing impairment,   b.  Ability to successfully perform activities of daily living,   c. Fall risk, and,   d. Home safety.   Subsequent AWV providing PPPS:  The provision of the following services to an eligible beneficiary by a health professional that include, and take into account the results of an updated health risk assessment, as those terms are defined in this section:   a.  Review (and administration if needed) of an updated health risk assessment (as defined in this section).   b.  An update of the individuals medical/family history.  c.  An update of the list of current providers and suppliers that are regularly involved in providing medical care to the individual, as that list was developed for the first AWV providing PPPS or the previous subsequent AWV providing PPPS.   d.  Measurement of an individuals weight (or waist circumference), BP, and other routine measurements as deemed appropriate, based on the individuals medical/family history.   e.  Detection of any cognitive impairment that the individual may have as defined in this section.   f.  An update to the following: