When I first heard that the proposed health care bill from Congress (HR 3962) essentially would not take effect until 2013, I became discouraged, because many people will suffer from now until then due to lack of health insurance. However, there are some provisions in the proposed bill that would take effect immediately on passage, as explained below by the Speaker of the House:
TOP 14 PROVISIONS THAT TAKE EFFECT IMMEDIATELY
1. BEGINS TO CLOSE THE MEDICARE PART D DONUT HOLE — Reduces the donut hole by $500 and institutes a 50%discount on brand-name drugs, effective January 1, 2010.
2. IMMEDIATE HELP FOR THE UNINSURED UNTIL EXCHANGE IS AVAILABLE (INTERIM HIGH-RISK POOL) — Creates atemporary insurance program until the Exchange is available for individuals who have been uninsured for severalmonths or have been denied a policy because of pre-existing conditions.
3. BANS LIFETIME LIMITS ON COVERAGE—Prohibits health insurance companies from placing lifetime caps on coverage.
4. ENDS RESCISSIONS—Prohibits insurers from nullifying or rescinding a patient’s policy when they file a claim forbenefits, except in the case of fraud.
5. EXTENDS COVERAGE FOR YOUNG PEOPLE UP TO 27TH BIRTHDAY THROUGH PARENTS’ INSURANCE— Requires healthplans to allow young people through age 26 to remain on their parents’ insurance policy, at the parents’ choice.
6. ELIMINATES COST-SHARING FOR PREVENTIVE SERVICES IN MEDICARE—Eliminates co-payments for preventiveservices and exempts preventive services from deductibles under the Medicare program.
7. IMPROVES HELP FOR LOW-INCOME MEDICARE BENEFICIARIES—Improves the low-income protection programs inMedicare to assure more individuals are able to access this vital help.
8. PROVIDES NEW CONSUMER PROTECTIONS IN MEDICARE ADVANTAGE— Prohibits Medicare Advantage plans fromcharging enrollees higher cost-sharing for services in their private plan than what is charged in traditional Medicare.
9. IMMEDIATE SUNSHINE ON PRICE GOUGING—Discourages excessive price increases by insurance companies throughreview and disclosure of insurance rate increases.
10. CONTINUITY FOR DISPLACED WORKERS—Allows Americans to keep their COBRA coverage until the Exchange is inplace and they can access affordable coverage.
11. CREATES NEW, VOLUNTARY, PUBLIC LONG-TERM CARE INSURANCE PROGRAM—Creates a long-term care insuranceprogram to be financed by voluntary payroll deductions to provide benefits to adults who become functionally disabled.
12. HELP FOR EARLY RETIREES—Creates a $10 billon fund to finance a temporary reinsurance program to help offset thecosts of expensive health claims for employers that provide health benefits for retirees age 55-64.
13. COMMUNITY HEALTH CENTERS—Increases funding for Community Health Centers to allow for a doubling of thenumber of patients seen by the centers over the next 5 years.
14. INCREASING NUMBER OF PRIMARY CARE DOCTORS — Provides new investment in training programs to increase thenumber of primary care doctors, nurses, and public health professionals.
PREPARED BY OFFICE OF SPEAKER PELOSI – OCTOBER 29, 2009
The proposed house bill only increases the burden on medical device manufacturers by adding an excise tax on each device sold, regardless of class, and requiring the creation of a device registry for Class III devices and Class II devices that are life-supporting or life-sustaining.
ReplyDeleteExcerpts below:
SEC. 552. EXCISE TAX ON MEDICAL DEVICES.
(a) IN GENERAL.—Chapter 31 of the Internal Revenue Code of 1986 is amended by adding at the end the
following new subchapter:
‘‘Subchapter D—Medical Devices
‘‘Sec. 4061. Medical devices.
‘‘SEC. 4061. MEDICAL DEVICES.
‘‘(a) IN GENERAL.—There is hereby imposed on the
first taxable sale of any medical device a tax equal to 2.5
percent of the price for which so sold.
‘‘(b) FIRST TAXABLE SALE.—For purposes of this
section—
‘‘(1) IN GENERAL.—The term ‘first taxable
sale’ means the first sale, for a purpose other than
for resale, after production, manufacture, or importation.
(c) EFFECTIVE DATE.—The amendments made by
this section shall apply to sales (and leases and uses treated as sales) after December 31, 2012.
Another pertinent section of the bill regarding device registries, which start 36 months post-enactment:
SEC. 2571. NATIONAL MEDICAL DEVICE REGISTRY.
(a) REGISTRY.—
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•HR 3962 IH
(1) IN GENERAL.—Section 519 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360i) is
amended—
(A) by redesignating subsection (g) as sub
ection (h); and
(B) by inserting after subsection (f) the
following:
‘‘National Medical Device Registry
‘‘(g)(1)(A) The Secretary shall establish a national
medical device registry (in this subsection referred to as
the ‘registry’) to facilitate analysis of postmarket safety
and outcomes data on each covered device.
‘‘(B) In this subsection, the term ‘covered device’—
‘‘(i) shall include each class III device; and
‘‘(ii) may include, as the Secretary determines
appropriate and specifies in regulation, a class II device
that is life-supporting or life-sustaining.
‘‘(C) Notwithstanding subparagraph (B)(i), the Sec19
retary may by order exempt a class III device from the
provisions of this subsection if the Secretary concludes
that inclusion of information on the device in the registry
will not provide useful information on safety or effective
ness.
(2) EFFECTIVE DATE.—The Secretary of
Health and Human Services shall establish and
begin implementation of the registry under section
519(g) of the Federal Food, Drug, and Cosmetic
Act, as added by paragraph (1), by not later than
the date that is 36 months after the date of the enactment of this Act, without regard to whether or
not final regulations to establish and operate the
registry have been promulgated by such date.
The Patient Protection Affordable Care Act, which is the health care reform bill being considered by the Senate, imposes a tax on all Class III devices and Class II devices that are sold for no less than $100 a unit, if the company is large enough. The tax is based upon a ratio of gross sales of the company over total gross sales within the industry. Unlike the congressional bill which taxes ALL medical devices at 2.5% of sales, the Senate bill does not tax Class I medical devices or Class II medical devices that sell for less than $100 a unit at all. If a company’s aggregate gross sales from Class III devices or Class II devices selling for at least $100 is less than 5 million dollars, the company is not taxed.
ReplyDelete[There is also a user fee for pharmaceutical manufacturers, and the “Botox” tax which is imposed on the RECIPIENT of the Botox rather than the manufacturer. If the recipient of Botox doesn’t pay the tax, then the manufacturer of Botox is responsible.]
See pertinent text below for medical devices ----- Steve
SEC. 9009. IMPOSITION OF ANNUAL FEE ON MEDICAL DEVICE MANUFACTURERS AND IMPORTERS.
(a) IMPOSITION OF FEE.—
(1) IN GENERAL.—Each covered entity engaged in the business of manufacturing or importing medical devices shall pay to the Secretary not later than the annual payment date of each calendar year beginning after 2009 a fee in an amount determined
under subsection (b).
(2) ANNUAL PAYMENT DATE.—For purposes of
this section, the term ‘‘annual payment date’’ means
with respect to any calendar year the date determined by the Secretary, but in no event later than September 30 of such calendar year.
(b) DETERMINATION OF FEE AMOUNT.—
(1) IN GENERAL.—With respect to each covered
entity, the fee under this section for any calendar
year shall be equal to an amount that bears the
same ratio to $2,000,000,000 as—
(A) the covered entity’s gross receipts from medical device sales taken into account during the preceding calendar year, bear to
(B) the aggregate gross receipts of all covered entities from medical device sales taken into account during such preceding calendar
year.
(2) GROSS RECEIPTS FROM SALES TAKEN INTO
ACCOUNT.—For purposes of paragraph (1), the gross receipts from medical device sales taken into account during any calendar year with respect to
any covered entity shall be determined in accordance
with the following table:
With respect to a covered entity’s aggregate gross receipts from medical device sales during the calendar
year that are:
The percentage of
gross receipts taken
into account is:
Not more than $5,000,000 .................................... 0 percent
More than $5,000,000 but not more than
$25,000,000. 50 percent
More than $25,000,000 ......................................... 100 percent.
(3) SECRETARIAL DETERMINATION.—The Secetary shall calculate the amount of each covered en16
tity’s fee for any calendar year under paragraph (1).
In calculating such amount, the Secretary shall determine such covered entity’s gross receipts from medical device sales on the basis of reports submitted by the covered entity under subsection (f)
and through the use of any other source of information available to the Secretary.
(c) COVERED ENTITY.—
(1) IN GENERAL.—For purposes of this section,
the term ‘‘covered entity’’ means any manufacturer
or importer with gross receipts from medical device
sales.
(d) MEDICAL DEVICE SALES.—For purposes of this
section—
(1) IN GENERAL.—The term ‘‘medical device
sales’’ means sales for use in the United States of
any medical device, other than the sales of a medical
device that—
(A) has been classified in class II under
section 513 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360c) and is primarily
sold to consumers at retail for not more than
$100 per unit, or
(B) has been classified in class I under
such section.