Regulations in the US Pharmaceutical and Medical Devices Market: Ken Research
by Ashish Kumar Market ResearcherKen
research announced recent publication on, "Country Focus: Healthcare, Regulatory and
Reimbursement Landscape in US".
The report is an essential source of information on and analysis of the
healthcare, regulatory and reimbursement landscape in the US. It identifies the
key trends in the country's healthcare market and provides insights into its
demographic, regulatory, and reimbursement landscape and healthcare
infrastructure. Most importantly, the report provides valuable insights into
the trends and segmentation of its pharmaceutical and medical device markets.
It uses data and information sourced from proprietary databases, secondary
research, and in-house analysis by team of industry experts. Profiles and SWOT
analyses of the major players in the pharmaceutical market gives exceptional
market view. The effective sales and marketing strategies can be understood by
understanding the competitive landscape and analysing competitors' performance
help gain competitive advantage. It is a very useful tool to organize your
sales and marketing efforts by identifying the market categories and segments
that present the most opportunities for consolidation, investment and strategic
partnership
HEALTHCARE LANDSCAPE:
The
population of the US in 2015 was 326 million, having grown at a CAGR of 1% from
2008. In 2015, the government spent 17.5% of GDP in 2015 on medical and health
science and exported USD 32.8 billion of pharmaceutical products. These
positive growth trends can be primarily attributed to
• Availability of latest drugs and
technologies
• Universal health coverage
• Access to healthcare facilities
Major
players in the medical device market include Johnson and Johnson, GE
Healthcare, Siemens, Medtronic, and Philips Healthcare. Health care in the
United States is provided by many distinct organizations. Health care
facilities are largely owned and operated by private sector businesses. 58% of
US community hospitals are non-profit, 21% are government owned, and 21% are
for-profit. According to the World Health Organization (WHO), the United States
spent more on health care per capita, and more on health care as percentage of
its GDP, than any other nation in 2011. Health spending was paid for by the
government in 2013, funded via programs such as Medicare, Medicaid, the
Children's Health Insurance Program, and the Veterans Health Administration.
People aged under 67 acquire insurance via their or a family member's employer,
by purchasing health insurance on their own, or are uninsured. Health insurance
for public sector employees is primarily provided by the government In the U.S.
Ownership of the health care system is mainly in private hands, though federal,
state, county, and city governments also own certain facilities.
The
non-profit hospitals share of total hospital capacity has remained relatively
stable for decades. There are also privately owned for-profit hospitals as well
as government hospitals in some locations, mainly owned by county and city
governments. The Hill-Burton Act was passed in 1946, which provided federal
funding for hospitals in exchange for treating poor patients.
REGULATORY AND LICENSING LANDSCAPE:
Healthcare
is subject to extensive regulation at both the federal and the state level,
much of which "arose haphazardly". Under this system, the federal
government cedes primary responsibility to the states under the
McCarran-Ferguson Act. Essential regulation includes the licensure of health
care providers at the state level and the testing and approval of
pharmaceuticals and medical devices by the U.S. Food and Drug Administration
(FDA), and laboratory testing. These regulations are designed to protect
consumers from ineffective or fraudulent healthcare. Additionally, states
regulate the health insurance market and they often have laws which require
that health insurance companies cover certain procedures although state
mandates generally do not apply to the self-funded health care plans offered by
large employers, which exempt from state laws under pre-emption clause of the
Employee Retirement Income Security Act.
In 2010, the Patient Protection and Affordable
Care Act (PPACA) was passed by President Barack Obama and includes various new
regulations, with one of the most notable being a health insurance mandate
which requires all citizens to purchase health insurance. While not regulation
per se, the federal government also has a major influence on the healthcare
market through its payments to providers under Medicare and Medicaid, which in
some cases are used as a reference point in the negotiations between medical
providers and insurance companies. State governments maintain state health
departments, and local governments (counties and municipalities) often have
their own health departments, usually branches of the state health department.
Regulations of a state board may have executive and police strength to enforce
state health laws. In some states, all members of state boards must be health
care professionals. Members of state boards may be assigned by the governor or
elected by the state committee The McCarran–Ferguson Act, which cedes regulation
to the states, does not itself regulate insurance, nor does it mandate that
states regulate insurance. "Acts of Congress" that do not expressly
purport to regulate the "business of insurance" will not preempt
state laws or regulations that regulate the "business of insurance."
The Act also provides that federal anti-trust laws will not apply to the
"business of insurance" as long as the state regulates in that area,
but federal anti-trust laws will apply in cases of boycott, coercion, and
intimidation.
REIMBURSEMENT LANDSCAPE
The
healthcare reimbursement system is an extremely multifaceted framework of
obtaining payment for services. One of the most problematic issues is that the
“rules” governing healthcare reimbursement change frequently, with government
payers sometimes changing on a day-to-day basis. n addition, the price for the
service is not the “retail” price that the provider charges for it. Payers have
a “maximum allowed payment” for every CPT code, which is the beginning point
(not the end point) of determining what they will pay. The payer then adjusts
the maximum allowed payment with “claim edits,” which they use to disqualify
payment for some services, and “payment rules,” which usually reduce payments
for some services. The American Medical Association (AMA) describes how
payments are affected by these two rules.
Key Factors Considered in the Report
US
Healthcare Industry Research
US
Pharmaceutical Industry Research
Pharmaceutical
Market Revenue US
US
Pharmaceutical Market Imports
Export
Volume Of Pharmaceutical Products US
US
Medical Devices Market Research
Healthcare
IT Market Research US
US
Cardiovascular Device Market Future Outlook
US Orthopedic Devices Market
For
more coverage click on the link below:
Related links:
Contact Us:
Ken Research
Ankur Gupta, Head Marketing & Communications
Ankur@kenresearch.com
+91-9015378249
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